sample.csv

nct_id,title,official_title,status,start_date,completion_date,sponsor_name,sponsor_class,conditions,study_type,phases,enrollment,allocation,masking,interventions,primary_outcomes,secondary_outcomes,minimum_age,maximum_age,sex,results_available,locations_count,countries,trial_duration_days,therapeutic_area,primary_endpoint_met
NCT02170727,A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1,A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1,COMPLETED,2014-06-26,2015-09-09,Bristol-Myers Squibb,INDUSTRY,[Hepatitis C Virus],INTERVENTIONAL,[PHASE3],199,NA,NONE,"[{'type': DRUG, 'name': DCV/ASV/BMS-791325, 'description': NULL}]","[{'measure': 'Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort', 'time_frame': Post treatment Week 12, 'description': 'Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA \\< LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.'}]","[{'measure': 'Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort', 'time_frame': Post treatment Week 12, 'description': 'Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA \\< LLOQ target detected or target not detected (LLOQ TD/TND).'}, {'measure': Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND, 'time_frame': 'On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)', 'description': 'Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) \\< lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).'}, {'measure': Percentage of Participants Who Achieved HCV RNA < LLOQ TND, 'time_frame': 'On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)', 'description': 'Percentage of treated participants with HCV RNA \\< LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.'}, {'measure': 'Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment', 'time_frame': Up to post treatment week 4, 'description': 'SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.'}, {'measure': 'Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline', 'time_frame': Up to post treatment week 4, 'description': 'Anemia was defined as hemoglobin \\< 10 g/dL on-treatment for subjects who had hemoglobin \\>= 10 g/dL at baseline.'}, {'measure': 'Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b', 'time_frame': Post treatment week 12, 'description': Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.}, {'measure': 'Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)', 'time_frame': Post treatment Week 12, 'description': 'Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.'}, {'measure': Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12, 'time_frame': Post treatment Week 12, 'description': Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.}, {'measure': Number of Participants With Selected Grade 3/4 Laboratory Abnormalities, 'time_frame': Post treatment week 4, 'description': Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated}, {'measure': Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs, 'time_frame': Up to post treatment week 4, 'description': 'Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.'}, {'measure': Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities, 'time_frame': Up to post treatment week 4, 'description': 'Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted.'}]",,,ALL,true,20,"[Russia, South Korea, Taiwan]",440,Infectious Disease,unknown
NCT01225562,"Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin","A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction",COMPLETED,2010-10-01,2014-12-01,AstraZeneca,INDUSTRY,"[Myocardial Infarction, Cardiovascular Death, Atherothrombosis, Stroke]",INTERVENTIONAL,[PHASE3],21379,RANDOMIZED,QUADRUPLE,"[{'type': DRUG, 'name': Ticagrelor 90 mg, 'description': Oral dose twice a day}, {'type': DRUG, 'name': Ticagrelor 60 mg, 'description': Oral dose twice a day}, {'type': DRUG, 'name': Ticagrelor Placebo, 'description': Oral dose twice a day}]","[{'measure': 'Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization', 'time_frame': Randomization up to 47 months, 'description': 'Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization'}, {'measure': 'Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients', 'time_frame': First dosing up to 48 months, 'description': 'A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of \\>= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug'}]","[{'measure': 'Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization', 'time_frame': Randomization up to 47 months, 'description': 'Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization'}, {'measure': Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization, 'time_frame': Randomization up to 47 months, 'description': 'Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization'}]","{'value': 50, 'unit': years}","{'value': 130, 'unit': years}",ALL,true,826,"[Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Peru, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, 'Turkey (Türkiye)', Ukraine, United Kingdom, United States]",1522,Cardiovascular,true
NCT00092859,A 2-Year Study of an Investigational Drug in Obese Patients (0557-011),"A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients",COMPLETED,2003-08-01,2005-06-01,Merck Sharp & Dohme LLC,INDUSTRY,[Obesity],INTERVENTIONAL,[PHASE3],1500,RANDOMIZED,DOUBLE,"[{'type': DRUG, 'name': MK0557, 'description': NULL}]","[{'measure': Body weight after 1 year of treatment. Safety and tolerability for 2 years., 'time_frame': After 1 & 2 years of treatment, 'description': NULL}]","[{'measure': Durability of weight loss over two years., 'time_frame': Over two years., 'description': NULL}]","{'value': 18, 'unit': years}",,ALL,false,0,[],670,Metabolic / Endocrine,unknown
NCT03081416,"""THINK Trial: Treatment of Headache With IntraNasal Ketamine: A Randomized Controlled Trial Evaluating the Efficacy of Intranasal Ketamine Versus Standard Therapy in the Management of Primary Headache Syndromes in the Emergency Department""","""THINK Trial: Treatment of Headache With IntraNasal Ketamine: A Randomized Controlled Trial Evaluating the Efficacy of Intranasal Ketamine Versus Standard Therapy in the Management of Primary Headache Syndromes in the Emergency Department""",COMPLETED,2016-05-01,2017-10-01,Brooke Army Medical Center,FED,"[Headache, Intranasal Ketamine]",INTERVENTIONAL,[PHASE3],80,RANDOMIZED,SINGLE,"[{'type': DRUG, 'name': Ketamine, 'description': Intranasal ketamine administration}, {'type': DRUG, 'name': Normal saline, 'description': NULL}, {'type': DRUG, 'name': Metoclopramide, 'description': Standard therapy}, {'type': DRUG, 'name': Ketorolac, 'description': standard therapy}, {'type': DRUG, 'name': Dexamethasone, 'description': Standard therapy}, {'type': DRUG, 'name': Benadryl, 'description': Standard therapy}]","[{'measure': VAS 30 min, 'time_frame': 30 min, 'description': Change in Visual Analogue Score at 30 minutes}]","[{'measure': VAS 60 min, 'time_frame': 60 min, 'description': Change in Visual Analogue Score at 60 minutes}, {'measure': NRS at discharge, 'time_frame': Discharge, 'description': Numerical Rating Scale at discharge}, {'measure': NRS 24 hours, 'time_frame': 24 hours, 'description': Pain NRS score at 24 hours post discharge}, {'measure': NRS 72 Hours, 'time_frame': 72 Hours, 'description': Pain NRS score at 72 hours post discharge}, {'measure': Side effects, 'time_frame': At 15 min then at 30 min intervals while in the ED, 'description': Side effects reported by patients in both treatments arms}, {'measure': Repeat ED/primary care encounters, 'time_frame': 24 and 72 hours, 'description': Need for repeat patient evaluation at 24-72 hours}]","{'value': 18, 'unit': years}","{'value': 65, 'unit': years}",ALL,false,1,[United States],518,Neurology / CNS,unknown
NCT00565123,Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis,"A Single- Centre, Randomised Study Of The Clinical And Microbiological Efficacy Of Decreasing The Dosage Of Levofloxacin 0,5% Eye Drops As Compared To Standard Eye Drop Dosage In Patients With Bacterial Conjunctivitis",COMPLETED,2004-09-01,2006-01-01,"Laser Microsurgery Centre, Poland",OTHER,[Bacterial Conjunctivitis],INTERVENTIONAL,"[PHASE2, PHASE3]",119,RANDOMIZED,SINGLE,"[{'type': DRUG, 'name': 0.5% levofloxacin eye drops, 'description': 0.5% levofloxacin eye drops three times daily to each eye for 5 days}, {'type': DRUG, 'name': 0.5% levofloxacin eye drops, 'description': '0.5% levofloxacin eye drops 2 hours on days 1 and 2, and then every 4 hours on days 3-5 (up to 4 times per day)'}]","[{'measure': The primary efficacy endpoint was the clinical cure., 'time_frame': '7(+-1) days', 'description': NULL}]","[{'measure': The secondary efficacy end point was the microbiological eradication., 'time_frame': '7(+-1) days', 'description': NULL}]","{'value': 18, 'unit': years}","{'value': 70, 'unit': years}",ALL,false,1,[Poland],487,Ophthalmology,unknown
NCT02230332,Alendronate to Prevent Loss of Bronchoprotection in Asthma,Proof of Concept Study of Alendronate for Asthma,COMPLETED,2015-01-01,2016-09-01,Milton S. Hershey Medical Center,OTHER,[Asthma],INTERVENTIONAL,"[PHASE2, PHASE3]",78,RANDOMIZED,QUADRUPLE,"[{'type': DRUG, 'name': Alendronate, 'description': NULL}, {'type': DRUG, 'name': Placebo, 'description': NULL}]","[{'measure': Salmeterol Protected Methacholine Challenge PC20, 'time_frame': 8 weeks after randomization, 'description': 'Following administration of Salmeterol, the concentration of Methacholine required to produce a 20% drop in FEV1 - measured in mg/ml and reported on log base 2 scale.'}]","[{'measure': Peripheral Blood Mononuclear Cell ADRB2 Cell Surface Density, 'time_frame': 8 weeks after randomization, 'description': NULL}, {'measure': Beta-2 Adrenergic Receptor Agonist-induced cAMP Production, 'time_frame': 8 weeks after randomization, 'description': 'Peripheral blood mononuclear cells cAMP concentrations measured using isoproterenol (ISO) as a beta-2 adrenergic receptor agonist, and using phosphate buffered saline (PBS) as a positive control. The outcome is expressed as the ratio of cAMP concentration using ISO relative to cAMP concentration using PBS.'}]","{'value': 18, 'unit': years}","{'value': 80, 'unit': years}",ALL,true,10,[United States],609,Respiratory,unknown
NCT06588296,Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight,"Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Active Psoriatic Arthritis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsA)",COMPLETED,2024-09-24,2026-04-23,Eli Lilly and Company,INDUSTRY,"[Psoriatic Arthritis, Obesity]",INTERVENTIONAL,[PHASE3],279,RANDOMIZED,NONE,"[{'type': DRUG, 'name': Ixekizumab, 'description': Administered SC}, {'type': DRUG, 'name': Tirzepatide, 'description': Administered SC}]","[{'measure': 'Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction', 'time_frame': Baseline up to Week 36, 'description': 'ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of Tender Joint Count (TJC) (0-68) and Swollen Joint Count (SJC) (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments:

1. Patient\'s Assessment of Arthritis Pain Visual Analog Scale (VAS)
2. Patient\'s Global Assessment of Disease Activity Numeric Rating Scale (PaGADA \\_NRS)
3. Physician\'s Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
4. Patient\'s Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)'}]","[{'measure': 'Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction', 'time_frame': Baseline up to Week 36, 'description': 'ACR20 is defined as at least 20% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 20% in the number of TJC (0-68) and SJC (0-66) and an improvement of at least 20% in at least 3 of these 5 assessments:

1. Patient\'s Assessment of Arthritis Pain Visual Analog Scale (VAS)
2. Patient\'s Global Assessment of Disease Activity Numeric Rating Scale (PaGADA \\_NRS)
3. Physician\'s Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
4. Patient\'s Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)'}, {'measure': Percentage of Participants Achieving ACR50, 'time_frame': Baseline up to Week 36, 'description': 'ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of TJC (0-68) and SJC (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments:

1. Patient\'s Assessment of Arthritis Pain Visual Analog Scale (VAS)
2. Patient\'s Global Assessment of Disease Activity Numeric Rating Scale (PaGADA \\_NRS)
3. Physician\'s Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
4. Patient\'s Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)'}, {'measure': Percentage of Participants Achieving at Least a 10% Weight Reduction, 'time_frame': Baseline up to Week 36, 'description': Percentage of Participants Who Achieved at Least a 10% Weight Reduction}]","{'value': 18, 'unit': years}","{'value': 80, 'unit': years}",ALL,false,86,"[Puerto Rico, United States]",576,Immunology / Rheumatology,unknown
NCT01768559,Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients,"A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin",COMPLETED,2013-01-01,2014-12-01,Sanofi,INDUSTRY,[Type 2 Diabetes],INTERVENTIONAL,[PHASE3],894,RANDOMIZED,NONE,"[{'type': DRUG, 'name': 'Lixisenatide (AVE0010)', 'description': 'Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection 30 to 60 minutes before breakfast or dinner.'}, {'type': DRUG, 'name': Insulin glulisine QD, 'description': 'Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before breakfast or dinner. The initial dose was 3-5 units and then individually titrated to obtain the SMPG value \\>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before lunch (if administered at breakfast) or at bedtime (if administered at dinner).'}, {'type': DRUG, 'name': Insulin glulisine TID, 'description': 'Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before each meal. The initial dose was 3-5 units for each meal and then individually titrated to obtain the SMPG value \\>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before the next meal or at bedtime (for injection at dinner).'}, {'type': DRUG, 'name': 'Insulin Glargine (Mandatory background drug)', 'description': 'Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL).'}, {'type': DRUG, 'name': 'Metformin (Background drug)', 'description': 'Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.'}]","[{'measure': Change in HbA1c From Baseline to Week 26, 'time_frame': 'Baseline, Week 26', 'description': 'Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.'}, {'measure': Change in Body Weight From Baseline to Week 26, 'time_frame': 'Baseline, Week 26', 'description': Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.

Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.}]","[{'measure': Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26, 'time_frame': Week 26, 'description': The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF.}, {'measure': Percentage of Participants With no Weight Gain at Week 26, 'time_frame': Week 26, 'description': The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug.}, {'measure': Change in Average 7-point SMPG Profiles From Baseline to Week 26, 'time_frame': 'Baseline, Week 26', 'description': 'Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.'}, {'measure': Change in FPG From Baseline to Week 26, 'time_frame': 'Baseline, Week 26', 'description': Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.}, {'measure': 'Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)', 'time_frame': 'Baseline, Week 26', 'description': The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.}, {'measure': 'Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)', 'time_frame': 'Baseline, Week 26', 'description': 'Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.'}, {'measure': Change in Insulin Glargine Dose From Baseline to Week 26, 'time_frame': 'Baseline, Week 26', 'description': Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.}, {'measure': Insulin Glulisine Dose at Week 26, 'time_frame': Week 26, 'description': The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.}, {'measure': Total Insulin Dose at Week 26, 'time_frame': Week 26, 'description': 'The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.

