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[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 661, Unnamed: 0: 824, NCT Number: NCT03915340, Study Title: Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions, Study URL: https://clinicaltrials.gov/study/NCT03915340, Acronym: , Study Status: COMPLETED, Brief Summary: This bioequivalence study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of propafenone after a single oral dose administration under fasting conditions., Study Results: NO, Conditions: Bioequivalence, Interventions: DRUG: Propafenone|DRUG: Rytmonorm, Primary Outcome Measures: Cmax of propafenone in plasma after administration of the test and the reference products, Maximum observed concentration in plasma, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|AUC0-T of propafenone in plasma after administration of the test and the reference products, Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration, Secondary Outcome Measures: Tmax of propafenone in plasma after administration of the test and the reference products, Time of maximum observed concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|TLQC of propafenone in plasma after administration of the test and the reference products, Time of last observed quantifiable concentration, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|AUC0-∞ of propafenone in plasma after administration of the test and the reference products, Area under the concentration time curve extrapolated to infinity, calculated as AUC0-T + ĈLQC (the predicted concentration at time TLQC) / λZ (apparent elimination rate constant), Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Residual area of propafenone in plasma after administration of the test and the reference products, Extrapolated area (i.e. percentage of AUC0-∞ due to extrapolation from TLQC to infinity), Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Time point where the log-linear elimination phase begins (TLIN) of propafenone in plasma after administration of the test and the reference products, Time point where the log-linear elimination phase begins, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|λZ of propafenone in plasma after administration of the test and the reference products, Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Thalf of propafenone in plasma after administration of the test and the reference products, Terminal elimination half-life, calculated as ln(2)/λZ, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Number of treatment-emergent adverse events for the test and the reference products, The safety population will include all subjects who received at least one dose of the test or the reference product. Any significant changes will be recorded as treatment-emergent adverse events only if they are judged clinically significant by the qualified investigator or delegate., Up to 23 days (after the first drug administration until the completion of clinical part of the study), Other Outcome Measures: , Sponsor: Pharmtechnology LLC, Collaborators: Altasciences Company Inc., Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 32.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER, Other IDs: PTL-P4-227 (v. 2.0 04/09/2019), Start Date: 2019-03-23, Primary Completion Date: 2019-05-08, Completion Date: 2019-05-08, First Posted: 2019-04-16, Results First Posted: , Last Update Posted: 2019-06-06, Locations: Altasciences Company Inc., Mount-Royal, Quebec, H3P 3P1, Canada, Study Documents: , criteria: "Inclusion Criteria:~1. Provision of signed and dated informed consent form (ICF)~2. Stated willingness to comply with all study procedures and availability for the duration of the study~3. Healthy adult male or female volunteer~4. A female volunteer must meet one of the following criteria:~ 1. Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug. An acceptable method of contraception includes one of the following:~ * Abstinence from heterosexual intercourse~ * Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)~ * Intrauterine device (with or without hormones)~ * Condom with intra-vaginally applied spermicide~ Or~ 2. Participant whose partner has had a vasectomy less than 6 months prior to dosing, and agrees to use an additional acceptable method of contraception from the first study drug administration through to at least 30 days after the last dose of the study drug~ Or~ 3. Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study drug administration)~5. A male volunteer meeting one of the following criteria:~ 1. Participant is able to procreate and agrees to use one of the accepted contraceptive regimens and not donate sperm from the first study drug administration to at least 90 days after the last drug administration. An acceptable method of contraception includes one of the following:~ * Abstinence from heterosexual intercourse~ * Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository)~ Or~ 2. Participant is unable to procreate; defined as surgically sterile (i.e. has undergone a vasectomy at least 180 days prior to the first study drug administration)~6. Volunteer aged at least 18 years of age but not older than 45 years~7. Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2~8. Non- or ex-smoker; an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration~9. Clinical laboratory values within the laboratory\\s stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator~10. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or electrocardiogram (ECG), as determined by an investigator~Exclusion Criteria:~1. Females who are lactating at screening~2. Females who are pregnant according to the pregnancy test at screening or prior to the first study drug administration~3. Seated pulse rate less than 50 Beats per Minute (bpm) or more than 90 bpm at the screening visit or prior to the first study drug administration~4. History of significant hypersensitivity to propafenone or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs~5. Presence of significant gastrointestinal, liver or kidney disease, or any other condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects~6. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability~7. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease~8. Presence of out-of-range cardiac interval (PR \\\\< 110 msec, PR \\\\> 200 msec, QRS \\\\< 60 msec, QRS \\\\>110 msec and QTc \\\\> 440 msec) on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by the investigator~9. History of myasthenia gravis~10. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\\\\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)~11. Any clinically significant illness in the 28 days prior to the first study drug administration~12. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy~13. Any history of tuberculosis~14. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration~15. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests~16. Volunteers who have already been included in a previous group for this clinical study~17. Volunteers who took propafenone in the 28 days prior to the first study drug administration~18. Volunteers who took an Investigational Product (IP) in the 28 days prior to the first study drug administration~19. Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration~20. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration", combined_text: Bioequivalence Study of Two Formulations of Propafenone 300 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions Cmax of propafenone in plasma after administration of the test and the reference products, Maximum observed concentration in plasma, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|AUC0-T of propafenone in plasma after administration of the test and the reference products, Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration Tmax of propafenone in plasma after administration of the test and the reference products, Time of maximum observed concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|TLQC of propafenone in plasma after administration of the test and the reference products, Time of last observed quantifiable concentration, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|AUC0-∞ of propafenone in plasma after administration of the test and the reference products, Area under the concentration time curve extrapolated to infinity, calculated as AUC0-T + ĈLQC (the predicted concentration at time TLQC) / λZ (apparent elimination rate constant), Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Residual area of propafenone in plasma after administration of the test and the reference products, Extrapolated area (i.e. percentage of AUC0-∞ due to extrapolation from TLQC to infinity), Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Time point where the log-linear elimination phase begins (TLIN) of propafenone in plasma after administration of the test and the reference products, Time point where the log-linear elimination phase begins, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|λZ of propafenone in plasma after administration of the test and the reference products, Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Thalf of propafenone in plasma after administration of the test and the reference products, Terminal elimination half-life, calculated as ln(2)/λZ, Time points 0.00 (prior to each drug administration) and 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00 hours after each drug administration|Number of treatment-emergent adverse events for the test and the reference products, The safety population will include all subjects who received at least one dose of the test or the reference product. Any significant changes will be recorded as treatment-emergent adverse events only if they are judged clinically significant by the qualified investigator or delegate., Up to 23 days (after the first drug administration until the completion of clinical part of the study) "Inclusion Criteria:~1. Provision of signed and dated informed consent form (ICF)~2. Stated willingness to comply with all study procedures and availability for the duration of the study~3. Healthy adult male or female volunteer~4. A female volunteer must meet one of the following criteria:~ 1. Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug. An acceptable method of contraception includes one of the following:~ * Abstinence from heterosexual intercourse~ * Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)~ * Intrauterine device (with or without hormones)~ * Condom with intra-vaginally applied spermicide~ Or~ 2. Participant whose partner has had a vasectomy less than 6 months prior to dosing, and agrees to use an additional acceptable method of contraception from the first study drug administration through to at least 30 days after the last dose of the study drug~ Or~ 3. Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study drug administration)~5. A male volunteer meeting one of the following criteria:~ 1. Participant is able to procreate and agrees to use one of the accepted contraceptive regimens and not donate sperm from the first study drug administration to at least 90 days after the last drug administration. An acceptable method of contraception includes one of the following:~ * Abstinence from heterosexual intercourse~ * Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository)~ Or~ 2. Participant is unable to procreate; defined as surgically sterile (i.e. has undergone a vasectomy at least 180 days prior to the first study drug administration)~6. Volunteer aged at least 18 years of age but not older than 45 years~7. Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2~8. Non- or ex-smoker; an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration~9. Clinical laboratory values within the laboratory\\s stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator~10. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or electrocardiogram (ECG), as determined by an investigator~Exclusion Criteria:~1. Females who are lactating at screening~2. Females who are pregnant according to the pregnancy test at screening or prior to the first study drug administration~3. Seated pulse rate less than 50 Beats per Minute (bpm) or more than 90 bpm at the screening visit or prior to the first study drug administration~4. History of significant hypersensitivity to propafenone or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs~5. Presence of significant gastrointestinal, liver or kidney disease, or any other condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects~6. History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability~7. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease~8. Presence of out-of-range cardiac interval (PR \\\\< 110 msec, PR \\\\> 200 msec, QRS \\\\< 60 msec, QRS \\\\>110 msec and QTc \\\\> 440 msec) on the ECG at screening or other clinically significant ECG abnormalities, unless deemed non-significant by the investigator~9. History of myasthenia gravis~10. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\\\\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)~11. Any clinically significant illness in the 28 days prior to the first study drug administration~12. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy~13. Any history of tuberculosis~14. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration~15. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests~16. Volunteers who have already been included in a previous group for this clinical study~17. Volunteers who took propafenone in the 28 days prior to the first study drug administration~18. Volunteers who took an Investigational Product (IP) in the 28 days prior to the first study drug administration~19. Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration~20. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration", Similarity Score: 0.6803929794644455}'}]
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from_dataset
| 0.680393
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[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 352, Unnamed: 0: 426, NCT Number: NCT01744873, Study Title: Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition, Study URL: https://clinicaltrials.gov/study/NCT01744873, Acronym: , Study Status: COMPLETED, Brief Summary: This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fed condition in normal, healthy, adult human subjects., Study Results: NO, Conditions: Fed, Interventions: DRUG: Bisoprolol Fumarate Tablet 10 mg|DRUG: Bisoprolol, Primary Outcome Measures: Cmax, Pre-dose, 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose, 3 months|AUC, Pre-dose and at 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose., 3 months, Secondary Outcome Measures: , Other Outcome Measures: , Sponsor: IPCA Laboratories Ltd., Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 24.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: Ipca/ARL-12/148, Start Date: 2012-08, Primary Completion Date: 2012-11, Completion Date: 2012-11, First Posted: 2012-12-07, Results First Posted: , Last Update Posted: 2012-12-07, Locations: Accutest Research Lab (I) Pvt. Ltd., Ahmedabad, Gujarat, India, Study Documents: , criteria: "Inclusion Criteria:~1. Male and Non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).~2. Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.~3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).~4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).~5. Willingness to follow the protocol requirements as evidenced by written informed consent.~6. Subject willing to give written informed consent.~7. Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.~8. No history of drug abuse in the past one year.~9. Non-smokers and non-alcoholics.~For female subject~* was child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies, Diaphragm, Intrauterine device and Abstinence.~OR~* was surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).~Exclusion Criteria:~1. Known history of hypersensitivity to Bisoprolol Fumarate, or related drugs.~2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.~3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.~4. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.~5. Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.~6. History of malignancy or other serious diseases.~7. Refusal to abstain from food for at least 10.00 hours prior to receiving the high-fat and high-calorie breakfast and for at least 04.00 hours post-dose, in each study period.~8. Any contraindication to blood sampling or difficulty in accessibility of veins.~9. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.~10. Refusal to avoid the use of xanthine-containing food or beverages (chocolates, tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.~11. Blood donation within 90 days prior to the commencement of the study.~12. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.~13. Found positive in breath alcohol test done before check-in for each study period.~14. Found positive in urine test for drugs of abuse done before check-in for each study period.~15. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.~16. History of problem in swallowing Tablet(s).~17. Female subject, demonstrating positive urine pregnancy test at the time of screening.~18. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.~19. Female subject, currently breast feeding or lactating.~20. Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.", combined_text: Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition Cmax, Pre-dose, 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose, 3 months|AUC, Pre-dose and at 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose., 3 months "Inclusion Criteria:~1. Male and Non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).~2. Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.~3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).~4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).~5. Willingness to follow the protocol requirements as evidenced by written informed consent.~6. Subject willing to give written informed consent.~7. Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.~8. No history of drug abuse in the past one year.~9. Non-smokers and non-alcoholics.~For female subject~* was child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies, Diaphragm, Intrauterine device and Abstinence.~OR~* was surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).~Exclusion Criteria:~1. Known history of hypersensitivity to Bisoprolol Fumarate, or related drugs.~2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.~3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.~4. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.~5. Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.~6. History of malignancy or other serious diseases.~7. Refusal to abstain from food for at least 10.00 hours prior to receiving the high-fat and high-calorie breakfast and for at least 04.00 hours post-dose, in each study period.~8. Any contraindication to blood sampling or difficulty in accessibility of veins.~9. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.~10. Refusal to avoid the use of xanthine-containing food or beverages (chocolates, tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.~11. Blood donation within 90 days prior to the commencement of the study.~12. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.~13. Found positive in breath alcohol test done before check-in for each study period.~14. Found positive in urine test for drugs of abuse done before check-in for each study period.~15. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.~16. History of problem in swallowing Tablet(s).~17. Female subject, demonstrating positive urine pregnancy test at the time of screening.~18. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.~19. Female subject, currently breast feeding or lactating.~20. Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.", Similarity Score: 0.672497819310299}'}]
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from_dataset
| 0.672498
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[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 738, Unnamed: 0: 924, NCT Number: NCT01513044, Study Title: Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions, Study URL: https://clinicaltrials.gov/study/NCT01513044, Acronym: , Study Status: COMPLETED, Brief Summary: "An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddys Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult,human, male subjects under fasting conditions.", Study Results: NO, Conditions: Healthy, Interventions: DRUG: Mycophenolate Mofetil|DRUG: Mycophenolate Mofetil, Primary Outcome Measures: Area Under Curve (AUC), Pre-dose, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 post dose, Secondary Outcome Measures: , Other Outcome Measures: , Sponsor: "Dr. Reddys Laboratories Limited", Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 68.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 08-VIN-182, Start Date: 2009-01, Primary Completion Date: 2009-01, Completion Date: 2009-01, First Posted: 2012-01-20, Results First Posted: , Last Update Posted: 2012-01-20, Locations: veeda clinical research Pvt. Ltd, Ahmedabad, Gujarat, 3 80 015, India, Study Documents: , criteria: "Inclusion Criteria:~* Subjects aged between 18 and 50 years (including both).~* Subjects\\ weight within the normal range according to normal values for the Body~* Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.~* Subjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.~* Subjects having clinically acceptable 12-lead electrocardiogram (ECG).~* Subjects having clinically acceptable chest X-Ray (PIA view).~* Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).~* Subjects having negative alcohol breath test.~* Subjects willing to adhere to the protocol requirements and to provide written informed consent.~Exclusion Criteria:~The subjects were excluded from the study, if they meet any of the following criteria:~* Hypersensitivity to Mycophenolate Mofetil or related drugs.~* History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.~* History or presence of significant alcoholism or drug abuse in the past one year.~* History or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).~* History or presence of asthma, urticaria or other significant allergic reactions.~* History or presence of significant gastric and/or duodenal ulceration.~* History or presence of glaucoma, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm and myasthenia gravis.~* History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.~* History or presence of cancer.~* Difficulty with donating blood.~* Difficulty in swallowing solids like tablets or capsules.~* Use of any prescribed medication or OTC medicinal products during the last two week prior to initiation of study.~* Major illness during 3 months before screening.~* Participation in a drug research study within past 3 months.~* Donation of blood in the past 3 months before screening.~* Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.~* History or presence of significant easy bruising or bleeding.~* History or presence of significant recent trauma.", combined_text: Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions Area Under Curve (AUC), Pre-dose, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 post dose "Inclusion Criteria:~* Subjects aged between 18 and 50 years (including both).~* Subjects\\ weight within the normal range according to normal values for the Body~* Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.~* Subjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.~* Subjects having clinically acceptable 12-lead electrocardiogram (ECG).~* Subjects having clinically acceptable chest X-Ray (PIA view).~* Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).~* Subjects having negative alcohol breath test.~* Subjects willing to adhere to the protocol requirements and to provide written informed consent.~Exclusion Criteria:~The subjects were excluded from the study, if they meet any of the following criteria:~* Hypersensitivity to Mycophenolate Mofetil or related drugs.~* History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.~* History or presence of significant alcoholism or drug abuse in the past one year.~* History or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).~* History or presence of asthma, urticaria or other significant allergic reactions.~* History or presence of significant gastric and/or duodenal ulceration.~* History or presence of glaucoma, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm and myasthenia gravis.~* History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.~* History or presence of cancer.~* Difficulty with donating blood.~* Difficulty in swallowing solids like tablets or capsules.~* Use of any prescribed medication or OTC medicinal products during the last two week prior to initiation of study.~* Major illness during 3 months before screening.~* Participation in a drug research study within past 3 months.~* Donation of blood in the past 3 months before screening.~* Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.~* History or presence of significant easy bruising or bleeding.~* History or presence of significant recent trauma.", Similarity Score: 0.6069201503187602}'}]
|
from_dataset
| 0.60692
|
[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 871, Unnamed: 0: 1092, NCT Number: NCT00460473, Study Title: A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery, Study URL: https://clinicaltrials.gov/study/NCT00460473, Acronym: , Study Status: TERMINATED, Brief Summary: The purpose of this study is to evaluate the efficacy and safety of perioperative use of dexmedetomidine in the prevention of postoperative delirium in subjects undergoing surgery for fractured hip with general anesthesia., Study Results: NO, Conditions: Delirium, Interventions: DRUG: Dexmedetomidine|DRUG: Placebo, Primary Outcome Measures: Percentage of subjects who experienced any postoperative delirium up to 3 days after the end of study drug infusion, The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)., Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion., Secondary Outcome Measures: Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion, Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.|Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion, Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.|Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics), During the intraoperative period, Post-anesthesia care unit period and the 3 days Follow-up Period.|Postoperative use of Midazolam, If RASS \\\\>0, midazolam (MDZ) 0.5-1 mg IV will be given until RASS \\\\<0. While in PACU during study drug infusion period, MDZ (0.5-1 mg IV) will be given if RASS \\\\>+1 under allowed maximum dose of study drug.\\n\\nRASS range:\\n\\n* +4 Combative -Overtly combative, violent, immediate danger to staff\\n* +3 Very agitated- Pulls or removes tubes or catheters, aggressive\\n* +2 Agitated- Frequent non-purposeful movements, fights ventilator\\n* +1 Restless- Anxious, but movements not aggressive or vigorous\\n* 0 Alert and calm\\n* -1 Drowsy - Not fully alert, but sustained awakening (eye opening, eye contact) to voice (\\\\>10 sec)\\n* -2 Light sedation - Briefly awakens with eye contact to voice (\\\\<10 sec)\\n* -3 Moderate sedation - Movement or eye opening to voice (but no eye contact)\\n* -4 Deep sedation No response to voice, but movement or eye opening to physical stimulation\\n* -5 Unarousable No response to voice or physical stimulation, During the PACU period (Approximately 2 hours)|Time-to-Aldrete score of ≥9, A score of 9-10 indicates the subject has recovered from anesthesia and is ready for discharge from the PACU., Every 15±5 minutes from arrival in the PACU (Approximately 2 hours)|Length of post-operative hospital stay, From the post operative period until subject discharged from hospital, Other Outcome Measures: , Sponsor: Hospira, now a wholly owned subsidiary of Pfizer, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE3, Enrollment: 52.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION, Other IDs: DEX-06-09, Start Date: 2007-04, Primary Completion Date: 2007-11, Completion Date: 2007-11, First Posted: 2007-04-16, Results First Posted: , Last Update Posted: 2015-07-24, Locations: "Loma Linda University Medical Center, Loma Linda, California, 92354, United States|LAC-USC Medical Center Los Angeles, Los Angeles, California, 90033, United States|Huntington Memorial Hospital, Pasadena, California, 91105, United States|University of Miami-Jackson Memorial Medical Center, Miami, Florida, 33101, United States|Southeastern Clinical Research Consultants, Orlando, Florida, 32804, United States|Orlando Regional Healthcare, Critical Care Medicine, Orlando, Florida, 32806, United States|G and G Research, Inc., Vero Beach, Florida, 32960, United States|Orthopaedic Center of Vero Beach, Vero Beach, Florida, 32960, United States|Medical College of Georgia, Augusta, Georgia, 30912, United States|University of Iowa Hospitals and Clinics, Dept. of Anesthesia, Iowa City, Iowa, 52242-1053, United States|Outcomes Research Institute, Louisville, Kentucky, 40202, United States|Louisiana State University, Dept. of Orthopaedic Surgery, Shreveport, Louisiana, 71103, United States|Spectrum Health Blodgett Campus, Grand Rapids, Michigan, 49506-2810, United States|William Beaumont Hospital, Royal Oak, Michigan, 48073, United States|Saint Marys Duluth Clinic Health System, Duluth, Minnesota, 55805, United States|Mayo Clinic College of Medicine, Dept. of Anesthesiology, Rochester, Minnesota, 55906, United States|University of Missouri, Columbia, Missouri, 65212, United States|Mount Sinai School of Medicine, Great Neck, New York, 11021, United States|New York University Medical Center, New York, New York, 10016, United States|Duke University Medical Center, Durham, North Carolina, 27705, United States|The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Ohio State University Medical Center, Columbus, Ohio, 43210, United States|University of Pittsburgh Medical Center, Presbyterian, Pittsburgh, Pennsylvania, 15213-2582, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15232, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|Research Concepts, Bellaire, Texas, 77401, United States|Parkland Health and Hospital System, Dallas, Texas, 75390-9179, United States|University of Virginia Health Systems, Charlottesville, Virginia, 22908-0710, United States|University of Wisconsin Medical School, Dept. of Anesthesiology, Madison, Wisconsin, 53792, United States|VA Medical Center, Milwaukee, Wisconsin, 53295, United States", Study Documents: , criteria: "Inclusion Criteria:~1. Adult (≥18 years old) male or female who will undergo surgery for fractured hip with general anesthesia within 72 hours of admission to hospital.~2. If female, subject is non-lactating and is either:~ 1. Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.~ 2. Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.~3. Subject is American Society of Anesthesiologists Physical Status I, II, III, or IV.~4. Subject (or subject\\s legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB).~Exclusion Criteria:~1. Cognitive function level by Mini Mental State Exam (MMSE) of ≤20.~2. Subject has a positive CAM-ICU result for delirium at Screening or Baseline.~3. Subject requires chronic antipsychotic therapy.~4. Subject is anticipated to require additional surgical procedures during the 72 hour Screening Period and the 3 days Follow-up Period.~5. Subject is anticipated to require repair of pelvic fractures (eg,acetabulum).~6. Subject has participated in a trial with any experimental drug or experimental implantable device within 30 days prior to the study drug administration, or has ever been enrolled in this study.~7. Subject known to be in liver failure.~8. Subject has an anticipated potential for increased intracranial pressure or an uncontrolled seizure disorder or known psychiatric illness that could confound a normal response during study assessment.~9. Subject has received treatment with a α2-agonist or antagonist (within 14 days of study entry).~10. Subject for whom opiates, benzodiazepines, DEX or other α2-agonists are contraindicated.~11. Subject has, per the investigator\\s judgment, a known or suspected physical or psychological dependence on an abused drug, other than alcohol.~12. Subject has acute unstable angina, acute myocardial infarction, HR \\\\<50 bpm, SBP \\\\<90 mmHg, or third degree heart block unless the subject has a pacemaker.~13. Subject has any condition or factor which, in the Investigator\\s opinion, might increase the risk to the subject.~14. Subject is not expected to live more than 60 days.", combined_text: A Research Study to Evaluate the Effectiveness of Dexmedetomidine in Preventing Delirium After Hip Fracture Repair Surgery Percentage of subjects who experienced any postoperative delirium up to 3 days after the end of study drug infusion, The presence of postoperative delirium will be determined by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)., Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion. Duration of postoperative delirium as determined by CAM-ICU up to 3 days after end of study drug infusion, Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.|Percentage of subjects who experienced postoperative delirium each day after end of study drug infusion, Twice daily (between 6:00-9:00 AM and 5:00-8:00 PM) until 3 days after the end of study drug infusion.|Perioperative use of all analgesics (Fentanyl, Morphine, and oral analgesics), During the intraoperative period, Post-anesthesia care unit period and the 3 days Follow-up Period.|Postoperative use of Midazolam, If RASS \\\\>0, midazolam (MDZ) 0.5-1 mg IV will be given until RASS \\\\<0. While in PACU during study drug infusion period, MDZ (0.5-1 mg IV) will be given if RASS \\\\>+1 under allowed maximum dose of study drug.\\n\\nRASS range:\\n\\n* +4 Combative -Overtly combative, violent, immediate danger to staff\\n* +3 Very agitated- Pulls or removes tubes or catheters, aggressive\\n* +2 Agitated- Frequent non-purposeful movements, fights ventilator\\n* +1 Restless- Anxious, but movements not aggressive or vigorous\\n* 0 Alert and calm\\n* -1 Drowsy - Not fully alert, but sustained awakening (eye opening, eye contact) to voice (\\\\>10 sec)\\n* -2 Light sedation - Briefly awakens with eye contact to voice (\\\\<10 sec)\\n* -3 Moderate sedation - Movement or eye opening to voice (but no eye contact)\\n* -4 Deep sedation No response to voice, but movement or eye opening to physical stimulation\\n* -5 Unarousable No response to voice or physical stimulation, During the PACU period (Approximately 2 hours)|Time-to-Aldrete score of ≥9, A score of 9-10 indicates the subject has recovered from anesthesia and is ready for discharge from the PACU., Every 15±5 minutes from arrival in the PACU (Approximately 2 hours)|Length of post-operative hospital stay, From the post operative period until subject discharged from hospital "Inclusion Criteria:~1. Adult (≥18 years old) male or female who will undergo surgery for fractured hip with general anesthesia within 72 hours of admission to hospital.~2. If female, subject is non-lactating and is either:~ 1. Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.~ 2. Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.~3. Subject is American Society of Anesthesiologists Physical Status I, II, III, or IV.~4. Subject (or subject\\s legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB).~Exclusion Criteria:~1. Cognitive function level by Mini Mental State Exam (MMSE) of ≤20.~2. Subject has a positive CAM-ICU result for delirium at Screening or Baseline.~3. Subject requires chronic antipsychotic therapy.~4. Subject is anticipated to require additional surgical procedures during the 72 hour Screening Period and the 3 days Follow-up Period.~5. Subject is anticipated to require repair of pelvic fractures (eg,acetabulum).~6. Subject has participated in a trial with any experimental drug or experimental implantable device within 30 days prior to the study drug administration, or has ever been enrolled in this study.~7. Subject known to be in liver failure.~8. Subject has an anticipated potential for increased intracranial pressure or an uncontrolled seizure disorder or known psychiatric illness that could confound a normal response during study assessment.~9. Subject has received treatment with a α2-agonist or antagonist (within 14 days of study entry).~10. Subject for whom opiates, benzodiazepines, DEX or other α2-agonists are contraindicated.~11. Subject has, per the investigator\\s judgment, a known or suspected physical or psychological dependence on an abused drug, other than alcohol.~12. Subject has acute unstable angina, acute myocardial infarction, HR \\\\<50 bpm, SBP \\\\<90 mmHg, or third degree heart block unless the subject has a pacemaker.~13. Subject has any condition or factor which, in the Investigator\\s opinion, might increase the risk to the subject.~14. Subject is not expected to live more than 60 days.", Similarity Score: 0.3264345263251206}'}]
|
from_dataset
| 0.326435
|
[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 725, Unnamed: 0: 907, NCT Number: NCT02172144, Study Title: Via Respimat® Inhaled BI 1744 CL Compared to Moxifloxacin and Placebo in Healthy Male and Female Volunteers, Study URL: https://clinicaltrials.gov/study/NCT02172144, Acronym: , Study Status: COMPLETED, Brief Summary: Study to investigate the effect of BI 1744 CL on the QT/QTc interval of the ECG (electrocardiogram) in comparison to placebo, Study Results: NO, Conditions: Healthy, Interventions: DRUG: BI 1744 CL solution for inhalation|DRUG: Placebo matching BI 1744 CL|DRUG: Moxifloxacin (Avalox®), Primary Outcome Measures: Change from baseline in the mean time-matched QTcI (QT interval, individually corrected according to the factor estimated from each subject), Baseline (day -1) and 20 to 120 min. after drug administration, Secondary Outcome Measures: Change of the QTcI at different point, Baseline (day -1) and 10 min. to 8 hours after drug administration|The mean of the QTcI values of all ECGs for Moxifloxacin and Placebo, 1 to 4 hours after drug administration, Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 24.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT, Other IDs: 1222.8, Start Date: 2007-06, Primary Completion Date: 2007-10, Completion Date: , First Posted: 2014-06-24, Results First Posted: , Last Update Posted: 2014-06-24, Locations: , Study Documents: , criteria: "Inclusion Criteria:~All participants in the study will be healthy males or females, ranging from 21 to 50 years of age, with a body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters). In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study~Exclusion Criteria:~* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* History of orthostatic hypotension, fainting spells or blackouts~* Chronic or clinically relevant acute infections~* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator~* Intake of drugs with a long half-life (\\\\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study~* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study~* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)~* Smoker (\\\\> 10 cigarettes or \\\\> 3 cigars of \\\\> 3 pipes/day)~* Inability to refrain from smoking on trial days~* Alcohol abuse (\\\\> 60 g/day for males and \\\\> 20 g/day for females)~* Drug abuse~* Blood donation (\\\\> 100 mL within four weeks prior to administration or during the trial)~* Any laboratory value outside the reference range if indicative of underlying disease or poor health~* Excessive physical activities within the last week before the trial or during the trial~* Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes~* Previous tendon disease related to quinolone treatment~* Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias~* Pulse rate at screening of \\\\> 80 bpm or \\\\< 45 bpm~* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR (Pulse rate) interval \\\\> 220 ms, QRS interval \\\\> 115 ms, QTcB \\\\> 450 ms, or QT (uncorrected) \\\\> 470 ms~For Female Subjects:~* Pregnancy~* Positive pregnancy test~* No adequate contraception (adequate contraception e.g. sterilisation, intrauterine-pressure, oral contraceptives)~* Inability to maintain this adequate contraception during the whole study period~* Lactation period", combined_text: Via Respimat® Inhaled BI 1744 CL Compared to Moxifloxacin and Placebo in Healthy Male and Female Volunteers Change from baseline in the mean time-matched QTcI (QT interval, individually corrected according to the factor estimated from each subject), Baseline (day -1) and 20 to 120 min. after drug administration Change of the QTcI at different point, Baseline (day -1) and 10 min. to 8 hours after drug administration|The mean of the QTcI values of all ECGs for Moxifloxacin and Placebo, 1 to 4 hours after drug administration "Inclusion Criteria:~All participants in the study will be healthy males or females, ranging from 21 to 50 years of age, with a body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters). In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study~Exclusion Criteria:~* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, clinically relevant electrolyte disturbances~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* History of orthostatic hypotension, fainting spells or blackouts~* Chronic or clinically relevant acute infections~* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator~* Intake of drugs with a long half-life (\\\\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study~* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study~* Participation in another trial with an investigational drug (within two months prior to administration or during the trial)~* Smoker (\\\\> 10 cigarettes or \\\\> 3 cigars of \\\\> 3 pipes/day)~* Inability to refrain from smoking on trial days~* Alcohol abuse (\\\\> 60 g/day for males and \\\\> 20 g/day for females)~* Drug abuse~* Blood donation (\\\\> 100 mL within four weeks prior to administration or during the trial)~* Any laboratory value outside the reference range if indicative of underlying disease or poor health~* Excessive physical activities within the last week before the trial or during the trial~* Hypersensitivity to treatment medication, moxifloxacin and/or related drugs of these classes~* Previous tendon disease related to quinolone treatment~* Congenital or documented acquired QT- prolongation, previous history of symptomatic arrhythmias~* Pulse rate at screening of \\\\> 80 bpm or \\\\< 45 bpm~* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR (Pulse rate) interval \\\\> 220 ms, QRS interval \\\\> 115 ms, QTcB \\\\> 450 ms, or QT (uncorrected) \\\\> 470 ms~For Female Subjects:~* Pregnancy~* Positive pregnancy test~* No adequate contraception (adequate contraception e.g. sterilisation, intrauterine-pressure, oral contraceptives)~* Inability to maintain this adequate contraception during the whole study period~* Lactation period", Similarity Score: 0.26284936888427396}'}]
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from_dataset
| 0.262849
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[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 656, Unnamed: 0: 816, NCT Number: NCT02214992, Study Title: Bioequivalence of Telmisartan/g Ramipril Fixed Dose Combination Compared With the Monocomponents Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers, Study URL: https://clinicaltrials.gov/study/NCT02214992, Acronym: , Study Status: COMPLETED, Brief Summary: Study to demonstrate the bioequivalence of 80 mg telmisartan/10 mg ramipril fixed dose combination versus its monocomponents given concurrently, Study Results: NO, Conditions: Healthy, Interventions: DRUG: Telmisartan/Ramipril|DRUG: Telmisartan|DRUG: Ramipril capsule|DRUG: Ramipril tablet, Primary Outcome Measures: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), up to 96 hours after drug administration|Cmax (maximum measured concentration of the analyte in plasma), up to 96 hours after drug administration, Secondary Outcome Measures: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point), up to 96 hours after drug administration|AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2), up to 96 hours after drug administration|tmax (time from dosing to the maximum concentration of the analyte in plasma), up to 96 hours after drug administration|λz (terminal rate constant in plasma), up to 96 hours after drug administration|t1/2 (terminal half-life of the analyte in plasma), up to 96 hours after drug administration|MRTpo (mean residence time of the analyte in the body after po administration), up to 96 hours after drug administration|CL/F (apparent clearance of the analyte in the plasma after extravascular administration), up to 96 hours after drug administration|Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose), up to 96 hours after drug administration|Number of patients with adverse events, up to 78 days|Number of patients with clinically relevant changes in laboratory tests, up to 78 days|Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse Rate), up to 78 days|Number of patients with clinically relevant changes in 12-lead Electrocardiogram (ECG), up to 78 days|Assessment of ttolerability by investigator on a 4-point scale, Day 5 of each treatment, Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 84.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 1236.5, Start Date: 2007-03, Primary Completion Date: 2007-06, Completion Date: , First Posted: 2014-08-13, Results First Posted: , Last Update Posted: 2014-08-13, Locations: , Study Documents: , criteria: "Inclusion Criteria:~* Healthy males and females according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests~* Age ≥ 18 and Age ≤ 55 years~* BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation~Exclusion Criteria:~* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance~* Any evidence of a clinically relevant concomitant disease~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Surgery of the gastrointestinal tract (except appendectomy)~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* History of relevant orthostatic hypotension, fainting spells or blackouts~* Chronic or relevant acute infections~* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)~* Intake of drugs with a long half-life (\\\\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial~* Use of drugs which might reasonably influence the results of the trial (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or inhibitors like cimetidine) or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial~* Participation in another trial with an investigational drug within two months prior to administration or during the trial~* Smoker (\\\\> 10 cigarettes or \\\\> 3 cigars or \\\\> 3 pipes/day)~* Inability to refrain from smoking during 24 hours prior to dosing and 24 hours after dosing~* Alcohol abuse (more than 60 g/day) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point, 96 hours after dosing~* Drug abuse~* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)~* Excessive physical activities (within one week prior to administration or during the trial)~* Any laboratory value outside the reference range that is of clinical relevance~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\\\>450 ms)~* A history of additional risk factors for torsade de pointes (e.g., heart failure, hyperkalemia, hypokalemia, family history of Long QT Syndrome)~* Any history of relevant low blood pressure~* Supine blood pressure at screening of systolic \\\\<110 mm Hg and diastolic \\\\<60 mm Hg~* History of urticaria~* History of angioneurotic edema~* Hereditary fructose intolerance~For female subjects:~* Pregnancy or planning to become pregnant during the study or within 2 months of study completion~* Positive pregnancy test~* Are not willing or are unable to use a reliable method of contraception (such as implants, injectables and combined oral contraceptives, sterilisation, intrauterine device, double barrier method, sexual abstinence) for at least 1 month prior to participation in the trial, during and up to 1 month after completion/termination of the trial~* Chronic use of oral contraception or hormone replacement containing ethinyl estradiol as the only method of contraception~* Currently lactating", combined_text: Bioequivalence of Telmisartan/g Ramipril Fixed Dose Combination Compared With the Monocomponents Telmisartan and Ramipril (Two Different Formulations) Given Concomitantly to Healthy Male and Female Volunteers AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), up to 96 hours after drug administration|Cmax (maximum measured concentration of the analyte in plasma), up to 96 hours after drug administration AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point), up to 96 hours after drug administration|AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2), up to 96 hours after drug administration|tmax (time from dosing to the maximum concentration of the analyte in plasma), up to 96 hours after drug administration|λz (terminal rate constant in plasma), up to 96 hours after drug administration|t1/2 (terminal half-life of the analyte in plasma), up to 96 hours after drug administration|MRTpo (mean residence time of the analyte in the body after po administration), up to 96 hours after drug administration|CL/F (apparent clearance of the analyte in the plasma after extravascular administration), up to 96 hours after drug administration|Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose), up to 96 hours after drug administration|Number of patients with adverse events, up to 78 days|Number of patients with clinically relevant changes in laboratory tests, up to 78 days|Number of patients with clinically relevant changes in Vital Signs (Blood Pressure, Pulse Rate), up to 78 days|Number of patients with clinically relevant changes in 12-lead Electrocardiogram (ECG), up to 78 days|Assessment of ttolerability by investigator on a 4-point scale, Day 5 of each treatment "Inclusion Criteria:~* Healthy males and females according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests~* Age ≥ 18 and Age ≤ 55 years~* BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation~Exclusion Criteria:~* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance~* Any evidence of a clinically relevant concomitant disease~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Surgery of the gastrointestinal tract (except appendectomy)~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* History of relevant orthostatic hypotension, fainting spells or blackouts~* Chronic or relevant acute infections~* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)~* Intake of drugs with a long half-life (\\\\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial~* Use of drugs which might reasonably influence the results of the trial (especially unspecific inducing agents like St.John´s wort (Hypericum perforatum) or inhibitors like cimetidine) or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial~* Participation in another trial with an investigational drug within two months prior to administration or during the trial~* Smoker (\\\\> 10 cigarettes or \\\\> 3 cigars or \\\\> 3 pipes/day)~* Inability to refrain from smoking during 24 hours prior to dosing and 24 hours after dosing~* Alcohol abuse (more than 60 g/day) or inability to stop alcoholic beverages for 24 hours prior to dosing and up to the last sampling time point, 96 hours after dosing~* Drug abuse~* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)~* Excessive physical activities (within one week prior to administration or during the trial)~* Any laboratory value outside the reference range that is of clinical relevance~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\\\>450 ms)~* A history of additional risk factors for torsade de pointes (e.g., heart failure, hyperkalemia, hypokalemia, family history of Long QT Syndrome)~* Any history of relevant low blood pressure~* Supine blood pressure at screening of systolic \\\\<110 mm Hg and diastolic \\\\<60 mm Hg~* History of urticaria~* History of angioneurotic edema~* Hereditary fructose intolerance~For female subjects:~* Pregnancy or planning to become pregnant during the study or within 2 months of study completion~* Positive pregnancy test~* Are not willing or are unable to use a reliable method of contraception (such as implants, injectables and combined oral contraceptives, sterilisation, intrauterine device, double barrier method, sexual abstinence) for at least 1 month prior to participation in the trial, during and up to 1 month after completion/termination of the trial~* Chronic use of oral contraception or hormone replacement containing ethinyl estradiol as the only method of contraception~* Currently lactating", Similarity Score: 0.22946490633872416}'}]
|
from_dataset
| 0.229465
|
[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 348, Unnamed: 0: 422, NCT Number: NCT02220673, Study Title: Serial Lung Function Measurements in Healthy and Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT) Administered With the Respimat® B (RMT-B), Study URL: https://clinicaltrials.gov/study/NCT02220673, Acronym: , Study Status: COMPLETED, Brief Summary: Primary objective: To investigate the safety and local tolerability of increasing cumulative doses (2, 4, 6 actuations) of a low (0.1%) and a high (0.5%) concentration of BHT administered via oral inhalation with the Respimat® inhaler B (RMT-B) vs. 2 inhalation solutions without BHT (placebo to BHT given by RMT B and placebo given by hydroxylfluoralkane metered dose inhaler (HFA MDI)). In a first step, the trial was performed in healthy subjects and - if no safety concerns arose - in a second step in patients with mild asthma who were sensitive to metacholine in a respective challenge test. Secondary objective: To explore the pharmacokinetics (PK) of BHT., Study Results: NO, Conditions: Asthma, Interventions: DRUG: BHT 0.1%|DRUG: BHT 0.5%|DRUG: Placebo for RMT-B|DRUG: Placebo for HFA-MDI, Primary Outcome Measures: Maximum decrease of forced expiratory volume in one second (FEV1), (Minimum FEV1 value over the interval 5 min to 2 h 50 min) minus (baseline value), baseline, 3 h after administration, Secondary Outcome Measures: Maximum decrease in FEV1 after 2 actuations, (minimum FEV1 value over the interval 5 min to 50 min) - (baseline value), baseline, up to 50 minutes after drug administration|Maximum decrease in FEV1 after 4 actuations, (minimum FEV1 value over the interval 1 h 5 min to 1 h 50 min) - (baseline value), baseline, up to 1:50 hours after drug administration|Maximum decrease in FEV1 after 6 actuations, (minimum FEV1 value over the interval 2 h 5 min to 2 h 50 min) - (baseline value), baseline, up to 2:50 hours after drug administration|Number of subjects with a decrease in FEV1, stratified into classes of 0-20%, \\\\>20-40%, and \\\\>40%, baseline, up to 2:50 hours after drug administration|Number of patients with cough episodes, within 5 min prior to the 1st inhalation and within 5 min after each of the 3 inhalations on each treatment day, up to 9 days|Number of patients requiring rescue medication, up to 60 min after each dosing|Number of patients with adverse events, up to 10 days after the last treatment day|Cmax (maximum measured concentration of the analyte in plasma), pre-dose, 2, 10, 25 and 55 min after each dosing|tmax (time from dosing to maximum measured concentration of the analyte in plasma), pre-dose, 2, 10, 25 and 55 min after each dosing|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz), pre-dose, 2, 10, 25 and 55 min after each dosing|Area under the curve (AUC) of FEV1, over 3 hours after first dosing|AUC of FEV1, over 1 hours after each dosing, Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 61.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT, Other IDs: 1256.13, Start Date: 2009-11, Primary Completion Date: 2010-05, Completion Date: , First Posted: 2014-08-20, Results First Posted: , Last Update Posted: 2014-08-20, Locations: , Study Documents: , criteria: "Inclusion Criteria:~Healthy subjects~* Male or female adult subjects~* Age ≥ 18 and ≤ 65 years~* Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2~* Non-smokers (within the last 5 years)~* Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) and the local legislation~* Proper use of RMT and MDI~* Able to perform technically satisfactory pulmonary function test~Patients with mild asthma~* Male or female adult subjects with intermittent and mild persistent asthma~* Age ≥ 18 and ≤ 65 years~* Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2~* FEV1 ≥ 70% predicted and stable for at least 7 days prior to randomization~* Short acting beta agonist (SABA) response documented in the last 6 months~* A history of wheeze, cough, dyspnoea or chest tightness following exposure to at least one of the following: cold, exercise, dry air, smoke, dust, allergens~* Positive methacholine challenge test reflecting mild to moderate bronchial hyperreactivity (PC20: 0.25-4.0 mg/mL) performed within two weeks prior randomization (at visit 1 or between visit 1 and 2)~* None or stable dosages of pulmonary medications (SABA only) in the past 6 weeks~* Non smokers or ex-smokers for the last 5 years~* Signed and dated written informed consent prior to admission to the trial in accordance with GCP and the local legislation~* Proper use of RMT and MDI~* Able to perform technically satisfactory pulmonary function test~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR)) deviating from normal and of clinical relevance~* Any laboratory value outside the reference range deemed of clinical relevance~* Pregnant or breast feeding women or women of childbearing potential without having a negative Human choriongonadotropin, β-subunit (ß-HCG) pregnancy test and without using a medically approved highly effective method of contraception for the previous 3 months~* Abnormal spirometry i.e., FEV1 \\\\<80% predicted and/or methacholine challenge at screening Visit 1 (or between Visits 1 and 2)~* Acute or chronic bacterial and viral infections of the lung~* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)~* Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Clinically relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* Use of drugs which might reasonably influence the results of the trial within 10 days prior to first administration or during the trial (assessed and judged by the investigator)~* Participation in another trial with an investigational drug within 1 month prior to administration or during the trial~* Alcohol abuse (more than 60 g/day)~* Drug abuse~* Blood donation (\\\\>120 mL within 4 weeks prior to administration or during the trial)~* Excessive physical activities (within 1 week prior to administration or during the trial)~* Any vulnerable subjects~* Inability to comply with protocol requirements, instructions and study related restrictions, dietary regimen of trial site, and improbability of completing the study~Patients with mild asthma~* Any finding of the medical examination (including BP, PR) deviating from normal and of clinical relevance~* Any laboratory value that was of clinical relevance~* Moderate or severe persistent asthma~* Pregnant or breast feeding women or women of childbearing potential without a negative ß-HCG pregnancy test and without using a medically approved highly effective method of contraception for the previous 3 months~* Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Clinically relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* Chronic or relevant acute infections~* Treated or non-treated bacterial and viral infections of the lung, including active or latent tuberculosis~* Use of any corticosteroids, long acting muscarinic antagonist (LAMA) or long acting beta agonists (LABA), all within 1 month prior to screening Visit 1 and prior to administration of investigational product (i.e., allergic patients could only participate outside their season)~* Clinically relevant perennial allergies (i.e., which need actual treatment)~* Methylxanthines, antihistamines, antileukotrienes, cromolyn/nedocromil sodium all within 1 month prior to screening Visit 1 and prior to administration of investigational product~* SABAs 12 h prior to each visit day~* Use of other drugs which reasonably influence the results of the trial within 10 days prior to first administration or during the trial (e.g., beta blockers, all antimuscarinic agents like phenothiazines and some antidepressants)~* Participation in another trial with an investigational product within 1 month prior to administration or during the trial~* Alcohol abuse (more than 60 g/day)~* Drug abuse~* Blood donation (\\\\>120 mL within 4 weeks prior to administration or during the trial)~* Excessive physical activities (within 3 days prior to administration or during the trial)~* Inability to comply with protocol requirements, instructions and trial related restrictions, dietary regimen of trial site, and improbability of completing the trial~* Any vulnerable patients", combined_text: Serial Lung Function Measurements in Healthy and Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT) Administered With the Respimat® B (RMT-B) Maximum decrease of forced expiratory volume in one second (FEV1), (Minimum FEV1 value over the interval 5 min to 2 h 50 min) minus (baseline value), baseline, 3 h after administration Maximum decrease in FEV1 after 2 actuations, (minimum FEV1 value over the interval 5 min to 50 min) - (baseline value), baseline, up to 50 minutes after drug administration|Maximum decrease in FEV1 after 4 actuations, (minimum FEV1 value over the interval 1 h 5 min to 1 h 50 min) - (baseline value), baseline, up to 1:50 hours after drug administration|Maximum decrease in FEV1 after 6 actuations, (minimum FEV1 value over the interval 2 h 5 min to 2 h 50 min) - (baseline value), baseline, up to 2:50 hours after drug administration|Number of subjects with a decrease in FEV1, stratified into classes of 0-20%, \\\\>20-40%, and \\\\>40%, baseline, up to 2:50 hours after drug administration|Number of patients with cough episodes, within 5 min prior to the 1st inhalation and within 5 min after each of the 3 inhalations on each treatment day, up to 9 days|Number of patients requiring rescue medication, up to 60 min after each dosing|Number of patients with adverse events, up to 10 days after the last treatment day|Cmax (maximum measured concentration of the analyte in plasma), pre-dose, 2, 10, 25 and 55 min after each dosing|tmax (time from dosing to maximum measured concentration of the analyte in plasma), pre-dose, 2, 10, 25 and 55 min after each dosing|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz), pre-dose, 2, 10, 25 and 55 min after each dosing|Area under the curve (AUC) of FEV1, over 3 hours after first dosing|AUC of FEV1, over 1 hours after each dosing "Inclusion Criteria:~Healthy subjects~* Male or female adult subjects~* Age ≥ 18 and ≤ 65 years~* Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2~* Non-smokers (within the last 5 years)~* Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) and the local legislation~* Proper use of RMT and MDI~* Able to perform technically satisfactory pulmonary function test~Patients with mild asthma~* Male or female adult subjects with intermittent and mild persistent asthma~* Age ≥ 18 and ≤ 65 years~* Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2~* FEV1 ≥ 70% predicted and stable for at least 7 days prior to randomization~* Short acting beta agonist (SABA) response documented in the last 6 months~* A history of wheeze, cough, dyspnoea or chest tightness following exposure to at least one of the following: cold, exercise, dry air, smoke, dust, allergens~* Positive methacholine challenge test reflecting mild to moderate bronchial hyperreactivity (PC20: 0.25-4.0 mg/mL) performed within two weeks prior randomization (at visit 1 or between visit 1 and 2)~* None or stable dosages of pulmonary medications (SABA only) in the past 6 weeks~* Non smokers or ex-smokers for the last 5 years~* Signed and dated written informed consent prior to admission to the trial in accordance with GCP and the local legislation~* Proper use of RMT and MDI~* Able to perform technically satisfactory pulmonary function test~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR)) deviating from normal and of clinical relevance~* Any laboratory value outside the reference range deemed of clinical relevance~* Pregnant or breast feeding women or women of childbearing potential without having a negative Human choriongonadotropin, β-subunit (ß-HCG) pregnancy test and without using a medically approved highly effective method of contraception for the previous 3 months~* Abnormal spirometry i.e., FEV1 \\\\<80% predicted and/or methacholine challenge at screening Visit 1 (or between Visits 1 and 2)~* Acute or chronic bacterial and viral infections of the lung~* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)~* Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Clinically relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* Use of drugs which might reasonably influence the results of the trial within 10 days prior to first administration or during the trial (assessed and judged by the investigator)~* Participation in another trial with an investigational drug within 1 month prior to administration or during the trial~* Alcohol abuse (more than 60 g/day)~* Drug abuse~* Blood donation (\\\\>120 mL within 4 weeks prior to administration or during the trial)~* Excessive physical activities (within 1 week prior to administration or during the trial)~* Any vulnerable subjects~* Inability to comply with protocol requirements, instructions and study related restrictions, dietary regimen of trial site, and improbability of completing the study~Patients with mild asthma~* Any finding of the medical examination (including BP, PR) deviating from normal and of clinical relevance~* Any laboratory value that was of clinical relevance~* Moderate or severe persistent asthma~* Pregnant or breast feeding women or women of childbearing potential without a negative ß-HCG pregnancy test and without using a medically approved highly effective method of contraception for the previous 3 months~* Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Clinically relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* Chronic or relevant acute infections~* Treated or non-treated bacterial and viral infections of the lung, including active or latent tuberculosis~* Use of any corticosteroids, long acting muscarinic antagonist (LAMA) or long acting beta agonists (LABA), all within 1 month prior to screening Visit 1 and prior to administration of investigational product (i.e., allergic patients could only participate outside their season)~* Clinically relevant perennial allergies (i.e., which need actual treatment)~* Methylxanthines, antihistamines, antileukotrienes, cromolyn/nedocromil sodium all within 1 month prior to screening Visit 1 and prior to administration of investigational product~* SABAs 12 h prior to each visit day~* Use of other drugs which reasonably influence the results of the trial within 10 days prior to first administration or during the trial (e.g., beta blockers, all antimuscarinic agents like phenothiazines and some antidepressants)~* Participation in another trial with an investigational product within 1 month prior to administration or during the trial~* Alcohol abuse (more than 60 g/day)~* Drug abuse~* Blood donation (\\\\>120 mL within 4 weeks prior to administration or during the trial)~* Excessive physical activities (within 3 days prior to administration or during the trial)~* Inability to comply with protocol requirements, instructions and trial related restrictions, dietary regimen of trial site, and improbability of completing the trial~* Any vulnerable patients", Similarity Score: 0.21924536462490632}'}]
|
from_dataset
| 0.219245
|
[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 206, Unnamed: 0: 251, NCT Number: NCT04789291, Study Title: A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food, Study URL: https://clinicaltrials.gov/study/NCT04789291, Acronym: , Study Status: COMPLETED, Brief Summary: The main objective of this trial is to investigate the relative bioavailability of BI 1595043 under fed state (Test, T) and under fasted state (Reference, R)., Study Results: YES, Conditions: Healthy, Interventions: DRUG: BI 1595043, Primary Outcome Measures: "Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.|Maximum Measured Concentration of BI 1595043 in Plasma (Cmax), Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.", Secondary Outcome Measures: "Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.", Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: MALE, Age: ADULT, Phases: PHASE1, Enrollment: 13.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 1445-0011|2020-004924-40, Start Date: 2021-05-18, Primary Completion Date: 2021-08-07, Completion Date: 2021-08-07, First Posted: 2021-03-09, Results First Posted: 2024-02-22, Last Update Posted: 2024-02-22, Locations: SGS Life Science Services - Clinical Research, Edegem, 2650, Belgium, Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/91/NCT04789291/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/91/NCT04789291/SAP_001.pdf, criteria: "Inclusion Criteria:~* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests~* Age of 18 to 50 years (inclusive)~* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)~* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation~* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:~ * Use of adequate contraception, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea~ * Sexually abstinent~ * Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) Unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion~Exclusion Criteria:~* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease assessed as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Further exclusion criteria apply", combined_text: A Study in Healthy Men to Test How BI 1595043 is Taken up in the Body When Given With or Without Food Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz), Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: \\sequence\\, \\subjects within sequences\\, \\period\\ and \\treatment\\. The effect \\subjects within sequences\\ was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration.|Maximum Measured Concentration of BI 1595043 in Plasma (Cmax), Maximum measured concentration of BI 1595043 in plasma (Cmax) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: \\sequence\\, \\subjects within sequences\\, \\period\\ and \\treatment\\. The effect \\subjects within sequences\\ was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration. Area Under the Concentration-time Curve of BI 1595043 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞), Area under the concentration-time curve of BI 1595043 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.\\n\\nThe statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data was logtransformed (natural logarithm) prior to fitting the ANOVA model.This model included effects accounting for the following sources of variation: \\sequence\\, \\subjects within sequences\\, \\period\\ and \\treatment\\. The effect \\subjects within sequences\\ was considered as random, whereas the other effects were considered as fixed., Within 3 hours before drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 144 and 168 hours following drug administration. "Inclusion Criteria:~* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests~* Age of 18 to 50 years (inclusive)~* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)~* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation~* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:~ * Use of adequate contraception, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea~ * Sexually abstinent~ * Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) Unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion~Exclusion Criteria:~* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease assessed as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Further exclusion criteria apply", Similarity Score: 0.21737232971614914}'}]
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from_dataset
| 0.217372
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[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 836, Unnamed: 0: 1048, NCT Number: NCT02209844, Study Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Powder in Healthy Male Subjects, Study URL: https://clinicaltrials.gov/study/NCT02209844, Acronym: , Study Status: COMPLETED, Brief Summary: To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847, Study Results: NO, Conditions: Healthy, Interventions: DRUG: BI 44847|DRUG: Placebo, Primary Outcome Measures: Number of patients with adverse events, up to day 12|Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate), up to day 12|Number of patients with clinically significant findings in ECG, up to day 12|Number of patients with clinically significant laboratory findings, up to day 12|Assessment of tolerability by the investigator on a 4-point scale, up to day 12, Secondary Outcome Measures: Cmax (maximum concentration of the analyte in plasma), up to 96 hours after drug administration|tmax (time from dosing to maximum concentration), up to 96 hours after drug administration|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), up to 96 hours after drug administration|%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation), up to 96 hours after drug administration|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point), up to 96 hours after drug administration|λz (terminal rate constant in plasma), up to 96 hours after drug administration|t1/2 (terminal half-life of the analyte in plasma), up to 96 hours after drug administration|MRTpo (mean residence time of the analyte in the body after oral administration), up to 96 hours after drug administration|CL/F (total clearance of the analyte in the plasma after extravascular administration), up to 96 hours after drug administration|Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose), up to 96 hours after drug administration|Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2), up to 72 hours after drug administration|fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2), up to 72 hours after drug administration|CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2), up to 72 hours after drug administration|Area under the plasma glucose concentration time curve, up to 96 hours after drug administration|Total amount of glucose excreted in urine, up to 72 hours after drug administration|Maximum glucose concentration in plasma, up to 96 hours after drug administration|Maximum glucose concentration in urine, up to 72 hours after drug administration, Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: MALE, Age: ADULT, Phases: PHASE1, Enrollment: 72.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT, Other IDs: 1224.1, Start Date: 2006-08, Primary Completion Date: 2007-01, Completion Date: , First Posted: 2014-08-06, Results First Posted: , Last Update Posted: 2014-08-06, Locations: , Study Documents: , criteria: "Inclusion Criteria:~1. Healthy males according to the following criteria:~ Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests~2. Age ≥ 18 and Age ≤ 50 years~3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)~4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation~Exclusion Criteria:~1. Any finding of the medical examination (including BP, pulse rate and ECG) deviating from normal and of clinical relevance~2. Any evidence of a clinically relevant concomitant disease~3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~5. History of relevant orthostatic hypotension, fainting spells or blackouts~6. Chronic or relevant acute infections~7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)~8. Intake of drugs with a long half-life (\\\\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial~9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial~10. Participation in another trial with an investigational drug within two months prior to administration or during the trial~11. Smoker (\\\\> 10 cigarettes or \\\\> 3 cigars or \\\\> 3 pipes/day)~12. Inability to refrain from smoking on trial days~13. Alcohol abuse (more than 60 g/day)~14. Drug abuse~15. Blood donation (more than 100 mL) within four weeks prior to administration or during the trial~16. Excessive physical activities (within one week prior to administration or during the trial)~17. Any laboratory value outside the reference range that is of clinical relevance~18. Inability to comply with dietary regimen of study centre~19. Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \\\\> 120 ms. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\\\> 450 ms or QT\\\\> 500 ms).~20. A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)~21. The use of concomitant medications that prolong the QT/QTc interval~22. Elevated urinary glucose levels at screening (\\\\> 15 mg/dl)", combined_text: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Powder in Healthy Male Subjects Number of patients with adverse events, up to day 12|Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate), up to day 12|Number of patients with clinically significant findings in ECG, up to day 12|Number of patients with clinically significant laboratory findings, up to day 12|Assessment of tolerability by the investigator on a 4-point scale, up to day 12 Cmax (maximum concentration of the analyte in plasma), up to 96 hours after drug administration|tmax (time from dosing to maximum concentration), up to 96 hours after drug administration|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity), up to 96 hours after drug administration|%AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation), up to 96 hours after drug administration|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point), up to 96 hours after drug administration|λz (terminal rate constant in plasma), up to 96 hours after drug administration|t1/2 (terminal half-life of the analyte in plasma), up to 96 hours after drug administration|MRTpo (mean residence time of the analyte in the body after oral administration), up to 96 hours after drug administration|CL/F (total clearance of the analyte in the plasma after extravascular administration), up to 96 hours after drug administration|Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose), up to 96 hours after drug administration|Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2), up to 72 hours after drug administration|fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2), up to 72 hours after drug administration|CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2), up to 72 hours after drug administration|Area under the plasma glucose concentration time curve, up to 96 hours after drug administration|Total amount of glucose excreted in urine, up to 72 hours after drug administration|Maximum glucose concentration in plasma, up to 96 hours after drug administration|Maximum glucose concentration in urine, up to 72 hours after drug administration "Inclusion Criteria:~1. Healthy males according to the following criteria:~ Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests~2. Age ≥ 18 and Age ≤ 50 years~3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)~4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation~Exclusion Criteria:~1. Any finding of the medical examination (including BP, pulse rate and ECG) deviating from normal and of clinical relevance~2. Any evidence of a clinically relevant concomitant disease~3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~5. History of relevant orthostatic hypotension, fainting spells or blackouts~6. Chronic or relevant acute infections~7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)~8. Intake of drugs with a long half-life (\\\\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial~9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial~10. Participation in another trial with an investigational drug within two months prior to administration or during the trial~11. Smoker (\\\\> 10 cigarettes or \\\\> 3 cigars or \\\\> 3 pipes/day)~12. Inability to refrain from smoking on trial days~13. Alcohol abuse (more than 60 g/day)~14. Drug abuse~15. Blood donation (more than 100 mL) within four weeks prior to administration or during the trial~16. Excessive physical activities (within one week prior to administration or during the trial)~17. Any laboratory value outside the reference range that is of clinical relevance~18. Inability to comply with dietary regimen of study centre~19. Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \\\\> 120 ms. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \\\\> 450 ms or QT\\\\> 500 ms).~20. A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)~21. The use of concomitant medications that prolong the QT/QTc interval~22. Elevated urinary glucose levels at screening (\\\\> 15 mg/dl)", Similarity Score: 0.2139696657817888}'}]
|
from_dataset
| 0.21397
|
[{'from': 'human', 'value': '{Study Title: A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body, Primary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Time Interval From 0 to 24 Hours After Administration of the First Dose (AUC0-24), Area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose AUC 0-24.\\n\\nStandard Error presented is actually geometric Standard Error. PKS-stat including participants data for AUC(0-24). The pharmacokinetic (PK) analysis set (PKS) included all subjects in the TS who provided at least one PK parameter that was defined as primary or secondary endpoint and who were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability., Pharmacokinetic (PK) samples were taken 2.00 hours (h) before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Maximum Measured Concentration of BI 1467335 in Plasma After Administration of the First Dose (Cmax), Maximum measured concentration of BI 1467335 in plasma after administration of the first dose (Cmax).\\n\\nStandard Error presented is actually geometric Standard Error., Pharmacokinetic (PK) samples were taken 2.00 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 1.|Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 28th Dose (AUCτ,28), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 28th dose (AUCτ,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 28th Dose (Cmax,28), Maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose (Cmax,28).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before last dose and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 24.00 h after dosing on day 28., Secondary Outcome Measures: Area Under the Concentration-time Curve of BI 1467335 in Plasma Over the Dosing Interval After Administration of the 14th Dose (AUCτ,14), Area under the concentration-time curve of BI 1467335 in plasma over the dosing interval after administration of the 14th dose (AUCτ,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14.|Maximum Measured Concentration of BI 1467335 in Plasma Following Administration of the 14th Dose (Cmax,14), Maximum measured concentration of BI 1467335 in plasma following administration of the 14th dose (Cmax,14).\\n\\nStandard Error presented is actually geometric Standard Error. As per the protocol, day is counted as "Day 1 = 0:00"., Pharmacokinetic samples were taken 0.0833 h before dosing and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00 and 23.917 h after dosing on day 14., criteria: "Inclusion Criteria:~* Despite of moderate renal impairment (Group 1) healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests~* Estimated glomerular filtration rate (eGFR) based on CKD-EPI formula for Group 1 between 30 and 59 mL/min/1.73m2 and for Group 2 ≥ 90 mL/min/1.73m2~* Age of 18 to 79 years (incl.)~* BMI of 18.5 to 34 kg/m2 (incl.)~* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation~* Male subjects, or female subjects who meet any of the following criteria (according to the CTFG Recommendations related to contraception and pregnancy testing in clinical trials, methods with a failure rate of less than 1% per year) starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion, e.g.:~ * Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives (inhibition of ovulation)~ * Hormonal intrauterine device~ * Sexually abstinent (defined as refraining from heterosexual intercourse during the entire period of risk)~ * A vasectomised sexual partner (provided that vasectomy was performed at least 1 year prior to enrolment and the vasectomised partner has received medical assessment of the surgical success)~ * Surgically sterilised (including bilateral tubal occlusion, hysterectomy)~ * Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of FSH above 40 U/L and estradiol below 30 ng/L is confirmatory)~Exclusion Criteria:~Healthy subjects~* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator~* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm~* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance~* Any evidence of a concomitant disease judged as clinically relevant by the investigator~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders~* Estimated glomerular filtration rate (eGFR) calculated by CKD-EPI formula \\\\< 90 mL/min/1.73m2~Subjects with moderate renal impairment~* Subject with significant diseases other than moderate renal impairment. A significant disease is defined as a disease which in the opinion of the investigator:~ * puts the subjects at risk because of participation in the study~ * may influence the results of the study~ * may influence the subject\\s ability to participate in the study~ * is not in a stable condition Diabetic or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria.~* Any finding of the medical examination (including BP, PR and ECG) of clinical relevance~* Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome) or biliary obstruction~* Clinically relevant laboratory abnormalities (except for renal function tests or deviation of clinical laboratory values that are related to renal impairment)~* eGFR calculated by CKD-EPI formula ≥ 60 mL/min/1.73m2 and \\\\< 30 mL/min/1.73m2~For all subjects~* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)~* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Chronic or relevant acute infections~* History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)~* Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)~* Participation in another trial where an investigational drug has been administered within 30 days prior to planned administration of trial medication or longer if required by local regulation, or within 5-half-lives of the investigational agent taken (whichever is longer), or current participation in another trial involving administration of investigational drug~* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)~* Inability to refrain from smoking on specified trial days~* Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)~* Drug abuse or positive drug screening~* Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial~* Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial~* Inability to comply with dietary regimen of trial site~* A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females) or any other relevant ECG finding at screening~* A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)~* Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study~Female subjects will not be allowed to participate if any of the following applies:~* Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after study completion~* Lactation period~Male subjects will not be allowed to participate if any of the following applies:~- Male subjects with WOCBP partner who are unwilling to use male contraception (condom or sexual abstinence) from the first administration of trial medication until 30 days after last administration of trial medication"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 641, Unnamed: 0: 798, NCT Number: NCT05661344, Study Title: A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems, Study URL: https://clinicaltrials.gov/study/NCT05661344, Acronym: , Study Status: COMPLETED, Brief Summary: "This study is open to adults aged 18 years and older. People without liver problems and people who have mild or moderate liver problems can join the study.\\n\\nThe purpose of this study is to find out how a medicine called BI 1015550 is taken up in the blood of people with and without liver problems. Liver problems may change how a medicine is processed in the body.\\n\\nParticipants are in the study for about 2 weeks. During this time, they visit the study site 6 times. On the second visit, participants stay overnight at the study site for 4 nights. At the visits, doctors take blood samples to measure the levels of BI 1015550 in participants blood. Then they compare the results between the groups of participants with and without liver problems. The doctors also check participants health and take note of any unwanted effects.", Study Results: NO, Conditions: Hepatic Insufficiency, Interventions: DRUG: BI 1015550, Primary Outcome Measures: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), up to 7 days|Maximum measured concentration of the analyte in plasma (Cmax), up to 7 days, Secondary Outcome Measures: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), up to 7 days, Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 28.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 1305-0027|2022-002811-45, Start Date: 2023-02-07, Primary Completion Date: 2023-09-13, Completion Date: 2023-09-13, First Posted: 2022-12-22, Results First Posted: , Last Update Posted: 2024-08-09, Locations: CRS Clinical Research Services Kiel GmbH, Kiel, 24105, Germany, Study Documents: , criteria: "Inclusion criteria applicable to all participants~* Male or female participants~* Age 18-79 years (inclusive)~* Body Mass Index (BMI) of 18.5 to 35 kilogram per square meter (kg/m2) (inclusive)~* Signed and dated written informed consent in accordance with Guideline for Guideline for Good Clinical Practice - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial~* Male participants are not required to use contraception~* Women of childbearing potential are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 7 days after trial completion. Of note, oral hormonal contraceptives are not considered as highly effective in this study due to the potential CYP3A induction by BI 1015550. Therefore, the following methods of contraception are considered adequate for female participants of childbearing potential:~ * Use of combined (oestrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom~ * Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom~ * Use of intrauterine device or intrauterine hormone-releasing system~ * Sexually abstinent~ * A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant. Female participants are not considered to be of childbearing potential if they are either surgically sterilised (including hysterectomy) or postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 Units per litre (U/L) and oestradiol below 30 nanogram per litre (ng/L) is confirmatory)~Inclusion criteria applying only to participants with impaired hepatic function~* Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points)~* further inclusion criteria apply~Inclusion criteria applying only to participants with normal hepatic function~* Individually matched to participants with hepatic impairment according to sex, age, and weight~* further inclusion criteria apply~Exclusion criteria applying to all participants~* Any evidence of a concomitant disease assessed as clinically relevant by the investigator~* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetic(s) (PK) of the trial medication (except appendectomy or simple hernia repair)~* Diseases of the central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder)~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Relevant chronic or acute infections~* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin or in situ carcinoma of uterine cervix~* further exclusion criteria apply~Exclusion criteria applying only to participants with hepatic impairment~* A marked prolongation of time from the start of the Q wave to the end of the T wave (QT)/ QT corrected for heart rate (QTc) interval (such as QT Corrected by the Fridericia Formula (QTcF) intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other relevant Electrocardiogram (ECG) finding at screening~* further exclusion criteria apply~Exclusion criteria applying only to participants with normal hepatic function~* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator~* further exclusion criteria apply", combined_text: A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), up to 7 days|Maximum measured concentration of the analyte in plasma (Cmax), up to 7 days Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), up to 7 days "Inclusion criteria applicable to all participants~* Male or female participants~* Age 18-79 years (inclusive)~* Body Mass Index (BMI) of 18.5 to 35 kilogram per square meter (kg/m2) (inclusive)~* Signed and dated written informed consent in accordance with Guideline for Guideline for Good Clinical Practice - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial~* Male participants are not required to use contraception~* Women of childbearing potential are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 7 days after trial completion. Of note, oral hormonal contraceptives are not considered as highly effective in this study due to the potential CYP3A induction by BI 1015550. Therefore, the following methods of contraception are considered adequate for female participants of childbearing potential:~ * Use of combined (oestrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom~ * Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom~ * Use of intrauterine device or intrauterine hormone-releasing system~ * Sexually abstinent~ * A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant. Female participants are not considered to be of childbearing potential if they are either surgically sterilised (including hysterectomy) or postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 Units per litre (U/L) and oestradiol below 30 nanogram per litre (ng/L) is confirmatory)~Inclusion criteria applying only to participants with impaired hepatic function~* Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points)~* further inclusion criteria apply~Inclusion criteria applying only to participants with normal hepatic function~* Individually matched to participants with hepatic impairment according to sex, age, and weight~* further inclusion criteria apply~Exclusion criteria applying to all participants~* Any evidence of a concomitant disease assessed as clinically relevant by the investigator~* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetic(s) (PK) of the trial medication (except appendectomy or simple hernia repair)~* Diseases of the central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder)~* History of relevant orthostatic hypotension, fainting spells, or blackouts~* Relevant chronic or acute infections~* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin or in situ carcinoma of uterine cervix~* further exclusion criteria apply~Exclusion criteria applying only to participants with hepatic impairment~* A marked prolongation of time from the start of the Q wave to the end of the T wave (QT)/ QT corrected for heart rate (QTc) interval (such as QT Corrected by the Fridericia Formula (QTcF) intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other relevant Electrocardiogram (ECG) finding at screening~* further exclusion criteria apply~Exclusion criteria applying only to participants with normal hepatic function~* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator~* further exclusion criteria apply", Similarity Score: 0.20586557208336773}'}]
|
from_dataset
| 0.205866
|
