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Diarrhea Secondary to Medications

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81. Etelcalcetide for treating secondary hyperparathyroidism

discussion 7 Clinical effectiveness 7 Cost effectiveness 11 Equality issues 14 Pharmaceutical Price Regulation Scheme (PPRS) 2014 14 Summary of appraisal committee's key conclusions 15 5 Implementation 21 6 Appraisal committee members and NICE project team 22 Appraisal committee members 22 NICE project team 22 Etelcalcetide for treating secondary hyperparathyroidism (TA448) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page (...) Etelcalcetide is indicated for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on haemodialysis. Adv Adverse erse reactions reactions Very common adverse reactions with etelcalcetide are decreased blood calcium, muscle spasms, diarrhoea, nausea and vomiting. For full details of adverse reactions and contraindications, see the summary of product characteristics. Recommended Recommended dose and dose and schedule schedule The recommended initial dose of etelcalcetide is 5

2017 National Institute for Health and Clinical Excellence - Technology Appraisals

82. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. Full Text available with Trip Pro

, double-blind study of abemaciclib/placebo (150 mg twice daily, continuous) plus nonsteroidal AI (1 mg anastrozole or 2.5 mg letrozole, daily). A total of 493 postmenopausal women with HR+, HER2- ABC with no prior systemic therapy in this setting were enrolled. The primary endpoint was investigator-assessed PFS (final analysis after 240 events); other endpoints included response and safety evaluations. Here we analyze the final PFS data and update secondary endpoints. The abemaciclib arm had (...) MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. At the MONARCH 3 interim analysis, abemaciclib plus a nonsteroidal aromatase inhibitor (AI) significantly improved progression-free survival (PFS) and objective response rate (ORR) with a tolerable safety profile as initial treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). MONARCH 3 is a randomized, phase III

2019 NPJ breast cancer Controlled trial quality: predicted high

83. Pattern of Rash, Diarrhea, and Hepatic Toxicities Secondary to Lapatinib and Their Association With Age and Response to Neoadjuvant Therapy: Analysis From the NeoALTTO Trial. Full Text available with Trip Pro

Pattern of Rash, Diarrhea, and Hepatic Toxicities Secondary to Lapatinib and Their Association With Age and Response to Neoadjuvant Therapy: Analysis From the NeoALTTO Trial. We investigated the pattern of rash, diarrhea, and hepatic adverse events (AEs) secondary to lapatinib and their association with age and pathologic complete response (pCR) in the Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (NeoALLTO) phase III trial.Patients with HER2-positive early breast cancer were (...) assigned to arms A and C were eligible (n = 306). Younger patients (≤ 50 years) experienced significantly more rash compared with older patients (74.4% v 47.9%; P < .0001). Diarrhea and hepatic AEs were observed in 78.8% and 41.2% of patients, respectively, with no differences in rate or severity or time of onset according to age. Early rash (ie, before starting paclitaxel) was independently associated with a higher chance of pCR, mainly in patients older than 50 years (odds ratio [OR] = 3.76; 95% CI

2013 Journal of Clinical Oncology Controlled trial quality: uncertain

84. Oral Phage Therapy of Acute Bacterial Diarrhea With Two Coliphage Preparations: A Randomized Trial in Children From Bangladesh. Full Text available with Trip Pro

Oral Phage Therapy of Acute Bacterial Diarrhea With Two Coliphage Preparations: A Randomized Trial in Children From Bangladesh. Antibiotic resistance is rising in important bacterial pathogens. Phage therapy (PT), the use of bacterial viruses infecting the pathogen in a species-specific way, is a potential alternative.T4-like coliphages or a commercial Russian coliphage product or placebo was orally given over 4 days to Bangladeshi children hospitalized with acute bacterial diarrhea. Safety (...) children, but the titers did not show substantial intestinal phage replication (secondary microbiology outcome). 60% of the children suffered from a microbiologically proven E. coli diarrhea; the most frequent diagnosis was ETEC infections. Bacterial co-pathogens were also detected. Half of the patients contained phage-susceptible E. coli colonies in the stool. E. coli represented less than 5% of fecal bacteria. Stool ETEC titers showed only a short-lived peak and were otherwise close

2016 EBioMedicine Controlled trial quality: uncertain

85. Truberzi (eluxadoline) - for the treatment of adults who have irritable bowel syndrome with diarrhoea

index BSS Bristol Stool Scale CHMP Committee for Medicinal Products for Human Use Cmax maximum observed plasma concentration CNS central nervous system CSR clinical study report EMA European Medicines Agency EU European Union FDA US Food and Drug Administration GERD gastroesophageal reflux disease GI gastrointestinal IBS irritable bowel syndrome IBS-d diarrhea-predominant irritable bowel syndrome IBS-m irritable bowel syndrome, where a mixture of constipation and diarrhea is predominant IBS-QoL (...) Truberzi (eluxadoline) - for the treatment of adults who have irritable bowel syndrome with diarrhoea 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 21 July 2016 EMA/549473/2016 Committee for Medicinal Products for Human Use

