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Diarrhea Secondary to Medications

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7321. The Hypotensive Effect of Metformin in Hypertensive Patients.

of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Metformin Metformin 850 mg twice a day for eight weeks versus Placebo Drug: Metformin metformin 850mg twice a day for eight weeks Other Name: Glucophage Drug: Placebo Outcome Measures Go to Primary Outcome Measures : The effect of metformin on blood pressure [ Time Frame: eight weeks ] The primary outcome was the difference in mean 24-hour BP variation between the two groups (...) (metformin versus placebo) after the intervention. Secondary Outcome Measures : The difference in mean of BP during daytime and nighttime in ABPM-24h, as well as the office BP and laboratory differences were considered secondary outcomes. [ Time Frame: eight weeks ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn

2013 Clinical Trials

7322. Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines

' of the protective efficacy of the oral live typhoid fever vaccine Vivotif®. Some of these Salmonellae are common causes of diarrhoea in travellers (0-30% of travellers diarrhea depending on the area). In a recent controlled study, the investigators showed that a cross-reactive immune response is elicited against different Salmonella spp. in healthy volunteers immunized with either the oral (Vivotif® ) or parenteral (Typherix®) typhoid vaccines (ISRCTN68125331). In the present study immune responses (...) prior to study start or planned vaccination during the study Current intake of antibiotics or end of antibiotic therapy <8 days before first IMP administration Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed Acute or chronic clinically significant

2013 Clinical Trials

7323. A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

: Change Outcome Measure up to 71 months ] Screening, Cycle 1, 3, 5, 7, 9, 11, End of treatment and thereafter every 6 months Area under the Curve (AUC), Cmax [ Time Frame: pre-dose, 2, 4, 6, 8, and 24 hours ] Drug-drug interactions (DDI) potential for palbociclib - endocrine combination therapy In the first 24 patients receiving tamoxifen or anastrozol together with palbociclib/placebo plasma PK samples will be drawn on pre-dose and 2, 4, 6, 8, and 24 hours post-dose for DDI assessment. In the first (...) drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to randomization. Male patients. 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 identifier (NCT number): NCT01864746 Locations Layout table for location information

2013 Clinical Trials

7324. Improving Autonomic Function and Balance in Diabetic Neuropathy

other than impaired glucose regulation based on careful clinical and laboratory evaluation by the physician. Current severe medical conditions that are active on the day of screening that would affect the patient's ability to participate in or complete the study. Autonomic neuropathy that is so severe that it would limit the patient's ability to participate in the study interventions. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you (...) of Research and Development Information provided by (Responsible Party): VA Office of Research and Development Study Details Study Description Go to Brief Summary: Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and early diabetes affects a considerably larger but unknown population group. At the current time there is no effective therapy to completely

2013 Clinical Trials

7325. Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC

-year ] The latency to the first remote failure Secondary Outcome Measures : Difference in the complete response rates between the two treatment arms [ Time Frame: 12 weeks after the completion of therapy ] Other Outcome Measures: Rates of toxicity [ Time Frame: 3-years ] Rates of toxicity will also be compared. Rates will be compared by the chi-square test.The Chemotherapy toxicity include thrombocytopenia, leukocytopenia , anemia, granulocytopenia,damage to hepatic function, damage to renal (...) function,constipation, diarrhea,vomiting and rash. The radiotherapy toxicities include mucositis, radiation dermatitis,dysphagia, xerostomia, skin fibrosis, trismus, hearing loss ane cranial neuropathy. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study

2013 Clinical Trials

7326. Phase 2 Study of AUY922 in NSCLC Patients With Exon 20 Insertion Mutations in EGFR

historically have reaped little benefit from EGFR-directed therapy due to the low affinity of this mutation for direct EGFR inhibitors, especially erlotinib and gefitinib (see Yasuda et al, Lancet Oncol 2011). This group of patients is ideal for studying other targeted therapeutic strategies that could affect the oncogene mutation in EGFR via alternative mechanisms. AUY922 is an investigational drug that may stop cancer cells from growing abnormally. This drug has been used in other research studies (...) . A standard eye exam will be done on Cycle 3, Day 1. Additional eye exams will be done if patients experience any eye-related symptoms, such as changes in vision. Within 1 week after the last dose of the study drug AUY922, patients will be asked to return to the clinic. At this visit the following will be done: physical examination, performance status, EKG, ECHO or MUGA scan, blood draw, urine test, eye exam, questions about side effects and other medications taken. Patients will be asked to return