The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9.'}, {'measure': Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia, 'time_frame': 'First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)', 'description': 'Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \\<60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.'}, {'measure': 'Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period', 'time_frame': Week 26, 'description': The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.}, {'measure': Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26, 'time_frame': Week 26, 'description': The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.}, {'measure': 'Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period', 'time_frame': Week 26, 'description': 'The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data.'}]","{'value': 18, 'unit': years}",,ALL,true,199,"[Canada, Chile, Czechia, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Poland, Romania, Russia, Spain, Ukraine, United Kingdom, United States]",699,Metabolic / Endocrine,unknown
NCT00265837,Laboratory-Treated Donor Bone Marrow in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer,Phase III Trial of T Lymphocyte Depletion by Elutriation and CD34 Add-Back for Allogeneic Bone Marrow Transplantation,COMPLETED,2002-12-01,2007-08-01,Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,OTHER,"[Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases]",INTERVENTIONAL,[PHASE3],72,RANDOMIZED,NONE,"[{'type': BIOLOGICAL, 'name': graft versus host disease prophylaxis/therapy, 'description': NULL}, {'type': PROCEDURE, 'name': allogeneic bone marrow transplantation, 'description': NULL}, {'type': PROCEDURE, 'name': in vitro-treated bone marrow transplantation, 'description': NULL}]","[{'measure': Incidence of graft-vs-host disease or graft failure, 'time_frame': NULL, 'description': NULL}]",,,"{'value': 65, 'unit': years}",ALL,false,1,[United States],1704,Oncology,unknown
NCT00598312,Safety and Efficacy Study of Leuprolide Acetate for Injectable Suspension 22.5 MG in the Treatment of Prostate Cancer,"A Phase 3, Open-Label, Multi-Center, Safety And Efficacy Study of Oakwood Laboratories' Leuprolide Acetate For Injectable Suspension 22.5 mg In Patients With Prostate Cancer",COMPLETED,2007-04-01,2008-08-01,"Oakwood Laboratories, LLC",INDUSTRY,[Prostate Cancer],INTERVENTIONAL,[PHASE3],201,RANDOMIZED,NONE,"[{'type': DRUG, 'name': Leuprolide Acetate for Injectable Suspension, 'description': 'Sustained release injectable microspheres, 22.5 mg, one injection every 84 days, 3-month product'}]","[{'measure': The percentage of responders who attain and maintain castrate levels of serum testosterone, 'time_frame': From Day 28 to Day 168., 'description': NULL}]","[{'measure': Safety as shown through laboratory parameters, 'time_frame': Day 0 - Day 168, 'description': 'Hematology, chemistry and urinalysis'}, {'measure': Leuprolide serum profiles following administration study drug product., 'time_frame': Day 0 - Day 168, 'description': 'Leuprolide levels (ng/dL) measured at designated time points to determine a pharmacokinetic profile for the product.'}, {'measure': Safety as shown through reported adverse events, 'time_frame': Day 0 -168, 'description': NULL}]","{'value': 45, 'unit': years}",,MALE,false,1,[United States],488,Oncology,unknown
NCT02522117,Atorvastatin in the Recipient's Kidney Graft From a Living Donor,"Effectiveness of Atorvastatin on IL2, IL6, TNFalpha and HLA Levels in the Recipient's Kidney Graft From a Living Donor",COMPLETED,2015-08-01,2018-01-01,Instituto Mexicano del Seguro Social,OTHER_GOV,[Renal Insufficiency],INTERVENTIONAL,[PHASE3],48,RANDOMIZED,DOUBLE,"[{'type': DRUG, 'name': Atorvastatin, 'description': 'Patients were assigned to two groups; one of them received oral atorvastatin (study group), and the other homologated placebo (control group) for 4 weeks before transplant. Then IL2, IL6, TNFalpha and HLA levels were assessed in the recipient\'s kidney graft by visual analog scale at prior reperfusion, and after 3 and 12 months.'}, {'type': DRUG, 'name': Placebo, 'description': 'Patients were assigned to two groups; one of them received oral atorvastatin (study group), and the other homologated placebo (control group) for 4 weeks before transplant. Then IL2, IL6, TNFalpha and HLA levels were assessed in the recipient\'s kidney graft by visual analog scale at prior reperfusion, and after 3 and 12 months.'}]","[{'measure': HLA levels in the kidney graft biopsy, 'time_frame': 12 months, 'description': 'HLA levels were measure by immunohistochemistry, observing alteration between groups.'}]","[{'measure': Renal function, 'time_frame': 12 months, 'description': 'In a blood sample and in a urine 24-hour collection, serum creatinine, serum urea, creatinine clearance, urine output, and proteinuria were measure. Differences in evolution and alteration between the 2 groups were registered.'}, {'measure': Kidney graft survival, 'time_frame': 12 months, 'description': 'In a renal biopsy using the Banff classification of renal allograft rejection grades, were assessed histologic and molecular features by microscopy and immunofluorescence. Alterations between groups were registered.'}, {'measure': Surgery complications, 'time_frame': 12 months, 'description': 'During surgical procedure and following, any kind of complication was registered.'}, {'measure': TNFalpha levels in the kidney graft biopsy, 'time_frame': 12 months, 'description': 'TNFalpha levels were measure by immunohistochemistry, observing alteration between groups.'}, {'measure': IL2 and IL6 levels in the kidney graft biopsy, 'time_frame': 12 months, 'description': 'IL2 and IL6 levels were measure by immunohistochemistry, observing alteration between groups.'}]","{'value': 18, 'unit': years}",,ALL,false,1,[Mexico],884,Other,unknown
NCT00113620,Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy,"A Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dextromethorphan and Quinidine at Two Dose Levels in the Treatment of the Pain of Diabetic Neuropathy",COMPLETED,2005-07-01,2007-02-01,Avanir Pharmaceuticals,INDUSTRY,"[Pain, Diabetic Neuropathy]",INTERVENTIONAL,[PHASE3],450,RANDOMIZED,DOUBLE,"[{'type': DRUG, 'name': Neurodex, 'description': NULL}]","[{'measure': Pain rating scale obtained from patient diaries, 'time_frame': NULL, 'description': NULL}]","[{'measure': Additional diary rating scales and scores obtained from clinic visits, 'time_frame': NULL, 'description': NULL}]","{'value': 18, 'unit': years}","{'value': 80, 'unit': years}",ALL,false,44,[United States],580,Neurology / CNS,unknown
NCT01817790,Assessment of Fluticasone Propionate on Ocular Allergy Symptoms,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy of Once-Daily Fluticasone Propionate Aqueous Nasal Spray 200mcg for 14 Days on Ocular Symptoms Associated With Seasonal Allergic Rhinitis",COMPLETED,2012-12-01,2013-02-01,GlaxoSmithKline,INDUSTRY,"[Allergic Rhinitis, Seasonal Allergic Rhinitis]",INTERVENTIONAL,[PHASE3],626,RANDOMIZED,TRIPLE,"[{'type': DRUG, 'name': Fluticasone propionate, 'description': 'Nasal spray formulation (200 mcg/day)'}, {'type': DRUG, 'name': Placebo, 'description': Vehicle for Fluticasone propionate aqueous nasal spray}]","[{'measure': 'Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)', 'time_frame': Baseline to 14 days, 'description': 'The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject\'s treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.'}]","[{'measure': Mean Change From Baseline in AM rTOSS, 'time_frame': Baseline to 14 days, 'description': 'rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For AM rToss, subjects completed rTOSS in the morning (AM score: prior to nasal spray use). The mean change from baseline in AM rTOSS was calculated as the subject\'s treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.'}, {'measure': Mean Change From Baseline in PM rTOSS, 'time_frame': Baseline to 14 days, 'description': 'rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For PM rTOSS, subjects completed rTOSS in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM rTOSS was calculated as the subject\'s treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.'}, {'measure': Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning, 'time_frame': Baseline to 14 days, 'description': 'The AM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject\'s treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.'}, {'measure': Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning, 'time_frame': Baseline to 14 days, 'description': 'The PM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject\'s treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.'}, {'measure': Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering, 'time_frame': Baseline to 14 days, 'description': 'The AM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject\'s treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.'}, {'measure': Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering, 'time_frame': Baseline to 14 days, 'description': 'The PM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject\'s treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.'}, {'measure': Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness, 'time_frame': Baseline to 14 days, 'description': 'The AM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye redness) was calculated as the subject\'s treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.'}, {'measure': Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness, 'time_frame': Baseline to 14 days, 'description': 'The PM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye redness) was calculated as the subject\'s treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.'}, {'measure': 'Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)', 'time_frame': Baseline to 14 days, 'description': 'Instantaneous total ocular symptom scores (iTOSS) assessments are self perceived evaluation of symptom severity immediately before the dose (how the subject feels at that point in time). iTOSS (possible score of 0-9) is the sum of 3 individual participant-assessed symptom scores for eye itching/burning, eye tearing/watering, and eye redness each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Mean changes from baseline were calculated as treatment period iTOSS minus baseline iTOSS.'}, {'measure': 'Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS)', 'time_frame': Baseline to 14 days, 'description': 'The rNCSS is a participant perceived evaluation of overall congestion symptom severity (evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe) which was completed once in the evening (PM), and once in the morning (AM). rNCSS is defined as the average of the PM rNCSS and the AM rNCSS of the next day prior to AM dosing. The mean change from baseline in rNCSS (daily, AM, PM)was calculated as the subject\'s treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.'}, {'measure': End-of-treatment Assessment of Response to Therapy for Ocular Symptoms, 'time_frame': Day 14, 'description': 'Overall response to therapy assessment was done using a 7-point categorical scale in which participants rated their response to therapy as follows: +3 = Significantly Improved; +2 = Moderately Improved; +1 = Mildly Improved; 0 = No Change; -1= Mildly Worse; -2 = Moderately Worse; -3 = Significantly Worse.'}, {'measure': Mean Change in Objective Assessment of Conjunctival Redness, 'time_frame': Baseline to 14 days, 'description': 'Conjunctival redness was evaluated as a clinical sign of SAR by the investigator. Scoring of severity was rated according to a 4-point scale: 0 = normal; 1 = Slightly pink; 2 = Moderately pink, some dilation; 3 = Intense red vessels, dilated.'}, {'measure': 'Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores', 'time_frame': Baseline to 14 days, 'description': 'MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. It measures five domains of functional impairment that are most important to subjects with SAR: practical problems, nasal symptoms, eye symptoms, activity limitations, and other symptoms. Participants scored their degree of impairment on a seven-point scale. (0 - 6). Mini RQLQ final score is the average of sub-scales, ranges from 0 (best possible outcome) to 6 (worst possible outcome).'}, {'measure': 'Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities', 'time_frame': Baseline to 14 days, 'description': 'MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Activity limitations is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).'}, {'measure': 'Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems', 'time_frame': Baseline to 14 days, 'description': 'MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. \'Practical Problems\' is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).'}, {'measure': 'Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms', 'time_frame': Baseline to 14 days, 'description': 'MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. ""Nose Symptoms"" is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).'}, {'measure': 'Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms', 'time_frame': Baseline to 14 days, 'description': 'MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. ""Eye Symptoms"" is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).'}, {'measure': 'Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms', 'time_frame': Baseline to 14 days, 'description': 'MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. ""Other Symptoms"" is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).'}]","{'value': 12, 'unit': years}",,ALL,true,1,[United States],62,Immunology / Rheumatology,true
NCT06341998,Clinical Study of Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children,Clinical Study of Sirolimus Combined With Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children,COMPLETED,2020-06-01,2024-02-01,Shandong First Medical University,OTHER,"[Germ Cell Tumor, Yolk Sac Tumor]",INTERVENTIONAL,"[PHASE2, PHASE3]",32,NA,NONE,"[{'type': DRUG, 'name': sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children, 'description': 'The planned treatment protocol comprised four cycles of the S-TIC regimen, which included sirolimus administered orally at a dose of 1 mg/m² from day 1 to day 21-28, nab-paclitaxel at a dose of 200 mg/m² on day 1, ifosfamide at a dose of 1200 mg/m² from day 2 to day 5, and carboplatin at a dose of 400 mg/m² on day 2. Additionally, mesna and sulfamethoxazole were prescribed to prevent hemorrhagic cystitis and Pneumocystis Jirovecii Pneumonia (PJP), respectively. Each cycle spanned a duration of three to four weeks. AFP levels were evaluated at the end of each cycle, and radiological assessments were conducted every two cycles. Surgical intervention decisions were made based on the results of these assessments.'}]","[{'measure': 'ORR: Objective Response Rate Allocation \'Non-Randomized\' implies that this is a multi-arm study, but only one arm has been specified. Objective Response Rate', 'time_frame': 'Each treatment cycle spans 3 to 4 weeks, 1-4 cycles, last at lest 3 to 16 weeks.', 'description': 'Each treatment cycle spans 21 to 28 days (equivalent to every 3 to 4 weeks). Provided that the treatment criteria outlined in the study are satisfied, the second and subsequent cycles will commence on either the 22nd or 29th day. In the event of severe drug-related adverse reactions, treatment will be discontinued, and the patient will be classified as having PD. Tumor response assessment will entail the re-evaluation of AFP and LDH levels every cycle, alongside imaging examinations every two cycles. Should AFP levels demonstrate a continuous increase over two consecutive monitoring sessions following the initial treatment cycle, or if imaging results indicate tumor progression, a diagnosis of PD will be made, resulting in the termination of the clinical trial. For pediatric patients whose trials have been terminated, alternative anti-tumor therapies will be administered in accordance with their individual clinical conditions.'}]","[{'measure': 'Secondary endpoints included the progression-free survival (PFS) rate, overall survival (OS), and safety profile.', 'time_frame': 'After each patient completed the clinical trial, they underwent imaging assessment examinations at 3/6/9/12/18/24/30/36/48/60 months after the end of the treatment.', 'description': 'The study employed a Simon\'s two-stage optimal design with a one-sided alpha of 20% and 95% power to test the null hypothesis of ≤5% objective response rate (ORR) against the alternative hypothesis of ≥20% ORR. In the first stage, 10 patients were enrolled: if ≤1 patient achieved an objective response (CR/PR), the trial would be terminated for futility. Otherwise, enrollment would expand to a total of 32 patients. The regimen would be considered promising if ≥6 objective responses were observed in the final analysis. The median PFS and overall survival (OS) were estimated using the Kaplan-Meier method, implemented through the ""survival"" and ""survminer"" packages in R software (version 4.2.2). Correlations between OS and other endpoints were assessed at the patient level using Spearman\'s rank correlation coefficient (ρ).'}]","{'value': 1, 'unit': years}","{'value': 18, 'unit': years}",ALL,false,1,[China],1340,Oncology,unknown
NCT01514461,"A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome","A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome",COMPLETED,2012-07-01,2014-05-01,Novartis Pharmaceuticals,INDUSTRY,['Familial Chylomicronemia Syndrome (FCS)'],INTERVENTIONAL,[PHASE3],45,RANDOMIZED,DOUBLE,"[{'type': DRUG, 'name': LCQ908, 'description': 'LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg'}, {'type': DRUG, 'name': Placebo, 'description': 'LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg'}]","[{'measure': Percent Change in Fasting Triglycerides From Baseline to 12 Weeks, 'time_frame': Baseline to 12 weeks, 'description': 'Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.'}]","[{'measure': 'Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL)', 'time_frame': 'Baseline, 12 weeks, 24 weeks, 52 weeks', 'description': 'Percentage calculated as (m/n)\\*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.'}, {'measure': 'Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL)', 'time_frame': '12 weeks, 24 weeks, 52 weeks', 'description': 'Percentage calculated as (m/n)\\*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.'}, {'measure': 'Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline', 'time_frame': 'Baseline, 12 weeks, 24 weeks, 52 weeks', 'description': 'Percentage calculated as (m/n)\\*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.'}, {'measure': 'Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds', 'time_frame': '12 weeks, 24 weeks, 52 weeks', 'description': 'Percentage of patients reaching target values of \\<1000 mg/dL or target values of \\< 2000 mg/dL for fasting triglycerides is reported. Pecentage calculated as (m/n)\\*100; where \'m\' The number of patients who reach target values for fasting triglyceride, \'n\' the number of patients with non-missing fasting triglyceride.'}, {'measure': Percent Change From Baseline in Fasting Triglycerides, 'time_frame': 'Baseline, 24 weeks, 52 weeks', 'description': NULL}, {'measure': Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12, 'time_frame': '0-24 hours at Baseline, Week 12', 'description': Post prandial peak triglycerides - maximum triglyceride value over 0-24 hours Post prandial triglycerides AUC0-24 - area under the time curve for triglycerides over 0-24 Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressed as a percentage change from baseline. hours}, {'measure': 'Pharmacokinetics of LCQ908 - Trough Concentration (Cmin) and Observed Maximum Blood Concentration (Cmax)', 'time_frame': '0, 1, 2, 3, 4, 6, and 24 hours at Week 12', 'description': 'Lowest observed blood concentration (Cmin) and observed maximum blood concentration (Cmax) following drug administration derived from non-compartmental analysis using scheduled sampling time for the whole dataset.'}, {'measure': 'Pharmacokinetics of LCQ908- Area Under the Plasma Concentration Time Curve AUC (0-24hour)', 'time_frame': '0, 1, 2, 3, 4, 6, and 24 hours at Week 12', 'description': The area under the concentration-time curve from time zero to 24 hours after drug administration was calculated by using linear trapezoidal rule.}, {'measure': 'Pharmacokinetics of LCQ908- Time to Reach Maximum Concentration Following Drug Administration Tmax (Hours)', 'time_frame': '0, 1, 2, 3, 4, 6, and 24 hours at Week 12', 'description': NULL}, {'measure': 'Pharmacokinetics of LCQ908- Average Observed Blood Concentration (Cavg)', 'time_frame': '0, 1, 2, 3, 4, 6, and 24 hours at Week 12', 'description': 'Average observed blood concentration measured by (AUC0-24)/24.'}, {'measure': 'Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death', 'time_frame': 52 weeks, 'description': NULL}]","{'value': 18, 'unit': years}",,ALL,true,14,"[Canada, France, Germany, Netherlands, South Africa, Spain, United Kingdom, United States]",669,Rare Disease / Orphan,false
NCT01292057,Aripiprazole Effects on Alcohol Drinking and Craving,Impulsivity and Drinking/Craving: Effect of a Dopamine Stabilizer Medication,COMPLETED,2011-02-01,2015-12-01,Medical University of South Carolina,OTHER,[Alcohol Dependence],INTERVENTIONAL,[PHASE3],99,RANDOMIZED,TRIPLE,"[{'type': DRUG, 'name': Aripiprazole, 'description': 'Aripiprazole(up to 15 mg/day) for 8 days'}, {'type': DRUG, 'name': Placebo, 'description': Placebo to match active drug Aripiprazole for 8 days}]","[{'measure': 'Total Number of Drinks Per Day During Natural (Usual Environment) Conditions', 'time_frame': 6-day observation period, 'description': '""Natural"" alcohol consumption period -- drinks per day consumed during the 6-day observation period'}, {'measure': Total Number of Drinks Consumed in Bar Lab, 'time_frame': 2 hours during the bar lab paradigm, 'description': 'This measure refers to a ""bar lab"" paradigm in which individuals received an initial ""priming"" drink of alcohol, targeted to produce a breath alcohol concentration (BrAC) of 30 mg%, and could then choose to consume up to 8 additional drinks, each targeted to produce a BrAC of 15 mg%, during the subsequent 2 hours. Thus, the total number of drinks consumed could range between 0 and 8.'}]",,"{'value': 21, 'unit': years}","{'value': 40, 'unit': years}",ALL,true,1,[United States],1764,Other,unknown
NCT00075088,Tele-Electrocardiography in Emergency Cardiac Care,Tele-electrocardiography in Emergency Cardiac Care,COMPLETED,2003-09-01,2009-06-01,"University of California, San Francisco",OTHER,"[Myocardial Infarction, Chest Pain]",INTERVENTIONAL,[PHASE3],794,RANDOMIZED,NONE,"[{'type': DEVICE, 'name': 'Electrocardiogram (ECG) Intervention', 'description': 'Pre-hospital electrocardiographic (ECG) monitoring with special software to detect myocardial ischemia and to automatically transmit an ECG to the destination hospital emergency department with a voice alarm announcing ""Incoming ECG from the field"" and print out in the ED.'}, {'type': OTHER, 'name': Routine Clinical Practice, 'description': ECG in the ED as part of routine clinical practice.}]","[{'measure': Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI, 'time_frame': Day 1, 'description': Time from ED arrival to first drug was determined as recommended by American College of Cardiology/American Heart Association 2007 guidelines for management of patients with unstable angina/non-STEMI}, {'measure': 'Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)', 'time_frame': Day 1, 'description': Mean door-to-balloon time}]","[{'measure': Rehospitalization and Mortality, 'time_frame': 4 years, 'description': NULL}]","{'value': 18, 'unit': years}",,ALL,true,1,[United States],2100,Cardiovascular,true
NCT00789633,Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer,"A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib 9 mg/kg/Day in Combination With Gemcitabine Compared to Placebo in Combination With Gemcitabine in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer",COMPLETED,2008-11-25,2012-08-31,AB Science,INDUSTRY,[Pancreatic Cancer],INTERVENTIONAL,[PHASE3],353,RANDOMIZED,QUADRUPLE,"[{'type': DRUG, 'name': Masitinib, 'description': Masitinib at 9 mg/kg/day given orally twice daily}, {'type': DRUG, 'name': Placebo, 'description': Matching placebo given orally twice daily}, {'type': DRUG, 'name': Gemcitabine, 'description': Gemcitabine at 1000 mg/m2 by intravenous infusion}]","[{'measure': 'Overall Survival (OS)', 'time_frame': 'From day of randomization to the date of death, assessed up to 60 months', 'description': 'Overall survival is defined as time in months from the randomization date to the date of death due to any cause. If a patient is not known to have died, then OS will be censored at the date of last known date patient alive.'}]","[{'measure': Survival rate, 'time_frame': 'Every 24 weeks, assessed up to 60 months', 'description': 'Defined as the proportion of patients alive at each time point, estimated with Kaplan-Meier distribution.'}, {'measure': 'Progression Free Survival (PFS)', 'time_frame': 'From day of randomization to disease progression or death, whichever came first, assessed up to 60 months', 'description': 'Progression Free Survival is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Disease progression will be assessed by the investigator on CT scan according to RECIST 1.1 criteria.'}]","{'value': 18, 'unit': years}",,ALL,false,68,"[Czechia, France, Lebanon, Romania, United States]",1375,Oncology,unknown
NCT00257062,A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Uncomplicated Infections of the Skin and the Supportive Layers Beneath the Skin,"A Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Oral Levofloxacin With That of Ciprofloxacin HCl in the Treatment of Uncomplicated Skin and Skin Structure Infections in Adults",COMPLETED,1993-01-01,1994-04-01,"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.",INDUSTRY,"['Skin Diseases, Infectious']",INTERVENTIONAL,[PHASE3],361,RANDOMIZED,DOUBLE,"[{'type': DRUG, 'name': Levofloxacin, 'description': NULL}]","[{'measure': 'Clinical response rate at post-therapy (defined as cured, improved or failed); microbiological response at post-therapy (rate of elimination of disease-causing bacteria, by patient, and by type of bacteria); incidence of adverse events', 'time_frame': NULL, 'description': NULL}]","[{'measure': Changes in physical examination and laboratory tests after treatment with the study drug, 'time_frame': NULL, 'description': NULL}]","{'value': 18, 'unit': years}",,ALL,false,0,[],455,Dermatology,unknown
NCT05630001,"Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan.","A Multicenter, Single Arm, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily Iptacopan in Adult PNH Patients Who Have Hb≥10 g/dL in Response to Anti-C5 Antibody and Switch to Iptacopan",COMPLETED,2023-04-24,2024-10-17,Novartis Pharmaceuticals,INDUSTRY,[Paroxysmal Nocturnal Hemoglobinuria],INTERVENTIONAL,[PHASE3],52,NA,NONE,"[{'type': DRUG, 'name': Iptacopan, 'description': 'Treatment with iptacopan at a dose of 200 mg b.i.d. will start on the first day (Day 1) and continue for 24 weeks.'}]","[{'measure': Change in Hb Levels as Mean of Visits Between Day 126 and Day 168 Compared to Baseline Tested for Non-inferiority, 'time_frame': 'Baseline, Day 126 to Day 168', 'description': 'Change in hemoglobin (Hb) levels as mean of visits between Day 126 and Day 168 compared to baseline.