2016 European Medicines Agency - EPARs

86. Partial seizures in children and young people with epilepsy: zonisamide as adjunctive therapy

published an evidence summary on zonisamide monotherapy for treating partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy in April 2013 (ESNM17). This evidence summary is based on a phase III double-blind RCT that assessed the efficacy and safety of adjunctive zonisamide therapy in 207 children and young people with partial epilepsy (Guerrini et al. 2013). This trial was the main efficacy study assessed by the European Medicines Agency when a licence (...) . The death was considered to be possibly treatment related: the young person (a 14-year-old male) experienced weight loss and diarrhoea which weakened their general condition to such an extent they were unable to take their anti-epileptic medications. This triggered a fatal episode of status Partial seizures in children and young people with epilepsy: zonisamide as adjunctive therapy (ESNM37) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions

2014 National Institute for Health and Clinical Excellence - Advice

87. Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial (Abstract)

Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial VEGF and VEGF receptor 2 (VEGFR-2)-mediated signalling and angiogenesis can contribute to the pathogenesis and progression of gastric cancer. We aimed to assess whether the addition of ramucirumab, a VEGFR-2 antagonist monoclonal antibody, to first-line chemotherapy improves outcomes (...) a central review of CT scans. Overall survival was a key secondary endpoint. This study is registered with ClinicalTrials.gov, number NCT02314117.Between Jan 28, 2015, and Sept 16, 2016, 645 patients were randomly assigned to receive ramucirumab plus fluoropyrimidine and cisplatin (n=326) or placebo plus fluoropyrimidine and cisplatin (n=319). Investigator-assessed progression-free survival was significantly longer in the ramucirumab group than the placebo group (hazard ratio [HR] 0·753, 95% CI 0·607-0

2019 EvidenceUpdates

88. Acute diarrhoea in children: racecadotril as an adjunct to oral rehydration

primary care. The majority of children in the UK recover from acute diarrhoea without treatment or by using ORS solution alone. Although adjunctive therapy with racecadotril appears to be effective and well tolerated, it is unclear which children would benefit from it and whether it is cost effective. A UK cost-effectiveness analysis (Rautenberg et al. 2012) has been published. It is not discussed here because cost-effectiveness analyses are outside the scope for Evidence summaries: new medicines (...) manage an episode of acute diarrhoea affecting their child at home, and in some cases without seeking professional advice. However, many parents and carers do seek advice from healthcare professionals. In a UK study (Armon et al. 2001), diarrhoeal illness accounted for 16% of medical presentations to a major paediatric accident and emergency department. The NICE clinical guideline on diarrhoea and vomiting in children under 5 advises that the usual duration of diarrhoea is 5–7 days and in most

2013 National Institute for Health and Clinical Excellence - Advice

89. Acute diarrhoea in adults: racecadotril

and gastroenteritis, particularly in frail and older people. The British national formulary (BNF) advises that antimotility drugs may be used to relieve symptoms of uncomplicated acute diarrhoea in adults; it may also be necessary to use oral rehydration salt (ORS) solution. Faecal incontinence: the management of faecal incontinence in adults (NICE clinical guideline 49) advises that antidiarrhoeal medication should be offered to people with faecal incontinence associated with loose stools once other causes (...) (such as excessive laxative use, dietary factors and other medication) have been excluded. The BNF advises that antispasmodics are occasionally of value in treating abdominal cramp associated with diarrhoea but they should not be used for primary treatment. Antibacterial drugs are generally unnecessary in simple gastroenteritis because the complaint usually resolves quickly Acute diarrhoea in adults: racecadotril (ESNM11) © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk

2013 National Institute for Health and Clinical Excellence - Advice

90. Diarrhoea - antibiotic associated

— for example, among other elderly residents in a care or nursing home. Stop any antibiotics not being used for treating C. difficile infection, if this is appropriate. Seek specialist advice if this is not possible and the diarrhoea is severe. Manage fluid loss as for acute gastroenteritis (for further information see , in the CKS topic on ). Avoid the use of antimotility drugs (such as loperamide) to treat diarrhoeal symptoms. If possible, avoid other drugs with anti-peristaltic effects (such as opioids (...) and meta-analyses Drugs and Therapeutics Bulletin (2019) Comparison of antibiotics for Clostridium difficile infection. British Medical Journal. [ ] Primary evidence No new randomized controlled trials published in the major journals since 1 January 2019. New policies New policies No new policies since 1 January 2019. New safety alerts New safety alerts No new safety alerts since 1 January 2019. Changes in product availability Changes in product availability No changes in product availability since 1

