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Diarrhea Secondary to Medications

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41. MASCC/ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy

MASCC/ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy MASCC=ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy Rajesh V. Lalla, DDS, PhD 1 ; Joanne Bowen, PhD 2 ; Andrei Barasch, DMD, MDSc 3 ; Linda Elting, PhD 4 ; Joel Epstein, DMD, MSD 5 ; Dorothy M. Keefe, MD 2 ; Deborah B. McGuire, PhD, RN 6 ; Cesar Migliorati, DDS, MS, PhD 7 ; Ourania Nicolatou-Galitis, DDS, MSc, DrDent 8 ; Douglas E. Peterson, DMD (...) , University of Connecticut Health Center, 263 Farmington Ave, Farmington, CT 06030-1605; Fax: (860)679-4760; Lalla@uchc.edu 1 University of Connecticut, Farmington, Connecticut; 2 University of Adelaide, Adelaide, South Australia, Australia; 3 Winthrop University Hospital, Mineola, New York; 4 The University of Texas MD Anderson Cancer Center, Houston, Texas; 5 City of Hope Medical Center, Duarte, California; 6 Virginia Commonwealth University, Richmond, Virginia; 7 University of Tennessee Health Science

2014 International Society for Oral Oncology

42. Zarxio (filgrastim-sndz) - medical review

Zarxio (filgrastim-sndz) - medical review CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125553Orig1s000 MEDICAL REVIEW(S) Page 1 Secondary (Team Leader) Review Date February 3, 2015 From Albert Deisseroth, MD, PhD Subject Secondary Review BLA Number 125553 Applicant Sandoz Date of Submission May 8, 2014 PDUFA Goal Date March 8, 2015 Proprietary Name Zarxio Dosage Regimen 300 mcg/0.5 mL PFS, 480 mcg/0.8 mL PFS Approved Indications Patients with cancer receiving myelosuppressive (...) chemotherapy; Patients with AML receiving induction or consolidation chemotherapy; Patients with cancer receiving bone marrow transplant; Patients undergoing peripheral blood progenitor cell collection; Patients with severe chronic neutropenia. Recommendation: Approval of EP2006 as a biosimilar to US-licensed Neupogen for all 5 indications for which US-licensed Neupogen is currently licensed Material Reviewed/Consulted Reviewer/Author Medical Officer Review Donna Przepiorka, MD, PhD Clinical Pharmacology

2015 FDA - Drug Approval Package

43. Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea

of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: PTM202 PTM202 is a medical nutrition product Other: PTM202 Placebo Comparator: Placebo The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor Other: Placebo Outcome Measures Go to Primary Outcome Measures : diarrhea duration [ Time Frame: 7 days ] Secondary Outcome Measures : food intake [ Time Frame: 7 days ] stool frequency [ Time Frame: 7 (...) Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea - 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. Study With Medical

2013 Clinical Trials

44. Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis

allergy to Lanthanum Carbonate hypophosphatemia (defined as serum phosphorus < 0.81 mmol/L) severe known liver insufficiency of biliary obstruction rectocolitis ulcerohaemorraghica, Crohn's disease, bowel obstruction, stomach/duodenal ulceration glucose/galactose malabsorption severe diarrhea or other gastrointestinal disorder, which might interfere with the ability to absorb oral medication pregnancy or breast-feeding female participant of childbearing potential unwilling to take efficient (...) Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis - 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

2017 Clinical Trials

45. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for Comprehensive Medical Care of Patients with Obesity

Summary 4-30 Evidence Base 30 Post-hoc Question: By inductive evaluation of all evidence-based recommendations, what are the core recommendations for medical care of patients with obesity? 30 Q1. Do the 3 phases of chronic disease prevention and treatment (i.e., primary, secondary, and tertiary) apply to the disease of obesity? 31 Q2. How should the degree of adiposity be measured in the clinical setting? 33 Q2.1. What is the best way to optimally screen or aggressively case-find for overweight (...) : By inductive evaluation of all evi- dence-based recommendations, what are the core recom- mendations for medical care of patients with obesity? Obesity and 3 Phases of Chronic Disease Prevention and Treatment • Q1. Do the 3 phases of chronic disease prevention and treatment (i.e., primary, secondary, and tertiary) apply to the disease of obesity? The Anthropometric Component of the Diagnosis of Obesity • Q2. How should the degree of adiposity be measured in the clinical setting? • Q2.1. What is the best