Baseline is defined as as the mean of three Hb assessments conducted at the central laboratory: two during screening and the third on Day 1.

The estimation of change from baseline in Hb levels was handled by the hypothetical strategy where participants were assumed as if they did not receive RBC transfusions while on treatment (RBC transfusions were expected to be rare).

Assuming that participants had stable Hb levels at study entry, the mean change from baseline in Hb level between Day 126 and Day 168 was expected to be unchanged should participants have continued on anti-C5 treatment. Non-inferiority of iptacopan was therefore tested by the null hypothesis (H0) against the alternate hypothesis (H1) comparing the mean change from baseline in Hb level in iptacopan between Day 126 and Day 168 (μ) to -1 g/dL: H0: μ \\<= -1, H1: μ \\> -1.'}]","[{'measure': Change in Hb Levels as Mean of Visits Between Day 126 and Day 168 Compared to Baseline Tested for Superiority, 'time_frame': 'Baseline, Day 126 to Day 168', 'description': 'Change in hemoglobin (Hb) levels as mean of visits between Day 126 and Day 168 compared to baseline.

Baseline is defined as as the mean of three Hb assessments conducted at the central laboratory: two during screening and the third on Day 1.'}, {'measure': Proportion of Hematological Responders to Iptacopan Treatment, 'time_frame': Day 126 to Day 168, 'description': 'Response defined as Hb ≥12 g/dL assessed between visits Day 126 and Day 168 in the absence of RBC transfusions, on three out of four measurements taken at the visits occurring in last six weeks'}, {'measure': Proportion of Participants Who Remain Free From Transfusions, 'time_frame': Day 1 to Day 168, 'description': Number of participants with absence of administration of packed RBC transfusions between Day 1 and Day 168}, {'measure': 'Change From Baseline in Absolute Reticulocytes Count (ARC) Levels', 'time_frame': 'Baseline, Day 126 to Day 168', 'description': Change from baseline in ARC levels as mean of visits between Day 126 and Day 168}, {'measure': 'Percentage Change From Baseline in Lactate Dehydrogenase (LDH) Levels', 'time_frame': 'Baseline, Day 126 to Day 168', 'description': Percentage change from baseline in LDH levels as mean of visits between Day 126 and Day 168}, {'measure': Change From Baseline in Treatment Satisfaction Score Using TSQM-9 Questionnaire, 'time_frame': 'Baseline, Day 84 and Day 168', 'description': 'Difference in scores of the Treatment Satisfaction Questionnaire for Medication(TSQM-9) between baseline and Day 84 and Day 168 assessed after switching from SoC (anti-C5) to iptacopan.

TSQM-9 is a patient reported outcomes measure that was designed to assess patients\' satisfaction with medication across three domains of effectiveness, convenience and global satisfaction. The TSQM-9 contains 3 questions in each domain. Domain scores range from 0 - 100 with higher scores representing better outcomes for the domain.'}, {'measure': Change From Baseline in Fatigue Score Using FACIT-F Questionnaire, 'time_frame': 'Baseline, Day 84 and Day 168', 'description': 'Change from baseline in patient-reported scores for the functional assessment of chronic illness therapy - Fatigue (FACIT-F) collected at Day 84 and Day 168.

The FACIT-F is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. All FACIT scales are scored so that a high score is better. As each of the 13 items of the FACIT-F scale ranges from 0-4, the range of possible scores is 0-52, with 0 being the worst possible score and 52 the best.'}, {'measure': 'Percentage of Patients Who Had Breakthrough Hemolysis (BTH) Event', 'time_frame': Up to 168 Days, 'description': 'Wilson method is used to calculate the confidence interval for the proportion of patients who had events.

The breakthrough is defined clinical if either there is a decrease in hemoglobin levels equal to or more than 2 g/dL (compared to the latest assessment) or if patients present signs or symptoms of gross hemoglobinuria, painful crisis, dysphagia or any other significant clinical PNH-related signs \\& symptoms, in presence of laboratory evidence of intravascular hemolysis.'}, {'measure': 'Percentage of Patients Who Had Major Adverse Vascular Events (MAVEs)', 'time_frame': Up to 168 Days, 'description': 'A MAVE is defined as: acute peripheral vascular occlusion, amputation (non-traumatic; nondiabetic), cerebral arterial occlusion/cerebrovascular accident, cerebral venous occlusion, dermal thrombosis, gangrene (non-traumatic; nondiabetic), hepatic/portal vein thrombosis (Budd-Chiari syndrome), mesenteric/visceral arterial thrombosis or infarction, mesenteric/visceral vein thrombosis or infarction, myocardial infarction, pulmonary embolus, renal arterial thrombosis, renal vein thrombosis, thrombophlebitis / deep vein thrombosis, transient ischemic attack, unstable angina or other.'}]","{'value': 18, 'unit': years}","{'value': 100, 'unit': years}",ALL,true,23,"[France, Germany, Italy, South Korea, Spain, 'Turkey (Türkiye)', United Kingdom, United States]",542,Other,true
NCT04518462,"Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries","A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic (in Popliteal Fossa) and Saphenous (in Adductor Canal) Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries",COMPLETED,2020-10-20,2021-04-05,"Pacira Pharmaceuticals, Inc",INDUSTRY,"[Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion, Hindfoot Fushion, Total Ankle Arthroplasty]",INTERVENTIONAL,[PHASE3],121,RANDOMIZED,QUADRUPLE,"[{'type': DRUG, 'name': Exparel, 'description': 'EXPAREL (bupivacaine liposome injectable suspension)'}, {'type': DRUG, 'name': Bupivacaine Hydrochloride, 'description': 0.25% bupivacaine}]","[{'measure': 'Magnitude of the Analgesic Effect (NRS Pain Intensity) (AUC)', 'time_frame': Post surgery - 96 hours, 'description': 'To compare the magnitude of the analgesic effect (NRS pain intensity scores) following a single dose injection of EXPAREL vs. bupivacaine hydrochloride (HCl) when administered as combined sciatic (in the popliteal fossa) and saphenous (in the adductor canal) nerve blocks in subjects undergoing lower extremity surgeries.

