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41. Non-inferiority Trials of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine.

Non-inferiority Trials of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine. Non-inferiority Trials of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine. - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (...) (100). Please remove one or more studies before adding more. Non-inferiority Trials of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine. (aCTIVE) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov

2017 Clinical Trials

42. Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis

dose. Week 2 to Week 14: SC injection of tralokinumab maintenance dose. CYP substrates - non-investigational medicinal products: Week -1, Week 1, and Week 15: oral administration of caffeine 100 mg, warfarin sodium 5 mg x2, omeprazole 20 mg, metoprolol tartrate 100 mg, and midazolam hydrochloride 2 mg. Drug: Tralokinumab Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation (...) Frame: From Day 1 up to Week 30 ] Presence of anti-drug antibodies (yes/no) [ Time Frame: From Day 1 up to Week 30 ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout

2018 Clinical Trials

43. Emerging Drugs for Duchenne Muscular Dystrophy

regulatory approval, a major barrier to the uptake of novel therapies for DMD is likely to be cost. Furthermore, there is the possibility for some of the medications to be used in combination, which will increase the cost further. Criteria will need to be determined to establish which patients are more likely to benefit, and to identify when a drug is no longer beneficial. Administering medication to children can be challenging. Idebenone and ataluren are orally administered and require multiple daily (...) and mortality. DMD is caused by a mutation of the dystrophin gene that results in a lack of dystrophin, a protein that is necessary for muscle cell function. The mainstays of current therapy to treat DMD are corticosteroids and assistive devices. This bulletin focuses on new and emerging drugs for DMD with completed phase IIb or phase III trials and includes ataluren (nonsense mutation suppression), eteplirsen (exon 51 skipping), and idebenone (adenosine triphosphate [ATP] modulation). Ezutromid (utrophin

2017 CADTH - Issues in Emerging Health Technologies

44. Emerging Drugs for Duchenne Muscular Dystrophy

regulatory approval, a major barrier to the uptake of novel therapies for DMD is likely to be cost. Furthermore, there is the possibility for some of the medications to be used in combination, which will increase the cost further. Criteria will need to be determined to establish which patients are more likely to benefit, and to identify when a drug is no longer beneficial. Administering medication to children can be challenging. Idebenone and ataluren are orally administered and require multiple daily (...) and mortality. DMD is caused by a mutation of the dystrophin gene that results in a lack of dystrophin, a protein that is necessary for muscle cell function. The mainstays of current therapy to treat DMD are corticosteroids and assistive devices. This bulletin focuses on new and emerging drugs for DMD with completed phase IIb or phase III trials and includes ataluren (nonsense mutation suppression), eteplirsen (exon 51 skipping), and idebenone (adenosine triphosphate [ATP] modulation). Ezutromid (utrophin

2017 CADTH - Issues in Emerging Health Technologies

45. Complex surgery and perioperative systemic therapy for genitourinary cancer of the retroperitoneum

for patients with advanced or mRCC. When prescribing systemic therapy for advanced or mRCC, several key factors must be taken into account: patients are best served if the prescribing physician is an oncology specialist knowledgeable of acute and long-term toxicities, drug interactions, and monitoring of treatment and response. Patients should be managed in a multidisciplinary environment with adequate resources, including nursing care, dietary care, and pharmacy support. Patients must be evaluated (...) Complex surgery and perioperative systemic therapy for genitourinary cancer of the retroperitoneum Guideline 3-20 A Quality Initiative of the Program in Evidence-Based Care (PEBC), Cancer Care Ontario (CCO) Complex surgery and perioperative systemic therapy for genitourinary cancer of the retroperitoneum A. Finelli, N. Coakley, J. Chin, T. Flood, A. Loblaw, C. Morash, R. Shayegan, R. Siemens, and the Genitourinary Cancer Guideline Development Group Report Date: August 8, 2019 For information

2019 Cancer Care Ontario

46. Preoperative or Postoperative Therapy for the Management of Patients with Stage II or III Rectal Cancer

standard fractionation (45- 50.4Gy in 25-28 fractions) preoperative RT+/-CT should be offered postoperative CT in the absence of direct evidence for this is described in more detail in the Discussion section of the systematic review for preoperative therapy (Section 2. Part 1). ? Enteritis, diarrhea, bowel obstruction or perforation, and fibrosis within the pelvis are associated with RT. Delayed adverse effects from RT include radiation enteritis (4%), small bowel obstruction (5%), rectal stricture (5 (...) resection, sphincter preserving surgery, quality of life, acute toxicities, postoperative morbidity (within 30 days of surgery ), and late toxicities (>90 days after surgery). If no significant difference in the primary outcome of interest was demonstrated, secondary outcomes were examined to form conclusions. For the comparison of preoperative RT versus surgery alone, the studies using short-course treatments and therapy were not expected to downstage the tumour; therefore, circumferential radial