[{'from': 'human', 'value': '{Study Title: "16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimers Disease Patients", Primary Outcome Measures: "Mean Change From Baseline in the Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-cog), The Alzheimers Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimers disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimers disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16", Secondary Outcome Measures: Change From Baseline in the Alzheimer\\s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score, ADCS-ADL is a scale based on caregiver\\s assessment of patient\\s activities of daily life. It is used in clinical studies on dementia \\\\& consists of 23 items and is designed to assess patient\\s basic \\\\& instrumental activities of daily life, such as the abilities necessary for personal care, communicating \\\\& interacting with other people, maintaining a household, conducting hobbies \\\\& interests, \\\\& making judgments \\\\& decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or "yes" or "no" questions with separate sub-questions. Higher score \\\\& more "yes" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient\\s functions. The total score is the sum of the scores of all the items \\\\& sub-questions,\\\\& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Mini-Mental State Examination (MMSE), MMSE was used to determine patient\\s eligibility to participate, is an easy \\\\& practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration \\\\& attention) \\\\& performance (recall, response to written/verbal commands, writing ability \\\\& reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient\\s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: \\\\<24=abnormal; Range: \\\\<21=Increased odds of dementia; \\\\>25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, \\\\<23=abnormal for high school education, \\\\<24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline \\\\& post-baseline values were calculated, Baseline, Week 16|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score, This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency \\\\& severity of the behavior disorders, \\\\& allows rapid assessment using screening questions. 10 questions in behavior domain \\\\& 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Caregiver Burden Inventory (CBI) Score, CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16, criteria: "Key Inclusion Criteria:~* Have a diagnosis of dementia of the Alzheimer\\s type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria~* MMSE score of ≥ 10 and ≤ 26~* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks~* Be in stable medical condition~* Have signed off informed consent form by patients or his/her legal guardian~Key Exclusion Criteria:~* Severe AD~* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition~* Attending other clinical trials or taking other clinical trial drugs~* A score of \\\\> 4 on the Modified Hachinski Ischemic Scale (MHIS);~* Patients who is using any AChEI or memantine"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 357, Unnamed: 0: 431, NCT Number: NCT06335173, Study Title: "A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimers Disease (ALTITUDE-AD)", Study URL: https://clinicaltrials.gov/study/NCT06335173, Acronym: ALTITUDE-AD, Study Status: RECRUITING, Brief Summary: "The primary purpose of this study is to evaluate the efficacy of sabirnetug infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimers disease.", Study Results: NO, Conditions: Alzheimer Disease, Interventions: DRUG: sabirnetug|DRUG: Placebo, Primary Outcome Measures: "Change from Baseline in Integrated Alzheimers Disease Rating Scale (iADRS) Score, iADRS is a validated composite of cognition and function made up of Alzheimers Disease Assessment Scale - Cognitive Subscale 13-item (ADAS-Cog13) and the Alzheimers Disease Cooperative Study - instrumental Activities of Daily Living scale (ADCS-iADL). ADAS-Cog13 is a rater-administered instrument consisting of 13 items assessing cognitive function areas most typically impaired in AD. ADAS-Cog13 scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently. iADL-items score ranges from 0 to 59 (lower scores indicating greater impairment). The iADRS is calculated as a linear combination of total scores from the ADAS-Cog13 and ADCS-iADL. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance., Baseline up to Week 80", Secondary Outcome Measures: Change from Baseline in ADCS-iADL Score, The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire to be answered by a participant\\s study partner, where a participant\\s performance level is rated over the last 4 weeks, based on a set of performance descriptions. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently, and include shopping, keeping appointments, traveling outside of the home, making a meal or snack, and reading and writing. The iADL-items score ranges from 0 to 59 with lower scores indicating greater impairment., Baseline up to Week 80|Change from Baseline in ADAS-Cog13 Score, ADAS-Cog is a rater-administered instrument, designed to assess the severity of dysfunction in cognition, characteristic of persons with AD. The ADAS-Cog13, the cognitive subscale of the ADAS, consists of 13 items assessing cognitive function areas most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, and digit cancellation. The scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition., Baseline up to Week 80|Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB), The CDR is obtained through semi-structured interviews of individuals with AD and informants. The ratings are obtained in six domains: memory, orientation, judgment \\\\& problem-solving, community affairs, home \\\\& hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0 = no impairment; 0.5 = questionable impairment; 1 = mild impairment; 2 = moderate impairment; and 3 = severe impairment. CDR-SB score is obtained by summing each of the domain scores, with scores ranging from 0 to 18. Higher scores reflect greater cognitive and functional impairment., Baseline up to Week 80|Change from Baseline in Mini-Mental State Examination (MMSE), MMSE is a standard staging and assessment tool in AD, designed for grading the cognitive state of individuals with AD. The scale comprises tasks concerning orientation, memory, attention, language, and praxis to evaluate an individual\\s cognitive state. MMSE total score ranges from 0 to 30, with lower scores indicative of greater cognitive impairment., Baseline up to Week 80|Change from Baseline in Quality of Life in Alzheimer\\s Disease (QoL-AD), The QOL-AD tool is a 13-item assessment with each question scored on a 4-point scale where 1 = poor quality of life and 4 = excellent quality of life. Scores range from 13 to 52 with higher scores indicating better quality of life., Baseline up to Week 80|Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score, NPI-Q is a validated questionnaire completed by informants about participants for whom they care. Each of the 12 NPI-Q domains contains a survey question (answered in Yes/No) that reflects the cardinal symptoms of that domain. If the domain response is "Yes," the informant then rates the severity of the symptoms present within the last month on a 3-point scale and the distress of the symptom using a 5-point scale. The total NPI-Q severity score is the sum of the individual severity scores for each symptom and ranges from 0 to 36, with higher scores indicating more severe behavioral impairment. The total NPI-Q distress score is the sum of the individual distress scores for each symptom and ranges from 0 to 60, with higher scores indicating greater caregiver distress., Baseline up to Week 80|Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L), EQ-5D-5L is a self-report survey that measures quality of life. The EQ-5D-5L consists of an EQ-5D descriptive system and EQ visual analog scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, each assigned a unique 1-digit number: no problems, slight problems, moderate problems, severe problems, and extreme problems. The digits are combined into a 5-digit number that describes the participant\\s health state. The EQ VAS records the participant\\s health on a vertical visual analog scale, where the endpoints are labeled 0= the best health you can imagine, and 100= the worst health you can imagine., Baseline up to Week 80|Change from Baseline in Resource Utilization in Dementia (RUD), The RUD questionnaire is a standardized tool and the most widely used instrument for resource use data collection in dementia, enabling comparison of costs of care across countries with differing health care provisions. It is designed to collect data on formal and informal care resource use and to be useful in different care settings, across different countries and care systems, and in both clinical studies and observational cost-of-illness studies., Baseline up to Week 80|Change from Baseline in Zarit Burden Interview (ZBI), ZBI consists of 22 items. Twenty-one of the items are designed to measure several aspects of burden, whereas Item 22 is a global measure of burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden., Baseline up to Week 80|Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by iADRS, Baseline up to Week 80|Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADCS-iADL, Baseline up to Week 80|Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADAS-Cog13, Baseline up to Week 80|Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by CDR-SB, Baseline up to Week 80|Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by MMSE, Baseline up to Week 80|Percentage of Participants with No Clinical Progression at One Year, No clinical progression in participants will be defined as no decline in CDR-SB score. The CDR is obtained through semi-structured interviews of individuals with AD and informants. The ratings are obtained in six domains: memory, orientation, judgment \\\\& problem-solving, community affairs, home \\\\& hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0 = no impairment; 0.5 = questionable impairment; 1 = mild impairment; 2 = moderate impairment; and 3 = severe impairment. CDR-SB score is obtained by summing each of the domain scores, with scores ranging from 0 to 18. Higher scores reflect greater cognitive and functional impairment., Baseline up to Week 80|Number of Participants with Treatment-Related Adverse Events (TEAEs), Baseline up to Week 80|Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI), Baseline up to Week 80|Number of Participants who Discontinue or Withdraw due to TEAE, Baseline up to Week 80|Number of Participants with Anti-Drug Antibodies (ADA) and Neutralizing Antibodies, Baseline up to Week 80|Number of Participants with Amyloid-Related Imaging Abnormality with Edema/Effusions (ARIA-E) and ARIA with Hemorrhage/Hemosiderin Deposition (ARIA-H) as Measured by Magnetic Resonance Imaging (MRI), Baseline up to Week 80|Number of Participants with Suicidal Ideation and Behavior as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS), The C-SSRS includes \\yes\\ or \\no\\ responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk., Baseline up to Week 80|Serum Concentration of sabirnetug, Pre-dose and multiple timepoints post dose up to 80 weeks|Concentration of sabirnetug in Cerebrospinal Fluid (CSF), Up to Week 76|CSF Concentrations of ACU193 in a Subset of Participants, Up to Week 76|Correlation Between sabirnetug Exposure with Clinical Efficacy Measures, Correlation between sabirnetug exposure and clinical outcomes (including iADRS, CDR-SB, ADCS-iADL, ADAS-Cog13, and MMSE) will be assessed in this study., Baseline up to 80 weeks|Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids, Baseline up to Week 76|Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) of Whole Brain Volume, Ventricular Volume, and Volume of Selected Regions of Interest, Baseline up to Week 76|Target Engagement Assessed by Measurement of sabirnetug- Amyloid-β oligomer (AβO) Complex in CSF, Up to Week 76|Change from Baseline in CSF Concentrations of Amyloid, Tau and Other Neurodegenerative Biomarkers, Baseline up to Week 76|Change from Baseline in CSF Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers in a Subset of Participants, Baseline up to Week 76|Change from Baseline in Blood Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers, Baseline up to Week 76|Correlation Between Change in Biomarker that Reflect Disease Progression and Clinical Changes, Assessment of the correlation between change in clinical outcomes (iADRS, CDR-SB, ADCS-iADL, ADAS-Cog13, and MMSE) and change in biomarker (amyloid PET) will be determined by computing Pearson\\s correlation coefficient for each treatment group., Up to 80 weeks, Other Outcome Measures: , Sponsor: Acumen Pharmaceuticals, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 540.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT, Other IDs: ACU193-201|2023-509807-34-00, Start Date: 2024-02-29, Primary Completion Date: 2026-10, Completion Date: 2026-10, First Posted: 2024-03-28, Results First Posted: , Last Update Posted: 2024-10-22, Locations: "The Neurology Center of Southern California - Carlsbad, Carlsbad, California, 92011-4219, United States|Neurology Center of North Orange County, Fullerton, California, 92835, United States|Irvine Medical Research, Irvine, California, 92614, United States|Healthy Brain Research, Long Beach, California, 90804, United States|Syrentis Clinical Research, Santa Ana, California, 92705, United States|CenExel - California Neuroscience Research Medical Group, Inc (CNR), Sherman Oaks, California, 91403-2131, United States|Yale School of Medicine - Alzheimers Disease Research Unit (ADRU), New Haven, Connecticut, 06510-3330, United States|Research Center for Clinical Studies, LLC, Norwalk, Connecticut, 06851-4903, United States|Re:Cognition Health - Fairfax, Washington, District of Columbia, 22031, United States|JEM Research Institute, Atlantis, Florida, 33462, United States|Bradenton Research Center, Bradenton, Florida, 34205, United States|Gil Fernandez-Yera, MD, PA, Coral Gables, Florida, 33135, United States|Brain Matters Research, Delray Beach, Florida, 33445, United States|Coral Clinical Research, Homestead, Florida, 33032, United States|K2 Medical Research - Villages, Lady Lake, Florida, 32159, United States|Finlay Medical Research, Miami, Florida, 33126, United States|Collier Neurologic Specialists (CNS), L.L.C., Naples, Florida, 34105-8522, United States|Ocala Health - Family Care Specialists - Ocala I, Ocala, Florida, 34470, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Alzheimers Research and Treatment Center - Stuart, Stuart, Florida, 34997, United States|K2 Medical Research - Tampa, Tampa, Florida, 33607, United States|Charter Research - Lady Lake, The Villages, Florida, 32162, United States|Alzheimers Research and Treatment Center - Wellington, Wellington, Florida, 33414, United States|Conquest Research, Winter Park, Florida, 32789, United States|Charter Research - Winter Park, Winter Park, Florida, 32792, United States|Columbus Memory Center, Columbus, Georgia, 31909, United States|Accel Research- Neurostudies, Decatur, Georgia, 30030, United States|CenExel - iResearch Atlanta, Decatur, Georgia, 30030, United States|CenExel - iResearch Savannah, Savannah, Georgia, 31405, United States|Office of Jeffrey S. Ross, MD, Northbrook, Illinois, 60640, United States|Boston Center for Memory, Newton, Massachusetts, 02459, United States|Hattiesburg Clinic - Memory Center, Hattiesburg, Mississippi, 39401-7246, United States|Las Vegas Medical Research Center, Las Vegas, Nevada, 89113-2215, United States|ActivMed Practices and Research, Portsmouth, New Hampshire, 03801, United States|Princeton Psychiatric Center, Princeton, New Jersey, 08540-2859, United States|The Cognitive and Research Center of New Jersey, Springfield, New Jersey, 07081, United States|CenExel - Advanced Memory Research Institute of NJ, Toms River, New Jersey, 08755, United States|IMA Clinical Research - Albuquerque, Albuquerque, New Mexico, 87109, United States|Neurological Associates of Albany, Albany, New York, 12208, United States|Neurological Institute of New York, New York, New York, 10032, United States|AMC Research, Matthews, North Carolina, 28105, United States|Cleveland Clinic - Lou Ruvo Center for Brain Health (CCLRCBH), Lakewood, Ohio, 44107, United States|Summit Research Network, Portland, Oregon, 97210, United States|Abington Neurological Associates, Abington, Pennsylvania, 19001, United States|Keystone Clinical Research, Norristown, Pennsylvania, 19462, United States|Rhode Island Mood and Memory, East Providence, Rhode Island, 02914, United States|Neurology Clinic. P.C, Cordova, Tennessee, 38018, United States|The Alliance for Multispecialty Research LLC (AMR), Knoxville, Tennessee, 37920-1511, United States|Senior Adult Specialty Research, Austin, Texas, 78757, United States|Gadolin Research, LLC, Beaumont, Texas, 77702, United States|Kerwin Medical Center, Dallas, Texas, 75231, United States|Okanagan Clinical Trials, Kelowna, British Columbia, Canada|Hippocampe d/b/a Ottawa Memory Clinic, Ottawa, Ontario, Canada|The Kawartha Regional Memory Clinic (KRMC), Peterborough, Ontario, Canada|Toronto Memory Program (TMP) (Neurology Research Inc.), Toronto, Ontario, Canada|MoCA Research and Innovations, Greenfield Park, Quebec, Canada|Chu Pellegrin, Bordeaux, France|Hopital Neurologique Pierre Wertheimer, Bron, France|Hôpital de la Timone, Marseille Cedex 05, France|Chu Montpellier, Montpellier, France|Hopital Lariboisiere, Paris, France|Institut de la Mémoire et de la Maladie dAlzheimer -IM2A, Paris, France|CHU de Rennes, CMRR, Rennes, France|CHU de NANTES-Hôpital Nord Laennec, Saint-Herblain, France|Hôpitaux Universitaires de Strasbourg, Strasbourg, France|Centre de Recherche du Gérontopôle - CHU de Toulouse Hôpital la Grave, Toulouse, France|Charité - Universitaetsmedizin Berlin, Berlin, Germany|Pharmakologisches Studienzentrum Chemnitz GmbH, Chemnitz, Germany|University Hospital of Cologne, Cologne, Germany|Saarland University Hospital, Homburg, Germany|Zentralinstitut für seelische Gesundheit, Mannheim, Germany|Technical University of Munich, School of Medicine and Health, Klinikum rechts der Isar, Munich, Germany|Rostock University Medical Center, Rostock, Germany|Praxisgemeinschaft Dr. Springub/Schwarz, Westerstede, Germany|Hospital Universitari General de catalunya, Sant Cugat Del Vallès, Barcelona, Spain|Fundacion CITA alzheimer, San Sebastián, Gipuzkoa, Spain|Fundacion Neuropolis - Hospital Viamed Montecanal, Cuarte de Huerva, Zaragoza, Spain|Fundacio ACE, Barcelona, Spain|Hospital Universitario Reina Sofia, Cordoba, Spain|Cae Oroitu, Getxo, Spain|Hospital Ruber, Madrid, Spain|Policlínica Gipuzkoa, San Sebastian, Spain|Hospital Victoria Eugenia, Sevilla, Spain|Hospital Universitari i Politècnic La Fe, Valencia, Spain|Re:Cognition Health - London, London, Greater London, United Kingdom|St. Pancras Clinical Research Ltd., London, Greater London, United Kingdom|Panthera Bio-Partners - Rochdale, Rochdale, Greater Manchester, United Kingdom|Re:Cognition Health - Winchester, Winchester, Hampshire, United Kingdom|Neuroclin Glasgow, Motherwell, Lanarkshire, United Kingdom|Panthera Bio-Partners - Preston, Preston, Lancashire, United Kingdom|Re:Cognition Health - Guildford, Guildford, Surrey, United Kingdom|Panthera Biopartners - Sheffield, Sheffield, Yorkshire, United Kingdom|Re:Cognition Health - Bristol, Bristol, United Kingdom", Study Documents: , criteria: "Inclusion Criteria:~* Body weight of at least 30 kilograms (kg) (66 pounds \\\\[lbs\\\\]) and no more than 160 kg (352 lbs) at Screening~* Must consent to apolipoprotein E4 (APOE4) genotype status assessment~* Must meet all of the following criteria~ 1. National Institute on Aging-Alzheimer\\s Association (NIA-AA) criteria for mild cognitive impairment (MCI) due to Alzheimer\\s Disease (AD) or probable AD~ 2. Screening score between 22 and 30 (inclusive) on the Mini-Mental State Examination (MMSE)~ 3. Screening score of 0.5 or 1.0 on the Clinical Dementia Rating Global Score (CDR-GS) and Screening score ≥0.5 on the CDR Memory Box score~ 4. Evidence of cerebral amyloid accumulation by either PET scan or CSF~* If using cholinesterase inhibitors or memantine to treat symptoms related to AD, doses must be stable for at least three months (12 weeks) prior to Baseline and every attempt should be made to keep them at stable doses throughout the study~* Must have a reliable informant or study partner who is willing and able to perform all the roles as specified in the study partner Informed Consent Form (ICF)~* Female participants must be surgically sterile or be at least one-year post-menopausal. Male participants with a female partner of child-bearing potential must use adequate contraception~Exclusion Criteria:~* Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI~* MRI of the brain that is inconsistent with MCI or AD or results showing greater than four ARIA-H, presence of any ARIA-E, or superficial siderosis~* History of significant or unstable neurological disease, other than AD, which may affect cognition or ability to complete the study, such as other dementias, serious infection of the brain, significant head trauma, uncontrolled seizures, stroke, or Parkinson´s disease~* Current serious or unstable clinically important illness that, in the judgment of the site investigator, is likely to affect cognitive assessment including visual and hearing impairment or affect the participant\\s safety or ability to complete the study~* Malignant disease in the last five years except for resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal posttreatment prostate-specific antibody (PSA)~* Geriatric Depression Scale-Short Form (GDS-SF) score \\\\>10 or current symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), criteria for major depressive disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the site investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study~* Suicide risk, as determined by meeting any of the following criteria:~ 1. Any suicide attempt or preparatory acts/behavior on the C-SSRS Baseline/Screening in the last six months~ 2. Suicidal ideation in the last six months as defined by a positive response to Question 5 (Suicidal Ideation) on the C-SSRS Baseline/Screening~ 3. Significant risk of suicide, as judged by the site investigator~* Conditions that may affect cognitive assessments during the study~* Alcohol use disorder and/or substance use disorder within the last five years", combined_text: A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer\\s Disease (ALTITUDE-AD) Change from Baseline in Integrated Alzheimer\\s Disease Rating Scale (iADRS) Score, iADRS is a validated composite of cognition and function made up of Alzheimer\\s Disease Assessment Scale - Cognitive Subscale 13-item (ADAS-Cog13) and the Alzheimer\\s Disease Cooperative Study - instrumental Activities of Daily Living scale (ADCS-iADL). ADAS-Cog13 is a rater-administered instrument consisting of 13 items assessing cognitive function areas most typically impaired in AD. ADAS-Cog13 scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently. iADL-items score ranges from 0 to 59 (lower scores indicating greater impairment). The iADRS is calculated as a linear combination of total scores from the ADAS-Cog13 and ADCS-iADL. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance., Baseline up to Week 80 Change from Baseline in ADCS-iADL Score, The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire to be answered by a participant\\s study partner, where a participant\\s performance level is rated over the last 4 weeks, based on a set of performance descriptions. The ADCS-iADL is a subset of the 23-item ADCS-ADL (items 6a and 7 to 23). The iADLs are more complex skills required to successfully live independently, and include shopping, keeping appointments, traveling outside of the home, making a meal or snack, and reading and writing. The iADL-items score ranges from 0 to 59 with lower scores indicating greater impairment., Baseline up to Week 80|Change from Baseline in ADAS-Cog13 Score, ADAS-Cog is a rater-administered instrument, designed to assess the severity of dysfunction in cognition, characteristic of persons with AD. The ADAS-Cog13, the cognitive subscale of the ADAS, consists of 13 items assessing cognitive function areas most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, and digit cancellation. The scores range from 0 to 85, with higher scores indicating a greater deficit of global cognition., Baseline up to Week 80|Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB), The CDR is obtained through semi-structured interviews of individuals with AD and informants. The ratings are obtained in six domains: memory, orientation, judgment \\\\& problem-solving, community affairs, home \\\\& hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0 = no impairment; 0.5 = questionable impairment; 1 = mild impairment; 2 = moderate impairment; and 3 = severe impairment. CDR-SB score is obtained by summing each of the domain scores, with scores ranging from 0 to 18. Higher scores reflect greater cognitive and functional impairment., Baseline up to Week 80|Change from Baseline in Mini-Mental State Examination (MMSE), MMSE is a standard staging and assessment tool in AD, designed for grading the cognitive state of individuals with AD. The scale comprises tasks concerning orientation, memory, attention, language, and praxis to evaluate an individual\\s cognitive state. MMSE total score ranges from 0 to 30, with lower scores indicative of greater cognitive impairment., Baseline up to Week 80|Change from Baseline in Quality of Life in Alzheimer\\s Disease (QoL-AD), The QOL-AD tool is a 13-item assessment with each question scored on a 4-point scale where 1 = poor quality of life and 4 = excellent quality of life. Scores range from 13 to 52 with higher scores indicating better quality of life., Baseline up to Week 80|Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score, NPI-Q is a validated questionnaire completed by informants about participants for whom they care. Each of the 12 NPI-Q domains contains a survey question (answered in Yes/No) that reflects the cardinal symptoms of that domain. If the domain response is "Yes," the informant then rates the severity of the symptoms present within the last month on a 3-point scale and the distress of the symptom using a 5-point scale. The total NPI-Q severity score is the sum of the individual severity scores for each symptom and ranges from 0 to 36, with higher scores indicating more severe behavioral impairment. The total NPI-Q distress score is the sum of the individual distress scores for each symptom and ranges from 0 to 60, with higher scores indicating greater caregiver distress., Baseline up to Week 80|Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L), EQ-5D-5L is a self-report survey that measures quality of life. The EQ-5D-5L consists of an EQ-5D descriptive system and EQ visual analog scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, each assigned a unique 1-digit number: no problems, slight problems, moderate problems, severe problems, and extreme problems. The digits are combined into a 5-digit number that describes the participant\\s health state. The EQ VAS records the participant\\s health on a vertical visual analog scale, where the endpoints are labeled 0= the best health you can imagine, and 100= the worst health you can imagine., Baseline up to Week 80|Change from Baseline in Resource Utilization in Dementia (RUD), The RUD questionnaire is a standardized tool and the most widely used instrument for resource use data collection in dementia, enabling comparison of costs of care across countries with differing health care provisions. It is designed to collect data on formal and informal care resource use and to be useful in different care settings, across different countries and care systems, and in both clinical studies and observational cost-of-illness studies., Baseline up to Week 80|Change from Baseline in Zarit Burden Interview (ZBI), ZBI consists of 22 items. Twenty-one of the items are designed to measure several aspects of burden, whereas Item 22 is a global measure of burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden., Baseline up to Week 80|Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by iADRS, Baseline up to Week 80|Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADCS-iADL, Baseline up to Week 80|Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADAS-Cog13, Baseline up to Week 80|Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by CDR-SB, Baseline up to Week 80|Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by MMSE, Baseline up to Week 80|Percentage of Participants with No Clinical Progression at One Year, No clinical progression in participants will be defined as no decline in CDR-SB score. The CDR is obtained through semi-structured interviews of individuals with AD and informants. The ratings are obtained in six domains: memory, orientation, judgment \\\\& problem-solving, community affairs, home \\\\& hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0 = no impairment; 0.5 = questionable impairment; 1 = mild impairment; 2 = moderate impairment; and 3 = severe impairment. CDR-SB score is obtained by summing each of the domain scores, with scores ranging from 0 to 18. Higher scores reflect greater cognitive and functional impairment., Baseline up to Week 80|Number of Participants with Treatment-Related Adverse Events (TEAEs), Baseline up to Week 80|Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI), Baseline up to Week 80|Number of Participants who Discontinue or Withdraw due to TEAE, Baseline up to Week 80|Number of Participants with Anti-Drug Antibodies (ADA) and Neutralizing Antibodies, Baseline up to Week 80|Number of Participants with Amyloid-Related Imaging Abnormality with Edema/Effusions (ARIA-E) and ARIA with Hemorrhage/Hemosiderin Deposition (ARIA-H) as Measured by Magnetic Resonance Imaging (MRI), Baseline up to Week 80|Number of Participants with Suicidal Ideation and Behavior as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS), The C-SSRS includes \\yes\\ or \\no\\ responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk., Baseline up to Week 80|Serum Concentration of sabirnetug, Pre-dose and multiple timepoints post dose up to 80 weeks|Concentration of sabirnetug in Cerebrospinal Fluid (CSF), Up to Week 76|CSF Concentrations of ACU193 in a Subset of Participants, Up to Week 76|Correlation Between sabirnetug Exposure with Clinical Efficacy Measures, Correlation between sabirnetug exposure and clinical outcomes (including iADRS, CDR-SB, ADCS-iADL, ADAS-Cog13, and MMSE) will be assessed in this study., Baseline up to 80 weeks|Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids, Baseline up to Week 76|Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) of Whole Brain Volume, Ventricular Volume, and Volume of Selected Regions of Interest, Baseline up to Week 76|Target Engagement Assessed by Measurement of sabirnetug- Amyloid-β oligomer (AβO) Complex in CSF, Up to Week 76|Change from Baseline in CSF Concentrations of Amyloid, Tau and Other Neurodegenerative Biomarkers, Baseline up to Week 76|Change from Baseline in CSF Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers in a Subset of Participants, Baseline up to Week 76|Change from Baseline in Blood Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers, Baseline up to Week 76|Correlation Between Change in Biomarker that Reflect Disease Progression and Clinical Changes, Assessment of the correlation between change in clinical outcomes (iADRS, CDR-SB, ADCS-iADL, ADAS-Cog13, and MMSE) and change in biomarker (amyloid PET) will be determined by computing Pearson\\s correlation coefficient for each treatment group., Up to 80 weeks "Inclusion Criteria:~* Body weight of at least 30 kilograms (kg) (66 pounds \\\\[lbs\\\\]) and no more than 160 kg (352 lbs) at Screening~* Must consent to apolipoprotein E4 (APOE4) genotype status assessment~* Must meet all of the following criteria~ 1. National Institute on Aging-Alzheimer\\s Association (NIA-AA) criteria for mild cognitive impairment (MCI) due to Alzheimer\\s Disease (AD) or probable AD~ 2. Screening score between 22 and 30 (inclusive) on the Mini-Mental State Examination (MMSE)~ 3. Screening score of 0.5 or 1.0 on the Clinical Dementia Rating Global Score (CDR-GS) and Screening score ≥0.5 on the CDR Memory Box score~ 4. Evidence of cerebral amyloid accumulation by either PET scan or CSF~* If using cholinesterase inhibitors or memantine to treat symptoms related to AD, doses must be stable for at least three months (12 weeks) prior to Baseline and every attempt should be made to keep them at stable doses throughout the study~* Must have a reliable informant or study partner who is willing and able to perform all the roles as specified in the study partner Informed Consent Form (ICF)~* Female participants must be surgically sterile or be at least one-year post-menopausal. Male participants with a female partner of child-bearing potential must use adequate contraception~Exclusion Criteria:~* Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI~* MRI of the brain that is inconsistent with MCI or AD or results showing greater than four ARIA-H, presence of any ARIA-E, or superficial siderosis~* History of significant or unstable neurological disease, other than AD, which may affect cognition or ability to complete the study, such as other dementias, serious infection of the brain, significant head trauma, uncontrolled seizures, stroke, or Parkinson´s disease~* Current serious or unstable clinically important illness that, in the judgment of the site investigator, is likely to affect cognitive assessment including visual and hearing impairment or affect the participant\\s safety or ability to complete the study~* Malignant disease in the last five years except for resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal posttreatment prostate-specific antibody (PSA)~* Geriatric Depression Scale-Short Form (GDS-SF) score \\\\>10 or current symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), criteria for major depressive disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the site investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study~* Suicide risk, as determined by meeting any of the following criteria:~ 1. Any suicide attempt or preparatory acts/behavior on the C-SSRS Baseline/Screening in the last six months~ 2. Suicidal ideation in the last six months as defined by a positive response to Question 5 (Suicidal Ideation) on the C-SSRS Baseline/Screening~ 3. Significant risk of suicide, as judged by the site investigator~* Conditions that may affect cognitive assessments during the study~* Alcohol use disorder and/or substance use disorder within the last five years", Similarity Score: 0.42335876529071503}'}]
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[{'from': 'human', 'value': '{Study Title: "16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimers Disease Patients", Primary Outcome Measures: "Mean Change From Baseline in the Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-cog), The Alzheimers Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimers disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimers disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16", Secondary Outcome Measures: Change From Baseline in the Alzheimer\\s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score, ADCS-ADL is a scale based on caregiver\\s assessment of patient\\s activities of daily life. It is used in clinical studies on dementia \\\\& consists of 23 items and is designed to assess patient\\s basic \\\\& instrumental activities of daily life, such as the abilities necessary for personal care, communicating \\\\& interacting with other people, maintaining a household, conducting hobbies \\\\& interests, \\\\& making judgments \\\\& decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or "yes" or "no" questions with separate sub-questions. Higher score \\\\& more "yes" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient\\s functions. The total score is the sum of the scores of all the items \\\\& sub-questions,\\\\& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Mini-Mental State Examination (MMSE), MMSE was used to determine patient\\s eligibility to participate, is an easy \\\\& practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration \\\\& attention) \\\\& performance (recall, response to written/verbal commands, writing ability \\\\& reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient\\s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: \\\\<24=abnormal; Range: \\\\<21=Increased odds of dementia; \\\\>25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, \\\\<23=abnormal for high school education, \\\\<24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline \\\\& post-baseline values were calculated, Baseline, Week 16|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score, This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency \\\\& severity of the behavior disorders, \\\\& allows rapid assessment using screening questions. 10 questions in behavior domain \\\\& 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Caregiver Burden Inventory (CBI) Score, CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16, criteria: "Key Inclusion Criteria:~* Have a diagnosis of dementia of the Alzheimer\\s type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria~* MMSE score of ≥ 10 and ≤ 26~* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks~* Be in stable medical condition~* Have signed off informed consent form by patients or his/her legal guardian~Key Exclusion Criteria:~* Severe AD~* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition~* Attending other clinical trials or taking other clinical trial drugs~* A score of \\\\> 4 on the Modified Hachinski Ischemic Scale (MHIS);~* Patients who is using any AChEI or memantine"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 543, Unnamed: 0: 669, NCT Number: NCT03770182, Study Title: Brain Stimulation for Neurological Patients, Study URL: https://clinicaltrials.gov/study/NCT03770182, Acronym: , Study Status: COMPLETED, Brief Summary: This is a prospective double-blind randomized placebo-controlled crossover clinical trial, Study Results: NO, Conditions: Alzheimer Disease, Interventions: DEVICE: NEUROLITH, Primary Outcome Measures: Consortium to Establish a Registry for Alzheimer\\s Disease (CERAD) - Corrected Total Score, CERAD stands for "The Consortium to Establish a Registry for Alzheimer\\s Disease". The CERAD was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer\\s disease (Fillenbaum 2008). CERAD is a cognitive test battery which is normalized for age, gender and education (Morris 1988). The CERAD total score (Chandler 2005) is a good measure for Alzheimer\\s Disease (Ehrensperger 2010, Rossetti 2010, Seo 2010, Hallikainen 2013).\\n\\nThe CERAD total score is a scale from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment"., month 3, Secondary Outcome Measures: Alzheimer\\s Disease Assessment Scale (ADAS), Cognitive test. The Alzheimer\\s Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer\\s disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.\\n\\nThe ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.\\n\\nIts cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains., immediately post-treatment|Alzheimer\\s Disease Assessment Scale (ADAS), Cognitive test. The Alzheimer\\s Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer\\s disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.\\n\\nThe ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.\\n\\nIts cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains., month 1|Alzheimer\\s Disease Assessment Scale (ADAS), Cognitive test. The Alzheimer\\s Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer\\s disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.\\n\\nThe ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.\\n\\nIts cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains., month 3|Neuropsychological Test Battery Vienna (NTBV), The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test, which was created to detect Alzheimer\\s Disease (Lehrner 2007)., immediately post-treatment|Neuropsychological Test Battery Vienna (NTBV), Cognitive test, month 1|Neuropsychological Test Battery Vienna (NTBV), Cognitive test, month 3|CERAD, Cognitive test, immediately post-treatment|CERAD, Cognitive test, month 1|CERAD, Cognitive test, month 3|Clock drawing test, The clock drawing test shows the visuoconstructive skills (Shulman 1986). The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best)., immediately post-treatment|Clock drawing test, Clock drawing test, month 1|Clock drawing test, Clock drawing test, month 3|Forgetfulness assessment inventory (FAI), FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.\\n\\nThe FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.\\n\\nThe total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints., immediately post-treatment|Forgetfulness assessment inventory (FAI), FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.\\n\\nThe FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.\\n\\nThe total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints., month 1|Forgetfulness assessment inventory (FAI), FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.\\n\\nThe FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.\\n\\nThe total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints., month 3|Instrumental Activities of Daily Living Scale (IADL) - Patient, IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., immediately post-treatment|IADL- Patient, IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., month 1|IADL- Patient, IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., month 3|Beck Depression Inventory (BDI), BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression)., immediately post-treatment|Beck Depression Inventory (BDI), BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression)., month 1|Beck Depression Inventory (BDI), BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression)., month 3|Prosopagnosia index (PI20), PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces., immediately post-treatment|Prosopagnosia index (PI20), PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces., month 1|Prosopagnosia index (PI20), PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces., month 3|Neuropsychiatric Inventory (NPI) (Care Taker), The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.\\n\\nThe Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer\\s disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.\\n\\nThe NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient\\s daytime and nighttime behaviors.\\n\\nThe total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains., immediately post-treatment|Neuropsychiatric Inventory (NPI) (Care Taker), The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.\\n\\nThe Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer\\s disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.\\n\\nThe NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient\\s daytime and nighttime behaviors.\\n\\nThe total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains., month 1|Neuropsychiatric Inventory (NPI) (Care Taker), The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.\\n\\nThe Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer\\s disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.\\n\\nThe NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient\\s daytime and nighttime behaviors.\\n\\nThe total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains., month 3|IADL (Care Taker), Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., immediately post-treatment|IADL (Care Taker), Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., month 1|IADL (Care Taker), Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., month 3|Bayer Activities of Daily Living Scale (B-ADL), The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale\\s main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items., [ Time Frame: immediately post-treatment ]|Bayer Activities of Daily Living Scale (B-ADL), The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale\\s main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items., [ Time Frame: month 1 ]|Bayer Activities of Daily Living Scale (B-ADL), The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale\\s main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items., [ Time Frame: month 3 ]|Geriatric Depression Scale - short form (GDS-15), The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression)., [ Time Frame: immediately post-treatment ]|Geriatric Depression Scale - short form (GDS-15), The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression)., [ Time Frame: month 1 ]|Geriatric Depression Scale - short form (GDS-15), The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression)., [ Time Frame: month 3 ]|Leisure Behavior (FZV; German: Freizeitverhalten), The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items., [ Time Frame: immediately post-treatment ]|Leisure Behavior (FZV; German: Freizeitverhalten), The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items., [ Time Frame: month 1 ]|Leisure Behavior (FZV; German: Freizeitverhalten), The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items., [ Time Frame: month 3 ]|anatomical Magnetic Resonance Imaging (MRI), 3 Tesla Magnetic Resonance Imaging (MRI) for safety reasons: no bleeding or anatomical changes to the brain., immediately post-treatment|functional Magnetic Resonance Imaging (fMRI), 3 Tesla functional Magnetic Resonance Imaging (MRI) to analyze brain activation and connectivity after TPS. This will be done according to Sperling 2001., immediately post-treatment, Other Outcome Measures: , Sponsor: Storz Medical AG, Collaborators: Medical University of Vienna, Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 60.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT, Other IDs: TPS-AD-Vienna, Start Date: 2017-01-01, Primary Completion Date: 2022-07-27, Completion Date: 2022-07-27, First Posted: 2018-12-10, Results First Posted: , Last Update Posted: 2023-11-22, Locations: Medical University of Vienna, Vienna, Austria, Study Documents: , criteria: "Inclusion Criteria:~* Clinically stable patients with probable Alzheimer\\s Disease (Diagnosis according to ICD-10 Criteria (F00))~* At least 3 months of stable antidementive therapy or no antidementive therapy necessary~* Signed written informed consent~* Monthly pregnancy test for women in childbearing years~* Age \\\\>= 18 years~Exclusion Criteria:~* Non-compliance with the protocol~* Pregnant or breastfeeding women~* Relevant intracerebral pathology unrelated to the Alzheimers\\s disease (e.g. Brain tumor)~* Hemophilia or other blood clotting disorders~* Cortisone treatment within the last 6 weeks before first treatment~* Thrombosis", combined_text: Brain Stimulation for Neurological Patients Consortium to Establish a Registry for Alzheimer\\s Disease (CERAD) - Corrected Total Score, CERAD stands for "The Consortium to Establish a Registry for Alzheimer\\s Disease". The CERAD was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer\\s disease (Fillenbaum 2008). CERAD is a cognitive test battery which is normalized for age, gender and education (Morris 1988). The CERAD total score (Chandler 2005) is a good measure for Alzheimer\\s Disease (Ehrensperger 2010, Rossetti 2010, Seo 2010, Hallikainen 2013).\\n\\nThe CERAD total score is a scale from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment"., month 3 Alzheimer\\s Disease Assessment Scale (ADAS), Cognitive test. The Alzheimer\\s Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer\\s disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.\\n\\nThe ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.\\n\\nIts cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains., immediately post-treatment|Alzheimer\\s Disease Assessment Scale (ADAS), Cognitive test. The Alzheimer\\s Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer\\s disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.\\n\\nThe ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.\\n\\nIts cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains., month 1|Alzheimer\\s Disease Assessment Scale (ADAS), Cognitive test. The Alzheimer\\s Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer\\s disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.\\n\\nThe ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.\\n\\nIts cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains., month 3|Neuropsychological Test Battery Vienna (NTBV), The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test, which was created to detect Alzheimer\\s Disease (Lehrner 2007)., immediately post-treatment|Neuropsychological Test Battery Vienna (NTBV), Cognitive test, month 1|Neuropsychological Test Battery Vienna (NTBV), Cognitive test, month 3|CERAD, Cognitive test, immediately post-treatment|CERAD, Cognitive test, month 1|CERAD, Cognitive test, month 3|Clock drawing test, The clock drawing test shows the visuoconstructive skills (Shulman 1986). The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best)., immediately post-treatment|Clock drawing test, Clock drawing test, month 1|Clock drawing test, Clock drawing test, month 3|Forgetfulness assessment inventory (FAI), FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.\\n\\nThe FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.\\n\\nThe total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints., immediately post-treatment|Forgetfulness assessment inventory (FAI), FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.\\n\\nThe FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.\\n\\nThe total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints., month 1|Forgetfulness assessment inventory (FAI), FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.\\n\\nThe FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.\\n\\nThe total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints., month 3|Instrumental Activities of Daily Living Scale (IADL) - Patient, IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., immediately post-treatment|IADL- Patient, IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., month 1|IADL- Patient, IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., month 3|Beck Depression Inventory (BDI), BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression)., immediately post-treatment|Beck Depression Inventory (BDI), BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression)., month 1|Beck Depression Inventory (BDI), BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression)., month 3|Prosopagnosia index (PI20), PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces., immediately post-treatment|Prosopagnosia index (PI20), PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces., month 1|Prosopagnosia index (PI20), PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces., month 3|Neuropsychiatric Inventory (NPI) (Care Taker), The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.\\n\\nThe Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer\\s disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.\\n\\nThe NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient\\s daytime and nighttime behaviors.\\n\\nThe total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains., immediately post-treatment|Neuropsychiatric Inventory (NPI) (Care Taker), The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.\\n\\nThe Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer\\s disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.\\n\\nThe NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient\\s daytime and nighttime behaviors.\\n\\nThe total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains., month 1|Neuropsychiatric Inventory (NPI) (Care Taker), The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.\\n\\nThe Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer\\s disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.\\n\\nThe NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient\\s daytime and nighttime behaviors.\\n\\nThe total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains., month 3|IADL (Care Taker), Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., immediately post-treatment|IADL (Care Taker), Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., month 1|IADL (Care Taker), Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton\\s Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.\\n\\nThe Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry)., month 3|Bayer Activities of Daily Living Scale (B-ADL), The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale\\s main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items., [ Time Frame: immediately post-treatment ]|Bayer Activities of Daily Living Scale (B-ADL), The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale\\s main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items., [ Time Frame: month 1 ]|Bayer Activities of Daily Living Scale (B-ADL), The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale\\s main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items., [ Time Frame: month 3 ]|Geriatric Depression Scale - short form (GDS-15), The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression)., [ Time Frame: immediately post-treatment ]|Geriatric Depression Scale - short form (GDS-15), The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression)., [ Time Frame: month 1 ]|Geriatric Depression Scale - short form (GDS-15), The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression)., [ Time Frame: month 3 ]|Leisure Behavior (FZV; German: Freizeitverhalten), The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items., [ Time Frame: immediately post-treatment ]|Leisure Behavior (FZV; German: Freizeitverhalten), The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items., [ Time Frame: month 1 ]|Leisure Behavior (FZV; German: Freizeitverhalten), The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items., [ Time Frame: month 3 ]|anatomical Magnetic Resonance Imaging (MRI), 3 Tesla Magnetic Resonance Imaging (MRI) for safety reasons: no bleeding or anatomical changes to the brain., immediately post-treatment|functional Magnetic Resonance Imaging (fMRI), 3 Tesla functional Magnetic Resonance Imaging (MRI) to analyze brain activation and connectivity after TPS. This will be done according to Sperling 2001., immediately post-treatment "Inclusion Criteria:~* Clinically stable patients with probable Alzheimer\\s Disease (Diagnosis according to ICD-10 Criteria (F00))~* At least 3 months of stable antidementive therapy or no antidementive therapy necessary~* Signed written informed consent~* Monthly pregnancy test for women in childbearing years~* Age \\\\>= 18 years~Exclusion Criteria:~* Non-compliance with the protocol~* Pregnant or breastfeeding women~* Relevant intracerebral pathology unrelated to the Alzheimers\\s disease (e.g. Brain tumor)~* Hemophilia or other blood clotting disorders~* Cortisone treatment within the last 6 weeks before first treatment~* Thrombosis", Similarity Score: 0.41584507245712604}'}]
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from_dataset
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[{'from': 'human', 'value': '{Study Title: "16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimers Disease Patients", Primary Outcome Measures: "Mean Change From Baseline in the Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-cog), The Alzheimers Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimers disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimers disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16", Secondary Outcome Measures: Change From Baseline in the Alzheimer\\s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score, ADCS-ADL is a scale based on caregiver\\s assessment of patient\\s activities of daily life. It is used in clinical studies on dementia \\\\& consists of 23 items and is designed to assess patient\\s basic \\\\& instrumental activities of daily life, such as the abilities necessary for personal care, communicating \\\\& interacting with other people, maintaining a household, conducting hobbies \\\\& interests, \\\\& making judgments \\\\& decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or "yes" or "no" questions with separate sub-questions. Higher score \\\\& more "yes" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient\\s functions. The total score is the sum of the scores of all the items \\\\& sub-questions,\\\\& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Mini-Mental State Examination (MMSE), MMSE was used to determine patient\\s eligibility to participate, is an easy \\\\& practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration \\\\& attention) \\\\& performance (recall, response to written/verbal commands, writing ability \\\\& reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient\\s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: \\\\<24=abnormal; Range: \\\\<21=Increased odds of dementia; \\\\>25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, \\\\<23=abnormal for high school education, \\\\<24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline \\\\& post-baseline values were calculated, Baseline, Week 16|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score, This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency \\\\& severity of the behavior disorders, \\\\& allows rapid assessment using screening questions. 10 questions in behavior domain \\\\& 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Caregiver Burden Inventory (CBI) Score, CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16, criteria: "Key Inclusion Criteria:~* Have a diagnosis of dementia of the Alzheimer\\s type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria~* MMSE score of ≥ 10 and ≤ 26~* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks~* Be in stable medical condition~* Have signed off informed consent form by patients or his/her legal guardian~Key Exclusion Criteria:~* Severe AD~* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition~* Attending other clinical trials or taking other clinical trial drugs~* A score of \\\\> 4 on the Modified Hachinski Ischemic Scale (MHIS);~* Patients who is using any AChEI or memantine"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 1001, Unnamed: 0: 1243, NCT Number: NCT03518073, Study Title: "A Study of LY3303560 in Participants With Early Symptomatic Alzheimers Disease", Study URL: https://clinicaltrials.gov/study/NCT03518073, Acronym: , Study Status: COMPLETED, Brief Summary: "The purpose of this study is to evaluate the safety and efficacy of a study drug that targets an abnormal protein in the brain found in people with Alzheimers Disease (AD).", Study Results: YES, Conditions: Alzheimer Disease (AD), Interventions: DRUG: Zagotenemab|DRUG: Placebo, Primary Outcome Measures: "Change From Baseline on the Integrated Alzheimers Disease Rating Scale (iADRS), Integrated Alzheimers Disease Rating Scale (iADRS) is a simple linear combination of scores from 13-item alzheimers disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimers disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether zagotenemab slows down the cognitive and functional decline associated with early symptomatic Alzheimers Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval., Baseline, Week 104", Secondary Outcome Measures: Change From Baseline on the Alzheimer\\s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score, The ADAS is a rater-administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with Alzheimer\\s Disease (AD). The cognitive subscale of the ADAS consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze completion measures. The ADAS-Cog13 scale ranges from 0 to 85, with higher scores indicating greater disease severity. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval., Baseline, Week 104|Change From Baseline on the Alzheimer\\s Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score, The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant\\s caregiver. The ADCS-ADL measures basic, instrumental activities of daily living by participants (instrumental activity items 6a, 7-23). The range for the ADCS-iADL is 0-59, with lower scores indicating greater disease severity. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval., Baseline, Week 104|Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score, CDR-SB is a semi-structured interview of participants and their caregivers. Participant\\s cognitive status is rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval., Baseline, Week 104|Change From Baseline on the Mini Mental Status Examination (MMSE) Score, The MMSE is a brief instrument used to assess cognitive function. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention. The maximum score for the first section is 21. The second section tests the ability of the person to name objects, follow verbal and written commands, write a sentence, and copy figures. The maximum score for the second section is 9. The range for the total MMSE score is 0 to 30, with lower scores indicating greater level of impairment. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval., Baseline, Week 104|Change From Baseline in Brain Aggregated Tau Deposition as Measured by Flortaucipir F-18 Positron Emission Tomography (PET) Scan., Deposition of abnormal tau protein in the brain associated with AD was assessed by quantitative PET scan using flortaucipir F-18. Flortaucipir is an F-18-labeled small molecule that binds with high affinity and selectivity to aggregated tau, and provides a measure of aggregated tau deposition in the brain, expressed as flortaucipir standardized uptake value ratio (SUVr). Change from baseline was calculated using mixed model repeated measures (MMRM) with fixed, categorical effects of treatment, visit, treatment-by-visit interaction, and continuous effect of baseline SUVr and age. A positive change from baseline indicates increased aggregated tau deposition that is believed to be associated with a more rapid rate of cognitive deterioration., Baseline, Week 104|Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI), Alzheimer\\s disease is also associated with pronounced brain atrophy, reflecting bulk neurodegenerative loss of gray and white matter. Progression of brain atrophy is assessed by vMRI, providing regional quantification of volume loss. Negative change from baseline indicates greater disease severity. Change from baseline was calculated using mixed model repeated measures (MMRM) with fixed, categorical effects of treatment, visit, treatment-by-visit interaction, and continuous effect of baseline vMRI, baseline intracranial volume (ICV) and age., Baseline, Week 104|Number of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).\\n\\n* Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent.\\n* Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide., Baseline through Week 104|Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Zagotenemab, A TE-ADA evaluable subject is considered to be TE-ADA positive:\\n\\n* If the subject has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement (treatment-boosted).\\n* If baseline result is ADA Not Present, then the subject is TE ADA positive if there is at least one postbaseline result of ADA Present with titer \\\\>= 1:10 (treatment-induced)., Baseline through Week 113, Other Outcome Measures: , Sponsor: Eli Lilly and Company, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 360.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT, Other IDs: 16124|I8G-MC-LMDC, Start Date: 2018-04-30, Primary Completion Date: 2021-08-23, Completion Date: 2021-10-25, First Posted: 2018-05-08, Results First Posted: 2022-08-30, Last Update Posted: 2022-08-30, Locations: "Banner Alzheimers Institute, Phoenix, Arizona, 85006, United States|Center for Neurosciences, Tucson, Arizona, 85718, United States|Pharmacology Research Institute, Encino, California, 91316, United States|Fullerton Neurology and Headache Center, Fullerton, California, 92835, United States|Irvine Clinical Research Center, Irvine, California, 92614, United States|Pharmacology Research Institute, Los Alamitos, California, 90720, United States|National Research Institute - Huntington Park, Panorama City, California, 91402, United States|Anderson Clinical Research, Redlands, California, 92374, United States|Pacific Research Network, San Diego, California, 92103, United States|Univ of California San Francisco, San Francisco, California, 94158, United States|Syrentis Clinical Research, Santa Ana, California, 92705, United States|New England Institute for Clinical Research, Stamford, Connecticut, 06905, United States|JEM Research Institute, Atlantis, Florida, 33462, United States|Julie B. Schwartzbard, MD, PA, Aventura, Florida, 33180, United States|Quantum Laboratories Clinical Research, Deerfield Beach, Florida, 33064, United States|Brain Matters Research, Delray Beach, Florida, 33445, United States|Neuropsychiatric Research Center of Southwest Florida, Fort Myers, Florida, 33912, United States|Infinity Clinical Research, LLC, Hollywood, Florida, 33024, United States|VIN-Victor Faradji, Miami, Florida, 33176, United States|Renstar Medical Research, Ocala, Florida, 34470, United States|BioClinica Inc, Orlando, Florida, 32806, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Brain Matters Research, Stuart, Florida, 34997, United States|Infinity Clinical Research, LLC, Sunrise, Florida, 33351, United States|Columbus Memory Center, PC, Columbus, Georgia, 31909, United States|Great Lakes Clinical Trials, Chicago, Illinois, 60640, United States|AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research, Elk Grove Village, Illinois, 60007, United States|Josephson Wallack Munshower Neurology, PC, Indianapolis, Indiana, 46256, United States|Rowe Neurology Institute, Lenexa, Kansas, 66214, United States|Cotton ONeil Clinic, Topeka, Kansas, 66606, United States|Pharmasite Research, Inc., Baltimore, Maryland, 21208, United States|Tufts Medical Center, Boston, Massachusetts, 02111, United States|Boston Center for Memory, Newton, Massachusetts, 02459, United States|Clinical Research Professionals, Chesterfield, Missouri, 63005, United States|The Cognitive and Research Center of New Jersey, Springfield, New Jersey, 07081, United States|Advanced Memory Research Institute of New Jersey, Toms River, New Jersey, 08755, United States|Raleigh Neurology Associates, P.A., Raleigh, North Carolina, 27607, United States|PMG Research of Winston-Salem, LLC, Winston-Salem, North Carolina, 27103, United States|Lindner Research Center, Cincinnati, Ohio, 45219, United States|Ohio State University Medical Center, Columbus, Ohio, 43210, United States|University of Cincinnati Health Neurology, Dayton, Ohio, 45417, United States|Lehigh Center for Clinical Research, Allentown, Pennsylvania, 18104, United States|Suburban Research Associates, Media, Pennsylvania, 19063, United States|Butler Hospital, Providence, Rhode Island, 02906, United States|Baylor AT&T Memory Center, Dallas, Texas, 75231, United States|Neurology Consultants of Dallas, PA, Dallas, Texas, 75243, United States|Houston Methodist Research Ins, Houston, Texas, 77030, United States|The Memory Clinic, Bennington, Vermont, 05201, United States|Cognition Health, Fairfax, Virginia, 22031, United States|Kawartha Centre - Redefining Healthy Aging, Peterborough, Ca-on, K9H 2P4, Canada|Toronto Memory Program, Toronto, Ontario, M3B2S7, Canada|Clinique de la Mémoire de lOutaouais, Gatineau, Quebec, J8T 8J1, Canada|NeuroSearch Developements, Greenfield Park, Quebec, J4V 2J2, Canada|Q&T Research Sherbrooke Inc., Sherbrooke, Quebec, J1J 2G2, Canada|National Center for Geriatrics and Gerontology, Obu City, Aichi, 4748511, Japan|Kobe City Medical Center General Hospital, Kobe, Hyogo, 650-0046, Japan|Nippon Medical School Hospital, Tokyo, Jp-13, 113-8603, Japan|National hospital Organization Utano National Hospital, Kyoto, Jp-26, 616-8255, Japan|Katayama Medical Clinic, Kurashiki, Jp-33, 710-0813, Japan|Shonan Kamakura General Hospital, Kamakura, Kanagawa, 247-8533, Japan", Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/73/NCT03518073/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT03518073/SAP_001.pdf, criteria: "Inclusion Criteria:~* Participants must have gradual and progressive change in memory function for \\\\>6 months.~* Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments.~Exclusion Criteria:~* Participants must not have significant neurological disease affecting the nervous system, other than AD, that affects cognition or may affect completion of the study.~* Participants must not have serious or unstable illness that could interfere with the analysis of the study or has a life expectancy \\\\<24 months.~* Participants must not have history of cancer within the last 5 years with the exception of certain types of skin, cervical, prostate, and other cancers that are not likely to recur or spread.~* Participants must not have serious risk for suicide.~* Participants must not have history of drug or alcohol use disorder within the last 2 years.~* Participants must not have multiple severe drug allergies~* Participants must not have HIV, Hepatitis B or Hepatitis C~* Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin (IVIG) therapy", combined_text: A Study of LY3303560 in Participants With Early Symptomatic Alzheimer\\s Disease Change From Baseline on the Integrated Alzheimer\\s Disease Rating Scale (iADRS), Integrated Alzheimer\\s Disease Rating Scale (iADRS) is a simple linear combination of scores from 13-item alzheimer\\s disease assessment scale-cognitive subscale (ADAS-Cog13) and the Alzheimer\\s disease cooperative study-instrumental activities of daily living scale (ADCS-iADL). It is used to assess whether zagotenemab slows down the cognitive and functional decline associated with early symptomatic Alzheimer\\s Disease, compared to placebo. The iADRS score ranges from 0 to 144 with lower scores indicating worse performance and higher score better performance. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval., Baseline, Week 104 Change From Baseline on the Alzheimer\\s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score, The ADAS is a rater-administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with Alzheimer\\s Disease (AD). The cognitive subscale of the ADAS consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze completion measures. The ADAS-Cog13 scale ranges from 0 to 85, with higher scores indicating greater disease severity. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval., Baseline, Week 104|Change From Baseline on the Alzheimer\\s Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score, The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant\\s caregiver. The ADCS-ADL measures basic, instrumental activities of daily living by participants (instrumental activity items 6a, 7-23). The range for the ADCS-iADL is 0-59, with lower scores indicating greater disease severity. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval., Baseline, Week 104|Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score, CDR-SB is a semi-structured interview of participants and their caregivers. Participant\\s cognitive status is rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval., Baseline, Week 104|Change From Baseline on the Mini Mental Status Examination (MMSE) Score, The MMSE is a brief instrument used to assess cognitive function. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention. The maximum score for the first section is 21. The second section tests the ability of the person to name objects, follow verbal and written commands, write a sentence, and copy figures. The maximum score for the second section is 9. The range for the total MMSE score is 0 to 30, with lower scores indicating greater level of impairment. Change from baseline was calculated using Bayesian disease progression model (DPM) with fixed, categorical effects of treatment, pooled site, acetylcholinesterase inhibitor (AChEI) use at baseline (yes/no), and the continuous effects of baseline score and age at baseline. Data presented are posterior mean with 95% credible interval., Baseline, Week 104|Change From Baseline in Brain Aggregated Tau Deposition as Measured by Flortaucipir F-18 Positron Emission Tomography (PET) Scan., Deposition of abnormal tau protein in the brain associated with AD was assessed by quantitative PET scan using flortaucipir F-18. Flortaucipir is an F-18-labeled small molecule that binds with high affinity and selectivity to aggregated tau, and provides a measure of aggregated tau deposition in the brain, expressed as flortaucipir standardized uptake value ratio (SUVr). Change from baseline was calculated using mixed model repeated measures (MMRM) with fixed, categorical effects of treatment, visit, treatment-by-visit interaction, and continuous effect of baseline SUVr and age. A positive change from baseline indicates increased aggregated tau deposition that is believed to be associated with a more rapid rate of cognitive deterioration., Baseline, Week 104|Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI), Alzheimer\\s disease is also associated with pronounced brain atrophy, reflecting bulk neurodegenerative loss of gray and white matter. Progression of brain atrophy is assessed by vMRI, providing regional quantification of volume loss. Negative change from baseline indicates greater disease severity. Change from baseline was calculated using mixed model repeated measures (MMRM) with fixed, categorical effects of treatment, visit, treatment-by-visit interaction, and continuous effect of baseline vMRI, baseline intracranial volume (ICV) and age., Baseline, Week 104|Number of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS), C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).\\n\\n* Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent.\\n* Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide., Baseline through Week 104|Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Zagotenemab, A TE-ADA evaluable subject is considered to be TE-ADA positive:\\n\\n* If the subject has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement (treatment-boosted).\\n* If baseline result is ADA Not Present, then the subject is TE ADA positive if there is at least one postbaseline result of ADA Present with titer \\\\>= 1:10 (treatment-induced)., Baseline through Week 113 "Inclusion Criteria:~* Participants must have gradual and progressive change in memory function for \\\\>6 months.~* Participants must have a family member or close friend who is with you at least 10 hours per week and can attend study appointments.~Exclusion Criteria:~* Participants must not have significant neurological disease affecting the nervous system, other than AD, that affects cognition or may affect completion of the study.~* Participants must not have serious or unstable illness that could interfere with the analysis of the study or has a life expectancy \\\\<24 months.~* Participants must not have history of cancer within the last 5 years with the exception of certain types of skin, cervical, prostate, and other cancers that are not likely to recur or spread.~* Participants must not have serious risk for suicide.~* Participants must not have history of drug or alcohol use disorder within the last 2 years.~* Participants must not have multiple severe drug allergies~* Participants must not have HIV, Hepatitis B or Hepatitis C~* Participants must not be receiving gamma globulin (IgG) or intravenous immunoglobulin (IVIG) therapy", Similarity Score: 0.38902031641294005}'}]
|
from_dataset
| 0.38902
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[{'from': 'human', 'value': '{Study Title: "16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimers Disease Patients", Primary Outcome Measures: "Mean Change From Baseline in the Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-cog), The Alzheimers Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimers disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimers disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16", Secondary Outcome Measures: Change From Baseline in the Alzheimer\\s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score, ADCS-ADL is a scale based on caregiver\\s assessment of patient\\s activities of daily life. It is used in clinical studies on dementia \\\\& consists of 23 items and is designed to assess patient\\s basic \\\\& instrumental activities of daily life, such as the abilities necessary for personal care, communicating \\\\& interacting with other people, maintaining a household, conducting hobbies \\\\& interests, \\\\& making judgments \\\\& decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or "yes" or "no" questions with separate sub-questions. Higher score \\\\& more "yes" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient\\s functions. The total score is the sum of the scores of all the items \\\\& sub-questions,\\\\& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Mini-Mental State Examination (MMSE), MMSE was used to determine patient\\s eligibility to participate, is an easy \\\\& practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration \\\\& attention) \\\\& performance (recall, response to written/verbal commands, writing ability \\\\& reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient\\s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: \\\\<24=abnormal; Range: \\\\<21=Increased odds of dementia; \\\\>25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, \\\\<23=abnormal for high school education, \\\\<24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline \\\\& post-baseline values were calculated, Baseline, Week 16|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score, This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency \\\\& severity of the behavior disorders, \\\\& allows rapid assessment using screening questions. 10 questions in behavior domain \\\\& 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Caregiver Burden Inventory (CBI) Score, CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16, criteria: "Key Inclusion Criteria:~* Have a diagnosis of dementia of the Alzheimer\\s type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria~* MMSE score of ≥ 10 and ≤ 26~* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks~* Be in stable medical condition~* Have signed off informed consent form by patients or his/her legal guardian~Key Exclusion Criteria:~* Severe AD~* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition~* Attending other clinical trials or taking other clinical trial drugs~* A score of \\\\> 4 on the Modified Hachinski Ischemic Scale (MHIS);~* Patients who is using any AChEI or memantine"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 811, Unnamed: 0: 1022, NCT Number: NCT00359944, Study Title: "Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimers Disease", Study URL: https://clinicaltrials.gov/study/NCT00359944, Acronym: , Study Status: COMPLETED, Brief Summary: "The purpose of this study is to investigate efficacy and safety of different doses of AC-3933 in patients with mild to moderate Alzheimers Disease.", Study Results: YES, Conditions: "Alzheimers Disease", Interventions: DRUG: AC-3933|DRUG: AC-3933|OTHER: Sugar Pill, Primary Outcome Measures: "Total Score of Alzheimers Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70), Change from baseline to week 16 of the double blind treatment in the Alzheimers Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimers Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment., Baseline to 16 weeks", Secondary Outcome Measures: Clinicians Interview Based Impression of Change (CIBIC)-Plus, Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment.\\n\\nCIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end., Baseline to 16 weeks|Disability Assessment for Dementia (DAD), Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores.\\n\\nThe DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction., Baseline to 16 Weeks, Other Outcome Measures: , Sponsor: Sumitomo Pharma America, Inc., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 171.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT, Other IDs: AC-3933-271, Start Date: 2006-02, Primary Completion Date: 2008-09, Completion Date: 2008-09, First Posted: 2006-08-03, Results First Posted: 2013-07-02, Last Update Posted: 2013-07-02, Locations: Clinical Trials Inc., LIttle Rock, Alaska, 72205, United States|PsyPharma Clinical Research Inc., Phoenix, Arizona, 85013, United States|ClinicalStudies Center LLC, Little Rock, Arkansas, 72205, United States|Vertex Clinical Research, Bakersfield, California, 93311, United States|East Bay Physicians Medical Grou[, Berkeley, California, 94705, United States|Margolin Brain Institute, Fresno, California, 93720, United States|Clinical Trials Associates, Mission Viejo, California, 92691, United States|University of California, Orange, California, 92868, United States|Pacific Research Network, San Diego, California, 92103, United States|Memory Disorder Clinic, Deerfield Beach, Florida, 33064, United States|Berma Research Group, Hialeah, Florida, 33016, United States|Advanced Research Institute of Miami, Miami, Florida, 33135, United States|Research Institute of Miami, Miami, Florida, 33135, United States|Research Center of Florida Inc., Miami, Florida, 33173, United States|Medical Research Group of Central Florida, Orange City, Florida, 32763, United States|Compass Research LLC, Orlando, Florida, 32806, United States|Department of Psychiatry and Behavioral Medicine, Tampa, Florida, 33613, United States|Stedman Clinical Trials LLC, Tampa, Florida, 33613, United States|Four Rivers Clinical Research Inc., Paducah, Kentucky, 42003, United States|Northern Michigan Neurology, Traverse City, Michigan, 49684, United States|Minneapolis, Minnesota, 53454, United States|Clinical Psychopharmacology Consultants PA, Saint Louis Park, Minnesota, 55416, United States|Precise Research Centers INc., Flowood, Mississippi, 37232, United States|Psych Care Consultants Research, Saint Louis, Missouri, 63128, United States|Odyssey Researcfh, Fargo, North Dakota, 58104, United States|Paradigm Research Professionals LLP, Oklahoma City, Oklahoma, 73112, United States|Cutting Edge Research Group, Oklahoma City, Oklahoma, 73116, United States|Tulsa Clinical Research LLC, Tulsa, Oklahoma, 74104, United States|The Clinical Trial Center, Jenkintown, Pennsylvania, 19046, United States|UT Medical Group Inc., Memphis, Tennessee, 38105, United States|Neurological Research Center, Inc., Bennington, Vermont, 05201, United States|International Clinical Research Associates LLC, Richmond, Virginia, 23229, United States|The Center for Excellence in Aging and Geriatric Health, Williamsburg, Virginia, 23185, United States|Internal Medicine Northwest, Tacoma, Washington, 98405, United States, Study Documents: , criteria: "Inclusion Criteria:~* Mild to moderate Alzheimer\\s Disease~* Male or female 55 years or older~* Living with caregiver~* Read, understand and speak English~Exclusion Criteria:~* Need to drive during the study~* Treatment with acetylcholinesterase inhibitors or NMDA antagonist, such as Aricept or Namenda, within 2 weeks of check-up and during the study~* Frequent Smoker~* Frequent Consumer of Caffeine", combined_text: Safety and Efficacy Study of AC-3933 in Adults With Mild to Moderate Alzheimer\\s Disease Total Score of Alzheimer\\s Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70), Change from baseline to week 16 of the double blind treatment in the Alzheimer\\s Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer\\s Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment., Baseline to 16 weeks Clinicians Interview Based Impression of Change (CIBIC)-Plus, Clinicians Interview Based Impression of Change (CIBIC)-Plus-Plus scores at week 16 of the double blind treatment.\\n\\nCIBIC-Plus is ranged between 1 and 7 (1=very much improved, 4=no change, and 7=very much worsened). We were expecting smaller value of CIBIC-Plus at the study end., Baseline to 16 weeks|Disability Assessment for Dementia (DAD), Change from baseline to week 16 of the double blind treatment in the Disability Assessment for Dementia (DAD) scores.\\n\\nThe DAD is administered as a clinician-assisted interview with the caregiver and was developed to assess functional abilities in ADLs in community-dwelling dementia patients. The scale consists of 40 questions assessing basic and instumental ADLs. A total score is obtained by adding the rating for each question and converting this total score out of 100. The items rated N/A are not considered for the total score. Higher scores represent less disability in activities of daily living (ADL) while lower scores indicate more dysfunction., Baseline to 16 Weeks "Inclusion Criteria:~* Mild to moderate Alzheimer\\s Disease~* Male or female 55 years or older~* Living with caregiver~* Read, understand and speak English~Exclusion Criteria:~* Need to drive during the study~* Treatment with acetylcholinesterase inhibitors or NMDA antagonist, such as Aricept or Namenda, within 2 weeks of check-up and during the study~* Frequent Smoker~* Frequent Consumer of Caffeine", Similarity Score: 0.38004159579197566}'}]
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[{'from': 'human', 'value': '{Study Title: "16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimers Disease Patients", Primary Outcome Measures: "Mean Change From Baseline in the Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-cog), The Alzheimers Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimers disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimers disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16", Secondary Outcome Measures: Change From Baseline in the Alzheimer\\s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score, ADCS-ADL is a scale based on caregiver\\s assessment of patient\\s activities of daily life. It is used in clinical studies on dementia \\\\& consists of 23 items and is designed to assess patient\\s basic \\\\& instrumental activities of daily life, such as the abilities necessary for personal care, communicating \\\\& interacting with other people, maintaining a household, conducting hobbies \\\\& interests, \\\\& making judgments \\\\& decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or "yes" or "no" questions with separate sub-questions. Higher score \\\\& more "yes" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient\\s functions. The total score is the sum of the scores of all the items \\\\& sub-questions,\\\\& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Mini-Mental State Examination (MMSE), MMSE was used to determine patient\\s eligibility to participate, is an easy \\\\& practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration \\\\& attention) \\\\& performance (recall, response to written/verbal commands, writing ability \\\\& reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient\\s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: \\\\<24=abnormal; Range: \\\\<21=Increased odds of dementia; \\\\>25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, \\\\<23=abnormal for high school education, \\\\<24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline \\\\& post-baseline values were calculated, Baseline, Week 16|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score, This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency \\\\& severity of the behavior disorders, \\\\& allows rapid assessment using screening questions. 10 questions in behavior domain \\\\& 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Caregiver Burden Inventory (CBI) Score, CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16, criteria: "Key Inclusion Criteria:~* Have a diagnosis of dementia of the Alzheimer\\s type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria~* MMSE score of ≥ 10 and ≤ 26~* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks~* Be in stable medical condition~* Have signed off informed consent form by patients or his/her legal guardian~Key Exclusion Criteria:~* Severe AD~* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition~* Attending other clinical trials or taking other clinical trial drugs~* A score of \\\\> 4 on the Modified Hachinski Ischemic Scale (MHIS);~* Patients who is using any AChEI or memantine"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 733, Unnamed: 0: 918, NCT Number: NCT05686044, Study Title: A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD, Study URL: https://clinicaltrials.gov/study/NCT05686044, Acronym: , Study Status: COMPLETED, Brief Summary: "The purpose of this study is to measure efficacy and safety of three different doses of buntanetap/Posiphen compared with placebo in participants with mild to moderate Alzheimers disease.\\n\\nStudy details include:\\n\\nThe double-blind treatment duration will include a screening period of up to 42 days followed by 12 weeks of treatment at home.\\n\\nThe study duration will be 4-5 months. There will be 4 in-clinic visits and 1 phone call.", Study Results: NO, Conditions: Alzheimer Disease, Interventions: DRUG: Buntanetap/Posiphen|DRUG: Placebo, Primary Outcome Measures: "Alzheimers Disease Assessment Scale-Cognitive Subscale 11, Alzheimers Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) measures cognitive functions and non-cognitive functions such as mood and behavior. It was designed to measure the cognitive and behavioral domains known to be affected in Alzheimer disease, including memory, language, orientation, construction, and planning of simple designs, and completed simple goal-oriented behaviors.\\n\\nSpecifically, the ADAS-Cog comprises ratings from 11 components: word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering test instructions, spoken language, word finding, and comprehension.\\n\\nTotal scores range from 0-70, with higher scores indicating greater cognitive impairment., Baseline to the end of treatment period (12 weeks)|Alzheimers Disease Cooperative Study-Clinical Global Impression of Change, Alzheimers Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) focuses on clinicians observations of change in the patients cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants.\\n\\nThe ADCS-CGIC measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner.\\n\\nA skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). Lower scores indicate better improvement., Baseline and week 12 clinic visits (12 weeks)", Secondary Outcome Measures: "Alzheimers Disease Cooperative Study-Instrumental Activities of Daily Living Scale, Alzheimers Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-ADL) is a 23-item inventory scale developed as a rater-administered questionnaire answered by the participants study partner.\\n\\nThe ADCS-ADL measures 6 basic activities of daily living (BADL) items and 17 instrumental activities of daily living (IADL) items that provide a total score from 0-78, with a lower score indicating greater severity. Basic activities include basic self-care tasks such as feeding, mobility, toileting, bathing, grooming and dressing. Instrumental activities are more complex and vary based on cultural norms, gender roles. As such, instrumental activities tend to include a broad range of activities.\\n\\nCaregivers are asked to rate the degree to which their family member or loved one can perform a variety of tasks. The assessed activities provide a total score from 0-78. Participants with a lower score indicates greater severity., Baseline to end of treatment period (12 weeks)|Mini Mental State Examination Score, The Mini Mental State Examination (MMSE) Score is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures).\\n\\nTotal score ranges from 0 to 30 with a lower score indicating greater disease severity., Screening (up to 42 days) through end of treatment period (12 weeks) for a total of up to 4.2 months|Digital Symbol Substitution Test, The digital symbol substitution test (DSST) asks individuals to record associations between different symbols and numbers within time limits.\\n\\nThe total score is the sum of all the correctly coded numbers. Higher scores indicate better performance., Baseline through the end of treatment period (12 weeks)", Other Outcome Measures: , Sponsor: Annovis Bio Inc., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2|PHASE3, Enrollment: 320.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT, Other IDs: ANVS -22002, Start Date: 2023-04-01, Primary Completion Date: 2024-02-13, Completion Date: 2024-02-13, First Posted: 2023-01-17, Results First Posted: , Last Update Posted: 2024-02-20, Locations: CCT Research - Gilbert Neurology Partners, Gilbert, Arizona, 85297, United States|CCT Research - Foothills Center, Phoenix, Arizona, 85004, United States|The Belinga Clinic, Fort Smith, Arkansas, 72916, United States|Sun Valley Research Center, Imperial, California, 92251, United States|CenExel Clinical Clinical Research, Inc, Los Alamitos, California, 90720, United States|Cenexel Rocky Mountain Clinical Research, Englewood, Colorado, 80113, United States|Ki Health Partners LLC D/B/A New England Institute for Clinical Research, Stamford, Connecticut, 06824, United States|Visionary Investigators Network, Aventura, Florida, 33180, United States|K2 Medical Research, Clermont, Florida, 34711, United States|The Neurology Institute - Coral Springs, Coral Springs, Florida, 33067-4640, United States|JY Research Inst., Cutler Bay, Florida, 33189, United States|Arrow Clinical trial, Daytona Beach, Florida, 32114, United States|Accel Research Sites - DeLand Clinical Research Unit, DeLand, Florida, 32720, United States|New Life Medical Research Center, Hialeah, Florida, 33012, United States|CenExel RCA, Hollywood, Florida, 33024, United States|Coral Clinic Reserach LLC, Homestead, Florida, 33032, United States|Charter Research, Lady Lake, Florida, 32159, United States|ClinCloud, LLC, Maitland, Florida, 32751, United States|K2 Medical Research, Maitland, Florida, 32751, United States|Merritt Island Clinical Research LLC, Merritt Island, Florida, 32952, United States|Premier Clinical Research Institute, Inc, Miami, Florida, 33122, United States|Gold Coast Health Research, LLC, Miami, Florida, 33155, United States|Medical Professional Clinical Research Center, Inc, Miami, Florida, 33165, United States|Reliant Medical Research, Miami, Florida, 33165, United States|Ezy Medical Research Co., Miami, Florida, 33175, United States|Nuovida Research Center, Miami, Florida, 33186, United States|Renstar Medical Research, Ocala, Florida, 34470, United States|Visionary Investigators Network, Pembroke Pines, Florida, 33026, United States|Napa Research, Pompano Beach, Florida, 33064, United States|K2 Medical Research, Tampa, Florida, 33067, United States|K2 Summit Research, The Villages, Florida, 32159, United States|ClinCloud, LLC, Viera, Florida, 32940, United States|Conquest Research, LLC, Winter Park, Florida, 32789, United States|Charter Research, Winter Park, Florida, 32792, United States|CenExel iResearch, LLC, Decatur, Georgia, 30030, United States|Center for Advanced Research & Education, Gainesville, Georgia, 30501, United States|Hawaii Pacific Neuroscience, LLC, Honolulu, Hawaii, 96817, United States|Southern Illinois University School of Medicine, Springfield, Illinois, 62702, United States|Josephson Wallack Munshower Neurology, P.C., Indianapolis, Indiana, 46256, United States|Northern Light Acadia Hospital, Bangor, Maine, 04401, United States|MedVadis Research, Waltham, Massachusetts, 02451, United States|Quest Research Institue, Farmington Hills, Michigan, 48334, United States|Insight Research Institute, Flint, Michigan, 48507, United States|Hassman Research Institute, Berlin, New Jersey, 08009, United States|CenExel Clinical Research, Inc, Toms River, New Jersey, 08755, United States|Velocity Clinical Research, Syracuse, New York, 13057, United States|SUNY Upstate Medical University, Syracuse, New York, 13210, United States|Duke University, Durham, North Carolina, 27705, United States|Neuroscience Centre (CINAC), Canton, Ohio, 44718, United States|Dayton Center for Neurological Disorders, Inc, Centerville, Ohio, 45459, United States|NeuroCare Plus, Houston, Texas, 77094, United States|Be Well Clinical Studies, LLC, Round Rock, Texas, 78681, United States|Central Texas Neurology Consultants, Round Rock, Texas, 78681, United States|Inland Northwest Research, Spokane, Washington, 99202-1342, United States, Study Documents: , criteria: "Inclusion Criteria:~1. Diagnosis of Alzheimer\\s disease according to NIA and NIA-AA criteria for probable AD~2. Male or female aged 55 - 85 years.~3. MMSE 14-24.~4. Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week) and will accompany the participant to study visits at designated times.~5. Female participants of childbearing potential\\\\* must have a negative urine pregnancy test at Screening, must be non-lactating and must agree to use a highly effective method of contraception (i.e., a method resulting in a failure rate of less than 1% per year when used consistently and correctly) during the trial and for 4 weeks after the last dose of trial treatment, such as:~ * Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation~ * Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation~ * Intrauterine device (IUD)~ * Intrauterine hormone-releasing system (IUS)~ * Bilateral tubal occlusion~ * Vasectomized partner (a vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the participant, and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used)~ * Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be in relation to the duration of the study and the preferred and usual lifestyle of the participant) \\\\*Non-childbearing potential includes surgically sterilized or postmenopausal with no menstrual bleeding for at least one year prior to study start.~6. Male participants must be sterile or sexually inactive or agree not to father a child during the study and one month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male subject must adopt a highly effective method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as:~ * Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation~ * Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation~ * Intrauterine device (IUD)~ * Intrauterine hormone-releasing system (IUS)~ * Bilateral tubal occlusion~7. Participants can provide written informed consent. If PI deems that participant cannot fully understand ICF to give consent, their legally authorized representative (LARs) can provide written informed consent. Participants can comply with scheduled visits, and other study-related procedures to complete the study with the help of the study partner.~8. No evidence of current suicidal ideation or previous suicide attempt in the past 2 months as evaluated in the Columbia Suicide Severity Rating Scale nor suicidal behavior in the past 6 months as per investigator.~9. Stability of permitted medications for at least 4 weeks prior to screening.~ 1. Cholinesterase inhibitors and/or memantine medication~ 2. Anticonvulsant medications used for epilepsy or mood stabilization, neuropathic pain indications.~ 3. Mood-stabilizing psychotropic agents, including, but not limited to, lithium.~10. Adequate visual and hearing ability (physical ability to perform all the study assessments) as per investigator.~11. Good general health with no disease expected to interfere with the study as per investigator.~Exclusion Criteria:~1. Has a history of a psychiatric disorder such as schizophrenia, bipolar disorder or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM). Mild depression or history of depression that is stable on treatment with a SSRI or SNRI medication at a stable dose is acceptable.~2. Has non-AD dementia, such as vascular dementia, Lewy body dementia, frontotemporal disease, Parkinson disease dementia, B12 and thyroid deficiency caused dementia.~3. History of a seizure disorder, if stable on medication is acceptable.~4. Has a history or current evidence of long QT syndrome, Fridericia\\s formula corrected QT (QTcF) interval ≥ 450 ms for men and 460 ms for women, or torsades de pointes.~5. Has bradycardia (\\\\<50 bpm) or tachycardia (\\\\>100 bpm) on the ECG at screening.~6. Has uncontrolled Type-1 or Type-2 diabetes. A subject with HbA1c levels up to 7.5% can be enrolled if the investigator believes the subject\\s diabetes is under control.~7. Has clinically significant renal (CKD-EPI with normal \\\\<60 mL/min/BSA (body surface area) or hepatic impairment (ALP \\\\> 2.0 ULN and/or total bilirubin \\\\> 2.0 ULN) .~8. Has any clinically significant abnormal laboratory values. Participants with liver function tests (aspartate aminotransferase \\\\[AST\\\\] or alanine aminotransferase \\\\[ALT\\\\]) greater than twice the upper limit of normal will be excluded.~9. Is at imminent risk of self-harm, based on clinical interview and responses on the C SSRS, or of harm to others in the opinion of the Investigators. Participants must be excluded if they report suicidal ideation with intent, with or without a plan or method (e. g. positive response to Items 4 or 5 in assessment of suicidal ideation on the C SSRS) in the past 2 months, or suicidal behavior in the past 6 months.~10. Has cancer or has had a malignant tumor within the past year, except participants who underwent potentially curative therapy with no evidence of recurrence. (Participants with stable untreated prostate cancer or skin cancers are not excluded).~11. Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version DSM.~12. Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater.~ The end of a previous investigational trial is the date the last dose of an investigational agent was taken.~13. Participants with learning disability or developmental delay.~14. Participants whom the site PI deems to be otherwise ineligible.~15. Participants with a known allergy to the investigational drug or any of its components. Here are all the inactive ingredients of the IMP:~ * Silicified Microcrystalline Cellulose~ * Dibasic Calcium Phosphate Dihydrate~ * Mannitol~ * Magnesium Stearate~ * Hypromellosee (capsule shells structure)~ * titanium dioxide (opacifier of the capsule shells)~16. Subject is currently pregnant, breast-feeding and/or lactating.~17. Subject is currently taking strong and moderate CYP3A4 inhibitors and/or inducers. (e.g., CYP3A4 inhibitors Itraconazole, Ketoconazole, Azamulin, Troleandomycin, Verapamil; CYP3A4 inducers Rifampicin)", combined_text: A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD Alzheimer\\s Disease Assessment Scale-Cognitive Subscale 11, Alzheimer\\s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) measures cognitive functions and non-cognitive functions such as mood and behavior. It was designed to measure the cognitive and behavioral domains known to be affected in Alzheimer disease, including memory, language, orientation, construction, and planning of simple designs, and completed simple goal-oriented behaviors.\\n\\nSpecifically, the ADAS-Cog comprises ratings from 11 components: word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering test instructions, spoken language, word finding, and comprehension.\\n\\nTotal scores range from 0-70, with higher scores indicating greater cognitive impairment., Baseline to the end of treatment period (12 weeks)|Alzheimer\\s Disease Cooperative Study-Clinical Global Impression of Change, Alzheimer\\s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) focuses on clinicians\\ observations of change in the patient\\s cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants.\\n\\nThe ADCS-CGIC measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner.\\n\\nA skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). Lower scores indicate better improvement., Baseline and week 12 clinic visits (12 weeks) Alzheimer\\s Disease Cooperative Study-Instrumental Activities of Daily Living Scale, Alzheimer\\s Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-ADL) is a 23-item inventory scale developed as a rater-administered questionnaire answered by the participant\\s study partner.\\n\\nThe ADCS-ADL measures 6 basic activities of daily living (BADL) items and 17 instrumental activities of daily living (IADL) items that provide a total score from 0-78, with a lower score indicating greater severity. Basic activities include basic self-care tasks such as feeding, mobility, toileting, bathing, grooming and dressing. Instrumental activities are more complex and vary based on cultural norms, gender roles. As such, instrumental activities tend to include a broad range of activities.\\n\\nCaregivers are asked to rate the degree to which their family member or loved one can perform a variety of tasks. The assessed activities provide a total score from 0-78. Participants with a lower score indicates greater severity., Baseline to end of treatment period (12 weeks)|Mini Mental State Examination Score, The Mini Mental State Examination (MMSE) Score is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures).\\n\\nTotal score ranges from 0 to 30 with a lower score indicating greater disease severity., Screening (up to 42 days) through end of treatment period (12 weeks) for a total of up to 4.2 months|Digital Symbol Substitution Test, The digital symbol substitution test (DSST) asks individuals to record associations between different symbols and numbers within time limits.\\n\\nThe total score is the sum of all the correctly coded numbers. Higher scores indicate better performance., Baseline through the end of treatment period (12 weeks) "Inclusion Criteria:~1. Diagnosis of Alzheimer\\s disease according to NIA and NIA-AA criteria for probable AD~2. Male or female aged 55 - 85 years.~3. MMSE 14-24.~4. Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week) and will accompany the participant to study visits at designated times.~5. Female participants of childbearing potential\\\\* must have a negative urine pregnancy test at Screening, must be non-lactating and must agree to use a highly effective method of contraception (i.e., a method resulting in a failure rate of less than 1% per year when used consistently and correctly) during the trial and for 4 weeks after the last dose of trial treatment, such as:~ * Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation~ * Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation~ * Intrauterine device (IUD)~ * Intrauterine hormone-releasing system (IUS)~ * Bilateral tubal occlusion~ * Vasectomized partner (a vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the participant, and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used)~ * Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be in relation to the duration of the study and the preferred and usual lifestyle of the participant) \\\\*Non-childbearing potential includes surgically sterilized or postmenopausal with no menstrual bleeding for at least one year prior to study start.~6. Male participants must be sterile or sexually inactive or agree not to father a child during the study and one month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male subject must adopt a highly effective method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as:~ * Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation~ * Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation~ * Intrauterine device (IUD)~ * Intrauterine hormone-releasing system (IUS)~ * Bilateral tubal occlusion~7. Participants can provide written informed consent. If PI deems that participant cannot fully understand ICF to give consent, their legally authorized representative (LARs) can provide written informed consent. Participants can comply with scheduled visits, and other study-related procedures to complete the study with the help of the study partner.~8. No evidence of current suicidal ideation or previous suicide attempt in the past 2 months as evaluated in the Columbia Suicide Severity Rating Scale nor suicidal behavior in the past 6 months as per investigator.~9. Stability of permitted medications for at least 4 weeks prior to screening.~ 1. Cholinesterase inhibitors and/or memantine medication~ 2. Anticonvulsant medications used for epilepsy or mood stabilization, neuropathic pain indications.~ 3. Mood-stabilizing psychotropic agents, including, but not limited to, lithium.~10. Adequate visual and hearing ability (physical ability to perform all the study assessments) as per investigator.~11. Good general health with no disease expected to interfere with the study as per investigator.~Exclusion Criteria:~1. Has a history of a psychiatric disorder such as schizophrenia, bipolar disorder or major depression according to the criteria of the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM). Mild depression or history of depression that is stable on treatment with a SSRI or SNRI medication at a stable dose is acceptable.~2. Has non-AD dementia, such as vascular dementia, Lewy body dementia, frontotemporal disease, Parkinson disease dementia, B12 and thyroid deficiency caused dementia.~3. History of a seizure disorder, if stable on medication is acceptable.~4. Has a history or current evidence of long QT syndrome, Fridericia\\s formula corrected QT (QTcF) interval ≥ 450 ms for men and 460 ms for women, or torsades de pointes.~5. Has bradycardia (\\\\<50 bpm) or tachycardia (\\\\>100 bpm) on the ECG at screening.~6. Has uncontrolled Type-1 or Type-2 diabetes. A subject with HbA1c levels up to 7.5% can be enrolled if the investigator believes the subject\\s diabetes is under control.~7. Has clinically significant renal (CKD-EPI with normal \\\\<60 mL/min/BSA (body surface area) or hepatic impairment (ALP \\\\> 2.0 ULN and/or total bilirubin \\\\> 2.0 ULN) .~8. Has any clinically significant abnormal laboratory values. Participants with liver function tests (aspartate aminotransferase \\\\[AST\\\\] or alanine aminotransferase \\\\[ALT\\\\]) greater than twice the upper limit of normal will be excluded.~9. Is at imminent risk of self-harm, based on clinical interview and responses on the C SSRS, or of harm to others in the opinion of the Investigators. Participants must be excluded if they report suicidal ideation with intent, with or without a plan or method (e. g. positive response to Items 4 or 5 in assessment of suicidal ideation on the C SSRS) in the past 2 months, or suicidal behavior in the past 6 months.~10. Has cancer or has had a malignant tumor within the past year, except participants who underwent potentially curative therapy with no evidence of recurrence. (Participants with stable untreated prostate cancer or skin cancers are not excluded).~11. Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version DSM.~12. Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater.~ The end of a previous investigational trial is the date the last dose of an investigational agent was taken.~13. Participants with learning disability or developmental delay.~14. Participants whom the site PI deems to be otherwise ineligible.~15. Participants with a known allergy to the investigational drug or any of its components. Here are all the inactive ingredients of the IMP:~ * Silicified Microcrystalline Cellulose~ * Dibasic Calcium Phosphate Dihydrate~ * Mannitol~ * Magnesium Stearate~ * Hypromellosee (capsule shells structure)~ * titanium dioxide (opacifier of the capsule shells)~16. Subject is currently pregnant, breast-feeding and/or lactating.~17. Subject is currently taking strong and moderate CYP3A4 inhibitors and/or inducers. (e.g., CYP3A4 inhibitors Itraconazole, Ketoconazole, Azamulin, Troleandomycin, Verapamil; CYP3A4 inducers Rifampicin)", Similarity Score: 0.3640696115015837}'}]
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from_dataset
| 0.36407
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[{'from': 'human', 'value': '{Study Title: "16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimers Disease Patients", Primary Outcome Measures: "Mean Change From Baseline in the Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-cog), The Alzheimers Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimers disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimers disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16", Secondary Outcome Measures: Change From Baseline in the Alzheimer\\s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score, ADCS-ADL is a scale based on caregiver\\s assessment of patient\\s activities of daily life. It is used in clinical studies on dementia \\\\& consists of 23 items and is designed to assess patient\\s basic \\\\& instrumental activities of daily life, such as the abilities necessary for personal care, communicating \\\\& interacting with other people, maintaining a household, conducting hobbies \\\\& interests, \\\\& making judgments \\\\& decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or "yes" or "no" questions with separate sub-questions. Higher score \\\\& more "yes" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient\\s functions. The total score is the sum of the scores of all the items \\\\& sub-questions,\\\\& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Mini-Mental State Examination (MMSE), MMSE was used to determine patient\\s eligibility to participate, is an easy \\\\& practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration \\\\& attention) \\\\& performance (recall, response to written/verbal commands, writing ability \\\\& reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient\\s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: \\\\<24=abnormal; Range: \\\\<21=Increased odds of dementia; \\\\>25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, \\\\<23=abnormal for high school education, \\\\<24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline \\\\& post-baseline values were calculated, Baseline, Week 16|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score, This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency \\\\& severity of the behavior disorders, \\\\& allows rapid assessment using screening questions. 10 questions in behavior domain \\\\& 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Caregiver Burden Inventory (CBI) Score, CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16, criteria: "Key Inclusion Criteria:~* Have a diagnosis of dementia of the Alzheimer\\s type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria~* MMSE score of ≥ 10 and ≤ 26~* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks~* Be in stable medical condition~* Have signed off informed consent form by patients or his/her legal guardian~Key Exclusion Criteria:~* Severe AD~* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition~* Attending other clinical trials or taking other clinical trial drugs~* A score of \\\\> 4 on the Modified Hachinski Ischemic Scale (MHIS);~* Patients who is using any AChEI or memantine"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 564, Unnamed: 0: 694, NCT Number: NCT02327182, Study Title: "Safety Study of MT-4666 in Subjects With Alzheimers Disease", Study URL: https://clinicaltrials.gov/study/NCT02327182, Acronym: , Study Status: TERMINATED, Brief Summary: "The objective of this study is to evaluate the safety and efficacy of 2 fixed dose of MT-4666 administered once daily for 52 weeks with or without receiving a concomitant acetylcholinesterase inhibitors (AChEIs), in patients with mild to moderate Alzheimers Disease (AD).", Study Results: NO, Conditions: "Alzheimers Disease", Interventions: DRUG: MT-4666, Primary Outcome Measures: "Safety of 2 fixed doses of EVP-6124 in subjects with Alzheimers disease. Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, Columbia Suicide Severity Rating Scale (C-SSRS), Up to week 56", Secondary Outcome Measures: Change in Mini Mental State Examination (MMSE), baseline to Week 52|Change in Neuropsychiatric Inventory (NPI) total score, baseline to Week 52, Other Outcome Measures: , Sponsor: Mitsubishi Tanabe Pharma Corporation, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE3, Enrollment: 117.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: P211-05, Start Date: 2014-12, Primary Completion Date: 2015-09, Completion Date: 2015-10, First Posted: 2014-12-30, Results First Posted: , Last Update Posted: 2015-11-13, Locations: Investigational site, Osaka, Kansai, Japan, Study Documents: , criteria: "Inclusion Criteria:~* Probable Alzheimer\\s disease consistent with the National Institute on Aging and the Alzheimer\\s Association Criteria for Diagnosis of Alzheimer\\s Disease (McKhann et al. 2011).~* MMSE score of ≥ 14 and ≤ 24 at the screening and ≥ 12 and ≤ 26 at the baseline.~* Modified Hachinski Ischemic Score (mHIS) ≤ 4 at the screening~* Appropriate caregiver available~* Subject living at home or in facilities who do not require continuous (24-hour) nursing care.~Exclusion Criteria:~* Diagnosis of any other disease which may cause dementia~* Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within last five years~* History of or current diagnosis of any psychosis~* History of myocardial infarction or unstable angina within six months before screening~* History of cerebrovascular disorder within 18 months before screening~* complication of hepatic disorder or renal dysfunction", combined_text: Safety Study of MT-4666 in Subjects With Alzheimer\\s Disease Safety of 2 fixed doses of EVP-6124 in subjects with Alzheimer\\s disease. Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, Columbia Suicide Severity Rating Scale (C-SSRS), Up to week 56 Change in Mini Mental State Examination (MMSE), baseline to Week 52|Change in Neuropsychiatric Inventory (NPI) total score, baseline to Week 52 "Inclusion Criteria:~* Probable Alzheimer\\s disease consistent with the National Institute on Aging and the Alzheimer\\s Association Criteria for Diagnosis of Alzheimer\\s Disease (McKhann et al. 2011).~* MMSE score of ≥ 14 and ≤ 24 at the screening and ≥ 12 and ≤ 26 at the baseline.~* Modified Hachinski Ischemic Score (mHIS) ≤ 4 at the screening~* Appropriate caregiver available~* Subject living at home or in facilities who do not require continuous (24-hour) nursing care.~Exclusion Criteria:~* Diagnosis of any other disease which may cause dementia~* Diagnosis of major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) within last five years~* History of or current diagnosis of any psychosis~* History of myocardial infarction or unstable angina within six months before screening~* History of cerebrovascular disorder within 18 months before screening~* complication of hepatic disorder or renal dysfunction", Similarity Score: 0.33720799399577855}'}]
|
from_dataset
| 0.337208
|