Numerical Rating Scale: an 11 point scale 0=no pain, 10= the worst pain imaginable. The area under the curve (AUC) of the NRS pain intensity scores from 0 to 96 hours post-surgery comparing EXPAREL to 0.25% bupivacaine HCl'}]","[{'measure': Total Opioid Consumption, 'time_frame': 0 hours to 96 hours, 'description': Total Opioid Consumption in oral morphine equivalents}, {'measure': Time to First Opioid, 'time_frame': Post Surgery through Day 14, 'description': Time to First Opioid following a single dose of EXPAREL vs. Bupivacain HCl}]","{'value': 18, 'unit': years}",,ALL,true,5,[United States],167,Other,unknown
NCT00100308,Unfractioned Heparin for Treatment of Sepsis,Unfractioned Heparin for Treatment of Sepsis: A Randomized Clinical Trial (The HETRASE Study),COMPLETED,2005-07-01,2007-07-01,Universidad de Antioquia,OTHER,"[Sepsis, Bacterial Infections]",INTERVENTIONAL,[PHASE3],319,RANDOMIZED,QUADRUPLE,"[{'type': DRUG, 'name': Unfractioned heparin, 'description': 'Low-dose continuous-infusion, 500 units/hour per seven days'}, {'type': DRUG, 'name': saline, 'description': Saline placebo}]","[{'measure': 'Change from baseline Multiple Organ Dysfunction (MOD) score', 'time_frame': 15 days, 'description': NULL}, {'measure': Length of stay, 'time_frame': During hospitalization, 'description': NULL}]","[{'measure': 28-day all-cause mortality, 'time_frame': 28 days, 'description': NULL}]","{'value': 18, 'unit': years}",,ALL,false,1,[Colombia],730,Infectious Disease,unknown
NCT00392899,Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery,Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer,COMPLETED,2006-10-01,2016-09-01,"Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan",OTHER,[Colorectal Cancer],INTERVENTIONAL,[PHASE3],2025,RANDOMIZED,NONE,"[{'type': DRUG, 'name': UFT adjuvant chemotherapy, 'description': 'UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.'}]","[{'measure': Disease-free survival, 'time_frame': 9 years, 'description': 'Disease-free survival is defined as the time from date of enrollement until date of recurrence, other malignancies or death from any cause, whichever comes first.'}]","[{'measure': Overall survival, 'time_frame': 9 years, 'description': Overall survival is defined as time from date of enrollment until date of death from any cause.}, {'measure': Types and severities of adverse events, 'time_frame': 15 months, 'description': 'Types and severities of adverse events from date of starting protocol treatment until 30 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.'}]","{'value': 20, 'unit': years}","{'value': 80, 'unit': years}",ALL,false,272,[Japan],3623,Oncology,unknown
NCT04210193,Is Intralymphatic Allergen Immunotherapy Effective and Safe?,Is Intralymphatic Allergen Immunotherapy Effective and Safe: a Human Randomized Clinical Trial- Substudy Borås With a Randomized Preseasonal Booster,COMPLETED,2014-04-25,2019-12-01,Lars Olaf Cardell,OTHER,[Allergic Rhinitis Due to Grass Pollen],INTERVENTIONAL,"[PHASE2, PHASE3]",15,RANDOMIZED,QUADRUPLE,"[{'type': DRUG, 'name': ALK Alutard 5-grasses, 'description': '0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection'}, {'type': DRUG, 'name': ALK Diluent, 'description': 0.1 mL of ALK Diluent as an intralymphatic injection}]","[{'measure': Change in the serum-level of timothy specific IgG4 after 1 month, 'time_frame': Change between baseline and 1 month after treatment., 'description': Blood samples with measurement of allergen specific blocking IgG4 antibodies}, {'measure': Change in the serum-level of timothy specific IgG4 after 9 months, 'time_frame': Change between baseline and 9 months after treatment., 'description': Blood samples with measurement of allergen specific blocking IgG4 antibodies}, {'measure': Change in the serum-level of timothy specific IgG4 2 months after booster, 'time_frame': 'Change between baseline and 2 months after the booster treatment (14 months after the basic treatment).', 'description': Blood samples with measurement of allergen specific blocking IgG4 antibodies}, {'measure': Change in the serum-level of timothy specific IgG4 10 months after booster, 'time_frame': 'Change between baseline and 10 months after the booster treatment (22 months after the basic treatment).', 'description': Blood samples with measurement of allergen specific blocking IgG4 antibodies}]",,"{'value': 18, 'unit': years}","{'value': 55, 'unit': years}",ALL,false,1,[Sweden],2046,Dermatology,unknown
NCT01697111,Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis,"A Multi-center, Randomized, Double-blinded, Placebo-controlled, and Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of an Extended Flexible Regimen of BAY 86-5300 [0.02 mg Ethinylestradiol (β-CDC) and 3 mg Drospirenone] in the Patients With Endometriosis",COMPLETED,2012-10-01,2014-12-01,Bayer,INDUSTRY,[Endometriosis],INTERVENTIONAL,[PHASE3],312,RANDOMIZED,TRIPLE,"[{'type': DRUG, 'name': 'EE20/DRSP(BAY86-5300)', 'description': 'One tablet \\[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\\] / day'}, {'type': DRUG, 'name': Placebo, 'description': 'One tablet (no active ingredient) / day and one tablet \\[0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone\\] / day, for the first 24 weeks and the later 28 weeks, respectively'}, {'type': DRUG, 'name': Dienogest, 'description': 'Dienogest 1mg twice a day (bid)'}]","[{'measure': 'Change of pelvic pain from baseline period (8 weeks before start of treatment) to period of treatment (weeks 17-24)', 'time_frame': 'Baseline period (8 weeks before start of treatment) and period of treatment (weeks 17-24)', 'description': 'The pelvic pain is measured as the severest pain marked by the participant on a Visual Analogue Scale (VAS)'}]","[{'measure': 'Pelvic pain during menstrual or withdrawal bleeding period (except for dyspareunia and defecation pain)', 'time_frame': Weeks 17-24 of treatment period, 'description': Pelvic pain is the worst pain on a 0-10 scale rated by the participant.}, {'measure': 'Pelvic pain during non-menstrual period and non-withdrawal bleeding period (except for dyspareunia and defecation pain)', 'time_frame': Weeks 17-24 of treatment period, 'description': Pelvic pain is the worst pain on a 0-10 scale rated by the participant.}, {'measure': Dyspareunia, 'time_frame': Weeks 17-24 of treatment period, 'description': 'In case having sexual intercourse, dyspareunia pain is the worst pain on a 0-10 scale rated by the participant in the last 24 hours.'}, {'measure': Average of pain, 'time_frame': Weeks 17-24 of treatment period, 'description': 'The average of pain is the mean value of the Visual Analogue Scale (VAS) value during the time frame calculated for each patient based on daily record of Patient Diary.'}, {'measure': Size of chocolate cyst, 'time_frame': 24 weeks after taking the initial study medication, 'description': 'In case chocolate cyst is detected, size of chocolate cyst is a mean length (mm) of the longest axis and the short axis (crossing) of the largest chocolate cyst determined by transvaginal ultrasonography.'}, {'measure': Endometrial thickness, 'time_frame': 24 weeks after taking the initial study medication, 'description': 'Endometrial thickness is the thickest value (mm) of endometrium determined by transvaginal ultrasonography.'}, {'measure': Number of days with spotting/bleeding, 'time_frame': Up to 52 weeks, 'description': Number of days with spotting/bleeding is determined based on daily record of Patient Diary.}]","{'value': 20, 'unit': years}",,FEMALE,false,32,[Japan],791,Other,unknown
NCT00157911,A Study to Evaluate Ezetimibe in Korean Patients With Primary Hypercholesterolemia (0653-042),"A Double-Blind, Randomized, Multicenter, Active-Comparative, 12-Week Study to Assess the Efficacy and Safety of the Drug in Conjunction With Another Drug in Korean Patients With Primary Hypercholesterolemia",COMPLETED,2002-12-01,2003-12-01,Organon and Co,INDUSTRY,[Hypercholerolemia],INTERVENTIONAL,[PHASE3],136,RANDOMIZED,DOUBLE,"[{'type': DRUG, 'name': 'MK0653; ezetimibe / Duration of Treatment: 12 weeks', 'description': NULL}, {'type': DRUG, 'name': 'Comparator: simvastatin / Duration of Treatment: 12 weeks', 'description': NULL}]","[{'measure': LDL-C, 'time_frame': NULL, 'description': NULL}]","[{'measure': 'TC, TG, HDL-C, Apolipoprotein A1, Apolipoprotein B, lipoprotein (a), LDL-C:HDL-C ratio, TC:HDL-C ratio', 'time_frame': NULL, 'description': NULL}]","{'value': 18, 'unit': years}",,ALL,false,0,[],365,Metabolic / Endocrine,unknown
NCT02822144,General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke,General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke,COMPLETED,2016-09-29,2020-08-01,Rennes University Hospital,OTHER,[Stroke],INTERVENTIONAL,[PHASE3],351,RANDOMIZED,SINGLE,"[{'type': DRUG, 'name': Etomidate, 'description': NULL}, {'type': DRUG, 'name': Succinylcholine, 'description': NULL}, {'type': DRUG, 'name': Propofol, 'description': NULL}, {'type': DRUG, 'name': Remifentanil, 'description': NULL}, {'type': DRUG, 'name': Lidocaine, 'description': NULL}]","[{'measure': Score on the modified Rankin scale, 'time_frame': 3 months, 'description': NULL}]","[{'measure': Recanalization delay, 'time_frame': Day 1, 'description': Delay between first symptoms and last angiography}, {'measure': 'Delay between patient\'s hospitalization and start of procedure', 'time_frame': Day 1, 'description': At the time of puncture}, {'measure': 'Quality of recanalization assessed with TICI (Thrombolysis in cerebral infarction) score', 'time_frame': Day 1, 'description': At the last angiography}, {'measure': NIHSS score, 'time_frame': Day 1, 'description': NULL}, {'measure': NIHSS score, 'time_frame': Day 7, 'description': NULL}, {'measure': 'Angiographic complications: number of patients wtih dissection, arterial rupture, thrombus in another territory', 'time_frame': Day 1, 'description': NULL}, {'measure': Mortality, 'time_frame': 3 months, 'description': NULL}, {'measure': Number of episodes of hypo- / hypertension, 'time_frame': 24 hours after thrombectomy, 'description': NULL}, {'measure': Number of patients with noradrenaline administration during anesthesia, 'time_frame': Day 1, 'description': NULL}, {'measure': Number of sedations converted to general anesthesia and reason, 'time_frame': Day 1, 'description': NULL}]","{'value': 18, 'unit': years}",,ALL,false,4,[France],1402,Cardiovascular,unknown
NCT01824667,Effect of B-GOS on GI Discomfort in Healthy Adults,"Double-blind, Placebo Controlled, Randomised, Multicentered, of Parallel Design Study to Determine the Effect of B-GOS on GI Discomfort in Healthy Adults",COMPLETED,2013-02-01,2013-11-01,Clasado Limited,INDUSTRY,[Healthy],INTERVENTIONAL,[PHASE3],400,RANDOMIZED,DOUBLE,"[{'type': DIETARY_SUPPLEMENT, 'name': B-GOS, 'description': NULL}, {'type': DIETARY_SUPPLEMENT, 'name': Maltodextrin, 'description': NULL}]","[{'measure': To determine the effect of B-GOS on GI discomfort, 'time_frame': Participants will be followed daily for 6 weeks, 'description': questionnaires}]","[{'measure': To conduct an assessment of stools, 'time_frame': Participants will be followed daily for 6 weeks., 'description': questionnaires}]","{'value': 18, 'unit': years}","{'value': 65, 'unit': years}",ALL,false,1,[United Kingdom],273,Other,unknown
NCT01112644,Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms,"A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate Improvement of Symptoms of RLS in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms Who Take OXN PR Compared to Subjects Taking Placebo (PLA).",COMPLETED,2010-04-01,2011-06-01,Mundipharma Research GmbH & Co KG,INDUSTRY,[Moderate to Severe Idiopathic RLS With Daytime Symptoms],INTERVENTIONAL,[PHASE3],205,RANDOMIZED,QUADRUPLE,"[{'type': DRUG, 'name': 'Oxycodone naloxone prolonged release tablets (OXN PR)', 'description': Different daily doses; intake every 12 hours}, {'type': OTHER, 'name': 'Placebo (PLA)', 'description': Different daily doses; intake every 12 hours}]","[{'measure': Changes in the IRLS score between the two treatment arms will be compared, 'time_frame': 12 weeks and a 6 month extension, 'description': 'The primary objective for the 12-week Titration-/Maintenance Period is:

IRLS: International Restless Legs Syndrome Study Group Rating Scale Assessment Period baseline (visit 3) to final Maintenance Period.'}]",,"{'value': 18, 'unit': years}",,ALL,false,3,"[Germany, Spain, Sweden]",426,Neurology / CNS,unknown
NCT00032630,Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass,"CSP #517 - Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass",COMPLETED,2002-04-01,2008-04-01,US Department of Veterans Affairs,FED,[Ischemic Heart Disease],INTERVENTIONAL,[PHASE3],2203,RANDOMIZED,SINGLE,"[{'type': PROCEDURE, 'name': Coronary artery bypass - on-pump, 'description': CABG procedure performed on heart lung machine}, {'type': PROCEDURE, 'name': Coronary artery bypass - off-pump, 'description': CABG procedure performed without the use of the heart lung machine}]","[{'measure': Short-term End Point, 'time_frame': 30 day, 'description': 'Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later.'}, {'measure': Long-term Composite, 'time_frame': one-year, 'description': 'Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year.'}]",,,,ALL,true,17,[United States],2192,Cardiovascular,unknown
NCT00294658,Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone Therapy,"A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone",COMPLETED,2006-06-01,2015-12-01,University of Alabama at Birmingham,OTHER,[Myasthenia Gravis],INTERVENTIONAL,[PHASE3],126,RANDOMIZED,SINGLE,"[{'type': PROCEDURE, 'name': thymectomy plus prednisone, 'description': The thymectomy will be performed as soon as possible after randomization.}, {'type': DRUG, 'name': prednisone alone, 'description': 'Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose.'}]","[{'measure': Time-weighted Average Quantitative Myasthenia Gravis Weakness Score Over 3 Years, 'time_frame': 'baseline, month 3, 4, 6 and every 3 months through 36 months', 'description': 'Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease. The time weighted average is a calculation that provides an integrated measure of the outcome over the time of followup. The denominator that was used to compute the time-weighted average for the Quantitative Myasthenia Gravis (QMG) score and the prednisone dose was the number of days from randomization to the last visit. Computations used the trapezoidal method where in the QMG score is multiplied by the number of days at this level from one visit to the next and added up over the entire followup experience and divided by the total number of days from randomization.'}, {'measure': 'Time-weighted Average Alternate-day Prednisone Dose (mg) Measured Over 3 Years', 'time_frame': 'baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months', 'description': 'Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.'}]","[{'measure': Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Prednisone Use at Enrollment, 'time_frame': 'baseline, month 3, 4, 6 and every 3 months through 36 months', 'description': 'Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.'}, {'measure': Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Sex, 'time_frame': 'baseline, month 3, 4, 6 and every 3 months through 36 months', 'description': 'Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.'}, {'measure': Subgroup Analyses of Time-weighted Average Quantitative Myasthenia Gravis Score by Age at Disease Onset, 'time_frame': 'baseline, month 3, 4, 6 and every 3 months through 36 months', 'description': 'Myasthenia Gravis (QMG) test. QMG total scores range from 0 to 39 for a given visit, with higher scores indicating more severe disease.'}, {'measure': 'Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Prednisone Use at Enrollment', 'time_frame': 'baseline, month 3, 4, 6 and every 3 months through 36 months', 'description': 'Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.'}, {'measure': 'Subgroup Analyses of Time-weighted Average Alternate-day Prednisone Dose (mg) by Sex', 'time_frame': 'baseline, month 3, 4, 6 and every 3 months through 36 months', 'description': 'Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.'}, {'measure': 'Subgroup Analyses of Time-weighted Average Average Alternate-day Prednisone Dose (mg) by Age at Disease Onset', 'time_frame': 'baseline, month 3, 4, 6 and every 3 months through 36 months', 'description': 'Participants reported alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prednisone dosages had been weighted over the days of reporting period.'}, {'measure': Number of Serious Adverse Events, 'time_frame': baseline to 3 years, 'description': 'Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)'}, {'measure': Number of Patients With at Least One Serious Adverse Events, 'time_frame': baseline to 3 years, 'description': 'Number of participant who experienced at least one serious adverse events over 3 years: Thymectomy plus prednisone n=25 (out of 66); Prednisone alone n=33 (out of 60)'}, {'measure': Classification of Serious Adverse Events, 'time_frame': baseline to 3 years, 'description': NULL}, {'measure': Hospitalization for Exacerbation of Myasthenia Gravis, 'time_frame': baseline to 2 years and baseline to 3 years, 'description': NULL}, {'measure': Cumulative Number of Hospital Days, 'time_frame': baseline to 3 years, 'description': 'Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)'}, {'measure': Reason for Hospitalization According to Medical Dictionary for Regulatory Activities Term, 'time_frame': baseline to 3 years, 'description': 'Number who had hospitalization: Thymectomy plus prednisone n=15 (out of 66); Prednisone alone n=31 (out of 60)'}, {'measure': 'Time-weighted Average Prescribed Alternate Day Prednisone Dose (mg)', 'time_frame': 'baseline-day 20, month 1,2, 3, 4, 6 and every 3 months through 36 months', 'description': 'Physicians reported prescribed alternate-day prednisone dose (mg) intake from baseline through withdrawn or completed 3 years follow up. The prescribed prednisone dosages had been weighted over the days of reporting period.'}, {'measure': 'Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 1: Penalized Using Maximum Dose Before Azathioprine)', 'time_frame': 'baseline, month 3, 4, 6 and every 3 months through 36 months', 'description': 'For each participant who took azathioprine, we penalized them by taking the maximum dose of prednisone before azathioprine was added. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.'}, {'measure': 'Penalized Time-weighted Average Alternative Day Prednisone Dose (mg; Method 2: Penalized Using Dose at Time of Starting Azathioprine)', 'time_frame': 'baseline, month 1 , 2 , 3, 4, 6 and every 3 months through 36 months', 'description': 'For each participant who took azathioprine, we penalized them by taking the prednisone dose at the time azathioprine commenced. We then applied the same method to compute the time-weighted alternative day prednisone dose from baseline, month 3, 4, 6 and every 3 months through 36 months.'}, {'measure': 'Time-Weighted Average MG Activity of Daily Living (MG-ADL)', 'time_frame': 'baseline, month 4, 6 and every 3 months through 36 months', 'description': 'MG Activity of Daily Living total scores range from 0 to 24, with the lower scores indicating better daily living quality of life.'}, {'measure': 'Time-Weighted Average MG Activity of Daily Living (MG-ADL) at Month 12, 24, and 36', 'time_frame': 'Month 12, 24, and 36', 'description': 'MG Activity of Daily Living total scores range from 0 to 24 by visit, with the lower scores indicating better daily living quality of life.'}, {'measure': Azathioprine Use, 'time_frame': baseline to 3 years, 'description': NULL}, {'measure': Plasma Exchange Use, 'time_frame': baseline to 3 years, 'description': NULL}, {'measure': Intravenous Immunoglobulin Use, 'time_frame': baseline to 3 years, 'description': NULL}, {'measure': 'Minimal Manifestation (MM) Status at Month 12, 24 and 36', 'time_frame': 'Month 12, 24 and 36', 'description': 'Number of participants who were in minimal manifestation status at month 12, 24 and 36.'}, {'measure': Cumulative Days in Hospital for Myasthenia Gravis Exacerbation, 'time_frame': baseline to 2 years, 'description': 'Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=17 (out of 60)'}, {'measure': Cumulative Days in Hospital for Myasthenia Gravis Exacerbation, 'time_frame': baseline to 3 years, 'description': 'Number of patients with MG exacerbation: Thymectomy plus prednisone=6 (out of 66); Prednisone alone=22 (out of 60)'}, {'measure': Short Form-36 Standardized Physical Component, 'time_frame': 'Month 0, Month 12, Month 24 and Month 36', 'description': 'Range from 0 to 100, the higher the physical component value, the better the mental health.'}, {'measure': Short Form-36 Standardized Mental Component, 'time_frame': 'Month 0, Month 12, Month 24 and Month 36', 'description': 'Range from 0 to 100, the higher the mental component value, the better the mental health.'}, {'measure': 'Treatment Associated Complications (TAC)', 'time_frame': 'Month 0, 1, 2, 3, 4 then every 3 months through Month 36', 'description': Treatment associated complications measured complications occurred by myasthenia gravis patients. Report number of participant with at least one complications by each visit.}, {'measure': 'Treatment Associated Symptoms (TAS)', 'time_frame': 'Month 0, 1, 2, 3, 4 then every 3 months through Month 36', 'description': Treatment associated symptoms measured myasthenia gravis symptoms such as back pain and/or bruises. Report number of participant with at least one treatment associated symptoms by each visit.}]","{'value': 18, 'unit': years}","{'value': 65, 'unit': years}",ALL,true,70,"[Argentina, Australia, Brazil, Canada, Chile, Germany, Italy, Japan, Mexico, Netherlands, Poland, Portugal, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States]",3470,Neurology / CNS,true
NCT00370890,A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy,A Multi-center Prospective Randomized Phase III Trial to Determine the Benefit of Adjuvant Chemotherapy Using Gemcitabine and Cisplatin in Nasopharyngeal Carcinoma Patients With Residual EBV DNA Following Primary Radiotherapy With or Without Concurrent Cisplatin,COMPLETED,2006-09-04,2021-10-26,Chinese University of Hong Kong,OTHER,[Nasopharyngeal Cancer],INTERVENTIONAL,[PHASE3],104,RANDOMIZED,NONE,"[{'type': DRUG, 'name': 'Adjuvant chemotherapy (gemcitabine and cisplatin)', 'description': Gemcitabine 1000 mg/m2 in 250 ml NS over 30 mins IV on Day 1 and 8 Cisplatin 40 mg/m2 in 1L NS over 2 h IV on Day 1 and 8 Cycle repeated every 3 weeks for total of 6 cycles}]","[{'measure': Relapse free survival, 'time_frame': 5 years, 'description': NULL}]","[{'measure': Overall survival, 'time_frame': 5 years, 'description': Overall survival is defined as the duration from the date of randomization to the date of death due to all causes or censored at the date of last follow-up}, {'measure': Loco-regional control, 'time_frame': 5 years, 'description': NULL}, {'measure': Metastasis-free survival, 'time_frame': 5 years, 'description': NULL}, {'measure': Toxicity of adjuvant chemotherapy, 'time_frame': 6 months, 'description': NULL}, {'measure': Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome, 'time_frame': 5 years, 'description': NULL}]","{'value': 18, 'unit': years}",,ALL,false,6,[Hong Kong],5531,Oncology,unknown
NCT04480593,The Use of Brazilian Green Propolis Extract (EPP-AF) in Patients Affected by COVID-19.,"The Use of Brazilian Green Propolis Extract (EPP-AF) in Patients Affected by COVID-19: a Randomized, Open and Pilot Clinical Study.",COMPLETED,2020-06-02,2020-08-30,D'Or Institute for Research and Education,OTHER,[Covid19],INTERVENTIONAL,"[PHASE2, PHASE3]",120,RANDOMIZED,SINGLE,"[{'type': DRUG, 'name': 'Brazilian Green Propolis Extract (EPP-AF)', 'description': 'Green propolis extract (EPP-AF) administered orally or via nasoenteral tube.'}, {'type': OTHER, 'name': Standard care, 'description': 'Standard treatment includes, as needed, supplemental oxygen (non-invasive and invasive), antibiotics or antivirals, corticosteroids, vasopressor support, renal replacement therapy and extracorporeal membrane oxygenation (ECMO).'}]","[{'measure': Composite clinical outcome with oxygen therapy dependency time or hospitalization time, 'time_frame': 1-28 days, 'description': 'Composite clinical outcome with oxygen therapy dependency time (in days) or hospitalization time (in days) after randomization.'}]","[{'measure': Percentage of participants with adverse events during the use of propolis, 'time_frame': 1-28 days, 'description': We will evaluate the presence or absence of symptoms related to the use of propolis through a questionnaire.}, {'measure': Rate and severity of acute kidney injury during the study, 'time_frame': 1-28 days, 'description': 'Assess the degree of acute kidney injury according to KDIGO (through serum creatinine or urine output).'}, {'measure': Renal replacement therapy., 'time_frame': 1-28 days, 'description': Assess need or not for renal replacement therapy.}, {'measure': Rate of need for vasopressor use, 'time_frame': 1-28 days, 'description': Describe the time needed for vasopressors in days after randomization}, {'measure': 'Need for intensive care unit (ICU)', 'time_frame': 1-28 days, 'description': Assess length of stay in the ICU after randomization in days}, {'measure': 'Intensive care unit (ICU) readmission', 'time_frame': 1-28 days, 'description': Rate of readmission to the ICU after randomization}, {'measure': Invasive oxygenation time, 'time_frame': 1-28 days, 'description': Assess the need for mechanical ventilation in days after randomization.}, {'measure': Variation of plasma c-reactive protein, 'time_frame': 1-7 days, 'description': Evaluate the variation in serum levels of c-reactive protein over the 7 days after randomization}]","{'value': 18, 'unit': years}",,ALL,false,1,[Brazil],89,Infectious Disease,unknown
NCT04486690,Neuroprotection During Open Heart Surgery,Neuroprotection During Open Heart Surgery Propofol Versus Ketofol,COMPLETED,2016-07-01,2017-06-30,ghada fouad,OTHER,[Open Heart Surgery],INTERVENTIONAL,[PHASE3],50,RANDOMIZED,DOUBLE,"[{'type': DRUG, 'name': 'Ketofol (propofol to ketamine ratio 1:1)', 'description': '* Ketofol 25-150 mic/kg/min with propofol to ketamine ratio 1:1.
* Fentanyl infusion, 1-2 mcg/kg/h.
* Atracurium infusion, 3-12 mic/kg/min'}, {'type': DRUG, 'name': propofol, 'description': 'Propofol infusion, 25-150 mcg/kg/min.

