Study Protocol Phase II clinical trial testing the safety and efficacy of
... refine and standardize MDMA-assisted psychotherapy for PTSD patients. If results of both of these pilot studies, plus another small pilot study to be conducted in Israel, are promising, the data gathered will be used to inform the design of two large (N= at least 280) multi-site Phase III studies of ...
... refine and standardize MDMA-assisted psychotherapy for PTSD patients. If results of both of these pilot studies, plus another small pilot study to be conducted in Israel, are promising, the data gathered will be used to inform the design of two large (N= at least 280) multi-site Phase III studies of ...
Agonists for Sedation in Pediatric Critical Care: A Systematic Review
... of sedative drug efficacy (18). The reduction in opioid consumption is a conveniently captured outcome and widely reported throughout included studies. Yet, it does not address therapeutic advantage conferred by the administration of α2 agonists other than lessening exposure to other potentially har ...
... of sedative drug efficacy (18). The reduction in opioid consumption is a conveniently captured outcome and widely reported throughout included studies. Yet, it does not address therapeutic advantage conferred by the administration of α2 agonists other than lessening exposure to other potentially har ...
AusPAR Attachment 2: Extract from the Clinical Evaluation Report
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
Systematic Review of Treatment for Amphetamine
... wide spread of amphetamine dependence and abuse. During the phase of chronic, high-dose consumption of amphetamines, many amphetamine users may have the experience of paranoia and hallucination. In addition, amphetamine withdrawal has been less studied although it is a common problem with a prevalen ...
... wide spread of amphetamine dependence and abuse. During the phase of chronic, high-dose consumption of amphetamines, many amphetamine users may have the experience of paranoia and hallucination. In addition, amphetamine withdrawal has been less studied although it is a common problem with a prevalen ...
Paracetamol versus placebo or physical methods for treating fever in
... cytokines produced by white blood cells. Experts suggest that cytokines act on the centre in the brain that regulates temperature (thermoregulatory centre) to initiate the physiological responses that result in fever (Kwiatkowski 1995). Fever also increases the rate at which the body uses its energy ...
... cytokines produced by white blood cells. Experts suggest that cytokines act on the centre in the brain that regulates temperature (thermoregulatory centre) to initiate the physiological responses that result in fever (Kwiatkowski 1995). Fever also increases the rate at which the body uses its energy ...
VA/DoD CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF DYSLIPIDEMIA
... Most NCEP recommendations are consensus statements designed to guide the broad clinical field of dyslipidemia. Many of the recommendations are based on observational studies with rational inferences based on biologic plausibility. Clinical practice guidelines have to guide practical decision-making ...
... Most NCEP recommendations are consensus statements designed to guide the broad clinical field of dyslipidemia. Many of the recommendations are based on observational studies with rational inferences based on biologic plausibility. Clinical practice guidelines have to guide practical decision-making ...
Establish the Maximum Tolerated Dose in Phase 1 Trials Using the 3+3 Method
... Phase-I trials are the first stage of testing experimental drugs/treatments in human subjects where an attempt is made to establish the dose range tolerated by volunteers for single or multiple doses and to determine whether a drug is safe to check for efficacy. Phase-I trials often include healthy ...
... Phase-I trials are the first stage of testing experimental drugs/treatments in human subjects where an attempt is made to establish the dose range tolerated by volunteers for single or multiple doses and to determine whether a drug is safe to check for efficacy. Phase-I trials often include healthy ...
Phase II clinical trial testing the safety and efficacy
... PTSD. MAPS' Clinical Plan (Doblin 2002) will require at least 5 years and will involve at least 600 subjects. Specific Hypotheses The proposed study is intended to test whether MDMA-assisted psychotherapy can be safely administered to people with treatment-resistant PTSD or veterans with PTSD sympto ...