2013 Clinical Trials

7327. Tremelimumab With Chemoembolization or Ablation for Liver Cancer

Date : December 31, 2019 Resource links provided by the National Library of Medicine related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: 1/Arm A1 Escalating doses of Tremelimumab + RFA or TACE Drug: Tremelimumab 3.5 mg/kg or 10 mg /kg IV every 4 weeks times 6 doses and then every 12 weeks for 2 years Procedure: RFA Performed on Day 36 Procedure: TACE Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and q6 months (...) and feasibility of combining Tremelimumab with trans-arterial catheter chemoembolization (TACE) or radiofrequency ablation (RFA) in patients with advanced HCC [ Time Frame: End of treatment ] List of adverse event frequency Secondary Outcome Measures : To evaluate clinical indicators of efficacy (response rate, time totumor progression, overall survival) in patients with advanced HCC undergoing TACE, radiofrequency ablation (RFA), cryoablation orstereotactic body radiation therapy (SBRT)... [ Time Frame

2013 Clinical Trials

7328. Autologous Transplant of EFS-ADA Modified Bone Marrow Cells for ADA-Deficient Severe Combined Immunodeficiency (SCID)

, 2018 Actual Study Completion Date : August 27, 2018 Resource links provided by the National Library of Medicine related topics: related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Gene Therapy Infusion of autologous EFS-ADA LV CD34+ cells Genetic: Infusion of autologous EFS-ADA LV CD34+ Infusion of OTL-101 after reduced intensity conditioning Other Name: OTL-101 Outcome Measures Go to Primary Outcome Measures : Assess safety by recording clinical (...) ] Monoclonal expansion of blood cells by vector-mediated activity will be assessed by nrLAM-PCR Overall survival [ Time Frame: 2 years ] Overall survival will be assessed Event-free survival [ Time Frame: 2 years ] Event-free survival will be assessed by determining the numbers of subjects who remain alive with adequate immune reconstitution and do not need an allogeneic hematopoietic stem cell transplant or re-institution of enzyme replacement therapy. Secondary Outcome Measures : Determine the frequency

2013 Clinical Trials

7330. A Study to Evaluate the Safety, Pharmacokinetics and Oral Bio Availability of Veliparib in Subjects With Solid Tumors

there is a clinical suspicion of central nervous system disease. Subjects with treated brain metastases that are radiographically or clinically stable for at least 4 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible, provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least one week prior to study drug administration). Clinically significant and uncontrolled major medical condition(s) including (...) 29, 2017 Resource links provided by the National Library of Medicine related topics: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Veliparib formulation A veliparib formulation A Drug: Veliparib veliparib Experimental: Veliparib formulation B Veliparib formulation B Drug: Veliparib veliparib Experimental: Veliparib formulation C veliparib formulation C Drug: Veliparib veliparib Outcome Measures Go to Primary Outcome Measures : Part 2 - Dose Escalation Cohort

2013 Clinical Trials

7331. Flax Muffins and Cholesterol Lowering

Completion Date : September 2019 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: 30g ground flaxseed per day consume 1 muffin containing 30g ground flaxseed every day for 4 weeks Other: muffin Experimental: 20g ground flaxseed per day consume 1 muffin containing 20g ground flaxseed every day for 4 weeks Other: muffin Placebo Comparator: 0g ground flaxseed per day consume 1 muffin containing 0g ground (...) flaxseed every day for 4 weeks Other: muffin Outcome Measures Go to Primary Outcome Measures : lipid profile [ Time Frame: 4 weeks ] plasma total cholesterol, HDL, LDL and triglycerides Secondary Outcome Measures : flax metabolites [ Time Frame: 4 weeks ] plasma enterolignans and phospholipid fatty acid composition blood pressure [ Time Frame: 4 weeks ] high sensitivity c-reactive protein (hsCRP) [ Time Frame: 4 weeks ] glucose [ Time Frame: 4 weeks ] Other Outcome Measures: gastrointestinal side