* Fentanyl infusion, 1-2 mcg/kg/h.
* Atracurium infusion, 3-12 mic/kg/min.'}]","[{'measure': Cerebral oxygenation, 'time_frame': from start of surgery and for 24 hours postoperative, 'description': 'Cerebral oxygenation as indicated by calculation of:

1. Arterio-Jugular oxygen content difference.
2. Estimated cerebral metabolic rate for O2(eCMRO2) eCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where ……. Ca jO2 is arterio-jugular O2 content difference.

   * PaCO2 is arterial CO2 tension'}]","[{'measure': blood pressure measurement, 'time_frame': from start of surgery and for 24 hours postoperative, 'description': measurement of invasive blood pressure}]","{'value': 30, 'unit': years}","{'value': 70, 'unit': years}",ALL,false,0,[],364,Cardiovascular,unknown
NCT00420160,Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?,Does Moderate Intensity Exercise Help Prevent Smoking Relapse Among Women?,COMPLETED,2007-02-01,2008-12-01,The Miriam Hospital,OTHER,"[Lung Cancer, Heart Disease, COPD]",INTERVENTIONAL,"[PHASE2, PHASE3]",59,RANDOMIZED,NONE,"[{'type': BEHAVIORAL, 'name': Smoking cessation treatment plus moderate intensity exercise, 'description': NULL}, {'type': BEHAVIORAL, 'name': Smoking cessation treatment plus health education, 'description': NULL}]","[{'measure': 7-day point prevalence smoking abstinence verified by saliva cotinine taken, 'time_frame': 'post-intervention (8 weeks after baseline)', 'description': NULL}]","[{'measure': 7-day point prevalence smoking abstinence verified by saliva cotinine, 'time_frame': 'taken one month post-intervention (12 weeks after baseline)', 'description': NULL}]","{'value': 18, 'unit': years}","{'value': 65, 'unit': years}",FEMALE,false,1,[United States],669,Cardiovascular,unknown
NCT01015001,A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine,A Pilot Double-blind Sham-controlled Trial of Repetitive Transcranial Magnetic Stimulation for Patients With Refractory Schizophrenia Treated With Clozapine,COMPLETED,2008-05-01,2009-12-01,Hospital de Clinicas de Porto Alegre,OTHER,"[Schizophrenia, Auditory Hallucinations]",INTERVENTIONAL,[PHASE3],20,RANDOMIZED,DOUBLE,"[{'type': PROCEDURE, 'name': 'Active rTMS x sham (placebo) rTMS', 'description': 'Seventeen right-handed patients with DSM-IV TR diagnosis of schizophrenia were randomized in two groups. One arm received 20 sessions of 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).

The other arm received sham (placebo) stimulation over the LTPC for the same period of time. All patients were considered as having refractory schizophrenia and in use of at least 400mg/day of clozapine and referred auditory hallucinations.'}, {'type': PROCEDURE, 'name': sham rTMS, 'description': 'same coil, same number of pulses but using an angled coil(90degres) over the frontotemporal region'}, {'type': PROCEDURE, 'name': '(1Hz) rTMS applied over the left temporoparietal cortex', 'description': '20 sessions lasting 20 minutes each of low-frequency (1Hz) rTMS applied over the left temporoparietal cortex (LTPC).'}]","[{'measure': Evaluate the effects of low frequency repetitive Transcranial Magnetic Stimulation applied over the left temporoparietal cortex of refractory schizophrenic patients on the severity of auditory hallucinations., 'time_frame': 2 years, 'description': NULL}]","[{'measure': 'The secondary outcomes are to evaluate the effects of the same rTMS protocol on their quality of life, functionality and general psychopathology.', 'time_frame': 2 years, 'description': NULL}]","{'value': 18, 'unit': years}","{'value': 65, 'unit': years}",ALL,false,1,[Brazil],579,Neurology / CNS,unknown
NCT01193634,Clinical Evaluation Of The PARADYM RF Device,Clinical Evaluation Of The PARADYM RF Device SORIN GROUP'S New IDC Platform,COMPLETED,2010-10-01,2012-03-01,LivaNova,INDUSTRY,[Heart Failure],INTERVENTIONAL,[PHASE3],75,NON_RANDOMIZED,NONE,"[{'type': DEVICE, 'name': VR 9250 / DR 9550 / CRT 9750, 'description': Active implantable defibrillators range}]","[{'measure': 'Demonstration of the Right ventricular (RV) autothreshold algorithm performances', 'time_frame': 1 month, 'description': Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test.}]","[{'measure': Incidence of adverse events, 'time_frame': 12 months, 'description': Any adverse event will be documented throughout the study and will be reported.}, {'measure': ICD electrical performances, 'time_frame': 12 months, 'description': Report all ICD electrical performances of the Paradym RF ICD.}, {'measure': Evaluation of the left ventricular lead performances, 'time_frame': 12 months, 'description': Report the electrical performances and lead mechanical handling at implant.}, {'measure': Evlauation of the Remote Monitoring Solution, 'time_frame': 12 months, 'description': Ensure the Home Monitoring setup procedure and daily life use are user friendly for the patient and the back office is convenient for the physician.}]","{'value': 18, 'unit': years}",,ALL,false,1,[Germany],517,Cardiovascular,unknown
NCT03682185,The Healthy Patterns Sleep Study,The Role of Palliative Care Interventions to Reduce Circadian Rhythm Disorders in Persons With Dementia: The Healthy Patterns Study,COMPLETED,2016-05-01,2021-05-31,University of Pennsylvania,OTHER,"[Dementia, Alzheimer Disease, Circadian Rhythm Disorders, Circadian Rhythm Sleep Disorder, Insomnia, Hypersomnia, Cognitive Impairment, Cognitive Decline, Mild Cognitive Impairment, Frontotemporal Dementia, Neurocognitive Disorders, Vascular Dementia, Sleep Disorder, Memory Impairment]",INTERVENTIONAL,[PHASE3],421,RANDOMIZED,SINGLE,"[{'type': BEHAVIORAL, 'name': Attention-Control Condition, 'description': 'This condition will contain no active elements beyond its nonspecific components, and no theoretical basis to support an effect on CRDs. The attention-control group will also involve 4 in-home visits and 4 brief telephone education sessions. The attention control group will receive printed educational and training materials from the Alzheimer\'s Association and the NIH on home modification, health promotion, talking to your doctor, and advanced care planning that coincide with session content.'}, {'type': BEHAVIORAL, 'name': Timed Activity Intervention, 'description': 'The timed activity group will involve 4 in-home visits and 4 brief telephone education sessions provided over 4 weeks. The timed activity intervention provides activities delivered at specific times in the daily cycle. The in-home sessions are spaced weekly so that the participants can have the opportunity to practice the activity with the interventionist and then on their own. During each session, the interventionist will reinforce activity use, review problem-solving approaches, and provide education.'}]","[{'measure': 'Change in the Quality of Life in Alzheimer\'s Disease (QOL-AD) Scale', 'time_frame': Baseline and 1 month, 'description': 'Person living with dementia quality of life. The QOL-AD scale uses a scale of 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient\'s physical health, mood, relationships, activities, and ability to complete tasks. Total scores are calculated by summing all domain scores. The total score range is 13 to 52, with higher scores indicating higher quality of life. Total scores were analyzed to see if there was a change from baseline to one month. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point. Change scores are reported.'}]","[{'measure': 'Neuropsychiatric Inventory (NPI)', 'time_frame': 4 Months, 'description': 'Neuropsychiatric Behaviors The Neuropsychiatric Inventory Questionnaire (NPI) is an informant-based instrument that measures the presence and severity of 12 Neuropsychiatric Symptoms (NPS) in patients with dementia, as well as informant distress.