2016 American Association of Clinical Endocrinologists

46. Chronicles of a Second Year Medical Student

Chronicles of a Second Year Medical Student Chronicles of a Second Year Medical Student – Clinical Correlations Search Chronicles of a Second Year Medical Student August 6, 2015 5 min read By Matthew Siow Peer Reviewed Day 1 of the medicine rotation: complete. I was on long call today, which meant three things. One, the hours during which I had to pretend I knew something were longer. Two, I saw a lot of things I had never seen before, from more common things like COPD exacerbations and acute (...) of cake. I’ll do a couple questions tonight just to get my feet wet. You know what they say: a journey of 1,397 questions begins with a single step. Question 1 A 65-year-old male comes to your office to establish care. He tells you he has spent the last 40 years working as a shark tank tester in Botswana and once came within 100 feet of touching a shark. He believes this close encounter has led him to develop an allergy to shark fin soup. He takes no medications but admits taking “some kind

2015 Clinical Correlations

47. HALT-D: A Phase II Evaluation of Crofelemer for the Prevention and Prophylaxis of Diarrhea in Patients With Breast Cancer on Pertuzumab-Based Regimens (PubMed)

or paclitaxel (THP) or trastuzumab, pertuzumab, docetaxel, and carboplatin (TCHP) will be randomized to receive crofelemer or no medication for diarrhea prophylaxis. The primary endpoint is incidence of all grade diarrhea for ≥ 2 consecutive days during cycles 1 to 2 of THP or TCHP. Secondary endpoints include overall incidence, duration, and severity of diarrhea; time to onset of diarrhea; use of other anti-diarrheal medications; stool frequency and consistency; and quality of life. HALT-D will provide (...) HALT-D: A Phase II Evaluation of Crofelemer for the Prevention and Prophylaxis of Diarrhea in Patients With Breast Cancer on Pertuzumab-Based Regimens Approximately 40% to 80% of patients receiving pertuzumab-directed therapy for human epidermal growth factor receptor 2 (HER2)-positive breast cancer will develop chemotherapy-induced diarrhea (CID). Loperamide and octreotide are frequently used to treat CID after diarrhea occurs, but neither is used prophylactically or targets the underlying

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2016 Clinical breast cancer Controlled trial quality: uncertain

48. Effect of Lactobacillus Reuteri DSM 17938 to Prevent Antibiotic-associated Diarrhea in Children

to Primary Outcome Measures : Incidence of antibiotic associated diarrhea [ Time Frame: 8 weeks time period after 1st day of antibiotic use ] The frequency and consistency of the stools were recorded daily according to Bristol score; a score <5 is described as normalization of stool and score equal or above 5 defined as diarrhea. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0 Secondary Outcome Measures : Incidence (...) according to Bristol score; a score <5 is described as normalization of stool and score equal or above 5 defined as diarrhea. Evaluation of antibiotic-associated diarrhea in patients who developed diarrhea severity [ Time Frame: 56 days ] Presence of dehydration, requiring medical care, requiring hospitalization, Vesikari scale score The frequency of other gastrointestinal symptoms other than diarrhea during the study (will be evaluated using the Gastrointestinal Symptom Rating Score) [ Time Frame: 56

2016 Clinical Trials

49. Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

qualifying for the study and signing informed consent, patients will undergo a two-week observation period during which stool consistency and frequency data and symptom data will be collected. Patients will then be randomized 60:40 to RHB-102 12 mg (BEKINDA) or placebo. Patients will continue on treatment for 8 weeks. Each medication will be given once daily. Condition or disease Intervention/treatment Phase Irritable Bowel Syndrome With Diarrhea Drug: BEKINDA Drug: Placebo Phase 2 Detailed Description (...) Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search