2013 Clinical Trials

7332. The Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma

compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma. Condition or disease Intervention/treatment Phase Endometrial Neoplasms Drug: Paclitaxel Drug: Paraplatin (Carboplatin Injection) Radiation: Pelvic Radiation Radiation: Vaginal Brachytherapy 1 Radiation: Vaginal brachytherapy 2 Phase 3 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 300 (...) , respiratory or throat tightness), and allergic reactions (i.e., life-threatening anaphylaxis) Complications of radiotherapy [ Time Frame: 3-month,6-month,1-year and 3-year ] To observe the subtle effect on quality of life (e.g., diarrhea, bowel symptoms) and vaginal stenosis. Quality of Life [ Time Frame: 3-month,6-month,1-year and 3-year ] Overall survival (OS) [ Time Frame: 3-year OS ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study

2013 Clinical Trials

7333. Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Wu-Chu-Yu Tang on Gastroesophageal Reflux Disease (GERD)

: Placebo Outcome Measures Go to Primary Outcome Measures : RDQ Questionnaire [ Time Frame: Chang from baseline RDQ score at week 4 (28 ± 5 days) ] Secondary Outcome Measures : GerD Questionnaire [ Time Frame: Chang from baseline GerD score at week 4 (28 ± 5 days) ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn (...) Recruitment Status : Unknown Verified March 2013 by China Medical University Hospital. Recruitment status was: Recruiting First Posted : April 2, 2013 Last Update Posted : April 2, 2013 Sponsor: China Medical University Hospital Information provided by (Responsible Party): China Medical University Hospital Study Details Study Description Go to Brief Summary: GERD is due to gastric content reflux to esophagus cause symptom and complication including intra-esophagus such as reflux esophagitis, and extra

2013 Clinical Trials

7334. Two Period / Two Treatment Cross-over to Assess the Effect of Florastor® on Gastrointestinal Tolerability, Safety, and PK in Healthy Subjects Receiving Zavesca®

and Zavesca with Placebo of Florastor. Gastrointestinal tolerability and PK endpoints, demographic, laboratory and safety testing, and AEs and SAEs will be collected throughout the seventy-four day study. Condition or disease Intervention/treatment Phase Diarrhea Drug: Treatment A Drug: Treatment B Phase 1 Detailed Description: This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, two period / two treatment, cross-over study with GI tolerability, safety, and PK assessments (...) -up periods). However, the duration may be up to 53 days if all visit windows are utilized. The Screening period may last up to 30 days prior to the first administration of study medication. Telephone follow-up will occur within 48-72 hours after last study drug dose in each treatment period to record SAEs/AEs and concomitant medications. In addition, subjects will be followed up 30 days after permanent study drug discontinuation for ongoing AEs and new SAEs via a telephone consult. Study Design

2013 Clinical Trials

7335. A Phase II Trial of Preoperative Chemotherapy for Biliary Tract Cancer (BTC) With Node Metastasis

abdominal effusion requiring treatment. Active concomitant malignancy. The case suspected of infection. Patients with water solubility diarrhea. Mental disease or psychotic manifestation. Under continuous steroid therapy. Patients with acute myocardial infarction. Patients with severe complications. Pregnancy or the desire to preserve fecundity. Serious drug hypersensitivity or a history of drug allergy. Any patients judged by the investigator to be unfit to participate in the study. Contacts (...) efficacy against various solid tumors, both alone and in combination with other cytotoxic drugs. S-1 monotherapy has yielded good results against advanced biliary tract cancer and gemcitabine/S-1 combination therapy has yielded promising results with acceptable toxicity levels for patients with advanced biliary tract cancer. Furthermore, the investigators reported the safety and efficacy of adding S-1 to gemcitabine/cisplatin combination regimen (GCS) for advanced biliary tract cancer. In this study