2019 NICE Clinical Knowledge Summaries

91. Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs

an alternative biologic therapy; Patients switching to a biosimilar (or starting a new cycle with the equivalent legacy drug), successfully completed and exited a previous course of therapy with the equivalent legacy drug. Exclusion Criteria: Under 18 years of age No clinical diagnosis of inflammatory rheumatic disease (either RA or AS), or IBD (CD or UC) Refused to participate or sign informed consent Contacts and Locations Go to Information from the National Library of Medicine To learn more about (...) and worldwide there is a need for updated independent real-world comparative effectiveness and safety data related to biologic drugs including biosimilar drugs. Biosimilar drugs hold potential to improve access to needed therapies at reduced cost enabling savings to be reallocated to other needs. However updated real-world evidence on comparative effectiveness and safety of biosimilar drugs is lacking. Investigators aim to demonstrate feasibility of creating network of clinical cohorts and other resources

2018 Clinical Trials

92. Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint Full Text available with Trip Pro

Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint Alosetron is approved to treat women with severe IBS and diarrhea (IBS-D) who have failed standard therapy. In our study, we aimed to evaluate alosetron efficacy using new US Food and Drug Administration (FDA) endpoints and utilization in clinical practice.This prospective, open-label, multicenter, observational 12-week study (...) evaluated women with severe IBS-D enrolled in the alosetron prescribing program. The coprimary FDA endpoints were changes from baseline in stool consistency and abdominal pain severity. Responders achieved a 30% decrease compared with baseline in weekly average of the worst abdominal pain in the past 24 h, and a 50% or greater reduction from baseline in the number of days/week with at least one stool of type 6 (mushy) or type 7 (watery) consistency. Secondary endpoints included changes from baseline

2018 Therapeutic advances in gastroenterology

93. Clinical and microbiologic efficacy of the piperazine-based drug lead MMV665917 in the dairy calf cryptosporidiosis model Full Text available with Trip Pro

of diarrhea. Furthermore, even though all animals received intensive supportive care, there was a strong trend towards improved secondary health outcomes, including general health, appetite, and dehydration measures amongst treated animals. These data establish MMV665917 as an outstanding lead compound for Cryptosporidium drug development. (...) Clinical and microbiologic efficacy of the piperazine-based drug lead MMV665917 in the dairy calf cryptosporidiosis model Cryptosporidiosis causes life-threatening diarrhea in infants, but the best available treatment is only modestly efficacious. Rodents infected with relevant Cryptosporidium species do not develop diarrhea, which complicates drug development. Cryptosporidium parvum infection of dairy calves, however, causes an illness like that seen in infants. Here, the clinical

2018 PLoS neglected tropical diseases

94. Demethylated Drug in the Treatment of Nasopharyngeal Carcinoma

Collaborator: Guilin Hospital of Traditional Chinese Medicine Information provided by (Responsible Party): Wei Jiang, Guilin Medical University, China Study Details Study Description Go to Brief Summary: The study is to observe the efficacy and toxicity of demethylating drug decitabine and cisplatin induced chemotherapy for 3 cycles followed by concurrent chemoradiotherapy in the treatment of regionally advanced nasopharyngeal carcinoma,followed up for 2 years, observing the 2-year survival rate (...) chemoradiotherapy Drug: Demethylated drug decitabine Induced treatment by demethylating drug decitabine 7mg/m2 d1-5 and cisplatin 80mg/m2 d1 for 3 cycles to regionally advanced nasopharyngeal carcinoma followed by concurrent chemoradiotherapy with cisplatin 80mg/m2 d1 for 3 cycles. Outcome Measures Go to Primary Outcome Measures : Progression-free survival [ Time Frame: 2 years ] The time from the first day of therapy to death or last follow-up Secondary Outcome Measures : Overall survival [ Time Frame: 2 years

2018 Clinical Trials

95. Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis

will be explored in secondary outcomes (from patient and programme perspective). The trial will evaluate the TRUNCATE-TB Management Strategy with 4 potential boosted regimens (180 per arm, total 900 with the standard TB management strategy arm). The boosted regimens include new drugs (licensed drugs, repurposed from other indications) and optimized doses of standard drugs, selected based on consideration of maximal sterilising effect, absence of drug-drug interactions, as well as safety and tolerability over (...) : This study uses a multi-arm, multi-stage (MAMS) parallel study design Masking: None (Open Label) Primary Purpose: Treatment Official Title: Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis Actual Study Start Date : March 21, 2018 Estimated Primary Completion Date : March 12, 2022 Estimated Study Completion Date : March 12, 2022 Resource links provided by the National Library of Medicine related topics: resources: Arms and Interventions Go