2016 Clinical Trials

50. A Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid® (Sacrosidase) Oral Solution in Subjects With Chronic Diarrhea and Sucrase Deficiency

Outcome Measures : Response to Sucraid and placebo in a parallel group study based on improvement in daily stool consistency, as assessed by the BSFS using SHMBT [ Time Frame: Up to 2 years ] Response to Sucraid and placebo based on improvement in daily stool consistency, as assessed by the Bristol Stool Form Scale (BSFS) over a 1-week treatment period in subjects with chronic diarrhea and sucrase deficiency using a sucrose hydrogen methane breath test (SHMBT). Secondary Outcome Measures : Effects (...) A Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid® (Sacrosidase) Oral Solution in Subjects With Chronic Diarrhea and Sucrase Deficiency A Trial to Evaluate the Frequency of Genetic Sucrase-Isomaltase Deficiency Genotypes, and the Efficacy and Safety of Sucraid® (Sacrosidase) Oral Solution in Subjects With Chronic Diarrhea and Sucrase Deficiency - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record

2016 Clinical Trials

51. Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD)

the intervention period of 6 weeks after starting antibiotic treatment; diarrhea is defined according WHO Secondary Outcome Measures : Cumulated duration of antibiotic-associated diarrhea (AAD) [ Time Frame: 6 weeks ] Number of days with diarrhea within the intervention period Gastrointestinal Symptom Rating Scale [ Time Frame: 6 weeks ] Standardized questionnaire according Dimenäs et al. Cumulative sverity of antibiotic-associated diarrhea (AAD) [ Time Frame: 6 weeks ] Sum of the values (obtained (...) Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD) Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD) - 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

2016 Clinical Trials

52. To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea.

as change from baseline in stool types per Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify feces on a scale from 1 to 7 according to increasing wateriness. Secondary Outcome Measures : Area under the plasma concentration-time profile (AUCtau) of LJN452 [ Time Frame: Day 1 (upto 8 hours), Day 2 (pre-dose) and Day 12 (upto 8 hours) in each treatment period ] Maximum plasma concentration (Cmax) of LJN452. [ Time Frame: Day 1 (upto 8 hours), Day 2 (pre-dose) and Day 12 (...) To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea. To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea. - 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

2016 Clinical Trials

53. Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea

of China Academy of Chinese Medical Sciences: IBS-D; Chang'an I Recipe; Placebo Additional relevant MeSH terms: Layout table for MeSH terms Syndrome Diarrhea Irritable Bowel Syndrome Disease Pathologic Processes Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases (...) Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea - 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

2016 Clinical Trials

54. Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial

Identifier: NCT02871908 Recruitment Status : Completed First Posted : August 18, 2016 Last Update Posted : March 20, 2018 Sponsor: Medical University of Warsaw Information provided by (Responsible Party): Hanna Szajewska, Medical University of Warsaw Study Details Study Description Go to Brief Summary: The aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children. Condition or disease Intervention/treatment Phase (...) for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e., negative laboratory stool tests for infectious agents). In all cases, loose or watery stools will correspond to scores of 5 to 7 on the BSF scale or A-consistency on the AISS. Secondary Outcome Measures : infectious diarrhea [ Time Frame: during antibiotic treatment, an average of 10 days and 7 days of follow up

2016 Clinical Trials

55. Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients

diarrhea [ Time Frame: 29 months ] Incidence of all grade diarrhea lasting 2 or more consecutive days during cycles 1 and 2 of chemotherapy Secondary Outcome Measures : Diarrhea any grade [ Time Frame: 29 months ] Incidence of diarrhea of any grade, as measured by CTCAE v4.0, by cycle and by stratum Grade 3-4 diarrhea [ Time Frame: 29 months ] Incidence of diarrhea of grade 3-4, as measured by CTCAE v4.0, by cycle and by stratum Diarrhea onset [ Time Frame: 29 months ] Time to onset of first episode (...) of diarrhea of any grade, overall and by stratum Diarrhea duration [ Time Frame: 29 months ] Duration (days) of any grade diarrhea, defined from day 1 to day 21, by cycle in which the episode started and by stratum Duration grade 3-4 diarrhea [ Time Frame: 29 months ] Duration (days) of grade 3-4 diarrhea, defined from day 1 to day 21, by cycle in which the episode started and by stratum Anti-diarrheal medications [ Time Frame: 29 months ] Use of anti-diarrheal medications (other than study drug