[{'from': 'human', 'value': '{Study Title: "16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimers Disease Patients", Primary Outcome Measures: "Mean Change From Baseline in the Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-cog), The Alzheimers Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimers disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimers disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16", Secondary Outcome Measures: Change From Baseline in the Alzheimer\\s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score, ADCS-ADL is a scale based on caregiver\\s assessment of patient\\s activities of daily life. It is used in clinical studies on dementia \\\\& consists of 23 items and is designed to assess patient\\s basic \\\\& instrumental activities of daily life, such as the abilities necessary for personal care, communicating \\\\& interacting with other people, maintaining a household, conducting hobbies \\\\& interests, \\\\& making judgments \\\\& decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or "yes" or "no" questions with separate sub-questions. Higher score \\\\& more "yes" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient\\s functions. The total score is the sum of the scores of all the items \\\\& sub-questions,\\\\& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Mini-Mental State Examination (MMSE), MMSE was used to determine patient\\s eligibility to participate, is an easy \\\\& practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration \\\\& attention) \\\\& performance (recall, response to written/verbal commands, writing ability \\\\& reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient\\s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: \\\\<24=abnormal; Range: \\\\<21=Increased odds of dementia; \\\\>25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, \\\\<23=abnormal for high school education, \\\\<24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline \\\\& post-baseline values were calculated, Baseline, Week 16|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score, This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency \\\\& severity of the behavior disorders, \\\\& allows rapid assessment using screening questions. 10 questions in behavior domain \\\\& 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Caregiver Burden Inventory (CBI) Score, CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16, criteria: "Key Inclusion Criteria:~* Have a diagnosis of dementia of the Alzheimer\\s type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria~* MMSE score of ≥ 10 and ≤ 26~* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks~* Be in stable medical condition~* Have signed off informed consent form by patients or his/her legal guardian~Key Exclusion Criteria:~* Severe AD~* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition~* Attending other clinical trials or taking other clinical trial drugs~* A score of \\\\> 4 on the Modified Hachinski Ischemic Scale (MHIS);~* Patients who is using any AChEI or memantine"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 1010, Unnamed: 0: 1256, NCT Number: NCT02281773, Study Title: A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment., Study URL: https://clinicaltrials.gov/study/NCT02281773, Acronym: , Study Status: COMPLETED, Brief Summary: The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment., Study Results: YES, Conditions: Schizophrenia, Interventions: DRUG: BI 409306 100 mg QD|DRUG: BI 498306 50 mg QD|DRUG: Placebo|DRUG: BI 498306 25 mg QD|DRUG: BI 409306 10 mg QD, Primary Outcome Measures: Change From Baseline in the Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment, MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as "learn and confirm" model including 2 stages. Stage 1 analysis was conducted to identify the meaningful cognition endpoint(s) (CANTAB domain(s)) and the selected endpoint(s) were to be pre-specified as the primary endpoint(s) for Stage 2 analysis. Since none of the CANTAB outcome measures was selected in the Stage 1 analysis at planned time based on the pre-specified criteria, the MCCB composite score was chosen as the primary endpoint in the Stage 2 analysis, as pre-defined., Baseline and Week 12|Occurrence of Serious Adverse Events (SAEs) (Including the Abnormalities of Physical Examination, Vital Signs, Electrocardiogram (ECG) Test and Laboratory Tests), Occurrence of serious adverse events (SAEs) (including the abnormalities of physical examination, vital signs, electrocardiogram (ECG) test and laboratory tests)., Up to 20 weeks|Occurrence of Protocol-specified Adverse Events of Special Interest (AESI), Occurrence of Protocol-specified adverse events of special interest (AESI)., Up to 20 weeks|Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS), Dramatic worsening of disease state as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented., Baseline, Week 6 and Week 12|Suicidality as Assessed by Columbia Suicidal Severity Rating Scale (C-SSRS), C-SSRS: Number (%) of subjects with an event of Suicidal Ideation (Wish to be dead, Non-specific active suicidal thoughts, Active suicidal ideation with any methods (not plan) without intent to act, Active suicidal ideation with some intent to act without specific plan, Active suicidal ideation with specific plan and intent) or Suicidal Behavior (Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide) or Self-injurious behavior without suicidal intent is presented. C-SSRS used only to evaluate whether the patient developed suicidal ideation or behavior and no composite score will be used. Questions in the 1st section of suicidal ideation and suicidal behavior assessments in C-SSRS are "yes" and "no" type questions. If patient had suicidal ideation or behavior, 2nd section will be performed to evaluate the details with the scale from 0 to 5 or 0 to 2 and the larger number means the more severe condition., Up to 12 weeks, Secondary Outcome Measures: "Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Global Ratings After 12 Weeks of Treatment, Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) global ratings after 12 weeks of treatment. SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functions. Each item was rated on a 4-point scale. Higher ratings reflected a greater degree of impairment. The SCoRS global total scores is the sum of the 20 items and it varies from 20 to 80 with 20 being the best outcome and 80 being the worst. If any individual item was missing, it was imputed with the average of that patients non missing responses. If \\\\>5 items were missing, the total score was missing., Baseline and Week 12|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 12 Weeks of Treatment, Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale score after 12 weeks of treatment. The CGI-S is a one-item evaluation completed by the clinician on the patients severity of psychopathology. The CGI-S was rated ordinally from one to 7. Higher scores indicate more severe symptoms., Baseline and Week 12|Patient Global Impressions-Improvement (PGI-I) Scale Score Measured After 12 Weeks of Treatment, Patient Global Impressions-Improvement (PGI-I) scale score measured after 12 weeks of treatment. The PGI of improvement is a simple evaluation completed by the patient to assess the patients overall evaluation of his/her status. The PGI of improvement was rated ordinally from one to 7. Higher scores indicate more severe symptoms., Up to 12 weeks|Change From Baseline in PANSS Negative Symptom Factor Score After 12 Weeks of Treatment (for Subset of Patients Diagnosed With Negative Symptom), Change from baseline in PANSS negative symptom factor score after 12 weeks of treatment (for subset of patients diagnosed with negative symptom). This outcome measure was not analysed due to low number of patients in the PANSS negative symptom subgroup. The PANSS negative symptom scale has 7 items. Each was rated from one to 7 points. The total factor score was the summation of the 7 points for each item, leading the total score ranging from 7 to 49., Baseline and Week 12|Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS), Change in psychopathology symptoms as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented., Baseline, Week 6 and Week 12", Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE2, Enrollment: 518.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT, Other IDs: 1289.6|2013-005015-28, Start Date: 2014-11-10, Primary Completion Date: 2016-05-26, Completion Date: 2016-06-13, First Posted: 2014-11-04, Results First Posted: 2017-10-19, Last Update Posted: 2017-10-19, Locations: K and S Professional Research Services, LLC, Little Rock, Arkansas, 72201, United States|Comprehensive Clinical Development, Inc., Cerritos, California, 90703, United States|Collaborative Neuroscience Network, Garden Grove, California, 92845, United States|Pacific Institute of Medical Research, Los Angeles, California, 90024, United States|SRSD, Inc. dba Synergy San Diego, National City, California, 91950, United States|NRC Research Institute, Orange, California, 92868, United States|Artemis Institute for Clinical Research, LLC, San Diego, California, 92103, United States|Collaborative Neuroscience Network, Torrance, California, 90502, United States|Comprehensive Clinical Development, Washington, D.C., District of Columbia, 20016, United States|Innovative Clinical Research, Lauderhill, Florida, 33319, United States|Florida Clinical Research Center, Maitland, Florida, 32751, United States|Behavioral Clinical Research, Inc., North Miami, Florida, 33161, United States|Atlanta Center, Atlanta, Georgia, 30331, United States|Northwestern University, Chicago, Illinois, 60611, United States|Uptown Research Institute, Chicago, Illinois, 60640, United States|Lake Charles Clinical Trials LLC, Lake Charles, Louisiana, 70629, United States|Mid-America Clinical Research, LLC, Saint Louis, Missouri, 63109, United States|St. Louis Clinical Trials, Saint Louis, Missouri, 63141, United States|Neurobehavioral Research, Inc., Cedarhurst, New York, 11516, United States|Finger Lakes Research, Rochester, New York, 14618, United States|University of Rochester Medical Center, Rochester, New York, 14623, United States|Richmond Behavioral Associates, Staten Island, New York, 10312, United States|Community Clinical Research, Inc., Austin, Texas, 78754, United States|InSite Clinical Research, DeSoto, Texas, 75115, United States|Dr. Alexander McIntyre Inc., Penticton, British Columbia, V2A 4M4, Canada|Depression, Mood Disorders and Schizophrenia Treatment Centr, Burlington, Ontario, L7R4E2, Canada|LVR-Klinikum Düsseldorf, Düsseldorf, 40629, Germany|Uniklinikum Heidelberg, Heidelberg, 69115, Germany|Universitätsklinikum Köln (AöR), Köln, 50937, Germany|Fujita Health University Hospital, Aichi, Toyoake, 470-1192, Japan|Hokkaido University Hospital, Hokkaido, Sapporo, 060-8648, Japan|Kobe University Hospital, Hyogo, Kobe, 650-0017, Japan|Nara Medical University Hospital, Nara, Kashihara, 634-8522, Japan|Kansai Med. Univ. Med. Ctr., Osaka, Neuropsychiatry, Osaka, Moriguchi-city, 570-8507, Japan|Hizen Psychiatric Center, Saga, PSY, Saga, Kanzaki-gun, 842-0192, Japan|Iwaki Clinic, Tokushima, Psychosomatic Medicine, Tokushima, Anan, 774-0014, Japan|National Center Neurology and Psychiatry, Tokyo, Kodaira, 187-8851, Japan|Showa University Karasuyama Hospital, Tokyo, Setagaya, 157-8577, Japan|Showa University East Hospital, Tokyo, Shinagawa, 142-0054, Japan|Chang-Hua Christian Hospital, Changhua, 500, Taiwan|Kai-Syuan Psychiatric Hospital, Kaohsiung, 802, Taiwan|NCKUH, Tainan, 704, Taiwan|Taipei City Hospital, Taipei, 110, Taiwan, Study Documents: , criteria: "Inclusion criteria:~1. Patients with established diagnoses of schizophrenia (per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)) with the following clinical features:~ a) Clinically stable and are in the residual (non-acute) phase of their illness for at least 8 weeks b) Current antipsychotic and concomitant psychotropic medications must meet the criteria below: b)-1 Maintained on current atypical (second generation) antipsychotic medications (in any approved dosage form) other than Clozapine and on current dose for at least 8 weeks prior to randomisation, and/or b)-2 Maintained on current typical (first generation) antipsychotic medications and on current dose for at least 6 months, optionally combined with anticholinergics if treated with a stable dose for at least 6 months prior to randomisation, and/or b)-3 Maintained on current concomitant psychotropic medications other than anticholinergics, antiepileptics and lithium, and on current dose for at least 8 weeks prior to randomisation. Antiepileptics and lithium are allowed if initiated at least 6 months prior to randomisation.~ b)-4 Anticholinergics, antiepileptics and lithium have been washed out for at least 6 months prior to randomisation if the treatments that patients were using before entering the clinical trial are discontinued.~ c) Have no more than a moderate severity rating on hallucinations and delusions (Positive and Negative Syndrome Scale (PANSS)-positive syndrome Hallucinatory Behavior item score \\\\< =4 and Delusions item score \\\\< = 4) d) Have no more than a moderate severity rating on positive formal thought disorder (PANSS-positive syndrome Conceptual Disorganization item score \\\\< = 4) e) Have a minimal level of extrapyramidal symptoms (Simpson-Angus Scale total score \\\\< 6) and depressive symptoms (PANSS-general psychopathology syndrome Depression item score \\\\< = 4)~2. Male or female patients age 18 to 55 years~3. Patients must exhibit reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures,in the investigator\\s opinion.~4. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and the local legislation. If the patient needs a legal representative, then this legal representative must give written informed consent as well.~5. Patients must have an identified informant who will be consistent throughout the study. The informant must interact with the subject at least 2 times a week.~Note: Informant ratings are needed for SCoRS global ratings at Randomisation Visit (Visit 2) and (early) End of Treatment Visit. In person informant ratings on the study visits are preferred whenever possible. However, if the informant is not available for in person ratings, telephone interview is acceptable. The informant must be available for a telephone interview at Visit 2 and (e)EOT Visit.~Exclusion criteria:~1. Patient treated with more than two antipsychotic medications (including more than two dosage forms)~2. Patient\\s cognitive impairment severity compromises the validity of the cognitive outcome measures, in the clinical judgment of the investigator~3. Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior)~4. Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)~5. In the judgment of the investigator, any clinically significant finding of the medical examination (including BP, PR and ECG) or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient\\s safety while participating in the clinical trial~6. History or diagnosis of symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hematological or hormonal disorders~7. For female patients:~ Pre-menopausal women (last menstruation \\\\< =1 year prior to informed consent) who:~ * are nursing or pregnant or~ * are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the trial until 28 days after the last treatment administration, and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, vasectomized partner, transdermal patch, intra uterine devices/systems (IUDs/IUSs), combined estrogen-progestin oral contraceptives as well as implantable or injectable hormonal contraceptives. Complete sexual abstinence (if acceptable by local health authorities) is allowed when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Double barrier methods are permissible (if acceptable by local health authorities, note that this is not an acceptable method in EU countries).~ For male patients:~ Men who are able to father a child, unwilling to be abstinent or use adequate contraception for the duration of study participation and for at least 28 days after treatment has ended.~8. Known history of HIV infection~9. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or any psychiatric disorders other than schizophrenia)~10. Any subject who on the Mini-international neuropsychiatric Interview (M.I.N.I.) has a categorical diagnosis of another current major psychiatric disorder.~11. History of malignancy within the last 5 years, except for basal cell carcinoma~12. Planned elective surgery requiring general anaesthesia, or hospitalisation for more than 1 day during the study period~13. Significant history of drug dependence or abuse (including alcohol, as defined in DSM-5-substance use disorder or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, PCP, amphetamine, heroin, or marijuana at screening~14. Patient needs to take long-acting hypnotics and anxiolytics (i.e. Diazepam)~15. Patients taking medications that are known to be strong or moderate CYP3A4 inhibitors~16. Participation in another trial with an investigational drug or procedure within 30 days or 6 half-lives (whichever is longer) or participation in another trial with any cognitive-enhancing therapy or procedure within 90 days prior to screening~17. Previous participation in any BI 409306 study~18. Not fluent in the language of the batteries/questionnaires which will be used in the country", combined_text: A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment. Change From Baseline in the Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment, MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as "learn and confirm" model including 2 stages. Stage 1 analysis was conducted to identify the meaningful cognition endpoint(s) (CANTAB domain(s)) and the selected endpoint(s) were to be pre-specified as the primary endpoint(s) for Stage 2 analysis. Since none of the CANTAB outcome measures was selected in the Stage 1 analysis at planned time based on the pre-specified criteria, the MCCB composite score was chosen as the primary endpoint in the Stage 2 analysis, as pre-defined., Baseline and Week 12|Occurrence of Serious Adverse Events (SAEs) (Including the Abnormalities of Physical Examination, Vital Signs, Electrocardiogram (ECG) Test and Laboratory Tests), Occurrence of serious adverse events (SAEs) (including the abnormalities of physical examination, vital signs, electrocardiogram (ECG) test and laboratory tests)., Up to 20 weeks|Occurrence of Protocol-specified Adverse Events of Special Interest (AESI), Occurrence of Protocol-specified adverse events of special interest (AESI)., Up to 20 weeks|Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS), Dramatic worsening of disease state as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented., Baseline, Week 6 and Week 12|Suicidality as Assessed by Columbia Suicidal Severity Rating Scale (C-SSRS), C-SSRS: Number (%) of subjects with an event of Suicidal Ideation (Wish to be dead, Non-specific active suicidal thoughts, Active suicidal ideation with any methods (not plan) without intent to act, Active suicidal ideation with some intent to act without specific plan, Active suicidal ideation with specific plan and intent) or Suicidal Behavior (Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide) or Self-injurious behavior without suicidal intent is presented. C-SSRS used only to evaluate whether the patient developed suicidal ideation or behavior and no composite score will be used. Questions in the 1st section of suicidal ideation and suicidal behavior assessments in C-SSRS are "yes" and "no" type questions. If patient had suicidal ideation or behavior, 2nd section will be performed to evaluate the details with the scale from 0 to 5 or 0 to 2 and the larger number means the more severe condition., Up to 12 weeks Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Global Ratings After 12 Weeks of Treatment, Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) global ratings after 12 weeks of treatment. SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functions. Each item was rated on a 4-point scale. Higher ratings reflected a greater degree of impairment. The SCoRS global total scores is the sum of the 20 items and it varies from 20 to 80 with 20 being the best outcome and 80 being the worst. If any individual item was missing, it was imputed with the average of that patient\\s non missing responses. If \\\\>5 items were missing, the total score was missing., Baseline and Week 12|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 12 Weeks of Treatment, Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale score after 12 weeks of treatment. The CGI-S is a one-item evaluation completed by the clinician on the patient\\s severity of psychopathology. The CGI-S was rated ordinally from one to 7. Higher scores indicate more severe symptoms., Baseline and Week 12|Patient Global Impressions-Improvement (PGI-I) Scale Score Measured After 12 Weeks of Treatment, Patient Global Impressions-Improvement (PGI-I) scale score measured after 12 weeks of treatment. The PGI of improvement is a simple evaluation completed by the patient to assess the patient\\s overall evaluation of his/her status. The PGI of improvement was rated ordinally from one to 7. Higher scores indicate more severe symptoms., Up to 12 weeks|Change From Baseline in PANSS Negative Symptom Factor Score After 12 Weeks of Treatment (for Subset of Patients Diagnosed With Negative Symptom), Change from baseline in PANSS negative symptom factor score after 12 weeks of treatment (for subset of patients diagnosed with negative symptom). This outcome measure was not analysed due to low number of patients in the PANSS negative symptom subgroup. The PANSS negative symptom scale has 7 items. Each was rated from one to 7 points. The total factor score was the summation of the 7 points for each item, leading the total score ranging from 7 to 49., Baseline and Week 12|Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS), Change in psychopathology symptoms as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented., Baseline, Week 6 and Week 12 "Inclusion criteria:~1. Patients with established diagnoses of schizophrenia (per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)) with the following clinical features:~ a) Clinically stable and are in the residual (non-acute) phase of their illness for at least 8 weeks b) Current antipsychotic and concomitant psychotropic medications must meet the criteria below: b)-1 Maintained on current atypical (second generation) antipsychotic medications (in any approved dosage form) other than Clozapine and on current dose for at least 8 weeks prior to randomisation, and/or b)-2 Maintained on current typical (first generation) antipsychotic medications and on current dose for at least 6 months, optionally combined with anticholinergics if treated with a stable dose for at least 6 months prior to randomisation, and/or b)-3 Maintained on current concomitant psychotropic medications other than anticholinergics, antiepileptics and lithium, and on current dose for at least 8 weeks prior to randomisation. Antiepileptics and lithium are allowed if initiated at least 6 months prior to randomisation.~ b)-4 Anticholinergics, antiepileptics and lithium have been washed out for at least 6 months prior to randomisation if the treatments that patients were using before entering the clinical trial are discontinued.~ c) Have no more than a moderate severity rating on hallucinations and delusions (Positive and Negative Syndrome Scale (PANSS)-positive syndrome Hallucinatory Behavior item score \\\\< =4 and Delusions item score \\\\< = 4) d) Have no more than a moderate severity rating on positive formal thought disorder (PANSS-positive syndrome Conceptual Disorganization item score \\\\< = 4) e) Have a minimal level of extrapyramidal symptoms (Simpson-Angus Scale total score \\\\< 6) and depressive symptoms (PANSS-general psychopathology syndrome Depression item score \\\\< = 4)~2. Male or female patients age 18 to 55 years~3. Patients must exhibit reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures,in the investigator\\s opinion.~4. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and the local legislation. If the patient needs a legal representative, then this legal representative must give written informed consent as well.~5. Patients must have an identified informant who will be consistent throughout the study. The informant must interact with the subject at least 2 times a week.~Note: Informant ratings are needed for SCoRS global ratings at Randomisation Visit (Visit 2) and (early) End of Treatment Visit. In person informant ratings on the study visits are preferred whenever possible. However, if the informant is not available for in person ratings, telephone interview is acceptable. The informant must be available for a telephone interview at Visit 2 and (e)EOT Visit.~Exclusion criteria:~1. Patient treated with more than two antipsychotic medications (including more than two dosage forms)~2. Patient\\s cognitive impairment severity compromises the validity of the cognitive outcome measures, in the clinical judgment of the investigator~3. Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior)~4. Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)~5. In the judgment of the investigator, any clinically significant finding of the medical examination (including BP, PR and ECG) or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient\\s safety while participating in the clinical trial~6. History or diagnosis of symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hematological or hormonal disorders~7. For female patients:~ Pre-menopausal women (last menstruation \\\\< =1 year prior to informed consent) who:~ * are nursing or pregnant or~ * are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the trial until 28 days after the last treatment administration, and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, vasectomized partner, transdermal patch, intra uterine devices/systems (IUDs/IUSs), combined estrogen-progestin oral contraceptives as well as implantable or injectable hormonal contraceptives. Complete sexual abstinence (if acceptable by local health authorities) is allowed when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Double barrier methods are permissible (if acceptable by local health authorities, note that this is not an acceptable method in EU countries).~ For male patients:~ Men who are able to father a child, unwilling to be abstinent or use adequate contraception for the duration of study participation and for at least 28 days after treatment has ended.~8. Known history of HIV infection~9. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or any psychiatric disorders other than schizophrenia)~10. Any subject who on the Mini-international neuropsychiatric Interview (M.I.N.I.) has a categorical diagnosis of another current major psychiatric disorder.~11. History of malignancy within the last 5 years, except for basal cell carcinoma~12. Planned elective surgery requiring general anaesthesia, or hospitalisation for more than 1 day during the study period~13. Significant history of drug dependence or abuse (including alcohol, as defined in DSM-5-substance use disorder or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, PCP, amphetamine, heroin, or marijuana at screening~14. Patient needs to take long-acting hypnotics and anxiolytics (i.e. Diazepam)~15. Patients taking medications that are known to be strong or moderate CYP3A4 inhibitors~16. Participation in another trial with an investigational drug or procedure within 30 days or 6 half-lives (whichever is longer) or participation in another trial with any cognitive-enhancing therapy or procedure within 90 days prior to screening~17. Previous participation in any BI 409306 study~18. Not fluent in the language of the batteries/questionnaires which will be used in the country", Similarity Score: 0.3050039483148165}'}]
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[{'from': 'human', 'value': '{Study Title: "16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimers Disease Patients", Primary Outcome Measures: "Mean Change From Baseline in the Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-cog), The Alzheimers Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimers disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimers disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16", Secondary Outcome Measures: Change From Baseline in the Alzheimer\\s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score, ADCS-ADL is a scale based on caregiver\\s assessment of patient\\s activities of daily life. It is used in clinical studies on dementia \\\\& consists of 23 items and is designed to assess patient\\s basic \\\\& instrumental activities of daily life, such as the abilities necessary for personal care, communicating \\\\& interacting with other people, maintaining a household, conducting hobbies \\\\& interests, \\\\& making judgments \\\\& decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or "yes" or "no" questions with separate sub-questions. Higher score \\\\& more "yes" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient\\s functions. The total score is the sum of the scores of all the items \\\\& sub-questions,\\\\& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Mini-Mental State Examination (MMSE), MMSE was used to determine patient\\s eligibility to participate, is an easy \\\\& practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration \\\\& attention) \\\\& performance (recall, response to written/verbal commands, writing ability \\\\& reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient\\s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: \\\\<24=abnormal; Range: \\\\<21=Increased odds of dementia; \\\\>25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, \\\\<23=abnormal for high school education, \\\\<24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline \\\\& post-baseline values were calculated, Baseline, Week 16|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score, This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency \\\\& severity of the behavior disorders, \\\\& allows rapid assessment using screening questions. 10 questions in behavior domain \\\\& 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Caregiver Burden Inventory (CBI) Score, CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16, criteria: "Key Inclusion Criteria:~* Have a diagnosis of dementia of the Alzheimer\\s type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria~* MMSE score of ≥ 10 and ≤ 26~* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks~* Be in stable medical condition~* Have signed off informed consent form by patients or his/her legal guardian~Key Exclusion Criteria:~* Severe AD~* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition~* Attending other clinical trials or taking other clinical trial drugs~* A score of \\\\> 4 on the Modified Hachinski Ischemic Scale (MHIS);~* Patients who is using any AChEI or memantine"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 586, Unnamed: 0: 719, NCT Number: NCT04732182, Study Title: "Telerehabilitation Alzheimers Disease Feasibility (TADF)", Study URL: https://clinicaltrials.gov/study/NCT04732182, Acronym: TADF, Study Status: UNKNOWN, Brief Summary: "This is a pilot RCT with equal arms: experimental arm and (wait list) control arm.\\n\\nAll participants will be in the early stage of Alzheimers disease and on stable medication. They will all continue with this medication for their 6 months participation.\\n\\nExperimental group will add weekly training on the experimental device, 5 days a week for 8 weeks. Training will involve therapeutic games aimed primarily at the memory cognitive domain. All participants will receive weekly calls from clinical coordinator and report on medication and overall health. Caregivers will also be enrolled so they support the trials.", Study Results: NO, Conditions: Alzheimer Disease|Healthy Aging, Interventions: "DEVICE: BrightGo cognitive training|DRUG: Standard of Care medication for early Alzheimers Disease", Primary Outcome Measures: Change in visual attention as measured by Neuropsychological Assessment Battery, Visual attention measured with the dots test of the Neuropsychological Assessment Battery (NAB). This is a delayed recognition span paradigm, in which an array of dots is exposed for a brief period, followed by a blank interference page, followed by a new array with one additional dot. The subject needs to point to the "new" dot. Test administered 3 times, minimum score 0 (none of the new dots found) to maximum 3 (all 3 new dots found). \\\\[Hartman 2006\\\\], at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Controlled Oral Word Change in language and executive function as measured by the Association Test (CFL/PRW) of the Multilingual Aphasia Examination, measure of language and executive function \\\\[Benton \\\\& Hamsher, 1994\\\\], at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Change in Cognitive executive function assessment score, Trail Making Test B (TMT-B), NAB Executive Functioning Module. This is a timed test (seconds) with less time indicative of better executive function \\\\[Raitan 1958\\\\], at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Change in verbal memory as measured by Hopkins Verbal Learning Test, Revised (HVLT-R), Hopkins Verbal Learning Test, Revised (HVLT-R) is a measure of verbal memory. It provides a brief assessment of immediate recall, delayed recall and delayed recognition. Subject is read a series of nouns in several categories, and the asked t repeat these nouns by writing them on a piece of paper. The test is repeated three times, and each time the score is a count of how many nouns were remembered by the subject. The second phase of the test involves delayed recall, which is administered after about 20 minutes from the original test. subject needs to write down all the nouns they remembered and these are counted. There is a maximum of 12 correct responses during delayed recall, so max score is 12 \\\\[Brandt 1991\\\\], at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Change in visuospatial memory as measured by Brief Visuospatial MemoryTest, Revised (BVMT-R), BVMT-R is a measure of visuospatial memory. In three Learning Trials, the subject views a stimulus page showing an geometric figure for 10 seconds, and there are 6 drawings presented. Then the subject is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Raw scores will be used, with higher numbers representing better outcomes \\\\[Benedict et al., 1996\\\\]., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Change in Beck Depression Inventory II (BDI II) score, a measure of depression severity, participants\\ depression measure with higher scores indicating higher severity (worse mood). Score range is 0 to 63, with 0 indicating normal mood (no depression), 1-13 minimal depression, 14-19 mild depression, 20-28 for moderate and 29-63 severe depression.\\\\[Beck 1996\\\\], at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months), Secondary Outcome Measures: "Change in the participants quality of life as measured by the Quality of Life in Alzheimers Disease Patient Version (QoL-AD), Questionnaire measures Quality of life for AD individuals (QoL-AD) \\\\[Longsdon 1996\\\\] The questionnaire has 13 items, each with a 4 possible outcomes (poor 1 point to Excellent 4 points). The score trance is 13 (worst) to 52 points representing the best outcome., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Functional Activities Questionnaire in Older Adults with Dementia, Questionnaire for AD patient independence in daily activities \\\\[Mayo 2016\\\\] The questionnaire has 10 items, each with a 4 possible outcomes (normal 0 points to Dependent 3 points). The score trance is 0 (best outcome) to 30 points representing the worst outcome., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Test of Premorbid Functioning (TOPF), The Advanced Clinical Solutions Test of Premorbid Functioning (TOPF) is a word reading test., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Controlled Oral Word Association Test (CFL/PRW) of the Multilingual Aphasia Examination, Test measures Language and executive function \\\\[Benton \\\\& Hamsher, 1994\\\\] RANGE, at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Categorical verbal fluency (Animal Naming), Test measures Language and executive function \\\\[Tombaugh et al., 1999\\\\] RANGE, at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Quality of Life in Alzheimers Disease (QoL-AD), Family Version, The Quality of Life in Alzheimers Disease (QoL-AD) is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.\\\\[Longsdon 1996\\\\]. Score range is 13 (worst outcome) to 52 (best outcome)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Grasp strength (Jamar dynamometer), Measure of sustained power grasping force. Three readings on a Jamar dynamometer are averaged. Higher values indicate more abbility to grasp forcefully (a better outcome)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Pinch strength (Jamar pinch meter), Measure of sustained pinch force. Three readings on a Jamar pinch meter are averaged. Higher values indicate more abbility to pinch forcefully (a better outcome)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Shoulder strength, Measure of deltoid muscle strength, measured using wrist weights. Higher values indicate more shoulder strength (a better outcome)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Arm range of motion (goniometer), Measure of upper extremity range of motion, measured using a mechanical goniometer. Higher values indicate more arm reach (a better outcome)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Jebsen test of hand function, Timed battery of 7 simulated ADLs. Each task is timed with a stop watch, with faster tack execution being a better outcome. Score range for each task is 1 second (best) to 180 seconds (worst - unable to execute task)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Chedokee test or independence in bimanual activities (CAHAI-9), Test has 9 simulated bimanual activities. Each task is scored in the amount of assistance needed to execute it, with a score range for each task of 1 (worst) to 7 (best). Total score range is 9 (worst) to 63 (best)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|University of Pennsylvania Smell Identification Test (UPSIT), This test is a standardized measure of olfactory identification accuracy, done by scratching odor generating special paper. is also a four choice multiple choice question on each page. The scents are released using a pencil. After each scent is released, the patient smells the level and detects the odor from the four choices. Higher score indicate better olfaction (better outcome). Minimum score is 0, Maximum score is 40, at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Subjective evaluation of BrightGo system and therapy, Subjective evaluation on a 5-point Likert scale of system and perceived benefits by participant and by caregiver. The score range is 1 (worst outcome) to 5 (best outcome), For experimental group test is at 4, and 8 weeks from baseline. For cross-over controlles test is at 12 and 16 weeks from baseline.", Other Outcome Measures: "Cybersickness Susceptibility Questionnaire, Form used at screening post-consent to determine a participants propensity for Determine propensity for simulation sickness \\\\[Freiwald et al 2020\\\\]. The questionnaire asks participants 13 general health and fitness questions (with yes/no answers) and to score 13 symptoms of cybersickness on a five point scale (0-4). Score range is 0 (best outcome - no likelihood of experiencing simulation sickness with the device) to 52 (worst outcome - certainty participant will experience severe simulation sickness)., at enrollment (20 minutes)|Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment, Used at screening post-consent to determine level of cognitive impairment \\\\[Nasreddine et al 2005\\\\] for participants. The form has a score range from 0 (worst) to 30 (best) - no cognitive impairments. The form will confirm a participant is in the score range of 19-25 range for early Alzheimers disease., at enrollment (20 minutes)|Pulse, Hart rate measured with medical meter, Before and after each of experimental session. For 3 months post-baseline for experimental group, or starting at 3 months from baseline for controll group. After cross over control group will take pulse for 3 months.|Blood pressure, Systolic and Diastolic Blood pressure, measured with medical meter, Before and after each of experimental session. For 3 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.|Game score, Score obtained by participant for each game played on the BrightGo system are converted to percent, with 0 percent being the worst outcome and 100 percent being the best outcome., During each experimental session. For 2 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.|Head Movement, Obtained by participant Head Mounted Display during the BrightGo sessions., During each experimental session. For 2 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.|Biosensor measure (eye blink), Eye blink rates measured during game play., During each experimental session. For 2 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.|Game difficulty, For each game played in an experimental session the system stores its difficulty level. This has a range of 1 (lowest difficulty) to 16 (highest difficulty), During each experimental session. For 2 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.|Biosensor measure (skin resistance), During an experimental session we store the skin resistance of the participant measured with a custom galvanic skin response system., During each experimental session. For 2 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.", Sponsor: Bright Cloud International Corp, Collaborators: National Institute on Aging (NIA)|Rutgers, The State University of New Jersey, Sex: ALL, Age: OLDER_ADULT, Phases: , Enrollment: 14.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT, Other IDs: Telerehab AD Feasibility|R43AG065035, Start Date: 2022-02-16, Primary Completion Date: 2022-12-31, Completion Date: 2023-02-28, First Posted: 2021-02-01, Results First Posted: , Last Update Posted: 2022-05-02, Locations: "Rutgers, The State University of New Jersey, New Brunswick, New Jersey, 08901-2066, United States|Bright Cloud Intl Corp, North Brunswick, New Jersey, 08902, United States", Study Documents: , criteria: "Inclusion Criteria:~* Age 65 to 85;~* Diagnosis of early Alzheimer\\s (Montreal Cognitive Assessment \\\\[MoCA\\\\] score of 19-25) \\\\[Nasreddine et al 2005\\\\].~* English speakers;~* Ability to actively move UE and to flex/extend fingers;~* Stable on Aricept 10 mg daily intake or Exelon 9.5 mg patch medication~* Able to consent;~* Living in the community in Central Jersey so to facilitate researchers travel to home for system installation and/or repairs,~* Living with a caregiver willing to support trials and be present during sessions;~* Good upper extremity motor function, close to full range of movement of arms and fingers.~Exclusion Criteria:~* Those younger than 65;~* Participating in other research studies;~* Severe visual impairments or legally blind;~* Severe hearing loss or deafness;~* Uncontrolled hypertension (\\\\>190/100 mmHg);~* Severe cognitive delay (MoCA \\\\<19);~* non-English speakers;~* Those unable to provide consent;~* Unable to move arms and fingers, or with severe arthritis;~* Severe propensity to simulation sickness;~* Those who are not cooperative with the evaluations pre-study ;~* Those who cannot produce reliable scores on the neuropsychological pre-study assessment because they do not comprehend the test, or have severe speech impairment;~* Those not living with a caregiver willing to support trials, and caregiver unwilling or unable to be present during sessions;~* Those that are unwilling allow home inspections to ascertain internet conditions in the home, to determine best placement for the experimental system, to install and remove system, and to provide repairs if needed.", combined_text: Telerehabilitation Alzheimer\\s Disease Feasibility (TADF) Change in visual attention as measured by Neuropsychological Assessment Battery, Visual attention measured with the dots test of the Neuropsychological Assessment Battery (NAB). This is a delayed recognition span paradigm, in which an array of dots is exposed for a brief period, followed by a blank interference page, followed by a new array with one additional dot. The subject needs to point to the "new" dot. Test administered 3 times, minimum score 0 (none of the new dots found) to maximum 3 (all 3 new dots found). \\\\[Hartman 2006\\\\], at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Controlled Oral Word Change in language and executive function as measured by the Association Test (CFL/PRW) of the Multilingual Aphasia Examination, measure of language and executive function \\\\[Benton \\\\& Hamsher, 1994\\\\], at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Change in Cognitive executive function assessment score, Trail Making Test B (TMT-B), NAB Executive Functioning Module. This is a timed test (seconds) with less time indicative of better executive function \\\\[Raitan 1958\\\\], at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Change in verbal memory as measured by Hopkins Verbal Learning Test, Revised (HVLT-R), Hopkins Verbal Learning Test, Revised (HVLT-R) is a measure of verbal memory. It provides a brief assessment of immediate recall, delayed recall and delayed recognition. Subject is read a series of nouns in several categories, and the asked t repeat these nouns by writing them on a piece of paper. The test is repeated three times, and each time the score is a count of how many nouns were remembered by the subject. The second phase of the test involves delayed recall, which is administered after about 20 minutes from the original test. subject needs to write down all the nouns they remembered and these are counted. There is a maximum of 12 correct responses during delayed recall, so max score is 12 \\\\[Brandt 1991\\\\], at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Change in visuospatial memory as measured by Brief Visuospatial MemoryTest, Revised (BVMT-R), BVMT-R is a measure of visuospatial memory. In three Learning Trials, the subject views a stimulus page showing an geometric figure for 10 seconds, and there are 6 drawings presented. Then the subject is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Raw scores will be used, with higher numbers representing better outcomes \\\\[Benedict et al., 1996\\\\]., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Change in Beck Depression Inventory II (BDI II) score, a measure of depression severity, participants\\ depression measure with higher scores indicating higher severity (worse mood). Score range is 0 to 63, with 0 indicating normal mood (no depression), 1-13 minimal depression, 14-19 mild depression, 20-28 for moderate and 29-63 severe depression.\\\\[Beck 1996\\\\], at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months) Change in the participant\\s quality of life as measured by the Quality of Life in Alzheimer\\s Disease Patient Version (QoL-AD), Questionnaire measures Quality of life for AD individuals (QoL-AD) \\\\[Longsdon 1996\\\\] The questionnaire has 13 items, each with a 4 possible outcomes (poor 1 point to Excellent 4 points). The score trance is 13 (worst) to 52 points representing the best outcome., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Functional Activities Questionnaire in Older Adults with Dementia, Questionnaire for AD patient independence in daily activities \\\\[Mayo 2016\\\\] The questionnaire has 10 items, each with a 4 possible outcomes (normal 0 points to Dependent 3 points). The score trance is 0 (best outcome) to 30 points representing the worst outcome., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Test of Premorbid Functioning (TOPF), The Advanced Clinical Solutions Test of Premorbid Functioning (TOPF) is a word reading test., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Controlled Oral Word Association Test (CFL/PRW) of the Multilingual Aphasia Examination, Test measures Language and executive function \\\\[Benton \\\\& Hamsher, 1994\\\\] RANGE, at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Categorical verbal fluency (Animal Naming), Test measures Language and executive function \\\\[Tombaugh et al., 1999\\\\] RANGE, at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Quality of Life in Alzheimers Disease (QoL-AD), Family Version, The Quality of Life in Alzheimers Disease (QoL-AD) is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.\\\\[Longsdon 1996\\\\]. Score range is 13 (worst outcome) to 52 (best outcome)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Grasp strength (Jamar dynamometer), Measure of sustained power grasping force. Three readings on a Jamar dynamometer are averaged. Higher values indicate more abbility to grasp forcefully (a better outcome)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Pinch strength (Jamar pinch meter), Measure of sustained pinch force. Three readings on a Jamar pinch meter are averaged. Higher values indicate more abbility to pinch forcefully (a better outcome)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Shoulder strength, Measure of deltoid muscle strength, measured using wrist weights. Higher values indicate more shoulder strength (a better outcome)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Arm range of motion (goniometer), Measure of upper extremity range of motion, measured using a mechanical goniometer. Higher values indicate more arm reach (a better outcome)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Jebsen test of hand function, Timed battery of 7 simulated ADLs. Each task is timed with a stop watch, with faster tack execution being a better outcome. Score range for each task is 1 second (best) to 180 seconds (worst - unable to execute task)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Chedokee test or independence in bimanual activities (CAHAI-9), Test has 9 simulated bimanual activities. Each task is scored in the amount of assistance needed to execute it, with a score range for each task of 1 (worst) to 7 (best). Total score range is 9 (worst) to 63 (best)., at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|University of Pennsylvania Smell Identification Test (UPSIT), This test is a standardized measure of olfactory identification accuracy, done by scratching odor generating special paper. is also a four choice multiple choice question on each page. The scents are released using a pencil. After each scent is released, the patient smells the level and detects the odor from the four choices. Higher score indicate better olfaction (better outcome). Minimum score is 0, Maximum score is 40, at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)|Subjective evaluation of BrightGo system and therapy, Subjective evaluation on a 5-point Likert scale of system and perceived benefits by participant and by caregiver. The score range is 1 (worst outcome) to 5 (best outcome), For experimental group test is at 4, and 8 weeks from baseline. For cross-over controlles test is at 12 and 16 weeks from baseline. "Inclusion Criteria:~* Age 65 to 85;~* Diagnosis of early Alzheimer\\s (Montreal Cognitive Assessment \\\\[MoCA\\\\] score of 19-25) \\\\[Nasreddine et al 2005\\\\].~* English speakers;~* Ability to actively move UE and to flex/extend fingers;~* Stable on Aricept 10 mg daily intake or Exelon 9.5 mg patch medication~* Able to consent;~* Living in the community in Central Jersey so to facilitate researchers travel to home for system installation and/or repairs,~* Living with a caregiver willing to support trials and be present during sessions;~* Good upper extremity motor function, close to full range of movement of arms and fingers.~Exclusion Criteria:~* Those younger than 65;~* Participating in other research studies;~* Severe visual impairments or legally blind;~* Severe hearing loss or deafness;~* Uncontrolled hypertension (\\\\>190/100 mmHg);~* Severe cognitive delay (MoCA \\\\<19);~* non-English speakers;~* Those unable to provide consent;~* Unable to move arms and fingers, or with severe arthritis;~* Severe propensity to simulation sickness;~* Those who are not cooperative with the evaluations pre-study ;~* Those who cannot produce reliable scores on the neuropsychological pre-study assessment because they do not comprehend the test, or have severe speech impairment;~* Those not living with a caregiver willing to support trials, and caregiver unwilling or unable to be present during sessions;~* Those that are unwilling allow home inspections to ascertain internet conditions in the home, to determine best placement for the experimental system, to install and remove system, and to provide repairs if needed.", Similarity Score: 0.30240409866197204}'}]
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[{'from': 'human', 'value': '{Study Title: "16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimers Disease Patients", Primary Outcome Measures: "Mean Change From Baseline in the Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-cog), The Alzheimers Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimers disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimers disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16", Secondary Outcome Measures: Change From Baseline in the Alzheimer\\s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score, ADCS-ADL is a scale based on caregiver\\s assessment of patient\\s activities of daily life. It is used in clinical studies on dementia \\\\& consists of 23 items and is designed to assess patient\\s basic \\\\& instrumental activities of daily life, such as the abilities necessary for personal care, communicating \\\\& interacting with other people, maintaining a household, conducting hobbies \\\\& interests, \\\\& making judgments \\\\& decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or "yes" or "no" questions with separate sub-questions. Higher score \\\\& more "yes" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient\\s functions. The total score is the sum of the scores of all the items \\\\& sub-questions,\\\\& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Mini-Mental State Examination (MMSE), MMSE was used to determine patient\\s eligibility to participate, is an easy \\\\& practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration \\\\& attention) \\\\& performance (recall, response to written/verbal commands, writing ability \\\\& reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient\\s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: \\\\<24=abnormal; Range: \\\\<21=Increased odds of dementia; \\\\>25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, \\\\<23=abnormal for high school education, \\\\<24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline \\\\& post-baseline values were calculated, Baseline, Week 16|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score, This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency \\\\& severity of the behavior disorders, \\\\& allows rapid assessment using screening questions. 10 questions in behavior domain \\\\& 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Caregiver Burden Inventory (CBI) Score, CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16, criteria: "Key Inclusion Criteria:~* Have a diagnosis of dementia of the Alzheimer\\s type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria~* MMSE score of ≥ 10 and ≤ 26~* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks~* Be in stable medical condition~* Have signed off informed consent form by patients or his/her legal guardian~Key Exclusion Criteria:~* Severe AD~* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition~* Attending other clinical trials or taking other clinical trial drugs~* A score of \\\\> 4 on the Modified Hachinski Ischemic Scale (MHIS);~* Patients who is using any AChEI or memantine"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 104, Unnamed: 0: 120, NCT Number: NCT00357994, Study Title: "Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinsons Subjects", Study URL: https://clinicaltrials.gov/study/NCT00357994, Acronym: , Study Status: COMPLETED, Brief Summary: The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks., Study Results: YES, Conditions: "Advanced Parkinsons Disease", Interventions: DRUG: Levodopa carbidopa intestinal gel (LCIG)|DRUG: Placebo gel|DRUG: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets|DRUG: Placebo (PBO) oral capsules|DEVICE: CADD-Legacy® 1400 ambulatory infusion pump|DEVICE: PEG tube|DEVICE: J-tube, Primary Outcome Measures: Change From Baseline to Week 12 in Average Daily Normalized "Off" Time, Based on the Parkinson\\s Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement., Baseline, Week 12, Secondary Outcome Measures: Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12, Based on the Parkinson\\s Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. "On" time without troublesome dyskinesia (involuntary muscle movement) is defined as "on" time without dyskinesia and "on" time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for "on" time without troublesome dyskinesia indicates improvement., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Summary Index at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms., Baseline, Week 12|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12, The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse., Baseline, Week 12|Change From Baseline in Unified Parkinson\\s Disease Rating Scale (UPDRS) Part II Score at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability., Baseline, Week 12|Change From Baseline in UPDRS Part III Score at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability., Baseline, Week 12|Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12, The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement., Baseline, Week 12|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12, The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver\\s health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver., Baseline, Week 12|Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Week 12, Based on the Parkinson\\s Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Unified Parkinson\\s Disease Rating Scale (UPDRS) Part I Score at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability., Baseline, Week 12|Change From Baseline in Unified Parkinson\\s Disease Rating Scale (UPDRS) Part IV Score at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability., Baseline, Week 12|Change From Baseline in Unified Parkinson\\s Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. Questions 32, 33, and 34 on UPDRS Part IV were totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability., Baseline, Week 12|Change From Baseline in Unified Parkinson\\s Disease Rating Scale (UPDRS) Total Score at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability., Baseline, Week 12|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12, The EQ-5D VAS records the participant\\s self-rated health on a scale from 0-100 where 100 is the \\best imaginable health state\\ and 0 is the \\worst imaginable health state.\\, Baseline, Week 12|Employment Impairment (EMP) I Status at Baseline, The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?)., Baseline|Employment Impairment (EMP) II Status at Week 12, The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument., Week 12 (or early termination), Other Outcome Measures: , Sponsor: AbbVie (prior sponsor, Abbott), Collaborators: Quintiles, Inc., Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE3, Enrollment: 36.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT, Other IDs: S187.3.001|2006-000577-29, Start Date: 2009-01, Primary Completion Date: 2011-10, Completion Date: 2011-10, First Posted: 2006-07-28, Results First Posted: 2015-01-16, Last Update Posted: 2015-01-16, Locations: Site Reference ID/Investigator# 45719, Los Angeles, California, 90033, United States|Site Reference ID/Investigator# 45718, Englewood, Colorado, 80113, United States|Site Reference ID/Investigator# 45722, Washington, District of Columbia, 20007, United States|Site Reference ID/Investigator# 45721, Bradenton, Florida, 34205, United States|Site Reference ID/Investigator# 45705, Gainesville, Florida, 32610, United States|Site Reference ID/Investigator# 45740, Baltimore, Maryland, 21201, United States|Site Reference ID/Investigator# 45739, St. Louis, Missouri, 63110, United States|Site Reference ID/Investigator# 45703, Burlington, Vermont, 05401, United States|Site Reference ID/Investigator# 44970, Bochum, 44791, Germany|Site Reference ID/Investigator# 44971, Bremerhaven, 27574, Germany|Site Reference ID/Investigator# 44973, Dresden, 01307, Germany|Site Reference ID/Investigator# 44965, Hanover, 30625, Germany|Site Reference ID/Investigator# 44964, Kiel, 24105, Germany|Site Reference ID/Investigator# 44966, Marburg, 35033, Germany|Site Reference ID/Investigator# 44968, Tuebingen, 72076, Germany, Study Documents: , criteria: "Inclusion Criteria:~* Idiopathic Parkinson\\s disease (PD) according to United Kingdom Parkinson\\s Disease Society (UKPDS) Brain Bank Criteria~* Levodopa-responsive participants who demonstrate some identifiable \\on response,\\ established by Investigator observation~* Demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated~Exclusion Criteria:~* Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism~* Undergone surgery for the treatment of PD~* Contraindications to levodopa~* Subjects with any neurological deficit that may interfere with the study assessments", combined_text: Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson\\s Subjects Change From Baseline to Week 12 in Average Daily Normalized "Off" Time, Based on the Parkinson\\s Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement., Baseline, Week 12 Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12, Based on the Parkinson\\s Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. "On" time without troublesome dyskinesia (involuntary muscle movement) is defined as "on" time without dyskinesia and "on" time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for "on" time without troublesome dyskinesia indicates improvement., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Summary Index at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms., Baseline, Week 12|Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12, The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse., Baseline, Week 12|Change From Baseline in Unified Parkinson\\s Disease Rating Scale (UPDRS) Part II Score at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability., Baseline, Week 12|Change From Baseline in UPDRS Part III Score at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability., Baseline, Week 12|Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12, The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement., Baseline, Week 12|Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12, The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver\\s health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=Never, 1=Rarely, 2=Sometimes, 3=Quite frequently, and 4= Nearly always). The caregiver burden is evaluated by the total score (Range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver., Baseline, Week 12|Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Week 12, Based on the Parkinson\\s Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Parkinson\\s Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12, The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson\\s disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness., Baseline, Week 12|Change From Baseline in Unified Parkinson\\s Disease Rating Scale (UPDRS) Part I Score at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability., Baseline, Week 12|Change From Baseline in Unified Parkinson\\s Disease Rating Scale (UPDRS) Part IV Score at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability., Baseline, Week 12|Change From Baseline in Unified Parkinson\\s Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. Questions 32, 33, and 34 on UPDRS Part IV were totaled to evaluate dyskinesias. Each of these questions is measured on a 5-point scale (0-4). The Part IV dyskinesia score will range from 0-12 and higher scores are associated with more disability., Baseline, Week 12|Change From Baseline in Unified Parkinson\\s Disease Rating Scale (UPDRS) Total Score at Week 12, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson\\s disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 no disability., Baseline, Week 12|Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12, The EQ-5D VAS records the participant\\s self-rated health on a scale from 0-100 where 100 is the \\best imaginable health state\\ and 0 is the \\worst imaginable health state.\\, Baseline, Week 12|Employment Impairment (EMP) I Status at Baseline, The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?)., Baseline|Employment Impairment (EMP) II Status at Week 12, The EMP instruments are designed to collect information regarding employment and ability to run a household. EMP I questions include: Are you currently in paid employment? (If yes, at which percentage have you been working during the last 4 weeks?); Have you got someone to run your household for you? (If yes, how much time per week does he/she spend in your household?); Are you retired? (If yes, for which reason?) The retirement question (from EMP I) is excluded from the EMP II instrument., Week 12 (or early termination) "Inclusion Criteria:~* Idiopathic Parkinson\\s disease (PD) according to United Kingdom Parkinson\\s Disease Society (UKPDS) Brain Bank Criteria~* Levodopa-responsive participants who demonstrate some identifiable \\on response,\\ established by Investigator observation~* Demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated~Exclusion Criteria:~* Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism~* Undergone surgery for the treatment of PD~* Contraindications to levodopa~* Subjects with any neurological deficit that may interfere with the study assessments", Similarity Score: 0.29076435896541264}'}]
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| 0.290764
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[{'from': 'human', 'value': '{Study Title: "16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimers Disease Patients", Primary Outcome Measures: "Mean Change From Baseline in the Alzheimers Disease Assessment Scale - Cognitive Subscale (ADAS-cog), The Alzheimers Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimers disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimers disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16", Secondary Outcome Measures: Change From Baseline in the Alzheimer\\s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score, ADCS-ADL is a scale based on caregiver\\s assessment of patient\\s activities of daily life. It is used in clinical studies on dementia \\\\& consists of 23 items and is designed to assess patient\\s basic \\\\& instrumental activities of daily life, such as the abilities necessary for personal care, communicating \\\\& interacting with other people, maintaining a household, conducting hobbies \\\\& interests, \\\\& making judgments \\\\& decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or "yes" or "no" questions with separate sub-questions. Higher score \\\\& more "yes" answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient\\s functions. The total score is the sum of the scores of all the items \\\\& sub-questions,\\\\& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Mini-Mental State Examination (MMSE), MMSE was used to determine patient\\s eligibility to participate, is an easy \\\\& practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration \\\\& attention) \\\\& performance (recall, response to written/verbal commands, writing ability \\\\& reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient\\s MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: \\\\<24=abnormal; Range: \\\\<21=Increased odds of dementia; \\\\>25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, \\\\<23=abnormal for high school education, \\\\<24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline \\\\& post-baseline values were calculated, Baseline, Week 16|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score, This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency \\\\& severity of the behavior disorders, \\\\& allows rapid assessment using screening questions. 10 questions in behavior domain \\\\& 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16|Change From Baseline in Caregiver Burden Inventory (CBI) Score, CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated., Baseline, Week 16, criteria: "Key Inclusion Criteria:~* Have a diagnosis of dementia of the Alzheimer\\s type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria~* MMSE score of ≥ 10 and ≤ 26~* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks~* Be in stable medical condition~* Have signed off informed consent form by patients or his/her legal guardian~Key Exclusion Criteria:~* Severe AD~* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition~* Attending other clinical trials or taking other clinical trial drugs~* A score of \\\\> 4 on the Modified Hachinski Ischemic Scale (MHIS);~* Patients who is using any AChEI or memantine"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 750, Unnamed: 0: 940, NCT Number: NCT00378092, Study Title: A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode, Study URL: https://clinicaltrials.gov/study/NCT00378092, Acronym: , Study Status: COMPLETED, Brief Summary: The purpose of this study is to evaluate the outcome of medication discontinuation, the safety and effectiveness of re-initiating risperidone long acting injection (RLAI) in case of relapse (the return of a medical problem) of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) during the study observation period of 36 months., Study Results: NO, Conditions: Schizophrenia, Interventions: DRUG: Oral risperidone|DRUG: Risperidone Long-Acting Injection (RLAI)|DRUG: Risperidone Long-Acting Injection (RLAI), Primary Outcome Measures: "Time to Relapse After Discontinuation of Risperidone Long-Acting Injection (RLAI) in First-Episode Participants Successfully Treated for 24 Months With RLAI in Previous Study (RIS-PSY-301) (Period 1), Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in Positive and Negative Syndrome Scale (PANSS) total score ranging from 30 (absent) to 210 (extreme ill); Clinical Global Impression (CGI-C) score of 6 (much worse); deliberate self-injury (as per adverse event \\\\[AE\\\\] reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting)., Month 36 or early withdrawal (EW)|Percentage of Participants who Relapsed After Discontinuation of RLAI (Period 1), Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in PANSS total score ranging from 30 (absent) to 210 (extreme ill); CGI-C score of 6 (much worse); deliberate self-injury (as per AE reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting)., Month 36 or EW|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After Re-Initiation of RLAI, at Month 24 or EW (Period 2), The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening., Baseline and Month 24 or EW|Time to Treatment Response After Re-Initiation of RLAI (Period 2), Time to treatment response after re-initiation of RLAI will be the time that elapse between Baseline assessment of PANSS for Period 2 and fulfilment of the response which is defined as greater than or equal to 20 percent improvement in PANSS total score. PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening., Month 24 or EW", Secondary Outcome Measures: "Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 36 or EW (Period 1), The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology (GP) subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening., Baseline and Month 36 or EW|Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 24 or EW (Period 2), The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology (GP) subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening., Baseline and Month 24 or EW|Change From Baseline in Marder PANSS Subscales Score at Month 36 or EW (Period 1), The PANSS total score consists of the sum of all 30 PANSS items and score ranges from 30 to 210. Higher scores indicate worsening. The symptoms are rated on a 7-point Marder scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 856; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility (UH) or excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28., Baseline and Month 36 or EW|Change From Baseline in Marder PANSS Subscales Score at Month 24 or EW (Period 2), The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point Marder scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, UH or excitement subscale and anxiety or depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity., Baseline and Month 24 or EW|Number of Participants With Disease Remission Based on PANSS (Period 1), A participants will be in remission when he/she is symptomatically stable and show progressive improvement in total recovery according to severity (mild or less simultaneously on 8 PANSS items:P1 delusions, P2 conceptual disorganization, P3 hallucinatory behavior, G9 unusual thought content, G5 mannerisms and posturing, N1 blunted affect, N4 social withdrawal, N6 lack of spontaneity or flow of conversation) and time (scores for 8 PANSS items above should not exceed the severity criterion mild at any time point of assessment for at least 6 months to meet the criteria of remission) criteria., Month 36 or EW|Number of Participants With Disease Remission Based on PANSS (Period 2), A participants will be in remission when he/she is symptomatically stable and show progressive improvement in total recovery according to severity (mild or less simultaneously on 8 PANSS items:P1 delusions, P2 conceptual disorganization, P3 hallucinatory behavior, G9 unusual thought content, G5 mannerisms and posturing, N1 blunted affect, N4 social withdrawal, N6 lack of spontaneity or flow of conversation) and time (scores for 8 PANSS items above should not exceed the severity criterion mild at any time point of assessment for at least 6 months to meet the criteria of remission) criteria., Month 24 or EW|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 36 or EW (Period 1), The CGI-S scale is a 7-point global assessment that measures the Clinicians impression of the severity of illness exhibited by a participant. A rating of 1=Normal, not at all ill and a rating of 7=Among the most extremely ill participants. Higher scores indicate worsening., Baseline and Month 36 or EW|Clinical Global Impression of Change (CGI-C) Score at Month 36 or EW (Period 1), The CGI-C scale is designed to assess the change in the clinical condition over time. The CGI-C consists of a 7-point rating of change, questioning if the clinical condition of the participant improved, remained unchanged, or worsened., Month 36 or EW|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 24 or EW (Period 2), The CGI-S scale is a 7-point global assessment that measures the Clinicians impression of the severity of illness exhibited by a participant. A rating of 1=Normal, not at all ill and a rating of 7=Among the most extremely ill participants. Higher scores indicate worsening., Baseline and Month 24 or EW|Clinical Global Impression of Change (CGI-C) Score in Period 2 at Month 24 or EW (Period 2), The CGI-C scale is designed to assess the change in the clinical condition over time. The CGI-C consists of a 7-point rating of change, questioning if the clinical condition of the participant improved, remained unchanged, or worsened., Month 24 or EW|Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 36 or EW (Period 1), The CDSS assesses the level of depression in participants with schizophrenia. It consists of 9 items: depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression, each scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score indicates more severe pathology., Baseline and Month 36 or EW|Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 24 or EW (Period 2), The CDSS assesses the level of depression in participants with schizophrenia. It consists of 9 items: depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression, each scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score indicates more severe pathology., Baseline and Month 24 or EW|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 36 or EW (Period 1), The SOFAS is a 100- point single item scale that assesses level of social and occupational functioning of a participant and is not directly influenced by the overall severity of the individuals psychological symptoms.The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information., Baseline and Month 36 or EW|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 24 or EW (Period 2), The SOFAS is a 100-point single item scale that assesses level of social and occupational functioning of a participant and is not directly influenced by the overall severity of the individuals psychological symptoms.The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information., Baseline and Month 24 or EW|Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 36 or EW (Period 1), The PGI-S is an 11-point (0=very well to 10=very poor) scale that requires the participants to rate the severity of their illness at the time of assessment, relative to the participants past experience. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse., Baseline and Month 36 or EW|Patient Global Impression-Change (PGI-C) Score at Month 36 or EW (Period 1), The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse ., Month 36 or EW|Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 24 or EW (Period 2), The PGI-S is an 11-point (0=very well to 10=very poor) scale that requires the participants to rate the severity of their illness at the time of assessment, relative to the participants past experience. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse., Baseline and Month 24 or EW|Patient Global Impression-Change (PGI-C) Score at Month 24 or EW (Period 2), The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse ., Month 24 or EW|Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 36 or EW (Period 1), The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in 2 six-item subscales: physical component summary (PCS) and MCS (mental component summary). The SF-12 score ranges from 10=maximum impairment to 70=no impairment., Baseline and Month 36 or EW|Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 24 or EW (Period 2), The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in 2 six-item subscales: physical component summary (PCS) and MCS (mental component summary). The SF-12 scores range from 10=maximum impairment to 70=no impairment., Baseline and Month 24 or EW", Other Outcome Measures: , Sponsor: Janssen Cilag N.V./S.A., Collaborators: , Sex: ALL, Age: CHILD, ADULT, Phases: PHASE4, Enrollment: 33.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: CR011992|RISSCH3024, Start Date: 2006-04, Primary Completion Date: 2010-03, Completion Date: 2010-03, First Posted: 2006-09-19, Results First Posted: , Last Update Posted: 2014-05-08, Locations: Bellville, South Africa, Study Documents: , criteria: Inclusion Criteria: - Participants who completed 24 months RIS-PSY-301 study - Surgically sterile female participants or practicing an effective method of birth control before entry and throughout the study; and must have shown a negative urine serum pregnancy test at baseline before study entry - Participants who have signed informed consent document Exclusion Criteria: - Participants requiring treatment with mood stabilizers or antidepressants at study entry - Participants with evidence of alcohol or drug abuse or dependence (except for nicotine and caffeine dependence) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosed in the last month before entry - Participants with a history of severe drug allergy, drug hypersensitivity, or neuroleptic malignant (cancerous) syndrome - Participants with known hypersensitivity to risperidone - Participants with acute risk of suicide at study entry or a history of suicidal attempt(s), combined_text: "A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode Time to Relapse After Discontinuation of Risperidone Long-Acting Injection (RLAI) in First-Episode Participants Successfully Treated for 24 Months With RLAI in Previous Study (RIS-PSY-301) (Period 1), Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in Positive and Negative Syndrome Scale (PANSS) total score ranging from 30 (absent) to 210 (extreme ill); Clinical Global Impression (CGI-C) score of 6 (much worse); deliberate self-injury (as per adverse event \\\\[AE\\\\] reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting)., Month 36 or early withdrawal (EW)|Percentage of Participants who Relapsed After Discontinuation of RLAI (Period 1), Relapse will be diagnosed if 1 or more of the following occurs: a 25 percent increase in PANSS total score ranging from 30 (absent) to 210 (extreme ill); CGI-C score of 6 (much worse); deliberate self-injury (as per AE reporting); emergence of clinically significant suicidal or homicidal ideation (as per AE reporting); or violent behavior resulting in significant injury to another person or significant property damage (as per AE reporting)., Month 36 or EW|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After Re-Initiation of RLAI, at Month 24 or EW (Period 2), The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening., Baseline and Month 24 or EW|Time to Treatment Response After Re-Initiation of RLAI (Period 2), Time to treatment response after re-initiation of RLAI will be the time that elapse between Baseline assessment of PANSS for Period 2 and fulfilment of the response which is defined as greater than or equal to 20 percent improvement in PANSS total score. PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening., Month 24 or EW Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 36 or EW (Period 1), The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology (GP) subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening., Baseline and Month 36 or EW|Change From Baseline in PANSS Total Score and Subscales of PANSS at Month 24 or EW (Period 2), The PANSS is a medical scale that assesses various symptoms of schizophrenia and provides a total score (sum of the scores of all 30 items) and scores for 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology (GP) subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening., Baseline and Month 24 or EW|Change From Baseline in Marder PANSS Subscales Score at Month 36 or EW (Period 1), The PANSS total score consists of the sum of all 30 PANSS items and score ranges from 30 to 210. Higher scores indicate worsening. The symptoms are rated on a 7-point Marder scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 856; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility (UH) or excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28., Baseline and Month 36 or EW|Change From Baseline in Marder PANSS Subscales Score at Month 24 or EW (Period 2), The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point Marder scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, UH or excitement subscale and anxiety or depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity., Baseline and Month 24 or EW|Number of Participants With Disease Remission Based on PANSS (Period 1), A participants will be in remission when he/she is symptomatically stable and show progressive improvement in total recovery according to severity (mild or less simultaneously on 8 PANSS items:P1 delusions, P2 conceptual disorganization, P3 hallucinatory behavior, G9 unusual thought content, G5 mannerisms and posturing, N1 blunted affect, N4 social withdrawal, N6 lack of spontaneity or flow of conversation) and time (scores for 8 PANSS items above should not exceed the severity criterion mild at any time point of assessment for at least 6 months to meet the criteria of remission) criteria., Month 36 or EW|Number of Participants With Disease Remission Based on PANSS (Period 2), A participants will be in remission when he/she is symptomatically stable and show progressive improvement in total recovery according to severity (mild or less simultaneously on 8 PANSS items:P1 delusions, P2 conceptual disorganization, P3 hallucinatory behavior, G9 unusual thought content, G5 mannerisms and posturing, N1 blunted affect, N4 social withdrawal, N6 lack of spontaneity or flow of conversation) and time (scores for 8 PANSS items above should not exceed the severity criterion mild at any time point of assessment for at least 6 months to meet the criteria of remission) criteria., Month 24 or EW|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 36 or EW (Period 1), The CGI-S scale is a 7-point global assessment that measures the Clinicians impression of the severity of illness exhibited by a participant. A rating of 1=Normal, not at all ill and a rating of 7=Among the most extremely ill participants. Higher scores indicate worsening., Baseline and Month 36 or EW|Clinical Global Impression of Change (CGI-C) Score at Month 36 or EW (Period 1), The CGI-C scale is designed to assess the change in the clinical condition over time. The CGI-C consists of a 7-point rating of change, questioning if the clinical condition of the participant improved, remained unchanged, or worsened., Month 36 or EW|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Month 24 or EW (Period 2), The CGI-S scale is a 7-point global assessment that measures the Clinicians impression of the severity of illness exhibited by a participant. A rating of 1=Normal, not at all ill and a rating of 7=Among the most extremely ill participants. Higher scores indicate worsening., Baseline and Month 24 or EW|Clinical Global Impression of Change (CGI-C) Score in Period 2 at Month 24 or EW (Period 2), The CGI-C scale is designed to assess the change in the clinical condition over time. The CGI-C consists of a 7-point rating of change, questioning if the clinical condition of the participant improved, remained unchanged, or worsened., Month 24 or EW|Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 36 or EW (Period 1), The CDSS assesses the level of depression in participants with schizophrenia. It consists of 9 items: depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression, each scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score indicates more severe pathology., Baseline and Month 36 or EW|Change From Baseline in Calgary Depression Scale Score for Schizophrenia (CDSS) at Month 24 or EW (Period 2), The CDSS assesses the level of depression in participants with schizophrenia. It consists of 9 items: depression, hopelessness, self-depreciation, pathological guilt, guilty ideas of reference, morning depression, early awakening, suicidal, observed depression, each scored on a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe). The total score is a sum of the scores of each item and may range from 0 to 27. Higher score indicates more severe pathology., Baseline and Month 24 or EW|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 36 or EW (Period 1), The SOFAS is a 100- point single item scale that assesses level of social and occupational functioning of a participant and is not directly influenced by the overall severity of the individuals psychological symptoms.The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information., Baseline and Month 36 or EW|Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Month 24 or EW (Period 2), The SOFAS is a 100-point single item scale that assesses level of social and occupational functioning of a participant and is not directly influenced by the overall severity of the individuals psychological symptoms.The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information., Baseline and Month 24 or EW|Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 36 or EW (Period 1), The PGI-S is an 11-point (0=very well to 10=very poor) scale that requires the participants to rate the severity of their illness at the time of assessment, relative to the participants past experience. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse., Baseline and Month 36 or EW|Patient Global Impression-Change (PGI-C) Score at Month 36 or EW (Period 1), The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse ., Month 36 or EW|Change From Baseline in Patient Global Impression-Severity (PGI-S) Score at Month 24 or EW (Period 2), The PGI-S is an 11-point (0=very well to 10=very poor) scale that requires the participants to rate the severity of their illness at the time of assessment, relative to the participants past experience. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse., Baseline and Month 24 or EW|Patient Global Impression-Change (PGI-C) Score at Month 24 or EW (Period 2), The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse ., Month 24 or EW|Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 36 or EW (Period 1), The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in 2 six-item subscales: physical component summary (PCS) and MCS (mental component summary). The SF-12 score ranges from 10=maximum impairment to 70=no impairment., Baseline and Month 36 or EW|Change From Baseline in 12-Item Short-Form (SF-12) Score - Quality of Life Survey at Month 24 or EW (Period 2), The SF-12 is a validated 12 question quality-of-life questionnaire. The SF-12 extracts 12 items from the SF-36 questionnaire in 2 six-item subscales: physical component summary (PCS) and MCS (mental component summary). The SF-12 scores range from 10=maximum impairment to 70=no impairment., Baseline and Month 24 or EW Inclusion Criteria: - Participants who completed 24 months RIS-PSY-301 study - Surgically sterile female participants or practicing an effective method of birth control before entry and throughout the study; and must have shown a negative urine serum pregnancy test at baseline before study entry - Participants who have signed informed consent document Exclusion Criteria: - Participants requiring treatment with mood stabilizers or antidepressants at study entry - Participants with evidence of alcohol or drug abuse or dependence (except for nicotine and caffeine dependence) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosed in the last month before entry - Participants with a history of severe drug allergy, drug hypersensitivity, or neuroleptic malignant (cancerous) syndrome - Participants with known hypersensitivity to risperidone - Participants with acute risk of suicide at study entry or a history of suicidal attempt(s)", Similarity Score: 0.28234767672750677}'}]
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from_dataset
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[{'from': 'human', 'value': '{Study Title: Case Series With Saneso 360° Gastroscope, Primary Outcome Measures: Successful EGD, Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken., Within 24 hours on study day, Secondary Outcome Measures: Endoscopist qualitative rating of the Saneso 360° gastroscope, Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable)., Within 24 hours on study day|Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG), Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG)., Within 7 days of completion of the study|Evaluation of adverse events (AEs) related to the device., AEs are assessed through 7 days after the procedure., Within 7 days of completion of the study|Evaluation of any potential mucosal injury, Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear)., Immediately after the use of the device, criteria: "Inclusion Criteria:~* 18 -74 years of age~* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.~* Scheduled for a clinically indicated routine EGD procedure~* ASA class 1-3.~Exclusion Criteria:~* Altered esophageal, gastric, or duodenal anatomy~* Pregnant women, children under 18 years of age, and adults over 75 years of age.~* Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.~* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor~* ASA class 4-5."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 718, Unnamed: 0: 900, NCT Number: NCT05318092, Study Title: Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism, Study URL: https://clinicaltrials.gov/study/NCT05318092, Acronym: APEX-AV, Study Status: COMPLETED, Brief Summary: To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE)., Study Results: YES, Conditions: Pulmonary Embolism|Acute Pulmonary Embolism, Interventions: DEVICE: AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE, Primary Outcome Measures: "Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA), Change in Right Ventricle to Left Ventricle (RV/LV) ratio between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the studys core lab., At 48 hours post-procedure|Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure., Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure, defined as:\\n\\nDevice-related death Major bleeding\\n\\nDevice-related SAEs of:\\n\\n* Clinical Deterioration\\n* Pulmonary Vascular Injury\\n* Cardiac Injury, Within 48 hours post-procedure", Secondary Outcome Measures: "Use of Thrombolytics Within 48 Hours of the Procedure., Use of thrombolytics within 48 hours of the procedure., Within 48 hours of the procedure|Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure., Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure., Within 30 days of the procedure|Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)., Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the studys core lab. Modified Miller Index ranges from 0 - 16 (higher values mean higher thrombus burden) and a greater negative change is a better outcome., At 48 hours post-procedure|Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure., Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure., Within 48 hours of the procedure|Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure., Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure., Within 30 days of the procedure|Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days., Symptomatic PE recurrence within 30 days., Within 30 days of the procedure", Other Outcome Measures: , Sponsor: Angiodynamics, Inc., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 122.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 2021-EVT-01, Start Date: 2022-10-19, Primary Completion Date: 2024-01-04, Completion Date: 2024-01-04, First Posted: 2022-04-08, Results First Posted: 2024-07-19, Last Update Posted: 2024-07-19, Locations: HonorHealth, Scottsdale, Arizona, 85258, United States|UCLA Health, Los Angeles, California, 90404, United States|Yale University, New Haven, Connecticut, 06519, United States|HCA Memorial Hospital Jacksonville, Jacksonville, Florida, 32216, United States|Emory University at Grady Memorial Hospital, Atlanta, Georgia, 30303, United States|Piedmont Heart Institute, Atlanta, Georgia, 30309, United States|OSF Healthcare, Peoria, Illinois, 61611, United States|Indiana University, Indianapolis, Indiana, 47405, United States|Community Hospital, Munster, Indiana, 46321, United States|Oshner Medical Center, Jefferson, Louisiana, 70121, United States|CentraCare Heart and Vascular Center, Saint Cloud, Minnesota, 56303, United States|Rutgers University, Newark, New Jersey, 07103, United States|Jacobi Medical Center, Bronx, New York, 10461, United States|University of Buffalo, Buffalo, New York, 14203, United States|Columbia University Medical Center/NYPH, New York, New York, 10032, United States|Ohio State University Wexner Medical Center, Columbus, Ohio, 43221, United States|Kettering Health, Miamisburg, Ohio, 45342, United States|UPMC Hamot, Erie, Pennsylvania, 16550, United States|Einstein Medical Center, Montgomery, Pennsylvania, 19403, United States|UPMC Pittsburgh, Pittsburgh, Pennsylvania, 15219, United States|Tennova Healthcare -Turkey Creek Medical Center, Knoxville, Tennessee, 37934, United States|Baylor Heart and Vascular Hospital, Dallas, Texas, 75226, United States|Memorial Hermann (University of Texas at Houston), Houston, Texas, 77030, United States|Methodist Hospital, San Antonio, Texas, 78229, United States|Aurora Health Care, Milwaukee, Wisconsin, 53215, United States, Study Documents: Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/92/NCT05318092/Prot_SAP_000.pdf, criteria: "Inclusion Criteria:~* Signed and dated informed consent form.~* 18 years of age and older.~* Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.~* Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).~* Right Ventricle to Left Ventricle (RV/LV) ratio of 0.9 or higher.~* Systolic blood pressure (SBP) of 90 mmHg or higher~* Heart rate of 130 beats per minute (BPM) or less prior to the procedure.~* Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.~Exclusion Criteria:~Excluded from the study if he/she meets any of the following exclusion criteria~* May be pregnant as determined by a positive pregnancy test or who are breastfeeding.~* Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants.~* Has used thrombolytics (tPA) in the past 30 days of baseline CTA.~* Has pulmonary hypertension with peak pulmonary artery pressure (PAP) \\\\> 70 mmHg.~* Fraction of inspired oxygen (FiO2) requirement \\\\>40% or \\\\>6 liters per minute (LPM) to keep oxygen saturations \\\\>90%~* Hematocrit \\\\<28% within 6 hours of the index procedure.~* Platelets count \\\\< 100,000/µL.~* Serum creatinine \\\\>1.8 mg/dL.~* International Normalized Ratio (INR) \\\\> 3~* Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) \\\\> 15.~* Presence of cancer requiring active chemotherapy.~* Known bleeding diathesis or coagulation disorder.~* Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.~* History of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, Heparin-induced thrombocytopenia (HIT) and/or chronic left heart disease with left ventricular ejection fraction ≤ 30%.~* Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.~* Requires Vasopressor after fluids to keep pressure ≥ 90 mmHg.~* With left bundle branch block.~* Has intracardiac lead in the right ventricle or atrium.~* Evidence such as imaging or other that suggests the subject is not appropriate for this procedure.~* Has life expectancy \\\\< 90 days.~* Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).~* Participation in another investigational study", combined_text: Evaluating the Safety and Efficacy of the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE for Treatment of Acute Pulmonary Embolism Change in Right Ventricle to Left Ventricle (RV/LV) Ratio Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA), Change in Right Ventricle to Left Ventricle (RV/LV) ratio between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study\\s core lab., At 48 hours post-procedure|Rate of Major Adverse Events (MAEs) Within 48 Hours After the Index Procedure., Rate of Major Adverse Events (MAEs) within the first 48 hours after the index procedure, defined as:\\n\\nDevice-related death Major bleeding\\n\\nDevice-related SAEs of:\\n\\n* Clinical Deterioration\\n* Pulmonary Vascular Injury\\n* Cardiac Injury, Within 48 hours post-procedure Use of Thrombolytics Within 48 Hours of the Procedure., Use of thrombolytics within 48 hours of the procedure., Within 48 hours of the procedure|Length of Stay in the Intensive Care Unit (ICU)/Hospital Within 30 Days Post-procedure., Length of stay in the Intensive care unit (ICU)/Hospital within 30 days post-procedure., Within 30 days of the procedure|Change in Modified Miller Index Between Baseline and 48 Hours Post-procedure Assessed by Computed Tomography Angiography (CTA)., Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by Computed Tomography Angiography (CTA) and read by the study\\s core lab. Modified Miller Index ranges from 0 - 16 (higher values mean higher thrombus burden) and a greater negative change is a better outcome., At 48 hours post-procedure|Rate of Device Related Complications Including Clinical Deterioration, Cardiac Injury, Pulmonary Vascular Injury, Major Bleeding, and Device-related Death Within 48 Hours of the Index Procedure., Rate of device related complications including clinical deterioration, cardiac injury, pulmonary vascular injury, major bleeding, and device-related death within 48 hours of the index procedure., Within 48 hours of the procedure|Rate of Device-related Serious Adverse Events (SAEs) and Death for Any Cause Within 30 Days Post-procedure., Rate of device-related Serious Adverse Events (SAEs) and death for any cause within 30 days post-procedure., Within 30 days of the procedure|Symptomatic Pulmonary Embolism (PE) Recurrence Within 30 Days., Symptomatic PE recurrence within 30 days., Within 30 days of the procedure "Inclusion Criteria:~* Signed and dated informed consent form.~* 18 years of age and older.~* Clinical signs and symptoms consistent with acute intermediate-risk pulmonary embolism for less than or equal to 14 days.~* Diagnosis of pulmonary embolism detected from computed tomography angiography (CTA).~* Right Ventricle to Left Ventricle (RV/LV) ratio of 0.9 or higher.~* Systolic blood pressure (SBP) of 90 mmHg or higher~* Heart rate of 130 beats per minute (BPM) or less prior to the procedure.~* Deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment.~Exclusion Criteria:~Excluded from the study if he/she meets any of the following exclusion criteria~* May be pregnant as determined by a positive pregnancy test or who are breastfeeding.~* Has any contraindication to systemic or therapeutic doses of heparin or anticoagulants.~* Has used thrombolytics (tPA) in the past 30 days of baseline CTA.~* Has pulmonary hypertension with peak pulmonary artery pressure (PAP) \\\\> 70 mmHg.~* Fraction of inspired oxygen (FiO2) requirement \\\\>40% or \\\\>6 liters per minute (LPM) to keep oxygen saturations \\\\>90%~* Hematocrit \\\\<28% within 6 hours of the index procedure.~* Platelets count \\\\< 100,000/µL.~* Serum creatinine \\\\>1.8 mg/dL.~* International Normalized Ratio (INR) \\\\> 3~* Has undergone a major trauma within the past 14 days of the index procedure and have Injury Severity Score (ISS) \\\\> 15.~* Presence of cancer requiring active chemotherapy.~* Known bleeding diathesis or coagulation disorder.~* Has had a cardiovascular or pulmonary surgery within the past 7 days of index procedure.~* History of severe or chronic pulmonary hypertension, uncompensated heart failure, chest irradiation, underlying lung disease that is oxygen dependent, Heparin-induced thrombocytopenia (HIT) and/or chronic left heart disease with left ventricular ejection fraction ≤ 30%.~* Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated.~* Requires Vasopressor after fluids to keep pressure ≥ 90 mmHg.~* With left bundle branch block.~* Has intracardiac lead in the right ventricle or atrium.~* Evidence such as imaging or other that suggests the subject is not appropriate for this procedure.~* Has life expectancy \\\\< 90 days.~* Dependent on extracorporeal life support such as extracorporeal membrane oxygenation (ECMO).~* Participation in another investigational study", Similarity Score: 0.13799050254737422}'}]
|
from_dataset
| 0.137991
|
[{'from': 'human', 'value': '{Study Title: Case Series With Saneso 360° Gastroscope, Primary Outcome Measures: Successful EGD, Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken., Within 24 hours on study day, Secondary Outcome Measures: Endoscopist qualitative rating of the Saneso 360° gastroscope, Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable)., Within 24 hours on study day|Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG), Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG)., Within 7 days of completion of the study|Evaluation of adverse events (AEs) related to the device., AEs are assessed through 7 days after the procedure., Within 7 days of completion of the study|Evaluation of any potential mucosal injury, Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear)., Immediately after the use of the device, criteria: "Inclusion Criteria:~* 18 -74 years of age~* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.~* Scheduled for a clinically indicated routine EGD procedure~* ASA class 1-3.~Exclusion Criteria:~* Altered esophageal, gastric, or duodenal anatomy~* Pregnant women, children under 18 years of age, and adults over 75 years of age.~* Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.~* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor~* ASA class 4-5."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 27, Unnamed: 0: 32, NCT Number: NCT02259894, Study Title: Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers, Study URL: https://clinicaltrials.gov/study/NCT02259894, Acronym: , Study Status: COMPLETED, Brief Summary: To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in healthy subjects, Study Results: NO, Conditions: Healthy, Interventions: DRUG: BIRT 2584 XX|DRUG: Placebo, Primary Outcome Measures: Number of participants with adverse events, Up to 16 days after drug administration|Number of participants with clinically significant changes in vital signs, Up to 16 days after drug administration|Number of participants with abnormal changes in clinical laboratory parameters, Up to 16 days after drug administration|Number of participants with abnormal findings in 12-lead ECG (electrocardiogram), Up to 16 days after drug administration|Number of participants with abnormal findings in physical examination, Screening and up to 16 days after drug administration, Secondary Outcome Measures: Cmax (maximum concentration in plasma), Up to 360 hours after drug administration|tmax (time from dosing to maximum concentration), Up to 360 hours after drug administration|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 extrapolated to infinity), Up to 360 hours after drug administration|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 to the last quantifiable analyte plasma concentration), Up to 360 hours after drug administration|λz (terminal rate constant in plasma), Up to 360 hours after drug administration|t1/2 (terminal half-life of the analyte in plasma), Up to 360 hours after drug administration|MRT(mean residence time of the analyte in the body), Up to 360 hours after drug administration|CL/F (apparent oral clearance in plasma after oral administration), Up to 360 hours after drug administration|Vz/F (apparent volume of distribution during the terminal phase λz) dose), Up to 360 hours after drug administration|Ae0-48 (amount of analyte that is eliminated in urine from 0-48 hours), Up to 48 hours after drug administration|fe0-48 (fraction of analyte eliminated in urine from 0-48 hours), Up to 48 hours after drug administration|CLR,0-48 (renal clearance of the analyte from 0-48 hours), Up to 48 hours after drug administration|Receptor occupancy as determined by binding of anti-LFA-1 antibody fragment (Fab), Up to 360 hours after drug administration|Inhibition of IL-2 production, in response to superantigen challenge ex vivo, Up to 360 hours after drug administration, Other Outcome Measures: , Sponsor: Boehringer Ingelheim, Collaborators: , Sex: MALE, Age: ADULT, Phases: PHASE1, Enrollment: 55.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT, Other IDs: 1206.1, Start Date: 2004-03, Primary Completion Date: 2004-06, Completion Date: , First Posted: 2014-10-09, Results First Posted: , Last Update Posted: 2014-10-09, Locations: , Study Documents: , criteria: "Inclusion Criteria:~* Healthy male subjects as determined by results of screening~* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation~* Age \\\\>=18 and \\\\<=50 years~* BMI \\\\>=18.5 and \\\\<=29.9 kg/m2~Exclusion Criteria:~* Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders~* Surgery of gastrointestinal tract (except appendectomy)~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* Relevant history of orthostatic hypotension, fainting spells or blackouts~* Chronic or relevant acute infections~* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator~* Intake of drugs with a long half-life (\\\\> 24 hours) (\\\\< 1 month prior to administration or during the trial)~* Use of any drugs, which might influence the results of the trial, (\\\\< 10 days prior to study drug administration or expected during the trial)~* Participation in another trial with an investigational drug (\\\\< 2 months prior to administration or expected during trial)~* Smoker (\\\\> 10 cigarettes or \\\\>3 cigars or \\\\>3 pipes/day)~* Alcohol abuse (\\\\> 60 g/day)~* Drug abuse~* Blood donation or loss \\\\> 400 mL, \\\\< 1 month prior to administration or expected during the trial~* Clinically relevant laboratory abnormalities~* Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \\\\> 110 ms or QT interval, Bazett correction (QTcB) \\\\> 450 ms or QT interval \\\\>500 ms~* Inability to comply with dietary regimen of study centre~* Inability to comply with investigator\\s instructions", combined_text: Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers Number of participants with adverse events, Up to 16 days after drug administration|Number of participants with clinically significant changes in vital signs, Up to 16 days after drug administration|Number of participants with abnormal changes in clinical laboratory parameters, Up to 16 days after drug administration|Number of participants with abnormal findings in 12-lead ECG (electrocardiogram), Up to 16 days after drug administration|Number of participants with abnormal findings in physical examination, Screening and up to 16 days after drug administration Cmax (maximum concentration in plasma), Up to 360 hours after drug administration|tmax (time from dosing to maximum concentration), Up to 360 hours after drug administration|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 extrapolated to infinity), Up to 360 hours after drug administration|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time) interval from 0 to the last quantifiable analyte plasma concentration), Up to 360 hours after drug administration|λz (terminal rate constant in plasma), Up to 360 hours after drug administration|t1/2 (terminal half-life of the analyte in plasma), Up to 360 hours after drug administration|MRT(mean residence time of the analyte in the body), Up to 360 hours after drug administration|CL/F (apparent oral clearance in plasma after oral administration), Up to 360 hours after drug administration|Vz/F (apparent volume of distribution during the terminal phase λz) dose), Up to 360 hours after drug administration|Ae0-48 (amount of analyte that is eliminated in urine from 0-48 hours), Up to 48 hours after drug administration|fe0-48 (fraction of analyte eliminated in urine from 0-48 hours), Up to 48 hours after drug administration|CLR,0-48 (renal clearance of the analyte from 0-48 hours), Up to 48 hours after drug administration|Receptor occupancy as determined by binding of anti-LFA-1 antibody fragment (Fab), Up to 360 hours after drug administration|Inhibition of IL-2 production, in response to superantigen challenge ex vivo, Up to 360 hours after drug administration "Inclusion Criteria:~* Healthy male subjects as determined by results of screening~* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation~* Age \\\\>=18 and \\\\<=50 years~* BMI \\\\>=18.5 and \\\\<=29.9 kg/m2~Exclusion Criteria:~* Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance~* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders~* Surgery of gastrointestinal tract (except appendectomy)~* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders~* Relevant history of orthostatic hypotension, fainting spells or blackouts~* Chronic or relevant acute infections~* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator~* Intake of drugs with a long half-life (\\\\> 24 hours) (\\\\< 1 month prior to administration or during the trial)~* Use of any drugs, which might influence the results of the trial, (\\\\< 10 days prior to study drug administration or expected during the trial)~* Participation in another trial with an investigational drug (\\\\< 2 months prior to administration or expected during trial)~* Smoker (\\\\> 10 cigarettes or \\\\>3 cigars or \\\\>3 pipes/day)~* Alcohol abuse (\\\\> 60 g/day)~* Drug abuse~* Blood donation or loss \\\\> 400 mL, \\\\< 1 month prior to administration or expected during the trial~* Clinically relevant laboratory abnormalities~* Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \\\\> 110 ms or QT interval, Bazett correction (QTcB) \\\\> 450 ms or QT interval \\\\>500 ms~* Inability to comply with dietary regimen of study centre~* Inability to comply with investigator\\s instructions", Similarity Score: 0.1339964134313257}'}]
|
from_dataset
| 0.133996
|
