Gastroenterology & Hepatology Clinical Trials

Statistical methods in gastroenterology & hepatology trials

The methods these trials rely on most, based on the statistical analyses posted to ClinicalTrials.gov, with the tutorial that explains each one.

All gastroenterology & hepatology trials

455 results

• “Answers in Hours” A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures: Complete Statistical AnalysisIndependent statistical analysis of "Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase NAResults postedn = 8NCT05523154
• 2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer: Complete Statistical AnalysisIndependent statistical analysis of 2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 2Results postedn = 21NCT01821105
• 276Independent statistical analysis of A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 1/2Results postedn = 11NCT01671488
• 3Dvs2DforUCIndependent statistical analysis of Evaluation of 3D Visualization for Total Colectomy: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02370056).Phase NAResults postedn = 53NCT02370056
• 5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer: Complete Statistical AnalysisIndependent statistical analysis of 5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 2Results postedn = 66NCT00308516
• 64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer: Complete Statistical AnalysisIndependent statistical analysis of 64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01939275).Phase NAResults postedn = 8NCT01939275
• A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy: Complete Statistical AnalysisIndependent statistical analysis of A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase NAResults postedn = 1,262NCT02345889
• A Chatbot Intervention for Reducing HPV Vaccine Hesitancy: Complete Statistical AnalysisIndependent statistical analysis of A Chatbot Intervention for Reducing HPV Vaccine Hesitancy: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05959564).Phase NAResults postedn = 456NCT05959564
• A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions: Complete Statistical AnalysisIndependent statistical analysis of A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo…Phase 3Results postedn = 333NCT03843541
• A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer: Complete Statistical AnalysisIndependent statistical analysis of A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase 1Results postedn = 20NCT02237157
• A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection: Complete Statistical AnalysisIndependent statistical analysis of A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection: primary endpoint results, effect estimate with confidence…Phase 2Results postedn = 35NCT00720434
• A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer: Complete Statistical AnalysisIndependent statistical analysis of A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 2Results postedn = 467NCT00652366
• A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn’s Disease: Complete Statistical AnalysisIndependent statistical analysis of A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 2/3Results postedn = 191NCT00989573
• A Dose-finding Study of OPC-6535 in Patients With Active Crohn’s Disease: Complete Statistical AnalysisIndependent statistical analysis of A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase 2Results postedn = 29NCT00317369
• A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants: Complete Statistical AnalysisIndependent statistical analysis of A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants: primary endpoint results, effect estimate…Phase 1Results postedn = 31NCT03570658
• A Multi-dose Study of ARC-520 in Patients With Hepatitis B ‘e’ Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection: Complete Statistical AnalysisIndependent statistical analysis of A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 2Results postedn = 32NCT02604212
• A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen: Complete Statistical AnalysisIndependent statistical analysis of A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 1Results postedn = 17NCT00623831
• A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies: Complete Statistical AnalysisIndependent statistical analysis of A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected…Phase 1/2Results postedn = 222NCT03829501
• A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis: primary endpoint results, effect estimate with confidence…Phase 2Results postedn = 77NCT03911713
• A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma: Complete Statistical AnalysisIndependent statistical analysis of A Phase I/Ib Study of AZD9150 (ISIS-STAT3Rx) in Patients With Advanced/Metastatic Hepatocellular Carcinoma: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 1Results postedn = 58NCT01839604
• A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency: Complete Statistical AnalysisIndependent statistical analysis of A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency: primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 1/2Results postedn = 5NCT00655707
• A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy: Complete Statistical AnalysisIndependent statistical analysis of A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy: primary endpoint results, effect estimate with…Phase 2Results postedn = 34NCT00587067
• A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients: Complete Statistical AnalysisIndependent statistical analysis of A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 3Results postedn = 183NCT01292239
• A Pilot Study of Acupuncture Treatment for Dysphagia: Complete Statistical AnalysisIndependent statistical analysis of A Pilot Study of Acupuncture Treatment for Dysphagia: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00797732).Phase NAResults postedn = 42NCT00797732
• A Prospective, Single-center, Single-arm, Pivotal Trial of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System: Complete Statistical AnalysisIndependent statistical analysis of A Prospective, Single-center, Single-arm, Pivotal Trial of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase NAResults postedn = 42NCT05715827