Neuropsychiatric symptoms are rated by the caregiver within a domain in terms of both frequency (1=rarely, less than once per week; 2=sometimes, about once per week; 3=often, several times per week; and 4=very often, once or more per day) and severity (1=mild; 2=moderate; 3=severe), thus yielding a composite symptom domain score (frequency × severity) ranging from 0 (absence of behavioral symptoms) to 144 points (maximum severity of behavioral symptoms).'}]","{'value': 18, 'unit': years}","{'value': 110, 'unit': years}",ALL,true,1,[United States],1856,Neurology / CNS,unknown
NCT01958671,"A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO)","A Phase 3, Randomized, Double-blind, Placebo-controlled, 26-week Multicenter Study With a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise",COMPLETED,2013-10-09,2016-07-28,Merck Sharp & Dohme LLC,INDUSTRY,[Type 2 Diabetes Mellitus],INTERVENTIONAL,[PHASE3],461,RANDOMIZED,DOUBLE,"[{'type': DRUG, 'name': Ertugliflozin 5 mg, 'description': 'One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).'}, {'type': DRUG, 'name': Ertugliflozin 10 mg, 'description': 'One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).'}, {'type': DRUG, 'name': Placebo to Ertugliflozin, 'description': 'One placebo tablet matching the ertugliflozin 5 mg tablet and/or 1 placebo tablet matching the ertugliflozin 10 mg tablet per day taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).'}, {'type': DRUG, 'name': Metformin, 'description': '500 mg (1 tablet) in the morning and 500 mg (1 tablet) in the evening for 2 weeks, 1000 mg (2 tablets 500 mg) in the morning and 500 mg (1 tablet) in the evening for 2 weeks and 1000 mg (2 tablets 500 mg) in the morning and 1000 mg (2 tablets 500 mg) in the evening, thereafter.'}, {'type': DRUG, 'name': Placebo to Metformin, 'description': '1 tablet in the morning and 1 tablet in the evening for 2 weeks, 2 tablets in the morning and 1 tablet in the evening for 2 weeks and 2 tablets in the morning and 2 tablets in the evening, thereafter.'}, {'type': DRUG, 'name': Glimepiride, 'description': Dosing and titration of glimepiride as rescue therapy was determined by the investigator.}]","[{'measure': Change From Baseline In A1C at Week 26, 'time_frame': Baseline and Week 26, 'description': A1C is measured as percent. The change from baseline is the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.}, {'measure': 'Percentage of Participants Experiencing An Adverse Event (AE)', 'time_frame': 'Up to 54 weeks (including 2 weeks following last dose)', 'description': An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.}, {'measure': Percentage of Participants Discontinuing Study Treatment Due to an AE, 'time_frame': Up to 52 weeks, 'description': An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.}]","[{'measure': Change From Baseline in FPG at Week 26, 'time_frame': Baseline and Week 26, 'description': The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of glycemic rescue therapy.}, {'measure': Change From Baseline in Body Weight at Week 26, 'time_frame': Baseline and Week 26, 'description': The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.}, {'measure': 'Percentage of Participants With A1C <7% (<53 mmol/Mol) at Week 26', 'time_frame': Week 26, 'description': A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.}, {'measure': 'Baseline 2-hour Post-prandial Glucose (2-hr PPG) Level', 'time_frame': Baseline, 'description': 'Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the Mixed Meal Tolerance Test (MMTT). Change from baseline in 2-hr PPG level at Week 26 data are presented in the following outcome measure.'}, {'measure': Change From Baseline in 2-hr PPG at Week 26, 'time_frame': Baseline and Week 26, 'description': The change from baseline is the Week 26 2-hr PPG minus the Week 0 2-hr PPG. Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the MMTT. Data presented exclude data following the initiation of rescue therapy.}, {'measure': 'Baseline Sitting Systolic Blood Pressure (SBP)', 'time_frame': Baseline, 'description': Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in SBP at Week 26 data are presented in the following outcome measure.}, {'measure': Change From Baseline in SBP at Week 26, 'time_frame': Baseline and Week 26, 'description': The change from baseline is the Week 26 SBP minus the Week 0 SBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.}, {'measure': 'Baseline Sitting Diastolic Blood Pressure (DBP)', 'time_frame': Baseline, 'description': Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in DBP at Week 26 data are presented in the following outcome measure.}, {'measure': Change From Baseline in DBP at Week 26, 'time_frame': Baseline and Week 26, 'description': The change from baseline is the Week 26 DBP minus the Week 0 DBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.}]","{'value': 18, 'unit': years}",,ALL,true,0,[],1023,Metabolic / Endocrine,true
NCT01936467,Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions,Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided,COMPLETED,2013-01-01,2015-01-01,Johns Hopkins University,OTHER,"[Pancreatic Solid Lesions, Pancreatic Mass]",INTERVENTIONAL,[PHASE3],121,RANDOMIZED,SINGLE,"[{'type': DEVICE, 'name': Standard technique EUS-FNA, 'description': 'Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.'}, {'type': DEVICE, 'name': Capillary suction technique for EUS FNA, 'description': 'Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously'}]","[{'measure': Diagnostic Yield of Capillary Technique, 'time_frame': up to 6 months, 'description': Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.}, {'measure': Diagnostic Yield of Standard Technique, 'time_frame': up to 6 months, 'description': Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.}, {'measure': Sensitivity of EUS-FNA With Capillary Technique, 'time_frame': 6 months, 'description': Sensitivity of the EUS-FNA with Capillary technique}, {'measure': Sensitivity of EUS-FNA With StandardTechnique, 'time_frame': 6 months, 'description': Sensitivity of the EUS-FNA with Capillary technique}, {'measure': Sensitivity of EUS-FNA, 'time_frame': 6 months, 'description': Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions}]","[{'measure': First Pass Diagnostic Rate, 'time_frame': immediate, 'description': The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass}, {'measure': Acquisition of Core Tissue, 'time_frame': immediate, 'description': The rate of acquiring core tissue of the pancreatic mass through EUS-FNA}, {'measure': Diagnostic Accuracy of EUS-FNA, 'time_frame': 6 months, 'description': The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease}]","{'value': 18, 'unit': years}","{'value': 90, 'unit': years}",ALL,true,2,[United States],730,Oncology,unknown
NCT03393975,"A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP)","A Phase 3, Prospective, Randomized, Controlled, Open-label, Multicenter, 2 Period Crossover Study With a Single Arm Continuation Evaluating the Safety And Efficacy of BAX 930 (rADAMTS13) in the Prophylactic And On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP])",COMPLETED,2017-10-13,2024-05-30,Baxalta now part of Shire,INDUSTRY,['Thrombotic Thrombocytopenic Purpura (TTP)'],INTERVENTIONAL,[PHASE3],52,RANDOMIZED,NONE,"[{'type': BIOLOGICAL, 'name': TAK-755, 'description': Participants in prophylaxis cohort will receive IV infusions of 40 IU/kg TAK-755 ORT during Period 1 and Period 2 and switch to TAK-755 SIN during Period 3 for six months once in a week or twice in a week. In On-demand cohort participants will receive daily IV dose of TAK-755.}, {'type': BIOLOGICAL, 'name': Standard of care, 'description': 'Participants will receive Investigator-recommended Standard of care (SoC).'}]","[{'measure': 'Number of Participants With Acute Thrombotic Thrombocytopenic Purpura (TTP) Events During Prophylactic Treatment', 'time_frame': Up to 74.5 months, 'description': 'As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts, in a combined manner for Periods 1 and 2 for TAK-755 and SoC treatments respectively, and separately for Period 3 in which all participants received TAK-755.'}]","[{'measure': 'Percentage of Acute Thrombotic Thrombocytopenic Purpura (TTP) Events Responding to TAK-755', 'time_frame': Up to 79.6 months, 'description': 'Percentage of acute TTP events responding to TAK-755, was defined as not requiring the use of another human disintegrin and metalloprotease with a thrombospondin type 1 motif, member 13 (ADAMTS13)-containing agent. As per planned analysis, data for this outcome measure were collected and reported only for the TAK-755 treatment arm of both the prophylaxis (irrespective of the prophylaxis periods) and on demand cohorts.'}, {'measure': Time to Resolution of Acute TTP Events, 'time_frame': Up to 79.6 months, 'description': 'Time to resolution of acute TTP events following initiation of treatment with TAK-755 or SoC agent was assessed. Acute TPP events were considered resolved when: (a) Platelet count was \\>150,000 per microliter (μL) or drop of platelet count was within 25 percent (%) of baseline, whichever occurred first, and (b) Elevation of lactate dehydrogenase (LDH) \\<1.5 x baseline or \\<1.5 x upper limit of normal (ULN). As per planned analysis, data for this outcome measure were collected and reported in a combined manner irrespective of the prophylaxis treatment Periods, partitioned per treatment received (TAK-755 and SoC) for the on demand and prophylactic cohorts.'}, {'measure': Number of Participants With Thrombocytopenia During Prophylactic Treatment, 'time_frame': Up to 79.6 months, 'description': 'Thrombocytopenia was defined as a decrease in platelet count ≥25 % of baseline or a platelet count \\<150,000/μL, reported by treatment arm for the prophylactic cohort. As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts, in a combined manner for Periods 1 and 2 for TAK-755 and SoC treatments respectively, and separately for Period 3 in which all participants received TAK-755.'}, {'measure': Number of Participants With Microangiopathic Hemolytic Anemia During Prophylactic Treatment, 'time_frame': Up to 79.6 months, 'description': 'Microangiopathic hemolytic anemia was defined as an elevation of LDH \\>1.5\\* of baseline or \\>1.5\\*ULN (with a possible evidence of schistocytes on blood smear) and was reported by treatment arm for the prophylactic cohort. As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts, in a combined manner for Periods 1 and 2 for TAK-755 and SoC treatments respectively, and separately for Period 3 in which all participants received TAK-755.'}, {'measure': Number of Participants With Neurological Symptoms During Prophylactic Treatment, 'time_frame': Up to 79.6 months, 'description': 'Neurological symptoms (TTP related) (e.g., confusion, dysphonia, dysarthria, focal or general motor symptoms including seizures), were reported by treatment arm for the prophylactic cohort. As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts, in a combined manner for Periods 1 and 2 for TAK-755 and SoC treatments respectively, and separately for Period 3 in which all participants received TAK-755.'}, {'measure': Number of Participants With Renal Dysfunction During Prophylactic Treatment, 'time_frame': Up to 79.6 months, 'description': 'Renal dysfunction was defined as an increase in serum creatinine \\>1.5\\*baseline. Number of participants with renal dysfunction were reported by treatment arm for the prophylactic cohort. As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts, in a combined manner for Periods 1 and 2 for TAK-755 and SoC treatments respectively, and separately for Period 3 in which all participants received TAK-755.'}, {'measure': Number of Participants With Abdominal Pain During Prophylactic Treatment, 'time_frame': Up to 79.6 months, 'description': 'Number of participants with abdominal pain (TTP related) were reported by treatment arm for the prophylaxis cohort. As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts, in a combined manner for Periods 1 and 2 for TAK-755 and SoC treatments respectively, and separately for Period 3 in which all participants received TAK-755.'}, {'measure': Number of Supplemental Doses Prompted by Subacute TTP Event During Prophylactic Treatment, 'time_frame': Up to 79.6 months, 'description': 'Number of supplemental doses prompted by subacute TTP events were reported by treatment for the prophylactic cohort. As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts, in a combined manner for Periods 1 and 2 for TAK-755 and SoC treatments respectively, and separately for Period 3 in which all participants received TAK-755.'}, {'measure': Number of Participants With Dose Modification Not Prompted by an Acute TTP Event During Prophylactic Treatment, 'time_frame': Up to 79.6 months, 'description': 'Number of participants with dose modification not prompted by an acute TTP event were reported by treatment for the prophylactic cohort. As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts, in a combined manner for Periods 1 and 2 for TAK-755 and SoC treatments respectively, and separately for Period 3 in which all participants received TAK-755.'}, {'measure': Number of Participants With Acute TTP Events on Their Final Dose, 'time_frame': Up to 79.6 months, 'description': 'Number of participants with acute TTP events on their final dose and dosing regimen for the prophylactic cohort were reported. As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts, in a combined manner for Periods 1 and 2 for TAK-755 and SoC treatments respectively, and separately for Period 3 in which all participants received TAK-755.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (Serious TEAEs)', 'time_frame': Up to 79.6 months, 'description': 'AE: Any untoward medical occurrence in participants administered IP that does not necessarily have a causal relationship with treatment. TEAE: AE that has start date-time on/after start date-time of first dose of treatment participant is taking on that assessment/period or if it has start date-time before start date-time of first dose but increases in severity on/after start date-time of the first dose of treatment. SAE: An untoward medical occurrence that at any dose meets 1 or more of following criteria: death; initial/prolonged in-patient hospitalization; life threatening experience; persistent/significant disability/incapacity; congenital anomaly, medically important event (may not be immediately life threatening or result in death or require hospitalization but may require medical or surgical intervention to prevent 1 of the other outcomes). Vital signs, clinical chemistry, hematology as assessed by the investigator were reported as AE.'}, {'measure': Number of Participants With Inhibitory Antibodies to ADAMTS13, 'time_frame': Up to 79.6 months, 'description': 'Number of participants with inhibitory antibodies to ADAMTS13 were reported. As per planned analysis, data for this outcome measure were collected and reported in a combined manner irrespective of the Prophylaxis Periods and partitioned as per the treatment received during the course of the study, presented for the prophylaxis cohorts only.'}, {'measure': Total Quantity of ADAMTS13 Administered During the Treatment of Acute TTP Events in Participants in TAK-755 Treatment Arm, 'time_frame': Up to 79.6 months, 'description': 'Total quantity of ADAMTS13 administered during the treatment of acute TTP events (all acute TTP events irrespective of central lab confirmation were included) was assessed. Acute TTP events typically require 3 to 4 days of intensified treatment. As per planned analysis, data for this outcome measure were collected and reported only for the TAK-755 treatment arm of both the prophylaxis (irrespective of the prophylaxis periods) and on demand cohorts.'}, {'measure': 'Incremental Recovery (IR) of ADAMTS13 Activity for SoC Agent and TAK-755 in Plasma During Prophylactic Treatment', 'time_frame': 'PK-I (Month 1:Day 1 up to 12), PK-II (Month 12:Day 1 up to 12), and PK-III (Month 19:Day 1 up to 12): Pre-infusion and at multiple timepoints post-infusion up to 288 hours', 'description': 'ADAMTS13 activity was measured by the fluorescent resonance energy transfer (FRETS) assay. IR was defined as body weight normalized maximum increase in plasma ADAMTS13 activity level. IR of ADAMTS13 activity for SoC agent and TAK-755 in plasma was assessed. (IU/mL)/(IU/kg) stands for (International units per milliliter)/(International units per kilogram). PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1, end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': IR of ADAMTS13 Antigen for SoC Agent and TAK-755 in Plasma During Prophylactic Treatment, 'time_frame': 'PK-I (Month 1:Day 1 up to 12), PK-II (Month 12:Day 1 up to 12), and PK-III (Month 19:Day 1 up to 12): Pre-infusion and at multiple timepoints post-infusion up to 288 hours', 'description': 'ADAMTS13 antigen was measured using a commercial ADAMTS13 enzyme-linked immunosorbent assay (ELISA) employing ADAMTS13 antigen. IR was defined as body weight normalized maximum increase in plasma ADAMTS13 antigen. IR of ADAMTS13 antigen for SoC agent and TAK-755 in plasma was assessed. (µg/mL)/ (µg/kg) stands for (microgram per milliliter)/(microgram per kilogram). PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1, end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Area Under the Plasma Curve [AUC]All of ADAMTS13 Activity for SoC Agent and TAK-755 in Plasma During Prophylactic Treatment', 'time_frame': 'PK-I (Month 1:Day 1 up to 12), PK-II (Month 12:Day 1 up to 12), and PK-III (Month 19:Day 1 up to 12): Pre-infusion and at multiple timepoints post-infusion up to 288 hours', 'description': 'h\\*IU/mL denotes for hours\\*international units per milliliters. PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': AUCall of ADAMTS13 Antigen for SoC Agent and TAK-755 in Plasma During Prophylactic Treatment, 'time_frame': 'PK-I (Month 1:Day 1 up to 12), PK-II (Month 12:Day 1 up to 12), and PK-III (Month 19:Day 1 up to 12): Pre-infusion and at multiple timepoints post-infusion up to 288 hours', 'description': 'h\\*µg/mL denotes for hours\\*microgram per milliliters. PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Terminal Half-Life (t1/2) of ADAMTS13 Activity and ADAMTS13 Antigen for SoC Agent and TAK-755 in Plasma During Prophylactic Treatment', 'time_frame': 'PK-I (Month 1:Day 1 up to 12), PK-II (Month 12:Day 1 up to 12), and PK-III (Month 19:Day 1 up to 12): Pre-infusion and at multiple timepoints post-infusion up to 288 hours', 'description': 'PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Mean Residence Time Extrapolated to Infinity (MRT0-inf) of ADAMTS13 Activity and ADAMTS13 Antigen for SoC Agent and TAK-755 in Plasma During Prophylactic Treatment', 'time_frame': 'PK-I (Month 1:Day 1 up to 12), PK-II (Month 12:Day 1 up to 12), and PK-III (Month 19:Day 1 up to 12): Pre-infusion and at multiple timepoints post-infusion up to 288 hours', 'description': 'PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Clearance (CL) of ADAMTS13 Activity and ADAMTS13 Antigen for SoC Agent and TAK-755 in Plasma During Prophylactic Treatment', 'time_frame': 'PK-I (Month 1:Day 1 up to 12), PK-II (Month 12:Day 1 up to 12), and PK-III (Month 19:Day 1 up to 12): Pre-infusion and at multiple timepoints post-infusion up to 288 hours', 'description': 'PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Volume at Steady State (Vss) of ADAMTS13 Activity and ADAMTS13 Antigen for SoC Agent and TAK-755 in Plasma During Prophylactic Treatment', 'time_frame': 'PK-I (Month 1:Day 1 up to 12), PK-II (Month 12:Day 1 up to 12), and PK-III (Month 19:Day 1 up to 12): Pre-infusion and at multiple timepoints post-infusion up to 288 hours', 'description': 'PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Maximum Concentration (Cmax) of ADAMTS13 Activity for SoC Agent and TAK-755 in Plasma During Prophylactic Treatment', 'time_frame': 'PK-I (Month 1:Day 1 up to 12), PK-II (Month 12:Day 1 up to 12), and PK-III (Month 19:Day 1 up to 12): Pre-infusion and at multiple timepoints post-infusion up to 288 hours', 'description': 'IU/mL stands for International units per milliliter. PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth,Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': Cmax of ADAMTS13 Antigen for SoC Agent and TAK-755 in Plasma During Prophylactic Treatment, 'time_frame': 'PK-I (Month 1:Day 1 up to 12), PK-II (Month 12:Day 1 up to 12), and PK-III (Month 19:Day 1 up to 12): Pre-infusion and at multiple timepoints post-infusion up to 288 hours', 'description': 'µg/mL stands for microgram per milliliter. PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Change From Baseline in Assessment of Von Willebrand Factor:Antigen (VWF:Ag) During Prophylactic Treatment', 'time_frame': 'PK-I (Month 1:Day 12), PK-II (Month 12:Day 12), and PK-III (Month 19:Day 12): Post-infusion at 288 hours', 'description': 'VWF:Ag is a measure of total VWF protein and was assessed using a sandwich ELISA employing polyclonal anti-human-VWF antibodies. Assessments of VWF:Ag at baseline and following infusion of the SoC agent and TAK-755 treatment during the initial PK assessment were reported. PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Change From Baseline in Assessment of Von Willebrand Factor:Ristocetin Cofactor Activity (VWF:RCo) During Prophylactic Treatment', 'time_frame': 'PK-I (Month 1:Day 12), PK-II (Month 12:Day 12), and PK-III (Month 19:Day 12): Post-infusion at 288 hours', 'description': 'VWF:RCo provides a measure of the ability of VWF to bind platelet glycoprotein Ib. Stabilized platelets are agglutinated in the presence of VWF and the antibiotic Ristocetin. Assessments of VWF:RCo at baseline and following infusion of the SoC agent and TAK-755 treatment during the initial PK assessment was reported. PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': Assessment of ADAMTS13 Activity Expressed as Pre-Infusion ADAMTS13 Levels, 'time_frame': 'PK-I (Month 1:Day 1), PK-II (Month 12:Day 1), and PK-III (Month 19:Day 1): Pre-infusion (within 1 hour)', 'description': 'PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Assessment of Select VWF Parameters Expressed as Pre-Infusion Levels of VWF:RCo', 'time_frame': 'PK-I (Month 1:Day 1), PK-II (Month 12:Day 1), and PK-III (Month 19:Day 1): Pre-infusion (within 1 hour)', 'description': 'PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Assessment of Select VWF Parameters Expressed as Pre-Infusion Levels of VWF:Ag', 'time_frame': 'PK-I (Month 1:Day 1), PK-II (Month 12:Day 1), and PK-III (Month 19:Day 1): Pre-infusion (within 1 hour)', 'description': 'PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Assessment of Select VWF Parameters Expressed as Pre-Infusion Levels of VWF:mm Low Resolution (Res.) Intermediate', 'time_frame': 'PK-I (Month 1:Day 1), PK-II (Month 12:Day 1), and PK-III (Month 19:Day 1): Pre-infusion (within 1 hour)', 'description': 'PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Assessment of Select VWF Parameters Expressed as Pre-Infusion Levels of VWF:mm Low Res. Large', 'time_frame': 'PK-I (Month 1:Day 1), PK-II (Month 12:Day 1), and PK-III (Month 19:Day 1): Pre-infusion (within 1 hour)', 'description': 'PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': 'Assessment of Select VWF Parameters Expressed as Pre-Infusion Levels of VWF:mm Low Res. Small', 'time_frame': 'PK-I (Month 1:Day 1), PK-II (Month 12:Day 1), and PK-III (Month 19:Day 1): Pre-infusion (within 1 hour)', 'description': 'PK-I, PK-II, and PK-III denote the crossover PK evaluation of a maximum of 14 days at the start of Prophylaxis Treatment Period 1 and end of Prophylaxis Treatment Periods 2 and 3 respectively. As per planned analysis, data for this outcome measure were collected and reported as per the treatment (intervention) received (rADAMTS13 manufactured in Orth, Austria \\[TAK-755 ORT\\], rADAMTS13 manufactured in Singapore \\[TAK-755 SIN\\], or SoC) during the course of the study, only for the prophylaxis cohorts. No participants received SoC in PK-II and PK-III thus there is no data for the same.'