[{'from': 'human', 'value': '{Study Title: Case Series With Saneso 360° Gastroscope, Primary Outcome Measures: Successful EGD, Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken., Within 24 hours on study day, Secondary Outcome Measures: Endoscopist qualitative rating of the Saneso 360° gastroscope, Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable)., Within 24 hours on study day|Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG), Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG)., Within 7 days of completion of the study|Evaluation of adverse events (AEs) related to the device., AEs are assessed through 7 days after the procedure., Within 7 days of completion of the study|Evaluation of any potential mucosal injury, Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear)., Immediately after the use of the device, criteria: "Inclusion Criteria:~* 18 -74 years of age~* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.~* Scheduled for a clinically indicated routine EGD procedure~* ASA class 1-3.~Exclusion Criteria:~* Altered esophageal, gastric, or duodenal anatomy~* Pregnant women, children under 18 years of age, and adults over 75 years of age.~* Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.~* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor~* ASA class 4-5."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 766, Unnamed: 0: 964, NCT Number: NCT04580940, Study Title: SpyGlass™ Discover Percutaneous, Study URL: https://clinicaltrials.gov/study/NCT04580940, Acronym: , Study Status: COMPLETED, Brief Summary: To document the clinical utility of percutaneous cholangiopancreatoscopy using a thin, disposable, flexible endoscope for evaluation and treatment of complex pancreaticobiliary disease in a prospective, multi-center case series, Study Results: NO, Conditions: Pancreatic Diseases|Bile Duct Obstruction|Bile Duct Diseases, Interventions: DEVICE: SpyGlass™ Discover Digital System, Primary Outcome Measures: Achieving clinical intent of procedure as indicated, Physicians will report achieving clinical success by recording the completed procedures compared to procedures planned by 30 days (+/- 3 days) after index PTCS., 1 month, Secondary Outcome Measures: Number of Adverse Events, Serious adverse events related to the study device, accessory devices used through the working channel of the SpyGlass™ Discover Digital Catheter or the cholangiopancreatoscopy portion of the PTCS procedure(s)., 1 month|Technical success, Rate at which SpyGlass™ Discover digital catheter can be advanced to the target lesion or stone(s) and visualize the target, During index procedure|Procedural Time, Time elapsed between first insertion to last removal of the SpyGlass™ Discover digital catheter, During index procedure|Number of PTCS procedures, Number of PTCS procedures required to achieve clinical success until the end of follow-up, 1 month|Endoscopist rating, Endoscopist rating of the following attributes when using SpyGlass™ Discover Digital Catheter compared to marketed reusable scopes Ability to complete the procedure Ability to retroflex Ability to selectively advance into targeted ducts Ability to obtain targeted biopsies Ability to grasp stones Ability to guide lithotripsy Ability to suction Ability to irrigate Ability to advance accessories through scope channel Image quality, During index procedure, Other Outcome Measures: , Sponsor: Boston Scientific Corporation, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 50.0, Funder Type: INDUSTRY, Study Type: OBSERVATIONAL, Study Design: Observational Model: |Time Perspective: p, Other IDs: E7160, Start Date: 2021-07-27, Primary Completion Date: 2022-12-14, Completion Date: 2023-01-14, First Posted: 2020-10-09, Results First Posted: , Last Update Posted: 2023-11-29, Locations: Virginia Mason Medical Center, Seattle, Washington, 98101, United States|Erasme University Hospital, Brussels, 1070, Belgium|Toronto General Hospital, University Health Network, Toronto, Ontario, M5G2N2, Canada|Evangelisches Krakenhaus Düsseldorf, Düsseldorf, 40217, Germany|Prince of Wales Hospital, Shatin, NewTerritories, 999077, Hong Kong|Asian Institute of Gastroenterology, Hyderabad, Somajiguda, 500-082, India|Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, 00168, Italy, Study Documents: , criteria: "Inclusion Criteria:~1. Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice~2. Written informed consent from patient or legally authorized representative of the patient~Exclusion Criteria:~1. Contraindication for cholangiopancreatoscopy~2. Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access~3. \\\\<18 years of age~4. Potentially vulnerable subjects, including, but not limited to pregnant women", combined_text: SpyGlass™ Discover Percutaneous Achieving clinical intent of procedure as indicated, Physicians will report achieving clinical success by recording the completed procedures compared to procedures planned by 30 days (+/- 3 days) after index PTCS., 1 month Number of Adverse Events, Serious adverse events related to the study device, accessory devices used through the working channel of the SpyGlass™ Discover Digital Catheter or the cholangiopancreatoscopy portion of the PTCS procedure(s)., 1 month|Technical success, Rate at which SpyGlass™ Discover digital catheter can be advanced to the target lesion or stone(s) and visualize the target, During index procedure|Procedural Time, Time elapsed between first insertion to last removal of the SpyGlass™ Discover digital catheter, During index procedure|Number of PTCS procedures, Number of PTCS procedures required to achieve clinical success until the end of follow-up, 1 month|Endoscopist rating, Endoscopist rating of the following attributes when using SpyGlass™ Discover Digital Catheter compared to marketed reusable scopes Ability to complete the procedure Ability to retroflex Ability to selectively advance into targeted ducts Ability to obtain targeted biopsies Ability to grasp stones Ability to guide lithotripsy Ability to suction Ability to irrigate Ability to advance accessories through scope channel Image quality, During index procedure "Inclusion Criteria:~1. Scheduled for a percutaneous transhepatic procedure to access the pancreaticobiliary anatomy that will accommodate passage of SpyGlass™ Discover Digital Catheter per local standard of practice~2. Written informed consent from patient or legally authorized representative of the patient~Exclusion Criteria:~1. Contraindication for cholangiopancreatoscopy~2. Subjects with unresolved adverse event(s) associated with prior percutaneous pancreaticobiliary ductal access~3. \\\\<18 years of age~4. Potentially vulnerable subjects, including, but not limited to pregnant women", Similarity Score: 0.1157977698995223}'}]
|
from_dataset
| 0.115798
|
[{'from': 'human', 'value': '{Study Title: Case Series With Saneso 360° Gastroscope, Primary Outcome Measures: Successful EGD, Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken., Within 24 hours on study day, Secondary Outcome Measures: Endoscopist qualitative rating of the Saneso 360° gastroscope, Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable)., Within 24 hours on study day|Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG), Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG)., Within 7 days of completion of the study|Evaluation of adverse events (AEs) related to the device., AEs are assessed through 7 days after the procedure., Within 7 days of completion of the study|Evaluation of any potential mucosal injury, Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear)., Immediately after the use of the device, criteria: "Inclusion Criteria:~* 18 -74 years of age~* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.~* Scheduled for a clinically indicated routine EGD procedure~* ASA class 1-3.~Exclusion Criteria:~* Altered esophageal, gastric, or duodenal anatomy~* Pregnant women, children under 18 years of age, and adults over 75 years of age.~* Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.~* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor~* ASA class 4-5."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 116, Unnamed: 0: 134, NCT Number: NCT03653091, Study Title: Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes, Study URL: https://clinicaltrials.gov/study/NCT03653091, Acronym: , Study Status: COMPLETED, Brief Summary: The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. The purpose of this study is to demonstrate the safety and effectiveness of the Fractyl DMR Procedure using the Revita™ System compared to a sham procedure. At 24 weeks, subjects randomized to the DMR procedure be continued to be followed per protocol till 48 Weeks and the Sham treatment arm will be offered to cross over to receive the DMR treatment and will be followed per protocol for 24 weeks post treatment., Study Results: YES, Conditions: Type 2 Diabetes, Interventions: DEVICE: Duodenal Mucosal Resurfacing (DMR)|DEVICE: Duodenal Mucosal Resurfacing Sham (Sham), Primary Outcome Measures: Change in Hemoglobin A1c (HbA1c), Change in HbA1c from baseline in DMR vs Sham groups, 24 weeks post procedure, Secondary Outcome Measures: , Other Outcome Measures: , Sponsor: Fractyl Health Inc., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 9.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT, Other IDs: C-40000, Start Date: 2018-09-28, Primary Completion Date: 2020-08-10, Completion Date: 2020-08-10, First Posted: 2018-08-31, Results First Posted: 2022-07-26, Last Update Posted: 2024-02-14, Locations: "Florida Hospital / TRANSLATIONAL RESEARCH INSTITUTE FOR METABOLISM AND DIABETES (TRI), Orlando, Florida, 32804, United States|Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States|Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States|University of Pennsylvania - Penn Metabolic Medicine, Philadelphia, Pennsylvania, 19104, United States|UTHealth, Houston, Texas, 77030, United States|Texas Diabetes Institute, San Antonio, Texas, 78229, United States", Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/91/NCT03653091/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/91/NCT03653091/SAP_001.pdf, criteria: "Inclusion Criteria:~1. Men and non-pregnant women 28-65 years of age~2. Diagnosed with T2D for at least 3 years~3. A1C of 7.5 - 9.5% (59-80 mmol/mol)~4. BMI ≥ 28 and ≤ 40 kg/m2~5. On two to three oral OADs (metformin plus one to two additional OADs) with two (see note below) at least at half maximum labeled dose (or highest tolerated) with no changes in medication in the 12 weeks prior to the Screening Visit (Visit 1) (Refer to ADA Standard of Medical Care in Diabetes 2018, Table 8.3 for the maximum approved daily dose of non-insulin glucose lowering agents) (43). Note: For subjects on sulfonylurea (SU) glucose-lowering drugs for diabetes, the only SUs permitted in the study will be glipizide or glimepiride, and their doses below half maximum labeled dosing will not be an exclusion for study entry. Patients unwilling to reduce the dose of SU at the time of the DMR procedure as described by protocol will be excluded.~6. Agree to use an additional glucose-lowering treatment (eg, liraglutide, other OAD with the exception of glyburide) if recommended by the study investigator in case of persistent hyperglycemia.~7. Agree not to donate blood during their participation in the study~8. Able to comply with study requirements and understand and sign the Informed Consent Form~9. Women of childbearing potential (WOCBP) must be using two acceptable methods of contraception throughout the study~10. Women must not be breastfeeding~Exclusion Criteria:~1. Diagnosed with Type 1 Diabetes (T1D)~2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma~3. Probable insulin production failure, defined as fasting C Peptide serum \\\\<1 ng/mL (333pmol/l)~4. Previous use of any types of insulin for \\\\>1 month (at any time, except for treatment of gestational diabetes)~5. Current use of injectable medications for diabetes (insulin, GLP-1RA)~6. Current use of glyburide, a sulfonylurea (SU) glucose-lowering drug for diabetes~7. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)~8. Known autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder~9. Previous GI surgery that could limit treatment of the duodenum such as Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions~10. History of chronic or acute pancreatitis~11. History of diabetic gastroparesis~12. Known active hepatitis or active liver disease~13. Acute gastrointestinal illness in the previous 7 days~14. Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn\\s disease~15. Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including Barrett\\s esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus~16. Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms~17. Known history of a structural or functional disorder of the stomach including gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (\\\\> 2 cm), cancer or any other disorder of the stomach~18. Known history of chronic symptoms suggestive of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety~19. Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the GI tract~20. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting~21. Active H. pylori infection (Subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)~22. History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia~23. Current use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure~24. Current use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure.~25. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of low dose aspirin is allowed.~26. Current use of serotonergic medications (SSRI)~27. Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit~28. Use of drugs known to affect GI motility (e.g. Metoclopramide)~29. Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications~30. Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on stable dose for at least 6 weeks prior to Screening~31. Persistent Anemia, defined as Hemoglobin \\\\<10 g/dL~32. Subjects who have donated blood or received a transfusion in the prior 3 months~33. Subjects with conditions that alter red blood cell turnover~34. Subjects with prosthetic joints~35. Significant cardiovascular disease including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack or stroke within the last 6 months~36. Moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) \\\\<45 ml/min/1.73m2 (estimated by MDRD)~37. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically-significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator~38. Active systemic infection~39. Active malignancy within the last 5 years (with the exception of treated basal cell or treated squamous cell carcinoma)~40. Subjects with a personal or family history of medullary thyroid carcinoma~41. Subjects with Multiple Endocrine Neoplasia syndrome type 2~42. Not a candidate for surgery or general anesthesia~43. Active illicit substance abuse or alcoholism~44. Current smoker~45. Participating in another ongoing clinical trial of an investigational drug or device~46. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation~47. Unwilling or unable to perform SMBG, complete the patient diary, or comply with study visits and other study procedures as required per protocol~Additional exclusion criteria to be confirmed during the screening process:~1. A1c post Run-In Phase \\\\< 7.5% (59 mmol/mol) or \\\\> 9.5% (86 mmol/mol)~2. Any severe hypoglycemic event, defined as hypoglycemia requiring third-party assistance; or any clinically significant hypoglycemic event, defined as self-monitored or laboratory plasma glucose level \\\\< 54 mg/dL (3.0 mmol/L); or ≥ 2 glucose alert values ≤70 mg/dL (3.9 mmol/L), unless a clear correctable precipitating factor can be identified, since the screening visit (Visit 1)~3. Uncontrolled hyperglycemia with a glucose level \\\\>270 mg/dl (\\\\>15 mmol/L) after an overnight fast or \\\\>360 mg/dl (\\\\>20 mmol/l) in a randomly performed measurement during Medication Run-In Period and confirmed by a second measurement (not on the same day)~4. Mean of 3 separate blood pressure measurements \\\\>180 mmHg (systolic) or \\\\>100 mmHg (diastolic)~5. WOCBP with a positive urine pregnancy test at Baseline Visit~6. Active and uncontrolled GERD defined as grade III esophagitis or greater~7. Abnormalities of the GI tract preventing endoscopic access to the duodenum~8. Anatomic abnormalities in the duodenum that would preclude the completion of the DMR procedure, including tortuous anatomy~9. Malignancy newly diagnosed by endoscopy~10. Upper gastrointestinal conditions such as ulcers, polyps, varices, strictures, congenital or acquired intestinal telangiectasia", combined_text: Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes Change in Hemoglobin A1c (HbA1c), Change in HbA1c from baseline in DMR vs Sham groups, 24 weeks post procedure "Inclusion Criteria:~1. Men and non-pregnant women 28-65 years of age~2. Diagnosed with T2D for at least 3 years~3. A1C of 7.5 - 9.5% (59-80 mmol/mol)~4. BMI ≥ 28 and ≤ 40 kg/m2~5. On two to three oral OADs (metformin plus one to two additional OADs) with two (see note below) at least at half maximum labeled dose (or highest tolerated) with no changes in medication in the 12 weeks prior to the Screening Visit (Visit 1) (Refer to ADA Standard of Medical Care in Diabetes 2018, Table 8.3 for the maximum approved daily dose of non-insulin glucose lowering agents) (43). Note: For subjects on sulfonylurea (SU) glucose-lowering drugs for diabetes, the only SUs permitted in the study will be glipizide or glimepiride, and their doses below half maximum labeled dosing will not be an exclusion for study entry. Patients unwilling to reduce the dose of SU at the time of the DMR procedure as described by protocol will be excluded.~6. Agree to use an additional glucose-lowering treatment (eg, liraglutide, other OAD with the exception of glyburide) if recommended by the study investigator in case of persistent hyperglycemia.~7. Agree not to donate blood during their participation in the study~8. Able to comply with study requirements and understand and sign the Informed Consent Form~9. Women of childbearing potential (WOCBP) must be using two acceptable methods of contraception throughout the study~10. Women must not be breastfeeding~Exclusion Criteria:~1. Diagnosed with Type 1 Diabetes (T1D)~2. History of diabetic ketoacidosis or hyperosmolar nonketotic coma~3. Probable insulin production failure, defined as fasting C Peptide serum \\\\<1 ng/mL (333pmol/l)~4. Previous use of any types of insulin for \\\\>1 month (at any time, except for treatment of gestational diabetes)~5. Current use of injectable medications for diabetes (insulin, GLP-1RA)~6. Current use of glyburide, a sulfonylurea (SU) glucose-lowering drug for diabetes~7. Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)~8. Known autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder~9. Previous GI surgery that could limit treatment of the duodenum such as Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions~10. History of chronic or acute pancreatitis~11. History of diabetic gastroparesis~12. Known active hepatitis or active liver disease~13. Acute gastrointestinal illness in the previous 7 days~14. Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn\\s disease~15. Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including Barrett\\s esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus~16. Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms~17. Known history of a structural or functional disorder of the stomach including gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (\\\\> 2 cm), cancer or any other disorder of the stomach~18. Known history of chronic symptoms suggestive of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety~19. Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the GI tract~20. Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting~21. Active H. pylori infection (Subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)~22. History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia~23. Current use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure~24. Current use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure.~25. Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of low dose aspirin is allowed.~26. Current use of serotonergic medications (SSRI)~27. Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit~28. Use of drugs known to affect GI motility (e.g. Metoclopramide)~29. Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications~30. Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on stable dose for at least 6 weeks prior to Screening~31. Persistent Anemia, defined as Hemoglobin \\\\<10 g/dL~32. Subjects who have donated blood or received a transfusion in the prior 3 months~33. Subjects with conditions that alter red blood cell turnover~34. Subjects with prosthetic joints~35. Significant cardiovascular disease including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack or stroke within the last 6 months~36. Moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) \\\\<45 ml/min/1.73m2 (estimated by MDRD)~37. Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically-significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator~38. Active systemic infection~39. Active malignancy within the last 5 years (with the exception of treated basal cell or treated squamous cell carcinoma)~40. Subjects with a personal or family history of medullary thyroid carcinoma~41. Subjects with Multiple Endocrine Neoplasia syndrome type 2~42. Not a candidate for surgery or general anesthesia~43. Active illicit substance abuse or alcoholism~44. Current smoker~45. Participating in another ongoing clinical trial of an investigational drug or device~46. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation~47. Unwilling or unable to perform SMBG, complete the patient diary, or comply with study visits and other study procedures as required per protocol~Additional exclusion criteria to be confirmed during the screening process:~1. A1c post Run-In Phase \\\\< 7.5% (59 mmol/mol) or \\\\> 9.5% (86 mmol/mol)~2. Any severe hypoglycemic event, defined as hypoglycemia requiring third-party assistance; or any clinically significant hypoglycemic event, defined as self-monitored or laboratory plasma glucose level \\\\< 54 mg/dL (3.0 mmol/L); or ≥ 2 glucose alert values ≤70 mg/dL (3.9 mmol/L), unless a clear correctable precipitating factor can be identified, since the screening visit (Visit 1)~3. Uncontrolled hyperglycemia with a glucose level \\\\>270 mg/dl (\\\\>15 mmol/L) after an overnight fast or \\\\>360 mg/dl (\\\\>20 mmol/l) in a randomly performed measurement during Medication Run-In Period and confirmed by a second measurement (not on the same day)~4. Mean of 3 separate blood pressure measurements \\\\>180 mmHg (systolic) or \\\\>100 mmHg (diastolic)~5. WOCBP with a positive urine pregnancy test at Baseline Visit~6. Active and uncontrolled GERD defined as grade III esophagitis or greater~7. Abnormalities of the GI tract preventing endoscopic access to the duodenum~8. Anatomic abnormalities in the duodenum that would preclude the completion of the DMR procedure, including tortuous anatomy~9. Malignancy newly diagnosed by endoscopy~10. Upper gastrointestinal conditions such as ulcers, polyps, varices, strictures, congenital or acquired intestinal telangiectasia", Similarity Score: 0.10963571156224274}'}]
|
from_dataset
| 0.109636
|
[{'from': 'human', 'value': '{Study Title: Case Series With Saneso 360° Gastroscope, Primary Outcome Measures: Successful EGD, Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken., Within 24 hours on study day, Secondary Outcome Measures: Endoscopist qualitative rating of the Saneso 360° gastroscope, Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable)., Within 24 hours on study day|Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG), Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG)., Within 7 days of completion of the study|Evaluation of adverse events (AEs) related to the device., AEs are assessed through 7 days after the procedure., Within 7 days of completion of the study|Evaluation of any potential mucosal injury, Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear)., Immediately after the use of the device, criteria: "Inclusion Criteria:~* 18 -74 years of age~* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.~* Scheduled for a clinically indicated routine EGD procedure~* ASA class 1-3.~Exclusion Criteria:~* Altered esophageal, gastric, or duodenal anatomy~* Pregnant women, children under 18 years of age, and adults over 75 years of age.~* Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.~* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor~* ASA class 4-5."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 226, Unnamed: 0: 273, NCT Number: NCT02987894, Study Title: PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry, Study URL: https://clinicaltrials.gov/study/NCT02987894, Acronym: PROGRESS, Study Status: COMPLETED, Brief Summary: The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU., Study Results: NO, Conditions: Aortic Stenosis, Interventions: DEVICE: ACURATE neo™ Aortic Bioprosthesis, Primary Outcome Measures: Change in total aortic regurgitation over time., total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up, post-implantation on index procedure date, 7- days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure, Secondary Outcome Measures: Incidence of all-cause mortality, Incidence of all-cause mortality at 30 days post index procedure, 30 days post-index procedure|Clinical events as defined per VARC-2 consensus document (VARC-2), Clinical events as defined per VARC-2 consensus document, Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Number of patients with procedural success according to VARC II criteria, Procedural success is defined as\\n\\nAbsence of intra-procedure mortality and complications arising during implantation of the prosthetic valve such as:\\n\\n* inability to properly seat the valve in the annulus\\n* need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment)\\n* surgical aortic valve replacement required to correct a severe aortic regurgitation or procedure complication The procedure can be considered as success despite the presence of residual aortic regurgitation which may be due to the anatomic configuration of the annulus or a calcific valvular annulus., at index- Procedure|Number of patients with device success, Device success is defined as:\\n\\n* Absence of intra-procedure mortality (procedure to 24H) AND,\\n* Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND,\\n* Intended performance of the prosthetic heart valve:\\n\\n * No prosthesis-patient mismatch (EAOi \\\\>0.85 cm2/m2) AND,\\n * Mean aortic valve gradient \\\\<20mmHg or peak velocity \\\\< 3 m/s AND,\\n * No moderate or severe prosthetic valve regurgitation.\\n\\nIn evaluating echo parameters, values at 7D/Discharge (whichever occurs first) will be used for each of the echo parameters above. If any of echo parameters is missing at 7-days or discharge, post-procedure data may be used for the missing values. If device success or failure cannot be determined due to missing of parameters listed above or un-evaluable echocardiography assessment, device success will be considered not obtainable., 7-days post-index procedure or discharge (whichever occurs first)|Number of patients with adverse events assessed by VARC-2 Composite Safety, VARC-2 Composite Safety at 30 days defined as:\\n\\n* All-cause mortality\\n* All stroke (disabling and non-disabling)\\n* Life-threatening bleeding\\n* Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)\\n* Coronary artery obstruction requiring intervention\\n* Major vascular complication\\n* Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVI), 30 days post-index procedure|Functional improvement, Functional improvement from baseline as per NYHA Functional Classification, 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Hemodynamic function improvement from baseline, Improvement from baseline of the hemodynamic function: effective orifice area and mean transprosthetic gradient, 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Valve related dysfunction, Valve related dysfunction defined as: mean aortic valve gradient ≥ 20mmHg, EOA ≤0.9-1.1 cm2, and/or DVI\\\\< 0.35, and/or moderate or severe prosthetic valve regurgitation (See VARC-2 and Figure 4 from VARC manuscript), 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure, Other Outcome Measures: , Sponsor: Symetis SA, Collaborators: , Sex: ALL, Age: OLDER_ADULT, Phases: , Enrollment: 500.0, Funder Type: INDUSTRY, Study Type: OBSERVATIONAL, Study Design: Observational Model: |Time Perspective: p, Other IDs: 2016-02, Start Date: 2017-01-02, Primary Completion Date: 2019-09, Completion Date: 2019-09, First Posted: 2016-12-09, Results First Posted: , Last Update Posted: 2020-04-09, Locations: "London Health Sciences Centre, University Hospital, London, Ontario, Canada|Saint Pauls Hospital, Porvidence Health Care Institute, Vancouver, BC V6Z 1Y6, Canada|Klinikum Augsburg, Augsburg, 86156, Germany|Zentralklinik Bad Berka, Bad Berka, 99437, Germany|Kerkhoff Kilnik, Bad Nauheim, 61231, Germany|Immanuel Hospital Bernau- Herzzentrum Brandenburg, Bernau, 13321, Germany|Sana-Herzzentrum Cottbus GmbH, Cottbus, 03048, Germany|St Johannes Hospital, Dortmund, 44137, Germany|Goethe Universität, Frankfurt, 60323, Germany|Universitätklinikum Giessen, Giessen, 35392, Germany|Universitätsklinikum Halle, Halle, 06097, Germany|Universitätsklinikum Jena, Jena, 07743, Germany|Städisches Klinikum Karlsruhe GmbH, Karlsruhe, 76133, Germany|Helios Klinik Fur Herzzchirurgie Karlsruhe, Karlsruhe, 76185, Germany|Universitätsklinikum, Köln, 50924, Germany|Sana Herzzentrum Leipzig, Leipzig, 04289, Germany|Universitätsklinikum Münster, Münster, 48149, Germany|Städische Kliniken, Neuss, 41464, Germany|Universitätsklinikum Tübingen, Tübingen, 72016, Germany|Ospedale Civile di Legnano, Legnano, Italy|Fondazione Toscana G.Monasterio, Ospedale del Cuore G.Pasquinucci, Massa, 54100, Italy|University Hospital NHS, Leicester, United Kingdom|Oford University Hospital, Oxford, United Kingdom", Study Documents: , criteria: "Inclusion Criteria:~1. Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use (Patients which are included but treated outside of the approved indication will be followed for safety reasons).~2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry. Patient agrees that anonymized imaging data will be sent to and analyzed by an external Core Laboratory.~3. The treating physician should ensure the subject will return for all required post procedure follow-up visits.~Exclusion Criteria:~1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.", combined_text: PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry Change in total aortic regurgitation over time., total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up, post-implantation on index procedure date, 7- days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure Incidence of all-cause mortality, Incidence of all-cause mortality at 30 days post index procedure, 30 days post-index procedure|Clinical events as defined per VARC-2 consensus document (VARC-2), Clinical events as defined per VARC-2 consensus document, Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Number of patients with procedural success according to VARC II criteria, Procedural success is defined as\\n\\nAbsence of intra-procedure mortality and complications arising during implantation of the prosthetic valve such as:\\n\\n* inability to properly seat the valve in the annulus\\n* need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment)\\n* surgical aortic valve replacement required to correct a severe aortic regurgitation or procedure complication The procedure can be considered as success despite the presence of residual aortic regurgitation which may be due to the anatomic configuration of the annulus or a calcific valvular annulus., at index- Procedure|Number of patients with device success, Device success is defined as:\\n\\n* Absence of intra-procedure mortality (procedure to 24H) AND,\\n* Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND,\\n* Intended performance of the prosthetic heart valve:\\n\\n * No prosthesis-patient mismatch (EAOi \\\\>0.85 cm2/m2) AND,\\n * Mean aortic valve gradient \\\\<20mmHg or peak velocity \\\\< 3 m/s AND,\\n * No moderate or severe prosthetic valve regurgitation.\\n\\nIn evaluating echo parameters, values at 7D/Discharge (whichever occurs first) will be used for each of the echo parameters above. If any of echo parameters is missing at 7-days or discharge, post-procedure data may be used for the missing values. If device success or failure cannot be determined due to missing of parameters listed above or un-evaluable echocardiography assessment, device success will be considered not obtainable., 7-days post-index procedure or discharge (whichever occurs first)|Number of patients with adverse events assessed by VARC-2 Composite Safety, VARC-2 Composite Safety at 30 days defined as:\\n\\n* All-cause mortality\\n* All stroke (disabling and non-disabling)\\n* Life-threatening bleeding\\n* Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)\\n* Coronary artery obstruction requiring intervention\\n* Major vascular complication\\n* Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVI), 30 days post-index procedure|Functional improvement, Functional improvement from baseline as per NYHA Functional Classification, 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Hemodynamic function improvement from baseline, Improvement from baseline of the hemodynamic function: effective orifice area and mean transprosthetic gradient, 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Valve related dysfunction, Valve related dysfunction defined as: mean aortic valve gradient ≥ 20mmHg, EOA ≤0.9-1.1 cm2, and/or DVI\\\\< 0.35, and/or moderate or severe prosthetic valve regurgitation (See VARC-2 and Figure 4 from VARC manuscript), 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure "Inclusion Criteria:~1. Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use (Patients which are included but treated outside of the approved indication will be followed for safety reasons).~2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry. Patient agrees that anonymized imaging data will be sent to and analyzed by an external Core Laboratory.~3. The treating physician should ensure the subject will return for all required post procedure follow-up visits.~Exclusion Criteria:~1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.", Similarity Score: 0.1024637588379592}'}]
|
from_dataset
| 0.102464
|
[{'from': 'human', 'value': '{Study Title: Case Series With Saneso 360° Gastroscope, Primary Outcome Measures: Successful EGD, Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken., Within 24 hours on study day, Secondary Outcome Measures: Endoscopist qualitative rating of the Saneso 360° gastroscope, Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable)., Within 24 hours on study day|Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG), Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG)., Within 7 days of completion of the study|Evaluation of adverse events (AEs) related to the device., AEs are assessed through 7 days after the procedure., Within 7 days of completion of the study|Evaluation of any potential mucosal injury, Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear)., Immediately after the use of the device, criteria: "Inclusion Criteria:~* 18 -74 years of age~* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.~* Scheduled for a clinically indicated routine EGD procedure~* ASA class 1-3.~Exclusion Criteria:~* Altered esophageal, gastric, or duodenal anatomy~* Pregnant women, children under 18 years of age, and adults over 75 years of age.~* Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.~* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor~* ASA class 4-5."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 708, Unnamed: 0: 884, NCT Number: NCT05093244, Study Title: Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment, Study URL: https://clinicaltrials.gov/study/NCT05093244, Acronym: RESPECT-ISR, Study Status: WITHDRAWN, Brief Summary: The objective of this study is to establish reasonable assurance of safety and effectiveness to support an FDA premarket approval (PMA) application for the SeQuent® Please ReX™ Drug Coated PTCA Balloon Catheter as indicated., Study Results: NO, Conditions: In-stent Coronary Artery Restenosis|Coronary Artery Restenosis|In-stent Restenosis, Interventions: DEVICE: SeQuent Please ReX|DEVICE: Plain old balloon angioplasty (POBA), Primary Outcome Measures: Freedom from target lesion failure (TLF), TLF is defined as the composite of any of the following events:\\n\\n* Clinically-driven target lesion revascularization (TLR)\\n* Myocardial infarction (MI; not clearly attributable to a nontarget vessel)\\n* Cardiovascular death, 12 months post-procedure, Secondary Outcome Measures: Late lumen loss (LLL), Assessed on the first 100 subjects reaching 9-month follow-up (angiographic cohort). Minimum lumen diameter (MLD) assessed at follow-up angiography minus the MLD assessed immediately after the index procedure. MLDs are measured by qualitative comparative analysis., 9 months post-procedure|All death, Death of subject., 12 months post-procedure and annually thereafter to study completion|Cardiovascular death, Death resulting from cardiovascular causes., 12 months post-procedure and annually thereafter to study completion|Myocardial infarction (MI), Not clearly attributable to a nontarget vessel, 12 months post-procedure and annually thereafter to study completion|Major adverse cardiac events (MACE), Defined as the composite of all death, clinically-driven TLR, and MI, 12 months post-procedure and annually thereafter to study completion|Stent thrombosis, Early, late, or very late; ARC category of definite or probable, 12 months post-procedure and annually thereafter to study completion|Clinically-driven target lesion revascularization (TLR), Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion., 12 months post-procedure and annually thereafter to study completion|Clinically-driven target vessel revascularization (TVR), Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion., 12 months post-procedure and annually thereafter to study completion|Device, lesion, and procedural success, Device success defined as achievement of a final residual stenosis of ≤30% (as determined by the angiographic core lab), using the SeQuent Please ReX or control balloon. Lesion success defined as achievement of a final residual stenosis of ≤0% (as determined by the angiographic core lab), using any device. Procedural success defined as lesion success without the occurrence of major adverse events during the procedure, where "major adverse event" is considered to be an event without the occurrence of in-hospital MI, TVR, or cardiac death., Post-procedure (device and lesion success) and at discharge (procedural success), Other Outcome Measures: , Sponsor: B. Braun Medical Inc., Collaborators: Bright Research Partners|Infraredx, Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 0.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: BIS-CL-5001, Start Date: 2023-02-10, Primary Completion Date: 2023-02-10, Completion Date: 2023-02-10, First Posted: 2021-10-26, Results First Posted: , Last Update Posted: 2023-02-14, Locations: , Study Documents: , criteria: "INCLUSION CRITERIA:~1. ISR (\\\\>50%) of a metallic coronary stent of any type (BMS or DES)~2. Symptomatic ischemic heart disease, including:~ * Chronic stable angina (and/or objective evidence of myocardial ischemia on functional study or fractional flow reserve \\\\[FFR\\\\] measurement) or~ * Acute coronary syndrome (unstable angina or non-ST-elevation myocardial infarction (NSTEMI)), who require elective or urgent percutaneous coronary intervention (PCI)~3. One or two ISR lesions requiring treatment~ * ISR lesions may be located in two different vessels~ * Additional non-ISR (de novo) lesions are permitted and may be located in the target or other vessels~4. Target lesion reference vessel diameter is ≥2.0 or ≤4.0 mm by visual estimation~5. Total lesion length less than or equal to 34 mm by visual estimation (to permit treatment with balloon up to 40 mm)~6. Male or female, age 18 years or older~7. Willing to provide written informed consent and written HIPAA authorization prior to initiation of study procedures~8. Willing to comply with the specified follow-up visits~9. Willing and able to comply with post-treatment medications (dual antiplatelet therapy (DAPT) followed by life-long aspirin)~10. Non-target lesions must be treated successfully (i.e., residual diameter stenosis \\\\<30% without complications) before proceeding to treatment of ISR lesion(s)~EXCLUSION CRITERIA:~1. Target lesion has undergone more than two prior stent implant procedures, i.e., more than two layers of stent are present at any segment of target lesion~2. Presents with ST-elevation myocardial infarction (STEMI)~3. STEMI within the past 72 hours~4. Chronic kidney disease, defined as glomerular filtration rate (GFR) \\\\<15 ml/min/1.73m\\\\^2 on baseline labs~5. Thrombocytopenia, defined as a platelet count of \\\\<50,000 microL on baseline labs~6. Target lesion is a chronic total occlusion~7. Bleeding diathesis, coagulopathy, or contraindication to antiplatelet therapy~8. Target lesion restenosis is within a bio-resorbable scaffold~9. Target lesion is located within the left main~10. Pregnant (verified with a urine or blood pregnancy test), breast-feeding, or planning to become pregnant~11. Severely disabled and/or life expectancy appears limited (≤12 months) according to the investigator\\s opinion~12. Known hypersensitivity to paclitaxel and/or resveratrol or any of the product ingredients~13. Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints~Note: Bifurcation lesions are not excluded; however, the main branch should be treated per randomization, and the side branch should be treated provisionally per current standard of care.~Angiographic Exclusion Criteria:~Subjects must not meet any of the following angiographic exclusion criteria after lesion preparation:~1. Dissection type C - F~2. TIMI \\\\< III~3. Residual stenosis \\\\>30%", combined_text: Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment Freedom from target lesion failure (TLF), TLF is defined as the composite of any of the following events:\\n\\n* Clinically-driven target lesion revascularization (TLR)\\n* Myocardial infarction (MI; not clearly attributable to a nontarget vessel)\\n* Cardiovascular death, 12 months post-procedure Late lumen loss (LLL), Assessed on the first 100 subjects reaching 9-month follow-up (angiographic cohort). Minimum lumen diameter (MLD) assessed at follow-up angiography minus the MLD assessed immediately after the index procedure. MLDs are measured by qualitative comparative analysis., 9 months post-procedure|All death, Death of subject., 12 months post-procedure and annually thereafter to study completion|Cardiovascular death, Death resulting from cardiovascular causes., 12 months post-procedure and annually thereafter to study completion|Myocardial infarction (MI), Not clearly attributable to a nontarget vessel, 12 months post-procedure and annually thereafter to study completion|Major adverse cardiac events (MACE), Defined as the composite of all death, clinically-driven TLR, and MI, 12 months post-procedure and annually thereafter to study completion|Stent thrombosis, Early, late, or very late; ARC category of definite or probable, 12 months post-procedure and annually thereafter to study completion|Clinically-driven target lesion revascularization (TLR), Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion., 12 months post-procedure and annually thereafter to study completion|Clinically-driven target vessel revascularization (TVR), Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion., 12 months post-procedure and annually thereafter to study completion|Device, lesion, and procedural success, Device success defined as achievement of a final residual stenosis of ≤30% (as determined by the angiographic core lab), using the SeQuent Please ReX or control balloon. Lesion success defined as achievement of a final residual stenosis of ≤0% (as determined by the angiographic core lab), using any device. Procedural success defined as lesion success without the occurrence of major adverse events during the procedure, where "major adverse event" is considered to be an event without the occurrence of in-hospital MI, TVR, or cardiac death., Post-procedure (device and lesion success) and at discharge (procedural success) "INCLUSION CRITERIA:~1. ISR (\\\\>50%) of a metallic coronary stent of any type (BMS or DES)~2. Symptomatic ischemic heart disease, including:~ * Chronic stable angina (and/or objective evidence of myocardial ischemia on functional study or fractional flow reserve \\\\[FFR\\\\] measurement) or~ * Acute coronary syndrome (unstable angina or non-ST-elevation myocardial infarction (NSTEMI)), who require elective or urgent percutaneous coronary intervention (PCI)~3. One or two ISR lesions requiring treatment~ * ISR lesions may be located in two different vessels~ * Additional non-ISR (de novo) lesions are permitted and may be located in the target or other vessels~4. Target lesion reference vessel diameter is ≥2.0 or ≤4.0 mm by visual estimation~5. Total lesion length less than or equal to 34 mm by visual estimation (to permit treatment with balloon up to 40 mm)~6. Male or female, age 18 years or older~7. Willing to provide written informed consent and written HIPAA authorization prior to initiation of study procedures~8. Willing to comply with the specified follow-up visits~9. Willing and able to comply with post-treatment medications (dual antiplatelet therapy (DAPT) followed by life-long aspirin)~10. Non-target lesions must be treated successfully (i.e., residual diameter stenosis \\\\<30% without complications) before proceeding to treatment of ISR lesion(s)~EXCLUSION CRITERIA:~1. Target lesion has undergone more than two prior stent implant procedures, i.e., more than two layers of stent are present at any segment of target lesion~2. Presents with ST-elevation myocardial infarction (STEMI)~3. STEMI within the past 72 hours~4. Chronic kidney disease, defined as glomerular filtration rate (GFR) \\\\<15 ml/min/1.73m\\\\^2 on baseline labs~5. Thrombocytopenia, defined as a platelet count of \\\\<50,000 microL on baseline labs~6. Target lesion is a chronic total occlusion~7. Bleeding diathesis, coagulopathy, or contraindication to antiplatelet therapy~8. Target lesion restenosis is within a bio-resorbable scaffold~9. Target lesion is located within the left main~10. Pregnant (verified with a urine or blood pregnancy test), breast-feeding, or planning to become pregnant~11. Severely disabled and/or life expectancy appears limited (≤12 months) according to the investigator\\s opinion~12. Known hypersensitivity to paclitaxel and/or resveratrol or any of the product ingredients~13. Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints~Note: Bifurcation lesions are not excluded; however, the main branch should be treated per randomization, and the side branch should be treated provisionally per current standard of care.~Angiographic Exclusion Criteria:~Subjects must not meet any of the following angiographic exclusion criteria after lesion preparation:~1. Dissection type C - F~2. TIMI \\\\< III~3. Residual stenosis \\\\>30%", Similarity Score: 0.10060942820168049}'}]
|
from_dataset
| 0.100609
|
[{'from': 'human', 'value': '{Study Title: Case Series With Saneso 360° Gastroscope, Primary Outcome Measures: Successful EGD, Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken., Within 24 hours on study day, Secondary Outcome Measures: Endoscopist qualitative rating of the Saneso 360° gastroscope, Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable)., Within 24 hours on study day|Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG), Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG)., Within 7 days of completion of the study|Evaluation of adverse events (AEs) related to the device., AEs are assessed through 7 days after the procedure., Within 7 days of completion of the study|Evaluation of any potential mucosal injury, Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear)., Immediately after the use of the device, criteria: "Inclusion Criteria:~* 18 -74 years of age~* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.~* Scheduled for a clinically indicated routine EGD procedure~* ASA class 1-3.~Exclusion Criteria:~* Altered esophageal, gastric, or duodenal anatomy~* Pregnant women, children under 18 years of age, and adults over 75 years of age.~* Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.~* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor~* ASA class 4-5."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 205, Unnamed: 0: 250, NCT Number: NCT05605691, Study Title: Post-Market Lower Eyelid Treatment With Renuvion in Greece, Study URL: https://clinicaltrials.gov/study/NCT05605691, Acronym: , Study Status: COMPLETED, Brief Summary: This is a prospective, multi-center, non-randomized, single-arm study of up to 15 subjects treated with the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System in the lower periorbital area on both sides of the face., Study Results: NO, Conditions: Skin Laxity, Interventions: DEVICE: Renuvion APR System, Primary Outcome Measures: "Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment., Improvement in the lower eyelid area as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers. Improvement will be assessed based on photographs taken at all visits using the sites 2D camera system., 180-Day", Secondary Outcome Measures: "Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment., Improvement in the lower eyelid area as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers. Improvement will be assessed based on photographs taken at all visits using the sites 2D camera system., 90-Day", Other Outcome Measures: Snap-Back Test Grade Analysis of Change from Baseline to Day 30, This test provides relative lower lid laxity. In normal lids, the skin snaps-back to the original position immediately; the longer it takes, the more laxity is present. To perform the snap-back test, pull the lower lid away and down from globe for several seconds and wait to see how long it returns to the original position without the subject blinking. Grade 0 (Normal lid that returns to position immediately on release), Grade I (Approx 2-3 seconds to return to original position), Grade II (4-5 seconds to return to original position), Grade III (\\\\>5 seconds but does return to original position with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test)., 30-Day|Snap-Back Test Grade Analysis of Change from Baseline to Day 90, This test provides relative lower lid laxity. In normal lids, the skin snaps-back to the original position immediately; the longer it takes, the more laxity is present. To perform the snap-back test, pull the lower lid away and down from globe for several seconds and wait to see how long it returns to the original position without the subject blinking. Grade 0 (Normal lid that returns to position immediately on release), Grade I (Approx 2-3 seconds to return to original position), Grade II (4-5 seconds to return to original position), Grade III (\\\\>5 seconds but does return to original position with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test)., 90-Day|Snap-Back Test Grade Analysis of Change from Baseline to Day 180, This test provides relative lower lid laxity. In normal lids, the skin snaps-back to the original position immediately; the longer it takes, the more laxity is present. To perform the snap-back test, pull the lower lid away and down from globe for several seconds and wait to see how long it returns to the original position without the subject blinking. Grade 0 (Normal lid that returns to position immediately on release), Grade I (Approx 2-3 seconds to return to original position), Grade II (4-5 seconds to return to original position), Grade III (\\\\>5 seconds but does return to original position with blinking), Grade IV (never returns to original position and continues to hand down in frank ectropion after the snap-back test)., 180-Day|Medical Canthal Laxity Test Analysis of Change from Baseline to Day 30, This test provides medial canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the medial canthal laxity test, pull the lower lid laterally away from the medial canthus and measure displacement of medial punctum. Grade 0 (\\\\<2mm displacement), Grade I (approx 2mm displacement), Grade II (approx 3mm displacement), Grade III (\\\\>3mm displacement), Grade IV (does not return to baseline after release and blinking)., 30-Day|Medical Canthal Laxity Test Analysis of Change from Baseline to Day 90, This test provides medial canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the medial canthal laxity test, pull the lower lid laterally away from the medial canthus and measure displacement of medial punctum. Grade 0 (\\\\<2mm displacement), Grade I (approx 2mm displacement), Grade II (approx 3mm displacement), Grade III (\\\\>3mm displacement), Grade IV (does not return to baseline after release and blinking)., 90-Day|Medical Canthal Laxity Test Analysis of Change from Baseline to Day 180, This test provides medial canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the medial canthal laxity test, pull the lower lid laterally away from the medial canthus and measure displacement of medial punctum. Grade 0 (\\\\<2mm displacement), Grade I (approx 2mm displacement), Grade II (approx 3mm displacement), Grade III (\\\\>3mm displacement), Grade IV (does not return to baseline after release and blinking)., 180-Day|Lateral Canthal Laxity Test Analysis of Change from Baseline to Day 30, This test provides lateral canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the lateral canthal laxity test, pull the lower lid medially away from the lateral canthus and measure displacement of lateral canthal corner. Grade 0 (\\\\<2mm displacement), Grade I (2-4mm displacement), Grade II (4-6mm displacement), Grade III (\\\\>6mm displacement), Grade IV (does not return to baseline after release and blinking)., 30-Day|Lateral Canthal Laxity Test Analysis of Change from Baseline to Day 90, This test provides lateral canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the lateral canthal laxity test, pull the lower lid medially away from the lateral canthus and measure displacement of lateral canthal corner. Grade 0 (\\\\<2mm displacement), Grade I (2-4mm displacement), Grade II (4-6mm displacement), Grade III (\\\\>6mm displacement), Grade IV (does not return to baseline after release and blinking)., 90-Day|Lateral Canthal Laxity Test Analysis of Change from Baseline to Day 180, This test provides lateral canthal laxity by means of measuring displacement. The greater the distance, the more the laxity. To perform the lateral canthal laxity test, pull the lower lid medially away from the lateral canthus and measure displacement of lateral canthal corner. Grade 0 (\\\\<2mm displacement), Grade I (2-4mm displacement), Grade II (4-6mm displacement), Grade III (\\\\>6mm displacement), Grade IV (does not return to baseline after release and blinking)., 180-Day|Subject Modified Global Aesthetic Improvement Scale (GAIS), The subject will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse., 90-Day|Subject Modified Global Aesthetic Improvement Scale (GAIS), The subject will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse., 180-Day|Investigator Modified Global Aesthetic Improvement Scale (GAIS), The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse., 90-Day|Investigator Modified Global Aesthetic Improvement Scale (GAIS), The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, and very much worse., 180-Day|Day 180 Patient Satisfaction Questionnaire (PSQ), At Day 180 Follow-Up visit, the study subjects will be asked to complete a subject satisfaction survey referring to the assessment of baseline photos, current photos, and a hand mirror. Yes/No - did you notice any improvement in your lower eyelid area? If yes, checkbox - improvement in wrinkles, less sagging skin, smother skin texture, other. How would you characterize your satisfaction with the treatment - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - would you recommend this treatment to your friends and family members., 180-Day|Average Pain at Procedure Day Reported by Subject, Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain", Procedure Day 0|Average Pain at Day 1 Reported by Subject, Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain", 1-Day|Average Pain at Day 3 Reported by Subject, Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain", 3-Day|Average Pain at Day 7 Reported by Subject, Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain", 7-Day|Average Pain at Day 30 Reported by Subject, Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain", 30-Day|Average Pain at Day 90 Reported by Subject, Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain", 90-Day|Average Pain at Day 180 Reported by Subject, Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is "No Pain" and 10 is "Worst Possible Pain", 180-Day, Sponsor: Apyx Medical, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 16.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: APX-22-04, Start Date: 2022-10-11, Primary Completion Date: 2024-03-05, Completion Date: 2024-03-05, First Posted: 2022-11-04, Results First Posted: , Last Update Posted: 2024-04-05, Locations: Metropolitan General Hospital, Athens, 15562, Greece, Study Documents: , criteria: "Inclusion Criteria:~* Male or female subjects, ages 18 - 75 years old.~* ASA Physical Status Classification System Class I and Class II subjects.~* Complaint of skin laxity or lines in the lower eyelid area.~* Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.~* Absence of physical conditions unacceptable to the investigator.~* Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.~* Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.~* Willing to release rights for the use of study photos, including in publication.~* Able to read, understand, sign, and date the informed consent.~* Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.~Exclusion Criteria:~* Subjects presenting with ASA Physical Status Classification System Classes III or higher.~* Festoons in the periorbital area.~* Prior cosmetic/aesthetic fillers (hyaluronic acid, poly-l-lactic acid, calcium hydroxylapatite, et.) in the study treatment area within the past 12 months.~* Pregnant, lactating, or plans to become pregnant during study participation.~* Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).~* Known hypersensitivity or allergy to ibuprofen or other NSAIDS.~* Previous surgery in the study treatment area.~* Active systemic or local skin disease that may alter wound healing.~* Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient\\s health.~* History of autoimmune disease (excluding Hashimoto\\s thyroiditis).~* Known susceptibility to keloid formation or hypertrophic scarring.~* Cancerous or pre-cancerous lesions in the area to be treated.~* Possesses a surgically implanted electronic device (i.e., pacemaker).~* Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.~* Participation in any other investigational study within 30 days prior to consent and throughout study participation.~* Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.", combined_text: Post-Market Lower Eyelid Treatment With Renuvion in Greece Day 180 Number of Participants With Improvement in Lower Eyelid Area as Determined by a Masked, Qualitative Assessment., Improvement in the lower eyelid area as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers. Improvement will be assessed based on photographs taken at all visits using the site\\s 2D camera system., 180-Day Day 90 Number of Participants With Improvement in the Lower Eyelid Area as Determined by a Masked, Qualitative Assessment., Improvement in the lower eyelid area as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers. Improvement will be assessed based on photographs taken at all visits using the site\\s 2D camera system., 90-Day "Inclusion Criteria:~* Male or female subjects, ages 18 - 75 years old.~* ASA Physical Status Classification System Class I and Class II subjects.~* Complaint of skin laxity or lines in the lower eyelid area.~* Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.~* Absence of physical conditions unacceptable to the investigator.~* Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.~* Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.~* Willing to release rights for the use of study photos, including in publication.~* Able to read, understand, sign, and date the informed consent.~* Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.~Exclusion Criteria:~* Subjects presenting with ASA Physical Status Classification System Classes III or higher.~* Festoons in the periorbital area.~* Prior cosmetic/aesthetic fillers (hyaluronic acid, poly-l-lactic acid, calcium hydroxylapatite, et.) in the study treatment area within the past 12 months.~* Pregnant, lactating, or plans to become pregnant during study participation.~* Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).~* Known hypersensitivity or allergy to ibuprofen or other NSAIDS.~* Previous surgery in the study treatment area.~* Active systemic or local skin disease that may alter wound healing.~* Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient\\s health.~* History of autoimmune disease (excluding Hashimoto\\s thyroiditis).~* Known susceptibility to keloid formation or hypertrophic scarring.~* Cancerous or pre-cancerous lesions in the area to be treated.~* Possesses a surgically implanted electronic device (i.e., pacemaker).~* Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.~* Participation in any other investigational study within 30 days prior to consent and throughout study participation.~* Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.", Similarity Score: 0.09803904792112174}'}]
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[{'from': 'human', 'value': '{Study Title: Case Series With Saneso 360° Gastroscope, Primary Outcome Measures: Successful EGD, Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken., Within 24 hours on study day, Secondary Outcome Measures: Endoscopist qualitative rating of the Saneso 360° gastroscope, Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable)., Within 24 hours on study day|Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG), Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG)., Within 7 days of completion of the study|Evaluation of adverse events (AEs) related to the device., AEs are assessed through 7 days after the procedure., Within 7 days of completion of the study|Evaluation of any potential mucosal injury, Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear)., Immediately after the use of the device, criteria: "Inclusion Criteria:~* 18 -74 years of age~* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.~* Scheduled for a clinically indicated routine EGD procedure~* ASA class 1-3.~Exclusion Criteria:~* Altered esophageal, gastric, or duodenal anatomy~* Pregnant women, children under 18 years of age, and adults over 75 years of age.~* Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.~* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor~* ASA class 4-5."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 212, Unnamed: 0: 257, NCT Number: NCT04693091, Study Title: Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology, Study URL: https://clinicaltrials.gov/study/NCT04693091, Acronym: REMAP-WEST-FEA, Study Status: UNKNOWN, Brief Summary: "The aim of this study is to explore the acceptability and feasibility of a novel medical device system for remote monitoring of breath and heart sounds (replicating remotely, and in an easy-to-use garment, that which a clinician would do with their stethoscope to listen to a patients chest, by evaluating sounds captured through a wearable device (Senti)). As a first-in-man study, the investigators will investigate the safety of the Senti device, the usability and acceptability of the device; and ensure technical and practical feasibility of the device in a real-world clinical setting.\\n\\n10 patients will be recruited (the study participants) in two tranches (6 and 4) who are being discharged from A\\\\&E into the care of the community respiratory team. These patients will wear the Senti device. The first tranche will use the device over a single session lasting 20 minutes only. The second tranche (which will include patients from tranche one, and which will only proceed if no adverse events are detected in tranche one), participants will wear the device at their discretion (particularly encouraged to wear overnight) over the course of 5 days. The investigators will survey the study participants to answer three key questions:\\n\\n1. What is the feasibility of the Senti data-capture device?\\n2. Is this device usable in clinical practice?\\n3. What are the requirements to train patients to use the device?\\n\\n The investigators will also consider:\\n4. Does the device function technically and practically, in real-world clinical scenarios?\\n5. What are the key expected and unexpected safety issues related to using the device (with a particular emphasis on whether the device is likely to cause pressure sores).\\n\\nThese questions will establish the feasibility of using the Senti data capture device as part of a novel medical device system for the autonomous evaluation and monitoring of bioacoustic signals.", Study Results: NO, Conditions: Respiratory Disease, Interventions: DEVICE: Senti V1.0 Device, Primary Outcome Measures: Patient-rated device acceptability, Patient questionnaire "on a scale of 1 ("I would not approve at all") to 5 ("I would greatly approve and would like this to become standard practice"), to what extent would you approve of this device being used to enable clinicians to assess your heart and lung sounds as part of a telephone consultation?", 1 month|Patient-rated device comfort, Patient questionnaire "on a scale of 1 ("Very difficult to use") to 5 ("Very easy to use"), how easy to use is the device?", 1 month|Patient-rated device ease of use, Patient questionnaire "on a scale of 1 ("Too uncomfortable to use for more than an hours or so") to 5 ("As comfortable as a T-Shirt"), how comfortable is the device?", 1 month|Expert-rated device data quality, An appropriately qualified person (with clinical experience of auscultation) to rate quality of data captured by the device, as compared subjectively against the quality that they typically expect from standard auscultation, on a scale of 1 ("Much poorer data quality \\\\[than standard auscultation\\\\]") to 3 ("equivocal data quality") to 5 ("Much higher data quality")., 1 month|Adverse events and adverse device events., The number of participants experiencing adverse events, both arising from use of the device or otherwise, will be reported. Adverse events will be categorised as unexpected or expected, serious or otherwise, device-related or un-related., 1 month, Secondary Outcome Measures: Length of time spent with the device on the patient., Length of time over which a patient has used the device, as measured using a structured, binned multiple-choice survey. This is a custom-made scale titled "In the past 24 hours, for how many hours have you worn the Senti device?" with a minimum value of 0 hours and a maximum value of 24 hours. 8 options which include a range of times are available for selection., 1 month|Length of time taken for the patient to apply the device, Length of time taken for the patient to put the device on, as measured by an investigator with a stop watch., 1 month|Time spent to train patients to use the device., Length of time taken to train patients to use the device, as measured by an investigator with a stop watch., 1 month|Pressure sore EPUAP grade, For those patients who develop pressure sores, the pressure sore will be graded using the European Pressure Ulcer Advisory Panel grading system from a grade of grade 1 through to grade 4, including unclassified gradings and moisture lesions. (Patients will be graded as "No pressure sores" if there are no pressure sores noted on examination)., Through study completion, once per day., Other Outcome Measures: , Sponsor: Senti Tech Ltd, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 10.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY, Other IDs: Senti-REMAP-WEST-FEA-1, Start Date: 2021-02, Primary Completion Date: 2021-03, Completion Date: 2021-04, First Posted: 2021-01-05, Results First Posted: , Last Update Posted: 2021-01-05, Locations: Senti Tech, Liverpool, Merseyside, L1 0AX, United Kingdom, Study Documents: , criteria: "Inclusion Criteria:~* Patients attending A\\\\&E who are being discharged from A\\\\&E into the care of the community respiratory team.~Exclusion Criteria:~* Patients unable to give their consent.~* Patients with a known sensitivity or allergy to any of the components of the device.~* Patients with any active implanted devices (such as pacemakers or vagal nerve stimulators).~* Patients with existing pressure sores across the area this device would come into contact (predominantly, across the thorax).~* Patients with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own ADLs; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).", combined_text: Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology Patient-rated device acceptability, Patient questionnaire "on a scale of 1 ("I would not approve at all") to 5 ("I would greatly approve and would like this to become standard practice"), to what extent would you approve of this device being used to enable clinicians to assess your heart and lung sounds as part of a telephone consultation?", 1 month|Patient-rated device comfort, Patient questionnaire "on a scale of 1 ("Very difficult to use") to 5 ("Very easy to use"), how easy to use is the device?", 1 month|Patient-rated device ease of use, Patient questionnaire "on a scale of 1 ("Too uncomfortable to use for more than an hours or so") to 5 ("As comfortable as a T-Shirt"), how comfortable is the device?", 1 month|Expert-rated device data quality, An appropriately qualified person (with clinical experience of auscultation) to rate quality of data captured by the device, as compared subjectively against the quality that they typically expect from standard auscultation, on a scale of 1 ("Much poorer data quality \\\\[than standard auscultation\\\\]") to 3 ("equivocal data quality") to 5 ("Much higher data quality")., 1 month|Adverse events and adverse device events., The number of participants experiencing adverse events, both arising from use of the device or otherwise, will be reported. Adverse events will be categorised as unexpected or expected, serious or otherwise, device-related or un-related., 1 month Length of time spent with the device on the patient., Length of time over which a patient has used the device, as measured using a structured, binned multiple-choice survey. This is a custom-made scale titled "In the past 24 hours, for how many hours have you worn the Senti device?" with a minimum value of 0 hours and a maximum value of 24 hours. 8 options which include a range of times are available for selection., 1 month|Length of time taken for the patient to apply the device, Length of time taken for the patient to put the device on, as measured by an investigator with a stop watch., 1 month|Time spent to train patients to use the device., Length of time taken to train patients to use the device, as measured by an investigator with a stop watch., 1 month|Pressure sore EPUAP grade, For those patients who develop pressure sores, the pressure sore will be graded using the European Pressure Ulcer Advisory Panel grading system from a grade of grade 1 through to grade 4, including unclassified gradings and moisture lesions. (Patients will be graded as "No pressure sores" if there are no pressure sores noted on examination)., Through study completion, once per day. "Inclusion Criteria:~* Patients attending A\\\\&E who are being discharged from A\\\\&E into the care of the community respiratory team.~Exclusion Criteria:~* Patients unable to give their consent.~* Patients with a known sensitivity or allergy to any of the components of the device.~* Patients with any active implanted devices (such as pacemakers or vagal nerve stimulators).~* Patients with existing pressure sores across the area this device would come into contact (predominantly, across the thorax).~* Patients with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own ADLs; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).", Similarity Score: 0.08803416979011837}'}]
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[{'from': 'human', 'value': '{Study Title: Case Series With Saneso 360° Gastroscope, Primary Outcome Measures: Successful EGD, Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken., Within 24 hours on study day, Secondary Outcome Measures: Endoscopist qualitative rating of the Saneso 360° gastroscope, Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable)., Within 24 hours on study day|Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG), Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG)., Within 7 days of completion of the study|Evaluation of adverse events (AEs) related to the device., AEs are assessed through 7 days after the procedure., Within 7 days of completion of the study|Evaluation of any potential mucosal injury, Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear)., Immediately after the use of the device, criteria: "Inclusion Criteria:~* 18 -74 years of age~* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.~* Scheduled for a clinically indicated routine EGD procedure~* ASA class 1-3.~Exclusion Criteria:~* Altered esophageal, gastric, or duodenal anatomy~* Pregnant women, children under 18 years of age, and adults over 75 years of age.~* Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.~* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor~* ASA class 4-5."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 343, Unnamed: 0: 415, NCT Number: NCT04252573, Study Title: Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication, Study URL: https://clinicaltrials.gov/study/NCT04252573, Acronym: ChEVAS One, Study Status: ACTIVE_NOT_RECRUITING, Brief Summary: Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms., Study Results: NO, Conditions: 1 Paravisceral Abdominal Aortic Aneurysm|2 Juxtarenal Abdominal Aortic Aneurysm|3 Pararenal Abdominal Aortic Aneurysm|4 Complex Abdominal Aortic Aneurysms, Interventions: DEVICE: Chimney Endovascular Aortic Sealing (ChEVAS) System, Primary Outcome Measures: Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure, The outcome at one-month post index procedure will be measured by the proportion of subjects that experience technical success and the absence of severe bowel ischemia, permanent paraplegia/paraparesis, renal failure, disabling stroke, abdominal aortic aneurysm rupture, and aneurysm-related mortality within 30-days of the index procedure., 1-Month|Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure, The outcome at one-year post index procedure will be measured by the proportion of subjects that experience freedom from abdominal aortic aneurysm rupture and aneurysm-related mortality up until 1-year (day 365), freedom from imaging-related findings in the 1-year window (Type 1 or 3 endoleak, migration \\\\> 10mm, AAA sac expansion \\\\> 5mm, and occlusion within the ChEVAS System not seen at the index procedure), and open conversion through day 365., 1-Year, Secondary Outcome Measures: , Other Outcome Measures: , Sponsor: Endologix, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 13.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: CP-0015, Start Date: 2020-06-29, Primary Completion Date: 2022-10-19, Completion Date: 2028-03, First Posted: 2020-02-05, Results First Posted: , Last Update Posted: 2024-04-05, Locations: Valley Vascular Consultants, Huntsville, Alabama, 35801, United States|MedStar Health Research Institute, Washington, District of Columbia, 20010, United States|Emory University, Atlanta, Georgia, 30322, United States|St Vincent Medical Group, Indianapolis, Indiana, 46260, United States|University of Missouri, Columbia, Missouri, 65212, United States|Cooper University Hospital, Camden, New Jersey, 08103, United States|Icahn School of Medicine at Mount Sinai, New York, New York, 10019, United States|Providence Portland, Portland, Oregon, 97213, United States, Study Documents: , criteria: "Inclusion Criteria:~* Adults at least 18-years old~* Subject provided informed consent~* Subject agrees to all follow-up visits~* Abdominal aortic aneurysm (AAA) with maximum sac diameter ≥5.0 cm, or ≥ 4.5 cm which has increased by ≥ 0.5cm within the last 6-months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA \\\\<4cm will be included~* Absence of significant cranial angulation of the visceral vessels that would preclude vessel cannulation and stenting~Exclusion Criteria:~* Requirement of home oxygen~* Psychiatric or other condition that may interfere with the study~* Participating in another clinical drug and/or device study, which could confound the results of this study (patient must have completed the primary endpoint of any previous study at least 30-days prior to enrollment in this study)~* Known allergy or contraindication to any device material, contrast, or anticoagulants~* Serum creatinine level \\\\>1.8mg/dL~* CVA or MI within three months of enrollment/treatment~* Prior stent in any target visceral vessel, the aorta or iliac artery that may interfere with delivery system introduction or stent placement~* Connective tissue diseases (e.g., Marfan Syndrome)~* Unsuitable vascular anatomy that may interfere with device introduction or deployment~* Pregnant, planning to become pregnant within 60 months, or breast feeding.", combined_text: Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure, The outcome at one-month post index procedure will be measured by the proportion of subjects that experience technical success and the absence of severe bowel ischemia, permanent paraplegia/paraparesis, renal failure, disabling stroke, abdominal aortic aneurysm rupture, and aneurysm-related mortality within 30-days of the index procedure., 1-Month|Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure, The outcome at one-year post index procedure will be measured by the proportion of subjects that experience freedom from abdominal aortic aneurysm rupture and aneurysm-related mortality up until 1-year (day 365), freedom from imaging-related findings in the 1-year window (Type 1 or 3 endoleak, migration \\\\> 10mm, AAA sac expansion \\\\> 5mm, and occlusion within the ChEVAS System not seen at the index procedure), and open conversion through day 365., 1-Year "Inclusion Criteria:~* Adults at least 18-years old~* Subject provided informed consent~* Subject agrees to all follow-up visits~* Abdominal aortic aneurysm (AAA) with maximum sac diameter ≥5.0 cm, or ≥ 4.5 cm which has increased by ≥ 0.5cm within the last 6-months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA \\\\<4cm will be included~* Absence of significant cranial angulation of the visceral vessels that would preclude vessel cannulation and stenting~Exclusion Criteria:~* Requirement of home oxygen~* Psychiatric or other condition that may interfere with the study~* Participating in another clinical drug and/or device study, which could confound the results of this study (patient must have completed the primary endpoint of any previous study at least 30-days prior to enrollment in this study)~* Known allergy or contraindication to any device material, contrast, or anticoagulants~* Serum creatinine level \\\\>1.8mg/dL~* CVA or MI within three months of enrollment/treatment~* Prior stent in any target visceral vessel, the aorta or iliac artery that may interfere with delivery system introduction or stent placement~* Connective tissue diseases (e.g., Marfan Syndrome)~* Unsuitable vascular anatomy that may interfere with device introduction or deployment~* Pregnant, planning to become pregnant within 60 months, or breast feeding.", Similarity Score: 0.08720014845624917}'}]
|
from_dataset
| 0.0872
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[{'from': 'human', 'value': '{Study Title: Case Series With Saneso 360° Gastroscope, Primary Outcome Measures: Successful EGD, Procedure success is assessed at the end of the procedure 1). Procedure success is defined as by successful intubation of the third portion of the duodenum. Photograph of the third portion of the duodenum will be taken., Within 24 hours on study day, Secondary Outcome Measures: Endoscopist qualitative rating of the Saneso 360° gastroscope, Endoscopists will rate their experience with the Saneso 360° gastroscope immediately following the completion of the study procedure 1) using a five-point Likert scales (5 - excellent; 4 - good; 3- acceptable; 2- difficult; and 1-unacceptable)., Within 24 hours on study day|Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG), Endoscopist qualitative rating of the Saneso 360° gastroscope compared to their past experience with traditional gastroscopes (TG) as it pertains to various design and performance related attributes using a 3-point Likert scale (Saneso gastroscope is 5 - superior to TG; 3 - the same as TG; 1 - inferior to TG)., Within 7 days of completion of the study|Evaluation of adverse events (AEs) related to the device., AEs are assessed through 7 days after the procedure., Within 7 days of completion of the study|Evaluation of any potential mucosal injury, Evaluation of any potential mucosal injury resulting from use of the study device immediately following the use of the device (0- no mucosal damage; 1- erythema; 2-bleeding; 3- superficial mucosal tear; 4- deep mucosal tear)., Immediately after the use of the device, criteria: "Inclusion Criteria:~* 18 -74 years of age~* Willing and able to comply with the study procedures and provide written informed consent to participate in the study.~* Scheduled for a clinically indicated routine EGD procedure~* ASA class 1-3.~Exclusion Criteria:~* Altered esophageal, gastric, or duodenal anatomy~* Pregnant women, children under 18 years of age, and adults over 75 years of age.~* Subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions.~* Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor~* ASA class 4-5."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 892, Unnamed: 0: 1118, NCT Number: NCT05705973, Study Title: Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients, Study URL: https://clinicaltrials.gov/study/NCT05705973, Acronym: NAGOMI COMPLEX, Study Status: RECRUITING, Brief Summary: The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster Nagomi™ sirolimus eluting coronary stent system (Ultimaster Nagomi™) in complex PCI subjects. The features for a complex PCI are based upon subgroup analysis of earlier published studies., Study Results: NO, Conditions: Cardiovascular Disease|Coronary Artery Occlusion|Ischemic Heart Disease, Interventions: DEVICE: Ultimaster Nagomi™, Primary Outcome Measures: Target Lesion Failure (TLF), Defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization., at 1-year post procedure, Secondary Outcome Measures: Delivery success, Delivery success is defined as an achievement of successful delivery of study stent to the target lesion, expansion of the study stent and withdrawal of the delivery catheter., Intraoperative|Lesion success, Lesion success is defined as the attainment of \\\\< 30% residual stenosis by visual estimate and/or \\\\< 50% (by QCA) using any percutaneous method (if QCA was not available, the visual estimate of diameter stenosis is used)., Intraoperative|Device success, Device Success is defined as delivery success with the achievement of a final residual diameter stenosis of the target lesion of \\\\< 30% by visual assessment and/or \\\\< 50% by QCA, using the assigned device only., Intraoperative|Procedure success, Procedure Success is defined as the achievement of \\\\< 30% residual stenosis by visual assessment in all target lesions using any percutaneous method without the occurrence of death, Q wave or WHO defined non-Q wave, or repeat revascularization of the target lesion during the hospital stay., during hospitalization, approximately 3 days|Target lesion failure (TLF), The composite of cardiovascular death, MI (not clearly attributable to a nontarget vessel) and clinically driven Target lesion revascularization (TLR)., at index procedure, 30 days, 6 months, 1 year, and 2 years|Patient oriented composite endpoint (POCE), Defined as composite of all-cause mortality, any MI and any coronary revascularization., at index procedure, 30 days, 6 months, 1 year, and 2 years|Death and subclassifications, Death may be subclassified as: Cardiovascular death, Noncardiovascular death or Undetermined death.\\n\\nCardiovascular death may include death caused by acute MI, death caused by sudden cardiac death, including unwitnessed, death resulting from heart failure, death caused by stroke, death caused by cardiovascular procedures, death resulting from cardiovascular hemorrhage, death resulting from other cardiovascular cause.\\n\\nNoncardiovascular death may include death from malignancy, death resulting from pulmonary causes, death caused by infection (including sepsis), death resulting from gastrointestinal causes, death resulting from accident/trauma, death caused by other noncardiovascular organ failure, death resulting from other.\\n\\nUndetermined cause of death is defined as a death not attributable to any other category because of the absence of any relevant source documents., at index procedure, 30 days, 6 months, 1 year, and 2 years|Myocardial infarction and subclassifications, Myocardial infarction - Absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit, plus 1 (or more) of the following criteria:\\n\\n* New significant\\\\* Q waves or equivalent\\n* Flow-limiting angiographic complications\\n* New "substantial" loss of myocardium on imaging \\\\* Q-wave criteria requires the development of new Q waves ≥40 ms in duration and ≥1 mm deep in voltage in ≥2 contiguous leads., at index procedure, 30 days, 6 months, 1 year, and 2 years|Revascularization and subclassifications, Successful revascularization of all lesions with angiographically a diameter stenosis ≥ 50%, at index procedure, 30 days, 6 months, 1 year, and 2 years|Stent thrombosis (ST) and subclassifications, Definite ST\\n\\nPresence of a thrombus that originates in the stent/scaffold or in the segment 5mm prox. or dist. to the stent/scaffold or in a side branch originating from the stented/scaffolded segment \\\\& at least 1 of the ff:\\n\\nAcute onset of ischemic symptoms at rest New ECG changes suggestive of acute ischemia Typical rise and fall in cardiac biomarkers Or Pathological confirmation of thrombosis Evidence of recent thrombus within the stent/scaffold determined at autopsy Examination of tissue retrieved ff. thrombectomy\\n\\nProbable ST Any MI that is related to documented acute ischemia in the territory of the implanted stent/scaffold w/out angiographic confirmation of stent/scaffold thrombosis and in the absence of any other obvious cause.\\n\\nOcclusive thrombus Thrombolysis in MI grade 0/1 flow w/in or prox. to a stent/scaffold segment. Nonocclusive thrombus Intracoronary thrombus defined as a noncalcified filling defect or lucency surrounded by contrast material seen in mu, at index procedure, 30 days, 6 months, 1 year, and 2 years|Bleeding (Bleeding Academic Research Consortium (BARC) 3-5), Type 3:Clinical, lab, and/or imaging evidence of bleeding w/ specific healthcare provider responses, as below:\\n\\nType 3a Any BT with overt bleeding Overt bleeding plus Hgb drop ≥3 to \\\\< 5 g/dL\\n\\nType 3b Overt bleeding plus Hgb drop ≥5 g/dL Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring IV vasoactive drugs\\n\\nType 3c Intracranial hemorrhage\\n\\nType 4:CABG-related bleeding Perioperative intracranial bleeding w/in 48 hr Reoperation after closure of sternotomy for bleeding control Transfusion of ≥5 U whole blood or packed RBC w/in a 48-hr period Chest tube output ≥2 L w/in a 24-hr period\\n\\nType 5:Fatal bleeding\\n\\nBleeding that directly causes death with no other explainable cause. Categorized as:\\n\\nType 5a Probable bleeding that is clinically suspicious as the cause of death, but bleeding is not directly observed and no autopsy or confirmatory imaging.\\n\\nType 5b Definite bleeding that is directly observed (clinical specimen or imaging), at index procedure, 30 days, 6 months, 1 year, and 2 years|Balance between bleeding (BARC 3-5) and thrombotic event (myocardial infarction and/or stent thrombosis), The number of patients with a BARC 3-5 bleeding in comparison to the number of patients with a myocardial infarction and/or a stent thrombosis., at index procedure, 30 days, 6 months, 1 year, and 2 years|Utilization of cardiovascular health care resources, Number of devices used during the procedure and use of anti-platelet and anti-thrombotic medication during the follow-up period., at index procedure, 30 days, 6 months, 1 year, and 2 years|Quality of Life assessment, Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire:\\n\\nThe first part of the questionnaire contain descriptive questions on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, each with 5 levels of responses.\\n\\nThe second part of the questionnaire contains a standard vertical 20-cm visual analog scale that is calibrated from \\the worst health you can imagine\\ (scored 0) at its base to \\the best health you can imagine\\ (scored 100) at its apex., at baseline, 30 days, 6 months, 1 year, and 2 years|Angina status assessment Seattle Angina Questionnaire (SAQ), Angina status will be assessed through the Seattle Angina Questionnaire (SAQ).\\n\\nThe SAQ is a validated disease-specific instrument for assessing the health status of patients with coronary artery disease.\\n\\nScoring: Scores range from 1-100 with higher scores indicating better health, at baseline, 30 days, 6 months, 1 year, and 2 years|QCA of the index procedure angiogram for a subset of patients with a Complex Bifurcation Lesion (CBL), Luminal dimensions of bifurcation lesions will be measured by off-line quantitative coronary angiography by a central core laboratory.\\n\\nThe objective of the QCA is to quantitate and express the benefit of the Proximal Optimisation Technique (POT). The POT balloon positioning is of importance in this technique as well as the balloon diameter to obtain optimal stent apposition in the main branch., procedure, Other Outcome Measures: , Sponsor: Terumo Europe N.V., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 3000.0, Funder Type: INDUSTRY, Study Type: OBSERVATIONAL, Study Design: Observational Model: |Time Perspective: p, Other IDs: T137E4, Start Date: 2023-04-25, Primary Completion Date: 2026-09, Completion Date: 2027-09, First Posted: 2023-01-31, Results First Posted: , Last Update Posted: 2024-01-24, Locations: Imelda Hospital, Bonheiden, Belgium|C.H.U. Charleroi, Charleroi, Belgium|Ziekenhuis Oost-Limburg, Genk, Belgium|CHR Citadelle, Liège, Belgium|Clinique Saint-Luc Bouge, Namur, Belgium|CHU UCL Mont Godinne Namur, Yvoir, Belgium|East Tallinn Central Hospital, Tallin, Estonia|Mater Private Network, Cork, Ireland|Mater Private Hospital, Dublin, Ireland|IRCCS Istituto Auxologico Italiano, Milano, Italy|Rijnstate Ziekenhuis, Arnhem, Netherlands|Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands|Catharina Hospital Eindhoven, Eindhoven, Netherlands|Medisch Centrum Leeuwarden, Leeuwarden, Netherlands|Maasstad Ziekenhuis, Rotterdam, Netherlands|Jeroen Bosch Ziekenhuis, s-Hertogenbosch, Netherlands|Hospital de la Santa Creu i Sant Pau, Barcelona, Spain|Hospital Universitario Juan Ramón Jiménez, Huelva, Spain|Salamanca University Hospital, Salamanca, Spain|Hospital Universitario Virgen del Rocio, Sevilla, Spain|Universitätsspital Basel, Basel, Switzerland|Istituto Cardiocentro Ticino, Lugano, Switzerland|Royal Sussex County Hospital, Brighton, United Kingdom|Lincolnshire Heart Centre Lincoln County Hospital, Lincoln, United Kingdom|Newcastle Freeman Hospital, Newcastle upon Tyne, United Kingdom|University Hospital Plymouth NHS trust, Plymouth, United Kingdom|University Hospital of North Midlands, Staffordshire, United Kingdom|Worcestershire Royal Hospital, Worcester, United Kingdom, Study Documents: , criteria: "General Inclusion Criteria:~1. Age ≥ 18 years~2. Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site~3. Ischemic heart disease with an indication for a PCI with, if available and per hospital guidelines, Heart Team consensus for a PCI procedure~4. Intention to treat all lesions requiring a PCI with the Ultimaster Nagomi stent~Complex Procedure Inclusion Criteria~Subject meets ≥ 1 of the complex procedure criteria:~1. Multivessel disease defined as ≥ 2 native coronary arteries and/or venous or arterial bypass grafts with a lesion requiring PCI~2. ≥ 3 stents implanted~3. ≥ 3 lesions treated~4. Complex bifurcation lesion defined as true bifurcation lesion (Medina 1.1.1, 1.0.1 or 0.1.1) with a side branch diameter \\\\> 2.5 mm plus one of the following:~i) side branch disease \\\\> 10 mm ii) calcified lesion iii) thrombotic lesion e) Bifurcation lesion implanted with two stents f) Total stent length implanted \\\\> 60 mm g) Chronic total occlusion defined as a 100% occlusion with antegrade TIMI 0 flow with at least a 3-month duration h) Left main stenting (main stem and/or bifurcation) i) Instent restenosis j) Severe calcified lesion with use of atherectomy or lithotripsy~Exclusion Criteria:~1. Any surgery requiring general anaesthesia, comorbidity or indication likely necessitating the discontinuation of dual anti-platelet therapy before the recommended duration of dual anti-platelet therapy per the ESC or national guidelines~2. An acute or evolving STEMI \\\\< 72 h after symptom onset~3. Hypersensitivity or contraindication to aspirin, heparin, L605 cobalt-chromium alloy, sirolimus or its structurally related compounds, lactide polymers or caprolactone polymers that cannot be pre-medicated~4. Known contrast sensitivity that cannot be premedicated~5. Pregnant and breastfeeding women~6. Life expectancy \\\\< 1 year for any cardiac or non-cardiac cause~7. Participation in another clinical study that has not yet completed its primary endpoint~8. Earlier enrolment in the Nagomi Complex study~9. Unlikely to be available for follow-up during the duration of the study (2 years)", combined_text: Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients Target Lesion Failure (TLF), Defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization., at 1-year post procedure Delivery success, Delivery success is defined as an achievement of successful delivery of study stent to the target lesion, expansion of the study stent and withdrawal of the delivery catheter., Intraoperative|Lesion success, Lesion success is defined as the attainment of \\\\< 30% residual stenosis by visual estimate and/or \\\\< 50% (by QCA) using any percutaneous method (if QCA was not available, the visual estimate of diameter stenosis is used)., Intraoperative|Device success, Device Success is defined as delivery success with the achievement of a final residual diameter stenosis of the target lesion of \\\\< 30% by visual assessment and/or \\\\< 50% by QCA, using the assigned device only., Intraoperative|Procedure success, Procedure Success is defined as the achievement of \\\\< 30% residual stenosis by visual assessment in all target lesions using any percutaneous method without the occurrence of death, Q wave or WHO defined non-Q wave, or repeat revascularization of the target lesion during the hospital stay., during hospitalization, approximately 3 days|Target lesion failure (TLF), The composite of cardiovascular death, MI (not clearly attributable to a nontarget vessel) and clinically driven Target lesion revascularization (TLR)., at index procedure, 30 days, 6 months, 1 year, and 2 years|Patient oriented composite endpoint (POCE), Defined as composite of all-cause mortality, any MI and any coronary revascularization., at index procedure, 30 days, 6 months, 1 year, and 2 years|Death and subclassifications, Death may be subclassified as: Cardiovascular death, Noncardiovascular death or Undetermined death.\\n\\nCardiovascular death may include death caused by acute MI, death caused by sudden cardiac death, including unwitnessed, death resulting from heart failure, death caused by stroke, death caused by cardiovascular procedures, death resulting from cardiovascular hemorrhage, death resulting from other cardiovascular cause.\\n\\nNoncardiovascular death may include death from malignancy, death resulting from pulmonary causes, death caused by infection (including sepsis), death resulting from gastrointestinal causes, death resulting from accident/trauma, death caused by other noncardiovascular organ failure, death resulting from other.\\n\\nUndetermined cause of death is defined as a death not attributable to any other category because of the absence of any relevant source documents., at index procedure, 30 days, 6 months, 1 year, and 2 years|Myocardial infarction and subclassifications, Myocardial infarction - Absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit, plus 1 (or more) of the following criteria:\\n\\n* New significant\\\\* Q waves or equivalent\\n* Flow-limiting angiographic complications\\n* New "substantial" loss of myocardium on imaging \\\\* Q-wave criteria requires the development of new Q waves ≥40 ms in duration and ≥1 mm deep in voltage in ≥2 contiguous leads., at index procedure, 30 days, 6 months, 1 year, and 2 years|Revascularization and subclassifications, Successful revascularization of all lesions with angiographically a diameter stenosis ≥ 50%, at index procedure, 30 days, 6 months, 1 year, and 2 years|Stent thrombosis (ST) and subclassifications, Definite ST\\n\\nPresence of a thrombus that originates in the stent/scaffold or in the segment 5mm prox. or dist. to the stent/scaffold or in a side branch originating from the stented/scaffolded segment \\\\& at least 1 of the ff:\\n\\nAcute onset of ischemic symptoms at rest New ECG changes suggestive of acute ischemia Typical rise and fall in cardiac biomarkers Or Pathological confirmation of thrombosis Evidence of recent thrombus within the stent/scaffold determined at autopsy Examination of tissue retrieved ff. thrombectomy\\n\\nProbable ST Any MI that is related to documented acute ischemia in the territory of the implanted stent/scaffold w/out angiographic confirmation of stent/scaffold thrombosis and in the absence of any other obvious cause.\\n\\nOcclusive thrombus Thrombolysis in MI grade 0/1 flow w/in or prox. to a stent/scaffold segment. Nonocclusive thrombus Intracoronary thrombus defined as a noncalcified filling defect or lucency surrounded by contrast material seen in mu, at index procedure, 30 days, 6 months, 1 year, and 2 years|Bleeding (Bleeding Academic Research Consortium (BARC) 3-5), Type 3:Clinical, lab, and/or imaging evidence of bleeding w/ specific healthcare provider responses, as below:\\n\\nType 3a Any BT with overt bleeding Overt bleeding plus Hgb drop ≥3 to \\\\< 5 g/dL\\n\\nType 3b Overt bleeding plus Hgb drop ≥5 g/dL Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring IV vasoactive drugs\\n\\nType 3c Intracranial hemorrhage\\n\\nType 4:CABG-related bleeding Perioperative intracranial bleeding w/in 48 hr Reoperation after closure of sternotomy for bleeding control Transfusion of ≥5 U whole blood or packed RBC w/in a 48-hr period Chest tube output ≥2 L w/in a 24-hr period\\n\\nType 5:Fatal bleeding\\n\\nBleeding that directly causes death with no other explainable cause. Categorized as:\\n\\nType 5a Probable bleeding that is clinically suspicious as the cause of death, but bleeding is not directly observed and no autopsy or confirmatory imaging.\\n\\nType 5b Definite bleeding that is directly observed (clinical specimen or imaging), at index procedure, 30 days, 6 months, 1 year, and 2 years|Balance between bleeding (BARC 3-5) and thrombotic event (myocardial infarction and/or stent thrombosis), The number of patients with a BARC 3-5 bleeding in comparison to the number of patients with a myocardial infarction and/or a stent thrombosis., at index procedure, 30 days, 6 months, 1 year, and 2 years|Utilization of cardiovascular health care resources, Number of devices used during the procedure and use of anti-platelet and anti-thrombotic medication during the follow-up period., at index procedure, 30 days, 6 months, 1 year, and 2 years|Quality of Life assessment, Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire:\\n\\nThe first part of the questionnaire contain descriptive questions on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, each with 5 levels of responses.\\n\\nThe second part of the questionnaire contains a standard vertical 20-cm visual analog scale that is calibrated from \\the worst health you can imagine\\ (scored 0) at its base to \\the best health you can imagine\\ (scored 100) at its apex., at baseline, 30 days, 6 months, 1 year, and 2 years|Angina status assessment Seattle Angina Questionnaire (SAQ), Angina status will be assessed through the Seattle Angina Questionnaire (SAQ).\\n\\nThe SAQ is a validated disease-specific instrument for assessing the health status of patients with coronary artery disease.\\n\\nScoring: Scores range from 1-100 with higher scores indicating better health, at baseline, 30 days, 6 months, 1 year, and 2 years|QCA of the index procedure angiogram for a subset of patients with a Complex Bifurcation Lesion (CBL), Luminal dimensions of bifurcation lesions will be measured by off-line quantitative coronary angiography by a central core laboratory.\\n\\nThe objective of the QCA is to quantitate and express the benefit of the Proximal Optimisation Technique (POT). The POT balloon positioning is of importance in this technique as well as the balloon diameter to obtain optimal stent apposition in the main branch., procedure "General Inclusion Criteria:~1. Age ≥ 18 years~2. Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site~3. Ischemic heart disease with an indication for a PCI with, if available and per hospital guidelines, Heart Team consensus for a PCI procedure~4. Intention to treat all lesions requiring a PCI with the Ultimaster Nagomi stent~Complex Procedure Inclusion Criteria~Subject meets ≥ 1 of the complex procedure criteria:~1. Multivessel disease defined as ≥ 2 native coronary arteries and/or venous or arterial bypass grafts with a lesion requiring PCI~2. ≥ 3 stents implanted~3. ≥ 3 lesions treated~4. Complex bifurcation lesion defined as true bifurcation lesion (Medina 1.1.1, 1.0.1 or 0.1.1) with a side branch diameter \\\\> 2.5 mm plus one of the following:~i) side branch disease \\\\> 10 mm ii) calcified lesion iii) thrombotic lesion e) Bifurcation lesion implanted with two stents f) Total stent length implanted \\\\> 60 mm g) Chronic total occlusion defined as a 100% occlusion with antegrade TIMI 0 flow with at least a 3-month duration h) Left main stenting (main stem and/or bifurcation) i) Instent restenosis j) Severe calcified lesion with use of atherectomy or lithotripsy~Exclusion Criteria:~1. Any surgery requiring general anaesthesia, comorbidity or indication likely necessitating the discontinuation of dual anti-platelet therapy before the recommended duration of dual anti-platelet therapy per the ESC or national guidelines~2. An acute or evolving STEMI \\\\< 72 h after symptom onset~3. Hypersensitivity or contraindication to aspirin, heparin, L605 cobalt-chromium alloy, sirolimus or its structurally related compounds, lactide polymers or caprolactone polymers that cannot be pre-medicated~4. Known contrast sensitivity that cannot be premedicated~5. Pregnant and breastfeeding women~6. Life expectancy \\\\< 1 year for any cardiac or non-cardiac cause~7. Participation in another clinical study that has not yet completed its primary endpoint~8. Earlier enrolment in the Nagomi Complex study~9. Unlikely to be available for follow-up during the duration of the study (2 years)", Similarity Score: 0.08701383437419795}'}]
|
from_dataset
| 0.087014
|
[{'from': 'human', 'value': '{Study Title: European Study Evaluating the EMBLOK Embolic Protection System During TAVR, Primary Outcome Measures: Performance Endpoint, successful insertion, placement and removal of the EMBLOK system, Day 1 to post procedure, Secondary Outcome Measures: Safety Endpoint (Rate of MACCE), Rate of MACCE, 30 days, criteria: "Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (\\\\> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.~Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject\\s legal representative completes written Informed Consent.~Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.~Subject has experienced a myocardial infarction within 30 days of the planned index procedure.~Subject has renal insufficiency, defined as a creatinine level \\\\> 2.5 mg/dl at the time of treatment.~Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.~Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.~Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \\\\> 38° C and/ or WBC \\\\> 15,000 IU.~Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 549, Unnamed: 0: 679, NCT Number: NCT01565720, Study Title: Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization, Study URL: https://clinicaltrials.gov/study/NCT01565720, Acronym: , Study Status: COMPLETED, Brief Summary: This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization in healthy adult subjects. Eligible subjects will be randomized to one of four treatment groups and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as an active control on the last dosing day to healthy subjects in one of the four groups. All treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on three study days. ECGs, vital signs, blood draws will be obtained throughout the study for safety and to assess the amount of study drug in body., Study Results: NO, Conditions: Pharmacokinetics of Isavuconazole|Healthy Volunteers, Interventions: DRUG: Isavuconazole|DRUG: Placebo|DRUG: Moxifloxacin, Primary Outcome Measures: "Change from baseline in QT interval corrected for heart rate using Fridericias correction (QTcF), Baseline and Day 13", Secondary Outcome Measures: Change from baseline in Electrocardiogram (ECG) variables: QT, PR, RR intervals, QRS, and Heart Rate, Baseline and Day 13, Other Outcome Measures: , Sponsor: Astellas Pharma Global Development, Inc., Collaborators: Basilea Pharmaceutica International Ltd, Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 161.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: , Other IDs: 9766-CL-0017, Start Date: 2012-03, Primary Completion Date: 2012-06, Completion Date: 2012-06, First Posted: 2012-03-29, Results First Posted: , Last Update Posted: 2012-07-09, Locations: Parexel, Glendale, California, 91206, United States, Study Documents: , criteria: "Inclusion Criteria:~* Subject must weigh at least 45 kg and have a body mass index of 18-30 kg/m2~* If female, the subject agrees to sexual abstinence, is surgically sterile, postmenopausal or using a medically acceptable double-barrier method to prevent pregnancy and agrees to continue using this method during the study and until two weeks after the end of the study. Female subjects must not be lactating or pregnant as documented by a negative pregnancy test at Screening and Day -3~* If male, the subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method during the study and until two weeks after the end of the study~* The subject\\s clinical laboratory test results at Screening and Day -3 are within normal limits or any abnormal results are considered not to be clinically significant~* The subject has a sitting systolic blood pressure between 90 and 140 mmHg, inclusive and diastolic blood pressure between 50 and 90 mmHg, inclusive at Screening and Day -3~* The subject has good venous access~Exclusion Criteria:~* The subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardio-vascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition that would preclude participation in the study~* The subject has evidence of any cardiac conduction abnormalities~* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia, torsade de pointes, structural heart disease, or family history of Long QT syndrome or Short QT syndrome~* The subject has potassium, calcium, or magnesium levels that are below the clinical laboratory\\s lower limit of normal~* The subject has a history of consuming more than 14 units of alcoholic beverages per week, has a history of alcohol abuse within the past 2 years prior to Screening, or has a positive screen for alcohol at Screening or Day 3. (NOTE: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor.)~* The subject has a history of drug, chemical, or substance abuse within the past 2 years prior to Screening or has a positive test at Screening or Day -3 for drugs of abuse~* The subject has used tobacco-containing products or nicotine-containing products within 3 months prior to Screening~* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Screening, or over-the-counter medication within 7 days prior to Screening (with the exception of acetaminophen up to 2 grams/day)~* The subject anticipates an inability to abstain from caffeine or alcohol for 48 hours prior to Day -3 and throughout the duration of the study~* The subject anticipates an inability to abstain from grapefruit, Seville oranges, star fruit, or any products containing these items from 72 hours prior to Day -3 and throughout the duration of the study~* The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 7 days prior to Day -3~* The subject has been vaccinated within the last 30 days prior to Screening~* The subject has a positive test for hepatitis C antibody or hepatitis B surface antigen at Screening or a known history of human immunodeficiency virus~* The subject has known or suspected hypersensitivity to any of the quinolone antibiotics or a history of tendonitis and/or liver function abnormality related to quinolone antibiotic treatment~* The subject has a known or suspected hypersensitivity to isavuconazole, the azole class of compounds, or any components of the study drugs~* The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to Screening~* The subject has had any significant blood loss, donated one or more units (450 mL) of blood or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to Day -3~* The subject has any other condition, which in the opinion of the investigator, precludes the subject\\s participation in the trial", combined_text: Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization Change from baseline in QT interval corrected for heart rate using Fridericia\\s correction (QTcF), Baseline and Day 13 Change from baseline in Electrocardiogram (ECG) variables: QT, PR, RR intervals, QRS, and Heart Rate, Baseline and Day 13 "Inclusion Criteria:~* Subject must weigh at least 45 kg and have a body mass index of 18-30 kg/m2~* If female, the subject agrees to sexual abstinence, is surgically sterile, postmenopausal or using a medically acceptable double-barrier method to prevent pregnancy and agrees to continue using this method during the study and until two weeks after the end of the study. Female subjects must not be lactating or pregnant as documented by a negative pregnancy test at Screening and Day -3~* If male, the subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy and agrees to continue using this method during the study and until two weeks after the end of the study~* The subject\\s clinical laboratory test results at Screening and Day -3 are within normal limits or any abnormal results are considered not to be clinically significant~* The subject has a sitting systolic blood pressure between 90 and 140 mmHg, inclusive and diastolic blood pressure between 50 and 90 mmHg, inclusive at Screening and Day -3~* The subject has good venous access~Exclusion Criteria:~* The subject has a previous history of any clinically significant gastro-intestinal, neurological, renal, hepatic, pulmonary, metabolic, cardio-vascular, psychiatric, endocrine, hematological disorder or disease, malignancy excluding non-melanoma skin cancer or any other medical condition that would preclude participation in the study~* The subject has evidence of any cardiac conduction abnormalities~* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia, torsade de pointes, structural heart disease, or family history of Long QT syndrome or Short QT syndrome~* The subject has potassium, calcium, or magnesium levels that are below the clinical laboratory\\s lower limit of normal~* The subject has a history of consuming more than 14 units of alcoholic beverages per week, has a history of alcohol abuse within the past 2 years prior to Screening, or has a positive screen for alcohol at Screening or Day 3. (NOTE: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor.)~* The subject has a history of drug, chemical, or substance abuse within the past 2 years prior to Screening or has a positive test at Screening or Day -3 for drugs of abuse~* The subject has used tobacco-containing products or nicotine-containing products within 3 months prior to Screening~* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Screening, or over-the-counter medication within 7 days prior to Screening (with the exception of acetaminophen up to 2 grams/day)~* The subject anticipates an inability to abstain from caffeine or alcohol for 48 hours prior to Day -3 and throughout the duration of the study~* The subject anticipates an inability to abstain from grapefruit, Seville oranges, star fruit, or any products containing these items from 72 hours prior to Day -3 and throughout the duration of the study~* The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 7 days prior to Day -3~* The subject has been vaccinated within the last 30 days prior to Screening~* The subject has a positive test for hepatitis C antibody or hepatitis B surface antigen at Screening or a known history of human immunodeficiency virus~* The subject has known or suspected hypersensitivity to any of the quinolone antibiotics or a history of tendonitis and/or liver function abnormality related to quinolone antibiotic treatment~* The subject has a known or suspected hypersensitivity to isavuconazole, the azole class of compounds, or any components of the study drugs~* The subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to Screening~* The subject has had any significant blood loss, donated one or more units (450 mL) of blood or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to Day -3~* The subject has any other condition, which in the opinion of the investigator, precludes the subject\\s participation in the trial", Similarity Score: 0.2897491139716416}'}]
