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Diarrhea Secondary to Medications

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141. Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial. Full Text available with Trip Pro

-controlled, randomized phase III trial involving community-based and academic institutions in 40 countries. Women with HER2-positive early-stage breast cancer with prior standard primary therapy and trastuzumab-based (neo)adjuvant therapy were randomized to neratinib 240 mg/day or placebo for 12 months. Safety, a secondary outcome, was assessed using the National Cancer Institute Common Terminology Criteria version 3.0. Health-related quality of life by diarrhea grade was assessed using Functional (...) Assessment of Cancer Therapy-Breast (FACT-B).Two thousand eight hundred sixteen women (1408 per group) were safety-evaluable. Grade 3 and 4 diarrhea occurred in 561 (39.8%) and 1 (0.1%) patients with neratinib versus 23 (1.6%) and 0 patients with placebo, respectively. In the neratinib group, 28.6% of patients had grade 3 events during month 1 decreasing to ≤ 6% after month 3. The median cumulative duration of grade 3/4 diarrhea with neratinib was 5 days (interquartile range, 2-9). Serious diarrheal

2019 Breast cancer research : BCR Controlled trial quality: predicted high

142. Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay

Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay Actual Study Start Date : January 22, 2018 Estimated Primary Completion Date : May 1, 2019 Estimated Study Completion Date : July 1, 2019 Resource links provided by the National Library of Medicine related topics: related topics: Groups and Cohorts Go to Group/Cohort Intervention/treatment Screening Population Cohort 1:Screening Population - Women presenting for routine XRM and / or breast US. Participants will be followed for one (...) , diarrhea, headache, vomiting, dizziness etc. Subject is pregnant, lactating, or undergoing fertility treatment. Subject has participated in this study, in another cohort, and the TM-B1 test was performed. Breast Cancer Population only: The subject's tumor has been surgically removed before sample collection for TM-B1 analysis. 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

2017 Clinical Trials

143. Evaluating an Intervention to Increase Use of Call Centre Support for Self-managed Medical Abortion

sell MA medications over the counter, they have inadequate knowledge about how women should take the medications and their potential complications, and do not offer adequate information and counselling to women buying the drugs. This study aims to evaluate if a pharmacy-based intervention to promote use of a support hotline (Marie Stopes Zambia (MSZ) call centre) among MA purchasers can increase use of the call centre, and to assess whether correct MA use and acceptability of self- administered MA (...) doses Self-reported satisfaction with self-administration of MA [ Time Frame: Day 14 after taking the first pill ] Satisfaction with the overall process, would recommend to a friend who needed an abortion, would use the same method again if needed an abortion again, feeling adequately prepared for various aspects of the medical abortion process. Secondary Outcome Measures : Cost of intervention per unit of call centre use [ Time Frame: Day 14 after taking first pill ] Increased unit cost

2017 Clinical Trials

144. Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin Compared With Dapagliflozin Added on Metformin Alone or Diabetes Medication Naïve Patient in Type 2 Diabetes Mellitus (Stable II Study)

the test and only participate in clinical trials after they have been found to be normal. Patients with pulmonary embolism, severe pulmonary dysfunction, or who are susceptible to be accompanied by hypoxemia at the time of Visit 1(Screening) Patients on drug therapy due to gastrointestinal disturbance including dehydration, diarrhea, and vomiting at the time of Visit 1(Screening) Patients with severe infection or severe trauma at the time of Visit 1(Screening) Patients with malnutrition status (...) is to evaluate the efficacy on glycemic variability and safety of gemigliptin 50 mg orally administered once daily for 12 weeks compared with Dapagliflozin 10mg in patients with type 2 diabetes mellitus who have inadequate glycemic control on metformin alone or diabetes medication naïve patient Condition or disease Intervention/treatment Phase Type 2 Diabetes Mellitus Drug: Gemigliptin 50mg Drug: Dapagliflozin 10mg Procedure: Diet/exercise questionnaire Device: Continuous Glucose Monitoring System(CGMS) Drug

2017 Clinical Trials

145. A phase 2 study of panitumumab with irinotecan as salvage therapy in chemorefractory KRAS exon 2 wild-type metastatic colorectal cancer patients. Full Text available with Trip Pro

