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Diarrhea Secondary to Medications

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101. 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

102. 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

103. 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

104. 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

105. 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

106. 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

107. 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

108. 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

109. 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

110. Medical Treatment for Microscopic Colitis: A Community Hospital’s Experience Full Text available with Trip Pro

Medical Treatment for Microscopic Colitis: A Community Hospital’s Experience Lymphocytic colitis (LC) is a chronic disorder characterized by watery diarrhea. This study sought to evaluate if LC recurs after therapy, and the time frame in which this occurs. Secondary objectives included length and type of therapy, drug-free intervals, and reasons for drug discontinuation.A retrospective chart review between January 1, 2008 and October 30, 2015 of patients with biopsy-confirmed lymphocytic (...) from 4.7 to 2.4 compared to 5.8 to 2.8 for those given 5-aminosalicylic acid (5-ASA). First-line medications budesonide and 5-aminosalicylic acid failed in 12/58 (21%) of patients, other drugs also resulted in therapy changes. Thirty-five percent required their initial therapy changed and of those 40% required a second change. Symptom exacerbations were documented during therapy for 19% of patients; therapy changes resulted in good response.Almost half of all LC cases (56/114) gradually improved

2018 Gastroenterology research

111. Inulin-Type Fructan Supplementation of 3 to 6 Year-Old Children Is Associated with Higher Fecal Bifidobacterium Concentrations and Fewer Febrile Episodes Requiring Medical Attention. Full Text available with Trip Pro

Inulin-Type Fructan Supplementation of 3 to 6 Year-Old Children Is Associated with Higher Fecal Bifidobacterium Concentrations and Fewer Febrile Episodes Requiring Medical Attention. Inulin-type fructans used in formula have been shown to promote microbiota composition and stool consistency closer to those of breastfed infants and to have beneficial effects on fever occurrence, diarrhea, and incidence of infections requiring antibiotic treatment in infants.The primary study aim was to explore (...) whether prophylactic supplementation with prebiotic fructans is able to influence the frequency of infectious diseases in kindergarten children during a winter period. A secondary objective was to ascertain the effect on the intestinal microbiota.142 boys and 128 girls aged 3-6 y were randomly allocated to consume 6 g/d fructans or maltodextrin for 24 wk. At baseline, stool samples were collected for microbiota analysis and anthropometric measurements were made. During the intervention period

2018 Journal of Nutrition Controlled trial quality: uncertain

112. pK of a Novel 200 mg Ibuprofen Medicated Plaster

Official Title: A Single and Multiple Dose, Randomised, Open-label, Cross-over, Healthy Volunteer, Phase I Study of the Pharmacokinetics of a Novel 200 mg Ibuprofen Medicated Plaster Actual Study Start Date : September 25, 2018 Estimated Primary Completion Date : October 18, 2018 Estimated Study Completion Date : October 31, 2018 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Arm Intervention/treatment Active Comparator: Test IMP Drug: Ibuprofen (...) of the volunteers will be randomly assigned to one of 2 possible administration sequences. Condition or disease Intervention/treatment Phase Healthy Drug: Ibuprofen 200 mg TEPI Medicated Plaster Drug: Aktren® 200 mg überzogene Tabletten (Ibuprofen) Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 16 participants Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment

2018 Clinical Trials

113. Bladder Antimuscarinic Medication and Accidental Bowel Leakage

: Severe constipation, fecal impaction or overflow fecal incontinence Inflammatory bowel disease, colorectal CA, spinal cord injury, multiple sclerosis, stroke, myasthenia gravis Infectious diarrhea Bothersome SUI (defined as "moderately" or greater bother on UDI-3) Patients planning to undergo surgery during study period Patients who are pregnant or intending to become pregnant during the study period Patients with contraindications to antimuscarinic medications (ie. closed angle glaucoma) Patients (...) on unstable or changing dosage of fiber or narcotics in the past 14 days Patients taking more than 2mg/day of loperamide (patients taking more than 2mg will be required a 2 week washout period) Patients currently taking medication for urgency urinary incontinence (these patients will also require a 2 week washout period) Patients initiating care with a pelvic floor physical therapist during the study period Contacts and Locations Go to Information from the National Library of Medicine To learn more about

2018 Clinical Trials

114. Branched Chain Amino Acids Ratio in Medical Foods

Amino Acids in Medical Foods for Methylmalonic and Propionic Acidemias (MMA/PROP) Estimated Study Start Date : June 1, 2018 Estimated Primary Completion Date : May 31, 2019 Estimated Study Completion Date : May 31, 2019 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: BCAA Ratio Different Branched-chain amino acid (BCAA) ratios will be tested. BCAA are comprised of 3 different (...) parameters (3rd -85th percentiles for weight). Children with claustrophobia. Children currently or recently taking medication or antibiotics. Children with food allergies. Children who cannot speak, write and read in English Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov

2018 Clinical Trials

115. Management of Infusion Reactions to Systemic Anticancer Therapy: ESMO Clinical Practice Guidelines

Management of Infusion Reactions to Systemic Anticancer Therapy: ESMO Clinical Practice Guidelines CLINICAL PRACTICE GUIDELINES Management of infusion reactions to systemic anticancer therapy: ESMO Clinical Practice Guidelines † S. Rosell o 1 , I. Blasco 1 , L. Garc ia Fabregat 1 , A. Cervantes 1 & K. Jordan 2 , on behalf of the ESMO Guidelines Committee * 1 Medical Oncology Department, CIBERONC, Biomedical Research Institute INCLIVA, Valencia, Spain; 2 Department of Medicine V, Hematology (...) experience associated with the use of a medical product in a patient’ [5]. The European Medicines Agency (EMA) de?nes an ADR as a response to a medicinal product which is noxious and unintended and which occurs at doses nor- mally used in humans for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modi?cation of physiological function [6]. An ADR may be classi?ed as: • A, Augmented pharmacological effects; • B, Bizarre; • C, Chronic effects; • D, Delayed effects; • E