|
from_dataset
| 0.289749
|
[{'from': 'human', 'value': '{Study Title: European Study Evaluating the EMBLOK Embolic Protection System During TAVR, Primary Outcome Measures: Performance Endpoint, successful insertion, placement and removal of the EMBLOK system, Day 1 to post procedure, Secondary Outcome Measures: Safety Endpoint (Rate of MACCE), Rate of MACCE, 30 days, criteria: "Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (\\\\> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.~Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject\\s legal representative completes written Informed Consent.~Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.~Subject has experienced a myocardial infarction within 30 days of the planned index procedure.~Subject has renal insufficiency, defined as a creatinine level \\\\> 2.5 mg/dl at the time of treatment.~Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.~Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.~Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \\\\> 38° C and/ or WBC \\\\> 15,000 IU.~Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 475, Unnamed: 0: 582, NCT Number: NCT01068782, Study Title: Study of Multiple Doses and Regimens of XL184 (Cabozantinib) in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse, Study URL: https://clinicaltrials.gov/study/NCT01068782, Acronym: , Study Status: COMPLETED, Brief Summary: This is a study of multiple regimens of single-agent XL184 in subjects with grade IV astrocytic tumor in first or second relapse. The Randomized Phase of the study will evaluate the safety, tolerability, and preliminary efficacy of four XL184 dosing regimens in separate study arms. Subjects will be randomized to one of the study arms, which will not be blinded. After the Randomized Phase, additional subjects will be enrolled to further expand one study arm in the Expansion Phase., Study Results: NO, Conditions: Astrocytic Tumors, Interventions: DRUG: XL184, Primary Outcome Measures: In the Randomized Phase, to evaluate the preliminary efficacy and tolerability of multiple regimens of XL184, Assessed every 1-3 weeks, during study visits|In the Expansion Phase, to evaluate the efficacy of XL184 treatment, Assessed every 6 weeks, Secondary Outcome Measures: To further evaluate the safety and tolerability of XL184 treatment during the entire treatment period, Assessed every 1-3 weeks, during study visits|To further characterize the pharmacokinetic and pharmacodynamic parameters of XL184, Assessed every 3-4 weeks, during study visits, Other Outcome Measures: , Sponsor: Exelixis, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 19.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: XL184-205, Start Date: 2010-04, Primary Completion Date: 2011-05, Completion Date: 2013-10, First Posted: 2010-02-15, Results First Posted: , Last Update Posted: 2014-07-30, Locations: Birmingham, Alabama, 35294, United States|Encinitas, California, 92024, United States|Pleasant Hill, California, 94523, United States|Chicago, Illinois, 60611, United States|Chicago, Illinois, 60637, United States|Boston, Massachusetts, 02115, United States|Detroit, Michigan, 48202, United States|Minneapolis, Minnesota, 55407, United States|Amhearst, New York, 14226, United States|Rochester, New York, 14642, United States|Cleveland, Ohio, 44195, United States|Hershey, Pennsylvania, 17033, United States|Dallas, Texas, 75246, United States|Dallas, Texas, 75426, United States|San Antonio, Texas, 78229, United States|Charlottesville, Virginia, 22908, United States|Seattle, Washington, 98122, United States|Calgary, Alberta, Canada|Montreal, Quebec, Canada, Study Documents: , criteria: "Inclusion Criteria:~* The subject has histologically confirmed diagnosis at any time of grade IV astrocytic tumor as determined by the investigator. Tumor samples will be required for pathology review.~* The subject has received prior standard radiation for any grade astrocytic tumor.~* The subject has received prior temozolomide (Temodar) therapy~* The subject has had one or two progressions as grade IV astrocytic tumor from any grade, as determined by investigator~* The subject must have a qualifying brain MRI scan within a specific timeframe prior to start of study treatment~* For subjects with recent tumor resection or biopsy, starting on study must occur a specified amount of time after the surgery and the subject must have recovered from the effects of surgery~* The subject has a Karnofsky Performance Status ≥ 70% and has the ability to swallow whole capsules~* The subject is capable of understanding the informed consent and has signed the informed consent document~* The subject has adequate organ and marrow function~* Sexually active subjects (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 6 months following discontinuation of study treatment~* The subject has had no other diagnosis of malignancy (certain exceptions apply)~* Female subjects of childbearing potential must have a negative pregnancy test at screening~Exclusion Criteria:~* The subject has received certain prior anticancer therapies within a certain amount of time before starting study treatment~* The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin~* The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or CT scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible~* The subject is unable to undergo MRI scan (eg, has pacemaker)~* The subject has received enzyme-inducing anti-epileptic agents within a certain time prior to starting study treatment (eg, carbamazepine, phenytoin, phenobarbital, primidone)~* The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤ 1 from AEs (except alopecia and lymphopenia) due to surgery, or other medications that were administered prior to study start~* The subject has evidence of unhealed wounds~* The subject is pregnant or breast-feeding~* The subject has serious intercurrent illness or a recent history of serious disease~* The subject has inherited bleeding diathesis or coagulopathy (disease affecting how blood clots) with the risk of bleeding~* The subject has a history of any medical or surgical conditions (eg, stomach or intestinal surgery or resection) that would potentially interfere with or alter gastrointestinal function~* The subject has a history of idiopathic pulmonary fibrosis or interstitial lung disease~* The subject has received any live virus vaccine or any inactivated vaccine within a certain amount of time before starting study treatment", combined_text: Study of Multiple Doses and Regimens of XL184 (Cabozantinib) in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse In the Randomized Phase, to evaluate the preliminary efficacy and tolerability of multiple regimens of XL184, Assessed every 1-3 weeks, during study visits|In the Expansion Phase, to evaluate the efficacy of XL184 treatment, Assessed every 6 weeks To further evaluate the safety and tolerability of XL184 treatment during the entire treatment period, Assessed every 1-3 weeks, during study visits|To further characterize the pharmacokinetic and pharmacodynamic parameters of XL184, Assessed every 3-4 weeks, during study visits "Inclusion Criteria:~* The subject has histologically confirmed diagnosis at any time of grade IV astrocytic tumor as determined by the investigator. Tumor samples will be required for pathology review.~* The subject has received prior standard radiation for any grade astrocytic tumor.~* The subject has received prior temozolomide (Temodar) therapy~* The subject has had one or two progressions as grade IV astrocytic tumor from any grade, as determined by investigator~* The subject must have a qualifying brain MRI scan within a specific timeframe prior to start of study treatment~* For subjects with recent tumor resection or biopsy, starting on study must occur a specified amount of time after the surgery and the subject must have recovered from the effects of surgery~* The subject has a Karnofsky Performance Status ≥ 70% and has the ability to swallow whole capsules~* The subject is capable of understanding the informed consent and has signed the informed consent document~* The subject has adequate organ and marrow function~* Sexually active subjects (male and female) must agree to use medically accepted methods of contraception during the course of the study and for 6 months following discontinuation of study treatment~* The subject has had no other diagnosis of malignancy (certain exceptions apply)~* Female subjects of childbearing potential must have a negative pregnancy test at screening~Exclusion Criteria:~* The subject has received certain prior anticancer therapies within a certain amount of time before starting study treatment~* The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin~* The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or CT scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible~* The subject is unable to undergo MRI scan (eg, has pacemaker)~* The subject has received enzyme-inducing anti-epileptic agents within a certain time prior to starting study treatment (eg, carbamazepine, phenytoin, phenobarbital, primidone)~* The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤ 1 from AEs (except alopecia and lymphopenia) due to surgery, or other medications that were administered prior to study start~* The subject has evidence of unhealed wounds~* The subject is pregnant or breast-feeding~* The subject has serious intercurrent illness or a recent history of serious disease~* The subject has inherited bleeding diathesis or coagulopathy (disease affecting how blood clots) with the risk of bleeding~* The subject has a history of any medical or surgical conditions (eg, stomach or intestinal surgery or resection) that would potentially interfere with or alter gastrointestinal function~* The subject has a history of idiopathic pulmonary fibrosis or interstitial lung disease~* The subject has received any live virus vaccine or any inactivated vaccine within a certain amount of time before starting study treatment", Similarity Score: 0.27465206709516166}'}]
|
from_dataset
| 0.274652
|
[{'from': 'human', 'value': '{Study Title: European Study Evaluating the EMBLOK Embolic Protection System During TAVR, Primary Outcome Measures: Performance Endpoint, successful insertion, placement and removal of the EMBLOK system, Day 1 to post procedure, Secondary Outcome Measures: Safety Endpoint (Rate of MACCE), Rate of MACCE, 30 days, criteria: "Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (\\\\> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.~Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject\\s legal representative completes written Informed Consent.~Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.~Subject has experienced a myocardial infarction within 30 days of the planned index procedure.~Subject has renal insufficiency, defined as a creatinine level \\\\> 2.5 mg/dl at the time of treatment.~Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.~Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.~Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \\\\> 38° C and/ or WBC \\\\> 15,000 IU.~Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 391, Unnamed: 0: 479, NCT Number: NCT01421082, Study Title: Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema, Study URL: https://clinicaltrials.gov/study/NCT01421082, Acronym: , Study Status: COMPLETED, Brief Summary: The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes., Study Results: NO, Conditions: Emphysema, Interventions: DEVICE: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.), Primary Outcome Measures: 6 minute walk test (6MWT), The primary effectiveness endpoint will be the improvement in the 6 minute walk test (6MWT) from Baseline compared to Follow-Up., 6 months, Secondary Outcome Measures: Adverse Events, The safety objective of this study is to identify the adverse effects attributed to device., 6 months, Other Outcome Measures: , Sponsor: Boston Scientific Corporation, Collaborators: PneumRx, Inc., Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2|PHASE3, Enrollment: 10.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: CLN0012, Start Date: 2012-02, Primary Completion Date: 2013-03, Completion Date: 2013-03, First Posted: 2011-08-22, Results First Posted: , Last Update Posted: 2021-07-16, Locations: University Medical Center Groningen - UMCG, Groningen, The Netherlands, 9700 RB, Netherlands, Study Documents: , criteria: "Inclusion Criteria:~Subject \\\\> 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form~Exclusion Criteria:~Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes", combined_text: Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema 6 minute walk test (6MWT), The primary effectiveness endpoint will be the improvement in the 6 minute walk test (6MWT) from Baseline compared to Follow-Up., 6 months Adverse Events, The safety objective of this study is to identify the adverse effects attributed to device., 6 months "Inclusion Criteria:~Subject \\\\> 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form~Exclusion Criteria:~Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes", Similarity Score: 0.2679577241364589}'}]
|
from_dataset
| 0.267958
|
[{'from': 'human', 'value': '{Study Title: European Study Evaluating the EMBLOK Embolic Protection System During TAVR, Primary Outcome Measures: Performance Endpoint, successful insertion, placement and removal of the EMBLOK system, Day 1 to post procedure, Secondary Outcome Measures: Safety Endpoint (Rate of MACCE), Rate of MACCE, 30 days, criteria: "Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (\\\\> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.~Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject\\s legal representative completes written Informed Consent.~Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.~Subject has experienced a myocardial infarction within 30 days of the planned index procedure.~Subject has renal insufficiency, defined as a creatinine level \\\\> 2.5 mg/dl at the time of treatment.~Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.~Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.~Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \\\\> 38° C and/ or WBC \\\\> 15,000 IU.~Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 823, Unnamed: 0: 1034, NCT Number: NCT01275092, Study Title: Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions (PCI), Study URL: https://clinicaltrials.gov/study/NCT01275092, Acronym: PRECISE, Study Status: COMPLETED, Brief Summary: The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the CorPath® 200 System in the delivery and manipulation of coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (PCI)., Study Results: YES, Conditions: Coronary Artery Disease|Coronary Disease|Myocardial Ischemia|Heart Diseases|Cardiovascular Diseases|Arteriosclerosis|Arterial Occlusive Diseases|Vascular Diseases, Interventions: DEVICE: CorPath robotic-assisted PCI, Primary Outcome Measures: Percentage of Participants With Clinical Procedural Success, Defined as \\\\<30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first., 48-hrs or hospital discharge, whichever occurs first|Percentage of Patients With Device Technical Success, Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation., 1 day, Secondary Outcome Measures: "The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table, Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operators position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio., 1 day", Other Outcome Measures: , Sponsor: Corindus Inc., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 164.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: CorPath PRECISE, Start Date: 2011-01, Primary Completion Date: 2011-12, Completion Date: 2012-01, First Posted: 2011-01-12, Results First Posted: 2013-08-08, Last Update Posted: 2013-08-08, Locations: "Washington Hospital Center, Washington, District of Columbia, 20010, United States|Northeast Georgia Heart Center, Gainesville, Georgia, 30501, United States|St. Elizabeths Medical Center, Boston, Massachusetts, 02135, United States|Columbia University Medical Center, New York, New York, 10032, United States|Saint Josephs Hospital, Syracuse, New York, 13203, United States|Wellmont CVA Heart Institute, Kingsport, Tennessee, 37660, United States|Virginia Commonwealth University, Richmond, Virginia, 23298, United States|Swedish Medical Center, Seattle, Washington, 98122, United States|CORBIC, Medellin, Colombia", Study Documents: , criteria: "General Inclusion Criteria:~1. Subject is between 18 and 99 years of age.~2. Subject is an acceptable candidate for PCI.~3. Subject must have clinical evidence of ischemic heart disease or a positive functional study.~4. Female subjects must be of non-child bearing potential, or if able to bear children, have a negative pregnancy test within 7 days prior to the CorPath procedure.~5. The subject or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.~Angiographic Inclusion Criteria:~1. Study lesion is a single de novo native coronary artery lesion. This lesion may consist of multiple lesions (with 10mm or less between diseased segments) and must be completely covered by a single stent with at least 2.0mm of normal segments on proximal and distal edges of the lesion.~2. Study reference vessel diameter is between 2.5mm and 4.0mm by visual estimate.~3. Study lesion length is less than or equal to 24.0mm by visual estimate.~4. Study lesion diameter showing stenosis of at least 50% by visual estimate.~General Exclusion Criteria:~1. Subject requires planned PCI or CABG (Coronary Artery Bypass Graft) within 30 days following the CorPath procedure.~2. Evidence of an acute myocardial infarction within 72 hours prior to the intended CorPath procedure.~3. Subject has documented left ventricular ejection fraction \\\\<30%.~4. Subject has undergone PCI within 72 hours prior to the CorPath procedure.~5. Subject has undergone PCI within 30 days prior to the CorPath procedure and experienced a major adverse coronary event (MACE) or a serious adverse event (SAE) as defined in the protocol.~6. Subject has known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel, stainless steel, cobalt chromium, or sensitivity to contrast media, including Visipaque™, which cannot be adequately pre-medicated or managed with clinically appropriate substitutes.~7. Subject has a platelet count \\\\<100,000 cells/mm3 or \\\\>700,000 cells/mm3, or a WBC (white blood cell) count of \\\\<3,000 cells/mm3 (e.g. thrombocytopenia, thrombocythemia, neutropenia or leukopenia).~8. Subject has a serum creatinine level of \\\\>2.0 mg/dL or eGFR (estimated Glomerular Filtration Rate) \\\\<30 ml/min as measured within 7 days prior to the procedure.~9. Subject has suffered a stroke within 30 days prior to planned CorPath procedure.~10. Subject has an active peptic ulcer or upper gastrointestinal bleeding within the 6 months prior to planned CorPath procedure.~11. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.~12. Subject is currently participating in another investigational drug or drug/device or device trial and has not completed the entire follow up period.~13. Femoral access is not possible.~Angiographic Exclusion Criteria:~1. Target lesion that cannot be fully covered by a single stent.~2. Subject requires treatment of more than one vessel.~3. Any previous stent placement within 5.0 mm (proximal or distal) of the target lesion.~4. The study lesion requires planned treatment with directional coronary atherectomy (DCA), laser, rotational atherectomy or any device except for balloon dilatation prior to stent placement.~5. The study vessel has evidence of intraluminal thrombus.~6. The study vessel has evidence of moderate to severe tortuosity (\\\\>90°) proximal to the target lesion.~7. The study lesion has any of the following characteristics:~ * Total occlusion.~ * Ostial location.~ * Is within 2.0 mm of a side branch measuring \\\\>2.0 mm in diameter.~ * Located at \\\\< 45° bend in the vessel.~ * Moderately to severely calcified.~ * Moderate to severe calcification in the vessel proximal to the target lesion.~ * Located in a native vessel distal to an anastomosis, with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass, and is approached through the bypass graft.~8. Unprotected left main coronary artery disease defined as an obstruction greater than 50% diameter stenosis in the left main coronary artery.", combined_text: Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions (PCI) Percentage of Participants With Clinical Procedural Success, Defined as \\\\<30% residual stenosis in CorPath 200 System treated lesions at the completion of the interventional procedure (including stent placement) in the absence of MACE, either within 48 hours of the procedure or prior to hospital discharge, whichever occurs first., 48-hrs or hospital discharge, whichever occurs first|Percentage of Patients With Device Technical Success, Defined as the successful advancement and retraction of PCI devices using the CorPath 200 System and without conversion to manual operation., 1 day The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table, Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator\\s position during the procedure. The radiation unit that was used was in milligray, but the measure is being reported as the ratio., 1 day "General Inclusion Criteria:~1. Subject is between 18 and 99 years of age.~2. Subject is an acceptable candidate for PCI.~3. Subject must have clinical evidence of ischemic heart disease or a positive functional study.~4. Female subjects must be of non-child bearing potential, or if able to bear children, have a negative pregnancy test within 7 days prior to the CorPath procedure.~5. The subject or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.~Angiographic Inclusion Criteria:~1. Study lesion is a single de novo native coronary artery lesion. This lesion may consist of multiple lesions (with 10mm or less between diseased segments) and must be completely covered by a single stent with at least 2.0mm of normal segments on proximal and distal edges of the lesion.~2. Study reference vessel diameter is between 2.5mm and 4.0mm by visual estimate.~3. Study lesion length is less than or equal to 24.0mm by visual estimate.~4. Study lesion diameter showing stenosis of at least 50% by visual estimate.~General Exclusion Criteria:~1. Subject requires planned PCI or CABG (Coronary Artery Bypass Graft) within 30 days following the CorPath procedure.~2. Evidence of an acute myocardial infarction within 72 hours prior to the intended CorPath procedure.~3. Subject has documented left ventricular ejection fraction \\\\<30%.~4. Subject has undergone PCI within 72 hours prior to the CorPath procedure.~5. Subject has undergone PCI within 30 days prior to the CorPath procedure and experienced a major adverse coronary event (MACE) or a serious adverse event (SAE) as defined in the protocol.~6. Subject has known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel, stainless steel, cobalt chromium, or sensitivity to contrast media, including Visipaque™, which cannot be adequately pre-medicated or managed with clinically appropriate substitutes.~7. Subject has a platelet count \\\\<100,000 cells/mm3 or \\\\>700,000 cells/mm3, or a WBC (white blood cell) count of \\\\<3,000 cells/mm3 (e.g. thrombocytopenia, thrombocythemia, neutropenia or leukopenia).~8. Subject has a serum creatinine level of \\\\>2.0 mg/dL or eGFR (estimated Glomerular Filtration Rate) \\\\<30 ml/min as measured within 7 days prior to the procedure.~9. Subject has suffered a stroke within 30 days prior to planned CorPath procedure.~10. Subject has an active peptic ulcer or upper gastrointestinal bleeding within the 6 months prior to planned CorPath procedure.~11. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.~12. Subject is currently participating in another investigational drug or drug/device or device trial and has not completed the entire follow up period.~13. Femoral access is not possible.~Angiographic Exclusion Criteria:~1. Target lesion that cannot be fully covered by a single stent.~2. Subject requires treatment of more than one vessel.~3. Any previous stent placement within 5.0 mm (proximal or distal) of the target lesion.~4. The study lesion requires planned treatment with directional coronary atherectomy (DCA), laser, rotational atherectomy or any device except for balloon dilatation prior to stent placement.~5. The study vessel has evidence of intraluminal thrombus.~6. The study vessel has evidence of moderate to severe tortuosity (\\\\>90°) proximal to the target lesion.~7. The study lesion has any of the following characteristics:~ * Total occlusion.~ * Ostial location.~ * Is within 2.0 mm of a side branch measuring \\\\>2.0 mm in diameter.~ * Located at \\\\< 45° bend in the vessel.~ * Moderately to severely calcified.~ * Moderate to severe calcification in the vessel proximal to the target lesion.~ * Located in a native vessel distal to an anastomosis, with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass, and is approached through the bypass graft.~8. Unprotected left main coronary artery disease defined as an obstruction greater than 50% diameter stenosis in the left main coronary artery.", Similarity Score: 0.2651904857704586}'}]
|
from_dataset
| 0.26519
|
[{'from': 'human', 'value': '{Study Title: European Study Evaluating the EMBLOK Embolic Protection System During TAVR, Primary Outcome Measures: Performance Endpoint, successful insertion, placement and removal of the EMBLOK system, Day 1 to post procedure, Secondary Outcome Measures: Safety Endpoint (Rate of MACCE), Rate of MACCE, 30 days, criteria: "Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (\\\\> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.~Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject\\s legal representative completes written Informed Consent.~Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.~Subject has experienced a myocardial infarction within 30 days of the planned index procedure.~Subject has renal insufficiency, defined as a creatinine level \\\\> 2.5 mg/dl at the time of treatment.~Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.~Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.~Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \\\\> 38° C and/ or WBC \\\\> 15,000 IU.~Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 476, Unnamed: 0: 583, NCT Number: NCT03742882, Study Title: A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects, Study URL: https://clinicaltrials.gov/study/NCT03742882, Acronym: , Study Status: COMPLETED, Brief Summary: "This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function.\\n\\nDegrees of hepatic impairment will be determined during screening by the subjects score according to Child-Pugh Classification Criteria.", Study Results: NO, Conditions: Hepatic Impairment, Interventions: DRUG: CC-90001, Primary Outcome Measures: Pharmacokinetic- AUC0-t, Estimation of AUC calculated from time zero to the last measured time point, UP to approximately 7 Days|Pharmacokinetic- AUC0-∞, Estimation of AUC calculated from time zero to infinity, UP to approximately 7 Days|Pharmacokinetic- Cmax, Estimation of observed maximum plasma concentration, UP to approximately Day 1|Pharmacokinetic- Tmax, Estimation of time to Cmax, UP to approximately Day 1|Pharmacokinetic- t1/2, Estimation of terminal elimination half-life, Up to approximately 7 days|Pharmacokinetic- CL/F, Estimation of apparent clearance of drug from plasma after extravascular administration, Up to approximately 7 days|Pharmacokinetic- Vz/F, Estimation of apparent volume of distribution during the terminal phase, Up to approximately 7 days, Secondary Outcome Measures: Adverse Events (AEs), Number of subjects with adverse event, From enrollment until at least 28 days after completion of study treatment, Other Outcome Measures: , Sponsor: Celgene, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 40.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: CC-90001-CP-005|U1111-1223-7431, Start Date: 2018-12-06, Primary Completion Date: 2019-06-10, Completion Date: 2019-06-10, First Posted: 2018-11-15, Results First Posted: , Last Update Posted: 2020-07-27, Locations: University of Miami Miller School of Medicine, Miami, Florida, 33136, United States|Orlando Clinical Research Center OCRC, Orlando, Florida, 32809, United States|Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville, Knoxville, Tennessee, 37920, United States|The Texas Liver Institute, San Antonio, Texas, 78215, United States, Study Documents: , criteria: "Inclusion Criteria:~1. Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.~2. Subject is willing and able to adhere to the study visit schedule and other protocol requirements, including the restrictions.~3. Subject is male, or non-pregnant and non-nursing female between ≥ 18 and ≤ 70 years of age at the time of signing the ICF.~4. Subject has Body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening.~5. Female subjects NOT of childbearing potential must:~ a. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before Screening, or postmenopausal (defined as 24 consecutive months without menses before Screening, with a follicle-stimulating hormone \\\\[FSH\\\\] level in the postmenopausal range according to the laboratory used at Screening); FSH to be performed at the discretion of the Investigator in consultation with the Medical Monitor.~6. Females of childbearing potential (FCBP)1 must have a negative pregnancy test at the Screening and Baseline Visits. While receiving Investigational Product (IP) and for at least 28 days after taking the dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: One highly effective method (e.g., hormonal contraception \\\\[oral, injection, implant, transdermal patch, vaginal ring\\\\]; intrauterine device; tubal ligation; or partner\\s vasectomy) and one additional form (latex condom or any nonlatex condom not made of natural \\\\[animal\\\\] membrane \\\\[eg, polyurethane\\\\], diaphragm, sponge).~ OR Option 2: Male or female condom PLUS 1 additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.~7. Male subjects must:~ a. Practice true abstinence2 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural \\\\[animal\\\\] membrane \\\\[latex condoms were recommended\\\\]) during sexual contact with a pregnant female or female of FCBP while participating in the study, during dose interruptions, and for at least 28 days after the dose of investigational product, even if he has undergone a successful vasectomy.~8. Subject has clinical laboratory safety test results that are within normal limits or acceptable to the Investigator.~9. Subject is afebrile (febrile is defined as ≥ 38°C or 100.3°F), with supine systolic blood pressure ≥ 90 and ≤ 160 mm Hg, supine diastolic blood pressure ≥ 50 and ≤ 100 mm Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute at Screening.~Exclusion Criteria:~The presence of any of the following will exclude a subject from enrollment:~1. Subject has any significant and relevant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study at the Investigator\\s discretion.~2. Subject has any condition that places the subject at an unacceptable risk if he or she were to participate in the study.~3. Subject has any condition that confounds the ability to interpret data from the study.~4. Subject is pregnant or breastfeeding.~5. Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever was longer).~6. Subject has used moderate or strong CYP3A4/5 inducers and/or inhibitors (including St. John\\s wort) within 30 days prior to dosing. The Indiana University P450 Drug Interactions Flockhart Table™ may be consulted for a list of such medications (http://medicine.iupui.edu/clinpharm/ddis/main-table).~7. Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure. Subjects with appendectomy and cholecystectomy may be included.~8. Subject has an estimated creatinine clearance \\\\< 60 mL/min as calculated using the Cockcroft-Gault formula.~9. Subject has donated blood or plasma within 2 weeks before dose administration to a blood bank or blood donation center.~10. Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dose administration, or positive drug screening test reflecting consumption of illicit drugs unless positive drug screen is due to prescription drug use that is approved by the Investigator and the Medical Monitor.~11. Subject has a history of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 1 year before dose administration, or a positive alcohol screen.~12. Subject has had a positive result to the test for human immunodeficiency virus (HIV) antibodies at Screening.~ • Chronic or resolved Hepatitis B or Hepatitis C are acceptable only if sequelae are limited to hepatic involvement and its consequent comorbidities. (ie, vasculitis, clinically significant globulinemia, etc. are unacceptable).~13. Subject smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).~14. Subject has received live vaccination (excluding seasonal flu vaccination) within 30 days of dosing.~15. Subject is part of the clinical staff personnel or a family member of the study site staff.~16. Subject is, for any reason, deemed by the investigator to be inappropriate for this study, including a subject who is unable to communicate or to cooperate with the investigator or the clinical staff.", combined_text: A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects Pharmacokinetic- AUC0-t, Estimation of AUC calculated from time zero to the last measured time point, UP to approximately 7 Days|Pharmacokinetic- AUC0-∞, Estimation of AUC calculated from time zero to infinity, UP to approximately 7 Days|Pharmacokinetic- Cmax, Estimation of observed maximum plasma concentration, UP to approximately Day 1|Pharmacokinetic- Tmax, Estimation of time to Cmax, UP to approximately Day 1|Pharmacokinetic- t1/2, Estimation of terminal elimination half-life, Up to approximately 7 days|Pharmacokinetic- CL/F, Estimation of apparent clearance of drug from plasma after extravascular administration, Up to approximately 7 days|Pharmacokinetic- Vz/F, Estimation of apparent volume of distribution during the terminal phase, Up to approximately 7 days Adverse Events (AEs), Number of subjects with adverse event, From enrollment until at least 28 days after completion of study treatment "Inclusion Criteria:~1. Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.~2. Subject is willing and able to adhere to the study visit schedule and other protocol requirements, including the restrictions.~3. Subject is male, or non-pregnant and non-nursing female between ≥ 18 and ≤ 70 years of age at the time of signing the ICF.~4. Subject has Body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening.~5. Female subjects NOT of childbearing potential must:~ a. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before Screening, or postmenopausal (defined as 24 consecutive months without menses before Screening, with a follicle-stimulating hormone \\\\[FSH\\\\] level in the postmenopausal range according to the laboratory used at Screening); FSH to be performed at the discretion of the Investigator in consultation with the Medical Monitor.~6. Females of childbearing potential (FCBP)1 must have a negative pregnancy test at the Screening and Baseline Visits. While receiving Investigational Product (IP) and for at least 28 days after taking the dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: One highly effective method (e.g., hormonal contraception \\\\[oral, injection, implant, transdermal patch, vaginal ring\\\\]; intrauterine device; tubal ligation; or partner\\s vasectomy) and one additional form (latex condom or any nonlatex condom not made of natural \\\\[animal\\\\] membrane \\\\[eg, polyurethane\\\\], diaphragm, sponge).~ OR Option 2: Male or female condom PLUS 1 additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.~7. Male subjects must:~ a. Practice true abstinence2 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural \\\\[animal\\\\] membrane \\\\[latex condoms were recommended\\\\]) during sexual contact with a pregnant female or female of FCBP while participating in the study, during dose interruptions, and for at least 28 days after the dose of investigational product, even if he has undergone a successful vasectomy.~8. Subject has clinical laboratory safety test results that are within normal limits or acceptable to the Investigator.~9. Subject is afebrile (febrile is defined as ≥ 38°C or 100.3°F), with supine systolic blood pressure ≥ 90 and ≤ 160 mm Hg, supine diastolic blood pressure ≥ 50 and ≤ 100 mm Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute at Screening.~Exclusion Criteria:~The presence of any of the following will exclude a subject from enrollment:~1. Subject has any significant and relevant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study at the Investigator\\s discretion.~2. Subject has any condition that places the subject at an unacceptable risk if he or she were to participate in the study.~3. Subject has any condition that confounds the ability to interpret data from the study.~4. Subject is pregnant or breastfeeding.~5. Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever was longer).~6. Subject has used moderate or strong CYP3A4/5 inducers and/or inhibitors (including St. John\\s wort) within 30 days prior to dosing. The Indiana University P450 Drug Interactions Flockhart Table™ may be consulted for a list of such medications (http://medicine.iupui.edu/clinpharm/ddis/main-table).~7. Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure. Subjects with appendectomy and cholecystectomy may be included.~8. Subject has an estimated creatinine clearance \\\\< 60 mL/min as calculated using the Cockcroft-Gault formula.~9. Subject has donated blood or plasma within 2 weeks before dose administration to a blood bank or blood donation center.~10. Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dose administration, or positive drug screening test reflecting consumption of illicit drugs unless positive drug screen is due to prescription drug use that is approved by the Investigator and the Medical Monitor.~11. Subject has a history of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 1 year before dose administration, or a positive alcohol screen.~12. Subject has had a positive result to the test for human immunodeficiency virus (HIV) antibodies at Screening.~ • Chronic or resolved Hepatitis B or Hepatitis C are acceptable only if sequelae are limited to hepatic involvement and its consequent comorbidities. (ie, vasculitis, clinically significant globulinemia, etc. are unacceptable).~13. Subject smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).~14. Subject has received live vaccination (excluding seasonal flu vaccination) within 30 days of dosing.~15. Subject is part of the clinical staff personnel or a family member of the study site staff.~16. Subject is, for any reason, deemed by the investigator to be inappropriate for this study, including a subject who is unable to communicate or to cooperate with the investigator or the clinical staff.", Similarity Score: 0.24996182662073055}'}]
|
from_dataset
| 0.249962
|
[{'from': 'human', 'value': '{Study Title: European Study Evaluating the EMBLOK Embolic Protection System During TAVR, Primary Outcome Measures: Performance Endpoint, successful insertion, placement and removal of the EMBLOK system, Day 1 to post procedure, Secondary Outcome Measures: Safety Endpoint (Rate of MACCE), Rate of MACCE, 30 days, criteria: "Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (\\\\> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.~Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject\\s legal representative completes written Informed Consent.~Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.~Subject has experienced a myocardial infarction within 30 days of the planned index procedure.~Subject has renal insufficiency, defined as a creatinine level \\\\> 2.5 mg/dl at the time of treatment.~Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.~Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.~Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \\\\> 38° C and/ or WBC \\\\> 15,000 IU.~Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 226, Unnamed: 0: 273, NCT Number: NCT02987894, Study Title: PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry, Study URL: https://clinicaltrials.gov/study/NCT02987894, Acronym: PROGRESS, Study Status: COMPLETED, Brief Summary: The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU., Study Results: NO, Conditions: Aortic Stenosis, Interventions: DEVICE: ACURATE neo™ Aortic Bioprosthesis, Primary Outcome Measures: Change in total aortic regurgitation over time., total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up, post-implantation on index procedure date, 7- days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure, Secondary Outcome Measures: Incidence of all-cause mortality, Incidence of all-cause mortality at 30 days post index procedure, 30 days post-index procedure|Clinical events as defined per VARC-2 consensus document (VARC-2), Clinical events as defined per VARC-2 consensus document, Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Number of patients with procedural success according to VARC II criteria, Procedural success is defined as\\n\\nAbsence of intra-procedure mortality and complications arising during implantation of the prosthetic valve such as:\\n\\n* inability to properly seat the valve in the annulus\\n* need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment)\\n* surgical aortic valve replacement required to correct a severe aortic regurgitation or procedure complication The procedure can be considered as success despite the presence of residual aortic regurgitation which may be due to the anatomic configuration of the annulus or a calcific valvular annulus., at index- Procedure|Number of patients with device success, Device success is defined as:\\n\\n* Absence of intra-procedure mortality (procedure to 24H) AND,\\n* Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND,\\n* Intended performance of the prosthetic heart valve:\\n\\n * No prosthesis-patient mismatch (EAOi \\\\>0.85 cm2/m2) AND,\\n * Mean aortic valve gradient \\\\<20mmHg or peak velocity \\\\< 3 m/s AND,\\n * No moderate or severe prosthetic valve regurgitation.\\n\\nIn evaluating echo parameters, values at 7D/Discharge (whichever occurs first) will be used for each of the echo parameters above. If any of echo parameters is missing at 7-days or discharge, post-procedure data may be used for the missing values. If device success or failure cannot be determined due to missing of parameters listed above or un-evaluable echocardiography assessment, device success will be considered not obtainable., 7-days post-index procedure or discharge (whichever occurs first)|Number of patients with adverse events assessed by VARC-2 Composite Safety, VARC-2 Composite Safety at 30 days defined as:\\n\\n* All-cause mortality\\n* All stroke (disabling and non-disabling)\\n* Life-threatening bleeding\\n* Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)\\n* Coronary artery obstruction requiring intervention\\n* Major vascular complication\\n* Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVI), 30 days post-index procedure|Functional improvement, Functional improvement from baseline as per NYHA Functional Classification, 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Hemodynamic function improvement from baseline, Improvement from baseline of the hemodynamic function: effective orifice area and mean transprosthetic gradient, 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Valve related dysfunction, Valve related dysfunction defined as: mean aortic valve gradient ≥ 20mmHg, EOA ≤0.9-1.1 cm2, and/or DVI\\\\< 0.35, and/or moderate or severe prosthetic valve regurgitation (See VARC-2 and Figure 4 from VARC manuscript), 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure, Other Outcome Measures: , Sponsor: Symetis SA, Collaborators: , Sex: ALL, Age: OLDER_ADULT, Phases: , Enrollment: 500.0, Funder Type: INDUSTRY, Study Type: OBSERVATIONAL, Study Design: Observational Model: |Time Perspective: p, Other IDs: 2016-02, Start Date: 2017-01-02, Primary Completion Date: 2019-09, Completion Date: 2019-09, First Posted: 2016-12-09, Results First Posted: , Last Update Posted: 2020-04-09, Locations: "London Health Sciences Centre, University Hospital, London, Ontario, Canada|Saint Pauls Hospital, Porvidence Health Care Institute, Vancouver, BC V6Z 1Y6, Canada|Klinikum Augsburg, Augsburg, 86156, Germany|Zentralklinik Bad Berka, Bad Berka, 99437, Germany|Kerkhoff Kilnik, Bad Nauheim, 61231, Germany|Immanuel Hospital Bernau- Herzzentrum Brandenburg, Bernau, 13321, Germany|Sana-Herzzentrum Cottbus GmbH, Cottbus, 03048, Germany|St Johannes Hospital, Dortmund, 44137, Germany|Goethe Universität, Frankfurt, 60323, Germany|Universitätklinikum Giessen, Giessen, 35392, Germany|Universitätsklinikum Halle, Halle, 06097, Germany|Universitätsklinikum Jena, Jena, 07743, Germany|Städisches Klinikum Karlsruhe GmbH, Karlsruhe, 76133, Germany|Helios Klinik Fur Herzzchirurgie Karlsruhe, Karlsruhe, 76185, Germany|Universitätsklinikum, Köln, 50924, Germany|Sana Herzzentrum Leipzig, Leipzig, 04289, Germany|Universitätsklinikum Münster, Münster, 48149, Germany|Städische Kliniken, Neuss, 41464, Germany|Universitätsklinikum Tübingen, Tübingen, 72016, Germany|Ospedale Civile di Legnano, Legnano, Italy|Fondazione Toscana G.Monasterio, Ospedale del Cuore G.Pasquinucci, Massa, 54100, Italy|University Hospital NHS, Leicester, United Kingdom|Oford University Hospital, Oxford, United Kingdom", Study Documents: , criteria: "Inclusion Criteria:~1. Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use (Patients which are included but treated outside of the approved indication will be followed for safety reasons).~2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry. Patient agrees that anonymized imaging data will be sent to and analyzed by an external Core Laboratory.~3. The treating physician should ensure the subject will return for all required post procedure follow-up visits.~Exclusion Criteria:~1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.", combined_text: PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry Change in total aortic regurgitation over time., total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up, post-implantation on index procedure date, 7- days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure Incidence of all-cause mortality, Incidence of all-cause mortality at 30 days post index procedure, 30 days post-index procedure|Clinical events as defined per VARC-2 consensus document (VARC-2), Clinical events as defined per VARC-2 consensus document, Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Number of patients with procedural success according to VARC II criteria, Procedural success is defined as\\n\\nAbsence of intra-procedure mortality and complications arising during implantation of the prosthetic valve such as:\\n\\n* inability to properly seat the valve in the annulus\\n* need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment)\\n* surgical aortic valve replacement required to correct a severe aortic regurgitation or procedure complication The procedure can be considered as success despite the presence of residual aortic regurgitation which may be due to the anatomic configuration of the annulus or a calcific valvular annulus., at index- Procedure|Number of patients with device success, Device success is defined as:\\n\\n* Absence of intra-procedure mortality (procedure to 24H) AND,\\n* Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND,\\n* Intended performance of the prosthetic heart valve:\\n\\n * No prosthesis-patient mismatch (EAOi \\\\>0.85 cm2/m2) AND,\\n * Mean aortic valve gradient \\\\<20mmHg or peak velocity \\\\< 3 m/s AND,\\n * No moderate or severe prosthetic valve regurgitation.\\n\\nIn evaluating echo parameters, values at 7D/Discharge (whichever occurs first) will be used for each of the echo parameters above. If any of echo parameters is missing at 7-days or discharge, post-procedure data may be used for the missing values. If device success or failure cannot be determined due to missing of parameters listed above or un-evaluable echocardiography assessment, device success will be considered not obtainable., 7-days post-index procedure or discharge (whichever occurs first)|Number of patients with adverse events assessed by VARC-2 Composite Safety, VARC-2 Composite Safety at 30 days defined as:\\n\\n* All-cause mortality\\n* All stroke (disabling and non-disabling)\\n* Life-threatening bleeding\\n* Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)\\n* Coronary artery obstruction requiring intervention\\n* Major vascular complication\\n* Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVI), 30 days post-index procedure|Functional improvement, Functional improvement from baseline as per NYHA Functional Classification, 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Hemodynamic function improvement from baseline, Improvement from baseline of the hemodynamic function: effective orifice area and mean transprosthetic gradient, 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure|Valve related dysfunction, Valve related dysfunction defined as: mean aortic valve gradient ≥ 20mmHg, EOA ≤0.9-1.1 cm2, and/or DVI\\\\< 0.35, and/or moderate or severe prosthetic valve regurgitation (See VARC-2 and Figure 4 from VARC manuscript), 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure "Inclusion Criteria:~1. Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use (Patients which are included but treated outside of the approved indication will be followed for safety reasons).~2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry. Patient agrees that anonymized imaging data will be sent to and analyzed by an external Core Laboratory.~3. The treating physician should ensure the subject will return for all required post procedure follow-up visits.~Exclusion Criteria:~1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.", Similarity Score: 0.24617609608389804}'}]
|
from_dataset
| 0.246176
|
[{'from': 'human', 'value': '{Study Title: European Study Evaluating the EMBLOK Embolic Protection System During TAVR, Primary Outcome Measures: Performance Endpoint, successful insertion, placement and removal of the EMBLOK system, Day 1 to post procedure, Secondary Outcome Measures: Safety Endpoint (Rate of MACCE), Rate of MACCE, 30 days, criteria: "Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (\\\\> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.~Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject\\s legal representative completes written Informed Consent.~Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.~Subject has experienced a myocardial infarction within 30 days of the planned index procedure.~Subject has renal insufficiency, defined as a creatinine level \\\\> 2.5 mg/dl at the time of treatment.~Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.~Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.~Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \\\\> 38° C and/ or WBC \\\\> 15,000 IU.~Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 268, Unnamed: 0: 323, NCT Number: NCT01054391, Study Title: Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae, Study URL: https://clinicaltrials.gov/study/NCT01054391, Acronym: , Study Status: UNKNOWN, Brief Summary: The purpose of this study is to determine whether the NEC device can effectively occlude the intracranial aneurysm or the carotid/vertebrobasilar fistula and maintain parent vessel patency, Study Results: NO, Conditions: Intracranial Aneurysms|Cavernous Carotid Fistula|Vertebrobasilar Fistula, Interventions: DEVICE: NEC - Neurovascular Embolization Cover, Primary Outcome Measures: Proportion of subjects who show complete occlusion of target aneurysm or or fistula as judged by Core Laboratory radiologist by angiography, 6 month follow-up|Proportion of subjects who experience neurologic death or ipsilateral stroke, 6 month follow-up, Secondary Outcome Measures: , Other Outcome Measures: , Sponsor: Nfocus Neuromedical, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 10.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: NEC001, Start Date: 2008-10, Primary Completion Date: 2010-12, Completion Date: , First Posted: 2010-01-22, Results First Posted: , Last Update Posted: 2010-01-22, Locations: Universitatsklinikum Schleswig-Holstein Campus Kiel Institut fur Neuroradiologie, Kiel, 24105, Germany|Universitatsklinikum Schleswig-Holstein Institut fur Neuroradiologie, Lubeck, 23538, Germany, Study Documents: , criteria: "Inclusion Criteria:~* Clinical diagnosis of unruptured aneurysm OR ruptured aneurysm in clinically stable patients in whom coils alone are not an efficient treatment in the opinion of the investigator (i.e., large neck or fusiform aneurysm) OR direct fistulae (Type A - traumatic or aneurismal) and indirect if dural branches come from the internal carotid or vertebral artery and cannot be embolized selectively~* Subject has a confirmed diagnosis of an intracranial (including intracavernous and intrapetrous regions) sidewall saccular aneurysm or carotid vertebrobasilar fistula~* Parent artery reference diameter is \\\\>2.5mm and \\\\<4.5mm~* Subject is an adult above age 18~* Subject is able to provide written Informed Consent~* Subject has good general health, is clinically stable, and is considered to be mentally sound~* Subject is able and is willing to meet all expected requirements of the clinical protocol, including attending the scheduled follow-up examinations for the duration of this trial.~Exclusion Criteria:~* Subject has subarachnoid hemorrhage (SAH) \\\\< three (3) weeks prior to NEC procedure~* Subject has had prior stenting of the target aneurysm.~* Subject is contraindicated for antiplatelet therapy,anticoagulant therapy, or radiographic contrast media.~* Subject has collagen vascular disease.~* Subject has a contraindication to angiography (e.g., serum creatinine level \\\\> 2.5 mg/dL)~* Subject has evidence of active infection at the time of treatment~* Subject is pregnant or breastfeeding or unwilling to use birth control for duration of study~* Subject has participated in a study involving an investigational drug or device within 30 days prior to proposed entry into subject study~* Subject is unable to comply with study procedures or protocol~* Subject has co-morbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days", combined_text: Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae Proportion of subjects who show complete occlusion of target aneurysm or or fistula as judged by Core Laboratory radiologist by angiography, 6 month follow-up|Proportion of subjects who experience neurologic death or ipsilateral stroke, 6 month follow-up "Inclusion Criteria:~* Clinical diagnosis of unruptured aneurysm OR ruptured aneurysm in clinically stable patients in whom coils alone are not an efficient treatment in the opinion of the investigator (i.e., large neck or fusiform aneurysm) OR direct fistulae (Type A - traumatic or aneurismal) and indirect if dural branches come from the internal carotid or vertebral artery and cannot be embolized selectively~* Subject has a confirmed diagnosis of an intracranial (including intracavernous and intrapetrous regions) sidewall saccular aneurysm or carotid vertebrobasilar fistula~* Parent artery reference diameter is \\\\>2.5mm and \\\\<4.5mm~* Subject is an adult above age 18~* Subject is able to provide written Informed Consent~* Subject has good general health, is clinically stable, and is considered to be mentally sound~* Subject is able and is willing to meet all expected requirements of the clinical protocol, including attending the scheduled follow-up examinations for the duration of this trial.~Exclusion Criteria:~* Subject has subarachnoid hemorrhage (SAH) \\\\< three (3) weeks prior to NEC procedure~* Subject has had prior stenting of the target aneurysm.~* Subject is contraindicated for antiplatelet therapy,anticoagulant therapy, or radiographic contrast media.~* Subject has collagen vascular disease.~* Subject has a contraindication to angiography (e.g., serum creatinine level \\\\> 2.5 mg/dL)~* Subject has evidence of active infection at the time of treatment~* Subject is pregnant or breastfeeding or unwilling to use birth control for duration of study~* Subject has participated in a study involving an investigational drug or device within 30 days prior to proposed entry into subject study~* Subject is unable to comply with study procedures or protocol~* Subject has co-morbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days", Similarity Score: 0.24602570523211487}'}]
|
from_dataset
| 0.246026
|
[{'from': 'human', 'value': '{Study Title: European Study Evaluating the EMBLOK Embolic Protection System During TAVR, Primary Outcome Measures: Performance Endpoint, successful insertion, placement and removal of the EMBLOK system, Day 1 to post procedure, Secondary Outcome Measures: Safety Endpoint (Rate of MACCE), Rate of MACCE, 30 days, criteria: "Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (\\\\> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.~Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject\\s legal representative completes written Informed Consent.~Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.~Subject has experienced a myocardial infarction within 30 days of the planned index procedure.~Subject has renal insufficiency, defined as a creatinine level \\\\> 2.5 mg/dl at the time of treatment.~Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.~Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.~Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \\\\> 38° C and/ or WBC \\\\> 15,000 IU.~Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 23, Unnamed: 0: 28, NCT Number: NCT01507194, Study Title: A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV), Study URL: https://clinicaltrials.gov/study/NCT01507194, Acronym: , Study Status: COMPLETED, Brief Summary: This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron., Study Results: NO, Conditions: Postoperative Nausea and Vomiting, Interventions: DRUG: Ondansetron|DRUG: Vestipitant, Primary Outcome Measures: Complete Response, No emesis and no further rescue medication, 10 min. after infusion start through 24 hrs. or discharge, Secondary Outcome Measures: Nausea Numeric Rating Scale (NNRS), Pre-dose; 5, 10, 15 min. post-dose; q 15 min. through 2 hrs. post-dose; q 2 hrs. through 24 hrs. post-dose; and 5 days post-dose|No Emesis/Vomiting, Pre-dose; continuous through 24 hrs. post-dose; and 5 days post-dose, Other Outcome Measures: , Sponsor: Accenture, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 131.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT, Other IDs: VNK115640, Start Date: 2012-02, Primary Completion Date: 2012-08, Completion Date: 2012-08, First Posted: 2012-01-10, Results First Posted: , Last Update Posted: 2012-10-02, Locations: "Helen Keller Hospital, Sheffield, Alabama, 35660, United States|Precision Trials, Phoenix, Arizona, 85032, United States|Visions Clinical Research, Boynton Beach, Florida, 33472, United States|CAP Anesthesia (St. Elizabeths Medical Center), Boston, Massachusetts, 02135, United States|Wake Forest University Anesthesia at Forsyth Medical Center, Winston Salem, North Carolina, 27157, United States|Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, 15213, United States|University of Pittsburg, Pittsburgh, Pennsylvania, 15232, United States", Study Documents: , criteria: "Inclusion Criteria:~* Male or Female post-operative surgical subjects between the ages of 18-75 years.~* Female subject is of non-childbearing potential or of child-bearing potential and agrees to use specified contraception methods.~* Has 3 or more of the following independent risk factors for PONV: female gender; non-smoker; history of PONV or motion sickness; or planned post- operative opioids.~* Has received one dose of ondansetron as part of a PONV prophylaxis regimen for the surgical procedure.~* Has received general anesthesia.~* Meets ASA Physical Status Classification of 1 or 2 without an E modifier preoperatively on the day of surgery and has hematology and blood chemistry values within acceptable limits for surgery.~* Is capable of giving written informed consent.~* Experiences breakthrough PONV defined as: post-operative nausea of ≥ 7 on the Nausea Numeric Rating Scale; nausea resulting in a subject request for an anti-emetic; or an episode of emesis or retching.~Exclusion Criteria:~* A history of HIV.~* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening.~* An ALT or AST \\\\>2.5 x ULN at Screening.~* Pregnant or lactating females.~* The subject is scheduled to undergo a laparoscopic biopsy only.~* The subject has a history of or is scheduled to undergo cardiac/cardiothoracic surgery.~* The subject is scheduled to receive neuraxial anesthesia(e.g., epidural, spinal, or caudal anesthesia)or total IV anesthesia.~* The subject is scheduled to receive propofol for maintenance of anesthesia (propofol as an induction agent is allowed).~* The subject is scheduled to receive an NK1 inhibitor (aprepitant/fosaprepitant) as part of a PONV prophylaxis regimen for the surgical procedure.~* The subject is scheduled to have gastric contents suctioned continuously during the surgical procedure via a nasogastric tube, or a nasogastric or oral gastric tube during the post-operative period. A single pass at the beginning or at the end of the procedure, and intraoperative gastric suctioning of air, will be permitted.~* The subject received an investigational drug within 30 days or was scheduled to receive any investigational drug in addition to vestipitant during the study period.~* The subject has persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to, gastric outlet obstruction, hypercalcemia, active peptic ulcer, increased intracranial pressure, chemotherapy, or brain metastases.~* The subject received radiation therapy to the abdomen or the pelvis within 7 days prior to receiving study medications and/or received radiation therapy to the abdomen or the pelvis in the evaluation period.~* The subject has a history of wound dehiscence.~* The subject has a history of any other illness which might pose an unacceptable risk by administering study medication.~* The subject has any current or past medical condition (e.g., vagotomy) and/or required medication to treat a condition that could affect the evaluation of the study.~* The subject has a known contraindication or hypersensitivity to ondansetron or ondansetron injection, any scheduled anaesthetic or analgesic agents, vestipitant or any component of the vestipitant formulation including Captisol.~* The subject received medication with known or potential antiemetic activity after the induction of anaesthesia (during the intraoperative or post- operative period) other than the planned Study Treatment.~* Current or planned use of strong or moderate inhibitors of CYP3A within 7 days or inducers of CYP3A within 14 days prior to study medication administration.~* The subject is unwilling or unable to follow the procedures outlined in the protocol.~* The subject is mentally or legally incapacitated.", combined_text: A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV) Complete Response, No emesis and no further rescue medication, 10 min. after infusion start through 24 hrs. or discharge Nausea Numeric Rating Scale (NNRS), Pre-dose; 5, 10, 15 min. post-dose; q 15 min. through 2 hrs. post-dose; q 2 hrs. through 24 hrs. post-dose; and 5 days post-dose|No Emesis/Vomiting, Pre-dose; continuous through 24 hrs. post-dose; and 5 days post-dose "Inclusion Criteria:~* Male or Female post-operative surgical subjects between the ages of 18-75 years.~* Female subject is of non-childbearing potential or of child-bearing potential and agrees to use specified contraception methods.~* Has 3 or more of the following independent risk factors for PONV: female gender; non-smoker; history of PONV or motion sickness; or planned post- operative opioids.~* Has received one dose of ondansetron as part of a PONV prophylaxis regimen for the surgical procedure.~* Has received general anesthesia.~* Meets ASA Physical Status Classification of 1 or 2 without an E modifier preoperatively on the day of surgery and has hematology and blood chemistry values within acceptable limits for surgery.~* Is capable of giving written informed consent.~* Experiences breakthrough PONV defined as: post-operative nausea of ≥ 7 on the Nausea Numeric Rating Scale; nausea resulting in a subject request for an anti-emetic; or an episode of emesis or retching.~Exclusion Criteria:~* A history of HIV.~* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening.~* An ALT or AST \\\\>2.5 x ULN at Screening.~* Pregnant or lactating females.~* The subject is scheduled to undergo a laparoscopic biopsy only.~* The subject has a history of or is scheduled to undergo cardiac/cardiothoracic surgery.~* The subject is scheduled to receive neuraxial anesthesia(e.g., epidural, spinal, or caudal anesthesia)or total IV anesthesia.~* The subject is scheduled to receive propofol for maintenance of anesthesia (propofol as an induction agent is allowed).~* The subject is scheduled to receive an NK1 inhibitor (aprepitant/fosaprepitant) as part of a PONV prophylaxis regimen for the surgical procedure.~* The subject is scheduled to have gastric contents suctioned continuously during the surgical procedure via a nasogastric tube, or a nasogastric or oral gastric tube during the post-operative period. A single pass at the beginning or at the end of the procedure, and intraoperative gastric suctioning of air, will be permitted.~* The subject received an investigational drug within 30 days or was scheduled to receive any investigational drug in addition to vestipitant during the study period.~* The subject has persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to, gastric outlet obstruction, hypercalcemia, active peptic ulcer, increased intracranial pressure, chemotherapy, or brain metastases.~* The subject received radiation therapy to the abdomen or the pelvis within 7 days prior to receiving study medications and/or received radiation therapy to the abdomen or the pelvis in the evaluation period.~* The subject has a history of wound dehiscence.~* The subject has a history of any other illness which might pose an unacceptable risk by administering study medication.~* The subject has any current or past medical condition (e.g., vagotomy) and/or required medication to treat a condition that could affect the evaluation of the study.~* The subject has a known contraindication or hypersensitivity to ondansetron or ondansetron injection, any scheduled anaesthetic or analgesic agents, vestipitant or any component of the vestipitant formulation including Captisol.~* The subject received medication with known or potential antiemetic activity after the induction of anaesthesia (during the intraoperative or post- operative period) other than the planned Study Treatment.~* Current or planned use of strong or moderate inhibitors of CYP3A within 7 days or inducers of CYP3A within 14 days prior to study medication administration.~* The subject is unwilling or unable to follow the procedures outlined in the protocol.~* The subject is mentally or legally incapacitated.", Similarity Score: 0.23263730814551456}'}]
|
from_dataset
| 0.232637
|
[{'from': 'human', 'value': '{Study Title: European Study Evaluating the EMBLOK Embolic Protection System During TAVR, Primary Outcome Measures: Performance Endpoint, successful insertion, placement and removal of the EMBLOK system, Day 1 to post procedure, Secondary Outcome Measures: Safety Endpoint (Rate of MACCE), Rate of MACCE, 30 days, criteria: "Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (\\\\> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.~Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject\\s legal representative completes written Informed Consent.~Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.~Subject has experienced a myocardial infarction within 30 days of the planned index procedure.~Subject has renal insufficiency, defined as a creatinine level \\\\> 2.5 mg/dl at the time of treatment.~Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.~Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.~Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \\\\> 38° C and/ or WBC \\\\> 15,000 IU.~Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 792, Unnamed: 0: 998, NCT Number: NCT01659944, Study Title: Study to Evaluate the Effect of Eliglustat on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adults, Study URL: https://clinicaltrials.gov/study/NCT01659944, Acronym: , Study Status: COMPLETED, Brief Summary: The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in healthy adults.\\n\\nThe secondary objective is to assess the safety and tolerability of a single oral dose of metoprolol 50 mg when administered alone and in combination with repeated oral doses of eliglustat 150 mg BID in healthy adults., Study Results: NO, Conditions: Healthy, Interventions: DRUG: Eliglustat|DRUG: Metoprolol, Primary Outcome Measures: Metoprolol area under the plasma concentration time curve from time zero to the last evaluable concentration (AUC0-last), Day 1 and Day 7; predose and up to 48 hours after drug administration|Metoprolol area under the plasma concentration time curve from time zero extrapolated to infinity (AUC0-∞), Day 1 and Day 7; Predose and up to 48 hours after drug administration, Secondary Outcome Measures: Maximum plasma concentration (Cmax) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Time to maximum plasma concentration (Tmax) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Terminal elimination half-life (T1/2) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Trough plasma concentration of eliglustat, Eliglustat plasma concentration observed just prior to administration during repeated dosing., Day 3, Day 4, Day 5, Day 6, Day 7 and Day 8.|Maximum plasma concentration (Cmax) of eliglustat, Day 7, up to 12 hours after drug administration|Time to maximum plasma concentration (Tmax) of eliglustat, Day 7; up to 12 hours after drug administration|Eliglustat area under the plasma concentration time curve during the dosing interval (AUC0-τ), Day 7; up to 12 hours after drug administration|Number of participants with adverse events, Day 1 through to Day 14, Other Outcome Measures: , Sponsor: Genzyme, a Sanofi Company, Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 14.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: |Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE, Other IDs: GZGD04112, Start Date: 2012-05, Primary Completion Date: 2012-06, Completion Date: 2012-07, First Posted: 2012-08-08, Results First Posted: , Last Update Posted: 2015-03-23, Locations: Austin, Texas, United States, Study Documents: , criteria: "Inclusion Criteria:~1. The subject is willing and able to provide signed informed consent.~2. The male or female subject is in good general health and between 18 and 40 years of age, inclusive.~3. The subject has a body weight of 50 to 100 kg (110 to 220 lb) with a body mass index (BMI) ≤32 kg/m2 at screening.~4. The subject\\s physical examination, laboratory, vital sign, and electrocardiogram (ECG) test results are within normal limits at screening and Day -1 or, if abnormal, are not considered clinically significant in the opinion of the Investigator.~5. The subject has been a non-smoker for at least 6 months prior to the time of providing informed consent, and is willing and able to abstain from smoking (and use of other forms of nicotine) until completion of the safety follow-up visit.~6. The subject has not used drugs of abuse for at least 6 months prior to Day -1 and is willing and able to abstain from using drugs of abuse until completion of the safety follow-up visit.~7. The subject is willing and able to abstain from alcohol for 48 hours prior to the first dose of study drug until completion of the safety follow-up visit.~8. The subject is willing and able to abstain from grapefruit, grapefruit juice or any other grapefruit-containing products for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.~9. The subject is willing and able to maintain a normal-fiber diet (i.e., to abstain from excess fiber-rich foods) for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.~10. Female subjects of childbearing potential must have a documented negative pregnancy test at screening, Day -1 and prior to dosing on Day 7 and be willing to use a medically accepted form of contraception (as defined in the protocol) from screening until 30 days after the last dose of study drug. A woman of childbearing potential is defined as any female who has not been amenorrheic for at least 2 years or has not undergone a hysterectomy or surgical sterilization.~Exclusion Criteria:~1. The subject is classified as a cytochrome P450 2D6 (CYP2D6) poor metabolizer (or an indeterminate metabolizer with neither allele known to be active) based on results of CYP2D6 genotyping performed at screening. (Note: Prior CYP2D6 genotyping results may be used for the purpose of determining study eligibility if a copy of the laboratory report is available and the genotyping results can be interpreted with the same classification system used by the study reference laboratory.)~2. The subject has a digestive disorder, including malabsorption, gastroenteritis, pancreatitis, gastroesophageal reflux disease, inflammatory bowel disease (including Crohn\\s disease), or any other digestive disorder which, in the opinion of the Investigator, may affect oral bioavailability (e.g., clinically significant constipation, diverticulitis, or irritable bowel syndrome).~3. The subject has had a gastrointestinal (GI) surgical procedure that might affect drug transit time, (e.g., cholecystectomy, GI bypass surgery, partial or total gastrectomy, or small bowel resection).~4. The subject has any of the following: Clinically significant coronary artery disease including history of myocardial infarction or ongoing signs or symptoms consistent with cardiac ischemia or heart failure; clinically significant arrhythmias or conduction defect such as 2nd or 3rd degree atrioventricular (AV) block, a PR interval ≥200 msec, complete bundle branch block, prolonged QTc interval (e.g., repeated demonstration of a QTc interval ≥430 msec for male subjects and ≥450 msec for female subjects), sustained ventricular tachycardia, heart rate \\\\<55 beats/min, or systolic blood pressure \\\\<110 mmHg.~5. The subject has a clinically significant organic disease, including cardiovascular, renal, hepatic, gastrointestinal, pulmonary, neurologic, endocrine, metabolic, or psychiatric disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precludes participation in the trial.~6. The subject has a disease, clinical finding, or any contraindication that would prohibit the use of metoprolol in a phase 1 study (i.e., risk of disease exacerbation outweighs benefit). Examples of these are clinical findings of glucose intolerance, poor arterial peripheral circulation or bronchospastic disease including asthma.~7. The subject has a history of fainting, postural lightheadedness, or any other postural symptoms.~8. The subject has received any prescription or non-prescription medication (with the exception of nonprescription-strength ibuprofen and acetaminophen, topical non-steroidal preparations, and topical hydrocortisone (up to 1% strength)) or dietary or herbal or fiber supplement within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug without the approval of both the Investigator and Sponsor.~9. The subject has received an immunization within 30 days of providing informed consent.~10. The subject has received an investigational product within 30 days prior to the first dose of study drug or plans to receive any other investigational product at any time during the course of this study.~11. The subject has a history of drug allergies that are clinically significant in the opinion of the Investigator (e.g., significant rash or hives).~12. The subject has a screening laboratory test result above the upper limit of normal for any of the following liver function tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyltransferase (GGT), and total bilirubin.~13. The subject tests positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or hepatitis B surface antigen at screening.~14. The subject tests positive for urine drugs of abuse, urine alcohol, or urine cotinine at screening.~15. The subject donated blood or blood products within 30 days prior to providing informed consent.~16. The subject\\s schedule or travel plans prevent the completion of all required visits.~17. The subject is scheduled for inpatient hospitalization, including elective surgery (inpatient or outpatient), during the study.~18. The subject has a history of cancer, with the exception of basal cell carcinoma.~19. The female subject of childbearing potential is pregnant or lactating.~20. The subject, in the opinion of the Investigator, is unable to adhere to the requirements of the study.", combined_text: Study to Evaluate the Effect of Eliglustat on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adults Metoprolol area under the plasma concentration time curve from time zero to the last evaluable concentration (AUC0-last), Day 1 and Day 7; predose and up to 48 hours after drug administration|Metoprolol area under the plasma concentration time curve from time zero extrapolated to infinity (AUC0-∞), Day 1 and Day 7; Predose and up to 48 hours after drug administration Maximum plasma concentration (Cmax) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Time to maximum plasma concentration (Tmax) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Terminal elimination half-life (T1/2) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Trough plasma concentration of eliglustat, Eliglustat plasma concentration observed just prior to administration during repeated dosing., Day 3, Day 4, Day 5, Day 6, Day 7 and Day 8.|Maximum plasma concentration (Cmax) of eliglustat, Day 7, up to 12 hours after drug administration|Time to maximum plasma concentration (Tmax) of eliglustat, Day 7; up to 12 hours after drug administration|Eliglustat area under the plasma concentration time curve during the dosing interval (AUC0-τ), Day 7; up to 12 hours after drug administration|Number of participants with adverse events, Day 1 through to Day 14 "Inclusion Criteria:~1. The subject is willing and able to provide signed informed consent.~2. The male or female subject is in good general health and between 18 and 40 years of age, inclusive.~3. The subject has a body weight of 50 to 100 kg (110 to 220 lb) with a body mass index (BMI) ≤32 kg/m2 at screening.~4. The subject\\s physical examination, laboratory, vital sign, and electrocardiogram (ECG) test results are within normal limits at screening and Day -1 or, if abnormal, are not considered clinically significant in the opinion of the Investigator.~5. The subject has been a non-smoker for at least 6 months prior to the time of providing informed consent, and is willing and able to abstain from smoking (and use of other forms of nicotine) until completion of the safety follow-up visit.~6. The subject has not used drugs of abuse for at least 6 months prior to Day -1 and is willing and able to abstain from using drugs of abuse until completion of the safety follow-up visit.~7. The subject is willing and able to abstain from alcohol for 48 hours prior to the first dose of study drug until completion of the safety follow-up visit.~8. The subject is willing and able to abstain from grapefruit, grapefruit juice or any other grapefruit-containing products for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.~9. The subject is willing and able to maintain a normal-fiber diet (i.e., to abstain from excess fiber-rich foods) for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.~10. Female subjects of childbearing potential must have a documented negative pregnancy test at screening, Day -1 and prior to dosing on Day 7 and be willing to use a medically accepted form of contraception (as defined in the protocol) from screening until 30 days after the last dose of study drug. A woman of childbearing potential is defined as any female who has not been amenorrheic for at least 2 years or has not undergone a hysterectomy or surgical sterilization.~Exclusion Criteria:~1. The subject is classified as a cytochrome P450 2D6 (CYP2D6) poor metabolizer (or an indeterminate metabolizer with neither allele known to be active) based on results of CYP2D6 genotyping performed at screening. (Note: Prior CYP2D6 genotyping results may be used for the purpose of determining study eligibility if a copy of the laboratory report is available and the genotyping results can be interpreted with the same classification system used by the study reference laboratory.)~2. The subject has a digestive disorder, including malabsorption, gastroenteritis, pancreatitis, gastroesophageal reflux disease, inflammatory bowel disease (including Crohn\\s disease), or any other digestive disorder which, in the opinion of the Investigator, may affect oral bioavailability (e.g., clinically significant constipation, diverticulitis, or irritable bowel syndrome).~3. The subject has had a gastrointestinal (GI) surgical procedure that might affect drug transit time, (e.g., cholecystectomy, GI bypass surgery, partial or total gastrectomy, or small bowel resection).~4. The subject has any of the following: Clinically significant coronary artery disease including history of myocardial infarction or ongoing signs or symptoms consistent with cardiac ischemia or heart failure; clinically significant arrhythmias or conduction defect such as 2nd or 3rd degree atrioventricular (AV) block, a PR interval ≥200 msec, complete bundle branch block, prolonged QTc interval (e.g., repeated demonstration of a QTc interval ≥430 msec for male subjects and ≥450 msec for female subjects), sustained ventricular tachycardia, heart rate \\\\<55 beats/min, or systolic blood pressure \\\\<110 mmHg.~5. The subject has a clinically significant organic disease, including cardiovascular, renal, hepatic, gastrointestinal, pulmonary, neurologic, endocrine, metabolic, or psychiatric disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precludes participation in the trial.~6. The subject has a disease, clinical finding, or any contraindication that would prohibit the use of metoprolol in a phase 1 study (i.e., risk of disease exacerbation outweighs benefit). Examples of these are clinical findings of glucose intolerance, poor arterial peripheral circulation or bronchospastic disease including asthma.~7. The subject has a history of fainting, postural lightheadedness, or any other postural symptoms.~8. The subject has received any prescription or non-prescription medication (with the exception of nonprescription-strength ibuprofen and acetaminophen, topical non-steroidal preparations, and topical hydrocortisone (up to 1% strength)) or dietary or herbal or fiber supplement within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug without the approval of both the Investigator and Sponsor.~9. The subject has received an immunization within 30 days of providing informed consent.~10. The subject has received an investigational product within 30 days prior to the first dose of study drug or plans to receive any other investigational product at any time during the course of this study.~11. The subject has a history of drug allergies that are clinically significant in the opinion of the Investigator (e.g., significant rash or hives).~12. The subject has a screening laboratory test result above the upper limit of normal for any of the following liver function tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyltransferase (GGT), and total bilirubin.~13. The subject tests positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or hepatitis B surface antigen at screening.~14. The subject tests positive for urine drugs of abuse, urine alcohol, or urine cotinine at screening.~15. The subject donated blood or blood products within 30 days prior to providing informed consent.~16. The subject\\s schedule or travel plans prevent the completion of all required visits.~17. The subject is scheduled for inpatient hospitalization, including elective surgery (inpatient or outpatient), during the study.~18. The subject has a history of cancer, with the exception of basal cell carcinoma.~19. The female subject of childbearing potential is pregnant or lactating.~20. The subject, in the opinion of the Investigator, is unable to adhere to the requirements of the study.", Similarity Score: 0.23186446052583845}'}]
|
from_dataset
| 0.231864
|
[{'from': 'human', 'value': '{Study Title: European Study Evaluating the EMBLOK Embolic Protection System During TAVR, Primary Outcome Measures: Performance Endpoint, successful insertion, placement and removal of the EMBLOK system, Day 1 to post procedure, Secondary Outcome Measures: Safety Endpoint (Rate of MACCE), Rate of MACCE, 30 days, criteria: "Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (\\\\> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.~Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject\\s legal representative completes written Informed Consent.~Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.~Subject has experienced a myocardial infarction within 30 days of the planned index procedure.~Subject has renal insufficiency, defined as a creatinine level \\\\> 2.5 mg/dl at the time of treatment.~Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.~Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.~Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \\\\> 38° C and/ or WBC \\\\> 15,000 IU.~Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 196, Unnamed: 0: 238, NCT Number: NCT02649894, Study Title: Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter, Study URL: https://clinicaltrials.gov/study/NCT02649894, Acronym: SWIFT, Study Status: COMPLETED, Brief Summary: The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions compared to approve catheter., Study Results: YES, Conditions: Malignant Pleural Effusion, Interventions: DEVICE: Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter|DEVICE: Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC), Primary Outcome Measures: The Proportion of Subjects Achieving Pleurodesis Without Recurrence., 30 days post catheter insertion, Secondary Outcome Measures: Time to Confirmed Pleurodesis, 30 days post insertion|Time to Recurrence, This endpoint was meant to measure time to recurrence; however, only 1 participant (in the SNCIPC group) had a recurrence so this outcome could not be analyzed., 90 days post insertion, Other Outcome Measures: Proportion of Surviving Subjects Without a Trapped Lung Diagnosis Following IPC Placement Who Have Confirmed Pleurodesis Without Recurrence at 14, 30, 60, 90 Days., Day 14, Day 30, Day 60, Day 90|Proportion of Subjects With Confirmed Pleurodesis and Without Recurrence 30 Days After IPC Placement by Cancer Type (Lung, Breast and Others)., 30 days.|Incidence of IPC Occlusion, 90 days|Incidence of Empyema and Cellulitis, 90 days|Pain Using 100 mm Visual Analog Scale (VAS), Chest pain was measured using a 100 mm VAS scale at baseline and at each subsequent visit. The resulting VAS score ranges from 0 to 100, with 0 indicating "No pain" and 100 indicating "Very severe pain". Therefore, the lower the number, the less chest pain the subject is feeling at the time., Baseline,Day 7, 14, 30, 45, 75, and 90, Sponsor: CareFusion, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 119.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT, Other IDs: CS-IP-VH-14-009, Start Date: 2016-05, Primary Completion Date: 2018-04-18, Completion Date: 2018-04-18, First Posted: 2016-01-08, Results First Posted: 2020-08-13, Last Update Posted: 2020-09-10, Locations: Heart Center Research, Huntsville, Alabama, 35801, United States|Stanford University School of Medicine/ Stanford Cancer Institute, Stanford, California, 94305, United States|Moffitt Cancer Center, Tampa, Florida, 33612, United States|Northwestern Unversity, Chicago, Illinois, 60611, United States|St. Vincent Medical Group, Indianapolis, Indiana, 46260, United States|Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Beth Israel Deconess Medical Center West, Boston, Massachusetts, 02215, United States|Washington Universtiy School of Medicine, Barnes Jewish Hospital, Saint Louis, Missouri, 63110, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|SUNY Upstate Hospital, Syracuse, New York, 13210, United States|UNC Hospital, Chapel Hill, North Carolina, 27599, United States|Duke University, Durham, North Carolina, 27710, United States|Vanderbuilt University, Nashville, Tennessee, 37232, United States|University of Texas, MD Anderson Cancer Center, Houston, Texas, 77030, United States|Huntsman Cancer Institute, Salt Lake City, Utah, 84112, United States|Southmead Hospital, Bristol, United Kingdom|Oxford Center for Respiratory Medicine, Churchill Hospital, Oxford, United Kingdom|Great Western Hospital, Swindon, United Kingdom, Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/94/NCT02649894/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/94/NCT02649894/SAP_001.pdf, criteria: "Inclusion Criteria:~* 1. Male or female, at least 18 years of age, inclusive. 2. Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:~ 1. There is histocytological confirmation of pleural malignancy~ 2. The effusion is an exudate (per Light\\s criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified.~ 3. Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved.~ 4. Subject is willing and able to provide written informed consent. 5. Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.~ 6. Subject has sufficient pleural fluid to allow safe insertion of an IPC. 7. Subject has negative pregnancy test if appropriate. 8. Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member or paid healthcare professional and applies to US sites only; UK subjects will have drainage managed by home-care nurses).~ Exclusion Criteria:~* 1. Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, 2 separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ≤30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after a pleural drainage.~Significant trapped lung is deemed present if any 1 of the following criteria is met:~1. A CXR shows hydropneumothorax.~2. A CXR shows ≥20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid.~3. A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough).~ 2. Subject has a Karnofsky score \\\\<50, or a World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more.~ 3. Subject is pregnant, planning to become pregnant, or is lactating. 4. Subject has a history of empyema. 5. Subject has a history of chylothorax. 6. Subject has an uncorrected coagulopathy. 7. Subject has a hypersensitivity to new or existing pleural catheter or it\\s components.~ 8. Subject has evidence, in the opinion of the Investigator, of either on-going systemic or pleural infection.~ 9. Subject has had a lobectomy or pneumonectomy on the side of the effusion. 10. Subject has undergone a previous attempt at ipsilateral pleurodesis which has failed.~ 11. Subject has previously been diagnosed with a serious immunodeficiency disorder.~ 12. Subject has bilateral pleural effusions, with both being at least moderate in size (greater than one-third of the hemithorax on CXR).~ 13. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile.~ 14. Subject has a mediastinal shift of ≥2 cm toward the side of the effusion. 15. Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the ipsilateral chest.~ 16. Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would mean participation in the study would be contraindicated.~ 17. Subject has no access to a telephone. 18. Subject has no documented blood values (complete blood count \\\\[CBC\\\\], coagulation tests, urea and electrolytes, and liver function tests \\\\[LFTs\\\\]) within the last 10 days.~ 19. Subject has previously participated in any clinical trial with the investigational device.~ 20. Subject currently enrolled in any other clinical investigation or who has participated in any clinical investigation in the 30 days prior to starting this study.", combined_text: Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter The Proportion of Subjects Achieving Pleurodesis Without Recurrence., 30 days post catheter insertion Time to Confirmed Pleurodesis, 30 days post insertion|Time to Recurrence, This endpoint was meant to measure time to recurrence; however, only 1 participant (in the SNCIPC group) had a recurrence so this outcome could not be analyzed., 90 days post insertion "Inclusion Criteria:~* 1. Male or female, at least 18 years of age, inclusive. 2. Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:~ 1. There is histocytological confirmation of pleural malignancy~ 2. The effusion is an exudate (per Light\\s criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified.~ 3. Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved.~ 4. Subject is willing and able to provide written informed consent. 5. Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.~ 6. Subject has sufficient pleural fluid to allow safe insertion of an IPC. 7. Subject has negative pregnancy test if appropriate. 8. Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member or paid healthcare professional and applies to US sites only; UK subjects will have drainage managed by home-care nurses).~ Exclusion Criteria:~* 1. Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, 2 separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ≤30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after a pleural drainage.~Significant trapped lung is deemed present if any 1 of the following criteria is met:~1. A CXR shows hydropneumothorax.~2. A CXR shows ≥20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid.~3. A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough).~ 2. Subject has a Karnofsky score \\\\<50, or a World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more.~ 3. Subject is pregnant, planning to become pregnant, or is lactating. 4. Subject has a history of empyema. 5. Subject has a history of chylothorax. 6. Subject has an uncorrected coagulopathy. 7. Subject has a hypersensitivity to new or existing pleural catheter or it\\s components.~ 8. Subject has evidence, in the opinion of the Investigator, of either on-going systemic or pleural infection.~ 9. Subject has had a lobectomy or pneumonectomy on the side of the effusion. 10. Subject has undergone a previous attempt at ipsilateral pleurodesis which has failed.~ 11. Subject has previously been diagnosed with a serious immunodeficiency disorder.~ 12. Subject has bilateral pleural effusions, with both being at least moderate in size (greater than one-third of the hemithorax on CXR).~ 13. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile.~ 14. Subject has a mediastinal shift of ≥2 cm toward the side of the effusion. 15. Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the ipsilateral chest.~ 16. Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Investigator, would mean participation in the study would be contraindicated.~ 17. Subject has no access to a telephone. 18. Subject has no documented blood values (complete blood count \\\\[CBC\\\\], coagulation tests, urea and electrolytes, and liver function tests \\\\[LFTs\\\\]) within the last 10 days.~ 19. Subject has previously participated in any clinical trial with the investigational device.~ 20. Subject currently enrolled in any other clinical investigation or who has participated in any clinical investigation in the 30 days prior to starting this study.", Similarity Score: 0.22917799694306493}'}]
|
from_dataset
| 0.229178
|
[{'from': 'human', 'value': {'Study Title': 'Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis', 'Primary Outcome Measures': 'Therapeutic Cure, Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures., 42 Days', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Male or non-pregnant, non-lactating females 18 years of age or older.~* Signed informed consent form, which meets all criteria of current FDA regulations.~* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.~* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.~* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.~* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.~Exclusion Criteria:~* Females who are pregnant, lactating or likely to become pregnant during the study.~* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.~* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.~* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.~* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.~* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.~* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.~* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.~* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.~* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.~* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.~* Patients who would be non-compliant with the requirements of the study protocol.~* Participation in a research study within 30 days prior to baseline visit.~* Employees or family members of employees of the research center or investigator.~* Previous participation in this study."'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 779, 'Unnamed: 0': 980, 'NCT Number': 'NCT01714544', 'Study Title': 'Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque Psoriasis', 'Study URL': 'https://clinicaltrials.gov/study/NCT01714544', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'The purpose of this study is to determine whether Cloderm Cream is effective for topical treatment of moderate psoriasis over 28 days.', 'Study Results': 'YES', 'Conditions': 'Psoriasis', 'Interventions': 'DRUG: Cloderm Cream', 'Primary Outcome Measures': "Investigator's Global Assessment (IGA), The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1)., 28 days", 'Secondary Outcome Measures': '', 'Other Outcome Measures': '', 'Sponsor': 'Promius Pharma, LLC', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE4', 'Enrollment': 60.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT', 'Other IDs': 'CDC1201', 'Start Date': '2012-10', 'Primary Completion Date': '2013-03', 'Completion Date': '', 'First Posted': '2012-10-26', 'Results First Posted': '2014-07-23', 'Last Update Posted': '2014-07-23', 'Locations': 'Radiant Research, Inc., Cincinnati, Ohio, 45249, United States|Oregon Medical Research, Portland, Oregon, 97223, United States|DermResearch, Inc., Austin, Texas, 78759, United States|Research Across America, Dallas, Texas, 75234, United States|Madison Skin and Research, Inc., Madison, Wisconsin, 53719, United States', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~1. Subject understands the study procedures and agrees to participate by giving written informed consent.~2. Subjects must be at least 18 years of age.~3. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.~4. Subjects with psoriasis involving 2 to 20% BSA, not including the face, scalp and intertriginous areas.~5. Subjects must have an IGA Grade of 3 at the Baseline Visit.~6. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (Visit 2) (test will have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception or remain sexually inactive throughout the study.~ All women of childbearing potential must be willing to undergo a urine pregnancy test at Visit 2 (Day 0), at Visit 4 (Day 14), and at Visit 5 (Day 28).~7. Subjects must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).~Exclusion Criteria:~1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.~2. Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).~3. Presence of pigmentation, extensive scarring, pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.~4. History of psoriasis unresponsive to topical treatments.~5. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.~6. Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).~7. Have received treatment for any type of cancer within 5 years of the Baseline Visit except for non-melanoma skin cancer and cervical cancer (in situ) are allowed within 1 year of the Baseline Visit.~8. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).~9. Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Note: Inhaled, intraocular and intranasal steroids are allowed.~10. Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.~11. Subjects with known hypersensitivity to clocortolone pivalate or any component of Cloderm Cream.~12. Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.~13. Subjects unable to comply with study requirements.~14. Female subjects who are pregnant (or planning to become pregnant) or breast-feeding."', 'combined_text': 'Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque Psoriasis Investigator\'s Global Assessment (IGA), The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1)., 28 days "Inclusion Criteria:~1. Subject understands the study procedures and agrees to participate by giving written informed consent.~2. Subjects must be at least 18 years of age.~3. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.~4. Subjects with psoriasis involving 2 to 20% BSA, not including the face, scalp and intertriginous areas.~5. Subjects must have an IGA Grade of 3 at the Baseline Visit.~6. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (Visit 2) (test will have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception or remain sexually inactive throughout the study.~ All women of childbearing potential must be willing to undergo a urine pregnancy test at Visit 2 (Day 0), at Visit 4 (Day 14), and at Visit 5 (Day 28).~7. Subjects must be in good general health as determined by the investigator and supported by the medical history and normal or not clinically significant abnormal vital signs (blood pressure and pulse).~Exclusion Criteria:~1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.~2. Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).~3. Presence of pigmentation, extensive scarring, pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.~4. History of psoriasis unresponsive to topical treatments.~5. History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.~6. Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, or alefacept).~7. Have received treatment for any type of cancer within 5 years of the Baseline Visit except for non-melanoma skin cancer and cervical cancer (in situ) are allowed within 1 year of the Baseline Visit.~8. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g., acitretin, isotretinoin).~9. Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy. Note: Inhaled, intraocular and intranasal steroids are allowed.~10. Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids (e.g., tazarotene, tretinoin) or 3) topical corticosteroids.~11. Subjects with known hypersensitivity to clocortolone pivalate or any component of Cloderm Cream.~12. Subjects who have participated in a study of an investigational drug 60 days prior to the Baseline Visit.~13. Subjects unable to comply with study requirements.~14. Female subjects who are pregnant (or planning to become pregnant) or breast-feeding."', 'Similarity Score': 0.18568869325580326}}]
|
from_dataset
| 0.185689
|