2018 Clinical Trials

96. To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Subjects With Rela

with AE's and serious adverse events (SAEs),Part 1 [ Time Frame: up to 4.5 years ] An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly (...) achieving Minimal residual disease (MRD) negativity, Part 2, Treatment A [ Time Frame: Every 4 weeks up to 4.5 years ] MRD negativity defined as the percentage of subjects who are MRD negative. Number of subjects with AE's and SAE's, Part 2 [ Time Frame: up to 4.5 years ] An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical

2018 Clinical Trials

97. Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers

determine the time course (onset), extent and offset of CYP2D6 inhibition in relation to the pharmacokinetic profiles of bupropion and metabolites. Condition or disease Intervention/treatment Phase Adverse Effect of Drug Therapy Metabolism Medications (Diagnosis) Drug: Bupropion Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 29 participants Intervention Model: Sequential Assignment Intervention Model Description (...) : Recruiting First Posted : February 2, 2018 Last Update Posted : July 23, 2018 See Sponsor: Indiana University Collaborator: National Institute of General Medical Sciences (NIGMS) Information provided by (Responsible Party): Zeruesenay Desta, Indiana University Study Details Study Description Go to Brief Summary: Primary objectives: To comprehensively characterize steady state stereoselective pharmacokinetics of bupropion and its primary and secondary metabolites in healthy volunteers To prospectively

2018 Clinical Trials

98. Enteral Nutrition and Vasoactive Drugs

Observational Model: Case-Only Time Perspective: Prospective Official Title: Enteral Nutrition in Critically Ill Patients Undergoing Vasoactive Drugs Therapy. The NUTRIVAD Study. Actual Study Start Date : January 15, 2017 Estimated Primary Completion Date : June 15, 2019 Estimated Study Completion Date : October 31, 2019 Groups and Cohorts Go to Intervention Details: Other: Enteral nutrition Enteral nutrition support Outcome Measures Go to Primary Outcome Measures : Dose of vasoactive drugs. [ Time Frame (...) Enteral Nutrition and Vasoactive Drugs Enteral Nutrition and Vasoactive Drugs - 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. Enteral Nutrition and Vasoactive Drugs (NUTRIVAD) The safety and scientific

2018 Clinical Trials

99. Anlotinib Plus Sintilimab for NSCLC Patients With First-generation EGFR-TKIs Drug Resistance Along With T790M Negative

-generation EGFR-TKIs Drug Resistance Along With T790M Negative NSCLC Actual Study Start Date : November 20, 2018 Estimated Primary Completion Date : December 31, 2019 Estimated Study Completion Date : December 31, 2021 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Anlotinib Hydrochloride+Sintilimab Participants receive Sintilimab (IBI 308) 200 mg, administered as intravenous (IV) infusion on Day 1 of each (...) (INR(international normalized ratio) >1.5 or PT(prothrombin time) > ULN+4 s or APTT(activated partial thromboplastin time ) > 1.5ULN), with bleeding tendency or receiving thrombolytic or anticoagulant treatment. Is expected to require any other form of antineoplastic therapy while on study. Received a live-virus vaccination within 30 days of planned start of study medication. Known sensitivity to any component of Anlotinib or Sintilimab. Has active autoimmune disease that has required systemic

2018 Clinical Trials

100. Comparison of Efficacy of LGIT and MAD Among Children With Drug Resistant Epilepsy

, 2018 Last Update Posted : December 7, 2018 See Sponsor: All India Institute of Medical Sciences, New Delhi Information provided by (Responsible Party): Sheffali Gulati, All India Institute of Medical Sciences, New Delhi Study Details Study Description Go to Brief Summary: To compare the efficacy of two less restrictive dietary therapies - LGIT and MAD, used for treatment of drug resistant epilepsy in children Condition or disease Intervention/treatment Phase Drug Resistant Epilepsy Ketogenic (...) : Comparison of Efficacy of Low Glycemic Index Therapy and Modified Atkins Diet Among Children With Drug Resistant Epilepsy: A Randomized Non-inferiority Trial Estimated Study Start Date : December 2018 Estimated Primary Completion Date : December 2019 Estimated Study Completion Date : December 2019 Resource links provided by the National Library of Medicine related topics: related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Low Glycemic Index therapy Specific dietary

2018 Clinical Trials

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