), with median PFS of 3.8 months (95% CI 2.7-4.3) and median OS of 12.5 months (95% CI 6.7-15.9). Wild-type BRAF patients showed a 13.0% response rate. No significant correlations between response and baseline biomarker expression were identified. Common grade 3-4 adverse events were diarrhoea and rash (18.0% each), hypomagnesaemia and asthenia (8.2% each).The addition of panitumumab to irinotecan as salvage therapy is feasible but has limited activity in irinotecan-refractory metastatic colorectal cancer (...) A phase 2 study of panitumumab with irinotecan as salvage therapy in chemorefractory KRAS exon 2 wild-type metastatic colorectal cancer patients. Targeted agents are standard treatment for RAS wild-type metastatic colorectal cancer in the first- and second-line settings. This phase 2 study determined the benefit of targeting the epidermal growth factor receptor (EGFR) with panitumumab plus irinotecan in irinotecan-refractory patients.KRAS exon-2 wild-type patients failing prior irinotecan

2019 British Journal of Cancer

146. CASSETTE-clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation: study protocol for a randomised controlled trial. Full Text available with Trip Pro

, or multifocal and non-contiguous skin and soft tissue/osteoarticular infections. Individuals who are immunosuppressed, moribund, with current severe diarrhoea or Clostridiodes difficile infection, pregnant, and those with anaphylaxis to β-lactams or lincosamides will be excluded. The primary outcomes measure is the number of days alive and free (1 or 0) of systemic inflammatory response syndrome (SIRS) within the first 14 days post randomisation. The secondary outcomes measure will include all-cause (...) CASSETTE-clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation: study protocol for a randomised controlled trial. Exotoxins are important virulence factors in Staphylococcus aureus. Clindamycin, a protein synthesis inhibitor antibiotic, is thought to limit exotoxin production and improve outcomes in severe S. aureus infections. However, randomised prospective data to support this are lacking.An open-label, multicentre, randomised controlled trial (RCT

2019 Trials Controlled trial quality: predicted high

147. A Phase I, Randomized, Controlled Clinical Study of CC-11050 in People Living With HIV With Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE). Full Text available with Trip Pro

A Phase I, Randomized, Controlled Clinical Study of CC-11050 in People Living With HIV With Suppressed Plasma Viremia on Antiretroviral Therapy (APHRODITE). Phosphodiesterase 4 inhibitors (PDE4i) are novel anti-inflammatory medications that have been approved for rheumatologic diseases and have been tested as host-directed therapy in tuberculosis. We examined the safety of CC-11050, a potent PDE4i in people living with HIV (PLWH) with suppressed HIV plasma viremia. We hypothesized that CC-11050 (...) could be used to modulate HIV-related inflammation.Thirty PLWH on antiretroviral therapy (ART) ≥ 1 year with suppressed HIV viremia were enrolled and randomized 2:1 to 12 weeks of CC-11050 200mg twice daily or placebo with follow-up at weeks 2, 4, 8, 12, and 16. Primary endpoint was safety. Secondary endpoints were the effect of CC-11050 on cytokines, monocyte, and T-cell activation and potential pharmacokinetic interaction between CC-11050 and Efavirenz (EFV).At baseline, median age was 49.5 years

2019 Open forum infectious diseases Controlled trial quality: uncertain

148. Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. (Abstract)

months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group).This study's findings indicate (...) Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. Locoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC.To assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS

2019 JAMA oncology Controlled trial quality: predicted high

149. Efficacy of erlotinib as first-line maintenance therapy in patients with locally advanced or metastatic nonsmall cell lung cancer who have not experienced disease progression or unacceptable toxicity during chemotherapy. Full Text available with Trip Pro

Efficacy of erlotinib as first-line maintenance therapy in patients with locally advanced or metastatic nonsmall cell lung cancer who have not experienced disease progression or unacceptable toxicity during chemotherapy. First-line maintenance with erlotinib in nonsmall cell lung cancer (NSCLC) patients without progression after four cycles of chemotherapy was well tolerated and significantly prolonged progression-free survival (PFS) compared with placebo.This open-label, single arm, Phase IV (...) , interventional study was designed to evaluate erlotinib as first-line maintenance after chemotherapy in Indian NSCLC patients. Primary efficacy objective was to evaluate PFS rate (PFSR) at week 52 and secondary objectives were determination of PFS, overall survival (OS), overall response rate (ORR), disease control rate, and safety.Patients were treated with erlotinib until disease progression/death/unacceptable toxicity or end of study. Patients with disease progression underwent scheduled clinical

2019 South Asian journal of cancer Controlled trial quality: uncertain

150. Combination of metformin and gefitinib as first-line therapy for non-diabetic advanced NSCLC patients with EGFR mutations: A randomized, double-blind phase 2 trial. (Abstract)