[{'from': 'human', 'value': {'Study Title': 'Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis', 'Primary Outcome Measures': 'Therapeutic Cure, Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures., 42 Days', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Male or non-pregnant, non-lactating females 18 years of age or older.~* Signed informed consent form, which meets all criteria of current FDA regulations.~* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.~* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.~* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.~* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.~Exclusion Criteria:~* Females who are pregnant, lactating or likely to become pregnant during the study.~* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.~* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.~* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.~* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.~* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.~* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.~* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.~* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.~* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.~* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.~* Patients who would be non-compliant with the requirements of the study protocol.~* Participation in a research study within 30 days prior to baseline visit.~* Employees or family members of employees of the research center or investigator.~* Previous participation in this study."'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 103, 'Unnamed: 0': 119, 'NCT Number': 'NCT03253094', 'Study Title': 'Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis', 'Study URL': 'https://clinicaltrials.gov/study/NCT03253094', 'Acronym': 'DOVE', 'Study Status': 'COMPLETED', 'Brief Summary': 'This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.', 'Study Results': 'YES', 'Conditions': 'Candida Vulvovaginitis', 'Interventions': 'DRUG: Fluconazole|DRUG: SCY-078', 'Primary Outcome Measures': 'Clinical Cure (Complete Resolution of Signs and Symptoms), Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit, 8-12 days', 'Secondary Outcome Measures': 'Co-occurrence of Clinical and Mycological Cure, The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure., 29 days', 'Other Outcome Measures': 'Incidence of Treatment Emergent Adverse Events, The number of subjects with treatment related adverse events, up to 29 days', 'Sponsor': 'Scynexis, Inc.', 'Collaborators': '', 'Sex': 'FEMALE', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE2', 'Enrollment': 186.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT', 'Other IDs': 'SCY-078-204', 'Start Date': '2017-08-01', 'Primary Completion Date': '2018-05-04', 'Completion Date': '2018-05-04', 'First Posted': '2017-08-17', 'Results First Posted': '2021-08-12', 'Last Update Posted': '2021-08-12', 'Locations': "UAB Personal Health Clinic, Birmingham, Alabama, 35294, United States|Precision Trials AZ, LLC, Phoenix, Arizona, 85032, United States|Women's Health Care Research Corp., San Diego, California, 92111, United States|Gulf Coast Research Group, LLC, Brandon, Florida, 33510, United States|Altus Research, Inc., Lake Worth, Florida, 33461, United States|OB-GYN Associates of Mid-Florida P.A., Leesburg, Florida, 34748, United States|New Age Medical Research Corp., Miami, Florida, 33186, United States|Visionary Investigators Network, South Miami, Florida, 33160, United States|Atlanta North Gynecology, P.C., Roswell, Georgia, 30075, United States|Cypress Medical Research Center, LLC, Wichita, Kansas, 67226, United States|Clinical Trials Management, LLC, Covington, Louisiana, 70433, United States|Clinical Trials Management, LLC, Metairie, Louisiana, 70006, United States|Women Under Study, LLC, New Orleans, Louisiana, 70125, United States|Tolan Park Medical Building, Detroit, Michigan, 48201, United States|Consultants in Women's Healthcare, Inc., Saint Louis, Missouri, 63131, United States|Lawrence OB/GYN Clinical Research, LLC, Lawrenceville, New Jersey, 08648, United States|Women's Health Research Center, Plainsboro, New Jersey, 08536, United States|Unified Women's Clinical Research - Central Carolina, Greensboro, North Carolina, 27408, United States|Wake Research Associates, LLC, Raleigh, North Carolina, 27612, United States|Drexel University, Philadelphia, Pennsylvania, 19102, United States|Medical Research South, LLC, Charleston, South Carolina, 29407, United States|WR-Medical Research Center of Memphis, LLC, Memphis, Tennessee, 38120, United States|Tmc Life Research, Inc., Houston, Texas, 77054, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|Seattle Women's Health, Research, Gynecology, Seattle, Washington, 98105, United States", 'Study Documents': 'Study Protocol, https://cdn.clinicaltrials.gov/large-docs/94/NCT03253094/Prot_001.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/94/NCT03253094/SAP_002.pdf', 'criteria': '"Key Inclusion Criteria:~1. Subject is a female of at least 18 years of age~2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)~Key Exclusion Criteria:~1. Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)~2. Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization~3. Subject is actively menstruating at the time of the Baseline visit.~4. Subject has uncontrolled diabetes mellitus.~5. Subject has a vaginal sample with pH \\>4.5.~6. Subject has a history of or an active cervical/vaginal cancer."', 'combined_text': 'Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis Clinical Cure (Complete Resolution of Signs and Symptoms), Measured by the percentage of subjects with clinical cure (complete resolution of signs and symptoms) at the test-of-cure (TOC) visit, 8-12 days Co-occurrence of Clinical and Mycological Cure, The percentage of subjects with both clinical cure and mycological eradication (negative fungal culture) the Test-of cure., 29 days "Key Inclusion Criteria:~1. Subject is a female of at least 18 years of age~2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)~Key Exclusion Criteria:~1. Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)~2. Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization~3. Subject is actively menstruating at the time of the Baseline visit.~4. Subject has uncontrolled diabetes mellitus.~5. Subject has a vaginal sample with pH \\>4.5.~6. Subject has a history of or an active cervical/vaginal cancer."', 'Similarity Score': 0.1839485567661471}}]
|
from_dataset
| 0.183949
|
[{'from': 'human', 'value': {'Study Title': 'Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis', 'Primary Outcome Measures': 'Therapeutic Cure, Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures., 42 Days', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Male or non-pregnant, non-lactating females 18 years of age or older.~* Signed informed consent form, which meets all criteria of current FDA regulations.~* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.~* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.~* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.~* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.~Exclusion Criteria:~* Females who are pregnant, lactating or likely to become pregnant during the study.~* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.~* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.~* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.~* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.~* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.~* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.~* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.~* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.~* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.~* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.~* Patients who would be non-compliant with the requirements of the study protocol.~* Participation in a research study within 30 days prior to baseline visit.~* Employees or family members of employees of the research center or investigator.~* Previous participation in this study."'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 110, 'Unnamed: 0': 126, 'NCT Number': 'NCT00563394', 'Study Title': 'MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers', 'Study URL': 'https://clinicaltrials.gov/study/NCT00563394', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': '224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.', 'Study Results': 'NO', 'Conditions': 'Diabetic Foot Ulcers', 'Interventions': 'DRUG: ofloxacin|DRUG: MSI-78', 'Primary Outcome Measures': 'Reduction in clinical signs and symptoms of the infection, a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy, Study day 10', 'Secondary Outcome Measures': 'microbiological response to therapy,, Measure microbiological response to therapy, Study day 10|Wound infection score, Measure wound infection score., Study day 10|Total wound score, Measure total wound score., Study day 10|Wound Area, Measure wound area., Study day 10|Wound Depth, Measure wound depth., Study day 10', 'Other Outcome Measures': '', 'Sponsor': 'Abeona Therapeutics, Inc', 'Collaborators': 'Genaera Corporation', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE3', 'Enrollment': 584.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT', 'Other IDs': 'MSI-78-303', 'Start Date': '1994-08', 'Primary Completion Date': '1996-07', 'Completion Date': '1996-07', 'First Posted': '2007-11-26', 'Results First Posted': '', 'Last Update Posted': '2020-09-03', 'Locations': 'Seattle VA Medical Center, Seattle, Washington, 98108-1597, United States', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~* Non-hospitalized ambulatory patients with diabetes mellitus~* Men or Women greater than 18 years old~* Patients must be considered reliable, willing and able to give consent~* Female patients must be postmenopausal for a least 6 months or surgically sterilized~* Localized infection of the ulcer that would ordinarily be treated on an outpatient basis~* Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected~* Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis~* Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot~* Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry~Exclusion Criteria:~* Patients requiring concurrent local or systemic antimicrobials during the study period for other infections~* Patients who are currently treated or awaiting dialysis~* Patients who are unable to care for their ulcers~* Patients with known alcohol or substance abuse within 6 months or study entry~* Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin~* Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents~* Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease.~* Previous enrollment in this study or previous treatment with MSI-78 Topical Cream~* Patients with gangrene or severely impaired arterial supply to any portion of the affected foot~* Other conditions considered by the investigator to be sound reason for disqualification~* Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream~* Women who are breast feeding, pregnant or attempting to become pregnant"', 'combined_text': 'MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers Reduction in clinical signs and symptoms of the infection, a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy, Study day 10 microbiological response to therapy,, Measure microbiological response to therapy, Study day 10|Wound infection score, Measure wound infection score., Study day 10|Total wound score, Measure total wound score., Study day 10|Wound Area, Measure wound area., Study day 10|Wound Depth, Measure wound depth., Study day 10 "Inclusion Criteria:~* Non-hospitalized ambulatory patients with diabetes mellitus~* Men or Women greater than 18 years old~* Patients must be considered reliable, willing and able to give consent~* Female patients must be postmenopausal for a least 6 months or surgically sterilized~* Localized infection of the ulcer that would ordinarily be treated on an outpatient basis~* Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected~* Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis~* Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot~* Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry~Exclusion Criteria:~* Patients requiring concurrent local or systemic antimicrobials during the study period for other infections~* Patients who are currently treated or awaiting dialysis~* Patients who are unable to care for their ulcers~* Patients with known alcohol or substance abuse within 6 months or study entry~* Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin~* Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents~* Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease.~* Previous enrollment in this study or previous treatment with MSI-78 Topical Cream~* Patients with gangrene or severely impaired arterial supply to any portion of the affected foot~* Other conditions considered by the investigator to be sound reason for disqualification~* Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream~* Women who are breast feeding, pregnant or attempting to become pregnant"', 'Similarity Score': 0.1500533113835431}}]
|
from_dataset
| 0.150053
|
[{'from': 'human', 'value': {'Study Title': 'Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis', 'Primary Outcome Measures': 'Therapeutic Cure, Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures., 42 Days', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Male or non-pregnant, non-lactating females 18 years of age or older.~* Signed informed consent form, which meets all criteria of current FDA regulations.~* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.~* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.~* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.~* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.~Exclusion Criteria:~* Females who are pregnant, lactating or likely to become pregnant during the study.~* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.~* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.~* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.~* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.~* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.~* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.~* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.~* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.~* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.~* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.~* Patients who would be non-compliant with the requirements of the study protocol.~* Participation in a research study within 30 days prior to baseline visit.~* Employees or family members of employees of the research center or investigator.~* Previous participation in this study."'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 988, 'Unnamed: 0': 1228, 'NCT Number': 'NCT05078827', 'Study Title': 'Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis', 'Study URL': 'https://clinicaltrials.gov/study/NCT05078827', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites.', 'Study Results': 'NO', 'Conditions': 'Actinic Keratoses', 'Interventions': 'DRUG: Test Product (A): Fluorouracil Cream, 5% topical cream|DRUG: Reference Product (B): Fluorouracil 5% Topical Cream of Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.|DRUG: Placebo Product (C): Test vehicle cream for fluorouracil 5% of Encube Ethicals Pvt. Ltd., India', 'Primary Outcome Measures': 'Therapeutic equivalence with Reference product, Therapeutic equivalence will be evaluated for the primary endpoint at Visit 4 in the PP population. If the 90% confidence interval on the absolute difference between the proportion of subjects who are considered a complete cure in the Test and the Reference product groups (pT - pR) is contained within \\[-20%, +20%\\], then therapeutic equivalence of the Test product to the Reference product will be considered to have been demonstrated, 6 weeks|Superiority to Placebo, The superiority of the Test and Reference products against the Placebo product will be evaluated for the primary endpoint at Visit 4 in the modified Intent-to-Treat (mITT) population using the last observation carried forward (LOCF). If the proportion of subjects who are considered a complete cure in the Test and the Reference product groups is numerically and statistically superior to that of the Placebo (p \\< 0.05; using a two-sided Cochran-Mantel-Haenszel \\[CMH\\] test, stratified by clinical site), then the superiority of the Test and Reference products over Placebo will be concluded, 6 weeks|Primary Efficacy End Point, The primary efficacy endpoint is the proportion of subjects in each treatment group with treatment success, defined as 100% clearance of all AK lesions (baseline or target AK lesions and any new AK lesions) within the designated treatment area (i.e., complete cure), assessed at study Week 6 (Day 43 ± 4, which is 4 weeks after completion of 2 weeks of treatment), 6 weeks', 'Secondary Outcome Measures': "Safety Analysis, All Safety analysis will be based on the Safety population. Adverse events will be classified using standard MedDRA terminology Version 24.0 or higher and summarized by treatment group. Summary tables comparing the type, incidence, date of onset, date of resolution, severity, action taken, outcome, and Investigator's opinion of relationship to the study product will be prepared by treatment group. If sufficient data exist, AE frequencies will be compared between treatments using Fisher's exact test. If the global Fisher's exact test is statistically significant among the three treatment groups at the 5% alpha level (i.e., p \\< 0.05), then Fisher's exact test using only the Test and Reference groups may be performed to identify any potential statistically significant differences that are clinically relevant between the two active treatment groups, 6 weeks", 'Other Outcome Measures': '', 'Sponsor': 'Encube Ethicals Pvt. Ltd.', 'Collaborators': 'CBCC Global Research', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE3', 'Enrollment': 458.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT', 'Other IDs': 'CBCC/2021/012', 'Start Date': '2022-03-01', 'Primary Completion Date': '2022-11-01', 'Completion Date': '2022-12-01', 'First Posted': '2021-10-15', 'Results First Posted': '', 'Last Update Posted': '2023-03-14', 'Locations': 'CBCC Global Research Site 005, Bakersfield, California, 93309, United States|CBCC Global Research Site 006, Cerritos, California, 90703, United States|CBCC Global Research Site 004, Lauderdale Lakes, Florida, 33308, United States|CBCC Global Research Site 001, Miami, Florida, 33015, United States|CBCC Global Research Site 002, Miami, Florida, 33175, United States|CBCC Global Research Site 003, Miramar, Florida, 33027, United States|CBCC Global Research Site 007, Sugarloaf, Pennsylvania, 18249, United States', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~* Willing and able to provide voluntary informed consent and follow the protocol requirements~* Males or females at least 18 years of age~* Subjects with at least five (5) and no more than ten (10) clinically typical, visible, discrete, AK lesions, each at least 4 mm in diameter on the face or bald scalp. In this interpretation, if the total number of lesions on the face and bald scalp exceeds 10 and there are either 5-10 lesions on the face or 5-10 lesions on the bald scalp then select the designated treatment area that has 5-10 lesions (i.e., face or bald scalp)~* Skin pigmentation (Fitzpatrick skin type I, II, and III) that will allow differentiation of erythema assessment~* Females of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL or equivalent units of human chorionic gonadotropin)~* Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double barrier method, oral, transdermal, injected, or implanted nonhormonal or hormonal contraceptive) throughout the study. Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.~Exclusion Criteria:~* Known hypersensitivity or allergy to Fluorouracil or any of the excipients in the Test, Reference or Placebo products~* Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, or other possible confounding skin conditions on the face or bald scalp~* Use within 6 months before Visit 1 on the face or bald scalp of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) ultraviolet B therapy~* Use within 1 month before Visit 1 on the face or scalp of 1) cryo destruction or chemo destruction, 2) curettage, 3) photodynamic therapy, 4) surgical excision, 5) topical 5-fluorouracil, 6) topical corticosteroids 7) topical diclofenac, 8) topical imiquimod, 9) topical retinoids, or 10) other treatments for AK including glycolic acid or over-the-counter products containing retinol, alpha or beta hydroxy acids~* Use within 1 month before Visit 1 of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) oral or injectable corticosteroids, or 4) cytotoxic drugs~* Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency~* Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol~* Employees of the Investigator or research center or their immediate family members~* Patients who have participated in this study previously~* Patient lived in the same household as currently enrolled subject"', 'combined_text': 'Therapeutic Equivalence of Fluorouracil Cream, 5% Compared With Fluorouracil 5% Topical Cream of MylanPharmaceuticals Inc., U.S.A in the Treatment of Actinic Keratosis Therapeutic equivalence with Reference product, Therapeutic equivalence will be evaluated for the primary endpoint at Visit 4 in the PP population. If the 90% confidence interval on the absolute difference between the proportion of subjects who are considered a complete cure in the Test and the Reference product groups (pT - pR) is contained within \\[-20%, +20%\\], then therapeutic equivalence of the Test product to the Reference product will be considered to have been demonstrated, 6 weeks|Superiority to Placebo, The superiority of the Test and Reference products against the Placebo product will be evaluated for the primary endpoint at Visit 4 in the modified Intent-to-Treat (mITT) population using the last observation carried forward (LOCF). If the proportion of subjects who are considered a complete cure in the Test and the Reference product groups is numerically and statistically superior to that of the Placebo (p \\< 0.05; using a two-sided Cochran-Mantel-Haenszel \\[CMH\\] test, stratified by clinical site), then the superiority of the Test and Reference products over Placebo will be concluded, 6 weeks|Primary Efficacy End Point, The primary efficacy endpoint is the proportion of subjects in each treatment group with treatment success, defined as 100% clearance of all AK lesions (baseline or target AK lesions and any new AK lesions) within the designated treatment area (i.e., complete cure), assessed at study Week 6 (Day 43 ± 4, which is 4 weeks after completion of 2 weeks of treatment), 6 weeks Safety Analysis, All Safety analysis will be based on the Safety population. Adverse events will be classified using standard MedDRA terminology Version 24.0 or higher and summarized by treatment group. Summary tables comparing the type, incidence, date of onset, date of resolution, severity, action taken, outcome, and Investigator\'s opinion of relationship to the study product will be prepared by treatment group. If sufficient data exist, AE frequencies will be compared between treatments using Fisher\'s exact test. If the global Fisher\'s exact test is statistically significant among the three treatment groups at the 5% alpha level (i.e., p \\< 0.05), then Fisher\'s exact test using only the Test and Reference groups may be performed to identify any potential statistically significant differences that are clinically relevant between the two active treatment groups, 6 weeks "Inclusion Criteria:~* Willing and able to provide voluntary informed consent and follow the protocol requirements~* Males or females at least 18 years of age~* Subjects with at least five (5) and no more than ten (10) clinically typical, visible, discrete, AK lesions, each at least 4 mm in diameter on the face or bald scalp. In this interpretation, if the total number of lesions on the face and bald scalp exceeds 10 and there are either 5-10 lesions on the face or 5-10 lesions on the bald scalp then select the designated treatment area that has 5-10 lesions (i.e., face or bald scalp)~* Skin pigmentation (Fitzpatrick skin type I, II, and III) that will allow differentiation of erythema assessment~* Females of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL or equivalent units of human chorionic gonadotropin)~* Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, intrauterine device, a double barrier method, oral, transdermal, injected, or implanted nonhormonal or hormonal contraceptive) throughout the study. Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.~Exclusion Criteria:~* Known hypersensitivity or allergy to Fluorouracil or any of the excipients in the Test, Reference or Placebo products~* Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, or other possible confounding skin conditions on the face or bald scalp~* Use within 6 months before Visit 1 on the face or bald scalp of 1) chemical peel, 2) dermabrasion, 3) laser abrasion, 4) PUVA (psoralen plus ultraviolet A) therapy, or 5) ultraviolet B therapy~* Use within 1 month before Visit 1 on the face or scalp of 1) cryo destruction or chemo destruction, 2) curettage, 3) photodynamic therapy, 4) surgical excision, 5) topical 5-fluorouracil, 6) topical corticosteroids 7) topical diclofenac, 8) topical imiquimod, 9) topical retinoids, or 10) other treatments for AK including glycolic acid or over-the-counter products containing retinol, alpha or beta hydroxy acids~* Use within 1 month before Visit 1 of 1) immunomodulators or immunosuppressive therapies, 2) interferon, 3) oral or injectable corticosteroids, or 4) cytotoxic drugs~* Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency~* Inability to understand the requirements of the study and the relative information or are unable or not willing to comply with the study protocol~* Employees of the Investigator or research center or their immediate family members~* Patients who have participated in this study previously~* Patient lived in the same household as currently enrolled subject"', 'Similarity Score': 0.1318712658850459}}]
|
from_dataset
| 0.131871
|
[{'from': 'human', 'value': {'Study Title': 'Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis', 'Primary Outcome Measures': 'Therapeutic Cure, Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures., 42 Days', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Male or non-pregnant, non-lactating females 18 years of age or older.~* Signed informed consent form, which meets all criteria of current FDA regulations.~* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.~* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.~* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.~* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.~Exclusion Criteria:~* Females who are pregnant, lactating or likely to become pregnant during the study.~* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.~* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.~* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.~* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.~* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.~* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.~* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.~* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.~* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.~* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.~* Patients who would be non-compliant with the requirements of the study protocol.~* Participation in a research study within 30 days prior to baseline visit.~* Employees or family members of employees of the research center or investigator.~* Previous participation in this study."'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 274, 'Unnamed: 0': 332, 'NCT Number': 'NCT00659594', 'Study Title': 'Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406)', 'Study URL': 'https://clinicaltrials.gov/study/NCT00659594', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'The primary objective of this placebo-controlled EEC study is to determine the time to onset of action of ciclesonide, applied as a nasal spray (200 mg, once daily) in patients with SAR.', 'Study Results': 'NO', 'Conditions': 'Rhinitis, Allergic, Seasonal|Hay Fever', 'Interventions': 'DRUG: Ciclesonide|DRUG: Placebo', 'Primary Outcome Measures': 'Time to onset of action, measured by a difference from placebo in the change from baseline in patient -assessed instantaneous TNSS following treatment, 14 hours', 'Secondary Outcome Measures': 'Changes in TNSS from baseline at each time point, 14 hours|Changes in individual nasal symptom score from baseline at each time point, 14 hours|Proportion of patients exhibiting good/excellent response at each time point defined as all components of the patient-assessed TNSS scored as mild or less in severity, 14 hours|Spontaneous and elicited adverse events (AEs), 14 hours|Physical exam (including nasal exam), 14 hours|Vital signs, 14 hours', 'Other Outcome Measures': '', 'Sponsor': 'AstraZeneca', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE3', 'Enrollment': 500.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: |Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT', 'Other IDs': 'BY9010/M1-406', 'Start Date': '2004-11', 'Primary Completion Date': '2005-02', 'Completion Date': '2005-09', 'First Posted': '2008-04-16', 'Results First Posted': '', 'Last Update Posted': '2016-12-02', 'Locations': 'Altana/Nycomed, Mississauga, Ontario, L4W1N2, Canada', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~1. Written informed consent signed and dated by the subject before conducting any study related procedure.~2. Male or female patients 18 years and older.~3. General good health, and free of any concomitant conditions or treatment that, in the judgment of the investigator, could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial.~4. A history of SAR to short ragweed pollen for a minimum of two years immediately preceding the study entry. In the investigator\'s judgment, the SAR during this two- year period must have been of sufficient severity and would be expected to require treatment during the ragweed season.~5. A demonstrated sensitivity to short ragweed pollen known to induce SAR through a standard skin prick test. A positive test is defined as a wheal diameter of at least 3 mm larger than the diluent (negative) control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (B0) is acceptable.~6. Female is of child-bearing potential and is currently using and will continue to use a medically reliable method of contraception for the entire study duration (e.g. oral, injectable, trans-cutaneous or implantable contraceptives or intrauterine devices or double-barrier protection). Females who are not sexually active must agree to use double-barrier protection should they become sexually active during the course of the study. Women of child-bearing potential, or less than 1 year postmenopausal, will require a negative urine pregnancy test at the Screening Visit (B0) as well as prior to initiation of treatment at Treatment Visit (T0).Female subjects will be considered of non-childbearing potential and will not require a urine pregnancy test if at least one of the following apply:~ * Before menarche;~ * More than one year postmenopausal;~ * Had a hysterectomy;~ * Had a bilateral ovariectomy or salpingectomy or tubal ligation;~ * Have a congenital sterility.~7. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, is capable of giving informed consent, will comply with all study requirements (visits, record keeping, etc), is suitable to participate, and will provide conscientious cooperation over the duration of the study and possesses the characteristics suitable to undertake this study.~8. Willingness to undergo a minimum of one (1) up to a maximum of five (5) priming sessions with short ragweed pollen in the EEC.~Exclusion Criteria:~1. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period. Females unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.~2. Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based upon the clinical estimate by the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days prior to Screening Visit - B0).~3. Participation in any investigational drug trial within the 30 days preceding the Screening Visit (B0) and thereafter.~4. A known hypersensitivity to any corticosteroid or any of the excipients in the formulation.~5. History of severe respiratory infection or disorder \\[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\\] within the 14 days preceding the Screening Visit (B0).~6. History of alcohol or drug abuse within the preceding two years from Screening Visit (B0).~7. History of a positive test for HIV, hepatitis B or hepatitis C.~8. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of b-agonists or any controller drugs (e.g. theophylline, leukotriene antagonist); intermittent use (less than or equal to 3 uses per week) of inhaled short-acting b-agonists is acceptable.~9. Use of any prohibited concomitant medications within the prescribed (per protocol) exclusion periods (refer to Section 6.3 of the protocol).~10. Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (B0) and thereafter. Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit (B0) AND is expected to continue through out the Baseline Period (B0 to T0 Visit) and Treatment Visit (T0).~11. Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit (B0) AND use of a stable (maintenance) dose (30 days or more prior to the Screening Visit (B0)) may be considered for inclusion provided no immunotherapy injections are received within 48 hours prior to a ragweed pollen exposure visit.~12. Previous participation in an intranasal ciclesonide study.~13. Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).~14. Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g., arthritis), during the past 60 days from Screening Visit B0), or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.~15. Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone for dermatological conditions within 30 days prior to the Screening Visit (B0), or presence of an underlying condition that can reasonably be expected to require treatment with such preparations during the course of the study (B0 to T0 Visit, both visits inclusive). Hydrocortisone of less than or equal to 1% concentration covering less than or equal to 10% of the total body surface without occlusion is acceptable.~16. History of epilepsy or seizures (excluding febrile seizures).~17. History of coronary artery disease, uncontrolled hypertension, or other clinically significant cardiovascular disease.~18. Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject\'s ability to participate in the clinical trial:~ * Impaired hepatic function including alcohol related liver disease or cirrhosis;~ * Glaucoma;~ * Any systemic infection;~ * Hematological, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism);~ * Gastrointestinal disease;~ * Malignancy (excluding basal cell carcinoma);~ * A current neuropsychiatric condition with or without drug therapy."', 'combined_text': 'Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406) Time to onset of action, measured by a difference from placebo in the change from baseline in patient -assessed instantaneous TNSS following treatment, 14 hours Changes in TNSS from baseline at each time point, 14 hours|Changes in individual nasal symptom score from baseline at each time point, 14 hours|Proportion of patients exhibiting good/excellent response at each time point defined as all components of the patient-assessed TNSS scored as mild or less in severity, 14 hours|Spontaneous and elicited adverse events (AEs), 14 hours|Physical exam (including nasal exam), 14 hours|Vital signs, 14 hours "Inclusion Criteria:~1. Written informed consent signed and dated by the subject before conducting any study related procedure.~2. Male or female patients 18 years and older.~3. General good health, and free of any concomitant conditions or treatment that, in the judgment of the investigator, could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the trial.~4. A history of SAR to short ragweed pollen for a minimum of two years immediately preceding the study entry. In the investigator\'s judgment, the SAR during this two- year period must have been of sufficient severity and would be expected to require treatment during the ragweed season.~5. A demonstrated sensitivity to short ragweed pollen known to induce SAR through a standard skin prick test. A positive test is defined as a wheal diameter of at least 3 mm larger than the diluent (negative) control wheal for the skin prick test. Documentation of a positive result 12 months prior to Screening Visit (B0) is acceptable.~6. Female is of child-bearing potential and is currently using and will continue to use a medically reliable method of contraception for the entire study duration (e.g. oral, injectable, trans-cutaneous or implantable contraceptives or intrauterine devices or double-barrier protection). Females who are not sexually active must agree to use double-barrier protection should they become sexually active during the course of the study. Women of child-bearing potential, or less than 1 year postmenopausal, will require a negative urine pregnancy test at the Screening Visit (B0) as well as prior to initiation of treatment at Treatment Visit (T0).Female subjects will be considered of non-childbearing potential and will not require a urine pregnancy test if at least one of the following apply:~ * Before menarche;~ * More than one year postmenopausal;~ * Had a hysterectomy;~ * Had a bilateral ovariectomy or salpingectomy or tubal ligation;~ * Have a congenital sterility.~7. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, is capable of giving informed consent, will comply with all study requirements (visits, record keeping, etc), is suitable to participate, and will provide conscientious cooperation over the duration of the study and possesses the characteristics suitable to undertake this study.~8. Willingness to undergo a minimum of one (1) up to a maximum of five (5) priming sessions with short ragweed pollen in the EEC.~Exclusion Criteria:~1. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period. Females unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.~2. Have clinically significant physical findings of nasal anatomical deformities causing greater than 50% obstruction based upon the clinical estimate by the investigator, including nasal polyps, septal defects or other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma, or surgery and atrophic rhinitis or rhinitis medicamentosa (within the last 60 days prior to Screening Visit - B0).~3. Participation in any investigational drug trial within the 30 days preceding the Screening Visit (B0) and thereafter.~4. A known hypersensitivity to any corticosteroid or any of the excipients in the formulation.~5. History of severe respiratory infection or disorder \\[including, but not limited to bronchitis, pneumonia, chronic sinusitis, influenza, severe acute respiratory syndrome (SARS)\\] within the 14 days preceding the Screening Visit (B0).~6. History of alcohol or drug abuse within the preceding two years from Screening Visit (B0).~7. History of a positive test for HIV, hepatitis B or hepatitis C.~8. Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of b-agonists or any controller drugs (e.g. theophylline, leukotriene antagonist); intermittent use (less than or equal to 3 uses per week) of inhaled short-acting b-agonists is acceptable.~9. Use of any prohibited concomitant medications within the prescribed (per protocol) exclusion periods (refer to Section 6.3 of the protocol).~10. Use of antibiotic therapy for acute conditions within 14 days prior to the Screening Visit (B0) and thereafter. Low doses of antibiotics taken for prophylaxis are permitted if the therapy was started prior to the Screening Visit (B0) AND is expected to continue through out the Baseline Period (B0 to T0 Visit) and Treatment Visit (T0).~11. Initiation of immunotherapy during the study period or dose escalation during the study period. However, initiation of immunotherapy 90 days or more prior to the Screening Visit (B0) AND use of a stable (maintenance) dose (30 days or more prior to the Screening Visit (B0)) may be considered for inclusion provided no immunotherapy injections are received within 48 hours prior to a ragweed pollen exposure visit.~12. Previous participation in an intranasal ciclesonide study.~13. Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit (B0).~14. Exposure to systemic corticosteroids for any indication, chronic or intermittent (e.g., arthritis), during the past 60 days from Screening Visit B0), or presence of an underlying condition that can reasonably be expected to require treatment with corticosteroids during the course of the study.~15. Use of topical corticosteroids in concentrations in excess of 1% hydrocortisone for dermatological conditions within 30 days prior to the Screening Visit (B0), or presence of an underlying condition that can reasonably be expected to require treatment with such preparations during the course of the study (B0 to T0 Visit, both visits inclusive). Hydrocortisone of less than or equal to 1% concentration covering less than or equal to 10% of the total body surface without occlusion is acceptable.~16. History of epilepsy or seizures (excluding febrile seizures).~17. History of coronary artery disease, uncontrolled hypertension, or other clinically significant cardiovascular disease.~18. Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the subject\'s ability to participate in the clinical trial:~ * Impaired hepatic function including alcohol related liver disease or cirrhosis;~ * Glaucoma;~ * Any systemic infection;~ * Hematological, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism);~ * Gastrointestinal disease;~ * Malignancy (excluding basal cell carcinoma);~ * A current neuropsychiatric condition with or without drug therapy."', 'Similarity Score': 0.12562623196123643}}]
|
from_dataset
| 0.125626
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[{'from': 'human', 'value': {'Study Title': 'Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis', 'Primary Outcome Measures': 'Therapeutic Cure, Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures., 42 Days', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Male or non-pregnant, non-lactating females 18 years of age or older.~* Signed informed consent form, which meets all criteria of current FDA regulations.~* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.~* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.~* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.~* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.~Exclusion Criteria:~* Females who are pregnant, lactating or likely to become pregnant during the study.~* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.~* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.~* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.~* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.~* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.~* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.~* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.~* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.~* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.~* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.~* Patients who would be non-compliant with the requirements of the study protocol.~* Participation in a research study within 30 days prior to baseline visit.~* Employees or family members of employees of the research center or investigator.~* Previous participation in this study."'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 951, 'Unnamed: 0': 1187, 'NCT Number': 'NCT02582073', 'Study Title': 'Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™', 'Study URL': 'https://clinicaltrials.gov/study/NCT02582073', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. The current therapeutic dose regimen for Grass MATA MPL is a course of four injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU and 18200 SU are being developed to compare with the current dose. The study is designed to explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA (without MPL) and placebo.', 'Study Results': 'NO', 'Conditions': 'Seasonal Allergic Rhinitis', 'Interventions': 'BIOLOGICAL: Placebo (0.5ml)|BIOLOGICAL: Placebo (1.0ml)|BIOLOGICAL: Grass MATA MPL (0.5ml) 5100SU|BIOLOGICAL: Grass MATA MPL (1.0ml) 10200SU|BIOLOGICAL: Grass MATA MPL (1.0ml) 18200SU|BIOLOGICAL: Grass MATA (0.5ml) 5100SU', 'Primary Outcome Measures': 'Post-treatment TSS, The primary efficacy endpoint will be the mean average of the last three TSS measurements recorded in each of the four post-treatment Visits 12 15. TSS will be measured during the four post-treatment mEEC™ sessions conducted on consecutive days 12-15, and is defined as the sum of individual NSS (rhinorrhea, congestion, sneezing and itchiness) and NNSS (itchy/gritty eyes, tearing/watery eyes, red/burning eyes and ear/palate itching)., 21-28 days after the last injection', 'Secondary Outcome Measures': 'Frequency of local adverse events (AEs), A Local AE is located at the injection site of study medication, occurring within 24 hours after the injection., A Local AE is located at the injection site of study medication, occurring within 24 hours after the injection.|Frequency of systemic adverse events (AEs), A Systemic AE is allergic signs and symptoms (e.g., conjunctivitis, rhinitis, cough and generalized urticaria including anaphylaxis) associated with the injection of study medication, occurring within 24 hours after the injection., 24 hours following each injection|Frequency of other AEs, All post-treatment AEs that do not fall into local or systemic AEs, Up to 1 year following injections|Frequency of AEs of special interest (AESI), AESI includes New Onset Autoimmune Disorders and Neuro-inflammatory events., Up to 1 year following injections|Safety laboratory values, Change in serum chemistry and haematology from baseline to Visit 16, Up to 12 weeks|Specific IgE, Change in grass specific IgE from baseline to Visit 16, Up to 12 weeks', 'Other Outcome Measures': '', 'Sponsor': 'Allergy Therapeutics', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'ADULT', 'Phases': 'PHASE2', 'Enrollment': 265.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT', 'Other IDs': 'GrassMATAMPL204', 'Start Date': '2015-11-07', 'Primary Completion Date': '2016-05-05', 'Completion Date': '2017-04-28', 'First Posted': '2015-10-21', 'Results First Posted': '', 'Last Update Posted': '2021-01-29', 'Locations': 'Inflamax Research Inc., Neptune, New Jersey, 07753, United States', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~1. Aged 18 to 50 years inclusive~2. Allergy to grass pollen allergen, defined by:~ 1. A history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis due to grass pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers for relief of symptoms, confirmed by the patient record if available.~ 2. A positive skin prick test for grass pollen allergen (wheal (longest diameter) of ≥ 5 mm greater than the negative control after skin prick testing) at Visit 1.~ 3. Specific IgE for grass pollen as documented by a specific IgE immunoassay, or equivalent test, with class ≥ 2 to grass pollen mix. Results from tests conducted under a generalized screening protocol within the past six months may be used and will not need to be repeated at V1 provided a copy of the test results is added to the source file.~3. Positive skin prick test to histamine (wheal (longest diameter) ≥ 3 mm greater than the negative control)~4. Negative skin prick test to the negative control (redness with wheal ≤ 2 mm is acceptable)~5. For asthmatic patients: Forced expiratory volume (FEV) in 1 second (FEV1) ≥ 80% of National Health and Nutrition Examination Surveys (NHANES) predicted, with a FEV1/Forced Vital Capacity (FVC) ratio ≥ 70%~6. Obtain the minimum qualifying symptom scores by the final pre treatment EEC visit to be enrolled into the study. Minimum qualifying TSS is at least 12 out of a possible 24 on at least one recording time, a TNSS score of at least 7 out of a possible 12 on at least one recording time, and a rhinorrhea score of at least 2 on at least two diary cards.~7. Observe the drug washout times for antihistamines, steroids etc. as specified in the protocol prior to screening (Visit 1). The use of other medications will be permitted if they are not expected to interfere with the ability of the patient to participate in the study and provided they have been on a stable regimen (i.e., the same dosage and administration) for six weeks prior to screening~8. Males or non pregnant, non lactating females who are:~ 1. Post menopausal (defined as at least 12 months natural spontaneous amenorrhea or at least 6 weeks following surgical menopause, i.e. bilateral oophorectomy)~ 2. Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation)~ 3. Of childbearing potential - with negative urinary and serological pregnancy test and use at least one of the following contraception methods:~ i. Stable hormonal contraceptive for ≥ 90 days prior to Visit 1 and for at least 7 days after the final injection. If \\< 90 days prior to the study, additional use of a double barrier method until 90 days reached is required.~ ii. Placement of an intrauterine device (IUD) or intrauterine system iii. Use of barrier methods of contraception (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository iv. Use of double barrier methods of contraception (e.g., male condom with diaphragm, male condom with cervical cap) v. Male sterilization with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate of the sole partner vi. True abstinence, when in line with the preferred and usual lifestyle of the patient; periodic abstinence, such as calendar, ovulation, symptothermal, post ovulation methods, and withdrawal are not acceptable methods of contraception.~9. Normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests.~10. Willing and able to give written informed consent.~11. Able to understand and comply with study instructions.~12. Willing and able to attend required study visits.~Exclusion Criteria:~1. In the presence of symptoms outside the grass pollen season coupled with a positive skin test to a perennial allergen, if as assessed by the Investigator the patient is unable to avoid the offending allergen.~2. Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications or the skin prick test result, such as:~ 1. Nasal polyposis~ 2. Any ocular disorder (other than allergic conjunctivitis) including presumed infectious ocular disease (bacterial, fungal, viral, etc.), which could interfere with the evaluation of the study medication~ 3. Rhinitis medicamentosa~ 4. Documented evidence of acute or significant chronic sinusitis or upper or lower respiratory tract infection within 30 days before Visit 2 as determined by the Investigator~ 5. Asthma, with the exception of mild asthma as, to lessen confounding by asthma medications. Patients taking corticosteroids for asthma at doses higher than budesonide MDI 400µg once a day or equivalent, as defined by the current GINA guideline, will be excluded.~3. Emergency room visit or admission for asthma in the 12 months prior to Visit 1 or history of a life-threatening asthma attack ever~4. Presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence~5. Presence of secondary alterations at the affected organ (i.e., emphysema, and bronchiectasis )~6. Current diagnosis of Type I diabetes. Patients with Type II diabetes will only be allowed to participate at the discretion of the Investigator~7. Autoimmune disease (e.g., of liver, kidney, lung, thyroid, nervous system, rheumatoid diseases) sarcoidosis, or NI disease (e.g., optic neuritis, multiple sclerosis or other demyelinating disease, encephalitis or encephalomyelitis, myelitis/transverse myelitis, myasthenia gravis, Guillain Barré syndrome, unexplained transitory neurological events)~8. History of cancer (excluding basal cell carcinoma) or concomitant illness (e.g., cardiovascular, pulmonary, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic, or psychiatric diseases or disorders) that, in the opinion of the Investigator, would pose a safety risk or compromise the interpretation of efficacy for this grass immunotherapy~9. Use of oral, intramuscular, intravenous corticosteroids, or potent or super-potent topical corticosteroids, from 30 days prior to screening up to Visit 16~10. Any systemic disorder that could interfere with the evaluation of the study medications~11. Presence of tattoos or other skin abnormalities in the upper arms which would prevent an accurate assessment of local skin reaction, at Investigator\'s discretion~12. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the study medication~13. Active or quiescent tuberculous infection of the respiratory tract, untreated local or systemic fungal or bacterial or systemic viral infections (e.g., chickenpox or measles) or parasitic or ocular herpes simplex~14. Experience of nasal septal ulcers, nasal surgery or nasal trauma within 90 days of Visit 1~15. Clinical history of anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis~16. Clinical history of immunodeficiency, including those who are on immunosuppressant therapy~17. Diseases with a pathogenesis interfering with the immune response and who have received medication which could influence the results of the study~18. Clinical history of recurrent idiopathic angioedema~19. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria~20. β blocker medication, including eye drops, for any indication~21. Monoamine Oxidase Inhibitor medication~22. Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated)~23. Clinical history of drug or alcohol abuse which would, at the Investigator\'s discretion, interfere with the patient\'s participation in the study~24. Clinical history, or evidence, of nasolacrimal drainage system malfunction~25. Any clinically significant abnormal laboratory value (as determined by the Investigator) at Visit 1~26. Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol or people considered as vulnerable or institutionalized~27. Have undergone specific immunotherapy with comparable allergen extracts. An exception will be allowed if prior immunotherapy with comparable allergen was successful, symptoms reappeared sometime after stopping the immunotherapy, and the immunotherapy was completed ≥ 3 years before Visit 1~28. Treatment with a preparation containing MPL® within 6 months prior to Visit 1~29. Participation in a clinical research study with an investigational medicinal product within 4 weeks of Visit 1 or concomitantly with this study, including the safety follow-up period up to 12 months following the last injection."', 'combined_text': 'Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™ Post-treatment TSS, The primary efficacy endpoint will be the mean average of the last three TSS measurements recorded in each of the four post-treatment Visits 12 15. TSS will be measured during the four post-treatment mEEC™ sessions conducted on consecutive days 12-15, and is defined as the sum of individual NSS (rhinorrhea, congestion, sneezing and itchiness) and NNSS (itchy/gritty eyes, tearing/watery eyes, red/burning eyes and ear/palate itching)., 21-28 days after the last injection Frequency of local adverse events (AEs), A Local AE is located at the injection site of study medication, occurring within 24 hours after the injection., A Local AE is located at the injection site of study medication, occurring within 24 hours after the injection.|Frequency of systemic adverse events (AEs), A Systemic AE is allergic signs and symptoms (e.g., conjunctivitis, rhinitis, cough and generalized urticaria including anaphylaxis) associated with the injection of study medication, occurring within 24 hours after the injection., 24 hours following each injection|Frequency of other AEs, All post-treatment AEs that do not fall into local or systemic AEs, Up to 1 year following injections|Frequency of AEs of special interest (AESI), AESI includes New Onset Autoimmune Disorders and Neuro-inflammatory events., Up to 1 year following injections|Safety laboratory values, Change in serum chemistry and haematology from baseline to Visit 16, Up to 12 weeks|Specific IgE, Change in grass specific IgE from baseline to Visit 16, Up to 12 weeks "Inclusion Criteria:~1. Aged 18 to 50 years inclusive~2. Allergy to grass pollen allergen, defined by:~ 1. A history of moderate to severe symptoms of seasonal allergic rhinitis and/or conjunctivitis due to grass pollen exposure that required repeated use of antihistamines, nasal steroids, and/or leukotriene modifiers for relief of symptoms, confirmed by the patient record if available.~ 2. A positive skin prick test for grass pollen allergen (wheal (longest diameter) of ≥ 5 mm greater than the negative control after skin prick testing) at Visit 1.~ 3. Specific IgE for grass pollen as documented by a specific IgE immunoassay, or equivalent test, with class ≥ 2 to grass pollen mix. Results from tests conducted under a generalized screening protocol within the past six months may be used and will not need to be repeated at V1 provided a copy of the test results is added to the source file.~3. Positive skin prick test to histamine (wheal (longest diameter) ≥ 3 mm greater than the negative control)~4. Negative skin prick test to the negative control (redness with wheal ≤ 2 mm is acceptable)~5. For asthmatic patients: Forced expiratory volume (FEV) in 1 second (FEV1) ≥ 80% of National Health and Nutrition Examination Surveys (NHANES) predicted, with a FEV1/Forced Vital Capacity (FVC) ratio ≥ 70%~6. Obtain the minimum qualifying symptom scores by the final pre treatment EEC visit to be enrolled into the study. Minimum qualifying TSS is at least 12 out of a possible 24 on at least one recording time, a TNSS score of at least 7 out of a possible 12 on at least one recording time, and a rhinorrhea score of at least 2 on at least two diary cards.~7. Observe the drug washout times for antihistamines, steroids etc. as specified in the protocol prior to screening (Visit 1). The use of other medications will be permitted if they are not expected to interfere with the ability of the patient to participate in the study and provided they have been on a stable regimen (i.e., the same dosage and administration) for six weeks prior to screening~8. Males or non pregnant, non lactating females who are:~ 1. Post menopausal (defined as at least 12 months natural spontaneous amenorrhea or at least 6 weeks following surgical menopause, i.e. bilateral oophorectomy)~ 2. Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation)~ 3. Of childbearing potential - with negative urinary and serological pregnancy test and use at least one of the following contraception methods:~ i. Stable hormonal contraceptive for ≥ 90 days prior to Visit 1 and for at least 7 days after the final injection. If \\< 90 days prior to the study, additional use of a double barrier method until 90 days reached is required.~ ii. Placement of an intrauterine device (IUD) or intrauterine system iii. Use of barrier methods of contraception (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository iv. Use of double barrier methods of contraception (e.g., male condom with diaphragm, male condom with cervical cap) v. Male sterilization with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate of the sole partner vi. True abstinence, when in line with the preferred and usual lifestyle of the patient; periodic abstinence, such as calendar, ovulation, symptothermal, post ovulation methods, and withdrawal are not acceptable methods of contraception.~9. Normally active and otherwise judged to be in good health on the basis of medical history, physical examination and routine laboratory tests.~10. Willing and able to give written informed consent.~11. Able to understand and comply with study instructions.~12. Willing and able to attend required study visits.~Exclusion Criteria:~1. In the presence of symptoms outside the grass pollen season coupled with a positive skin test to a perennial allergen, if as assessed by the Investigator the patient is unable to avoid the offending allergen.~2. Concurrent disease that might complicate or interfere with investigation or evaluation of the study medications or the skin prick test result, such as:~ 1. Nasal polyposis~ 2. Any ocular disorder (other than allergic conjunctivitis) including presumed infectious ocular disease (bacterial, fungal, viral, etc.), which could interfere with the evaluation of the study medication~ 3. Rhinitis medicamentosa~ 4. Documented evidence of acute or significant chronic sinusitis or upper or lower respiratory tract infection within 30 days before Visit 2 as determined by the Investigator~ 5. Asthma, with the exception of mild asthma as, to lessen confounding by asthma medications. Patients taking corticosteroids for asthma at doses higher than budesonide MDI 400µg once a day or equivalent, as defined by the current GINA guideline, will be excluded.~3. Emergency room visit or admission for asthma in the 12 months prior to Visit 1 or history of a life-threatening asthma attack ever~4. Presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence~5. Presence of secondary alterations at the affected organ (i.e., emphysema, and bronchiectasis )~6. Current diagnosis of Type I diabetes. Patients with Type II diabetes will only be allowed to participate at the discretion of the Investigator~7. Autoimmune disease (e.g., of liver, kidney, lung, thyroid, nervous system, rheumatoid diseases) sarcoidosis, or NI disease (e.g., optic neuritis, multiple sclerosis or other demyelinating disease, encephalitis or encephalomyelitis, myelitis/transverse myelitis, myasthenia gravis, Guillain Barré syndrome, unexplained transitory neurological events)~8. History of cancer (excluding basal cell carcinoma) or concomitant illness (e.g., cardiovascular, pulmonary, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic, or psychiatric diseases or disorders) that, in the opinion of the Investigator, would pose a safety risk or compromise the interpretation of efficacy for this grass immunotherapy~9. Use of oral, intramuscular, intravenous corticosteroids, or potent or super-potent topical corticosteroids, from 30 days prior to screening up to Visit 16~10. Any systemic disorder that could interfere with the evaluation of the study medications~11. Presence of tattoos or other skin abnormalities in the upper arms which would prevent an accurate assessment of local skin reaction, at Investigator\'s discretion~12. Clinical history of allergy, hypersensitivity or intolerance to the excipients of the study medication~13. Active or quiescent tuberculous infection of the respiratory tract, untreated local or systemic fungal or bacterial or systemic viral infections (e.g., chickenpox or measles) or parasitic or ocular herpes simplex~14. Experience of nasal septal ulcers, nasal surgery or nasal trauma within 90 days of Visit 1~15. Clinical history of anaphylactic reactions to foods, insect venom, exercise, drugs or idiopathic anaphylaxis~16. Clinical history of immunodeficiency, including those who are on immunosuppressant therapy~17. Diseases with a pathogenesis interfering with the immune response and who have received medication which could influence the results of the study~18. Clinical history of recurrent idiopathic angioedema~19. Tyrosine metabolism disorders, especially tyrosinemia and alkaptonuria~20. β blocker medication, including eye drops, for any indication~21. Monoamine Oxidase Inhibitor medication~22. Unable to receive epinephrine therapy (i.e., use of epinephrine is contraindicated)~23. Clinical history of drug or alcohol abuse which would, at the Investigator\'s discretion, interfere with the patient\'s participation in the study~24. Clinical history, or evidence, of nasolacrimal drainage system malfunction~25. Any clinically significant abnormal laboratory value (as determined by the Investigator) at Visit 1~26. Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol or people considered as vulnerable or institutionalized~27. Have undergone specific immunotherapy with comparable allergen extracts. An exception will be allowed if prior immunotherapy with comparable allergen was successful, symptoms reappeared sometime after stopping the immunotherapy, and the immunotherapy was completed ≥ 3 years before Visit 1~28. Treatment with a preparation containing MPL® within 6 months prior to Visit 1~29. Participation in a clinical research study with an investigational medicinal product within 4 weeks of Visit 1 or concomitantly with this study, including the safety follow-up period up to 12 months following the last injection."', 'Similarity Score': 0.12545961961174135}}]
|
from_dataset
| 0.12546
|
[{'from': 'human', 'value': {'Study Title': 'Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis', 'Primary Outcome Measures': 'Therapeutic Cure, Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures., 42 Days', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Male or non-pregnant, non-lactating females 18 years of age or older.~* Signed informed consent form, which meets all criteria of current FDA regulations.~* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.~* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.~* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.~* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.~Exclusion Criteria:~* Females who are pregnant, lactating or likely to become pregnant during the study.~* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.~* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.~* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.~* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.~* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.~* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.~* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.~* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.~* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.~* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.~* Patients who would be non-compliant with the requirements of the study protocol.~* Participation in a research study within 30 days prior to baseline visit.~* Employees or family members of employees of the research center or investigator.~* Previous participation in this study."'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 526, 'Unnamed: 0': 647, 'NCT Number': 'NCT05660382', 'Study Title': 'Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis', 'Study URL': 'https://clinicaltrials.gov/study/NCT05660382', 'Acronym': '', 'Study Status': 'RECRUITING', 'Brief Summary': 'The goal of this clinical trial is to prove the that miconazole oil works well on fungal infections of the ears, by comparing the drug with a placebo. The researcher or the participants will not know if they are getting the drug or the placebo. The researcher will show the participants how to use the drug or placebo. After 14 days of using the drug or placebo, the participants will be examined by the researcher and graded on how well the drug worked on the ear(s) fungal infection. Participants will also be checked and asked for any bad side effects from the drug or the placebo.', 'Study Results': 'NO', 'Conditions': 'Otomycosis', 'Interventions': 'DRUG: Miconazole (2%) oil and mineral oil|OTHER: Placebo', 'Primary Outcome Measures': 'primary efficacy endpoint, Clinical Cure, defined as score of zero (0) for fungal elements and each of the signs/symptoms of pruritus, aural fullness and debris, at the Test of Cure visit., Day 22, test of cure', 'Secondary Outcome Measures': 'Clinical Cure at the End of Treatment, Score of zero (0) for fungal elements and for each signs/symptoms of otomycosis (debris, pruritus and aural fullness), Day 15, end of treatment|Modified Clinical Cure at Test of Cure, Score of zero (0) for fungal elements, and score of "0" or "1" for each signs/symptoms of otomycosis (debris, pruritus and aural fullness), Day 22, test of cure|Modified Clinical Cure at End of Treatment, Score of zero (0) for fungal elements, and score of "0" or "1" for each signs/symptoms of otomycosis (debris, pruritus and aural fullness), Day 15, end of treatment', 'Other Outcome Measures': '', 'Sponsor': 'Hill Dermaceuticals, Inc.', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'CHILD, ADULT, OLDER_ADULT', 'Phases': 'PHASE3', 'Enrollment': 100.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT', 'Other IDs': 'MZ-1015-ESP3-054', 'Start Date': '2023-03-02', 'Primary Completion Date': '2024-09', 'Completion Date': '2024-11', 'First Posted': '2022-12-21', 'Results First Posted': '', 'Last Update Posted': '2024-09-24', 'Locations': 'Head and Neck Surgery Specialist, Chula Vista, California, 91910, United States|Advanced ENT & Allergy, Louisville, Kentucky, 40220, United States|Charleston ENT Associates, LLC, North Charleston, South Carolina, 29406, United States|Carolina ENT, Orangeburg, South Carolina, 29118, United States|Spartanburg / Greer ENT & Allergy, Spartanburg, South Carolina, 29303, United States|Alamo ENT Associates, San Antonio, Texas, 78258, United States|ENT Center Of Utah, Salt Lake City, Utah, 84102, United States', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~1. Male or non-pregnant, non-lactating females~2. Diagnosis of uncomplicated otomycosis of the external ear only, in the ear(s) that will be treated with study drug, with a score for fungal elements of 1 in each ear to be treated with study drug (see Section 7.4 for definitions of the scores for each of the otomycosis signs and symptoms). Subjects must also have the following signs and symptoms of otomycosis in the study ear: pruritus ≥2; debris ≥2; and aural fullness ≥2.~3. General good health as determined by medical examination and medical history, and who are free of clinically significant disease, including diabetes mellitus that is not well-controlled or that could interfere with the study~4. Females of childbearing potential must have had a negative urine pregnancy test at Screening/Baseline and must agree to use an effective method of contraception (as defined in Section 8.5) from Screening/Baseline up through the End of Treatment visit (see Section 6). Females of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \\>12 consecutive months). Females who are using oral, implanted, or injectable contraceptive hormones, an intrauterine device (IUD), barrier methods (diaphragm, condoms, spermicide) to prevent pregnancy, practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of childbearing potential~5. Subjects and/or their caregivers (as appropriate for the age of the subject) must have full legal capacity to volunteer~6. Subjects and/or their caregivers must have completed an appropriately administered institutional review board (IRB)-approved informed consent and assent (as applicable) prior to any study related procedures~7. Subjects and their caregivers (as applicable) must agree to comply with all requirements of the protocol~8. For subjects with only one ear meeting all study eligibility criteria, the subject will be eligible for the study, and the ear meeting all eligibility criteria will be treated with study drug and considered to be the study ear for the purposes of study evaluations. In case of bilateral otomycosis in which at least one ear meet all study eligibility criteria, the subject will be eligible for the study, both ears may be treated with study drug provided that both ears have a score of 1 for fungal elements, and the worse ear will be considered to be the study ear for the purposes of study evaluations. If both ears meet study eligibility criteria and are determined by the investigator to have the same degree of infection at Screening/Baseline, the left ear will be considered to be the study ear for the purposes of study evaluations.~Exclusion Criteria:~1. Any other dermatoses or conditions of the ear that may interfere with the evaluation of otomycosis, including concomitant otic infections (including bacterial infection) that require antimicrobial treatment, disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s) that will be treated with study drug~2. Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated with study drug~3. History of prior surgery directly affecting and compromising the external auditory canal and/or tympanic membrane of the ear(s) that will be treated with study drug, except for prior tympanostomy tube(s) that have already been removed and completely healed~4. Use of any topical medicated treatments for otomycosis within 14 days of study entry for the ear(s) that will be treated with study drug~5. Use of any systemic antifungal therapy within 28 days of study entry, warfarin within 28 days of study entry, immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry~6. Fever of ≥100°F at study entry~7. Recurrent otomycosis that has been unresponsive to previous antifungal treatment within the last 12 months~8. Known hypersensitivity to any of the components in the test formulation~9. Participation in another investigative trial within 28 days of study entry."', 'combined_text': 'Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis primary efficacy endpoint, Clinical Cure, defined as score of zero (0) for fungal elements and each of the signs/symptoms of pruritus, aural fullness and debris, at the Test of Cure visit., Day 22, test of cure Clinical Cure at the End of Treatment, Score of zero (0) for fungal elements and for each signs/symptoms of otomycosis (debris, pruritus and aural fullness), Day 15, end of treatment|Modified Clinical Cure at Test of Cure, Score of zero (0) for fungal elements, and score of "0" or "1" for each signs/symptoms of otomycosis (debris, pruritus and aural fullness), Day 22, test of cure|Modified Clinical Cure at End of Treatment, Score of zero (0) for fungal elements, and score of "0" or "1" for each signs/symptoms of otomycosis (debris, pruritus and aural fullness), Day 15, end of treatment "Inclusion Criteria:~1. Male or non-pregnant, non-lactating females~2. Diagnosis of uncomplicated otomycosis of the external ear only, in the ear(s) that will be treated with study drug, with a score for fungal elements of 1 in each ear to be treated with study drug (see Section 7.4 for definitions of the scores for each of the otomycosis signs and symptoms). Subjects must also have the following signs and symptoms of otomycosis in the study ear: pruritus ≥2; debris ≥2; and aural fullness ≥2.~3. General good health as determined by medical examination and medical history, and who are free of clinically significant disease, including diabetes mellitus that is not well-controlled or that could interfere with the study~4. Females of childbearing potential must have had a negative urine pregnancy test at Screening/Baseline and must agree to use an effective method of contraception (as defined in Section 8.5) from Screening/Baseline up through the End of Treatment visit (see Section 6). Females of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \\>12 consecutive months). Females who are using oral, implanted, or injectable contraceptive hormones, an intrauterine device (IUD), barrier methods (diaphragm, condoms, spermicide) to prevent pregnancy, practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of childbearing potential~5. Subjects and/or their caregivers (as appropriate for the age of the subject) must have full legal capacity to volunteer~6. Subjects and/or their caregivers must have completed an appropriately administered institutional review board (IRB)-approved informed consent and assent (as applicable) prior to any study related procedures~7. Subjects and their caregivers (as applicable) must agree to comply with all requirements of the protocol~8. For subjects with only one ear meeting all study eligibility criteria, the subject will be eligible for the study, and the ear meeting all eligibility criteria will be treated with study drug and considered to be the study ear for the purposes of study evaluations. In case of bilateral otomycosis in which at least one ear meet all study eligibility criteria, the subject will be eligible for the study, both ears may be treated with study drug provided that both ears have a score of 1 for fungal elements, and the worse ear will be considered to be the study ear for the purposes of study evaluations. If both ears meet study eligibility criteria and are determined by the investigator to have the same degree of infection at Screening/Baseline, the left ear will be considered to be the study ear for the purposes of study evaluations.~Exclusion Criteria:~1. Any other dermatoses or conditions of the ear that may interfere with the evaluation of otomycosis, including concomitant otic infections (including bacterial infection) that require antimicrobial treatment, disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s) that will be treated with study drug~2. Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated with study drug~3. History of prior surgery directly affecting and compromising the external auditory canal and/or tympanic membrane of the ear(s) that will be treated with study drug, except for prior tympanostomy tube(s) that have already been removed and completely healed~4. Use of any topical medicated treatments for otomycosis within 14 days of study entry for the ear(s) that will be treated with study drug~5. Use of any systemic antifungal therapy within 28 days of study entry, warfarin within 28 days of study entry, immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry~6. Fever of ≥100°F at study entry~7. Recurrent otomycosis that has been unresponsive to previous antifungal treatment within the last 12 months~8. Known hypersensitivity to any of the components in the test formulation~9. Participation in another investigative trial within 28 days of study entry."', 'Similarity Score': 0.12516598312030144}}]
|
from_dataset
| 0.125166
|
[{'from': 'human', 'value': {'Study Title': 'Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis', 'Primary Outcome Measures': 'Therapeutic Cure, Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures., 42 Days', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Male or non-pregnant, non-lactating females 18 years of age or older.~* Signed informed consent form, which meets all criteria of current FDA regulations.~* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.~* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.~* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.~* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.~Exclusion Criteria:~* Females who are pregnant, lactating or likely to become pregnant during the study.~* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.~* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.~* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.~* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.~* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.~* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.~* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.~* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.~* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.~* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.~* Patients who would be non-compliant with the requirements of the study protocol.~* Participation in a research study within 30 days prior to baseline visit.~* Employees or family members of employees of the research center or investigator.~* Previous participation in this study."'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 194, 'Unnamed: 0': 236, 'NCT Number': 'NCT01721694', 'Study Title': 'Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection', 'Study URL': 'https://clinicaltrials.gov/study/NCT01721694', 'Acronym': '', 'Study Status': 'WITHDRAWN', 'Brief Summary': 'To evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5% Loteprednol eye drops for the treatment of ocular inflammation and infection associated bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual administration of azithromycin 1.5% and 0.5% Loteprednol (separately).', 'Study Results': 'NO', 'Conditions': 'Ocular Inflammation|Infection Associated Blepharitis|Keratitis|Conjunctivitis, Bacterial', 'Interventions': 'DRUG: azithromycin 1.5%/Loteprednol 0,5% + placebo|DRUG: azithromycin 1.5% + Loteprednol 0,5% (separately)', 'Primary Outcome Measures': 'Clinical cure, Clinical cure achieved when the score of the cardinal ocular signs (hyperemia in the bulbar conjunctiva, palpebral, exudate / conjunctival discharge, eyelid erythema and flaking / crust eyelid) is zero at the time of conclusion of the study (D8), Day 8', 'Secondary Outcome Measures': 'irradication of pathogens, Success obtained with microbiological irradication of pathogens present at baseline, Day 8', 'Other Outcome Measures': 'ophthalmic evaluation, decrease of visual acuity, corneal/anterior chamber changes, IOP increase and adverse event reporting, Day 4 and Day 8', 'Sponsor': 'Adapt Produtos Oftalmológicos Ltda.', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE3', 'Enrollment': 0.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT', 'Other IDs': 'AZILOT-12|131.835', 'Start Date': '2012-12', 'Primary Completion Date': '2013-03', 'Completion Date': '2013-05', 'First Posted': '2012-11-06', 'Results First Posted': '', 'Last Update Posted': '2014-12-11', 'Locations': 'Department of Ophthalmology of Hospital São Paulo, São Paulo, 04023-062, Brazil', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~* Patients were male or female, of any race and age minimum of 18 years.~* Blepharitis should provide diagnostic and / or keratitis and / or conjunctivitis with or without bacterial involvement corneal by biomicroscopy, with positive staining corneal fluorescein and also provide a composite score ≥ 2 on: bulbar conjunctival hyperemia, eyelid conjunctiva, secretion / exudate conjunctival erythema and flaking eyelids / eyelid crust on at least one eye (the same eye) on Day 1 visit~Exclusion Criteria:~* Intraocular hypertension or uncontrolled glaucoma.~* Use of contact lenses during the study.~* Capacity unilateral visual only.~* Suspected fungal infection, viral (eg, herpes simplex epithelial, dendritic keratitis) or Acanthamoeba, or any other disease where the use of corticosteroids is contraindicated.~* Use of any topical ophthalmic medications preserved during study participation. Not be allowed eyedrops preserved (eg artificial tears).~* Use of any antibacterial agent oral or topical ophthalmic until 72 hours prior to study entry.~* Use of systemic steroids within 14 days prior to study entry. Ophthalmic topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs), until one week before admission to the study. Will not be allowed to use these medications during study participation. Will not be allowed to use nasal steroids during the study. Will be allowed to use inhaled steroids to aid inhaler. Will be allowed steroids dermal topics.~* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) systemic up to 24 hours prior to study entry or at any time during the study, unless the patient is under treatment regimen with stable (not necessary) for at least 2 months before Admission and therapy continues throughout the study.~* Any disturbance or ocular or systemic disease, complicating factors or structural abnormality that affects the conduct or outcome of the study in a negative way or represents an undue risk to patient safety, according to the opinion of the investigator.~* Any current immunosuppressive disorder (eg, HIV-positive), or immunosuppressive therapy (including chemotherapy).~* Known allergy or suspected allergy or hypersensitivity to fluoroquinolones, to steroids or any other component of the study drug;~* Pregnant or lactating. (Women of childbearing age may be admitted if they use contraception and submit urine pregnancy test negative);~* Any patient who has a family member who participates in this study"', 'combined_text': 'Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of Ocular Inflammation and Infection Clinical cure, Clinical cure achieved when the score of the cardinal ocular signs (hyperemia in the bulbar conjunctiva, palpebral, exudate / conjunctival discharge, eyelid erythema and flaking / crust eyelid) is zero at the time of conclusion of the study (D8), Day 8 irradication of pathogens, Success obtained with microbiological irradication of pathogens present at baseline, Day 8 "Inclusion Criteria:~* Patients were male or female, of any race and age minimum of 18 years.~* Blepharitis should provide diagnostic and / or keratitis and / or conjunctivitis with or without bacterial involvement corneal by biomicroscopy, with positive staining corneal fluorescein and also provide a composite score ≥ 2 on: bulbar conjunctival hyperemia, eyelid conjunctiva, secretion / exudate conjunctival erythema and flaking eyelids / eyelid crust on at least one eye (the same eye) on Day 1 visit~Exclusion Criteria:~* Intraocular hypertension or uncontrolled glaucoma.~* Use of contact lenses during the study.~* Capacity unilateral visual only.~* Suspected fungal infection, viral (eg, herpes simplex epithelial, dendritic keratitis) or Acanthamoeba, or any other disease where the use of corticosteroids is contraindicated.~* Use of any topical ophthalmic medications preserved during study participation. Not be allowed eyedrops preserved (eg artificial tears).~* Use of any antibacterial agent oral or topical ophthalmic until 72 hours prior to study entry.~* Use of systemic steroids within 14 days prior to study entry. Ophthalmic topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs), until one week before admission to the study. Will not be allowed to use these medications during study participation. Will not be allowed to use nasal steroids during the study. Will be allowed to use inhaled steroids to aid inhaler. Will be allowed steroids dermal topics.~* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) systemic up to 24 hours prior to study entry or at any time during the study, unless the patient is under treatment regimen with stable (not necessary) for at least 2 months before Admission and therapy continues throughout the study.~* Any disturbance or ocular or systemic disease, complicating factors or structural abnormality that affects the conduct or outcome of the study in a negative way or represents an undue risk to patient safety, according to the opinion of the investigator.~* Any current immunosuppressive disorder (eg, HIV-positive), or immunosuppressive therapy (including chemotherapy).~* Known allergy or suspected allergy or hypersensitivity to fluoroquinolones, to steroids or any other component of the study drug;~* Pregnant or lactating. (Women of childbearing age may be admitted if they use contraception and submit urine pregnancy test negative);~* Any patient who has a family member who participates in this study"', 'Similarity Score': 0.12309639138854725}}]
|
from_dataset
| 0.123096
|
[{'from': 'human', 'value': {'Study Title': 'Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis', 'Primary Outcome Measures': 'Therapeutic Cure, Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures., 42 Days', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Male or non-pregnant, non-lactating females 18 years of age or older.~* Signed informed consent form, which meets all criteria of current FDA regulations.~* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.~* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.~* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.~* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.~Exclusion Criteria:~* Females who are pregnant, lactating or likely to become pregnant during the study.~* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.~* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.~* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.~* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.~* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.~* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.~* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.~* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.~* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.~* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.~* Patients who would be non-compliant with the requirements of the study protocol.~* Participation in a research study within 30 days prior to baseline visit.~* Employees or family members of employees of the research center or investigator.~* Previous participation in this study."'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 751, 'Unnamed: 0': 941, 'NCT Number': 'NCT06363292', 'Study Title': 'Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects.', 'Study URL': 'https://clinicaltrials.gov/study/NCT06363292', 'Acronym': '', 'Study Status': 'RECRUITING', 'Brief Summary': 'This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®.', 'Study Results': 'NO', 'Conditions': 'Ophthalmological Agent Toxicity|Bacterial Conjunctivitis', 'Interventions': 'DRUG: PRO-231|DRUG: VIGAMOXI®', 'Primary Outcome Measures': "Incidence of unexpected adverse events related to the interventions, Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention., Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)|Incidence of conjunctival hyperemia and chemosis, Any signs of conjunctival hyperemia and chemosis in between interventions., Days 3 (Visit 1), and 8 (Final Visit)|Changes in Best Corrected Visual Acuity (BCVA), The BCVA will be evaluated through Snellen chart., Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)|Changes in the integrity of the ocular surface (fluorescein staining), Changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale. The standard Oxford scale for fluorescein staining has the following criteria: Grade 0- Equal to or less than panel A; Grade I- Equal to or less than panel B, greater than panel A; Grade II- Equal to or less than panel C, greater than panel B; Grade III- Equal or less than panel D, greater than panel C; Grade IV- Equal or less than panel E, greater than panel D; Grade V- Greater than panel E., Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)|Changes in the Ocular Comfort Index (OCI) score between interventions., The subjects will be questioned regarding this symptoms' incidence., Days 3 (Visit 1), and 8 (Final Visit)", 'Secondary Outcome Measures': 'Incidence of unexpected adverse events (excluding conjunctival hyperemia and chemosis), Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention, excluding conjunctival hyperemia and chemosis., Days 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)|To assess the tolerability of PRO-231 ophthalmic solution, To assess the tolerability of PRO-231 ophthalmic solution applied to the ocular surface, in healthy volunteers, versus VIGAMOXI®, by means of: Presence of ocular symptoms (burning, foreign body sensation, pruritus and lacrimation) between interventions., Days 3 (Visit 1), 8 (Final Visit)', 'Other Outcome Measures': '', 'Sponsor': 'Laboratorios Sophia S.A de C.V.', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'ADULT', 'Phases': 'PHASE1', 'Enrollment': 36.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT', 'Other IDs': 'SOPH231-1221/I', 'Start Date': '2024-01-30', 'Primary Completion Date': '2024-05-30', 'Completion Date': '2024-05-30', 'First Posted': '2024-04-12', 'Results First Posted': '', 'Last Update Posted': '2024-04-15', 'Locations': 'IIMET Investigación e Innovación en Medicina Traslacional, Guadalajara, Jalisco, 44610, Mexico', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~* Having the ability to voluntarily give their signed informed consent.~* Ophthalmologically and clinically healthy subjects.~* Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.~* Age between 18 to 45 years.~* Male or female gender.~* Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO \\[Tubal Ligation\\]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form \\[ICF\\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.~* Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.~* Corneal staining ≤ grade I on the Oxford Scale.~* Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.~Exclusion Criteria:~* History of hypersensitivity to fluoroquinolones, steroid anti-inflammatories, or any of the components of the drugs under investigation.~* Use of ophthalmic medications from any pharmacological group.~* Use of medications by any other route of administration.~* Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.~* History of eye surgery in the last 6 months.~* Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.~* In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.~* Having participated in any clinical research study 30 days prior to inclusion in this study.~* Having previously participated in this same study.~* History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial Hypertension.~* Diagnosis of glaucoma or ocular hypertension.~* Known diagnosis of liver or heart disease.~* Presenting active inflammatory or infectious disease at the time of entry into the study.~* Presenting unresolved lesions or traumas at the time of entry into the study.~* Having been subjected to non-ophthalmological surgical procedures in the last 3 months.~* Being or having an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an employee of the research site or the sponsor, and who directly participates in this study.~* Active smoking (specified as the consumption of cigarettes regardless of the amount and frequency, 4 weeks prior to study inclusion and during the intervention period of this study).~* Active alcoholism (specified as the consumption of alcoholic beverages, regardless of the amount and frequency, 72 hours prior to study inclusion and during the intervention period of this study).~Elimination Criteria~* Withdrawal of their consent to participate in the study (informed consent form).~* Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient\'s fitness to safely continue with the study procedures.~* Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).~* Non-tolerability or hypersensitivity to any of the drugs under investigation.~* Adherence \\< 80% determined by the subject\'s diary and corroborated by the final weight of the research products (RP) compared to the initial weight."', 'combined_text': 'Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects. Incidence of unexpected adverse events related to the interventions, Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention., Days 0 (Basal Visit), 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)|Incidence of conjunctival hyperemia and chemosis, Any signs of conjunctival hyperemia and chemosis in between interventions., Days 3 (Visit 1), and 8 (Final Visit)|Changes in Best Corrected Visual Acuity (BCVA), The BCVA will be evaluated through Snellen chart., Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)|Changes in the integrity of the ocular surface (fluorescein staining), Changes in the integrity of the ocular surface using fluorescein staining and evaluated through the Oxford scale. The standard Oxford scale for fluorescein staining has the following criteria: Grade 0- Equal to or less than panel A; Grade I- Equal to or less than panel B, greater than panel A; Grade II- Equal to or less than panel C, greater than panel B; Grade III- Equal or less than panel D, greater than panel C; Grade IV- Equal or less than panel E, greater than panel D; Grade V- Greater than panel E., Days 0 (Basal Visit), Days 3 (Visit 1) and 8 (Final Visit)|Changes in the Ocular Comfort Index (OCI) score between interventions., The subjects will be questioned regarding this symptoms\' incidence., Days 3 (Visit 1), and 8 (Final Visit) Incidence of unexpected adverse events (excluding conjunctival hyperemia and chemosis), Any unfavorable medical condition affecting the subject after the administration of the investigation product, related to such intervention, excluding conjunctival hyperemia and chemosis., Days 3 (Visit 1), 8 (Final Visit) and 12 (Safety Call)|To assess the tolerability of PRO-231 ophthalmic solution, To assess the tolerability of PRO-231 ophthalmic solution applied to the ocular surface, in healthy volunteers, versus VIGAMOXI®, by means of: Presence of ocular symptoms (burning, foreign body sensation, pruritus and lacrimation) between interventions., Days 3 (Visit 1), 8 (Final Visit) "Inclusion Criteria:~* Having the ability to voluntarily give their signed informed consent.~* Ophthalmologically and clinically healthy subjects.~* Being able to and willing to comply with scheduled visits, treatment plan, and other study procedures.~* Age between 18 to 45 years.~* Male or female gender.~* Women of childbearing potential who have not undergone Bilateral Tubal Occlusion (BTO \\[Tubal Ligation\\]), hysterectomy, or bilateral oophorectomy must ensure continuation (initiated ≥ 30 days prior to signing the informed consent form \\[ICF\\]) of the use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.~* Best corrected visual acuity (BCVA) of 20/30 or better in both eyes.~* Corneal staining ≤ grade I on the Oxford Scale.~* Having an intraocular pressure ≥ 10 and ≤ 21 mmHg.~Exclusion Criteria:~* History of hypersensitivity to fluoroquinolones, steroid anti-inflammatories, or any of the components of the drugs under investigation.~* Use of ophthalmic medications from any pharmacological group.~* Use of medications by any other route of administration.~* Use of non-steroidal anti-inflammatory drugs, steroid anti-inflammatory drugs, or antibiotics by any route of administration in the last 30 days.~* History of eye surgery in the last 6 months.~* Use of contact lenses for a period less than two weeks prior to the start of the study, and during the intervention period of this study.~* In the case of women: being pregnant, breastfeeding, or planning to become pregnant within the study period.~* Having participated in any clinical research study 30 days prior to inclusion in this study.~* Having previously participated in this same study.~* History of any chronic-degenerative disease, including Diabetes Mellitus or Systemic Arterial Hypertension.~* Diagnosis of glaucoma or ocular hypertension.~* Known diagnosis of liver or heart disease.~* Presenting active inflammatory or infectious disease at the time of entry into the study.~* Presenting unresolved lesions or traumas at the time of entry into the study.~* Having been subjected to non-ophthalmological surgical procedures in the last 3 months.~* Being or having an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an employee of the research site or the sponsor, and who directly participates in this study.~* Active smoking (specified as the consumption of cigarettes regardless of the amount and frequency, 4 weeks prior to study inclusion and during the intervention period of this study).~* Active alcoholism (specified as the consumption of alcoholic beverages, regardless of the amount and frequency, 72 hours prior to study inclusion and during the intervention period of this study).~Elimination Criteria~* Withdrawal of their consent to participate in the study (informed consent form).~* Occurrence of a serious adverse event, whether related or not to the interventions, that in the opinion of the principal investigator (PI) and/or the sponsor, could affect the patient\'s fitness to safely continue with the study procedures.~* Non-tolerability or hypersensitivity to any of the compounds used during the tests -(fluorescein, tetracaine).~* Non-tolerability or hypersensitivity to any of the drugs under investigation.~* Adherence \\< 80% determined by the subject\'s diary and corroborated by the final weight of the research products (RP) compared to the initial weight."', 'Similarity Score': 0.12144215923159792}}]
|
from_dataset
| 0.121442
|
[{'from': 'human', 'value': {'Study Title': 'Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis', 'Primary Outcome Measures': 'Therapeutic Cure, Patients with both mycological cure and clinical cure at the final follow-up visit two weeks fter the end of treatment (Day 42) will be considered therapeutic cures., 42 Days', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Male or non-pregnant, non-lactating females 18 years of age or older.~* Signed informed consent form, which meets all criteria of current FDA regulations.~* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.~* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.~* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.~* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.~Exclusion Criteria:~* Females who are pregnant, lactating or likely to become pregnant during the study.~* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.~* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.~* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.~* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.~* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.~* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.~* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.~* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.~* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.~* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.~* Patients who would be non-compliant with the requirements of the study protocol.~* Participation in a research study within 30 days prior to baseline visit.~* Employees or family members of employees of the research center or investigator.~* Previous participation in this study."'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 144, 'Unnamed: 0': 171, 'NCT Number': 'NCT00837291', 'Study Title': 'A Study of the Efficacy and Safety of CF101 to Patients With Osteoarthritis of the Knee', 'Study URL': 'https://clinicaltrials.gov/study/NCT00837291', 'Acronym': '', 'Study Status': 'WITHDRAWN', 'Brief Summary': 'This study will test the effectiveness of CF101 in treating the symptoms of osteoarthritis (OA) of the knee. Eligible patients will be given either CF101 or matching placebo tablets and their symptoms will be evaluated over the 12 week treatment period.', 'Study Results': 'NO', 'Conditions': 'Osteoarthritis of the Knee', 'Interventions': 'DRUG: CF101|DRUG: Placebo', 'Primary Outcome Measures': 'Proportion of responders by OMERACT-OARSI definition, 12 weeks', 'Secondary Outcome Measures': "Safety, as assessed through vital signs, physical examinations, adverse event reporting, clinical laboratory testing, and ECGs, 14 weeks|Change from baseline in total WOMAC score, and pain, physical function, and stiffness subscale scores, 12 weeks|Change from baseline in physician's and patient's global assessments, 12 weeks", 'Other Outcome Measures': '', 'Sponsor': 'Can-Fite BioPharma', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE2', 'Enrollment': 0.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT', 'Other IDs': 'CF101-221OA', 'Start Date': '2018-11', 'Primary Completion Date': '2018-12', 'Completion Date': '2019-01', 'First Posted': '2009-02-05', 'Results First Posted': '', 'Last Update Posted': '2018-02-01', 'Locations': 'Barzilai Medical Center, Ashkelon, Israel', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~* Males and females age 40 years or above~* Clinical evidence of knee OA, as indicated by:~ * Pain requiring treatment with NSAID or coxib medication for analgesia for at least 6 months prior to the screening visit, and~ * Pain requiring treatment with NSAID or coxib medication for analgesia on the majority of days during the preceding month~* Radiographic evidence of knee OA, as indicated by findings of Kellgren-Lawrence Grade 2 or 3 within 1 year prior to the screening visit2~* American College of Rheumatology functional class I, II, or III3~* WOMAC pain subscale score ≥40 mm at baseline~* WOMAC function subscale score \\>20 mm at baseline~* PGA \\>10 mm at baseline~* In the Investigator\'s opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol~* Negative screening serum pregnancy test for female patients of childbearing potential~* Females of childbearing potential must utilize, throughout the course of the trial, 2 methods of contraception deemed adequate by the Investigator (for example, oral contraceptive pills plus a barrier method)~* All aspects of the protocol explained and written informed consent obtained~Exclusion Criteria:~* Predominant patellofemoral disease~* Concomitant local or systemic inflammatory arthropathy which could confound evaluation of the knee~* Ipsilateral hip or extremity disease which could confound evaluation of the knee~* History of clinical significant trauma or surgery to the index knee~* Arthroscopy to the index knee within 6 months prior to the screening visit~* Corticosteroid, hyaluronic acid, or other intraatricular injection to the index knee within 3 months prior to the screening visit~* Use of chondroitin sulfate and/or glucosamine, or diacerin, within 2 weeks prior to the screening visit~* Concomitant requirement for NSAID, coxib medication, or opioid analgesics (acetaminophen is allowed)~* Use of systemic corticosteroids \\>10 mg/d of prednisone, or equivalent~* Presence or history of uncontrolled arterial hypertension or symptomatic hypotension~* Significant cardiac arrhythmia or conduction block, congestive heart failure, or any other evidence of clinically significant heart disease; other clinically significant findings on screening electrocardiogram (ECG)~* Hemoglobin level \\<10.0 gm/dL at the screening visit~* White blood cell count \\<3000/mm3 at the screening visit~* Platelet count \\<125,000/mm3 at the screening visit~* Serum creatinine level outside the central laboratory\'s normal limits at the screening visit~* Liver aminotransferase (ALT and/or AST) levels greater than the upper limit of normal at the screening visit~* Known or suspected immunodeficiency or human immunodeficiency virus positivity~* Pregnancy, lactation, or inadequate contraception as judged by the Investigator~* Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to screening~* History of drug or alcohol dependence~* History of malignancy within the past 5 years (excluding excised basal or squamous cell carcinoma of the skin)~* Diagnosis of Parkinson\'s Disease~* Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient\'s ability to complete the study, and/or compromise the objectives of the study"', 'combined_text': 'A Study of the Efficacy and Safety of CF101 to Patients With Osteoarthritis of the Knee Proportion of responders by OMERACT-OARSI definition, 12 weeks Safety, as assessed through vital signs, physical examinations, adverse event reporting, clinical laboratory testing, and ECGs, 14 weeks|Change from baseline in total WOMAC score, and pain, physical function, and stiffness subscale scores, 12 weeks|Change from baseline in physician\'s and patient\'s global assessments, 12 weeks "Inclusion Criteria:~* Males and females age 40 years or above~* Clinical evidence of knee OA, as indicated by:~ * Pain requiring treatment with NSAID or coxib medication for analgesia for at least 6 months prior to the screening visit, and~ * Pain requiring treatment with NSAID or coxib medication for analgesia on the majority of days during the preceding month~* Radiographic evidence of knee OA, as indicated by findings of Kellgren-Lawrence Grade 2 or 3 within 1 year prior to the screening visit2~* American College of Rheumatology functional class I, II, or III3~* WOMAC pain subscale score ≥40 mm at baseline~* WOMAC function subscale score \\>20 mm at baseline~* PGA \\>10 mm at baseline~* In the Investigator\'s opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol~* Negative screening serum pregnancy test for female patients of childbearing potential~* Females of childbearing potential must utilize, throughout the course of the trial, 2 methods of contraception deemed adequate by the Investigator (for example, oral contraceptive pills plus a barrier method)~* All aspects of the protocol explained and written informed consent obtained~Exclusion Criteria:~* Predominant patellofemoral disease~* Concomitant local or systemic inflammatory arthropathy which could confound evaluation of the knee~* Ipsilateral hip or extremity disease which could confound evaluation of the knee~* History of clinical significant trauma or surgery to the index knee~* Arthroscopy to the index knee within 6 months prior to the screening visit~* Corticosteroid, hyaluronic acid, or other intraatricular injection to the index knee within 3 months prior to the screening visit~* Use of chondroitin sulfate and/or glucosamine, or diacerin, within 2 weeks prior to the screening visit~* Concomitant requirement for NSAID, coxib medication, or opioid analgesics (acetaminophen is allowed)~* Use of systemic corticosteroids \\>10 mg/d of prednisone, or equivalent~* Presence or history of uncontrolled arterial hypertension or symptomatic hypotension~* Significant cardiac arrhythmia or conduction block, congestive heart failure, or any other evidence of clinically significant heart disease; other clinically significant findings on screening electrocardiogram (ECG)~* Hemoglobin level \\<10.0 gm/dL at the screening visit~* White blood cell count \\<3000/mm3 at the screening visit~* Platelet count \\<125,000/mm3 at the screening visit~* Serum creatinine level outside the central laboratory\'s normal limits at the screening visit~* Liver aminotransferase (ALT and/or AST) levels greater than the upper limit of normal at the screening visit~* Known or suspected immunodeficiency or human immunodeficiency virus positivity~* Pregnancy, lactation, or inadequate contraception as judged by the Investigator~* Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to screening~* History of drug or alcohol dependence~* History of malignancy within the past 5 years (excluding excised basal or squamous cell carcinoma of the skin)~* Diagnosis of Parkinson\'s Disease~* Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient\'s ability to complete the study, and/or compromise the objectives of the study"', 'Similarity Score': 0.11875057796079456}}]
|
from_dataset
| 0.118751
|