2019 Cancer Care Ontario

47. Therapies for Clinically Localized Prostate Cancer

Medical School Boston, MA Alvin Cabrera, M.D. Kaiser Permanente Seattle, WA Richard M. Hoffman, M.D., M.P.H. University of Iowa Carver College of Medicine Iowa City, IA Terrence Kungel Chairman, Emeritus of the Maine Coalition to Fight Prostate Cancer Woolwich, ME v Therapies for Clinically Localized Prostate Cancer Structured Abstract Objective. To update findings from previous Agency for Healthcare Research and Quality (AHRQ)- and American Urological Association (AUA)-funded reviews evaluating (...) Therapies for Clinically Localized Prostate Cancer Therapies for Clinically Localized Prostate Cancer Comparative Effectiveness Review Number 230 R Comparative Effectiveness Review Number 230 Therapies for Clinically Localized Prostate Cancer Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. 290-2015-0000-81 Prepared by: Minnesota Evidence-based Practice Center Minneapolis, MN

2020 Effective Health Care Program (AHRQ)

48. Cannabidiol (Epidyolex) - As adjunctive therapy of seizures associated with  Dravet syndrome (DS) in conjunction with clobazam, for patients 2 years of age and older.

Cannabidiol (Epidyolex) - As adjunctive therapy of seizures associated with  Dravet syndrome (DS) in conjunction with clobazam, for patients 2 years of age and older. 1 Published 7 September 2020 1 SMC2262 cannabidiol 100mg/ml oral solution (Epidyolex®) GW Research Ltd 7 August 2020 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised (...) that was inadequately controlled by other anti-epileptic drugs. This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting. Chairman Scottish Medicines Consortium www.scottishmedicines.org.uk 2 Indication For use as adjunctive therapy of seizures

2020 Scottish Medicines Consortium

49. Nutrition Therapy in the Patient with COVID-19 Disease Requiring ICU Care

Nutrition Therapy in the Patient with COVID-19 Disease Requiring ICU Care 1 Nutrition Therapy in the Patient with COVID-19 Disease Requiring ICU Care Updated April 1, 2020 Robert Martindale, PhD, MD –Professor of Surgery, Department of Surgery, Oregon Health and Science University, Portland Oregon Jayshil J. Patel MD– Associate Professor of Medicine, Division of Pulmonary & Critical Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin Beth Taylor DCN, RD-AP- Research Scientist (...) (Specialized Pro-resolving Mediators) seem to be the active participant. Currently with only animal data and a few human trials, inadequate specific human trials are available to make this a formal recommendation. While theoretical benefits are described with other types of formulas to enhance tolerance (small peptide/MCT oil formulas), failure to improve outcome in a similar population of patients in a medical ICU does not warrant their Nutrition Therapy in the Patient with COVID-19 Disease Requiring ICU

2020 American Society for Parenteral and Enteral Nutrition

50. Therapy for Stage IV Non-Small Cell Lung Cancer without Driver Alterations

Center at Johns Hopkins University, Baltimore, MD 6 Juravinski Cancer Centre, Hamilton, Ontario, Canada 7 University of Colorado School of Medicine, Denver, CO 8 Banner MD Anderson Cancer Center, Greeley, CO 9 Affiliated Oncologists, Chicago Ridge, IL 10 Lahey Hospital and Medical Center, Burlington, MA 11 Norton Cancer Institute, Louisville, KY 12 William Beaumont Hospital, Royal Oak, MI 13 University of Texas Southwestern Medical Center, Dallas, TX 14 Princess Margaret Cancer Centre, University (...) Health Network, Toronto, Ontario, Canada 15 City of Hope, City of Duarte, CA 16 Memorial Sloan Kettering Cancer Center, New York, NY 17 Kingston General Hospital, School of Medicine, Queen’s University, Ontario, Canada 18 Catalan Institute of Oncology, Barcelona, Spain 19 Inova Schar Cancer Institute, Falls Church, VA 20 Postgraduate Institute of Medical Education and Research, Chandigarh, India 21 Sarah Cannon Research Institute, Nashville, TN 22 Patient advocate 23 Circle of Hope for Cancer

