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Diarrhea Secondary to Medications

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141. Clinical Studies by Using Accelerated PDX Model to Screen Drugs for Advanced Solid Tumor

in subjects with advanced malignant tumor. Condition or disease Intervention/treatment Phase Metastatic Cancer Drug: Non Chemotherapy Drug: Chemotherapy and target therapy Drug: Chinese herb medicine Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 50 participants Intervention Model: Single Group Assignment Intervention Model Description: This single center, open-label, single arm, non-randomized study is designed to evaluate (...) safety, progression-free survival(PFS),overall survival (OS), objective response rate (OPR), and disease control rate (DCR) of chemotherapy or target therapy or chinese medicine based on the Alphacait screening system in subjects with advanced malignant tumor. Masking: None (Open Label) Primary Purpose: Treatment Official Title: Clinical Studies by Using Alphacait to Screen Drug Combinations for Advanced Solid Tumor Actual Study Start Date : January 1, 2017 Estimated Primary Completion Date

2017 Clinical Trials

142. Drug Interaction With Proton Pump Inhibitors for Nifedipine ER Tablets

by (Responsible Party): Food and Drug Administration (FDA) Study Details Study Description Go to Brief Summary: The purpose of this study is to measure the amount of study drug present in blood after being administered a generic version of nifedipine extended-release tablets, 60 mg (Valeant Pharmaceuticals, LLC) and brand-name version PROCARDIA XL extended-release tablets, 60 mg (Pfizer Inc.) individually and in presence of stomach acid reducing drug (antacid), omeprazole/sodium bicarbonate capsules, 40 mg (...) gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting, swallowing disorder), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first dosing, as determined by the PI/Sub-Investigator. QTc interval > 430 milliseconds for males and > 450 milliseconds for females, unless deemed otherwise by the PI/Sub-Investigator. Abnormal clinical

2017 Clinical Trials

143. Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers

study. Condition or disease Intervention/treatment Phase Aging Drug: Sirolimus Drug: Metformin Drug: Diclofenac Phase 1 Detailed Description: The primary endpoint of the study is the profile of differences in transcript levels of age-associated genes such as those in the lamin-A, insulin like growth factor (IGF) and NFKB pathways as well as noncoding RNAs in topical agent-exposed arm skin versus placebo exposed arm skin in healthy volunteers. The secondary endpoints include (1) differences in skin (...) (Participant, Outcomes Assessor) Primary Purpose: Basic Science Official Title: Phase 1 Study of the Effects of Combining Topical FDA-approved Drugs on Age-related Pathways on the Skin of Healthy Volunteers Actual Study Start Date : March 1, 2017 Estimated Primary Completion Date : July 1, 2017 Estimated Study Completion Date : December 31, 2017 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Arm Intervention/treatment Sirolimus, metformin, diclofenac

2017 Clinical Trials

144. Two, three, and four-drug regimens for HIV post-exposure prophylaxis in a North American sexual assault victim population. (Abstract)

effects (72.2% vs. 17.6%) in the later cohort. We subsequently compared all patients in either cohort who received four-drug therapy (N=128) versus those who received two or three-drug regimens (N=47). The two or three-drug regimen group had a higher completion rate (66.0% vs. 42.2%; p=0.03), and a lower rate of reported side effects (19.1% vs. 53.9%), specifically for nausea (12.8% vs. 36.7%), constipation (0% vs. 7.9%), diarrhea (2.1% vs. 21.1%), mood changes (0% vs. 10.9%), headache (2.1% vs. 16.4 (...) care facility before and after the introduction of two and three-drug post-exposure prophylaxis regimens. Our primary outcome was completion of the 28-day regimen. Secondary objectives included HIV seroconversion rates and patient reported side effects.Six-hundred-thirty charts from a 2-year period were reviewed, and 429 met inclusion criteria. There was no difference in completion rates of post-exposure prophylaxis between the two cohorts (50.5% vs. 51.6%). However, there were fewer reported side

2017 American Journal of Emergency Medicine

145. Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer. Full Text available with Trip Pro

in a single-arm, multicenter trial in patients with relapsed/refractory metastatic TNBC who received a 10 mg/kg starting dose on days 1 and 8 of 21-day repeated cycles. The primary end points were safety and objective response rate; secondary end points were progression-free survival and overall survival. Results In 69 patients who received a median of five prior therapies (range, one to 12) since diagnosis, the confirmed objective response rate was 30% (partial response, n = 19; complete response, n = 2 (...) Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer. Purpose Trop-2, expressed in most triple-negative breast cancers (TNBCs), may be a potential target for antibody-drug conjugates. Sacituzumab govitecan, an antibody-drug conjugate, targets Trop-2 for the selective delivery of SN-38, the active metabolite of irinotecan. Patients and Methods We evaluated sacituzumab govitecan

2017 Journal of Clinical Oncology

146. Phase 1 dose-escalation study of mirvetuximab soravtansine (IMGN853), a folate receptor α-targeting antibody-drug conjugate, in patients with solid tumors. Full Text available with Trip Pro

escalating from 0.15 to 7.0 mg/kg. No meaningful drug accumulation was observed with the dosing regimen of once every 3 weeks. The most common treatment-related adverse events were fatigue, blurred vision, and diarrhea, the majority of which were grade 1 or 2. The dose-limiting toxicities observed were grade 3 hypophosphatemia (5.0 mg/kg) and grade 3 punctate keratitis (7.0 mg/kg). Two patients, both of whom were individuals with epithelial ovarian cancer, achieved confirmed tumor responses according (...) Phase 1 dose-escalation study of mirvetuximab soravtansine (IMGN853), a folate receptor α-targeting antibody-drug conjugate, in patients with solid tumors. Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate that selectively targets folate receptor α (FRα). In this phase 1 dose-escalation study, the authors investigated IMGN853 in patients with FRα-positive solid tumors.Patients received IMGN853 on day 1 of a 21-day cycle (once every 3 weeks dosing), with cycles repeated until

2017 Cancer

147. Menopausal Symptoms: Comparative Effectiveness of Therapies

Women's Health Center, Massachusetts General Hospital Associate Professor of OB/Gyn and Reproductive Biology, Harvard Medical School Boston, MA Lynne Shuster, M.D., FACP Assistant Professor of Medicine Mayo Clinic Rochester, MN vi Menopausal Symptoms: Comparative Effectiveness of Therapies Structured Abstract Objectives. To systematically review and synthesize evidence evaluating the comparative effectiveness of treatments for menopausal symptoms, along with potential long-term benefits and harms (...) of those treatments. Data sources. The following electronic databases were searched through January 2014: MEDLINE ® , Embase ® , Cochrane Controlled Trials Register, and AMED Allied and Complementary Medicine. Gray literature searches included clinicaltrials.gov, the Food and Drug Administration Web site, and relevant conference abstracts. Review methods. Menopausal symptom outcomes included: vasomotor, quality of life, psychological, sexual function, urogenital, and sleep disturbance. Randomized

2015 Effective Health Care Program (AHRQ)

148. 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

149. 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

150. 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

151. 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

152. 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

153. 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

154. 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

155. 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

156. 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

157. 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

158. 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

159. 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

160. 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

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