2016 Clinical Trials

56. Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders

drink 2 - Acidified dairy drink without ferments consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28) Outcome Measures Go to Primary Outcome Measures : Occurrence of AAD [ Time Frame: From Day 0 to Day 28 ] Secondary Outcome Measures : Duration of AAD [ Time Frame: From Day 0 to Day 28 ] Time to event of AAD [ Time Frame: From Day 0 to Day 28 ] Occurrence of Clostridium difficile Associated Diarrhea [ Time Frame: From Day 0 to Day 28 ] Time to event of Clostridium (...) Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders - 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

2016 Clinical Trials

57. Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

to Primary Outcome Measures : Efficacy: Cure of diarrhea without recurrence in intention to treat population [ Time Frame: 56 days ] Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period. Adverse Events [ Time Frame: 56 days ] Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities (...) . Secondary Outcome Measures : Efficacy: Cure of diarrhea without recurrence in a per protocol population [ Time Frame: 56 days ] Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period. Efficacy: cure of diarrhea in intention to treat and per protocol populations [ Time Frame: 10 days ] Cure is defined as less than 3 bowel motions per day for 2 consecutive

2016 Clinical Trials

58. Probiotics for the Prevention of Antibiotic-Associated Diarrhea

will power the trial based GRSd, a more conservative AAD incidence (23%). The investigators will also power the trial for a smaller treatment effect (39% relative risk reduction). Secondary Outcome Measures : Severity of AAD [ Time Frame: 2 weeks after antibiotic completion ] The investigators will assess severity using the qPAD and the investigators will employ definitions for diarrhea from the Canadian Nosocomial Infection Surveillance Program, modified for use in children, defined as: severe: ≥6 loose (...) Probiotics for the Prevention of Antibiotic-Associated Diarrhea Probiotics for the Prevention of Antibiotic-Associated Diarrhea - 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. Probiotics for the Prevention

2016 Clinical Trials

59. Prevention of Irinotecan Induced Diarrhea by Probiotics

of grade 3/4 diarrhea) of probiotic formula PROBIO-FIX INUM® given orally to patients with colorectal cancer starting new line of irinotecan based chemotherapy. Response will be defined as prevention of grade 3/4 diarrhea according to definition of NCI CTC version 4.0 Secondary Outcome Measures : Progression-free survival [ Time Frame: 1 year ] Progression-free survival period will be evaluated according to standard protocol. Prevention of any grade of diarrhea [ Time Frame: 6 weeks ] To determine (...) Prevention of Irinotecan Induced Diarrhea by Probiotics Prevention of Irinotecan Induced Diarrhea by Probiotics - 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. Prevention of Irinotecan Induced Diarrhea

2016 Clinical Trials

60. Clinical Trial of CBS-2004 in Prevention of Travelers' Diarrhea

with study drug and placebo during the period of prophylaxis and through the last clinic visit. [ Time Frame: 7 weeks ] To assess the effectiveness of CBS 2004 by evaluating the development of traveler's diarrhea (TD) with CBS-2004 versus placebo based on time to first unformed stool associated with a TD episode [ Time Frame: 7 weeks ] Secondary Outcome Measures : Assess the number of work days lost due to diarrhea [ Time Frame: 7 weeks ] Assess percentages of subjects requiring treatment for diarrhea (...) Clinical Trial of CBS-2004 in Prevention of Travelers' Diarrhea Clinical Trial of CBS-2004 in Prevention of Travelers' Diarrhea - 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. Clinical Trial of CBS-2004

2016 Clinical Trials

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