[{'from': 'human', 'value': '{Study Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis, Primary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population), 6 Months, Secondary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population), 36 Months, criteria: "Inclusion Criteria:~* Male or non pregnant female at least 18 years of age at time of consent~* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \\\\> 1 year duration~* At the time of enrollment (Day 1), study eye has \\\\< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.~* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart~* Subject is not planning to undergo elective ocular surgery during the study~* Subject has ability to understand and sign the Informed Consent Form~* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures~* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:~ * systemic corticosteroid or other systemic therapies given for at least 3 months, and/or~ * at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis~OR the study eye has experienced recurrence:~• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid~Exclusion Criteria:~* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert~* History of posterior uveitis only that is not accompanied by vitritis or macular edema~* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze~* Uveitis with infectious etiology~* Vitreous hemorrhage~* Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)~* Ocular malignancy in either eye, including choroidal melanoma~* Toxoplasmosis scar in study eye or scar related to previous viral retinitis~* Previous viral retinitis~* Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures~* Media opacity precluding evaluation of retina and vitreous~* Peripheral retinal detachment in area of insertion~* Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)~* IOP \\\\> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye~* Chronic hypotony (\\\\< 6 mmHg)~* Ocular surgery on the study eye within 3 months prior to study Day 1~* Capsulotomy in study eye within 30 days prior to study Day 1~* Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1~* Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1~* Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1~* Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1~* Subjects requiring chronic systemic or inhaled corticosteroid therapy (\\\\>15mg prednisone daily) or chronic systemic immunosuppressive therapy~* Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1~* Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis~* Systemic infection within 30 days prior to study Day 1~* Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Treatment with an investigational drug or device within 30 days prior to study Day 1~* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit~* Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 40, Unnamed: 0: 45, NCT Number: NCT00061594, Study Title: A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular Degeneration, Study URL: https://clinicaltrials.gov/study/NCT00061594, Acronym: , Study Status: COMPLETED, Brief Summary: This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration., Study Results: NO, Conditions: Macular Degeneration, Interventions: DRUG: rhuFab V2 (ranibizumab), Primary Outcome Measures: , Secondary Outcome Measures: , Other Outcome Measures: , Sponsor: Genentech, Inc., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE3, Enrollment: 426.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: |Masking: DOUBLE|Primary Purpose: TREATMENT, Other IDs: FVF2587g, Start Date: 2003-05, Primary Completion Date: , Completion Date: 2006-09, First Posted: 2003-05-30, Results First Posted: , Last Update Posted: 2014-03-19, Locations: "Retina Centers, P.C., Tucson, Arizona, 85704, United States|University of Arizona, Tucson, Arizona, 85711, United States|Retina-Vitreous Associates Medical Group, Beverly Hills, California, 90211, United States|UC Irvine, Irvine, California, 92697, United States|Doheny Eye Institute, Los Angeles, California, 90033, United States|California Vitreoretinal Research Center, Menlo Park, California, 94025, United States|No. California Retina-Vitreous Associates, Mountain View, California, 94040, United States|UCSF School of Medicine, San Francisco, California, 94143, United States|Danbury Eye Physicians & Surgeons, Danbury, Connecticut, 06810, United States|New England Retina Associates, Hamden, Connecticut, 06518, United States|Florida Retina Institute, Daytona Beach, Florida, 32114, United States|Retina Vitreous Consultants, Ft. Lauderdale, Florida, 33334, United States|Retina Consultants of Southwest Florida, Ft. Myers, Florida, 33901, United States|Retina Health Center, Ft. Myers, Florida, 33901, United States|Retina Associates of South Florida, Margate, Florida, 33063, United States|Bascom Palmer Eye Institute, Miami, Florida, 33136, United States|Central Florida Retina, Orlando, Florida, 32806, United States|Retina Care Specialists, Palm Beach Gardens, Florida, 33410, United States|Bascom Palmer Eye Institute, Palm Beach Gardens, Florida, 33418, United States|Ophthalmic Consultants, Sarasota, Florida, 34239, United States|Southern Vitreoretinal Associates PA, Tallahassee, Florida, 32308, United States|University of South Florida, Tampa, Florida, 33612, United States|Emory University, Atlanta, Georgia, 30322, United States|Medical College of Georgia, Augusta, Georgia, 30912, United States|Thomas A. Ciulla, MD, PC, Indianapolis, Indiana, 46280, United States|University of Kansas Medical Center, Kansas City, Kansas, 66160, United States|Retina Associates PC, Annapolis, Maryland, 21401, United States|New England Eye Center, Boston, Massachusetts, 02111, United States|Center for Eye Research, Boston, Massachusetts, 02114, United States|New England Retina Consultants, West Springfield, Massachusetts, 01089, United States|University of Michigan, Ann Arbor, Michigan, 48105, United States|Associated Retinal Consultants, Grand Rapids, Michigan, 49546, United States|Associated Retinal Consultants, P.C., Royal Oak, Michigan, 48073, United States|Retina Consultants of Michigan, Southfield, Michigan, 48034, United States|Retina Associates of St. Louis, Florissant, Missouri, 63031, United States|St. Louis University Eye Institute, St. Louis, Missouri, 63104, United States|Delaware Valley Retina Associates, Lawrenceville, New Jersey, 08648, United States|Lions Eye Institute, Albany, New York, 12208, United States|Ophthalmic Consultants of Long Island, Rockville Centre, New York, 11570, United States|Western Carolina Retinal Associates, PA, Asheville, North Carolina, 28803, United States|Southeast Clinical Research, Charlotte, North Carolina, 28210, United States|Duke Univ Medical Center/Duke Eye Center, Durham, North Carolina, 22710, United States|Retina Associates of Cleveland, Beachwood, Ohio, 44122, United States|Flavio Company, Cincinnati, Ohio, 45242, United States|Cleveland Clinic Foundation/Cole Eye Institute, Cleveland, Ohio, 44195, United States|Midwest Retina, Columbus, Ohio, 43215, United States|Retina Vitreous Associates, Toledo, Ohio, 43608, United States|Retinal Associates of Oklahoma, Oklahoma City, Oklahoma, 73120, United States|Retina & Vitreous Center of So. Oregon, Ashland, Oregon, 97520, United States|Pennsylvania Retina Specialists, Camp Hill, Pennsylvania, 17011, United States|Wills Eye Hospital, Philadelphia, Pennsylvania, 19107, United States|Allegheny General Hospital, Pittsburgh, Pennsylvania, 15212, United States|Retina Consultants of Charleston, Charleston, South Carolina, 29414, United States|Palmetto Retina Center, Columbia, South Carolina, 29204, United States|BH Regional Eye Institute, Rapid City, South Dakota, 57701, United States|Southeastern Retina Associates, P.C., Knoxville, Tennessee, 37909, United States|Retina Vitreous Associates, Nashville, Tennessee, 37203, United States|Austin Retina Associates, Austin, Texas, 78705, United States|Brian Berger, MD P.A., Austin, Texas, 78705, United States|Retina Specialists, Desoto, Texas, 75115, United States|UTMB, Galveston, Texas, 77555, United States|Vitreoretinal Consultants, Houston, Texas, 77030, United States|Valley Retina Institute, P.A., McAllen, Texas, 78503, United States|Univ of Texas Health Science Center, San Antonio, Texas, 78229, United States|Medical Center Ophthalmology, San Antonio, Texas, 78240, United States|Rocky Mountain Retina Consultants, Salt Lake City, Utah, 84107, United States|John Moran Eye Center/Univ of Utah, Salt Lake City, Utah, 84132, United States|Retina Group of Washington, Fairfax, Virginia, 22031, United States|Vitreoretinal Associates, Seattle, Washington, 98104, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|University of Melbourne, Department of Ophthalmology, East Melbourne, VIC-3002, Australia|Marsden Eye Research Pty Ltd, Parramatta, NSW 2150, Australia|Save Sight Institute, Sydney, NSW-2000, Australia|Westmead Hospital, Westmead, NSW-2145, Australia|Onci klinika FNKV, Praha 10, 100 00, Czech Republic|Clinique dOphtalmologie, Creteil Cedex, F-94010, France|Clinique Monticelli, Marseille, F-13008, France|Hôpital Lariboisière, Paris Cedex 10, F-75475, France|Universitätsklinikum Bonn, Bonn, D-53105, Germany|Universitatskliniken Koln, Koln, D-50924, Germany|Universitätsklinikum Leipzig, Leipzig, D-04103, Germany|Semmelweis University, 1st Ophthalmological Department, Budapest, H-1083, Hungary", Study Documents: , criteria: "Inclusion Criteria:~* Signed informed consent~* Age \\\\>=50 years~* Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne product labeling~* Future treatment with PDT using verteporfin anticipated or expected in the study eye~* Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) in the study eye~* A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is \\\\>=50% of the total lesion size~* Total lesion size of less than or equal to 5400 um in greatest linear dimension (GLD)~* Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye~Exclusion Criteria:~* Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye~* Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0~* Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)~* Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye~* Previous subfoveal focal laser photocoagulation in the study eye~* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0~* History of vitrectomy surgery in the study eye~* History of submacular surgery or other surgical intervention for AMD in the study eye~* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)~* Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either \\\\>=50% of the total lesion area or \\\\>=1 disc area (DA) in size~* Subfoveal fibrosis or atrophy in the study eye~* CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia~* Retinal pigment epithelial tear involving the macula in the study eye~* Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the Investigator could either: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period~* Active intraocular inflammation (grade trace or above) in the study eye~* Current vitreous hemorrhage in the study eye~* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye~* History of idiopathic or autoimmune-associated uveitis in either eye~* Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye~* Aphakia or absence of the posterior capsule in the study eye~* Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia~* Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0~* Uncontrolled glaucoma in the study eye (defined as intraocular pressure \\\\>=30 mmHg despite treatment with anti-glaucoma medication)~* History of glaucoma filtering surgery in the study eye~* History of corneal transplant in the study eye~* Premenopausal women not using adequate contraception~* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications~* Current treatment for active systemic infection~* History of allergy to fluorescein, not amenable to treatment~* Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center~* Inability to comply with study or follow up procedures", combined_text: A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular Degeneration "Inclusion Criteria:~* Signed informed consent~* Age \\\\>=50 years~* Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne product labeling~* Future treatment with PDT using verteporfin anticipated or expected in the study eye~* Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) in the study eye~* A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is \\\\>=50% of the total lesion size~* Total lesion size of less than or equal to 5400 um in greatest linear dimension (GLD)~* Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye~Exclusion Criteria:~* Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye~* Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0~* Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)~* Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye~* Previous subfoveal focal laser photocoagulation in the study eye~* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0~* History of vitrectomy surgery in the study eye~* History of submacular surgery or other surgical intervention for AMD in the study eye~* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)~* Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either \\\\>=50% of the total lesion area or \\\\>=1 disc area (DA) in size~* Subfoveal fibrosis or atrophy in the study eye~* CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia~* Retinal pigment epithelial tear involving the macula in the study eye~* Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the Investigator could either: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period~* Active intraocular inflammation (grade trace or above) in the study eye~* Current vitreous hemorrhage in the study eye~* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye~* History of idiopathic or autoimmune-associated uveitis in either eye~* Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye~* Aphakia or absence of the posterior capsule in the study eye~* Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia~* Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0~* Uncontrolled glaucoma in the study eye (defined as intraocular pressure \\\\>=30 mmHg despite treatment with anti-glaucoma medication)~* History of glaucoma filtering surgery in the study eye~* History of corneal transplant in the study eye~* Premenopausal women not using adequate contraception~* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications~* Current treatment for active systemic infection~* History of allergy to fluorescein, not amenable to treatment~* Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center~* Inability to comply with study or follow up procedures", Similarity Score: 0.5316002639846321}'}]
|
from_dataset
| 0.5316
|
[{'from': 'human', 'value': '{Study Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis, Primary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population), 6 Months, Secondary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population), 36 Months, criteria: "Inclusion Criteria:~* Male or non pregnant female at least 18 years of age at time of consent~* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \\\\> 1 year duration~* At the time of enrollment (Day 1), study eye has \\\\< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.~* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart~* Subject is not planning to undergo elective ocular surgery during the study~* Subject has ability to understand and sign the Informed Consent Form~* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures~* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:~ * systemic corticosteroid or other systemic therapies given for at least 3 months, and/or~ * at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis~OR the study eye has experienced recurrence:~• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid~Exclusion Criteria:~* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert~* History of posterior uveitis only that is not accompanied by vitritis or macular edema~* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze~* Uveitis with infectious etiology~* Vitreous hemorrhage~* Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)~* Ocular malignancy in either eye, including choroidal melanoma~* Toxoplasmosis scar in study eye or scar related to previous viral retinitis~* Previous viral retinitis~* Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures~* Media opacity precluding evaluation of retina and vitreous~* Peripheral retinal detachment in area of insertion~* Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)~* IOP \\\\> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye~* Chronic hypotony (\\\\< 6 mmHg)~* Ocular surgery on the study eye within 3 months prior to study Day 1~* Capsulotomy in study eye within 30 days prior to study Day 1~* Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1~* Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1~* Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1~* Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1~* Subjects requiring chronic systemic or inhaled corticosteroid therapy (\\\\>15mg prednisone daily) or chronic systemic immunosuppressive therapy~* Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1~* Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis~* Systemic infection within 30 days prior to study Day 1~* Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Treatment with an investigational drug or device within 30 days prior to study Day 1~* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit~* Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 453, Unnamed: 0: 554, NCT Number: NCT00456482, Study Title: Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant, Study URL: https://clinicaltrials.gov/study/NCT00456482, Acronym: , Study Status: TERMINATED, Brief Summary: This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide., Study Results: NO, Conditions: Non-infectious Uveitis, Interventions: DRUG: Fluocinolone Acetonide 0.59mg|DRUG: Fluocinolone Acetonide 2.1mg, Primary Outcome Measures: Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye., 1 year pre-implantation; 3 years post-implantation, Secondary Outcome Measures: Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys., 1 year pre-implantation; 3 years post-implantation, Other Outcome Measures: , Sponsor: Bausch & Lomb Incorporated, Collaborators: , Sex: ALL, Age: CHILD, ADULT, OLDER_ADULT, Phases: PHASE2|PHASE3, Enrollment: 239.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT, Other IDs: 415-004, Start Date: 2002-05, Primary Completion Date: 2006-04, Completion Date: 2006-04, First Posted: 2007-04-05, Results First Posted: , Last Update Posted: 2011-12-08, Locations: , Study Documents: , criteria: "Inclusion Criteria:~* Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent,~* Non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study,~* Had clinically \\quiet\\ eyes at surgery.~Exclusion Criteria:~* Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.", combined_text: Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye., 1 year pre-implantation; 3 years post-implantation Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys., 1 year pre-implantation; 3 years post-implantation "Inclusion Criteria:~* Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent,~* Non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study,~* Had clinically \\quiet\\ eyes at surgery.~Exclusion Criteria:~* Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.", Similarity Score: 0.4707224256167573}'}]
|
from_dataset
| 0.470722
|
[{'from': 'human', 'value': '{Study Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis, Primary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population), 6 Months, Secondary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population), 36 Months, criteria: "Inclusion Criteria:~* Male or non pregnant female at least 18 years of age at time of consent~* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \\\\> 1 year duration~* At the time of enrollment (Day 1), study eye has \\\\< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.~* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart~* Subject is not planning to undergo elective ocular surgery during the study~* Subject has ability to understand and sign the Informed Consent Form~* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures~* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:~ * systemic corticosteroid or other systemic therapies given for at least 3 months, and/or~ * at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis~OR the study eye has experienced recurrence:~• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid~Exclusion Criteria:~* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert~* History of posterior uveitis only that is not accompanied by vitritis or macular edema~* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze~* Uveitis with infectious etiology~* Vitreous hemorrhage~* Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)~* Ocular malignancy in either eye, including choroidal melanoma~* Toxoplasmosis scar in study eye or scar related to previous viral retinitis~* Previous viral retinitis~* Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures~* Media opacity precluding evaluation of retina and vitreous~* Peripheral retinal detachment in area of insertion~* Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)~* IOP \\\\> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye~* Chronic hypotony (\\\\< 6 mmHg)~* Ocular surgery on the study eye within 3 months prior to study Day 1~* Capsulotomy in study eye within 30 days prior to study Day 1~* Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1~* Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1~* Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1~* Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1~* Subjects requiring chronic systemic or inhaled corticosteroid therapy (\\\\>15mg prednisone daily) or chronic systemic immunosuppressive therapy~* Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1~* Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis~* Systemic infection within 30 days prior to study Day 1~* Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Treatment with an investigational drug or device within 30 days prior to study Day 1~* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit~* Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 188, Unnamed: 0: 228, NCT Number: NCT05903794, Study Title: A Study of EXG102-031 in Patients With wAMD (Everest), Study URL: https://clinicaltrials.gov/study/NCT05903794, Acronym: , Study Status: RECRUITING, Brief Summary: In neovascular (wet) age-related macular degeneration (nAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with nAMD., Study Results: NO, Conditions: Neovascular (Wet) Age-related Macular Degeneration (nAMD), Interventions: BIOLOGICAL: EXG102-031, Primary Outcome Measures: Evaluation of safety and tolerability, Frequency, type, and intensity of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs), Throughout 52 weeks, Secondary Outcome Measures: Evaluation of potential efficacy, Change from baseline in best corrected visual acuity (BCVA) measured by ETDRS method, 52 weeks post administration|Evaluation of potential safety, Frequency, type, and intensity of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs), Through week 24|Evaluation of supplementary therapy injections received, Average number of doses of anti-vascular endothelial growth factor (VEGF) supplemental therapy received, Throughout 52 weeks post administration, Other Outcome Measures: , Sponsor: Exegenesis Bio, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 12.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: EXG102-031 (211), Start Date: 2023-07-24, Primary Completion Date: 2024-12-31, Completion Date: 2025-12-31, First Posted: 2023-06-15, Results First Posted: , Last Update Posted: 2024-09-19, Locations: Sierra Eye Associates, Reno, Nevada, 89502, United States|Erie Retina Research, Erie, Pennsylvania, 16507, United States, Study Documents: , criteria: "Inclusion Criteria:~1. Male or female, age ≥ 50 years of age;~2. Diagnosis of nAMD and current active lesion in the study eye at Screening;~3. An ETDRS BCVA letter scores between 73 and 19 letters in the study eye;~4. Response to anti-VEGF treatment during Screening;~5. The study eye must be a pseudophakic lens (post-cataract surgery status); and~6. Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening.~Exclusion Criteria:~1. Presence of any ocular disease or history of disease in the study eye other than nAMD that may affect central visual acuity and/or macular detection, including retinal detachment, or in the opinion of the investigator could limit VA improvement in the study eye;~2. Presence in the study eye of CNV or macular edema due to causes other than AMD;~3. Presence in the study eye of scarring, fibrosis or atrophy involving the macula;~4. Subretinal hemorrhage accumulating in the center of the macula of the test eye, with an area of hemorrhage ≥ 4 optic disc diameters;~5. Active ocular infection in either eye;~6. Presence of advanced glaucoma or uncontrolled glaucoma in the study eye;~7. History of intraocular surgery in the study eye within 90 days of screening; or~8. Prior receipt of any ocular or systemic gene therapy agent.", combined_text: A Study of EXG102-031 in Patients With wAMD (Everest) Evaluation of safety and tolerability, Frequency, type, and intensity of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs), Throughout 52 weeks Evaluation of potential efficacy, Change from baseline in best corrected visual acuity (BCVA) measured by ETDRS method, 52 weeks post administration|Evaluation of potential safety, Frequency, type, and intensity of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs), Through week 24|Evaluation of supplementary therapy injections received, Average number of doses of anti-vascular endothelial growth factor (VEGF) supplemental therapy received, Throughout 52 weeks post administration "Inclusion Criteria:~1. Male or female, age ≥ 50 years of age;~2. Diagnosis of nAMD and current active lesion in the study eye at Screening;~3. An ETDRS BCVA letter scores between 73 and 19 letters in the study eye;~4. Response to anti-VEGF treatment during Screening;~5. The study eye must be a pseudophakic lens (post-cataract surgery status); and~6. Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening.~Exclusion Criteria:~1. Presence of any ocular disease or history of disease in the study eye other than nAMD that may affect central visual acuity and/or macular detection, including retinal detachment, or in the opinion of the investigator could limit VA improvement in the study eye;~2. Presence in the study eye of CNV or macular edema due to causes other than AMD;~3. Presence in the study eye of scarring, fibrosis or atrophy involving the macula;~4. Subretinal hemorrhage accumulating in the center of the macula of the test eye, with an area of hemorrhage ≥ 4 optic disc diameters;~5. Active ocular infection in either eye;~6. Presence of advanced glaucoma or uncontrolled glaucoma in the study eye;~7. History of intraocular surgery in the study eye within 90 days of screening; or~8. Prior receipt of any ocular or systemic gene therapy agent.", Similarity Score: 0.45462217873766453}'}]
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from_dataset
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[{'from': 'human', 'value': '{Study Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis, Primary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population), 6 Months, Secondary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population), 36 Months, criteria: "Inclusion Criteria:~* Male or non pregnant female at least 18 years of age at time of consent~* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \\\\> 1 year duration~* At the time of enrollment (Day 1), study eye has \\\\< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.~* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart~* Subject is not planning to undergo elective ocular surgery during the study~* Subject has ability to understand and sign the Informed Consent Form~* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures~* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:~ * systemic corticosteroid or other systemic therapies given for at least 3 months, and/or~ * at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis~OR the study eye has experienced recurrence:~• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid~Exclusion Criteria:~* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert~* History of posterior uveitis only that is not accompanied by vitritis or macular edema~* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze~* Uveitis with infectious etiology~* Vitreous hemorrhage~* Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)~* Ocular malignancy in either eye, including choroidal melanoma~* Toxoplasmosis scar in study eye or scar related to previous viral retinitis~* Previous viral retinitis~* Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures~* Media opacity precluding evaluation of retina and vitreous~* Peripheral retinal detachment in area of insertion~* Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)~* IOP \\\\> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye~* Chronic hypotony (\\\\< 6 mmHg)~* Ocular surgery on the study eye within 3 months prior to study Day 1~* Capsulotomy in study eye within 30 days prior to study Day 1~* Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1~* Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1~* Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1~* Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1~* Subjects requiring chronic systemic or inhaled corticosteroid therapy (\\\\>15mg prednisone daily) or chronic systemic immunosuppressive therapy~* Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1~* Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis~* Systemic infection within 30 days prior to study Day 1~* Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Treatment with an investigational drug or device within 30 days prior to study Day 1~* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit~* Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 299, Unnamed: 0: 362, NCT Number: NCT05141994, Study Title: Clinical Study on the Efficacy and Safety of BAT5906 Injection, Study URL: https://clinicaltrials.gov/study/NCT05141994, Acronym: , Study Status: COMPLETED, Brief Summary: This study is a multi-center, open, and phase II clinical study to evaluate the efficacy and safety of BAT5906 injection in patients with wet age-related macular degeneration. The results of the BAT5906 Phase I study show that it is safe from 0.3-4.0 mg, and that higher doses (2.5 mg and 4 mg) may be substituted for the duration of maintenance efficacy; drugs with the same target (such as brolucizumab and Abecip) have also been found in clinical studies High doses can extend the interval and reduce the frequency of administration. Therefore, in this study, two doses with better safety and efficacy were selected, once every 4 weeks, followed by 3 consecutive injections for treatment as needed, and preliminary exploration of the best clinical effective dose and replacement frequency, Study Results: NO, Conditions: Wet Age-related Macular Degeneration, Interventions: DRUG: 2.5mg of BAT5906|DRUG: 4mg of BAT5906, Primary Outcome Measures: Dose-response relationships, Trend chart of changes in the best corrected visual acuity from baseline, week 24, Secondary Outcome Measures: BCVA, the best corrected visual acuity, week 12 ，week 48|CRT, The mean thickness of the central retina with a diameter of 1mm, centered on the fixed point of view, week 12 ，week 24，week 48|95% confidence interval, The estimated interval of the population parameters constructed from the sample statistics, week 12 ，week 24，week 48|Average times of administration, The times of administration of each dose group were summarized, week 24，week 48, Other Outcome Measures: Pharmacokinetic（Cmax）, Pharmacokinetic parameters, up tp week 48|Pharmacokinetic（Tmax）, Pharmacokinetic parameters, up tp week 48|Pharmacokinetic（AUC0-Tau）, Pharmacokinetic parameters, up tp week 48|Pharmacokinetic（AR）, Pharmacokinetic parameters, up tp week 48|Pharmacokinetic（DF）, Pharmacokinetic parameters, up tp week 48|Pharmacokinetic（t1/2）, Pharmacokinetic parameters, up tp week 48|Pharmacokinetic（Vz）, Pharmacokinetic parameters, up tp week 48|Pharmacokinetic（Vss）, Pharmacokinetic parameters, up tp week 48|Pharmacokinetic（CL）, Pharmacokinetic parameters, up tp week 48|VEGF, Peripheral vascular endothelial growth factor analysis, up tp week 48|ADA, Immunogenicity analysis, up tp week 48, Sponsor: Bio-Thera Solutions, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 48.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: BAT5906-002-CR, Start Date: 2020-08-26, Primary Completion Date: 2022-09-06, Completion Date: 2022-09-06, First Posted: 2021-12-02, Results First Posted: , Last Update Posted: 2024-04-16, Locations: "Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100730, China|Eye Hospital of China Academy of Chinese Medical Sciences, Beijing, China|Peking University First Hospital, Beijing, China|The First Affiliated Hospital of Bengbu Medical College, Bengbu, China|Zhejiang Provincial Peoples Hospital, Hangzhou, China|Jieyang Peoples Hospital, Jieyang, China|The First Hospital of Jilin University, Jilin, China|he Affiliated Eye Hospital of Nanchang University, Nanchang, China|Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, China|The Affiliated Hospital of Qingdao University, Qingdao, China|Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong, Shantou, China|West China Hospital of Sichuan University, Sichuan, China|Wenzhou Medical University Affiliated Optometry Hospital, Wenzhou, China|The Second Xiangya Hospital of Central South University, Xiangya, China|Henan Provincial Eye Hospital, Zhengzhou, China|The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China", Study Documents: , criteria: "Inclusion Criteria:~* Only the following criteria are met:~ 1. The patient or his legal representative authorized by the patient signs the informed consent, fully understands the test content, process and possible adverse reactions, and is willing to follow up within the time specified in the test;~ 2. Age 50-85 years old (including boundary value), male or female;~ 3. The patient diagnosed with active choroidal neovascularization (CNV) disease secondary to wet age-related macular degeneration is confirmed by the reading center during screening;~ 4. The total area of research eye lesions ≤ 30mm2 (12 optic disc areas), confirmed by the reading center before random enrollment;~ 5. At the time of screening and baseline, the BCVA of the study eye was 73-24 letters (using the ETDRS visual acuity table, including the boundary value) (equivalent to the snellen visual acuity score of the study eye of 20/40 to 20/400);~ 6. At the time of screening and baseline, the contralateral eye BCVA ≥ 34 letters (using the ETDRS visual acuity table, which is equivalent to snellen vision ≥ 20/200). For the subjects in the PK group, the investigator must judge that the contralateral eye is expected to be 3 No anti-VEGF treatment is required within a month.~Exclusion Criteria:~* If a patient meets any of the following conditions, they cannot enter the study:~Those with the following eye conditions:~1. The research eye has map-like atrophy involving the fovea, scars or fibrosis, anterior macular membrane, dense exudate hard exudation, RPE tear, etc. (confirmed by the reading center during screening);~2. Research eye retinal hemorrhage ≥ 4 optic disc areas (confirmed by the reading center during screening);~3. The research eye has significant interference with vision detection, anterior segment and fundus assessment of the refractive medium is turbid or the pupil is not dilated;~4. The research eye is combined with other fundus diseases (such as diabetic retinal degeneration, retinal vein occlusion, vascular streaking, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease, etc.);~5. The research eye has pupil afferent defects (APD)~6. There are uncontrolled glaucoma in the research eye at the time of screening and baseline, defined as the intraocular pressure is still higher than 21mmHg after drug treatment, or according to the investigator\\s judgment;~7. The pre-screening research eye had received dexamethasone intravitreal implant (Ozurdex) treatment or fluocinolone intravitreal implant (Iluvien) treatment;~8. Within 3 months before the screening, the research eye had received the following treatments: photodynamic therapy (PDT), total retina laser photocoagulation, macular laser photocoagulation, transpupillary thermotherapy, etc., for AMD therapy;~9. The research eye has undergone the following ophthalmic operations: vitrectomy, macular transposition, anti-glaucoma surgery;~10. Have undergone external eye surgery or cataract surgery within 3 months before the study eye screening or during the study period;~11. The study eye has no lens (excluding intraocular lens) or posterior lens capsule rupture (except YAG laser posterior capsulotomy after implantation of intraocular lens more than 1 month after screening);~12. Contralateral eye received photodynamic (PDT) treatment within 1 month before screening;~13. A history of uveitis in any eye;~14. Vitreous hemorrhage in any eye during the screening period or history of vitreous hemorrhage within 4 weeks before baseline;~15. Any eye has pseudocapsular exfoliation syndrome;~16. Any eye has active eye infection (eg: blepharitis, infectious conjunctivitis, keratitis, scleritis, iridocyclitis, endophthalmitis);~17. Within 3 months before the screening, any eye had received intravitreal injection of anti-VEGF drugs (such as abecept, compaq, ranibizumab, bevacizumab, etc.);~18. Injection of corticosteroid drugs (such as triamcinolone acetonide, dexamethasone, etc.) into any eye, periocular or subconjunctival eye within 3 months before screening;~ Those with any of the following general conditions:~19. Currently in use or may need to use systemic drugs that may cause crystal toxicity or retinal toxicity, such as deferoxamine, chloroquine/hydroxychloroquine, phenothiazine, ethambutol or tamoxifen, etc.;~20. Have an allergic reaction or history of fluorescein sodium and indocyanine green, have a history of allergy to protein products for treatment or diagnosis, or are known to have allergic reactions to any monoclonal antibody;~21. Previously received systemic anti-VEGF treatment;~22. Patients with large doses of oral or injectable corticosteroids and other hormonal drugs (\\\\>10 mg prednisolone or the same dose/day) within 6 months before screening, but patients who use steroid drugs for inhalation, nasal cavity or local skin small doses except;~23. Poorly controlled diabetic patients are defined as glycated hemoglobin\\\\> 10%;~24. Those who had surgery within 1 month before screening and did not heal, or according to the judgment of the investigator;~25. There are clinically significant systemic infectious diseases that require intravenous antibiotic therapy;~26. Those who have a history of myocardial infarction, cerebral infarction and angina within 6 months before screening;~27. Those who have active disseminated intravascular coagulation and obvious bleeding tendency within 3 months before screening, or have received anticoagulant and antiplatelet therapy except aspirin/NSAIDs within 14 days before screening;~28. Hypertension patients with poor control (defined as blood pressure \\\\>160/100 mmHg after treatment with antihypertensive drugs);~29. Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory and other system diseases and malignant tumors);~ Those with abnormalities in any of the following laboratory tests:~30. Abnormal liver and kidney function (this test stipulates that ALT and AST shall not be higher than the upper limit of the normal value of the laboratory in the center by 2.5 times; Crea and BUN shall not be higher than the upper limit of the normal value of the laboratory in the center by 2 times);~31. Patients with abnormal blood coagulation function (prothrombin time\\\\> upper limit of normal value 3 seconds or activated partial thromboplastin time\\\\> upper limit of normal value 10 seconds);~32. Any one of the following infected patients: active hepatitis B (if HBsAg(+) requires HBV DNA must be \\\\>500 IU/mL or the hospital maximum limit), hepatitis C, AIDS or syphilis (syphilis RPR positive test) ;~ Women and men of childbearing age in any of the following situations:~33. Women who are pregnant, pregnant or breastfeeding (pregnancy is defined as a positive blood/urine pregnancy test in this trial); male or female subjects of fertility do not agree to the entire study period and within 3 months after the end of the visit period Take appropriate contraceptive measures (such as IUDs, birth control pills or condoms, etc.). For women who have not been menopausal or have been menopausal but have not met the menopause time continuously for more than 12 months, and have not undergone sterilization surgery (ovarian and/or hysterectomy), they are defined as having fertility. The definition of fertility may be adjusted according to local standards in each region.~ Note: High-efficiency contraception methods include total abstinence, IUD, double barrier method (eg condom + diaphragm with spermicides, implanted contraceptives, hormonal contraceptives \\\\[contraceptives, implanted contraceptives, transdermal Patches, hormone-vaginal appliances or sustained-release injections\\\\], or the partner has undergone vasectomy and is confirmed to have no sperm); other:~34. Those who have participated in clinical trials of any drugs (excluding vitamins and minerals) within 3 months before screening;~35. The researchers believe that those who need to be excluded.", combined_text: Clinical Study on the Efficacy and Safety of BAT5906 Injection Dose-response relationships, Trend chart of changes in the best corrected visual acuity from baseline, week 24 BCVA, the best corrected visual acuity, week 12 ，week 48|CRT, The mean thickness of the central retina with a diameter of 1mm, centered on the fixed point of view, week 12 ，week 24，week 48|95% confidence interval, The estimated interval of the population parameters constructed from the sample statistics, week 12 ，week 24，week 48|Average times of administration, The times of administration of each dose group were summarized, week 24，week 48 "Inclusion Criteria:~* Only the following criteria are met:~ 1. The patient or his legal representative authorized by the patient signs the informed consent, fully understands the test content, process and possible adverse reactions, and is willing to follow up within the time specified in the test;~ 2. Age 50-85 years old (including boundary value), male or female;~ 3. The patient diagnosed with active choroidal neovascularization (CNV) disease secondary to wet age-related macular degeneration is confirmed by the reading center during screening;~ 4. The total area of research eye lesions ≤ 30mm2 (12 optic disc areas), confirmed by the reading center before random enrollment;~ 5. At the time of screening and baseline, the BCVA of the study eye was 73-24 letters (using the ETDRS visual acuity table, including the boundary value) (equivalent to the snellen visual acuity score of the study eye of 20/40 to 20/400);~ 6. At the time of screening and baseline, the contralateral eye BCVA ≥ 34 letters (using the ETDRS visual acuity table, which is equivalent to snellen vision ≥ 20/200). For the subjects in the PK group, the investigator must judge that the contralateral eye is expected to be 3 No anti-VEGF treatment is required within a month.~Exclusion Criteria:~* If a patient meets any of the following conditions, they cannot enter the study:~Those with the following eye conditions:~1. The research eye has map-like atrophy involving the fovea, scars or fibrosis, anterior macular membrane, dense exudate hard exudation, RPE tear, etc. (confirmed by the reading center during screening);~2. Research eye retinal hemorrhage ≥ 4 optic disc areas (confirmed by the reading center during screening);~3. The research eye has significant interference with vision detection, anterior segment and fundus assessment of the refractive medium is turbid or the pupil is not dilated;~4. The research eye is combined with other fundus diseases (such as diabetic retinal degeneration, retinal vein occlusion, vascular streaking, pathological myopia, retinal detachment, macular hole, toxoplasmosis, optic nerve disease, etc.);~5. The research eye has pupil afferent defects (APD)~6. There are uncontrolled glaucoma in the research eye at the time of screening and baseline, defined as the intraocular pressure is still higher than 21mmHg after drug treatment, or according to the investigator\\s judgment;~7. The pre-screening research eye had received dexamethasone intravitreal implant (Ozurdex) treatment or fluocinolone intravitreal implant (Iluvien) treatment;~8. Within 3 months before the screening, the research eye had received the following treatments: photodynamic therapy (PDT), total retina laser photocoagulation, macular laser photocoagulation, transpupillary thermotherapy, etc., for AMD therapy;~9. The research eye has undergone the following ophthalmic operations: vitrectomy, macular transposition, anti-glaucoma surgery;~10. Have undergone external eye surgery or cataract surgery within 3 months before the study eye screening or during the study period;~11. The study eye has no lens (excluding intraocular lens) or posterior lens capsule rupture (except YAG laser posterior capsulotomy after implantation of intraocular lens more than 1 month after screening);~12. Contralateral eye received photodynamic (PDT) treatment within 1 month before screening;~13. A history of uveitis in any eye;~14. Vitreous hemorrhage in any eye during the screening period or history of vitreous hemorrhage within 4 weeks before baseline;~15. Any eye has pseudocapsular exfoliation syndrome;~16. Any eye has active eye infection (eg: blepharitis, infectious conjunctivitis, keratitis, scleritis, iridocyclitis, endophthalmitis);~17. Within 3 months before the screening, any eye had received intravitreal injection of anti-VEGF drugs (such as abecept, compaq, ranibizumab, bevacizumab, etc.);~18. Injection of corticosteroid drugs (such as triamcinolone acetonide, dexamethasone, etc.) into any eye, periocular or subconjunctival eye within 3 months before screening;~ Those with any of the following general conditions:~19. Currently in use or may need to use systemic drugs that may cause crystal toxicity or retinal toxicity, such as deferoxamine, chloroquine/hydroxychloroquine, phenothiazine, ethambutol or tamoxifen, etc.;~20. Have an allergic reaction or history of fluorescein sodium and indocyanine green, have a history of allergy to protein products for treatment or diagnosis, or are known to have allergic reactions to any monoclonal antibody;~21. Previously received systemic anti-VEGF treatment;~22. Patients with large doses of oral or injectable corticosteroids and other hormonal drugs (\\\\>10 mg prednisolone or the same dose/day) within 6 months before screening, but patients who use steroid drugs for inhalation, nasal cavity or local skin small doses except;~23. Poorly controlled diabetic patients are defined as glycated hemoglobin\\\\> 10%;~24. Those who had surgery within 1 month before screening and did not heal, or according to the judgment of the investigator;~25. There are clinically significant systemic infectious diseases that require intravenous antibiotic therapy;~26. Those who have a history of myocardial infarction, cerebral infarction and angina within 6 months before screening;~27. Those who have active disseminated intravascular coagulation and obvious bleeding tendency within 3 months before screening, or have received anticoagulant and antiplatelet therapy except aspirin/NSAIDs within 14 days before screening;~28. Hypertension patients with poor control (defined as blood pressure \\\\>160/100 mmHg after treatment with antihypertensive drugs);~29. Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory and other system diseases and malignant tumors);~ Those with abnormalities in any of the following laboratory tests:~30. Abnormal liver and kidney function (this test stipulates that ALT and AST shall not be higher than the upper limit of the normal value of the laboratory in the center by 2.5 times; Crea and BUN shall not be higher than the upper limit of the normal value of the laboratory in the center by 2 times);~31. Patients with abnormal blood coagulation function (prothrombin time\\\\> upper limit of normal value 3 seconds or activated partial thromboplastin time\\\\> upper limit of normal value 10 seconds);~32. Any one of the following infected patients: active hepatitis B (if HBsAg(+) requires HBV DNA must be \\\\>500 IU/mL or the hospital maximum limit), hepatitis C, AIDS or syphilis (syphilis RPR positive test) ;~ Women and men of childbearing age in any of the following situations:~33. Women who are pregnant, pregnant or breastfeeding (pregnancy is defined as a positive blood/urine pregnancy test in this trial); male or female subjects of fertility do not agree to the entire study period and within 3 months after the end of the visit period Take appropriate contraceptive measures (such as IUDs, birth control pills or condoms, etc.). For women who have not been menopausal or have been menopausal but have not met the menopause time continuously for more than 12 months, and have not undergone sterilization surgery (ovarian and/or hysterectomy), they are defined as having fertility. The definition of fertility may be adjusted according to local standards in each region.~ Note: High-efficiency contraception methods include total abstinence, IUD, double barrier method (eg condom + diaphragm with spermicides, implanted contraceptives, hormonal contraceptives \\\\[contraceptives, implanted contraceptives, transdermal Patches, hormone-vaginal appliances or sustained-release injections\\\\], or the partner has undergone vasectomy and is confirmed to have no sperm); other:~34. Those who have participated in clinical trials of any drugs (excluding vitamins and minerals) within 3 months before screening;~35. The researchers believe that those who need to be excluded.", Similarity Score: 0.442780744630444}'}]
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from_dataset
| 0.442781
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[{'from': 'human', 'value': '{Study Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis, Primary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population), 6 Months, Secondary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population), 36 Months, criteria: "Inclusion Criteria:~* Male or non pregnant female at least 18 years of age at time of consent~* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \\\\> 1 year duration~* At the time of enrollment (Day 1), study eye has \\\\< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.~* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart~* Subject is not planning to undergo elective ocular surgery during the study~* Subject has ability to understand and sign the Informed Consent Form~* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures~* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:~ * systemic corticosteroid or other systemic therapies given for at least 3 months, and/or~ * at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis~OR the study eye has experienced recurrence:~• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid~Exclusion Criteria:~* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert~* History of posterior uveitis only that is not accompanied by vitritis or macular edema~* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze~* Uveitis with infectious etiology~* Vitreous hemorrhage~* Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)~* Ocular malignancy in either eye, including choroidal melanoma~* Toxoplasmosis scar in study eye or scar related to previous viral retinitis~* Previous viral retinitis~* Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures~* Media opacity precluding evaluation of retina and vitreous~* Peripheral retinal detachment in area of insertion~* Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)~* IOP \\\\> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye~* Chronic hypotony (\\\\< 6 mmHg)~* Ocular surgery on the study eye within 3 months prior to study Day 1~* Capsulotomy in study eye within 30 days prior to study Day 1~* Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1~* Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1~* Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1~* Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1~* Subjects requiring chronic systemic or inhaled corticosteroid therapy (\\\\>15mg prednisone daily) or chronic systemic immunosuppressive therapy~* Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1~* Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis~* Systemic infection within 30 days prior to study Day 1~* Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Treatment with an investigational drug or device within 30 days prior to study Day 1~* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit~* Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 967, Unnamed: 0: 1204, NCT Number: NCT05984927, Study Title: NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration, Study URL: https://clinicaltrials.gov/study/NCT05984927, Acronym: , Study Status: RECRUITING, Brief Summary: This study will evaluate the safety, tolerability, and preliminary efficacy of NG101 AAV gene therapy administered by subretinal injections into a single selected eye as a single selected dose for patients with wet age-related macular degeneration (wAMD)., Study Results: NO, Conditions: Age-Related Macular Degeneration, Interventions: GENETIC: NG101 AAV gene therapy, Primary Outcome Measures: Adverse Events, Incidence and severity of ocular and non-ocular adverse events (AEs) for each cohort, From Day 0 (pre-treatment) through Week 24, Secondary Outcome Measures: Ocular and Non -Ocular Adverse Events after week 24, Incidence and severity of ocular and non-ocular AEs from Day 0 (pre-treatment) through Weeks 52 and Week 260 for each cohort, From Day 0 (pre-treatment) and through Weeks 52, 104, 156, 208 and 260|Systemic Immunogenic Response, Change in concentration of Anti-NG101 Transgene protein antibodies, Anti-AAV8 Neutralizing antibodies, and Anti-AAV8 Antibodies in serum samples, From Day -14 to Weeks 4, 8, 12, 24, 52, and 104|Systemic Immunogenic Response, Change in concentration of expressed aflibercept protein in serum samples, From Day -14 to Weeks 4, 12, and 104|Systemic Immunogenic Response, Change in AAV vector (NG101) genome copies as measured by qPCR in blood samples, From Day -14 to Day 7, and Weeks 2, 4, and week 12.|Systemic Immunogenic Response, Change in concentration of expressed aflibercept protein in vitreous samples, From Day 0 (pre-treatment) to Weeks 12, 24, 52, and 104|Signs of CNV Activity, Change of 1 or more signs of CNV activity assessed by Optical coherence tomography, From Day -7 to Weeks 8, 24, 52, and 104|Central Subfield Thickness (CST), Change in CST assessed with OCT, From Day -7 to Weeks 24, 52, 104, 156, 208, and 260|Best Corrected Visual Acuity (BCVA), Change in BCVA assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) scale, From Day -7 to Weeks 24, 52, 104, 156, 208 and 260|Cumulative Number of Rescue Therapy Injections, The cumulative number of rescue therapy injections per subject to maintain CNV control, From Week 24 to Weeks 52, 104, 156, 208, and 260, Other Outcome Measures: , Sponsor: Neuracle Genetics, Inc, Collaborators: ORA, Inc., Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1|PHASE2, Enrollment: 18.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: NG101WA-01, Start Date: 2023-09-08, Primary Completion Date: 2025-01, Completion Date: 2030-01, First Posted: 2023-08-09, Results First Posted: , Last Update Posted: 2024-10-23, Locations: Cincinnati Eye Institute, Cincinnati, Ohio, 45242, United States|Vancouver Coastal Health Research Institute, Vancouver, British Columbia, V5Z 3N9, Canada|Sunnybrook Ophthalmology and Vision Services, Toronto, Ontario, M4N 3M5, Canada|Vitreous Retina Macula Specialists of Toronto, Toronto, Ontario, M8X 2X3, Canada, Study Documents: , criteria: "Inclusion Criteria:~1. Subjects ≥ 50 and ≤ 89 years of age with a diagnosis of active subfoveal CNV secondary to wAMD in the Study Eye~2. BCVA between 20/63 and 20/400 in the Study Eye, with BCVA decrement primarily attributable to wAMD~3. Administration of at least 3 anti-VEGF injections in potential study eye in the past 6 months, the most recent of which was within 2 months prior to Screening.~4. Must be pseudo phakic (status post cataract surgery) in the Study Eye~5. Female subjects must be either: (1) of non-childbearing potential; or (2) of childbearing potential and using an acceptable method of birth control with a negative pregnancy test. Male subjects agree to refrain from sperm donations and practice contraception to avoid any pregnancy for 3 months after.~6. Normal blood pressure (BP) and heart rate (HR), or near normal BP and HR not considered clinically significant (NCS) by the Investigator at the Screening Visits (Day -30 to Day -8 and Day -7) after 10 minutes resting in supine or sitting position~7. Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to the performance of any study-related procedures~8. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations~Exclusion Criteria:~1. CNV or macular edema in the Study Eye secondary to any causes other than AMD~2. Any condition preventing visual acuity improvement in the Study Eye, e.g., fibrosis, atrophy, or retinal pigment epithelial tear in the center of the macula~3. Any ophthalmic condition that precludes adequate ophthalmic examination or requires treatment~4. Retinal detachment or history of retinal detachment in the Study Eye~5. Active uncontrolled glaucoma with intraocular pressure (IOP) ≥ 30 mmHg despite treatment with more than 2 glaucoma medications, advanced glaucoma with cup-to-disc ratio of ≥ 0.9, visual field defects secondary to glaucoma that involve the macula, and/or optic atrophy from glaucoma~6. History of intravitreal therapy in the Study Eye, such as intravitreal steroid injection or an investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening~7. History of vitrectomy, trabeculectomy, glaucoma tube-shunt procedure, minimally invasive glaucoma surgery (MIGS) device, or other filtration surgery in the Study Eye~8. Any prior treatment with photodynamic therapy or retinal laser for the treatment of wAMD~9. Any prior therapeutic radiation in the region of the Study Eye such as whole brain radiation, proton beam radiation, gamma knife treatment, or plaque brachytherapy~10. Any previous intraocular or refractive surgery on the Study Eye within 6 months~11. Any previous gene therapy in the Study Eye~12. Presence of an ocular implant in the Study Eye at Screening, excluding intraocular lens and custom flex iris prosthesis~13. Any diabetic retinopathy or other retinal vascular disease including retinal vein occlusion, retinal artery occlusion, retinal arterial macro aneurysm, ocular ischemic syndrome, retinal vasculitis, vitritis, posterior uveitis~14. Any medically uncontrolled diabetes, defined as HbA1C \\\\> 8.0~15. History of ocular melanoma~16. History of any known inherited retinal disease~17. Currently taking any anticoagulant therapy, which is deemed medically necessary and cannot be permanently stopped at least 2 weeks prior to NG101 injection, excluding prophylactic low-dose aspirin therapy~18. Any underlying systemic diseases as unstable or severe cardiovascular, cerebrovascular, dementia or neurodegenerative diseases of a level that prevents adequate evaluation of the subject during the study, active malignancy or currently undergoing treatment for active malignancy at Screening or a history of malignancy that precludes completion of this 260 week study, and immunocompromised conditions and/or need for immunosuppressive therapy.~19. Active hepatitis B or C~20. History of human immunodeficiency virus (HIV), active tuberculosis, and/or syphilis~21. Any significant illness that would preclude study compliance and follow-up~22. Subjects who, in the Investigator\\s opinion, lack the mental capacity to provide written informed consent for study participation", combined_text: NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration Adverse Events, Incidence and severity of ocular and non-ocular adverse events (AEs) for each cohort, From Day 0 (pre-treatment) through Week 24 Ocular and Non -Ocular Adverse Events after week 24, Incidence and severity of ocular and non-ocular AEs from Day 0 (pre-treatment) through Weeks 52 and Week 260 for each cohort, From Day 0 (pre-treatment) and through Weeks 52, 104, 156, 208 and 260|Systemic Immunogenic Response, Change in concentration of Anti-NG101 Transgene protein antibodies, Anti-AAV8 Neutralizing antibodies, and Anti-AAV8 Antibodies in serum samples, From Day -14 to Weeks 4, 8, 12, 24, 52, and 104|Systemic Immunogenic Response, Change in concentration of expressed aflibercept protein in serum samples, From Day -14 to Weeks 4, 12, and 104|Systemic Immunogenic Response, Change in AAV vector (NG101) genome copies as measured by qPCR in blood samples, From Day -14 to Day 7, and Weeks 2, 4, and week 12.|Systemic Immunogenic Response, Change in concentration of expressed aflibercept protein in vitreous samples, From Day 0 (pre-treatment) to Weeks 12, 24, 52, and 104|Signs of CNV Activity, Change of 1 or more signs of CNV activity assessed by Optical coherence tomography, From Day -7 to Weeks 8, 24, 52, and 104|Central Subfield Thickness (CST), Change in CST assessed with OCT, From Day -7 to Weeks 24, 52, 104, 156, 208, and 260|Best Corrected Visual Acuity (BCVA), Change in BCVA assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) scale, From Day -7 to Weeks 24, 52, 104, 156, 208 and 260|Cumulative Number of Rescue Therapy Injections, The cumulative number of rescue therapy injections per subject to maintain CNV control, From Week 24 to Weeks 52, 104, 156, 208, and 260 "Inclusion Criteria:~1. Subjects ≥ 50 and ≤ 89 years of age with a diagnosis of active subfoveal CNV secondary to wAMD in the Study Eye~2. BCVA between 20/63 and 20/400 in the Study Eye, with BCVA decrement primarily attributable to wAMD~3. Administration of at least 3 anti-VEGF injections in potential study eye in the past 6 months, the most recent of which was within 2 months prior to Screening.~4. Must be pseudo phakic (status post cataract surgery) in the Study Eye~5. Female subjects must be either: (1) of non-childbearing potential; or (2) of childbearing potential and using an acceptable method of birth control with a negative pregnancy test. Male subjects agree to refrain from sperm donations and practice contraception to avoid any pregnancy for 3 months after.~6. Normal blood pressure (BP) and heart rate (HR), or near normal BP and HR not considered clinically significant (NCS) by the Investigator at the Screening Visits (Day -30 to Day -8 and Day -7) after 10 minutes resting in supine or sitting position~7. Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to the performance of any study-related procedures~8. Willingness and ability to comply with schedule for follow-up visits and postoperative evaluations~Exclusion Criteria:~1. CNV or macular edema in the Study Eye secondary to any causes other than AMD~2. Any condition preventing visual acuity improvement in the Study Eye, e.g., fibrosis, atrophy, or retinal pigment epithelial tear in the center of the macula~3. Any ophthalmic condition that precludes adequate ophthalmic examination or requires treatment~4. Retinal detachment or history of retinal detachment in the Study Eye~5. Active uncontrolled glaucoma with intraocular pressure (IOP) ≥ 30 mmHg despite treatment with more than 2 glaucoma medications, advanced glaucoma with cup-to-disc ratio of ≥ 0.9, visual field defects secondary to glaucoma that involve the macula, and/or optic atrophy from glaucoma~6. History of intravitreal therapy in the Study Eye, such as intravitreal steroid injection or an investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening~7. History of vitrectomy, trabeculectomy, glaucoma tube-shunt procedure, minimally invasive glaucoma surgery (MIGS) device, or other filtration surgery in the Study Eye~8. Any prior treatment with photodynamic therapy or retinal laser for the treatment of wAMD~9. Any prior therapeutic radiation in the region of the Study Eye such as whole brain radiation, proton beam radiation, gamma knife treatment, or plaque brachytherapy~10. Any previous intraocular or refractive surgery on the Study Eye within 6 months~11. Any previous gene therapy in the Study Eye~12. Presence of an ocular implant in the Study Eye at Screening, excluding intraocular lens and custom flex iris prosthesis~13. Any diabetic retinopathy or other retinal vascular disease including retinal vein occlusion, retinal artery occlusion, retinal arterial macro aneurysm, ocular ischemic syndrome, retinal vasculitis, vitritis, posterior uveitis~14. Any medically uncontrolled diabetes, defined as HbA1C \\\\> 8.0~15. History of ocular melanoma~16. History of any known inherited retinal disease~17. Currently taking any anticoagulant therapy, which is deemed medically necessary and cannot be permanently stopped at least 2 weeks prior to NG101 injection, excluding prophylactic low-dose aspirin therapy~18. Any underlying systemic diseases as unstable or severe cardiovascular, cerebrovascular, dementia or neurodegenerative diseases of a level that prevents adequate evaluation of the subject during the study, active malignancy or currently undergoing treatment for active malignancy at Screening or a history of malignancy that precludes completion of this 260 week study, and immunocompromised conditions and/or need for immunosuppressive therapy.~19. Active hepatitis B or C~20. History of human immunodeficiency virus (HIV), active tuberculosis, and/or syphilis~21. Any significant illness that would preclude study compliance and follow-up~22. Subjects who, in the Investigator\\s opinion, lack the mental capacity to provide written informed consent for study participation", Similarity Score: 0.38556725196656494}'}]
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from_dataset
| 0.385567
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[{'from': 'human', 'value': '{Study Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis, Primary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population), 6 Months, Secondary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population), 36 Months, criteria: "Inclusion Criteria:~* Male or non pregnant female at least 18 years of age at time of consent~* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \\\\> 1 year duration~* At the time of enrollment (Day 1), study eye has \\\\< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.~* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart~* Subject is not planning to undergo elective ocular surgery during the study~* Subject has ability to understand and sign the Informed Consent Form~* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures~* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:~ * systemic corticosteroid or other systemic therapies given for at least 3 months, and/or~ * at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis~OR the study eye has experienced recurrence:~• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid~Exclusion Criteria:~* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert~* History of posterior uveitis only that is not accompanied by vitritis or macular edema~* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze~* Uveitis with infectious etiology~* Vitreous hemorrhage~* Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)~* Ocular malignancy in either eye, including choroidal melanoma~* Toxoplasmosis scar in study eye or scar related to previous viral retinitis~* Previous viral retinitis~* Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures~* Media opacity precluding evaluation of retina and vitreous~* Peripheral retinal detachment in area of insertion~* Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)~* IOP \\\\> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye~* Chronic hypotony (\\\\< 6 mmHg)~* Ocular surgery on the study eye within 3 months prior to study Day 1~* Capsulotomy in study eye within 30 days prior to study Day 1~* Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1~* Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1~* Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1~* Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1~* Subjects requiring chronic systemic or inhaled corticosteroid therapy (\\\\>15mg prednisone daily) or chronic systemic immunosuppressive therapy~* Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1~* Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis~* Systemic infection within 30 days prior to study Day 1~* Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Treatment with an investigational drug or device within 30 days prior to study Day 1~* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit~* Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 727, Unnamed: 0: 910, NCT Number: NCT00818844, Study Title: Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery, Study URL: https://clinicaltrials.gov/study/NCT00818844, Acronym: , Study Status: COMPLETED, Brief Summary: The purpose of this study is to compare the macular volume of patients treated with a 3-month course of topical Nepafenac (0.1% solution) to patients treated with a placebo course following epiretinal membrane surgery., Study Results: NO, Conditions: Epiretinal Membrane, Interventions: DRUG: Nepafenac 0.1%|OTHER: BSS, Primary Outcome Measures: Macular thickness, Macular thickness as measured by SD-OCT, 12 weeks post operative, Secondary Outcome Measures: Visual Acuity, 3 months, Other Outcome Measures: , Sponsor: Alcon Research, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE4, Enrollment: 40.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION, Other IDs: SMA-08-10, Start Date: 2009-01, Primary Completion Date: 2010-06, Completion Date: 2010-06, First Posted: 2009-01-08, Results First Posted: , Last Update Posted: 2015-08-14, Locations: Dan Miller, Cincinnati, Ohio, 45242, United States, Study Documents: , criteria: "Inclusion Criteria:~* 18 year of age or older, of any race and either sex.~* Able to understand and sign an informed consent that has been approved by an Institutional Review Board.~* Must agree to comply with study visit schedule and other study requirements.~* Must have vision loss associated with idiopathic epiretinal membrane and secondary retinal edema.~* Must have pre-operative central foveal thickness greater than 300 microns.~* Prior cataract surgery must be at least 6 months postoperative.~ * Other protocol-defined inclusion criteria may apply.~Exclusion Criteria:~* Vision loss associated with maculopathies other than idiopathic epiretinal membrane and secondary retinal edema (e.g. branch retinal vein occlusion, central retinal vein occlusion, wet macular degeneration, diabetic retinopathy, posterior uveitis).~* Dry macular degeneration (drusen) with central geographic atrophy.~* Concomitant cataract surgery performed at the time of study vitrectomy.~* Prior vitrectomy surgery in the study eye(s).~* Prior macula laser treatment in the study eye(s).~* Prior periocular steroid injections in the study eye(s) within preceding 6 months.~* Prior cataract surgery in the study eye(s) within the last 6 months.~* Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.~* Use of topical ocular medications during the study period.~* Antibiotics (systemic or topical) outside of study protocol may not be used within 7 days of preoperative/baseline visit or anytime after this visit for the duration of the study.~* Women of childbearing potential not using reliable means of birth control.~* Women who are pregnant or lactating.~* Enrollment of more than one person per household at the same time.~* Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator\\s staff, or individuals living in the households of these individuals.~* Participation in any investigational drug or device study within 30 days of entering this study. Note: Patients may have both eyes enrolled in this study provided that 2nd eye enrollment takes place 30 days after completion of the first eye. Second eye will receive the same study treatment as first eye.~ * Other protocol-defined exclusion criteria may apply.", combined_text: Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery Macular thickness, Macular thickness as measured by SD-OCT, 12 weeks post operative Visual Acuity, 3 months "Inclusion Criteria:~* 18 year of age or older, of any race and either sex.~* Able to understand and sign an informed consent that has been approved by an Institutional Review Board.~* Must agree to comply with study visit schedule and other study requirements.~* Must have vision loss associated with idiopathic epiretinal membrane and secondary retinal edema.~* Must have pre-operative central foveal thickness greater than 300 microns.~* Prior cataract surgery must be at least 6 months postoperative.~ * Other protocol-defined inclusion criteria may apply.~Exclusion Criteria:~* Vision loss associated with maculopathies other than idiopathic epiretinal membrane and secondary retinal edema (e.g. branch retinal vein occlusion, central retinal vein occlusion, wet macular degeneration, diabetic retinopathy, posterior uveitis).~* Dry macular degeneration (drusen) with central geographic atrophy.~* Concomitant cataract surgery performed at the time of study vitrectomy.~* Prior vitrectomy surgery in the study eye(s).~* Prior macula laser treatment in the study eye(s).~* Prior periocular steroid injections in the study eye(s) within preceding 6 months.~* Prior cataract surgery in the study eye(s) within the last 6 months.~* Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.~* Use of topical ocular medications during the study period.~* Antibiotics (systemic or topical) outside of study protocol may not be used within 7 days of preoperative/baseline visit or anytime after this visit for the duration of the study.~* Women of childbearing potential not using reliable means of birth control.~* Women who are pregnant or lactating.~* Enrollment of more than one person per household at the same time.~* Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator\\s staff, or individuals living in the households of these individuals.~* Participation in any investigational drug or device study within 30 days of entering this study. Note: Patients may have both eyes enrolled in this study provided that 2nd eye enrollment takes place 30 days after completion of the first eye. Second eye will receive the same study treatment as first eye.~ * Other protocol-defined exclusion criteria may apply.", Similarity Score: 0.37432654187527237}'}]
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from_dataset
| 0.374327
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[{'from': 'human', 'value': '{Study Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis, Primary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population), 6 Months, Secondary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population), 36 Months, criteria: "Inclusion Criteria:~* Male or non pregnant female at least 18 years of age at time of consent~* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \\\\> 1 year duration~* At the time of enrollment (Day 1), study eye has \\\\< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.~* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart~* Subject is not planning to undergo elective ocular surgery during the study~* Subject has ability to understand and sign the Informed Consent Form~* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures~* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:~ * systemic corticosteroid or other systemic therapies given for at least 3 months, and/or~ * at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis~OR the study eye has experienced recurrence:~• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid~Exclusion Criteria:~* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert~* History of posterior uveitis only that is not accompanied by vitritis or macular edema~* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze~* Uveitis with infectious etiology~* Vitreous hemorrhage~* Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)~* Ocular malignancy in either eye, including choroidal melanoma~* Toxoplasmosis scar in study eye or scar related to previous viral retinitis~* Previous viral retinitis~* Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures~* Media opacity precluding evaluation of retina and vitreous~* Peripheral retinal detachment in area of insertion~* Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)~* IOP \\\\> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye~* Chronic hypotony (\\\\< 6 mmHg)~* Ocular surgery on the study eye within 3 months prior to study Day 1~* Capsulotomy in study eye within 30 days prior to study Day 1~* Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1~* Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1~* Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1~* Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1~* Subjects requiring chronic systemic or inhaled corticosteroid therapy (\\\\>15mg prednisone daily) or chronic systemic immunosuppressive therapy~* Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1~* Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis~* Systemic infection within 30 days prior to study Day 1~* Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Treatment with an investigational drug or device within 30 days prior to study Day 1~* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit~* Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 937, Unnamed: 0: 1172, NCT Number: NCT06470373, Study Title: A Phase 3 Clinical Trial to Compare RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration, Study URL: https://clinicaltrials.gov/study/NCT06470373, Acronym: , Study Status: NOT_YET_RECRUITING, Brief Summary: This clinical study is designed to demonstrate the equivalence of the two Investigational Products by comparing the efficacy, safety, tolerability and immunogenicity of RBS-001 and Eylea® in subjects with Neovascular age-related macular degeneration., Study Results: NO, Conditions: Neovascular Age-related Macular Degeneration (nAMD), Interventions: DRUG: RBS-001 Solution for intravitreal injection|DRUG: Eylea® Solution for intravitreal injection, Primary Outcome Measures: Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 8 weeks after the IP treatment, The change from baseline (Day 1) to 8 weeks after the IP treatment, Secondary Outcome Measures: Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 4, 8, 12, 16, 20, and 24 weeks after the IP treatment, The change from baseline (Day 1) to 4, 8, 12, 16, 20, and 24 weeks after the IP treatment, Other Outcome Measures: , Sponsor: Rophibio, Inc., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE3, Enrollment: 434.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT, Other IDs: PD-CP-Y1, Start Date: 2024-09, Primary Completion Date: 2026-09, Completion Date: 2026-09, First Posted: 2024-06-24, Results First Posted: , Last Update Posted: 2024-06-24, Locations: Associated Retina Consultants - Phoenix, Phoenix, Arizona, 85021, United States|Associated Retina Consultants - Gilbert, Phoenix, Arizona, 85297, United States|Retina Partners of Northwest Arkansas, PLLC, Springdale, Arkansas, 72764, United States|Erie Retina Research, Erie, Pennsylvania, 16507, United States|Charles Retina Institute, Germantown, Tennessee, 38138, United States|Retina Research Institute of Texas, Abilene, Texas, 79606, United States|Strategic Clinical Research Group, LLC, Willow Park, Texas, 76087, United States, Study Documents: , criteria: "Inclusion Criteria:~1. Age ≥ 50 years at screening~2. Individuals with active CNV lesion secondary to AMD in the study eye, proven by fluorescein angiography (FA) and confirmed by the central reading center during the screening period~3. Individuals with CNV area in the study eye accounting for ≥ 50% of the total lesion, including macular hemorrhage, scar, atrophy, fibrosis and neovascularization, proven by FA and confirmed by the central reading center during the screening period~4. Individuals with intraretinal or subretinal fluid in the study eye due to active CNV, proven by optical coherence tomography (OCT) and confirmed by the central reading center during the screening period~5. Individuals with BCVA of 34 to 73 letters measured by ETDRS letter score at the screening and baseline visits in the study eye~6. Individuals who voluntarily decide to participate in the clinical study after being fully informed of the details of the clinical study and who provide written consent to comply with the study instructions during the clinical study~Exclusion Criteria:~1. Individuals whose study eye lesion meets any of the following criteria~ * Total lesion\\\\* size - \\\\> 23 mm2 \\\\[9 disc areas (DAs)\\\\] (Must be proven by FA)~ * Subretinal hemorrhage (or subfoveal hemorrhage) - ≥ 50% of the total lesion\\\\* \\\\[≥ 1 DA (In the case of subfoveal hemorrhage, fovea must be surrounded 270 degrees by visible CNV.)\\\\]~ * Scar or fibrosis - ≥ 50% of the total lesion\\\\* or Scar, fibrosis, or atrophy involving the center of the fovea~ * Retinal pigment epithelial tears or rips - Macular involvement~ * Macular hole - At any stage, if present in the study eye~ * Other causes of CNV - Ocular histoplasmosis syndrome, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, pathologic myopia (spherical equivalent of negative 8 diopters or more or axial length of 25 mm or more), etc.~2. Individuals with any of the following concurrent diseases at screening or for a specified period of time~ i. Concurrent ocular disease ii. Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg (despite adequate treatment) iii. Uncontrolled diabetes mellitus, at the investigator\\s discretion iv. Congestive heart failure with New York Heart Association (NYHA) functional classification 3 or 4 or any clinically significant heart disease including ventricular arrhythmia and atrial fibrillation, at the investigator\\s discretion v. Active systemic infection undergoing treatment or recurrent clinically significant infections within 4 weeks prior to the first dose of the IP~3. Individuals with any medical history of the following at screening:~ i. Other ophthalmic disease in the study eye that may affect safety/efficacy assessments in the subject or may require medical/surgical interventions during the clinical study at the investigator\\s discretion (e.g., vitreomacular traction, glaucoma undergoing treatment, retinal detachment, corneal dystrophy, etc.) ii. Diabetic retinopathy (DR)\\\\*, diabetic macular edema (DME), retinal vein occlusion (RVO), uveitis, or other vascular disease affecting the retina (other than nAMD) in either eye \\\\*Mild non-proliferative DR will be permitted.~ iii. Stroke, transient ischemic attack, pulmonary embolism, deep venous thrombosis or myocardial infarction within the past 24 weeks iv. Hypersensitivity reactions to aflibercept or other drugs to be used in the clinical study (fluorescein, mydriatic drops, etc.) v. Malignancy within the last 5 years (however, individuals with basal cell, cutaneous squamous cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma who are in stable long-term follow-up without therapeutic medication, procedures, or surgery can participate in this clinical trial) vi. Organ or bone marrow transplantation~4. Individuals with a history of any of the following medication or non-pharmacological treatment for the study eye i. Glaucoma filtering surgery, vitrectomy or corneal transplantation ii. Simple intraocular or periocular surgery (e.g., cataract surgery, simple neodymium yttrium aluminum garnet (Nd:YAG) laser capsulotomy on a pseudophakic eye due to posterior capsular opacification, etc.) within 12 weeks or eyelid surgery within 4 weeks prior to the screening visit \\\\[Laser iridotomy will be permitted.\\\\] iii. Macular photodynamic therapy (PDT) with verteporfin, transpupillary thermotherapy, radiotherapy or retinal laser treatment (e.g., focal laser photocoagulation, pan-retinal photocoagulation, etc.) iv. Periocular radiotherapy v. Any anti-VEGF treatment for nAMD (including participation in other clinical studies) vi. Treatment for retinal detachment (medication or non-pharmacological treatment) vii. IVT corticosteroid injection, sub-tenon or periocular corticosteroid injection within 24 weeks or IVT corticosteroid implantation within 36 months prior to the screening visit~5. Individuals with any of the following medication or non-pharmacological treatment history:~ i. Systemic anti-VEGF therapy within 12 weeks prior to the first dose of the IP ii. Any anti-VEGF treatment of nAMD in the fellow eye within 8 weeks prior to the first dose of the IP iii. Current use at screening of medications known to be toxic to the lens, retina, or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, ethambutol.~ iv. Systemic corticosteroids administered within 12 weeks prior to the first dose of the IP (prednisolone ≤ 10 mg/day and equivalent dose administered for 14 days or less or inhaled/intranasal/dermal agents will be permitted.) v. Other IP within 12 weeks or 5 times the half-life (whichever is longer) prior to the first dose of the IP~6. Individuals with BCVA of fewer than 34 letters measured by ETDRS letter score at the screening and baseline visits in the fellow eye~7. Individuals who have only one functional eye (monocular vision)~8. Pregnant \\\\[human chorionic gonadotropin (hCG) positive\\\\] or breastfeeding women of childbearing potential at the screening and baseline visits~9. Men or women of childbearing potential who are unwilling to use adequate methods of contraception\\\\* from the time of written informed consent to 12 weeks after the last dose of the IP~ \\\\* Adequate methods of contraception: Hormonal contraceptives (oral contraceptive pill, contraceptive patch, etc.), intrauterine device or intrauterine system implantation, sterilization procedure or surgery (vasectomy, bilateral tubal ligation, etc.), complete abstinence~10. Individuals considered by the investigator to be ineligible for study participation for any reasons other than the inclusion and exclusion criteria", combined_text: A Phase 3 Clinical Trial to Compare RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 8 weeks after the IP treatment, The change from baseline (Day 1) to 8 weeks after the IP treatment Change in Best-Corrected Visual Acuity (BCVA) measured by Early treatment Diabetic Retinopathy Study (ETDRS) letter score at 4, 8, 12, 16, 20, and 24 weeks after the IP treatment, The change from baseline (Day 1) to 4, 8, 12, 16, 20, and 24 weeks after the IP treatment "Inclusion Criteria:~1. Age ≥ 50 years at screening~2. Individuals with active CNV lesion secondary to AMD in the study eye, proven by fluorescein angiography (FA) and confirmed by the central reading center during the screening period~3. Individuals with CNV area in the study eye accounting for ≥ 50% of the total lesion, including macular hemorrhage, scar, atrophy, fibrosis and neovascularization, proven by FA and confirmed by the central reading center during the screening period~4. Individuals with intraretinal or subretinal fluid in the study eye due to active CNV, proven by optical coherence tomography (OCT) and confirmed by the central reading center during the screening period~5. Individuals with BCVA of 34 to 73 letters measured by ETDRS letter score at the screening and baseline visits in the study eye~6. Individuals who voluntarily decide to participate in the clinical study after being fully informed of the details of the clinical study and who provide written consent to comply with the study instructions during the clinical study~Exclusion Criteria:~1. Individuals whose study eye lesion meets any of the following criteria~ * Total lesion\\\\* size - \\\\> 23 mm2 \\\\[9 disc areas (DAs)\\\\] (Must be proven by FA)~ * Subretinal hemorrhage (or subfoveal hemorrhage) - ≥ 50% of the total lesion\\\\* \\\\[≥ 1 DA (In the case of subfoveal hemorrhage, fovea must be surrounded 270 degrees by visible CNV.)\\\\]~ * Scar or fibrosis - ≥ 50% of the total lesion\\\\* or Scar, fibrosis, or atrophy involving the center of the fovea~ * Retinal pigment epithelial tears or rips - Macular involvement~ * Macular hole - At any stage, if present in the study eye~ * Other causes of CNV - Ocular histoplasmosis syndrome, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, pathologic myopia (spherical equivalent of negative 8 diopters or more or axial length of 25 mm or more), etc.~2. Individuals with any of the following concurrent diseases at screening or for a specified period of time~ i. Concurrent ocular disease ii. Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg (despite adequate treatment) iii. Uncontrolled diabetes mellitus, at the investigator\\s discretion iv. Congestive heart failure with New York Heart Association (NYHA) functional classification 3 or 4 or any clinically significant heart disease including ventricular arrhythmia and atrial fibrillation, at the investigator\\s discretion v. Active systemic infection undergoing treatment or recurrent clinically significant infections within 4 weeks prior to the first dose of the IP~3. Individuals with any medical history of the following at screening:~ i. Other ophthalmic disease in the study eye that may affect safety/efficacy assessments in the subject or may require medical/surgical interventions during the clinical study at the investigator\\s discretion (e.g., vitreomacular traction, glaucoma undergoing treatment, retinal detachment, corneal dystrophy, etc.) ii. Diabetic retinopathy (DR)\\\\*, diabetic macular edema (DME), retinal vein occlusion (RVO), uveitis, or other vascular disease affecting the retina (other than nAMD) in either eye \\\\*Mild non-proliferative DR will be permitted.~ iii. Stroke, transient ischemic attack, pulmonary embolism, deep venous thrombosis or myocardial infarction within the past 24 weeks iv. Hypersensitivity reactions to aflibercept or other drugs to be used in the clinical study (fluorescein, mydriatic drops, etc.) v. Malignancy within the last 5 years (however, individuals with basal cell, cutaneous squamous cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma who are in stable long-term follow-up without therapeutic medication, procedures, or surgery can participate in this clinical trial) vi. Organ or bone marrow transplantation~4. Individuals with a history of any of the following medication or non-pharmacological treatment for the study eye i. Glaucoma filtering surgery, vitrectomy or corneal transplantation ii. Simple intraocular or periocular surgery (e.g., cataract surgery, simple neodymium yttrium aluminum garnet (Nd:YAG) laser capsulotomy on a pseudophakic eye due to posterior capsular opacification, etc.) within 12 weeks or eyelid surgery within 4 weeks prior to the screening visit \\\\[Laser iridotomy will be permitted.\\\\] iii. Macular photodynamic therapy (PDT) with verteporfin, transpupillary thermotherapy, radiotherapy or retinal laser treatment (e.g., focal laser photocoagulation, pan-retinal photocoagulation, etc.) iv. Periocular radiotherapy v. Any anti-VEGF treatment for nAMD (including participation in other clinical studies) vi. Treatment for retinal detachment (medication or non-pharmacological treatment) vii. IVT corticosteroid injection, sub-tenon or periocular corticosteroid injection within 24 weeks or IVT corticosteroid implantation within 36 months prior to the screening visit~5. Individuals with any of the following medication or non-pharmacological treatment history:~ i. Systemic anti-VEGF therapy within 12 weeks prior to the first dose of the IP ii. Any anti-VEGF treatment of nAMD in the fellow eye within 8 weeks prior to the first dose of the IP iii. Current use at screening of medications known to be toxic to the lens, retina, or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, ethambutol.~ iv. Systemic corticosteroids administered within 12 weeks prior to the first dose of the IP (prednisolone ≤ 10 mg/day and equivalent dose administered for 14 days or less or inhaled/intranasal/dermal agents will be permitted.) v. Other IP within 12 weeks or 5 times the half-life (whichever is longer) prior to the first dose of the IP~6. Individuals with BCVA of fewer than 34 letters measured by ETDRS letter score at the screening and baseline visits in the fellow eye~7. Individuals who have only one functional eye (monocular vision)~8. Pregnant \\\\[human chorionic gonadotropin (hCG) positive\\\\] or breastfeeding women of childbearing potential at the screening and baseline visits~9. Men or women of childbearing potential who are unwilling to use adequate methods of contraception\\\\* from the time of written informed consent to 12 weeks after the last dose of the IP~ \\\\* Adequate methods of contraception: Hormonal contraceptives (oral contraceptive pill, contraceptive patch, etc.), intrauterine device or intrauterine system implantation, sterilization procedure or surgery (vasectomy, bilateral tubal ligation, etc.), complete abstinence~10. Individuals considered by the investigator to be ineligible for study participation for any reasons other than the inclusion and exclusion criteria", Similarity Score: 0.31230568707303114}'}]
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[{'from': 'human', 'value': '{Study Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis, Primary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population), 6 Months, Secondary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population), 36 Months, criteria: "Inclusion Criteria:~* Male or non pregnant female at least 18 years of age at time of consent~* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \\\\> 1 year duration~* At the time of enrollment (Day 1), study eye has \\\\< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.~* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart~* Subject is not planning to undergo elective ocular surgery during the study~* Subject has ability to understand and sign the Informed Consent Form~* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures~* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:~ * systemic corticosteroid or other systemic therapies given for at least 3 months, and/or~ * at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis~OR the study eye has experienced recurrence:~• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid~Exclusion Criteria:~* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert~* History of posterior uveitis only that is not accompanied by vitritis or macular edema~* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze~* Uveitis with infectious etiology~* Vitreous hemorrhage~* Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)~* Ocular malignancy in either eye, including choroidal melanoma~* Toxoplasmosis scar in study eye or scar related to previous viral retinitis~* Previous viral retinitis~* Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures~* Media opacity precluding evaluation of retina and vitreous~* Peripheral retinal detachment in area of insertion~* Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)~* IOP \\\\> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye~* Chronic hypotony (\\\\< 6 mmHg)~* Ocular surgery on the study eye within 3 months prior to study Day 1~* Capsulotomy in study eye within 30 days prior to study Day 1~* Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1~* Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1~* Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1~* Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1~* Subjects requiring chronic systemic or inhaled corticosteroid therapy (\\\\>15mg prednisone daily) or chronic systemic immunosuppressive therapy~* Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1~* Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis~* Systemic infection within 30 days prior to study Day 1~* Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Treatment with an investigational drug or device within 30 days prior to study Day 1~* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit~* Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 914, Unnamed: 0: 1143, NCT Number: NCT06210373, Study Title: Assessment of Efficacy and Safety of the Use of Two Eye Gel Products Containing 5% Dexpanthenol in Patients With Moderate to Severe Dry Eye Syndrome, Study URL: https://clinicaltrials.gov/study/NCT06210373, Acronym: , Study Status: RECRUITING, Brief Summary: The prospective, multicentric, randomized, non-inferiority, controlled, open-label clinical investigation will evaluate the efficacy and safety of the use of Myrialen® gel vs.\\n\\nRecugel®, two eye gel products containing 5% dexpanthenol, in patients with moderate to severe dry eye syndrome.\\n\\nA total of 110 evaluable patients (55 in each treatment group), ≥18 years of age, will be required for data analysis. A total of 124 patients (62 in each treatment group) will be randomized to replace potential early withdrawals or non-evaluable patients.The primary objective of this investigation is to demonstrate non-inferior efficacy of Test Myrialen® gel over the Reference Recugel® in improving corneal and conjunctival surface state, assessed through slit lamp biomicroscopy examination, in patients with moderate to severe dry eye syndrome., Study Results: NO, Conditions: Dry Eye Disease, Interventions: DEVICE: Myrialen Gel|DEVICE: Recugel, Primary Outcome Measures: Efficacy assessment through National Eye Institute (NEI) total score compared to baseline, The NEI/Industry Workshop guidelines will be used as grading scale of the corneal and conjunctiva damage used. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which will be scored on a scale of 0-3, with a maximal score of 15. Both nasally and temporally, the conjunctiva will be divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 and with a maximal score of 9 for the nasal and temporal conjunctiva., Day 30, Secondary Outcome Measures: Efficacy assessment through National Eye Institute (NEI) total score compared to baseline, The NEI/Industry Workshop guidelines will be used as grading scale of the corneal and conjunctiva damage used. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which will be scored on a scale of 0-3, with a maximal score of 15. Both nasally and temporally, the conjunctiva will be divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 and with a maximal score of 9 for the nasal and temporal conjunctiva., Day 7|Efficacy assessment through National Eye Institute (NEI) corneal score compared to baseline, The NEI/Industry Workshop guidelines will be used as grading scale of the corneal and conjunctiva damage used. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which will be scored on a scale of 0-3, with a maximal score of 15., Day 7 and Day 30|Efficacy assessment through National Eye Institute (NEI) conjunctival score compared to baseline, The NEI/Industry Workshop guidelines will be used as grading scale of the corneal and conjunctiva damage used. . Both nasally and temporally, the conjunctiva will be divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 and with a maximal score of 9 for the nasal and temporal conjunctiva., Day 7 and Day 30|Assessment of Changes in impact of Dry Eye on Everyday living (IDEEL) questionnaire (symptom-bother and impact on daily life modules) from baseline, The IDEEL is divided into different sectionsa and only two will be considered in patient evaluation. The "Dry Eye Symptom-Bother" module includes 20 items: Item 1 from 0 "none of the time" to 4 "all of the time"; Items 2-from 1 "not at all" to 4 "very much". Score 0="I did not have this symptom / Not applicable"; and the "Dry Eye Impact on Daily Life" module composed of 3 sections: dry eye on daily living activities (9 items), emotional impact (12 items) and impact on work (6 items).Items 1-9 are scored on a 5-point Likert-like scale from 1 "all of the time" to 5 "none of the time". Items 10-21, 23-27 are scored on a 5-point Likert-like scale from 0 "all of the time" to 4 "none of the time". Item 22 is scored on a dichotomous scale: 1 "Yes", 0 "No". This item is not included in the calculation of the scores., Day 30|Assessment of Changes in Tear-Film Break-Up Time from baseline, The tear film is observed under cobalt-blue filtered light of the slit lamp biomicroscope and the time that elapses between the last blink and appearance of the first break in the tear film is recorded with a stopwatch (a break is seen as a dark spot in a sea of blue). TFBUT results of less than 10 seconds are consistent with dry eyes.\\n\\nThe TFBUT will be measured twice during the first minute after the instillation of the fluorescein.\\n\\nIf the 2 readings differ by more than 2 seconds a third reading will be taken. The TFBUT value will be the average of the 2 or 3 measurements., Day 7 and Day 30|Assessment of quantitative normalization of the tear film from baseline, Change in Schirmer\\s Test values from baseline. The Schirmer\\s test measures the quantity of total tear secretion, including reflex and basal tears, produced by the eye. A 35 mm x 5 mm size filter paper strip is used to measure the amount of tears that are produced over a period of 5 minutes. The wet portion of the strip is measured in millimeters. The test is done under ambient light. The patient is instructed to look forward and to blink normally during the course of the test. Normal mean test values range from 8 mm to 33 mm, but an accepted normal value is greater than 10 mm. Patients with dry eyes have wetting values of less than 5 mm in 5 minutes., Day 7 and Day 30|Assessment of qualitative normalization of the tear film from baseline, Changes will be evaluated through the tear meniscus height. The tear (lacrimal) meniscus examination is conducted using slit-lamp biomicroscopy (narrow slit and low intensity light) and observing the tear (lacrimal) meniscus height. Values are considered normal if within the 0.3 to 0.5-mm range., Day 30|Assessment of changes in visual acuity from baseline, Visual function will be assessed by distance visual acuity measurement. Both uncorrected distance visual acuity (UNVA, vision with no extraocular optical correction) and best corrected distance visual acuity (BCVA, defined as obtained with the best possible refractive correction) will be measured using the Snellen chart. Visual acuity values will be expressed in decimal, fraction or logMAR. All assessments will be performed using standard charts and procedures at specified visual angle, illumination and contrast. Current refraction will be determined prior to visual acuity testing to obtain best-corrected vision, Day 30|Assessment of incidence of treatment-emergent adverse events, Safety and tolerabiltiy will be assessed through the analysis of Incidence and nature of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs); Incidence and nature of Adverse Device Effects (ADEs) and serious ADEs (SADEs) during the entire investigation duration; Incidence and nature of Investigational Medical Device Deficiencies (IMDDs) during the entire investigation duration., Day 30, Other Outcome Measures: Changes in confocal microscopy of density of dendritic cells from baseline, The changes will be evaluated through the use of confocal microscopy. The density of dendritic cells at the level of the sub-epithelial basal membrane evaluated in the central cornea (number of cells/mm2) will be evaluated according to single-layer epithelium, two cellular layers evidenced, more than two cellular layers evidenced., Day 30|Changes in confocal microscopy in stratification of the epithelium from baseline, The changes will be evaluated through the use of confocal microscopy. The stratification of the epithelium will be evaluated according to single-layer epithelium, two cellular layers evidenced, more than two cellular layers evidenced., Day 30, Sponsor: Fidia Farmaceutici s.p.a., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 124.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: IS57-21-01, Start Date: 2022-11-16, Primary Completion Date: 2024-11, Completion Date: 2024-12, First Posted: 2024-01-18, Results First Posted: , Last Update Posted: 2024-07-29, Locations: "Ospdale SS.Annunziata-Università degli Studi G.dAnnunzio, Chieti, Pescara, 66100, Italy|Università degli studi Federico II, Napoli, 80131, Italy|Humanitas Gradenigo, Torino, 10153, Italy", Study Documents: , criteria: "Inclusion Criteria:~1. Patient written informed consent to participate in the study obtained according to Good Clinical Practice (GCP);~2. Male and female patients aged ≥18 years;~3. Patients with new diagnosis of dry eye syndrome (according to Tear Film and Ocular Surface Society \\\\[TFOS\\\\] Dry Eye Workshop \\\\[DEWS\\\\] II definition), or previous diagnosis of dry eye syndrome not treated in the previous 15 days;~4. Diagnosis of dry eye syndrome performed through the following exams: slit lamp examination (SLE), Impact of Dry Eye on Everyday Living (IDEEL) questionnaire, tear (lacrimal) meniscus exam, Schirmer\\s test, Tear Film Break-Up Time (TFBUT), fluorescein and lissamine green staining of the cornea and conjunctiva (respectively). In case of bilateral dry eye syndrome, only the worst eye, defined as the eye with the higher severity of impairment according to theInvestigator\\s judgment based on the above exams, will be considered for assessments (although both eyes will be treated). In the case of bilateral dry eye syndrome with both eyes having the same level of impairment, the right eye will be considered for assessments by convention;~5. Sodium fluorescein and lissamine green staining score of the cornea and conjunctiva(respectively) ≥ 2 National Eye Institute (NEI) grid, defined as the sum of 5 areas per eye using a 0 (normal) to 3 (severe) scale) in the worst eye for the corneal staining and the sum of 6 areas per eye using a 0 (normal) to 3 (severe) scale in the worst eye for the conjunctival staining;~6. A Schirmer test value \\\\< 10 mm;~7. A TFBUT value ≥ 5 sec;~8. Patient able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator\\s judgment;~9. Females of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status - or not postmenopausal for at least one year) must have a negative urine pregnancy test result at Screening and must use an appropriate method of contraception for at least 30 days before inclusion in the study and during the whole study period, according to the definition in ICH M3 Guideline:~A highly effective method is defined as that which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Highly effective birth control methods include:~combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.~Exclusion Criteria:~1. Any ocular disease other than dry eye syndrome requiring treatment with ophthalmological topical medications with re-epithelizing, trophic, anti-infective or anti-inflammatory effect (e.g. antibiotics, corticosteroids, gel re-epithelizing, platelet-rich plasma, autologous serum, medication with vitamin A, hyaluronic acid-based products) in either eye at the time of study enrolment and in the previous 30 days;~2. Any active ocular infection or active inflammation in either eye unrelated to dry eye syndrome;~3. Presence or history of any systemic or ocular disorder, condition or disease (with particular attention to malignancies and neuro-oncological diseases) that, according to Investigator\\s judgment, can interfere with the conduct of the required study procedures or the assessment of the efficacy or the interpretation of the study results or the incidence of adverse events;~4. Use of therapeutic or refractive contact lenses in either eye in the previous 20 days and at the time of study enrolment;~5. History of ocular surgery in either eye, excluding corneal refractive or cataract procedures, within 90 days of study enrolment;~6. Treatment with any other therapy that, according to Investigator\\s judgment, could interfere with the assessment of the efficacy or incidence of adverse events;~7. Hypersensitivity and/or allergy to any of Myrialen® gel and/or Recugel® ingredients;~8. Women pregnant or breastfeeding or women who could become pregnant and are not using effective contraception;~9. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the investigation;~10. Participation in another clinical investigation within the past 30 days or previous enrolment in this investigation.", combined_text: Assessment of Efficacy and Safety of the Use of Two Eye Gel Products Containing 5% Dexpanthenol in Patients With Moderate to Severe Dry Eye Syndrome Efficacy assessment through National Eye Institute (NEI) total score compared to baseline, The NEI/Industry Workshop guidelines will be used as grading scale of the corneal and conjunctiva damage used. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which will be scored on a scale of 0-3, with a maximal score of 15. Both nasally and temporally, the conjunctiva will be divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 and with a maximal score of 9 for the nasal and temporal conjunctiva., Day 30 Efficacy assessment through National Eye Institute (NEI) total score compared to baseline, The NEI/Industry Workshop guidelines will be used as grading scale of the corneal and conjunctiva damage used. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which will be scored on a scale of 0-3, with a maximal score of 15. Both nasally and temporally, the conjunctiva will be divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 and with a maximal score of 9 for the nasal and temporal conjunctiva., Day 7|Efficacy assessment through National Eye Institute (NEI) corneal score compared to baseline, The NEI/Industry Workshop guidelines will be used as grading scale of the corneal and conjunctiva damage used. The cornea will be divided into five sectors (central, superior, inferior, nasal and temporal), each of which will be scored on a scale of 0-3, with a maximal score of 15., Day 7 and Day 30|Efficacy assessment through National Eye Institute (NEI) conjunctival score compared to baseline, The NEI/Industry Workshop guidelines will be used as grading scale of the corneal and conjunctiva damage used. . Both nasally and temporally, the conjunctiva will be divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 and with a maximal score of 9 for the nasal and temporal conjunctiva., Day 7 and Day 30|Assessment of Changes in impact of Dry Eye on Everyday living (IDEEL) questionnaire (symptom-bother and impact on daily life modules) from baseline, The IDEEL is divided into different sectionsa and only two will be considered in patient evaluation. The "Dry Eye Symptom-Bother" module includes 20 items: Item 1 from 0 "none of the time" to 4 "all of the time"; Items 2-from 1 "not at all" to 4 "very much". Score 0="I did not have this symptom / Not applicable"; and the "Dry Eye Impact on Daily Life" module composed of 3 sections: dry eye on daily living activities (9 items), emotional impact (12 items) and impact on work (6 items).Items 1-9 are scored on a 5-point Likert-like scale from 1 "all of the time" to 5 "none of the time". Items 10-21, 23-27 are scored on a 5-point Likert-like scale from 0 "all of the time" to 4 "none of the time". Item 22 is scored on a dichotomous scale: 1 "Yes", 0 "No". This item is not included in the calculation of the scores., Day 30|Assessment of Changes in Tear-Film Break-Up Time from baseline, The tear film is observed under cobalt-blue filtered light of the slit lamp biomicroscope and the time that elapses between the last blink and appearance of the first break in the tear film is recorded with a stopwatch (a break is seen as a dark spot in a sea of blue). TFBUT results of less than 10 seconds are consistent with dry eyes.\\n\\nThe TFBUT will be measured twice during the first minute after the instillation of the fluorescein.\\n\\nIf the 2 readings differ by more than 2 seconds a third reading will be taken. The TFBUT value will be the average of the 2 or 3 measurements., Day 7 and Day 30|Assessment of quantitative normalization of the tear film from baseline, Change in Schirmer\\s Test values from baseline. The Schirmer\\s test measures the quantity of total tear secretion, including reflex and basal tears, produced by the eye. A 35 mm x 5 mm size filter paper strip is used to measure the amount of tears that are produced over a period of 5 minutes. The wet portion of the strip is measured in millimeters. The test is done under ambient light. The patient is instructed to look forward and to blink normally during the course of the test. Normal mean test values range from 8 mm to 33 mm, but an accepted normal value is greater than 10 mm. Patients with dry eyes have wetting values of less than 5 mm in 5 minutes., Day 7 and Day 30|Assessment of qualitative normalization of the tear film from baseline, Changes will be evaluated through the tear meniscus height. The tear (lacrimal) meniscus examination is conducted using slit-lamp biomicroscopy (narrow slit and low intensity light) and observing the tear (lacrimal) meniscus height. Values are considered normal if within the 0.3 to 0.5-mm range., Day 30|Assessment of changes in visual acuity from baseline, Visual function will be assessed by distance visual acuity measurement. Both uncorrected distance visual acuity (UNVA, vision with no extraocular optical correction) and best corrected distance visual acuity (BCVA, defined as obtained with the best possible refractive correction) will be measured using the Snellen chart. Visual acuity values will be expressed in decimal, fraction or logMAR. All assessments will be performed using standard charts and procedures at specified visual angle, illumination and contrast. Current refraction will be determined prior to visual acuity testing to obtain best-corrected vision, Day 30|Assessment of incidence of treatment-emergent adverse events, Safety and tolerabiltiy will be assessed through the analysis of Incidence and nature of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs); Incidence and nature of Adverse Device Effects (ADEs) and serious ADEs (SADEs) during the entire investigation duration; Incidence and nature of Investigational Medical Device Deficiencies (IMDDs) during the entire investigation duration., Day 30 "Inclusion Criteria:~1. Patient written informed consent to participate in the study obtained according to Good Clinical Practice (GCP);~2. Male and female patients aged ≥18 years;~3. Patients with new diagnosis of dry eye syndrome (according to Tear Film and Ocular Surface Society \\\\[TFOS\\\\] Dry Eye Workshop \\\\[DEWS\\\\] II definition), or previous diagnosis of dry eye syndrome not treated in the previous 15 days;~4. Diagnosis of dry eye syndrome performed through the following exams: slit lamp examination (SLE), Impact of Dry Eye on Everyday Living (IDEEL) questionnaire, tear (lacrimal) meniscus exam, Schirmer\\s test, Tear Film Break-Up Time (TFBUT), fluorescein and lissamine green staining of the cornea and conjunctiva (respectively). In case of bilateral dry eye syndrome, only the worst eye, defined as the eye with the higher severity of impairment according to theInvestigator\\s judgment based on the above exams, will be considered for assessments (although both eyes will be treated). In the case of bilateral dry eye syndrome with both eyes having the same level of impairment, the right eye will be considered for assessments by convention;~5. Sodium fluorescein and lissamine green staining score of the cornea and conjunctiva(respectively) ≥ 2 National Eye Institute (NEI) grid, defined as the sum of 5 areas per eye using a 0 (normal) to 3 (severe) scale) in the worst eye for the corneal staining and the sum of 6 areas per eye using a 0 (normal) to 3 (severe) scale in the worst eye for the conjunctival staining;~6. A Schirmer test value \\\\< 10 mm;~7. A TFBUT value ≥ 5 sec;~8. Patient able to comprehend the full nature and the purpose of the study, including possible risks and side effects, and subjects able to cooperate with the Investigator and to comply with the requirements of the entire study (including ability to attend all the planned study visits according to the time limits), based on Investigator\\s judgment;~9. Females of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status - or not postmenopausal for at least one year) must have a negative urine pregnancy test result at Screening and must use an appropriate method of contraception for at least 30 days before inclusion in the study and during the whole study period, according to the definition in ICH M3 Guideline:~A highly effective method is defined as that which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Highly effective birth control methods include:~combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.~Exclusion Criteria:~1. Any ocular disease other than dry eye syndrome requiring treatment with ophthalmological topical medications with re-epithelizing, trophic, anti-infective or anti-inflammatory effect (e.g. antibiotics, corticosteroids, gel re-epithelizing, platelet-rich plasma, autologous serum, medication with vitamin A, hyaluronic acid-based products) in either eye at the time of study enrolment and in the previous 30 days;~2. Any active ocular infection or active inflammation in either eye unrelated to dry eye syndrome;~3. Presence or history of any systemic or ocular disorder, condition or disease (with particular attention to malignancies and neuro-oncological diseases) that, according to Investigator\\s judgment, can interfere with the conduct of the required study procedures or the assessment of the efficacy or the interpretation of the study results or the incidence of adverse events;~4. Use of therapeutic or refractive contact lenses in either eye in the previous 20 days and at the time of study enrolment;~5. History of ocular surgery in either eye, excluding corneal refractive or cataract procedures, within 90 days of study enrolment;~6. Treatment with any other therapy that, according to Investigator\\s judgment, could interfere with the assessment of the efficacy or incidence of adverse events;~7. Hypersensitivity and/or allergy to any of Myrialen® gel and/or Recugel® ingredients;~8. Women pregnant or breastfeeding or women who could become pregnant and are not using effective contraception;~9. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the investigation;~10. Participation in another clinical investigation within the past 30 days or previous enrolment in this investigation.", Similarity Score: 0.307807918433618}'}]