}, {'measure': Number of Participants With Total Binding Antibodies to ADAMTS13 During Prophylactic Treatment, 'time_frame': Up to 79.6 months, 'description': 'Total binding antibodies to ADAMTS13 were measured by an ELISA-based assay, detecting total immunoglobulins (IgG, IgA, and IgM). As per planned analysis, data for this outcome measure were collected and reported per sequence (Prophylaxis Cohort I: TAK-755 Then SoC and Prophylaxis Cohort II: SoC Then TAK-755) for the prophylaxis cohorts only.'}, {'measure': Number of Participants With Neutralizing Antibodies to ADAMTS13 During Prophylactic Treatment, 'time_frame': Up to 79.6 months, 'description': 'Neutralizing antibodies were measured by a Bethesda method with Nijmegen modification using the ADAMTS13 FRETS-VWF73 activity assay. As per planned analysis, data for this outcome measure were collected and reported per sequence (Prophylaxis Cohort I: TAK-755 Then SoC and Prophylaxis Cohort II: SoC Then TAK-755) for the prophylaxis cohorts only.'}, {'measure': 'Number of Participants With Anti-Chinese Hamster Ovary (Anti-CHO) Protein Antibodies During Prophylactic Treatment', 'time_frame': Up to 79.6 months, 'description': 'Total immunoglobulin antibodies (Immunoglobulin G \\[IgG\\], A \\[IgA\\], and M \\[IgM\\]) against CHO protein were analyzed using ELISA assay. As per planned analysis, data for this outcome measure were collected and reported per sequence (Prophylaxis Cohort I: TAK-755 Then SoC and Prophylaxis Cohort II: SoC Then TAK-755) for the prophylaxis cohorts only.'}, {'measure': 'Health Related Quality of Life (HRQoL) Assessed as Change From Baseline in cTTP-Patient Experience Questionnaire (cTTP-PEQ) Total Score', 'time_frame': 'Baseline, Urgent Treatment Period: Day 7, End of Period 1 (Month 6), End of Period 2 (Month 12), and End of Period 3 (Month 19)', 'description': 'The cTTP-PEQ consists of 26 questions designed to assess the participant\'s experience of fatigue, joint, muscle, abdominal \\&chest pain in the previous 24 hours, neurologic manifestations, bruising, feelings of depression and mood alterations, and activity limitation in the past 7 days, and participant\'s attitudes, experienced side effects, work/school absences and travel impact associated with treatment received for TTP during the previous 2 weeks. The cTTP PEQ is focused on measuring the symptoms and impacts of disease. The total scores range from 0 to 162. A higher score indicates greater burden and poor quality of life. As per planned analysis,for the prophylaxis cohorts the data for this outcome measure were collected and reported by categorizing as per Prophylaxis Periods and per age groups,≥12 years,12 to 18 years,≥18 years for both on demand(OD) and prophylaxis cohorts. No participants in the OD Cohorts had cTTP-PEQ data available for analysis at scheduled post-baseline visits.'}, {'measure': 'Health Related Quality of Life (HRQoL) Assessed as Change From Baseline in Physical and Mental Component Scores of the 36-Item Short Form Health Survey Version 2 (SF-36v2)', 'time_frame': 'Baseline, Urgent Treatment Period: Day 7, End of Period 1 (Month 6), End of Period 2 (Month 12), and End of Period 3 (Month 19)', 'description': 'SF-36v2 is questionnaire that evaluated participant\'s health related quality of life. It included 36 questions related to 8 health dimensions: physical functioning, role-physical(role limitations due to physical health problems), bodily pain, general health, vitality(energy/fatigue),social functioning, role-emotional(role limitations due to emotional problems),\\& mental health. Based on these 4 scales(physical functioning, role-physical, bodily pain, general health), physical component score was generated which ranges between 0 \\&100, with higher scores indicating a better quality of life. Based on these 4 scales(vitality, social functioning, role-emotional,\\&mental health), mental component score was generated ranging between 0\\&100, with higher scores=better quality of life. As per planned analysis, for the prophylaxis cohorts data for this outcome measure were collected\\&reported by categorizing as per Prophylaxis Periods and per component scores for both on demand\\&prophylaxis cohorts.'}, {'measure': 'Health Related Quality of Life (HRQoL) Assessed as Change From Baseline in Abbreviated 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) Domain Scores', 'time_frame': 'Baseline, Urgent Treatment Period: Day 7, End of Period 1 (Month 6), End of Period 2 (Month 12), and End of Period 3 (Month 19)', 'description': 'TSQM is a treatment satisfaction measure used to assess the overall level of participant\'s satisfaction or dissatisfaction with their medications. TSQM-9 is a 9-item, validated, self-administered instrument used to assess participant\'s satisfaction with medication. The three domains assessed are treatment effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicates greater satisfaction in that domain. As per planned analysis, for the prophylaxis cohorts data for this outcome measure were collected and reported by categorizing as per Prophylaxis Periods and per domain scores for both on demand and prophylaxis cohorts.'}, {'measure': 'Health Related Quality of Life (HRQoL) Assessed as Change From Baseline in EuroQoL 5 Dimensions Questionnaire 3-Level (EQ-5D-3L) Domain Scores', 'time_frame': 'Baseline, Urgent Treatment Period: Day 7, End of Period 1 (Month 6), End of Period 2 (Month 12), and End of Period 3 (Month 19)', 'description': 'EQ-5D-3L health questionnaire is a participant-answered questionnaire scoring 5 dimensions(domains) - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on an ordinal scale with 3 available levels of response and scores ranging from 1 to 3, ""no problems,"" ""some problems,"" and ""extreme problems,"" respectively. Lower scores for the domains in the EQ-5D-3L indicate improvement. As per planned analysis, for the prophylaxis cohorts data for this outcome measure were collected and reported by categorizing as per Prophylaxis Periods and per domain scores for both on demand and prophylaxis cohorts.'}, {'measure': 'Health Related Quality of Life (HRQoL) Assessed as Change From Baseline in EQ-5D-youth (EQ-5D-Y) Domain Scores', 'time_frame': 'Baseline, Urgent Treatment Period: Day 7, End of Period 1 (Month 6), End of Period 2 (Month 12), and End of Period 3 (Month 19)', 'description': 'EQ-5D-Y health questionnaire is a participant answered questionnaire scoring 5 dimensions (domains) - mobility, self-care, usual activities, pain/discomfort and anxiety/depression assessed in participants aged from 8 to 16 years. The EQ-5D-Y descriptive system includes 5 descriptive items: Mobility, self-care, doing usual activities, having pain or discomfort, and feeling anxiety or depressed. Each dimension is scored at 3 levels: 1=No problems, 2=some problems, and 3=a lot of problems. Lower scores for the domains in the EQ-5D-Y indicate improvement. As per planned analysis, for the prophylaxis cohorts data for this outcome measure were collected and reported by categorizing as per Prophylaxis Periods and per domain scores for both on demand and prophylaxis cohorts.'}, {'measure': 'Health Related Quality of Life (HRQoL) Assessed as Change From Baseline in Pediatric Quality of Life Inventory (Peds QL) Scale Total Scores', 'time_frame': 'Baseline, Urgent Treatment Period: Day 7, End of Period 1 (Month 6), End of Period 2 (Month 12), and End of Period 3 (Month 19)', 'description': 'The PedsQL is a generic health related quality of life instrument designed specifically for a pediatric population and captures following domains: physical functioning, emotional functioning, social functioning, school functioning, psychosocial summary, physical health and total score. The Peds-QL total score consists of all 23 items of all domains. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better quality of life. As per planned analysis, for the prophylaxis cohorts data for this outcome measure were collected and reported by categorizing as per Prophylaxis Periods and per age groups, 2 to \\< 5 years, 5 to \\< 8 years, 8 to \\< 13 years, and 13 to \\< 18 years, for both on demand and prophylaxis cohorts.'}, {'measure': 'Resource Utilization: Annualized Length of Hospital Stay for Acute TTP Events for Prophylaxis Cohorts', 'time_frame': Up to 79.6 months, 'description': 'The annualized number of days participants stayed in hospital for acute TTP events were assessed. As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts in a combined manner for Periods 1 and 2 for SoC treatment and for Periods 1, 2, and 3 for TAK-755 treatment respectively.'}, {'measure': 'Resource Utilization: Annualized Number of Acute Care Visits for Prophylaxis Cohorts', 'time_frame': Up to 79.6 months, 'description': 'Annualized number of acute care visits was calculated as the number of acute care visits × 365.25/(End date - treatment start date + 1). As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts in a combined manner for Periods 1 and 2 for SoC treatment and for Periods 1, 2, and 3 for TAK-755 treatment respectively.'}, {'measure': 'Resource Utilization: Annualized Number of Days Missed From School or Work for Prophylaxis Cohorts', 'time_frame': Up to 79.6 months, 'description': 'Annualized number of days missed from school or work were assessed. As per planned analysis, data for this outcome measure were collected and reported only for the prophylaxis cohorts in a combined manner for Periods 1 and 2 for SoC treatment and for Periods 1, 2, and 3 for TAK-755 treatment respectively.'}]","{'value': 0, 'unit': years}","{'value': 70, 'unit': years}",ALL,true,33,"[Austria, France, Germany, Italy, Japan, Poland, Spain, United Kingdom, United States]",2421,Other,true
NCT03849222,Evaluation the Effect of Using of Apical Matrix With Apexification Procedure on Apical Healing of Necrotic Immature Teeth,Enhancement of Apexification Procedure Outcome of Non Vital Incompletely Formed Roots Using Apical Matrix,COMPLETED,2013-08-20,2016-09-01,Al-Azhar University,OTHER,"[Pulp Necrosis, Apexification]",INTERVENTIONAL,"[PHASE2, PHASE3]",32,RANDOMIZED,DOUBLE,"[{'type': PROCEDURE, 'name': Apexification, 'description': NULL}, {'type': DRUG, 'name': MTA, 'description': NULL}, {'type': DRUG, 'name': 'Ca(OH)2', 'description': NULL}, {'type': DRUG, 'name': Apical matrix, 'description': 'collagen membrane (Biocollagen; Bioteck:Turin, Italy)'}]","[{'measure': Change in pain on percussion, 'time_frame': 'baseline, 3 months, 6 months, and 12 months', 'description': 'Assessed by tapping the tooth with the back of the mirror (Present or absent) binary outcome'}, {'measure': Change in swelling and/or sinus, 'time_frame': 'baseline, 3 months, 6 months, and 12 months', 'description': Assessed by visual examination of labial vestibule.The presence of swelling or sinus reported by a binary question yes/no}, {'measure': Change in periapical pathosis, 'time_frame': 12 months, 'description': Change in periapical bone density on follow up radiographs to assess the healing process}]","[{'measure': presence of a calcified apical barrier or not, 'time_frame': '3, 6 and 12 months', 'description': Teeth will be reviewed clinically and radiographically in order to detect the calcific barrier formation}, {'measure': 'Periapical Lesion scored with periapical index ( PAI)', 'time_frame': 12 months, 'description': 'Radio graphically The periapical index provides an ordinal scale of 5 scores ranging from \'\'healthy\'\' to \'\'severe periodontitis with exacerbating features\'\'. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss.(4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).baseline, 3 months, 6 months, and 12 months'}]","{'value': 8, 'unit': years}","{'value': 16, 'unit': years}",ALL,false,0,[],1108,Other,unknown
NCT02139306,Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF),A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients With Nonsense Mutation Cystic Fibrosis,COMPLETED,2014-08-01,2016-11-01,PTC Therapeutics,INDUSTRY,[Cystic Fibrosis],INTERVENTIONAL,[PHASE3],279,RANDOMIZED,QUADRUPLE,"[{'type': DRUG, 'name': 'Ataluren (PTC124®)', 'description': Oral Ataluren TID}, {'type': DRUG, 'name': Placebo, 'description': Oral Placebo TID}]","[{'measure': 'Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48', 'time_frame': From Baseline to Week 48, 'description': 'The FEV1 is the volume of air forcibly exhaled in one second and is measured using forced expiratory air spirometry. Change in ppFEV1 at Week 48 was defined as the average between the change from baseline at Week 40 and that at Week 48. Baseline for ppFEV1 was defined as an average of ppFEV1 at Screening (Weeks -4 to -1) and Baseline (Day 1) visits.'}]","[{'measure': 48-week Rate of Pulmonary Exacerbations, 'time_frame': Week 48, 'description': 'Pulmonary exacerbations were assessed using expanded Fuchs criteria. The expanded Fuchs exacerbation is defined as the presence of at least 4 of 12 Fuchs\' signs and symptoms requiring treatment with any form of antibiotic treatment (inhaled, oral, or intravenous). Fuchs\' signs and symptoms included increased cough; change in sputum volume, color, or consistency; new or increased hemoptysis; increased dyspnea during moderate or mild exertion, or at rest; sinus pain or tenderness; change in sinus discharge; malaise, fatigue, or lethargy; anorexia or weight loss; temperature above 38 degrees Celsius; change in findings on chest examination; relative 10% decrease in ppFEV1, and chest radiography results consistent with pulmonary infection. The 48-week rate was calculated as: 48-week rate = total number of events /treatment duration by week\\*48.'}, {'measure': 'Change From Baseline in the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Domain at Week 48', 'time_frame': 'Baseline (Day 1) and Week 48', 'description': 'The teen/adult CFQ-R was used for this study. It was developed specifically for participants with cystic fibrosis. It is a disease-specific instrument designed to measure impact on overall health, daily life, perceived well-being, and symptoms. The respiratory domain assessed respiratory symptoms like coughing, congestion, wheezing etc. Scaling of each item is done via 4-point Likert scales. Scores for each item are summed up to generate a domain score. Scores ranges from 0 to 100, with higher scores indicating better health and lower scores indicating worse health.'}, {'measure': 'Change From Baseline in Body Mass Index (BMI) at Week 48', 'time_frame': 'Baseline (Day 1) and Week 48', 'description': Malnutrition is common in participants with cystic fibrosis. The BMI is an important clinical measure of nutritional status.}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)', 'time_frame': 'From study drug administration to 4-week post treatment follow-up visit (approximately 52 weeks)', 'description': 'An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from first dose of study drug to 4 weeks after last dose of study drug. An SAE is an untoward medical occurrence or effect associated with the use of a study drug at any dose, regardless of whether it is considered to be related to the study drug, which results in one of the following: death; inpatient hospitalization or prolongation of existing hospitalization; life threatening adverse event; persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; any other medically important event; or a pregnancy resulting in spontaneous abortion, stillbirth, neonatal death, or congenital anomaly.'}, {'measure': Number of Participants With TEAEs by Severity and Relationship to Study Drugs, 'time_frame': 'From study drug administration to 4-week post treatment follow-up visit (approximately 52 weeks)', 'description': 'The relationship of TEAEs to the study drugs were assessed as: probable related, possibly related, unlikely related, and unrelated. The severity of TEAEs were graded using the Common Terminology Criteria for Adverse Events, Version 3.0 as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal).'}, {'measure': Number of Participants With SAEs by Severity and Relationship to Study Drugs, 'time_frame': 'From study drug administration to 4-week post treatment follow-up visit (approximately 52 weeks)', 'description': 'The relationship of SAEs to the study drugs were assessed as: probable related, possibly related, unlikely related, and unrelated. The severity of SAEs were graded using the Common Terminology Criteria for Adverse Events, Version 3.0 as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal).'}, {'measure': Number of Participants With Abnormal Vital Signs Reported as TEAEs, 'time_frame': 'From study drug administration to 4-week post treatment follow-up visit (approximately 52 weeks)', 'description': 'Vital signs included systolic and diastolic blood pressure, pulse rate, pulse oximetry, and body temperature. Participants with abnormal vital signs who required clinical intervention or further investigation (beyond ordering a repeat \\[confirmatory\\] test) unless they are associated with an already reported clinical event are reported.'}, {'measure': Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs, 'time_frame': 'From study drug administration to 4-week post treatment follow-up visit (approximately 52 weeks)', 'description': 'Clinical laboratory tests included haematology, biochemistry, and urinalysis. Participants with abnormal laboratory parameters who required clinical intervention or further investigation (beyond ordering a repeat \\[confirmatory\\] test) unless they are associated with an already reported clinical event are reported.'}, {'measure': Number of Participants With Abnormal Electrocardiogram Reported as TEAEs, 'time_frame': 'From study drug administration to 4-week post treatment follow-up visit (approximately 52 weeks)', 'description': 'Participants with abnormal electrocardiogram who required clinical intervention or further investigation (beyond ordering a repeat \\[confirmatory\\] test) unless they are associated with an already reported clinical event are reported.'}]","{'value': 6, 'unit': years}",,ALL,true,88,"[Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Spain, United Kingdom, United States]",823,Respiratory,false
NCT04745299,Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALS,"A Double-blind, Randomized, Multicenter, Placebo-Controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Lenzumestrocel(Neuronata-R® Inj.) in Patients With Amyotrophic Lateral Sclerosis",COMPLETED,2021-02-24,2024-11-13,"Corestemchemon, Inc.",INDUSTRY,[Amyotrophic Lateral Sclerosis],INTERVENTIONAL,[PHASE3],123,RANDOMIZED,QUADRUPLE,"[{'type': BIOLOGICAL, 'name': Lenzumestrocel, 'description': 'Single cycle administration group : injections twice in a 26-day interval Multiple administration group : injections twice in a 26-day interval followed by repeated three times injections every three months'}, {'type': DRUG, 'name': Riluzole, 'description': 'concomitant administration of Riluzole to all groups, except subjects to whom Riluzole administration is deemed impossible owing to adverse events as determined by medical experts'}, {'type': DRUG, 'name': Placebo Comparator, 'description': 'Single cycle administration group: Placebo comparator is injected three times every three months after injection of Lenzumestrocel twice in a 26-day interval.