... PTSD. MAPS' Clinical Plan (Doblin 2002) will require at least 5 years and will involve at least 600 subjects. Specific Hypotheses The proposed study is intended to test whether MDMA-assisted psychotherapy can be safely administered to people with treatment-resistant PTSD or veterans with PTSD sympto ...
a PDF of this supplement
... 30-day, 12-month, and 3-year results of the Valiant Stent Graft in patients with thoracic aortic aneurysms. This was a prospective, nonrandomized, pivotal trial at 24 sites in the United States that enrolled a total of 160 patients. Technical success was achieved in 96.3% of patients being treated. ...
... 30-day, 12-month, and 3-year results of the Valiant Stent Graft in patients with thoracic aortic aneurysms. This was a prospective, nonrandomized, pivotal trial at 24 sites in the United States that enrolled a total of 160 patients. Technical success was achieved in 96.3% of patients being treated. ...
highlights of prescribing information
... Women of childbearing potential and men must use at least two forms of effective contraception during treatment and for at least 6 months after treatment has concluded. One of these forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone. Oral co ...
... Women of childbearing potential and men must use at least two forms of effective contraception during treatment and for at least 6 months after treatment has concluded. One of these forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone. Oral co ...
Benzoyl Peroxide Cleansers for the Treatment of Acne Vulgaris: Status D
... The ability of BPO gels to reduce acne lesion counts and suppress P acnes is well-established.1,2 However, the ability of specific BPO cleansers to produce true clinical benefit by suppressing P acnes, reducing acne lesion counts, and providing additional benefit when used in combination with other ...
... The ability of BPO gels to reduce acne lesion counts and suppress P acnes is well-established.1,2 However, the ability of specific BPO cleansers to produce true clinical benefit by suppressing P acnes, reducing acne lesion counts, and providing additional benefit when used in combination with other ...
Radius Health, Inc. - Nasdaq`s INTEL Solutions
... otherwise). The Corporation shall cooperate with each Holder in supplying such information as may be necessary for such holder to complete and file any information reporting forms presently or hereafter required by the Commission as a condition to the availability of an exemption from the Securities ...
... otherwise). The Corporation shall cooperate with each Holder in supplying such information as may be necessary for such holder to complete and file any information reporting forms presently or hereafter required by the Commission as a condition to the availability of an exemption from the Securities ...
Cough/Cold Medications - PAXpress
... NOTE: Claims for cough and cold products for clients less than 2 years of age are not covered by Texas Medicaid. Prior authorization for these agents will not be accepted. Table C Drugs Requiring Prior Authorization for Children ≥ 2 to < 10 Years of Age ...
... NOTE: Claims for cough and cold products for clients less than 2 years of age are not covered by Texas Medicaid. Prior authorization for these agents will not be accepted. Table C Drugs Requiring Prior Authorization for Children ≥ 2 to < 10 Years of Age ...
AusPAR: Brentuximab vedotin
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
... The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. ...
Use of 5 -Reductase Inhibitors for Prostate Cancer
... important to note that guidelines cannot always account for individual variation among patients. Guidelines are not intended to supplant physician judgment with respect to particular patients or special clinical situations and cannot be considered inclusive of all proper methods of care or exclusive ...
... important to note that guidelines cannot always account for individual variation among patients. Guidelines are not intended to supplant physician judgment with respect to particular patients or special clinical situations and cannot be considered inclusive of all proper methods of care or exclusive ...
Product Monograph Template - Standard - GlaxoSmithKline
... aqueous nasal spray) therapy is not achieved until 2 to 3 days of treatment have been completed. Treatment of seasonal rhinitis should, if possible, start before the exposure to allergens. Although FLONASE® will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summe ...
... aqueous nasal spray) therapy is not achieved until 2 to 3 days of treatment have been completed. Treatment of seasonal rhinitis should, if possible, start before the exposure to allergens. Although FLONASE® will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summe ...
HIGHLIGHTS OF PRESCRIBING INFORMATION These
... WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs in combination with other antiretrovirals [see Warning ...
... WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs in combination with other antiretrovirals [see Warning ...
Pharmaceutical Administration and Regulations in Japan
... http://www.jpma.or.jp/about/issue/gratis/index2.html (Japanese) http://www.jpma.or.jp/english/parj/1003.html (English) ...