2020 American Society of Clinical Oncology Guidelines

51. Eluxadoline for treating irritable bowel syndrome with diarrhoea

Evidence 6 4 Committee discussion 7 Nature of the condition 7 Current practice 7 Clinical effectiveness 9 Cost effectiveness 11 Cost-effectiveness results 15 Innovation 16 Pharmaceutical Price Regulation Scheme 2014 16 Conclusion 16 Summary of appraisal committee's key conclusions 17 5 Implementation 22 6 Appraisal committee members and NICE project team 23 Appraisal committee members 23 NICE project team 23 Eluxadoline for treating irritable bowel syndrome with diarrhoea (TA471) © NICE 2018. All (...) , and it is started in secondary care. 1.2 Stop eluxadoline at 4 weeks if there is inadequate relief of the symptoms of irritable bowel syndrome with diarrhoea. 1.3 These recommendations are not intended to affect treatment with eluxadoline that was started in the NHS before this guidance was published. Adults having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

52. Efficacy and safety of paclitaxel with or without targeted therapy as second-line therapy in advanced gastric cancer: A meta-analysis. Full Text available with Trip Pro

the databases of PubMed, Embase, Web of Science and the Cochrane Library published between January 2000 and August 2019. Only randomized controlled trials were eligible. Statistical analysis was performed by meta-analysis. The primary end points were progression-free survival and overall survival, objective response rate and adverse events were the secondary end points.A total of 4 randomized controlled trials with 1574 patients (PTX + targeted therapy, n = 786; PTX, n = 788) were included for the final (...) significant differences were observed in the incidences of grade 3 to 5 anemia, decreased appetite, nausea, diarrhea and abdominal pain between the two treatments (P >.05).Second-line PTX+targeted therapy is a more effective treatment option with tolerable safety profile for advanced gastric cancer as a result of improved survival, though with additional toxicity.

2020 Medicine

53. Comparison of oral rehydration therapies in acute diarrhoea: A network meta-analysis of randomized clinical trials

Comparison of oral rehydration therapies in acute diarrhoea: A network meta-analysis of randomized clinical trials Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Email salutation (e.g. "Dr Smith" or "Joanne") for correspondence (...) by full-text screening of the eligible articles for final inclusion. In each phase, 2 observers will independently assess each article. Discrepancies will be resolved through discussion, or by consulting a third investigator. ">Procedure for study selection Example : Title-abstract screening: 1. Not an original full research paper (e.g. review, editorial) 2. Not an in vivo animal study 3. No metastases/ only primary tumor 4. No control group 5. Combination therapy or contamination 6. Not about

2018 PROSPERO

54. CAR T-cell therapy: a summary of evidence

frameworks are in place, or under consideration, for the delivery of CAR T-cell therapy? Regulatory approvals At the time of writing, regulatory approvals of two CAR T-cell therapies have been granted by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Health Canada (see Appendix 5). The US was the first to approve two CAR T-cell therapies for two indications: tisagenlecleucel (Kymriah, Novartis) received FDA approval in August 2017 for adults with relapsed or refractory (...) -cell therapy 30, 31, 34, 35, 42, 47, 52 • Large number of early stage, single-arm trials in small populations, and with short follow-up • Lack of familiarity with regulatory processes for those developing the treatments (more often universities or non-commercial bodies rather than pharmaceutical companies). 32 A report by CADTH looked at all medicines approved under a number of EMA, FDA and Health Canada special designations and indicated that CAR T-cell therapies have so far been eligible

2018 Sax Institute Evidence Check

55. Drug interventions for the treatment of obesity in children and adolescents. Full Text available with Trip Pro

effects of any pharmacological intervention are comprehensively assessed. Adverse events should be reported in a more standardised manner specifying amongst other things the number of participants experiencing at least one adverse event. The requirement of regulatory authorities (US Food and Drug Administration and European Medicines Agency) for trials of all new medications to be used in children and adolescents should drive an increase in the number of high quality trials. (...) of eating disorders or type 2 diabetes, or included participants with a secondary or syndromic cause of obesity. In addition, we excluded trials which included growth hormone therapies and pregnant participants.Two review authors independently assessed trial quality and extracted data following standard Cochrane methodology. Where necessary we contacted authors for additional information.We included 21 trials and identified eight ongoing trials. The included trials evaluated metformin (11 trials

2016 Cochrane

56. Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn's disease. Full Text available with Trip Pro

Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn's disease. The prevention of relapse is a major issue in the management of Crohn's disease. Corticosteroids, the mainstay of treatment of acute exacerbations, are not effective for maintenance of remission and its chronic use is limited by numerous adverse events. Randomised controlled trials assessing the efficacy of oral 5-aminosalicylic acid (5-ASA) agents for maintenance of medically-induced remission (...) in Crohn's disease have produced conflicting results.To conduct a systematic review to evaluate the efficacy and safety of oral 5-ASA agents for the maintenance of medically-induced remission in Crohn's disease.We searched MEDLINE, EMBASE, CENTRAL and the IBD Group Specialized Register from inception to 8 June 2016. We also searched reference lists and conference proceedings.We included randomised controlled trials that compared oral 5-ASA agents to either placebo or sulphasalazine in patients