Control group: Placebo comparator is injected twice in a 26-day interval followed by repeated three times injcections every three months'}]","[{'measure': 'Joint rank scores (CAFS, Combined Assessment of Functional and Survival)', 'time_frame': 'at 12 months, and 6 months', 'description': 'Joint rank score is derived from Combined Assessment of Function and Survival. Functional assessment is based on ALSFRS-R scores and survival assessment is based on the period from randomization to physical death. Joint rank score will be calculated with ALSFRS-R score data and survival. For each pairwise comparison, a study participant is assigned a score and then the summed scores are ranked for all participants.

The higher ranking, the higher score, and the lower ranking, the lower score. And the average rank score is then calculated for each treatment group. A higher mean rank score indicates that participants in that treatment group, on average, fared better.

1. The difference in joint rank scores between multiple administration group and control group at 12 months.
2. The difference in joint rank scores between single cycle administration group and control group at 6 months'}]","[{'measure': 'Joint rank scores (CAFS, Combined Assessment of Functional and Survival)', 'time_frame': at 6 months, 'description': 'Joint rank score is derived from Combined Assessment of Function and Survival. Functional assessment is based on ALSFRS-R scores and survival assessment is based on the period from randomization to physical death. Joint rank score will be calculated with ALSFRS-R score data and survival. For each pairwise comparison, a study participant is assigned a score and then the summed scores are ranked for all participants.

The higher ranking, the higher score, and the lower ranking, the lower score. And the average rank score is then calculated for each treatment group. A higher mean rank score indicates that participants in that treatment group, on average, fared better.

The difference in joint rank scores between multiple administration group and control group at 6 months.'}, {'measure': 'Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score', 'time_frame': 'at 12 months, 6 months', 'description': 'ALSFRS-R is an instrument designed to evaluate functional status of subjects with amyotrophic lateral sclerosis (Lou Gehrig\'s disease), such as gross motor activity, fine motor activity, bulbar function and respiration function. It consists of 12 items; 3 items for mouth functions, 4 items for upper limb and overall fine motor functions, 2 items for lower limb functions and 3 items for respiration functions. Each item is evaluated in 5-point scale (0\\~4). A higher score means a better functional status.

1. Change of ALSFRS-R score measured at baseline and 12 months (multiple administration group and control group)
2. Change of ALSFRS-R score measured at baseline and 6 months (single cycle administration and control group)'}, {'measure': Time to event, 'time_frame': 'at 12 months, 6 months', 'description': 'Time to Event is defined as physical death, tracheostomy recognized as the point where disease progression functionally stops or chronic use of ventilator, whichever comes earlier. Chronic use of ventilator means that ventilator is used for more than 20 hours in a day and such use is continued for more than 30 days and that a subject in vegetative state requires full supports from other persons to maintain living.

1. Time to event for 12 months (multiple administration group and control group)
2. Time to event for 6 months (single cycle administration group and control group)'}]","{'value': 25, 'unit': years}","{'value': 75, 'unit': years}",ALL,false,5,[South Korea],1358,Neurology / CNS,unknown
NCT04626921,"A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis","VISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis",COMPLETED,2020-10-22,2023-09-06,Clene Nanomedicine,INDUSTRY,[Relapsing Multiple Sclerosis],INTERVENTIONAL,"[PHASE2, PHASE3]",55,NA,NONE,"[{'type': DRUG, 'name': CNM-Au8, 'description': 30 mg of CNM-Au8}]","[{'measure': Change in Best-Corrected Low-Contrast Letter Acuity score., 'time_frame': 2 years, 'description': Mean change in BC-LCLA from baseline to end of study across all eyes as measured by 2.5% low contrast Sloan Letter Chart.}, {'measure': Incidence of treatment-emergent AEs throughout the study., 'time_frame': 2 years, 'description': Safety endpoint include incidence of treatment-emergent AEs.}]","[{'measure': Measure of neurological function assessed by a functional composite responder analysis., 'time_frame': 2 years, 'description': Mean change in Functional Composite Responder Analysis Score from Baseline to End of Study.}]","{'value': 18, 'unit': years}","{'value': 55, 'unit': years}",ALL,false,5,[Australia],1049,Neurology / CNS,unknown
NCT00712348,Switchover Trial From Imiglucerase to Plant Cell Expressed Recombinant Human Glucocerebrosidase,"A Phase 3 Multicenter, Open-label, Switchover Trial to Assess the Safety and Efficacy of Plant Cell Expressed Recombinant Human Glucocerebrosidase in Patients With Gaucher Disease Treated With Imiglucerase",COMPLETED,2008-12-01,2013-05-01,Pfizer,INDUSTRY,[Gaucher Disease],INTERVENTIONAL,[PHASE3],31,NA,NONE,"[{'type': DRUG, 'name': Taliglucerase alfa, 'description': Intravenous infusion every 2 weeks}]","[{'measure': Hemoglobin, 'time_frame': Every 3 months from Baseline to Month 9, 'description': NULL}]",,"{'value': 2, 'unit': years}",,ALL,true,10,"[Australia, Canada, Israel, Spain, United Kingdom, United States]",1612,Rare Disease / Orphan,unknown
NCT01158365,Dermacyd in Odor Reducing.,"Single Center, Open, Cross-over, Phase III Study for Comparative Evaluation of Safety Use and Efficacy in the Odor Reduce and Vaginal Moisturize Increase for Intimates Use Products Dermacyd Femina Delicata, Dermacyd Femina Breeze, Dermacyd Teen Sweet Flower, Dermacyd Teen Fresh Mix and Dermacyd Femina Comparing to the Control Product Glycerine Vegetal Soap Granado Traditional.",COMPLETED,2010-07-01,2010-12-01,Sanofi,INDUSTRY,[Hygiene],INTERVENTIONAL,[PHASE3],230,RANDOMIZED,NONE,"[{'type': DRUG, 'name': 'LACTIC ACID (Dermacid)', 'description': 'Route of administration: local'}, {'type': DRUG, 'name': Glycerine Vegetal Soap Granado Traditional, 'description': 'Route of administration: local'}]","[{'measure': Reduction of genital odor and increase hydration in genital mucosa, 'time_frame': 'From the treatment start to the end of the study (day 67)', 'description': 'Patient\'s questionnaire will be completed at V1, V2 and V4. Reduction of vaginal odor, increase in the moisture area, and perception about some items like foam, facility of rinsing, final touch of the mucosa, final fragrance, and cleaning sensation will be rated on a 5-point scale.'}]","[{'measure': Evaluation of the integrity of the mucosa, 'time_frame': 'From the treatment start to the end of the study (day 67)', 'description': 'Onset of erythema, edema, scaling, blisters or other clinical sign will be evaluated.'}]","{'value': 18, 'unit': years}","{'value': 45, 'unit': years}",FEMALE,false,1,[Brazil],153,Other,unknown
NCT00621504,Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia,"A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia",COMPLETED,2008-01-01,2009-06-01,Forest Laboratories,INDUSTRY,[Bacterial Pneumonia],INTERVENTIONAL,[PHASE3],606,RANDOMIZED,QUADRUPLE,"[{'type': DRUG, 'name': Ceftaroline fosamil for Injection, 'description': '2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days'}, {'type': DRUG, 'name': IV Ceftriaxone, 'description': '1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days'}, {'type': DRUG, 'name': Placebo, 'description': 'Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind'}, {'type': DRUG, 'name': Clarithromycin, 'description': 'In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.'}]","[{'measure': 'Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations', 'time_frame': 8 to 15 days after last dose of study drug, 'description': 'Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary

Failure: Any of the following:

* Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy
* Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia
* Death wherein pneumonia (ie,CABP) was considered causative

Indeterminate: Inability to determine an outcome'}, {'measure': 'Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population', 'time_frame': 8-15 days after last dose of study drug, 'description': NULL}]","[{'measure': 'Clinical Response at End of Therapy (EOT)', 'time_frame': Last day of study drug administration, 'description': NULL}, {'measure': 'Microbiological Success Rate at Test of Cure (TOC)', 'time_frame': 8-15 days after last dose of study drug, 'description': NULL}, {'measure': 'Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)', 'time_frame': 8-15 days after last day of study drug, 'description': NULL}, {'measure': Clinical and Microbiological Response by Pathogen at TOC, 'time_frame': 8-15 days after last dose of study drug, 'description': NULL}, {'measure': 'Clinical Relapse at Late Follow Up (LFU)', 'time_frame': 21-35 days after last dose of study drug, 'description': NULL}, {'measure': Microbiological Re-infection/Recurrence at LFU, 'time_frame': 21 to 35 days after last dose of study drug, 'description': NULL}, {'measure': Evaluate Safety, 'time_frame': 'first dose, throughout the treatment period, and up to the TOC visit', 'description': NULL}]","{'value': 18, 'unit': years}",,ALL,true,168,"[Argentina, Austria, Brazil, Bulgaria, Estonia, France, Georgia, Germany, Hungary, India, Lithuania, Malaysia, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Switzerland, Thailand, Ukraine, United States]",517,Infectious Disease,unknown
NCT02140697,Efficacy and Safety of Hippophae Rhamnoides L. Leaf Extract on Body Fat,,COMPLETED,2014-05-01,2014-12-01,Chonbuk National University Hospital,OTHER,[Obesity],INTERVENTIONAL,"[PHASE2, PHASE3]",80,RANDOMIZED,DOUBLE,"[{'type': DIETARY_SUPPLEMENT, 'name': 'Hippophae rhamnoides L. Leaf Extract (3g/day)', 'description': 'Hippophae rhamnoides L. Leaf extract (3g/day), parallel design'}, {'type': DIETARY_SUPPLEMENT, 'name': 'Placebo (3g/day)', 'description': 'Placebo (3g/day), parallel design'}]","[{'measure': Changes in body fat mass, 'time_frame': Baseline and 12 week, 'description': 'Body fat mass was measured in study baseline and visit 3(12 week).'}]","[{'measure': Change in percent body fat, 'time_frame': Baseline and 12 week, 'description': 'Percent body fat was measured in study baseline and visit 3(12 week).'}, {'measure': Change in fat free mass, 'time_frame': Baseline and 12 week, 'description': 'Fat Free Mass was measured in study baseline and visit 3(12 week).'}, {'measure': Change in weight, 'time_frame': Baseline and 12 week, 'description': 'Weight was measured in study baseline and visit 3(12 week).'}, {'measure': Change in body mass index, 'time_frame': Baseline and 12 week, 'description': 'Body mass index was measured in study baseline and visit 3(12 week).'}]","{'value': 19, 'unit': years}","{'value': 65, 'unit': years}",ALL,false,1,[South Korea],214,Metabolic / Endocrine,unknown
NCT02523599,Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty,"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the XaraColl® Bupivacaine Implant (300 mg Bupivacaine Hydrochloride) After Open Laparotomy Hernioplasty",COMPLETED,2015-08-01,2016-04-01,Innocoll,INDUSTRY,"['Pain, Postoperative']",INTERVENTIONAL,[PHASE3],305,RANDOMIZED,QUADRUPLE,"[{'type': DRUG, 'name': XaraColl, 'description': Surgical implantation of 3 bupivacaine collagen implants}, {'type': OTHER, 'name': Placebo, 'description': 'Plain collagen implant (vehicle)'}]","[{'measure': SPI24, 'time_frame': 0 to 24 hours, 'description': 'Sum of Pain Intensity (SPI24). The time weighted sum of pain intensity from 0 to 24 hours (ie, the area under the NRS PI curve from 0 to 24 hours). Where 0 indicated ""no pain"" and 10 indicated ""worst pain possible"". This type of measurement scale is called ""NRS"" or Numerical Rating Scale For the purpose of (SPI) computation, PI at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. SPI will not be calculated for randomized but not treated patients. A lower score is a better outcome. Minimum value would be ""0"" and Maximum value would be 240. Time-weighted SPI is calculated as the sum of the pain intensities between successive time points (i.e., if SPI24 = ∑\\[PI x (time t - time t-1)\\], where ""t"" represents a given time point,""t-1"" represents the previous time point, and time is expressed in hours). This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule.'}]","[{'measure': TOpA24, 'time_frame': Time 0 through 24 hours, 'description': 'Total use of opioid analgesia (TOpA) from Time 0 through 24 hours (TOpA24). This is a basic measurement of counting in total the number of morphine tablets (15 mg) patients had use within a 24 hour period (typically called ""rescue"" to help manage pain. Zero (0) is the ""lowest"" score. The lower the number of tablets the better outcome.'}, {'measure': TOpA48, 'time_frame': Time 0 through 48 hours, 'description': 'Total use of Opioid Analgesia from Time 0 through 48 hours (TOpA48) This is a basic measurement of counting in total the number of morphine tablets (15 mg) patients had use within a 48-hour period (typically called ""rescue"" to help manage pain. Zero (0) is the ""lowest"" score. The lower the number of tablets the better outcome.'}, {'measure': TOpA72, 'time_frame': Time 0 through 72 hours, 'description': 'Total use of Opioid Analgesia (TOpA) from Time 0 through 72 hours. This is a basic measurement of counting in total the number of morphine tablets patients had use within a 72-hour period (typically called ""rescue"" to help manage pain. Zero (0) is the ""lowest"" score. The lower the number of tablets the better outcome.'}, {'measure': SPI48, 'time_frame': 0 to 48 hours, 'description': 'Sum of pain intensity (SPI).The time weighted sum of pain intensity from 0 to 48 hours (ie, the area under the NRS PI curve from 0 to 48 hours). For the purpose of SPI computation, Pain Intensity at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. Minimum value would be ""0"" and Maximum value would be 480. Time-weighted SPI is calculated as the sum of the pain intensities between successive time points (i.e., if SPI24 = ∑\\[PI x (time t - time t-1)\\], where ""t"" represents a given time point,""t-1"" represents the previous time point, and time is expressed in hours). This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule.'}, {'measure': SPI72, 'time_frame': 0 to 72 hours, 'description': 'Sum of pain intensity (SPI). The time weighted sum of pain intensity from 0 to 72 hours (ie, the area under the NRS PI curve from 0 to 72 hours). For the purpose of SPI computation, PI at Time 0 (Baseline PI) is set to zero for all patients who have test article implantation. Where 0 indicates ""no pain"" and 10 indicated ""worst pain possible"". A lower score is a better outcome. Minimum value would be ""0"" and Maximum value would be 720. Time-weighted SPI is calculated as the sum of the pain intensities between successive time points (i.e., if SPI72 = ∑\\[PI x (time t - time t-1)\\], where ""t"" represents a given time point,""t-1"" represents the previous time point, and time is expressed in hours). This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule.'}]","{'value': 18, 'unit': years}",,ALL,true,23,[United States],244,Other,unknown