• A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome: Complete Statistical AnalysisIndependent statistical analysis of A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome: primary endpoint results, effect estimate with confidence…Phase NAResults postedn = 27NCT02477423
• A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer: Complete Statistical AnalysisIndependent statistical analysis of A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer: primary endpoint results, effect estimate with…Phase 2Results postedn = 84NCT00192075
• A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI): Complete Statistical AnalysisIndependent statistical analysis of A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency…Phase 3Results postedn = 82NCT00788593
• A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G: Complete Statistical AnalysisIndependent statistical analysis of A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase NAResults postedn = 91NCT02388269
• A Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West Haven Criteria) Hepatic Encephalopathy (HE) [The RETRO Study]: Complete Statistical AnalysisIndependent statistical analysis of A Retrospective, Open-label, Uncontrolled Cohort Study to Assess the Effectiveness and Safety of Lactulose Retention Enema in the Treatment of Cirrhotic Patients With Grade 3 or 4 (West…Phase NAResults postedn = 50NCT02377947
• A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients: Complete Statistical AnalysisIndependent statistical analysis of A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients: primary endpoint results, effect estimate with confidence…Phase 3Results postedn = 119NCT01330316
• A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults: Complete Statistical AnalysisIndependent statistical analysis of A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase 3Results postedn = 459NCT02481947
• A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01: Complete Statistical AnalysisIndependent statistical analysis of A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase 3Results postedn = 336NCT03285308
• A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia: Complete Statistical AnalysisIndependent statistical analysis of A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 2Results postedn = 146NCT00515034
• A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP): Complete Statistical AnalysisIndependent statistical analysis of A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04578496).Phase 3Results postedn = 16NCT04578496
• A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men: Complete Statistical AnalysisIndependent statistical analysis of A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase NAResults postedn = 128NCT06052202
• A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen: Complete Statistical AnalysisIndependent statistical analysis of A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen: primary endpoint results, effect…Phase 2Results postedn = 171NCT00615056
• A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy: Complete Statistical AnalysisIndependent statistical analysis of A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy: primary endpoint results, effect estimate…Phase 3Results postedn = 917NCT03017235
• A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms: Complete Statistical AnalysisIndependent statistical analysis of A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced…Phase 4Results postedn = 30NCT00658333
• A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma: Complete Statistical AnalysisIndependent statistical analysis of A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma: primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 1/2Results postedn = 62NCT05908786
• A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del: Complete Statistical AnalysisIndependent statistical analysis of A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 3Results postedn = 176NCT04105972
• A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy: Complete Statistical AnalysisIndependent statistical analysis of A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 3Results postedn = 507NCT03525574
• A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy: Complete Statistical AnalysisIndependent statistical analysis of A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04362761).Phase 3Results postedn = 172NCT04362761
• A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies: Complete Statistical AnalysisIndependent statistical analysis of A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination With Immune Therapies in Advanced or Metastatic Malignancies: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 1/2Results postedn = 52NCT03241173
• A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma: Complete Statistical AnalysisIndependent statistical analysis of A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma: primary endpoint results, effect estimate with confidence interval,…Phase 2Results postedn = 106NCT02981342
• A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection: Complete Statistical AnalysisIndependent statistical analysis of A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 2Results postedn = 88NCT04398134
• A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn’s Disease: Complete Statistical AnalysisIndependent statistical analysis of A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 3Results postedn = 28NCT01958827
• A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis: Complete Statistical AnalysisIndependent statistical analysis of A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 3Results postedn = 274NCT00853099
• A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer: Complete Statistical AnalysisIndependent statistical analysis of A Study of Avastin (Bevacizumab) Added to a Chemotherapeutic Regimen in Patients With Metastatic Pancreatic Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 3Results postedn = 607NCT01214720
• A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer: Complete Statistical AnalysisIndependent statistical analysis of A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 2Results postedn = 45NCT02013830

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