. Metformin combined with gefitinib resulted in a remarkably higher incidence of diarrhea compared to the control arm (78.38% vs 43.24%).Our study showed that addition of metformin resulted in non-significantly worse outcomes and increased toxicity and hence does not support its concurrent use with first-line EGFR-TKI therapy in non-diabetic EGFRm NSCLC patients.Copyright ©2019, American Association for Cancer Research. (...) Combination of metformin and gefitinib as first-line therapy for non-diabetic advanced NSCLC patients with EGFR mutations: A randomized, double-blind phase 2 trial. Preclinical and retrospective studies suggested a role for metformin in sensitizing diabetic non-small cell lung cancer (NSCLC) patients to epidermal growth factor receptor(EGFR) tyrosine kinase inhibitors(TKIs). We therefore examined its effects in combination with gefitinib in non-diabetic patients harboring EGFR mutations (EGFRm

2019 Clinical Cancer Research Controlled trial quality: predicted high

151. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy (Abstract)

MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy Purpose MONARCH 2 ( ClinicalTrials.gov identifier: NCT02107703) compared the efficacy and safety of abemaciclib, a selective cyclin-dependent kinase 4 and 6 inhibitor, plus fulvestrant with fulvestrant alone in patients with advanced breast cancer (ABC). Patients and Methods MONARCH 2 was a global, double-blind, phase III study of women (...) with hormone receptor-positive and human epidermal growth factor receptor 2-negative ABC who had progressed while receiving neoadjuvant or adjuvant endocrine therapy (ET), ≤ 12 months from the end of adjuvant ET, or while receiving first-line ET for metastatic disease. Patients were randomly assigned 2:1 to receive abemaciclib or placebo (150 mg twice daily) on a continuous schedule and fulvestrant (500 mg, per label). The primary end point was investigator-assessed progression-free survival (PFS), and key

2017 EvidenceUpdates

152. Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA (Abstract)

Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA Purpose In patients with metastatic castration-resistant prostate cancer (mCRPC), overall survival (OS) is significantly improved with cabazitaxel versus mitoxantrone after prior docetaxel treatment. FIRSTANA ( ClinicalTrials.gov identifier: NCT01308567) assessed whether cabazitaxel 20 mg/m2 (C20) or 25 mg/m2 (C25) is superior to docetaxel (...) 75 mg/m2 (D75) in terms of OS in patients with chemotherapy-naïve mCRPC. Patients and Methods Patients with mCRPC and Eastern Cooperative Oncology Group performance status of 0 to 2 were randomly assigned 1:1:1 to receive C20, C25, or D75 intravenously every 3 weeks plus daily prednisone. The primary end point was OS. Secondary end points included safety; progression-free survival (PFS); tumor, prostate-specific antigen, and pain response; pharmacokinetics; and health-related quality of life

2017 EvidenceUpdates

153. Prescribing patterns of dependence forming medicines

included in the analysis see Appendix 30. GABAergic medicines are approved for the treatment of a range of conditions including epilepsy, neuropathic pain, fibromyalgia, generalised anxiety disorder and restless drug syndrome. Off-label uses include migraine, social phobia, panic disorder, mania, bipolar disorder and alcohol withdrawal. GMS General Medical Services GP General Practitioner GPRD General Practice Research Database HES Hospital Period Statistics HSCIC Health and Social Care Information (...) website. In addition, references cited in articles previously found located on the US National Library of Medicine National Institutes of Health (NCBI/PubMed.gov) website. Papers were identified with the following search terms: ‘benzodiazepines’, ‘Z-drugs’, ‘prescribing trends’, ‘opiates’, ‘hypnotics’, ‘anxiolytics’, ‘analgesics’, ‘GABAergic’, ‘pregabalin’, ‘gapapentin’, ‘opioids’, and ‘dependence forming medication’. The focus was on studies published after 2009, so as to provide an update

2017 Public Health Research Consortium

154. 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 (...) malnutrition (defined as weight for height of less than -3 SD below median, per WHO Standards (6). Child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening. History of hypersensitivity or allergy to milk or egg 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

2013 Clinical Trials

155. Etelcalcetide (Parsabiv) - reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism)

Etelcalcetide (Parsabiv) - reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism) 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 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2016. Reproduction is authorised provided the source (...) of the product 7 2. Scientific discussion 8 2.1. Introduction 8 2.1.1. Problem statement 8 2.1.2. About the product 9 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active Substance 10 General information 10 Manufacture, characterisation and process controls 10 Specification 11 Stability 12 2.2.3. Finished Medicinal Product 12 Manufacture of the product and process controls 13 Product specification 13 Stability of the product 14 Adventitious agents 15 2.2.4. Discussion on chemical, pharmaceutical