2013 Clinical Trials

7336. Modified ORS Solution for Severely Malnourished Children

: April 1, 2013 Last Update Posted: December 21, 2016 Last Verified: January 2006 Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh: Diarrhoea; Severe malnutrition; Benefiber; ReSoMal; modified ORS Additional relevant MeSH terms: Layout table for MeSH terms Diarrhea Malnutrition Signs and Symptoms, Digestive Signs and Symptoms Nutrition Disorders (...) Information provided by (Responsible Party): International Centre for Diarrhoeal Disease Research, Bangladesh Study Details Study Description Go to Brief Summary: Diarrhoea and malnutrition are the common childhood illnesses responsible for higher deaths in developing counties. Physiologically, malnourished children excrete lower amounts of salts and water in diarrhoeal stools, and they also are unable to handle excessive salts and water load. Some times they are found to be hyponatraemic due to the shift

2013 Clinical Trials

7337. Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

. [ Time Frame: After 60 days of either placebo treatment or active drug treatment ] Secondary Outcome Measures : mean difference between 60 days of probiotics versus 120 days of probiotics in gastrointestinal change score from baseline to day 120 of treatment. [ Time Frame: After 120 days of placebo treatment or active drug treatment ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor (...) or the proposed European League Against Rheumatism (EULAR) criteria for very early diagnosis of systemic sclerosis. SSc overlap syndromes (ie SSc occurring in overlap with other connective tissue diseases) SSc-associated GI symptoms (heartburn, dysphagia, vomiting, bloating/distension, faecal soilage, diarrhoea, constipation) not due to other causes as determined by clinical evaluation, with a total GIT score of at least 0.10 Stable doses of immunosuppressive treatment, corticosteroids, and GI medications

2013 Clinical Trials

7338. Daunorubicin Hydrochloride, Cytarabine, and Nilotinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection or gastric bypass surgery) Acute or chronic pancreatic disease Known (...) Analysis Drug: Nilotinib Other: Pharmacological Study Phase 2 Detailed Description: PRIMARY OBJECTIVES: I. To determine the complete response rates of combination nilotinib, cytarabine, and daunorubicin (daunorubicin hydrochloride) in patients newly diagnosed with acute myeloid leukemia (AML) and v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (Kit) overexpression. SECONDARY OBJECTIVES: I. Determine the 2-year overall survival (OS) and disease-free survival (DFS) rates. II. Determine

2013 Clinical Trials

7339. A Phase I Study of Subutinib Maleate Capsules on Toleration and Pharmacokinetics

. The subject has received small molecule targeted drug therapy of inhibition of VEGFR-2 and PDGFRβ According to the investigator's judgment, there are concomitant diseases which will seriously do harm to the subject's safety or obstruct the subject to complete the study. 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 (...) : March 7, 2013 Last Update Posted : March 8, 2013 Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Collaborator: Fudan University Information provided by (Responsible Party): Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Study Details Study Description Go to Brief Summary: purpose: to explore the maximum tolerated dose, dose-limiting toxicity of oral Subutinib Maleate capsules and rational dosage regimen for phase Ⅱ study Experimental Design: A phase Ⅰ study of single-center Test drug

2013 Clinical Trials

7340. Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis

with primary nasopharyngeal carcinoma. Receiving 68-72 Gray of radiation dose. Age between 18 and 65 years. KPS≥70. Patient who has given his/her written consent before any specific procedure of the protocol. Exclusion Criteria: Severe uncontrolled infection. Pregnant or breast-feeding females. Allergy to this medicine. Diarrhea. Outcome measures: Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI CTCAE v3.0 Pain: WHO,Numerical Rating Scale(NRS) Tumor response (...) concentration of 1.5μg/ml).Patient is instructed to use the solution five times daily. Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily Radiotherapy: Intensity modulated radiation therapy(IMRT) Chemotherapy:Docetaxel or cisplatin weekly or cisplatin once every three weeks during radiotherapy. Drug: rhGM-CSF The rhGM-CSF is prepared as a mouthwash solution,diluting 150μg in 100ml water(final concentration of 1.5μg/ml).Patient is instructed to use the solution five times daily. Other

2013 Clinical Trials

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