2017 European Society for Medical Oncology

116. Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: a randomized, double-blind, placebo-controlled, multicenter, phase II trial. (Abstract)

Efficacy of combination therapy with probiotics and mosapride in patients with IBS without diarrhea: a randomized, double-blind, placebo-controlled, multicenter, phase II trial. Probiotics can be beneficial in irritable bowel syndrome (IBS). Mosapride citrate, a selective 5-HT4 receptor agonist, stimulates gastrointestinal motility. We investigated the efficacy of combination therapy with probiotics and mosapride for non-diarrheal-type IBS.Two hundred and eighty-five IBS patients were randomly (...) IBS, the improvements in stool frequency and consistency were significantly higher in the treatment groups 4 and 1, respectively, than those in the placebo group.Combination therapy with probiotics and mosapride is effective for relief of symptoms in patients with non-diarrheal-type IBS. The study has been registered in the US National Library of Medicine (http://www.clinicaltrials.gov, NCT01505777).© 2015 John Wiley & Sons Ltd.

2015 Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society Controlled trial quality: predicted high

117. Oral zinc supplementation for children with acute diarrhoea: a quasi-experimental study. (Abstract)

duration and frequency of diarrhoea. Secondary outcomes included changes in bodyweight, drugs side-effects, and episodes of any or severe dehydration. Data were analysed with SPSS. Outcome measures were compared with the Mann-Whitney U-test, student's t test, odds ratio, or χ2 test. The study was approved by the ministry of health and the Helsinki Committee in the Gaza Strip. Parents of the children provided verbally informed consent before participation.We enrolled 140 children (aged 1-120 months (...) Oral zinc supplementation for children with acute diarrhoea: a quasi-experimental study. Diarrhoea causes 15% of under-5 mortality in developing countries. Zinc (Zn) stores in the body are known to be depleted during acute diarrhoea. The aim of this study was to evaluate the efficacy of Zn given with standard treatment to children with acute or moderate diarrhoea.In this quasi-unmasked, parallel-group study, we enrolled children with diarrhoea at El-Dorra Paediatric Hospital, Gaza Strip

2018 Lancet Controlled trial quality: uncertain

118. Therapies Targeting the Nervous System for Chronic Pelvic Pain Relief

is by a multidisciplinary team potentially including those with expertise in hormonal, medical, invasive/ surgical and psychological therapeutic modalities. Although more invasive therapies should be reserved for patients who are refractory to standard treatment of any identified pathology or where no such * The International Association for the Study of Pain (IASP) no longer recommends the use of the term interstitial cystitis (IC), having replaced it with the more correct bladder pain syndrome (BPS). However (...) in at least partly alleviating pain, would be expected to improve quality of life and may help to prevent the development of long-lasting central changes. 2. Medical treatments 2.1 Antidepressant and anticonvulsant medication Antidepressant and anticonvulsant drugs have been a mainstay of the management of chronic pain, particularly neuropathic pain, for many years, 9–13 although the mechanisms of action are not completely understood. It appears that antidepressants act by altering activity within pain

2015 Royal College of Obstetricians and Gynaecologists

119. Recommendations for the control of multi-drug resistant gram-negatives - carbapenem resistant enterobacteriaceae

screened for CRE, until results of screening are negative. 3.2.2 All patients with CRE should be managed using contact precautions in a single room with their own toilet facilities. If a single room is not available: ? ? Prioritise single rooms for those at highest risk of secondary transmission, such as those who have diarrhoea or are incontinent (urine or faeces), those who have wounds with uncontrolled drainage and those with medical devices in situ. ? ? CRE positive patients should not be grouped (...) and practitioners may be assisted by use of an inter-facility or community transfer form, in addition to verbal communications. This should include information on whether the patient has been colonised and/or infected with CRE or other multi-drug resistant organisms, the dates and results of any relevant clinical and/or surveillance cultures and an assessment of the risk of secondary transmission (taking into account conditions such as diarrhoea or incontinence of urine or faeces, wounds with uncontrolled

2014 Clinical Practice Guidelines Portal

120. Diagnosis and management of glycogen storage disease type I: a practice guideline of the American College of Medical Genetics and Genomics

storage disease type I (GSD I) after reviewing the autopsy reports of two children whose livers and kidneys contained excessive amounts of Submitted 12 August 2014; accepted 12 August 2014; advance online publication 6 November 2014. doi:10.1038/gim.2014.128 Genet Med 00 00 2014 Genetics in Medicine 10.1038/gim.2014.128 ACMG Standards and Guidelines 00 00 12August2014 12August2014 © American College of Medical Genetics and Genomics 6November2014 Purpose: Glycogen storage disease type I (GSD I (...) , Durham, North Carolina, USA; 2 Division of Metabolic Disorders, Children’ s Hospital of Orange County, Orange, California, USA; 3 Division of Genetics, Nemours Children’ s Clinic, Jacksonville, Florida, USA; 4 Departments of Pediatrics and Medicine, Columbia University Medical Center, New Y ork, New Y ork, USA; 5 Department of Pediatrics, University of Florida College of Medicine, Gainesville, Florida, USA; 6 Department of Medicine, University of W ashington, Seattle, W ashington, USA; 7 Division

2014 American College of Medical Genetics and Genomics

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