2016 European Medicines Agency - EPARs

156. Transcutaneous electric nerve stimulation over acupoints for patients with diarrhea-predominant irritable bowel syndrome: Protocol for systematic review and meta-analysis. Full Text available with Trip Pro

Transcutaneous electric nerve stimulation over acupoints for patients with diarrhea-predominant irritable bowel syndrome: Protocol for systematic review and meta-analysis. At present, drug therapy for diarrhea-predominant irritable bowel syndrome (IBS-D) has made great progress; however, it does not often produce a satisfying curative effect. Transcutaneous electric nerve stimulation over acupoints (Acu-TENS) might be more effective in improving patient's symptoms and producing fewer side (...) -effects as a result.Although with a great progress of the drug therapy for IBS-D, it is often hard to achieve its satisfactory curative effect. Acu-TENS that may be effective to improve patients' symptoms and fewer side-effects will be sought. There is no systematic review concerning the efficacy of Acu-TENS for IBS-D published. Therefore, this review aims to systematically evaluate the efficacy of Acu-TENS on IBS-D.Four English (PubMed, EMBASE, The Cochrane Library, Web of Science) and 4 Chinese

2018 Medicine

157. Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea

Study Completion Date : September 1, 2019 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Racecadotril plus standard treatment oral rehydration solution Drug: Racecadotril plus ORS Racecadotril plus ORS Outcome Measures Go to Primary Outcome Measures : Duration of diarrhea (hours) between the start of treatment until last diarrheal/watery stool before recovery or end of study treatment (treatment (...) duration maximal 5 days [ Time Frame: 5 days ] Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary Secondary Outcome Measures : Number of recovered subjects [ Time Frame: 5 days ] Number of recovered subjects Global Physician Assessment at the end of treatment [ Time Frame: 5 days ] scores 1-6 Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal

2018 Clinical Trials

158. Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea

, 2018 Actual Study Completion Date : September 10, 2018 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Racecadotril plus standard treatment oral rehydration solution Drug: Racecadotril plus ORS Racecadotril plus ORS Active Comparator: ORS (standard treatment) Drug: ORS ORS Outcome Measures Go to Primary Outcome Measures : Duration of diarrhea (hours) between the start of treatment until last diarrheal (...) /watery stool before recovery or end of study treatment (treatment duration maximal 5 days) [ Time Frame: 5 days ] Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary Secondary Outcome Measures : Number of recovered subjects per treatment group [ Time Frame: 5 days ] Number of recovered subjects per treatment group Global Physician Assessment at the end of treatment [ Time Frame: 5 days ] scores 1-6 Eligibility Criteria Go

2018 Clinical Trials

159. Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence

: Not yet recruiting First Posted : April 5, 2018 Last Update Posted : February 27, 2019 See Sponsor: University of North Carolina, Chapel Hill Collaborator: Allergan Information provided by (Responsible Party): University of North Carolina, Chapel Hill Study Details Study Description Go to Brief Summary: Accidental bowel leakage (fecal incontinence) increases in people who have diarrhea and sensations of urgency to have a bowel movement. Drugs such as loperamide (Imodium) that reduce diarrhea improve (...) accidental bowel leakage, but loperamide has disadvantages: it is difficult to find a dose that does not cause constipation, and it does not reduce urge sensations. Eluxadoline is a new drug that is effective for reducing diarrhea, abdominal pain, and urgency in patients with irritable bowel syndrome, and it may be less likely than loperamide to cause severe constipation. Therefore, eluxadoline may help patients manage accidental bowel leakage caused by diarrhea. The chemical name for Viberzi®

2018 Clinical Trials

160. Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea

. University of Michigan More Information Go to Layout table for additonal information Responsible Party: William Chey, Professor of Internal Medicine, Medical School and Professor of Nutritional Sciences, School of Public Health, University of Michigan ClinicalTrials.gov Identifier: Other Study ID Numbers: HUM00142925 First Posted: November 2, 2018 Last Update Posted: February 8, 2019 Last Verified: February 2019 Layout table for additional information Studies a U.S. FDA-regulated Drug Product: Yes (...) ) symptoms.Included patients will be requested to answer online surveys and will undergo treatment with rifaximin. Hydrogen breath testing and biologic samples collection will also be completed during the study. Condition or disease Intervention/treatment Phase Irritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea Drug: Rifaximin Device: Glucose and lactulose hydrogen breath testing Phase 4 Detailed Description: The study aims to determine whether hydrogen breath testing can be used to identify patients

2018 Clinical Trials

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