... http://www.jpma.or.jp/about/issue/gratis/index2.html (Japanese) http://www.jpma.or.jp/english/parj/1003.html (English) ...
FLONASE (fluticasone propionate) Nasal Spray, 50 mcg
... 3 trials for 6 months of open-label treatment. Two of these trials demonstrated that patients treated with FLONASE Nasal Spray at a dosage of 100 mcg twice daily exhibited statistically significant decreases in TNSS compared with patients treated with vehicle. Individualization of Dosage: Patients s ...
... 3 trials for 6 months of open-label treatment. Two of these trials demonstrated that patients treated with FLONASE Nasal Spray at a dosage of 100 mcg twice daily exhibited statistically significant decreases in TNSS compared with patients treated with vehicle. Individualization of Dosage: Patients s ...
Topic
... reproducibility of specific amyloid PET acquisition procedures and protocols under standardized conditions, which must be established separately for each amyloid tracer and must be applicable to the range of PET instrumentation in common use. In addition, the implementation of amyloid PET requires a ...
... reproducibility of specific amyloid PET acquisition procedures and protocols under standardized conditions, which must be established separately for each amyloid tracer and must be applicable to the range of PET instrumentation in common use. In addition, the implementation of amyloid PET requires a ...
Trastuzumab in the adjuvant setting: a practical review
... the full exploitation of its clinical potential [21] . Cardiac dysfunction has been associated with trastuzumab use. Prior exposure or concomitant administration with anthracyclines significantly increases the risk of developing cardiac dysfunc‑ tion during trastuzumab treatment [11] . Although tra ...
... the full exploitation of its clinical potential [21] . Cardiac dysfunction has been associated with trastuzumab use. Prior exposure or concomitant administration with anthracyclines significantly increases the risk of developing cardiac dysfunc‑ tion during trastuzumab treatment [11] . Although tra ...
MINISTRY OF EDUCATION AND SCIENCE KYRGYZ REPUBLIC
... 42. Interpretation of results radioisotope study of the kidneys. 43. Interpretation of results of renal biopsy. 44. Inspection and palpation of the thyroid gland 45. Interpretation of the results of radioisotope studies of thyroid cancer. 46. Interpretation of biochemical blood tests results. 47. Re ...
... 42. Interpretation of results radioisotope study of the kidneys. 43. Interpretation of results of renal biopsy. 44. Inspection and palpation of the thyroid gland 45. Interpretation of the results of radioisotope studies of thyroid cancer. 46. Interpretation of biochemical blood tests results. 47. Re ...
Collecting Empirical Physician Time Data
... EHRs is difficult because EHR systems vary and are not consistently employed across departments within a single health system. Fifth, EHR data are likely to be available only for certain types of services and not for others (e.g., office-based procedures or tests), and direct observation is more fea ...
... EHRs is difficult because EHR systems vary and are not consistently employed across departments within a single health system. Fifth, EHR data are likely to be available only for certain types of services and not for others (e.g., office-based procedures or tests), and direct observation is more fea ...
Full Report - NIHR Journals Library
... Secondly, the HTA Programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour. Thirdly, through its Technology Assessment Report (TAR) call-off contract, the HTA Programme commissions ...
... Secondly, the HTA Programme provides grants for clinical trials for researchers who identify research questions. These are assessed for importance to patients and the NHS, and scientific rigour. Thirdly, through its Technology Assessment Report (TAR) call-off contract, the HTA Programme commissions ...
Product Monograph Template - Standard
... The safety and efficacy of AERIUS DUAL ACTION 12 HOUR has not been established in patients with impaired hepatic function, and there are insufficient data to give adequate dose recommendations. The combination product is not recommended for use in patients with impaired hepatic function (See ACTION ...
... The safety and efficacy of AERIUS DUAL ACTION 12 HOUR has not been established in patients with impaired hepatic function, and there are insufficient data to give adequate dose recommendations. The combination product is not recommended for use in patients with impaired hepatic function (See ACTION ...