2016 Cochrane

57. Drugs for multiple sclerosis - Drug Facts Box for Fingolimod

for? 1 To improve the symptoms of highly active relapsing remitting multiple sclerosis (as a disease-modifying therapy) Who is this drug for? 1 Adults with high disease activity despite treatment with a beta-interferon Adults with rapidly evolving severe relapsing remitting multiple sclerosis Who should not be taking this drug? 1 Patients under age 18 Patients with severe hepatic impairment Patients with high risk of infections or active infections, or malignancies 3 How is this drug administered? 1 (...) Orally as a capsule What dose of this drug is administered? 1 One 0.5 mg tablet How often is this drug administered? 1 Once daily What is the cost of this drug? One 28-tablet pack, sufficient for one patient for one month, costs £1,470 What are the adverse reactions associated with this drug? 1 Most commonly: influenza viral infections, headache, cough, diarrhoea, back pain, raised alanine transaminase Licensing timeline Launched in the UK in March 2011 Other information: Treatment with fingolimod

2013 West Midlands Clinical Support Unit

58. Liposomal formulation of daunorubicin & cytarabine (Vyxeos) - treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (AML) or AML with myelodysplasia-related changes

Liposomal formulation of daunorubicin & cytarabine (Vyxeos) - treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (AML) or AML with myelodysplasia-related changes Published 11 March 2019 1 SMC2130 liposomal formulation of daunorubicin/cytarabine 44mg/100mg powder for concentrate for solution for infusion (Vyxeos®) Jazz Pharmaceuticals UK Ltd 8 February 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS (...) Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission assessed under the end of life and ultra-orphan medicine process liposomal formulation of daunorubicin/cytarabine (Vyxeos ® ) is accepted for use within NHSScotland. Indication under review: The treatment of adults with newly diagnosed, therapy- related acute myeloid leukaemia (AML) or AML with myelodysplasia-related changes.In a randomised phase

2019 Scottish Medicines Consortium

59. Guidelines for the investigation of chronic diarrhoea in adults

to appraise the quality of evidence and grading of recommendations. These guidelines deal with clinical assessment in primary and secondary care of a patient with diar- rhoea, the exclusion of cancer or inflammation, and detecting common disorders such as bile acid diar- rhoea, microscopic colitis, lactose malabsorption or post radiation diarrhoea, together with rarer causes of malabsorption and surgical disorders as outlined in figure 1. Options for therapy are not dealt with as it is beyond the remit (...) of recommendation strong). group.bmj.com on April 16, 2018 - Published by http://gut.bmj.com/ Downloaded from 15 Arasaradnam RP , et al. Gut 2018;0:1–20. doi:10.1136/gutjnl-2017-315909 Guidelines after surgery but can also be seen after radiotherapy, in Crohn’s disease and secondary to some medications. 226 Small and large bowel resection clearly reduces absorptive capacity. At the extreme, this results in short bowel syndrome characterised clinically by chronic diarrhoea, dehydration, elec- trolyte

2018 British Society of Gastroenterology

60. Preventive effect of kampo medicine (hangeshashin-to, TJ-14) plus minocycline against afatinib-induced diarrhea and skin rash in patients with non-small cell lung cancer Full Text available with Trip Pro

TJ-14 (7.5 g/day) and minocycline (100 mg/day) were administered simultaneously from the start of afatinib administration. The primary end point was the incidence of ≥ grade 3 (G3) diarrhea (increase of ≥7 stools/day over baseline) during the first 4 weeks of treatment. The secondary end points were the incidence of ≥ G3 oral mucositis (severe pain interfering with oral intake) and $ G3 skin toxicity (severe or medically significant but not immediately life-threatening).A total of 29 patients (...) Preventive effect of kampo medicine (hangeshashin-to, TJ-14) plus minocycline against afatinib-induced diarrhea and skin rash in patients with non-small cell lung cancer Diarrhea and oral mucositis induced by afatinib can cause devastating quality of life issues for patients undergoing afatinib treatment. Several studies have shown that hangeshashin-to (TJ-14) might be useful for chemotherapy-induced diarrhea and oral mucositis. In this study, we investigated the prophylactic effects of TJ-14

2017 OncoTargets and therapy

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