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[{'from': 'human', 'value': '{Study Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis, Primary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population), 6 Months, Secondary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population), 36 Months, criteria: "Inclusion Criteria:~* Male or non pregnant female at least 18 years of age at time of consent~* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \\\\> 1 year duration~* At the time of enrollment (Day 1), study eye has \\\\< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.~* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart~* Subject is not planning to undergo elective ocular surgery during the study~* Subject has ability to understand and sign the Informed Consent Form~* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures~* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:~ * systemic corticosteroid or other systemic therapies given for at least 3 months, and/or~ * at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis~OR the study eye has experienced recurrence:~• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid~Exclusion Criteria:~* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert~* History of posterior uveitis only that is not accompanied by vitritis or macular edema~* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze~* Uveitis with infectious etiology~* Vitreous hemorrhage~* Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)~* Ocular malignancy in either eye, including choroidal melanoma~* Toxoplasmosis scar in study eye or scar related to previous viral retinitis~* Previous viral retinitis~* Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures~* Media opacity precluding evaluation of retina and vitreous~* Peripheral retinal detachment in area of insertion~* Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)~* IOP \\\\> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye~* Chronic hypotony (\\\\< 6 mmHg)~* Ocular surgery on the study eye within 3 months prior to study Day 1~* Capsulotomy in study eye within 30 days prior to study Day 1~* Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1~* Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1~* Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1~* Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1~* Subjects requiring chronic systemic or inhaled corticosteroid therapy (\\\\>15mg prednisone daily) or chronic systemic immunosuppressive therapy~* Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1~* Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis~* Systemic infection within 30 days prior to study Day 1~* Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Treatment with an investigational drug or device within 30 days prior to study Day 1~* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit~* Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 903, Unnamed: 0: 1131, NCT Number: NCT00502073, Study Title: Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-005), Study URL: https://clinicaltrials.gov/study/NCT00502073, Acronym: , Study Status: COMPLETED, Brief Summary: The purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome., Study Results: NO, Conditions: Dry Eye Syndromes, Interventions: DRUG: cyclosporine, Primary Outcome Measures: , Secondary Outcome Measures: , Other Outcome Measures: , Sponsor: Sirion Therapeutics, Inc., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE3, Enrollment: , Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: , Other IDs: ST-603-005, Start Date: , Primary Completion Date: , Completion Date: , First Posted: 2007-07-17, Results First Posted: , Last Update Posted: 2011-07-01, Locations: Eye Center Northeast, Bangor, Maine, 04401, United States, Study Documents: , criteria: "Inclusion Criteria:~* Diagnosis of moderate to severe dry eye syndrome with or without Sjogren\\s syndrome or other autoimmune disease~Exclusion Criteria:~* Intraocular or refractive surgery in the study eye within 3 months prior to study start~* Unwilling to discontinue use of contact lenses during the run-in and duration of the study~* Pregnancy or lactation", combined_text: Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-005) "Inclusion Criteria:~* Diagnosis of moderate to severe dry eye syndrome with or without Sjogren\\s syndrome or other autoimmune disease~Exclusion Criteria:~* Intraocular or refractive surgery in the study eye within 3 months prior to study start~* Unwilling to discontinue use of contact lenses during the run-in and duration of the study~* Pregnancy or lactation", Similarity Score: 0.3028661242816024}'}]
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from_dataset
| 0.302866
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[{'from': 'human', 'value': '{Study Title: Safety and Efficacy Study of a FAI Insert in Subjects With Chronic Non-infectious Posterior Uveitis, Primary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 6 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye within 6 Months Including Reason for Imputed Recurrence (ITT Population), 6 Months, Secondary Outcome Measures: Number of Participants With Recurrence of Uveitis in Study Eye Within 36 Months, Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months Including Reason for Imputed Recurrence (ITT Population), 36 Months, criteria: "Inclusion Criteria:~* Male or non pregnant female at least 18 years of age at time of consent~* One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis \\\\> 1 year duration~* At the time of enrollment (Day 1), study eye has \\\\< 10 anterior chamber cells/High Power Field (HPF) and a vitreous haze ≤ grade 2.~* Visual acuity of study eye is at least 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart~* Subject is not planning to undergo elective ocular surgery during the study~* Subject has ability to understand and sign the Informed Consent Form~* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures~* During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:~ * systemic corticosteroid or other systemic therapies given for at least 3 months, and/or~ * at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis~OR the study eye has experienced recurrence:~• at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid~Exclusion Criteria:~* Allergy to fluocinolone acetonide or any component of the Fluocinolone Acetonide Intravitreal (FAI) insert~* History of posterior uveitis only that is not accompanied by vitritis or macular edema~* History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze~* Uveitis with infectious etiology~* Vitreous hemorrhage~* Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)~* Ocular malignancy in either eye, including choroidal melanoma~* Toxoplasmosis scar in study eye or scar related to previous viral retinitis~* Previous viral retinitis~* Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures~* Media opacity precluding evaluation of retina and vitreous~* Peripheral retinal detachment in area of insertion~* Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable Intraocular pressure (IOP) in the normal range (10-21 mmHg)~* IOP \\\\> 21 mmHg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye~* Chronic hypotony (\\\\< 6 mmHg)~* Ocular surgery on the study eye within 3 months prior to study Day 1~* Capsulotomy in study eye within 30 days prior to study Day 1~* Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1~* Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1~* Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1~* Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1~* Subjects requiring chronic systemic or inhaled corticosteroid therapy (\\\\>15mg prednisone daily) or chronic systemic immunosuppressive therapy~* Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1~* Subjects who have tested positive for human immune deficiency virus (HIV), tuberculosis or syphilis~* Systemic infection within 30 days prior to study Day 1~* Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study~* Treatment with an investigational drug or device within 30 days prior to study Day 1~* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit~* Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 679, Unnamed: 0: 847, NCT Number: NCT04829344, Study Title: A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution, Study URL: https://clinicaltrials.gov/study/NCT04829344, Acronym: , Study Status: COMPLETED, Brief Summary: This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution., Study Results: YES, Conditions: Anesthesia, Local, Interventions: DRUG: AG-920|DRUG: Placebo, Primary Outcome Measures: The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes, Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO.", 5 minutes post dose, Secondary Outcome Measures: How Long it Takes One Dose of AG-920 to Anesthetize the Eye, Mean time to no pain score (onset), 20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.|How Long One Dose of AG-920 Anesthetizes the Eye, Mean duration of anesthetic effect, 20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Total number of participants with TEAEs, from randomization through study completion (up to 5 days) on average of 2 days.|Number of Participants With a Change in Biomicroscopy, Slit lamp biomicroscopy and external eye exam measures will be summarized at each measured timepoint using discrete summary statistics. Clinician examined the eyelid, conjunctiva, cornea, anterior chamber, iris, pupil, and lens of the eye with the aid of a slit lamp., change from baseline through end of study at Day 5|Change in Visual Acuity, Visual Acuity data will be summarized at each time point using continuous and discrete summaries of Logarithmic Minimum Angle of Resolution (logMAR)., change from baseline through end of study at Day 5, Other Outcome Measures: , Sponsor: American Genomics, LLC, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE3, Enrollment: 120.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE, Other IDs: AG-920-CS302, Start Date: 2021-03-30, Primary Completion Date: 2021-05-06, Completion Date: 2021-05-10, First Posted: 2021-04-02, Results First Posted: 2024-10-10, Last Update Posted: 2024-10-10, Locations: American Genomics Site 2, McAllen, Texas, 78503, United States, Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/44/NCT04829344/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/44/NCT04829344/SAP_001.pdf, criteria: "Inclusion Criteria:~1. Provide written informed consent prior to any study-related procedures being performed.~2. Is male or a non-pregnant, non-lactating female aged 18 years or older.~3. Willing and able to follow instructions and be present for the required study visits.~4. Have an Early Treatment Diabetic Retinopathy Study (ETDRS) Best Correct Visual Acuity (BCVA) of 20/200 or better in each eye.~5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.~6. Certified as healthy by clinical assessment.~7. Verbal communication skills adequate to participate.~8. Able to tolerate bilateral instillation of Over-The-Counter artificial tear product based on investigator judgement.~Exclusion Criteria:~1. Have participated in an investigational study within the past 30 days.~2. Have a contraindication to local anesthetics.~3. Have known decreased corneal or conjunctival sensitivity.~4. Have had ocular surgery in either eye within the past 90 days.~5. Have had an intravitreal injection in either eye within 14 days.~6. Have ocular disease requiring punctual plugs or ocular inflammation.~7. Are currently using a systemic opioid or opiate analgesic or topical NSAID.~8. Cannot withhold their over the counter (OTC) artificial tear lubricant products for one hour preceding or following study medication.~9. Any condition, including alcohol or drug dependency, that would limit the subject\\s ability to comply with the procedures of the protocol.", combined_text: A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution The Percentage of Patients Who Experienced Ocular Anesthesia Following Treatment of AG-920 Compared to Placebo at 5 Minutes, Immediately following EACH pinch test, subjects will be asked "Was that painful" "Yes" or "NO.", 5 minutes post dose How Long it Takes One Dose of AG-920 to Anesthetize the Eye, Mean time to no pain score (onset), 20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.|How Long One Dose of AG-920 Anesthetizes the Eye, Mean duration of anesthetic effect, 20, 40 and 60 seconds following dosing or until pain stops. 5-minutes post dose. If subject became anesthetized before 5 minutes, every 5 minutes for up to 30 minutes or until pain resumes.|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Total number of participants with TEAEs, from randomization through study completion (up to 5 days) on average of 2 days.|Number of Participants With a Change in Biomicroscopy, Slit lamp biomicroscopy and external eye exam measures will be summarized at each measured timepoint using discrete summary statistics. Clinician examined the eyelid, conjunctiva, cornea, anterior chamber, iris, pupil, and lens of the eye with the aid of a slit lamp., change from baseline through end of study at Day 5|Change in Visual Acuity, Visual Acuity data will be summarized at each time point using continuous and discrete summaries of Logarithmic Minimum Angle of Resolution (logMAR)., change from baseline through end of study at Day 5 "Inclusion Criteria:~1. Provide written informed consent prior to any study-related procedures being performed.~2. Is male or a non-pregnant, non-lactating female aged 18 years or older.~3. Willing and able to follow instructions and be present for the required study visits.~4. Have an Early Treatment Diabetic Retinopathy Study (ETDRS) Best Correct Visual Acuity (BCVA) of 20/200 or better in each eye.~5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.~6. Certified as healthy by clinical assessment.~7. Verbal communication skills adequate to participate.~8. Able to tolerate bilateral instillation of Over-The-Counter artificial tear product based on investigator judgement.~Exclusion Criteria:~1. Have participated in an investigational study within the past 30 days.~2. Have a contraindication to local anesthetics.~3. Have known decreased corneal or conjunctival sensitivity.~4. Have had ocular surgery in either eye within the past 90 days.~5. Have had an intravitreal injection in either eye within 14 days.~6. Have ocular disease requiring punctual plugs or ocular inflammation.~7. Are currently using a systemic opioid or opiate analgesic or topical NSAID.~8. Cannot withhold their over the counter (OTC) artificial tear lubricant products for one hour preceding or following study medication.~9. Any condition, including alcohol or drug dependency, that would limit the subject\\s ability to comply with the procedures of the protocol.", Similarity Score: 0.2946924923237966}'}]
|
from_dataset
| 0.294692
|
[{'from': 'human', 'value': '{Study Title: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice, Primary Outcome Measures: Progressive-Free Survival (PFS), PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\\\\>=) 50 percent (%) of previously involved sites from nadir., Approximately up to 5 years, Secondary Outcome Measures: "Overall Response Rate (ORR), ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician., Approximately up to 5 years|Time to First Response, Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response., Approximately up to 5 years|Time to Best Response, Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response., Approximately up to 5 years|Duration of Response, Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \\\\>=50% of previously involved sites from nadir., Approximately up to 5 years|Overall survival (OS), Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death., Approximately up to 5 years|Duration of Ibrutinib Therapy, Duration of ibrutinib therapy in CLL and MCL participants will be reported., Approximately up to 5 years|Duration of a Treatment-Free Period, Duration of treatment-free period in CLL and MCL participants will be reported., Every 6 months (Approximately up to 5 years)|Duration of the First Non-Ibrutinib Subsequent Therapy Period, Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported., Approximately up to 5 years|Participants Daily Dose, Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed., Approximately up to 5 years|Number of Participants Who Require Dose Modifications, Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported., Approximately up to 5 years|Number of Medications Added, Number of medications added in the CLL and MCL treatment will be reported., Approximately up to 5 years", criteria: "Inclusion Criteria:~* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:~ 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or~ 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or~ 3. treatment of participants with relapsed or refractory MCL~* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Has not participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program~* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification~Exclusion Criteria:~* Currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 134, Unnamed: 0: 158, NCT Number: NCT05479994, Study Title: Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Study URL: https://clinicaltrials.gov/study/NCT05479994, Acronym: , Study Status: RECRUITING, Brief Summary: The purpose of this study is to evaluate the efficacy of BGB-11417 in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Study Results: NO, Conditions: Leukemia|Lymphoma|Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma|Small Lymphocytic Lymphoma|Relapsed Chronic Lymphocytic Leukemia, Interventions: DRUG: BGB-11417, Primary Outcome Measures: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC), Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for partiticpants with small lymphocytic lymphoma (SLL), Up to 2 Years, Secondary Outcome Measures: "Overall Response Rate (ORR) as assessed by the investigator, Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for participants with small lymphocytic lymphoma (SLL), Up to 2 Years|Duration of response (DoR) as determined by the IRC and the investigator, DoR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first, Up to 5 Years|Progression Free Survival (PFS) as determined by the IRC and the investigator, PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first., Up to 5 Years|Time to Response (TTR) as assessed by investigator and IRC, TTR is defined as the time from treatment initiation to the first documented response., Up to 2 Years|Overall Survival (OS), defined as time from the start of treatment to the date of death due to any cause, Up to 5 Years|Participants Reported Outcome as measured by EQ-5D-5L questionnaires, The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to)., Up to 5 Years|Participant Reported Outcomes as measured by NFLymSI-18, The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (NFLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 Not at all to 4 Very much and is divided into a total score., Up to 5 Years|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5 and the Grading Scale for Hematologic Toxicity in CLL Studies, Up to 5 Years|Number of participants with clinically significant changes from baseline in vital signs, Vital signs include systolic and diastolic blood pressure, heart rate, and body temperature, Up to 5 Years|Number of participants with clinically significant changes from baseline in clinical laboratory values, Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis, Up to 5 Years|Number of Participants With Clinically Significant Physical Examination Findings, A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems, Up to 5 Years", Other Outcome Measures: , Sponsor: BeiGene, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 97.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: BGB-11417-202|CTR20222085, Start Date: 2022-10-24, Primary Completion Date: 2025-04-30, Completion Date: 2027-08-25, First Posted: 2022-07-29, Results First Posted: , Last Update Posted: 2024-05-21, Locations: Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital, Hefei, Anhui, 230088, China|Peking University Third Hospital, Beijing, Beijing, 100000, China|Beijing Hospital, Beijing, Beijing, 100730, China|Beijing Friendship Hospital, Capital Medical University(Tongzhou), Beijing, Beijing, 101100, China|Fujian Cancer Hospital, Fuzhou, Fujian, 350014, China|Quanzhou First Affliated Hospital of Fujian Medical University, Quanzhou, Fujian, 362000, China|Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, 510000, China|Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, 550004, China|The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, 471003, China|Nanyang Central Hospital, Nanyang, Henan, 473000, China|Henan Cancer Hospital, Zhengzhou, Henan, 450000, China|Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology, Wuhan, Hubei, 430030, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China|Zhongda Hospital Southeast University, Nanjing, Jiangsu, 210009, China|Affiliated Hospital of Jiangnan University South Campus, Wuxi, Jiangsu, 214122, China|The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221000, China|Northern Jiangsu Peoples Hospital, Yangzhou, Jiangsu, 225001, China|The First Hospital of Jilin University, Changchun, Jilin, 130021, China|Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110004, China|Shaanxi Provincial Peoples Hospital, Xian, Shaanxi, 710068, China|Shandong Provincial Hospital, Jinan, Shandong, 250021, China|Jining No Peoples Hospital, Jining, Shandong, 272000, China|Yantai Yuhuangding Hospital, Yantai, Shandong, 264000, China|Rui Jin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200025, China|Affiliated Zhongshan Hospital of Fudan University, Shanghai, Shanghai, 200032, China|The Third Peoples Hospital of Datong, Datong, Shanxi, 037008, China|Shanxi Bethune Hospital, Taiyuan, Shanxi, 030032, China|Dazhou Central Hospital, Dazhou, Sichuan, 635099, China|Peoples Hospital of Deyang City, Deyang, Sichuan, 618000, China|Institute of Hematology and Hospital of Blood Disease, Tianjin, Tianjin, 300020, China|The First Peoples Hospital of Kashgar, Kashgar, Xinjiang, 844099, China|Yunnan Cancer Hospital, Kunming, Yunnan, 650100, China|Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China|Ningbo First Hospital, Ningbo, Zhejiang, 315010, China, Study Documents: , criteria: "Key Inclusion Criteria~1. Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria:~ 1. Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or~ 2. Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator.~2. Participants who require treatment based on the iwCLL 2018 criteria~3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2~4. Life expectancy of \\\\> 6 month~Key Exclusion Criteria~1. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or low risk (Gleason score ≤ 6) localized prostate cancer~2. Underlying medical conditions that, in the investigator\\s opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results~3. A known history of or currently suspected Richter\\s syndrome~4. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion)~5. Prior allogeneic stem cell transplant~Note: Other protocol defined Inclusion/Exclusion criteria may apply", combined_text: Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC), Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for partiticpants with small lymphocytic lymphoma (SLL), Up to 2 Years Overall Response Rate (ORR) as assessed by the investigator, Defined as the proportion of participants who achieved a complete response (CR), complete remission with incomplete marrow recovery (CRi), nodular partial response (nPR), or partial response (PR) per the 2018 iwCLL guidelines for participants with chronic lymphocytic leukemia (CLL) or Defined as the proportion of participants who achieved PR or better per the Lugano Classification for participants with small lymphocytic lymphoma (SLL), Up to 2 Years|Duration of response (DoR) as determined by the IRC and the investigator, DoR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first, Up to 5 Years|Progression Free Survival (PFS) as determined by the IRC and the investigator, PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first., Up to 5 Years|Time to Response (TTR) as assessed by investigator and IRC, TTR is defined as the time from treatment initiation to the first documented response., Up to 2 Years|Overall Survival (OS), defined as time from the start of treatment to the date of death due to any cause, Up to 5 Years|Participants Reported Outcome as measured by EQ-5D-5L questionnaires, The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to)., Up to 5 Years|Participant Reported Outcomes as measured by NFLymSI-18, The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index-18 (NFLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 \\Not at all\\ to 4 \\Very much\\ and is divided into a total score., Up to 5 Years|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), with adverse events leading to discontinuation, and AEs graded according NCI-CTCAE Version 5 and the Grading Scale for Hematologic Toxicity in CLL Studies, Up to 5 Years|Number of participants with clinically significant changes from baseline in vital signs, Vital signs include systolic and diastolic blood pressure, heart rate, and body temperature, Up to 5 Years|Number of participants with clinically significant changes from baseline in clinical laboratory values, Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis, Up to 5 Years|Number of Participants With Clinically Significant Physical Examination Findings, A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems, Up to 5 Years "Key Inclusion Criteria~1. Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria:~ 1. Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or~ 2. Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator.~2. Participants who require treatment based on the iwCLL 2018 criteria~3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2~4. Life expectancy of \\\\> 6 month~Key Exclusion Criteria~1. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or low risk (Gleason score ≤ 6) localized prostate cancer~2. Underlying medical conditions that, in the investigator\\s opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results~3. A known history of or currently suspected Richter\\s syndrome~4. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion)~5. Prior allogeneic stem cell transplant~Note: Other protocol defined Inclusion/Exclusion criteria may apply", Similarity Score: 0.33408316501201574}'}]
|
from_dataset
| 0.334083
|
[{'from': 'human', 'value': '{Study Title: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice, Primary Outcome Measures: Progressive-Free Survival (PFS), PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\\\\>=) 50 percent (%) of previously involved sites from nadir., Approximately up to 5 years, Secondary Outcome Measures: "Overall Response Rate (ORR), ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician., Approximately up to 5 years|Time to First Response, Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response., Approximately up to 5 years|Time to Best Response, Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response., Approximately up to 5 years|Duration of Response, Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \\\\>=50% of previously involved sites from nadir., Approximately up to 5 years|Overall survival (OS), Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death., Approximately up to 5 years|Duration of Ibrutinib Therapy, Duration of ibrutinib therapy in CLL and MCL participants will be reported., Approximately up to 5 years|Duration of a Treatment-Free Period, Duration of treatment-free period in CLL and MCL participants will be reported., Every 6 months (Approximately up to 5 years)|Duration of the First Non-Ibrutinib Subsequent Therapy Period, Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported., Approximately up to 5 years|Participants Daily Dose, Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed., Approximately up to 5 years|Number of Participants Who Require Dose Modifications, Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported., Approximately up to 5 years|Number of Medications Added, Number of medications added in the CLL and MCL treatment will be reported., Approximately up to 5 years", criteria: "Inclusion Criteria:~* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:~ 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or~ 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or~ 3. treatment of participants with relapsed or refractory MCL~* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Has not participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program~* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification~Exclusion Criteria:~* Currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 783, Unnamed: 0: 987, NCT Number: NCT00593944, Study Title: Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL), Study URL: https://clinicaltrials.gov/study/NCT00593944, Acronym: MDX1342-02, Study Status: COMPLETED, Brief Summary: The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected., Study Results: NO, Conditions: Chronic Lymphocytic Leukemia, Interventions: BIOLOGICAL: MDX-1342, Primary Outcome Measures: incidence and severity of treatment-emergent adverse events, all events will be followed to resolution, Secondary Outcome Measures: response, 12 weeks|clinical laboratory tests, study duratation - each visit|physical examination, study duration - each visit|electrocardiogram, at screening and study completion|diagnostic testing, at screening and study completion|pharmacokinetics sampling, at each dosing visit, Other Outcome Measures: , Sponsor: Bristol-Myers Squibb, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 15.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: MDX1342-02|IM130-002, Start Date: 2008-08, Primary Completion Date: 2010-05, Completion Date: 2010-05, First Posted: 2008-01-15, Results First Posted: , Last Update Posted: 2013-05-22, Locations: Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States|Roswell Park Cancer Institute, Buffalo, New York, 14263, United States|Oncology Consultants, PA, Houston, Texas, 77024, United States, Study Documents: , criteria: "Inclusion Criteria:~* relapsed/refractory CD19-positive CLL~* At least 28 days since prior treatment for CLL~* ECOG PS 0-2~* Screening laboratory values must be met~Exclusion Criteria:~* No prior anti-CD19 antibody tx~* No active, uncontrolled infection~* No prior allogeneic bone marrow transplant~* No autoimmune disease", combined_text: Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL) incidence and severity of treatment-emergent adverse events, all events will be followed to resolution response, 12 weeks|clinical laboratory tests, study duratation - each visit|physical examination, study duration - each visit|electrocardiogram, at screening and study completion|diagnostic testing, at screening and study completion|pharmacokinetics sampling, at each dosing visit "Inclusion Criteria:~* relapsed/refractory CD19-positive CLL~* At least 28 days since prior treatment for CLL~* ECOG PS 0-2~* Screening laboratory values must be met~Exclusion Criteria:~* No prior anti-CD19 antibody tx~* No active, uncontrolled infection~* No prior allogeneic bone marrow transplant~* No autoimmune disease", Similarity Score: 0.26605741624956825}'}]
|
from_dataset
| 0.266057
|
[{'from': 'human', 'value': '{Study Title: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice, Primary Outcome Measures: Progressive-Free Survival (PFS), PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\\\\>=) 50 percent (%) of previously involved sites from nadir., Approximately up to 5 years, Secondary Outcome Measures: "Overall Response Rate (ORR), ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician., Approximately up to 5 years|Time to First Response, Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response., Approximately up to 5 years|Time to Best Response, Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response., Approximately up to 5 years|Duration of Response, Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \\\\>=50% of previously involved sites from nadir., Approximately up to 5 years|Overall survival (OS), Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death., Approximately up to 5 years|Duration of Ibrutinib Therapy, Duration of ibrutinib therapy in CLL and MCL participants will be reported., Approximately up to 5 years|Duration of a Treatment-Free Period, Duration of treatment-free period in CLL and MCL participants will be reported., Every 6 months (Approximately up to 5 years)|Duration of the First Non-Ibrutinib Subsequent Therapy Period, Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported., Approximately up to 5 years|Participants Daily Dose, Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed., Approximately up to 5 years|Number of Participants Who Require Dose Modifications, Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported., Approximately up to 5 years|Number of Medications Added, Number of medications added in the CLL and MCL treatment will be reported., Approximately up to 5 years", criteria: "Inclusion Criteria:~* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:~ 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or~ 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or~ 3. treatment of participants with relapsed or refractory MCL~* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Has not participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program~* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification~Exclusion Criteria:~* Currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 187, Unnamed: 0: 227, NCT Number: NCT02110394, Study Title: Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia, Study URL: https://clinicaltrials.gov/study/NCT02110394, Acronym: NORMA, Study Status: COMPLETED, Brief Summary: Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia, Study Results: NO, Conditions: Chronic Lymphocytic Leukemia, Interventions: OTHER: bendamustine|OTHER: rituximab, Primary Outcome Measures: Overall response rate, Within 60-90 days after end of treatment, Secondary Outcome Measures: Adverse drug reactions, At all post-treatment visits (up to 30 days after end of treatment)|Treatment Failure (TF), Within 60-90 days after end of treatment|Time to Progression (TTP), 60 months|Progression-Free Survival (PFS), 60 months|Relapse following complete or partial remission, 60 months|Overall survival, 60 months|Quality of Life of patients receiving Ribomustin therapy, At all post-treatment visits (up to 30 days after end of treatment), Other Outcome Measures: , Sponsor: Astellas Pharma Europe B.V., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: , Enrollment: 190.0, Funder Type: INDUSTRY, Study Type: OBSERVATIONAL, Study Design: Observational Model: |Time Perspective: p, Other IDs: RU-BEN-NI-003, Start Date: 2012-06, Primary Completion Date: 2015-08, Completion Date: 2015-08, First Posted: 2014-04-10, Results First Posted: , Last Update Posted: 2016-07-06, Locations: "Republic Clinical Hospital n.a. N.A. Semashko, Buryatia, Ulan-Ude, Russian Federation|Alexandro-Mariinskaia Regional Clinical Hospital/13, Astrakhan, 414056, Russian Federation|Vologda Reginal Clinical Hospital #2, Cherepovets, Russian Federation|Irkutsk Regional Clinical Hospital/08, Irkutsk, 664079, Russian Federation|Kaliningrad City Clinical Hospital, Kaliningrad, Russian Federation|Regional Clinical Hospital#1/04, Khabarovsk, 630009, Russian Federation|District Cancer Center od Khanty -Mansiysk, Khanty-Mansiysk, Russian Federation|National Medical Surgical Center n.a.N.I.Pirogov/15, Moscow, 105203, Russian Federation|RONC n.a.N.N.Blokhin/21, Moscow, 115478, Russian Federation|Сentral Clinical Hospital n.a.N.A.Semashko/20, Moscow, 129128, Russian Federation|Central Clinical Hospital of Department of Presidential Affairs, Moscow, Russian Federation|Haematology Centre at Main Military Clinical Hospital n.a. N.N. Burdenko, Moscow, Russian Federation|Murmansk Regional Clinical Hospital n.a.P.A.Bayandin/31, Murmansk, 183047, Russian Federation|Nizhniy Novgorod Regional Clinical Hospital n.a.N.A.Semashko/14, Nizhniy Novgorod, 603126, Russian Federation|Medical Radiology Scientific Center/23, Obninsk, 249036, Russian Federation|Omsk Regional Clinical Hospital, Omsk, Russian Federation|Orenburg State Medical Academy/011, Orenburg, 460000, Russian Federation|Perm regional hospital, Perm, Russian Federation|Karelia Republican Сlinical Hospital n.a.V.A.Baranov/32, Petrozavodsk, 185019, Russian Federation|Pskov Regional Clinical Hospital, Pskov, Russian Federation|Rostov Scientific Research Oncology Institution/03, Rostov-on-Don, 344037, Russian Federation|Site 70001 Private Practice, Saint-Petersburg, 197341, Russian Federation|Military-Medical Academy n.a. Kirova, Saint-Petersburg, 197758, Russian Federation|Samara State Medical University Clinics/28, Samara, 443099, Russian Federation|Saratov State Medical University n.a. V.I.Razumovskiy, Saratov, Russian Federation|Road Clinical Hospital on Smolensk station OAO RZhD/12, Smolensk, 214025, Russian Federation|Komi Republican Oncology Dispensary /01, Syktyvkar, 167904, Russian Federation|Tula Regional Clinical Hospital/07, Tula, 300053, Russian Federation|Tyumen Regional Clinical Hospital#1/27, Tyumen, 625023, Russian Federation|Regional Clinical Hospital/26, Ulyanovsk, 432063, Russian Federation|Volgograd Regional Clinical Oncology Dispensary#1/25, Volgograd, 400138, Russian Federation|Vologda Regional Clinical Hospital, Vologda, Russian Federation|Yekaterinburg City Hospital #7, Yekaterinburg, Russian Federation|Yekaterinburg Regional Clinical Hospital #1, Yekaterinburg, Russian Federation", Study Documents: , criteria: "Inclusion Criteria:~* Patients with chronic lymphocytic leukemia (CLL) with current or planned first line therapy with Ribomustin~* Informed Consent Form for personal data handling signed by the program participant~Exclusion Criteria:~* Any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of CLL~* Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment~* Contraindications for Ribomustin usage in accordance with product label", combined_text: Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia Overall response rate, Within 60-90 days after end of treatment Adverse drug reactions, At all post-treatment visits (up to 30 days after end of treatment)|Treatment Failure (TF), Within 60-90 days after end of treatment|Time to Progression (TTP), 60 months|Progression-Free Survival (PFS), 60 months|Relapse following complete or partial remission, 60 months|Overall survival, 60 months|Quality of Life of patients receiving Ribomustin therapy, At all post-treatment visits (up to 30 days after end of treatment) "Inclusion Criteria:~* Patients with chronic lymphocytic leukemia (CLL) with current or planned first line therapy with Ribomustin~* Informed Consent Form for personal data handling signed by the program participant~Exclusion Criteria:~* Any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of CLL~* Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment~* Contraindications for Ribomustin usage in accordance with product label", Similarity Score: 0.20851489559823846}'}]
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from_dataset
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[{'from': 'human', 'value': '{Study Title: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice, Primary Outcome Measures: Progressive-Free Survival (PFS), PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\\\\>=) 50 percent (%) of previously involved sites from nadir., Approximately up to 5 years, Secondary Outcome Measures: "Overall Response Rate (ORR), ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician., Approximately up to 5 years|Time to First Response, Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response., Approximately up to 5 years|Time to Best Response, Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response., Approximately up to 5 years|Duration of Response, Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \\\\>=50% of previously involved sites from nadir., Approximately up to 5 years|Overall survival (OS), Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death., Approximately up to 5 years|Duration of Ibrutinib Therapy, Duration of ibrutinib therapy in CLL and MCL participants will be reported., Approximately up to 5 years|Duration of a Treatment-Free Period, Duration of treatment-free period in CLL and MCL participants will be reported., Every 6 months (Approximately up to 5 years)|Duration of the First Non-Ibrutinib Subsequent Therapy Period, Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported., Approximately up to 5 years|Participants Daily Dose, Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed., Approximately up to 5 years|Number of Participants Who Require Dose Modifications, Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported., Approximately up to 5 years|Number of Medications Added, Number of medications added in the CLL and MCL treatment will be reported., Approximately up to 5 years", criteria: "Inclusion Criteria:~* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:~ 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or~ 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or~ 3. treatment of participants with relapsed or refractory MCL~* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Has not participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program~* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification~Exclusion Criteria:~* Currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 799, Unnamed: 0: 1007, NCT Number: NCT03860844, Study Title: Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia, Study URL: https://clinicaltrials.gov/study/NCT03860844, Acronym: ISAKIDS, Study Status: TERMINATED, Brief Summary: Primary Objective:\\n\\nEvaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML)\\n\\nSecondary Objectives:\\n\\n* Safety and tolerability assessments\\n* Assessment of infusion reactions (IRs)\\n* Pharmacokinetics (PK) of isatuximab\\n* Minimal residual disease\\n* Overall response rate\\n* Overall survival\\n* Event free survival\\n* Duration of response\\n* Relationship between clinical effects and CD38 receptor density and occupancy, Study Results: YES, Conditions: Acute Lymphoblastic Leukemia|Acute Myeloid Leukemia, Interventions: DRUG: Isatuximab|DRUG: Dexamethasone or equivalent|DRUG: Fludarabine|DRUG: Cytarabine|DRUG: Liposomal daunorubicin|DRUG: Daunorubicin (nonliposomal)|DRUG: Idarubicin|DRUG: Filgrastim or equivalent|DRUG: Mitoxantrone|DRUG: Doxorubicin|DRUG: Vincristine|DRUG: Pegaspargase (PEG) Asparaginase|DRUG: Cyclophosphamide|DRUG: Etoposide|DRUG: Methotrexate|DRUG: L - Asparginase|DRUG: Hydroxyurea|DRUG: L - Asparaginase (Erwinase), Primary Outcome Measures: "Percentage of Participants With Complete Response (CR) Rate, The complete response rate (CR + CRi \\\\[complete response with incomplete peripheral recovery\\\\]) was defined as the percentage of participants achieving complete response (CR + CRi) assessed by the investigator per National Comprehensive Cancer Network (NCCN) guidelines version 1.2018 criteria. CR was defined as \\\\<5% blasts in a bone marrow aspirate (BMA) with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL); Absolute neutrophil count (ANC) \\\\>=1000/microliter (mcL); platelets \\\\>100000/mcL; red blood cell transfusion independence. If the physician documented transfusion dependency related to study treatment and not to the participants underlying disease, CRi was reported. CRi met the same criteria as for CR, except neutrophils and/or platelets recovery (ANC \\\\<1000/mcL or platelets \\\\<100000/mcL)., From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks", Secondary Outcome Measures: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs), An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as an AE which occurred after the first dose of study treatment administration until the last dose plus 30 days, or until the start of hematological recovery period or a new anti-leukemia/lymphoma therapy, whichever occurred first., From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)|Number of Participants With Infusion Reactions (IRs), An IR was an AE related to isatuximab typically with onset within 24 hours from the start of the isatuximab infusion and was reported by the investigator., From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)|B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab, Plasma samples were collected at specified timepoints to determine the AUC of isatuximab., From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10|AML: AUC of Isatuximab, Plasma samples were collected at specified timepoints to determine the AUC of isatuximab., From Week 0 to Week 1, Week 0 to Week 3, and Week 0 to Week 8|B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough), Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab., Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57|AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough), Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab., Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 2 Day 15|B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab, Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab., At end of infusion on Cycle 1 Days 1 and 29|AML: Ceoi of Isatuximab, Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab., At end of infusion on Cycle 1 Days 1 and 15|Number of Participants With Negative Minimal Residual Disease (MRD), MRD assessment was performed centrally by next generation sequencing using clonoSEQ and T-cell receptor assays for B-ALL and T-ALL cohorts respectively. It was performed by flow cytometry for AML cohort. Number of participants with CR or CRi who achieved negative MRD in bone marrow and blood was analyzed. In AML indication, peripheral blood tissue is not representative of the tumor burden and cannot be used to assess MRD., From screening until the study completion date, approximately 45 months|Overall Response Rate (ORR), ORR:Percentage of participants with CR/CRi or partial response (PR) for blood and bone marrow disease based on NCCN guideline. CR: \\\\<5% blasts in BMA with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL);ANC \\\\>=1000/mcL; platelets \\\\>100000/mcL; RBC transfusion independence. If the physician documented transfusion dependency related to study treatment;not to participant\\s underlying disease, CRi was reported. CRi met the same criteria as CR, except neutrophils and/or platelets recovery (ANC \\\\<1000/mcL or platelets \\\\<100000/mcL). PR: \\\\>50% decrease in the sum of the product of the greatest perpendicular diameters of the mediastinal enlargement. For participants with a previous positive positron emission tomography (PET) scan, a post-treatment PET was to be positive in at least 1 previously involved site., From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks|Overall Survival (OS), Overall survival was defined as the time interval from the date of first study treatment administration to death from any cause. It was estimated using the Kaplan-Meier method. Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley., From first study treatment administration up to death due to any cause, a maximum of 45 months|Event-Free Survival (EFS), EFS was defined as the time interval from the date of first study treatment administration to the date of the first of: completion or going off protocol induction/consolidation therapy without CR, relapse from CR, or death due to any cause, whichever occurred first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley., From study treatment administration up to the date of first documented disease progression or death due to any cause, a maximum of 45 months|Duration of Response (DoR), Duration of response was defined as the time from the date of the first response to the date of first disease progression or death from any cause, whichever happens first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley., From first documented response up to the date of first documented disease progression or death due to any cause, a maximum of 45 months|Cluster of Differentiation (CD)38 Receptor Density, Blood samples were collected to assess CD38 receptor density as a predictive biomarker. It was assessed across complete responders and non-complete responders. The Antibody Binding Capacity (ABC) was calculated using the following equation: ABC = 10\\\\^(Logarithm(Mean Fluorescence Intensity)\\\\*a+b) where "a" was the slope and "b" was the Y-intercept of the calibration curve equation. Specific and absolute quantitative values (specific antibody-binding capacity \\\\[sABC\\\\]) of binding of the selected antibodies were calculated after subtraction of the negative isotypic immunoglobulin G (IgG) control., Pre-dose on Day 1|CD38 Receptor Occupancy, Blood samples were collected to assess CD38 receptor occupancy as a pharmacodynamics marker. It was assessed across complete responders and non-complete responders. Multicolor flow cytometry assay was validated for CD38 receptor occupancy (CD38RO) quantification, based on the use of two murine monoclonal antibodies (MAbs), one competing with SAR650984 to determine the number of free CD38 receptors (MAb1) and one recognizing a different binding epitope on CD38 to measure the total number of receptors (MAb2) at the cell surface of the cancer cells. Cells were tagged with either MAb1 (Tube #1) or MAb2 (Tube #2). The percentage RO was calculated using the following equation: % CD38RO = \\\\[(sABC MAb2 - sABC MAb1)/sABC MAb2\\\\] X 100., Pre-dose on Day 15, Other Outcome Measures: , Sponsor: Sanofi, Collaborators: , Sex: ALL, Age: CHILD, Phases: PHASE2, Enrollment: 67.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: ACT15378|PIP - 2018-002697-45|U1111-1202-1096|2018-002697-45, Start Date: 2019-08-06, Primary Completion Date: 2022-09-12, Completion Date: 2023-05-26, First Posted: 2019-03-04, Results First Posted: 2023-11-15, Last Update Posted: 2024-05-16, Locations: "Sarah Cannon Research Institute-Site Number:8400001, Nashville, Tennessee, 37203, United States|Childrens Medical Center of Dallas-Site Number:8400002, Dallas, Texas, 75235, United States|Investigational Site Number :0320002, Caba, Buenos Aires, C1181ACH, Argentina|Investigational Site Number :0320006, Capital Federal, Buenos Aires, C1425DUC, Argentina|Investigational Site Number :0320005, Buenos Aires, C1118AAT, Argentina|Investigational Site Number :0320004, Buenos Aires, C1245AAM, Argentina|Investigational Site Number :0760013, Curitiba, Paraná, 80250-060, Brazil|Investigational Site Number :0760006, Curitiba, Paraná, 81520-060, Brazil|Investigational Site Number :0760007, Porto Alegre, Rio Grande Do Sul, 90035 003, Brazil|Investigational Site Number :0760010, Jau, São Paulo, 17210-070, Brazil|Investigational Site Number :0760009, Ribeirao Preto, São Paulo, 14048-900, Brazil|Investigational Site Number :0760001, Sao Paulo, São Paulo, 08270-070, Brazil|Investigational Site Number :0760004, Sao Paulo, São Paulo, 4023-062, Brazil|Investigational Site Number :2080001, Copenhagen, 2100, Denmark|Investigational Site Number :2500002, Lille, 59037, France|Investigational Site Number :2500003, Lyon, 69008, France|Investigational Site Number :2500001, PARIS Cedex 12, 75571, France|Investigational Site Number :2500004, PARIS Cedex 19, 75935, France|Investigational Site Number :2760005, Erlangen, 91054, Germany|Investigational Site Number :2760003, Hamburg, 20246, Germany|Investigational Site Number :2760006, Münster, 48149, Germany|Investigational Site Number :3000001, Athens, 115 27, Greece|Investigational Site Number :3480002, Budapest, 1094, Hungary|Investigational Site Number :3800002, Genova, Liguria, 16147, Italy|Investigational Site Number :3800001, Monza, Lombardia, 20900, Italy|Investigational Site Number :3800003, Torino, Piemonte, 10126, Italy|Investigational Site Number :3800005, Verona, Veneto, 37126, Italy|Investigational Site Number :4100001, Seoul, Seoul-teukbyeolsi, 03080, Korea, Republic of|Investigational Site Number :4100002, Seoul, Seoul-teukbyeolsi, 06351, Korea, Republic of|Investigational Site Number :4100004, Seoul, Seoul-teukbyeolsi, 137-701, Korea, Republic of|Investigational Site Number :4840001, Monterrey, Nuevo León, 64460, Mexico|Investigational Site Number :4840005, Col. Rancho Menchaca, Querétaro, 76140, Mexico|Investigational Site Number :5280001, Utrecht, 3584 CS, Netherlands|Investigational Site Number :5780001, Bergen, 5021, Norway|Investigational Site Number :5780002, Oslo, 0342, Norway|Investigational Site Number :6040001, Arequipa, Peru|Investigational Site Number :6040002, Lima, 34, Peru|Investigational Site Number :6200002, Coimbra, 3000-602, Portugal|Investigational Site Number :6200001, Lisboa, 1099-023, Portugal|Investigational Site Number :6200003, Porto, 4200-162, Portugal|Investigational Site Number :7520001, Göteborg, 416 85, Sweden", Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/44/NCT03860844/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/44/NCT03860844/SAP_001.pdf, criteria: "Inclusion criteria:~* Participant 28 days to less than 18 years of age, at the time of signing the informed consent.~* Participants must have had a confirmed diagnosis of relapsed Acute Lymphoblastic Leukemia (ALL) of T- or B-cell origin including T-lymphoblastic lymphoma (LBL), or relapsed Acute Myeloblastic Leukemia (AML) including participants with history of myelodysplasia.~* Participants must have been previously treated for their disease and have relapsed or are refractory to most recent treatment. Participants in first or second relapse were eligible regardless of the remission duration.~* Participants who had no more than 1 prior salvage therapy.~* White Blood Cell (WBC) counts below 20 x10\\\\^9/L on Day 1 before isatuximab administration~Exclusion criteria:~* Any serious active disease or co-morbid condition which, in the opinion of the Investigator, may interfere with the safety of the study treatment or the compliance with the study protocol.~* Participants must have been off prior treatment with immunotherapy/investigational agents and chemotherapy for \\\\>2 weeks and must have recovered from acute toxicity before the first study treatment administration. Exceptions were participants who needed to receive cytoreductive chemotherapy in order to decrease tumor burden (the study treatment may have started earlier if necessitated by the patient\\s medical condition (eg, rapidly progressive disease) following discussion with the Sponsor).~* Prior stem cell transplant within 3 months and/or evidence of active systemic Graft versus Host Disease (GVHD) and/or immunosuppressive therapy for GVHD within 1 week before the first study treatment administration.~* Participants with LBL with bone marrow blasts \\\\<5%.~* Participants with Burkitt-type ALL.~* Acute leukemia with testicular or central nerve system involvement alone.~* Participants who had developed therapy related acute leukemia.~* Live vaccine(s) within 30 days prior to the first IMP administration or plans to receive such vaccines during the study until 90 days after the last IMP administration.~* Participants with white blood cell count \\\\> 50 x10\\\\^9/L at the time of screening visit.~* Participants who had been exposed to anti-CD38 therapies within 6 months prior to Day-1.~The above information was not intended to contain all considerations relevant to a patient\\s potential participation in a clinical trial.", combined_text: Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia Percentage of Participants With Complete Response (CR) Rate, The complete response rate (CR + CRi \\\\[complete response with incomplete peripheral recovery\\\\]) was defined as the percentage of participants achieving complete response (CR + CRi) assessed by the investigator per National Comprehensive Cancer Network (NCCN) guidelines version 1.2018 criteria. CR was defined as \\\\<5% blasts in a bone marrow aspirate (BMA) with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL); Absolute neutrophil count (ANC) \\\\>=1000/microliter (mcL); platelets \\\\>100000/mcL; red blood cell transfusion independence. If the physician documented transfusion dependency related to study treatment and not to the participant\\s underlying disease, CRi was reported. CRi met the same criteria as for CR, except neutrophils and/or platelets recovery (ANC \\\\<1000/mcL or platelets \\\\<100000/mcL)., From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs), An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as an AE which occurred after the first dose of study treatment administration until the last dose plus 30 days, or until the start of hematological recovery period or a new anti-leukemia/lymphoma therapy, whichever occurred first., From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)|Number of Participants With Infusion Reactions (IRs), An IR was an AE related to isatuximab typically with onset within 24 hours from the start of the isatuximab infusion and was reported by the investigator., From the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort)|B-ALL and T-ALL: Area Under the Concentration Time Curve (AUC) of Isatuximab, Plasma samples were collected at specified timepoints to determine the AUC of isatuximab., From Week 0 to Week 1, Week 0 to Week 5, and Week 0 to Week 10|AML: AUC of Isatuximab, Plasma samples were collected at specified timepoints to determine the AUC of isatuximab., From Week 0 to Week 1, Week 0 to Week 3, and Week 0 to Week 8|B-ALL and T-ALL: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough), Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab., Cycle 1 Day 8, Cycle 1 Day 15, Cycle 1 Day 22, Cycle 1 Day 29, Cycle 2 Day 43, Cycle 2 Day 57|AML: Plasma Concentration Reached by Isatuximab Before Next Dose Administration (Ctrough), Plasma samples were collected at specified timepoints to determine the Ctrough of isatuximab., Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 2 Day 15|B-ALL and T-ALL: Concentrations at the End of Infusion (Ceoi) of Isatuximab, Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab., At end of infusion on Cycle 1 Days 1 and 29|AML: Ceoi of Isatuximab, Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab., At end of infusion on Cycle 1 Days 1 and 15|Number of Participants With Negative Minimal Residual Disease (MRD), MRD assessment was performed centrally by next generation sequencing using clonoSEQ and T-cell receptor assays for B-ALL and T-ALL cohorts respectively. It was performed by flow cytometry for AML cohort. Number of participants with CR or CRi who achieved negative MRD in bone marrow and blood was analyzed. In AML indication, peripheral blood tissue is not representative of the tumor burden and cannot be used to assess MRD., From screening until the study completion date, approximately 45 months|Overall Response Rate (ORR), ORR:Percentage of participants with CR/CRi or partial response (PR) for blood and bone marrow disease based on NCCN guideline. CR: \\\\<5% blasts in BMA with spicules; no circulating blasts (ALL)/no blasts with Auer rods (AML) or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement (ALL), trilineage hematopoiesis (ALL);ANC \\\\>=1000/mcL; platelets \\\\>100000/mcL; RBC transfusion independence. If the physician documented transfusion dependency related to study treatment;not to participant\\s underlying disease, CRi was reported. CRi met the same criteria as CR, except neutrophils and/or platelets recovery (ANC \\\\<1000/mcL or platelets \\\\<100000/mcL). PR: \\\\>50% decrease in the sum of the product of the greatest perpendicular diameters of the mediastinal enlargement. For participants with a previous positive positron emission tomography (PET) scan, a post-treatment PET was to be positive in at least 1 previously involved site., From enrollment until the primary analysis completion date of 12 Sep 2022; the median duration of exposure was approximately 7 weeks|Overall Survival (OS), Overall survival was defined as the time interval from the date of first study treatment administration to death from any cause. It was estimated using the Kaplan-Meier method. Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley., From first study treatment administration up to death due to any cause, a maximum of 45 months|Event-Free Survival (EFS), EFS was defined as the time interval from the date of first study treatment administration to the date of the first of: completion or going off protocol induction/consolidation therapy without CR, relapse from CR, or death due to any cause, whichever occurred first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley., From study treatment administration up to the date of first documented disease progression or death due to any cause, a maximum of 45 months|Duration of Response (DoR), Duration of response was defined as the time from the date of the first response to the date of first disease progression or death from any cause, whichever happens first. It was estimated using the Kaplan-Meier method. CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley., From first documented response up to the date of first documented disease progression or death due to any cause, a maximum of 45 months|Cluster of Differentiation (CD)38 Receptor Density, Blood samples were collected to assess CD38 receptor density as a predictive biomarker. It was assessed across complete responders and non-complete responders. The Antibody Binding Capacity (ABC) was calculated using the following equation: ABC = 10\\\\^(Logarithm(Mean Fluorescence Intensity)\\\\*a+b) where "a" was the slope and "b" was the Y-intercept of the calibration curve equation. Specific and absolute quantitative values (specific antibody-binding capacity \\\\[sABC\\\\]) of binding of the selected antibodies were calculated after subtraction of the negative isotypic immunoglobulin G (IgG) control., Pre-dose on Day 1|CD38 Receptor Occupancy, Blood samples were collected to assess CD38 receptor occupancy as a pharmacodynamics marker. It was assessed across complete responders and non-complete responders. Multicolor flow cytometry assay was validated for CD38 receptor occupancy (CD38RO) quantification, based on the use of two murine monoclonal antibodies (MAbs), one competing with SAR650984 to determine the number of free CD38 receptors (MAb1) and one recognizing a different binding epitope on CD38 to measure the total number of receptors (MAb2) at the cell surface of the cancer cells. Cells were tagged with either MAb1 (Tube #1) or MAb2 (Tube #2). The percentage RO was calculated using the following equation: % CD38RO = \\\\[(sABC MAb2 - sABC MAb1)/sABC MAb2\\\\] X 100., Pre-dose on Day 15 "Inclusion criteria:~* Participant 28 days to less than 18 years of age, at the time of signing the informed consent.~* Participants must have had a confirmed diagnosis of relapsed Acute Lymphoblastic Leukemia (ALL) of T- or B-cell origin including T-lymphoblastic lymphoma (LBL), or relapsed Acute Myeloblastic Leukemia (AML) including participants with history of myelodysplasia.~* Participants must have been previously treated for their disease and have relapsed or are refractory to most recent treatment. Participants in first or second relapse were eligible regardless of the remission duration.~* Participants who had no more than 1 prior salvage therapy.~* White Blood Cell (WBC) counts below 20 x10\\\\^9/L on Day 1 before isatuximab administration~Exclusion criteria:~* Any serious active disease or co-morbid condition which, in the opinion of the Investigator, may interfere with the safety of the study treatment or the compliance with the study protocol.~* Participants must have been off prior treatment with immunotherapy/investigational agents and chemotherapy for \\\\>2 weeks and must have recovered from acute toxicity before the first study treatment administration. Exceptions were participants who needed to receive cytoreductive chemotherapy in order to decrease tumor burden (the study treatment may have started earlier if necessitated by the patient\\s medical condition (eg, rapidly progressive disease) following discussion with the Sponsor).~* Prior stem cell transplant within 3 months and/or evidence of active systemic Graft versus Host Disease (GVHD) and/or immunosuppressive therapy for GVHD within 1 week before the first study treatment administration.~* Participants with LBL with bone marrow blasts \\\\<5%.~* Participants with Burkitt-type ALL.~* Acute leukemia with testicular or central nerve system involvement alone.~* Participants who had developed therapy related acute leukemia.~* Live vaccine(s) within 30 days prior to the first IMP administration or plans to receive such vaccines during the study until 90 days after the last IMP administration.~* Participants with white blood cell count \\\\> 50 x10\\\\^9/L at the time of screening visit.~* Participants who had been exposed to anti-CD38 therapies within 6 months prior to Day-1.~The above information was not intended to contain all considerations relevant to a patient\\s potential participation in a clinical trial.", Similarity Score: 0.20188572406844996}'}]
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from_dataset
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[{'from': 'human', 'value': '{Study Title: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice, Primary Outcome Measures: Progressive-Free Survival (PFS), PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\\\\>=) 50 percent (%) of previously involved sites from nadir., Approximately up to 5 years, Secondary Outcome Measures: "Overall Response Rate (ORR), ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician., Approximately up to 5 years|Time to First Response, Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response., Approximately up to 5 years|Time to Best Response, Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response., Approximately up to 5 years|Duration of Response, Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \\\\>=50% of previously involved sites from nadir., Approximately up to 5 years|Overall survival (OS), Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death., Approximately up to 5 years|Duration of Ibrutinib Therapy, Duration of ibrutinib therapy in CLL and MCL participants will be reported., Approximately up to 5 years|Duration of a Treatment-Free Period, Duration of treatment-free period in CLL and MCL participants will be reported., Every 6 months (Approximately up to 5 years)|Duration of the First Non-Ibrutinib Subsequent Therapy Period, Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported., Approximately up to 5 years|Participants Daily Dose, Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed., Approximately up to 5 years|Number of Participants Who Require Dose Modifications, Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported., Approximately up to 5 years|Number of Medications Added, Number of medications added in the CLL and MCL treatment will be reported., Approximately up to 5 years", criteria: "Inclusion Criteria:~* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:~ 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or~ 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or~ 3. treatment of participants with relapsed or refractory MCL~* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Has not participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program~* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification~Exclusion Criteria:~* Currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 715, Unnamed: 0: 896, NCT Number: NCT04305444, Study Title: "Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkins Lymphomas", Study URL: https://clinicaltrials.gov/study/NCT04305444, Acronym: , Study Status: ACTIVE_NOT_RECRUITING, Brief Summary: "Targeted drug therapies have greatly improved outcomes for patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) and non-Hodgkins lymphoma. However, single drug therapies have limitations, therefore, the current study is evaluating a novel oral combination of targeted drugs as a way of overcoming these limitations. This study will determine the efficacy of the triple combination therapy, DTRM-555, in patients with R/R CLL or R/R non-Hodgkins lymphoma.", Study Results: NO, Conditions: "Relapsed Chronic Lymphocytic Leukemia|Refractory Chronic Lymphocytic Leukemia|Diffuse Large B Cell Lymphoma|Follicular Lymphoma|Richters Transformation", Interventions: DRUG: DTRM-555, Primary Outcome Measures: Complete Responses (CR) and Partial Responses (PR) with DTRM-555 in the five disease-specific cohorts, Response in lymphoma patients will be assessed according to Lugano 2014 criteria guidelines for response assessment of Hodgkin and non-Hodgkin lymphoma. Response in CLL patients will be assessed according to International Workshop on CLL (iwCLL) 2018 criteria for treatment of CLL., 24 months, Secondary Outcome Measures: Treatment-Emergent Adverse Events (AEs) in the five disease-specific cohorts, Percentage of participants with Treatment-Emergent Adverse Events (AEs), 24 months|Overall Response Rate (ORR) with DTRM-555 in the five disease-specific cohorts, Response in lymphoma patients will be assessed according to Lugano 2014 criteria guidelines for response assessment of Hodgkin and non-Hodgkin lymphoma. Response in CLL patients will be assessed according to iwCLL 2018 criteria for treatment of CLL., 6, 12 and 24 months|Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine key pharmacokinetic parameters for the three drugs, Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine Area Under the Curves (AUC), 24 hours|Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine key pharmacokinetic parameters for the three drugs, Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine Maximum Observed Plasma or Blood Concentrations (Cmax), 24 hours|Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine key pharmacokinetic parameters for the three drugs, Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine the Times to Reach Cmax (tmax), 24 hours|Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine key pharmacokinetic parameters for the three drugs, Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine Elimination Half-Lives (t1/2), 24 hours, Other Outcome Measures: , Sponsor: Zhejiang DTRM Biopharma, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 120.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: DTRM-555_001, Start Date: 2020-04-24, Primary Completion Date: 2024-12, Completion Date: 2024-12, First Posted: 2020-03-12, Results First Posted: , Last Update Posted: 2024-08-29, Locations: Mayo Clinic, Phoenix, Arizona, 85054, United States|Yale - Smillow Cancer Hospital, New Haven, Connecticut, 06511, United States|Mayo Clinic, Jacksonville, Florida, 32224, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Duke Cancer Institute, Durham, North Carolina, 27710, United States|University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, 19104, United States|VA Medical Center - Memphis, Memphis, Tennessee, 38104-2127, United States, Study Documents: , criteria: "Inclusion Criteria:~* Patients must provide written informed consent.~* Patients with a diagnosis of R/R CLL or other B-cell neoplasms (i.e., ABC DLBCL, GCB DLBCL, Richter\\s transformation and tFL) who have no available approved therapies, or patients with a diagnosis of non-Hodgkin\\s lymphoma, which has relapsed and/or is refractory to standard therapy.~ a. Patients with R/R CLL must have been exposed to Bruton\\s tyrosine kinase (BTK) or B-Cell CLL/Lymphoma 2 (BCL2) inhibitor-based therapy in prior lines of therapy but must not have known Cys481 resistance mutation prior to study enrollment.~* Age ≥ 18 years.~* Life expectancy greater than 12 weeks.~* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~* Ability to swallow and retain capsules and/or tablets.~* Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.~* If the patient consents to an optional tumor biopsy, he/she must have a tumor that can be safely biopsied and undergo a baseline tumor biopsy procedure, or be willing to provide available archival tissue collected within 6 months of signing the Informed Consent Form (ICF), and one post-Cycle 1 treatment biopsy.~* Patients must have at least one target lesion according to Lugano Classification. Patients with R/R CLL are exempt from this requirement.~* Women of child-bearing potential must have a negative serum or urine pregnancy test.~* Women of child-bearing potential must agree to use 2 reliable methods of contraception beginning 4 weeks prior to the initiation of treatment, during therapy, and for at least 4 weeks after the last drug administration.~* Men must agree to use a latex or synthetic condom during sexual contact with a pregnant female or a female of child-bearing potential, for the duration of the study and for at least 4 weeks after the last drug administration, even if they have undergone a successful vasectomy.~Exclusion Criteria:~* Received prior systemic anticancer treatment within the following time frames:~ 1. Chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 21 days prior to starting study treatment.~ 2. Targeted therapies within 5 biological half-lives prior to starting study treatment.~* Patients with active infections requiring therapy are not eligible for entry into the study until resolution of the infection; however, patients on prophylactic antibiotics, antifungals or antivirals are eligible for entry into the study.~* Pregnant or lactating individuals.~* Impaired hepatic or renal function as demonstrated by any of the following laboratory values:~ 1. Aspartate transaminase (AST) or alanine transaminase (ALT) \\\\> 2.5 x upper limit of normal (ULN); for patients with liver involvement, \\\\> 5 x ULN~ 2. Total bilirubin \\\\> 1.5 x ULN (Patients with a history of Gilbert\\s syndrome may participate if total bilirubin is less than or equal to 3 x ULN and the AST/ALT and alkaline phosphatase meet the protocol-specified levels for eligibility)~ 3. Alkaline phosphatase \\\\> 2.5 x ULN~ 4. Glomerular filtration rate \\\\< 50 mL/min, as assessed using the standard methodology at the investigating center (i.e., Cockcroft-Gault), or serum creatinine \\\\> 1.5 x ULN~* International normalized ratio (INR) \\\\> 1.5 or other evidence of impaired hepatic synthesis function.~* Absolute neutrophil count \\\\< 1.0 x 109/L or platelets \\\\< 100 x 109/L, unless due to disease-related bone marrow impairment as confirmed by bone marrow biopsy during screening or due to standard of care treatment within 2 months prior to signing of informed consent. Patients with bone marrow impairment will be excluded if their absolute neutrophil count (ANC) is \\\\< 0.5 x 109/L and platelets \\\\< 50 x 109/L.~* Previous allogeneic bone marrow transplant is restricted, unless transplant was greater than 3 months prior and there is no evidence of acute or chronic graft versus host disease.~* Central nervous system involvement with malignancy.~* Patients who have poorly controlled diabetes mellitus or whose glucose values cannot be controlled with medical treatment.~* Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer, squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more.~* Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.~* Documented or known bleeding disorder.~* Requirement for anticoagulation treatment that increases INR or activated partial thromboplastin time above the normal range (low molecular weight heparin and heparin line flush allowed).~* Patients requiring the use of strong CYP3A4, CYP1A2, or P-gp inhibitors.~* Patients with a significant cardiovascular disease or condition, including:~ 1. myocardial infarction within 6 months of study entry,~ 2. New York Heart Association Class III or IV heart failure,~ 3. uncontrolled dysrhythmias or poorly controlled angina,~ 4. history of serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia, ≥ 3 beats in a row) and/or risk factors (e.g., heart failure, hypokalemia, or family history of Long QT Syndrome),~ 5. baseline prolongation of QT/QTc interval (repeated demonstration of corrected QT interval (QTc) ≥ 450 msec for men and 470 msec for women), and~ 6. left ventricular ejection fraction (LVEF) \\\\< 45% by multiple gated acquisition (MUGA) and /or echocardiogram (ECHO).", combined_text: Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin\\s Lymphomas Complete Responses (CR) and Partial Responses (PR) with DTRM-555 in the five disease-specific cohorts, Response in lymphoma patients will be assessed according to Lugano 2014 criteria guidelines for response assessment of Hodgkin and non-Hodgkin lymphoma. Response in CLL patients will be assessed according to International Workshop on CLL (iwCLL) 2018 criteria for treatment of CLL., 24 months Treatment-Emergent Adverse Events (AEs) in the five disease-specific cohorts, Percentage of participants with Treatment-Emergent Adverse Events (AEs), 24 months|Overall Response Rate (ORR) with DTRM-555 in the five disease-specific cohorts, Response in lymphoma patients will be assessed according to Lugano 2014 criteria guidelines for response assessment of Hodgkin and non-Hodgkin lymphoma. Response in CLL patients will be assessed according to iwCLL 2018 criteria for treatment of CLL., 6, 12 and 24 months|Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine key pharmacokinetic parameters for the three drugs, Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine Area Under the Curves (AUC), 24 hours|Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine key pharmacokinetic parameters for the three drugs, Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine Maximum Observed Plasma or Blood Concentrations (Cmax), 24 hours|Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine key pharmacokinetic parameters for the three drugs, Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine the Times to Reach Cmax (tmax), 24 hours|Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine key pharmacokinetic parameters for the three drugs, Plasma or blood concentration versus time profiles of DTRMWXHS-12, everolimus and pomalidomide will be evaluated to determine Elimination Half-Lives (t1/2), 24 hours "Inclusion Criteria:~* Patients must provide written informed consent.~* Patients with a diagnosis of R/R CLL or other B-cell neoplasms (i.e., ABC DLBCL, GCB DLBCL, Richter\\s transformation and tFL) who have no available approved therapies, or patients with a diagnosis of non-Hodgkin\\s lymphoma, which has relapsed and/or is refractory to standard therapy.~ a. Patients with R/R CLL must have been exposed to Bruton\\s tyrosine kinase (BTK) or B-Cell CLL/Lymphoma 2 (BCL2) inhibitor-based therapy in prior lines of therapy but must not have known Cys481 resistance mutation prior to study enrollment.~* Age ≥ 18 years.~* Life expectancy greater than 12 weeks.~* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~* Ability to swallow and retain capsules and/or tablets.~* Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.~* If the patient consents to an optional tumor biopsy, he/she must have a tumor that can be safely biopsied and undergo a baseline tumor biopsy procedure, or be willing to provide available archival tissue collected within 6 months of signing the Informed Consent Form (ICF), and one post-Cycle 1 treatment biopsy.~* Patients must have at least one target lesion according to Lugano Classification. Patients with R/R CLL are exempt from this requirement.~* Women of child-bearing potential must have a negative serum or urine pregnancy test.~* Women of child-bearing potential must agree to use 2 reliable methods of contraception beginning 4 weeks prior to the initiation of treatment, during therapy, and for at least 4 weeks after the last drug administration.~* Men must agree to use a latex or synthetic condom during sexual contact with a pregnant female or a female of child-bearing potential, for the duration of the study and for at least 4 weeks after the last drug administration, even if they have undergone a successful vasectomy.~Exclusion Criteria:~* Received prior systemic anticancer treatment within the following time frames:~ 1. Chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 21 days prior to starting study treatment.~ 2. Targeted therapies within 5 biological half-lives prior to starting study treatment.~* Patients with active infections requiring therapy are not eligible for entry into the study until resolution of the infection; however, patients on prophylactic antibiotics, antifungals or antivirals are eligible for entry into the study.~* Pregnant or lactating individuals.~* Impaired hepatic or renal function as demonstrated by any of the following laboratory values:~ 1. Aspartate transaminase (AST) or alanine transaminase (ALT) \\\\> 2.5 x upper limit of normal (ULN); for patients with liver involvement, \\\\> 5 x ULN~ 2. Total bilirubin \\\\> 1.5 x ULN (Patients with a history of Gilbert\\s syndrome may participate if total bilirubin is less than or equal to 3 x ULN and the AST/ALT and alkaline phosphatase meet the protocol-specified levels for eligibility)~ 3. Alkaline phosphatase \\\\> 2.5 x ULN~ 4. Glomerular filtration rate \\\\< 50 mL/min, as assessed using the standard methodology at the investigating center (i.e., Cockcroft-Gault), or serum creatinine \\\\> 1.5 x ULN~* International normalized ratio (INR) \\\\> 1.5 or other evidence of impaired hepatic synthesis function.~* Absolute neutrophil count \\\\< 1.0 x 109/L or platelets \\\\< 100 x 109/L, unless due to disease-related bone marrow impairment as confirmed by bone marrow biopsy during screening or due to standard of care treatment within 2 months prior to signing of informed consent. Patients with bone marrow impairment will be excluded if their absolute neutrophil count (ANC) is \\\\< 0.5 x 109/L and platelets \\\\< 50 x 109/L.~* Previous allogeneic bone marrow transplant is restricted, unless transplant was greater than 3 months prior and there is no evidence of acute or chronic graft versus host disease.~* Central nervous system involvement with malignancy.~* Patients who have poorly controlled diabetes mellitus or whose glucose values cannot be controlled with medical treatment.~* Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer, squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more.~* Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.~* Documented or known bleeding disorder.~* Requirement for anticoagulation treatment that increases INR or activated partial thromboplastin time above the normal range (low molecular weight heparin and heparin line flush allowed).~* Patients requiring the use of strong CYP3A4, CYP1A2, or P-gp inhibitors.~* Patients with a significant cardiovascular disease or condition, including:~ 1. myocardial infarction within 6 months of study entry,~ 2. New York Heart Association Class III or IV heart failure,~ 3. uncontrolled dysrhythmias or poorly controlled angina,~ 4. history of serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia, ≥ 3 beats in a row) and/or risk factors (e.g., heart failure, hypokalemia, or family history of Long QT Syndrome),~ 5. baseline prolongation of QT/QTc interval (repeated demonstration of corrected QT interval (QTc) ≥ 450 msec for men and 470 msec for women), and~ 6. left ventricular ejection fraction (LVEF) \\\\< 45% by multiple gated acquisition (MUGA) and /or echocardiogram (ECHO).", Similarity Score: 0.1991263933754615}'}]
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from_dataset
| 0.199126
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[{'from': 'human', 'value': '{Study Title: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice, Primary Outcome Measures: Progressive-Free Survival (PFS), PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\\\\>=) 50 percent (%) of previously involved sites from nadir., Approximately up to 5 years, Secondary Outcome Measures: "Overall Response Rate (ORR), ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician., Approximately up to 5 years|Time to First Response, Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response., Approximately up to 5 years|Time to Best Response, Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response., Approximately up to 5 years|Duration of Response, Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \\\\>=50% of previously involved sites from nadir., Approximately up to 5 years|Overall survival (OS), Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death., Approximately up to 5 years|Duration of Ibrutinib Therapy, Duration of ibrutinib therapy in CLL and MCL participants will be reported., Approximately up to 5 years|Duration of a Treatment-Free Period, Duration of treatment-free period in CLL and MCL participants will be reported., Every 6 months (Approximately up to 5 years)|Duration of the First Non-Ibrutinib Subsequent Therapy Period, Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported., Approximately up to 5 years|Participants Daily Dose, Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed., Approximately up to 5 years|Number of Participants Who Require Dose Modifications, Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported., Approximately up to 5 years|Number of Medications Added, Number of medications added in the CLL and MCL treatment will be reported., Approximately up to 5 years", criteria: "Inclusion Criteria:~* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:~ 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or~ 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or~ 3. treatment of participants with relapsed or refractory MCL~* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Has not participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program~* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification~Exclusion Criteria:~* Currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 264, Unnamed: 0: 319, NCT Number: NCT05036291, Study Title: A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors, Study URL: https://clinicaltrials.gov/study/NCT05036291, Acronym: , Study Status: RECRUITING, Brief Summary: This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors, Study Results: NO, Conditions: Advanced Solid Tumor, Interventions: DRUG: NB004 tablets, Primary Outcome Measures: Incidence of dose-limiting toxicities----Part 1/2, Dose-limiting toxicities will be reviewed as a subset of adverse events that occurs within the first 28 days of dosing and meet protocol-specified criteria., When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators.|Incidence of adverse events----Part 1/2, An adverse event is any untoward medical occurrence in a participant who received study drug without regard to causal relationship., Approximately 24 months since the first subject enrolled|Objective Response Rate (ORR) ----Part 3, Objective Response Rate (ORR) is defined as the percentage of patients whose efficacy is confirmed as complete response (CR) or partial response (PR), [Time Frame: Approximately 24 months since the first subject enrolled]|Duration of Response (DOR) ----Part 3, DOR is defined as the time from the date of first documented response until date of documented progression, for subjects who achieve CR or PR., [Time Frame: Approximately 24 months since the first subject enrolled]|Time to Response (TTR) ----Part 3, TTR is defined as the time interval between the date of first administration and the date of the first recording of response. At the same time, the initial response time and the time to best response will be calculated., [Time Frame: Approximately 24 months since the first subject enrolled]|Progression-free Survival (PFS) ----Part 3, PFS is defined as the time from the date of the first dose until the date of disease progression, as defined by RECIST v1.1, or death., [Time Frame: Approximately 24 months since the first subject enrolled]|Clinical Benefit Rate (CBR) ----Part 3, CBR is defined as the number of subjects with CR or PR or with SD maintained ≥24 weeks (as assessed by the Investigator, using RECIST v1.1) divided by the number of subjects in the analysis. Subjects without a postbaseline tumor assessment will be considered as having no clinical benefit., [Time Frame: Approximately 24 months since the first subject enrolled]|Overall survival (OS) ----Part 3, OS is defined as the time from treatment start with study drug until event of death due to any cause., [Time Frame: Approximately 24 months since the first subject enrolled], Secondary Outcome Measures: Maximum observed plasma concentration (Cmax)----Part 1, Maximum observed plasma concentration (Cmax), Approximately 24 months since the first subject enrolled|Time to Cmax (Tmax)----Part 1, Time to Cmax (Tmax), Approximately 24 months since the first subject enrolled|Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) ----Part 1, AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last, Approximately 24 months since the first subject enrolled|Terminal elimination half life----Part 1, Terminal elimination half life, Approximately 24 months since the first subject enrolled|Objective Response Rate (ORR)----Part 2, Objective Response Rate (ORR) is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR), Approximately 24 months since the first subject enrolled|Duration of Response(DOR)----Part 2, DOR is defined as the time from the date of first documented response until date of documented progression, for subjects who achieve CR or PR., Approximately 24 months since the first subject enrolled|Clinical Benefit Rate (CBR) ----Part 2, CBR is defined as the number of subjects with CR or PR or with SD maintained ≥24 weeks (as assessed by the Investigator, using RECIST v1.1) divided by the number of subjects in the analysis. Subjects without a postbaseline tumor assessment will be considered as having no clinical benefit., [Time Frame: Approximately 24 months since the first subject enrolled]|Time to Response (TTR) ----Part 2, TTR is defined as the time interval between the date of first administration and the date of the first recording of response. At the same time, the initial response time and the time to best response will be calculated., [Time Frame: Approximately 24 months since the first subject enrolled]|Progression-free Survival (PFS) ----Part 2, PFS is defined as the time from the date of the first dose until the date of disease progression, as defined by RECIST, [Time Frame: Approximately 24 months since the first subject enrolled]|Overall survival (OS) ----Part 2, OS is defined as the time from treatment start with study drug until event of death due to any cause, [Time Frame: Approximately 24 months since the first subject enrolled], Other Outcome Measures: , Sponsor: Ningbo Newbay Technology Development Co., Ltd, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 120.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: NB004-01, Start Date: 2021-10-01, Primary Completion Date: 2025-02-01, Completion Date: 2025-06-01, First Posted: 2021-09-05, Results First Posted: , Last Update Posted: 2023-11-18, Locations: Providence Cancer Institute, Portland, Oregon, 97213, United States|The University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States, Study Documents: , criteria: "Inclusion Criteria:~1. males or females of any race\\\\>(=)18 years age.~2. Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1).~ Pathologically confirmed locally advanced or metastatic solid tumors with KRAS G12C mutation as determined by a test that has been approved by FDA or local health authority (part 2\\\\&3).~3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~4. Life expectancy\\\\>(=)12 weeks.~5. Adequate organ and marrow function.~6. Measurable or evaluable disease.~Exclusion Criteria:~1. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose.~2. Toxicities from previous anti-cancer therapy that have not recovered as required.~3. Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis.~4. Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV):~5. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose.~6. Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose.~7. Received prior treatment with a PIM kinase inhibitor.", combined_text: A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors Incidence of dose-limiting toxicities----Part 1/2, Dose-limiting toxicities will be reviewed as a subset of adverse events that occurs within the first 28 days of dosing and meet protocol-specified criteria., When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators.|Incidence of adverse events----Part 1/2, An adverse event is any untoward medical occurrence in a participant who received study drug without regard to causal relationship., Approximately 24 months since the first subject enrolled|Objective Response Rate (ORR) ----Part 3, Objective Response Rate (ORR) is defined as the percentage of patients whose efficacy is confirmed as complete response (CR) or partial response (PR), [Time Frame: Approximately 24 months since the first subject enrolled]|Duration of Response (DOR) ----Part 3, DOR is defined as the time from the date of first documented response until date of documented progression, for subjects who achieve CR or PR., [Time Frame: Approximately 24 months since the first subject enrolled]|Time to Response (TTR) ----Part 3, TTR is defined as the time interval between the date of first administration and the date of the first recording of response. At the same time, the initial response time and the time to best response will be calculated., [Time Frame: Approximately 24 months since the first subject enrolled]|Progression-free Survival (PFS) ----Part 3, PFS is defined as the time from the date of the first dose until the date of disease progression, as defined by RECIST v1.1, or death., [Time Frame: Approximately 24 months since the first subject enrolled]|Clinical Benefit Rate (CBR) ----Part 3, CBR is defined as the number of subjects with CR or PR or with SD maintained ≥24 weeks (as assessed by the Investigator, using RECIST v1.1) divided by the number of subjects in the analysis. Subjects without a postbaseline tumor assessment will be considered as having no clinical benefit., [Time Frame: Approximately 24 months since the first subject enrolled]|Overall survival (OS) ----Part 3, OS is defined as the time from treatment start with study drug until event of death due to any cause., [Time Frame: Approximately 24 months since the first subject enrolled] Maximum observed plasma concentration (Cmax)----Part 1, Maximum observed plasma concentration (Cmax), Approximately 24 months since the first subject enrolled|Time to Cmax (Tmax)----Part 1, Time to Cmax (Tmax), Approximately 24 months since the first subject enrolled|Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) ----Part 1, AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last, Approximately 24 months since the first subject enrolled|Terminal elimination half life----Part 1, Terminal elimination half life, Approximately 24 months since the first subject enrolled|Objective Response Rate (ORR)----Part 2, Objective Response Rate (ORR) is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR), Approximately 24 months since the first subject enrolled|Duration of Response(DOR)----Part 2, DOR is defined as the time from the date of first documented response until date of documented progression, for subjects who achieve CR or PR., Approximately 24 months since the first subject enrolled|Clinical Benefit Rate (CBR) ----Part 2, CBR is defined as the number of subjects with CR or PR or with SD maintained ≥24 weeks (as assessed by the Investigator, using RECIST v1.1) divided by the number of subjects in the analysis. Subjects without a postbaseline tumor assessment will be considered as having no clinical benefit., [Time Frame: Approximately 24 months since the first subject enrolled]|Time to Response (TTR) ----Part 2, TTR is defined as the time interval between the date of first administration and the date of the first recording of response. At the same time, the initial response time and the time to best response will be calculated., [Time Frame: Approximately 24 months since the first subject enrolled]|Progression-free Survival (PFS) ----Part 2, PFS is defined as the time from the date of the first dose until the date of disease progression, as defined by RECIST, [Time Frame: Approximately 24 months since the first subject enrolled]|Overall survival (OS) ----Part 2, OS is defined as the time from treatment start with study drug until event of death due to any cause, [Time Frame: Approximately 24 months since the first subject enrolled] "Inclusion Criteria:~1. males or females of any race\\\\>(=)18 years age.~2. Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1).~ Pathologically confirmed locally advanced or metastatic solid tumors with KRAS G12C mutation as determined by a test that has been approved by FDA or local health authority (part 2\\\\&3).~3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~4. Life expectancy\\\\>(=)12 weeks.~5. Adequate organ and marrow function.~6. Measurable or evaluable disease.~Exclusion Criteria:~1. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose.~2. Toxicities from previous anti-cancer therapy that have not recovered as required.~3. Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis.~4. Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV):~5. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose.~6. Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose.~7. Received prior treatment with a PIM kinase inhibitor.", Similarity Score: 0.19764165331475983}'}]
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from_dataset
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[{'from': 'human', 'value': '{Study Title: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice, Primary Outcome Measures: Progressive-Free Survival (PFS), PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\\\\>=) 50 percent (%) of previously involved sites from nadir., Approximately up to 5 years, Secondary Outcome Measures: "Overall Response Rate (ORR), ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician., Approximately up to 5 years|Time to First Response, Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response., Approximately up to 5 years|Time to Best Response, Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response., Approximately up to 5 years|Duration of Response, Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \\\\>=50% of previously involved sites from nadir., Approximately up to 5 years|Overall survival (OS), Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death., Approximately up to 5 years|Duration of Ibrutinib Therapy, Duration of ibrutinib therapy in CLL and MCL participants will be reported., Approximately up to 5 years|Duration of a Treatment-Free Period, Duration of treatment-free period in CLL and MCL participants will be reported., Every 6 months (Approximately up to 5 years)|Duration of the First Non-Ibrutinib Subsequent Therapy Period, Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported., Approximately up to 5 years|Participants Daily Dose, Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed., Approximately up to 5 years|Number of Participants Who Require Dose Modifications, Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported., Approximately up to 5 years|Number of Medications Added, Number of medications added in the CLL and MCL treatment will be reported., Approximately up to 5 years", criteria: "Inclusion Criteria:~* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:~ 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or~ 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or~ 3. treatment of participants with relapsed or refractory MCL~* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Has not participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program~* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification~Exclusion Criteria:~* Currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 171, Unnamed: 0: 209, NCT Number: NCT03565991, Study Title: Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors, Study URL: https://clinicaltrials.gov/study/NCT03565991, Acronym: , Study Status: TERMINATED, Brief Summary: Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect., Study Results: YES, Conditions: Locally Advanced or Metastatic Solid Tumors|Genes, BRCA 1, Interventions: DRUG: Avelumab|DRUG: Talazoparib, Primary Outcome Measures: Percentage of Participants With Confirmed Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR), For participants with solid tumors, except metastatic Castration Resistant Prostate Cancer (mCRPC), OR was defined as a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1), both confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. For participants with mCRPC, OR was defined as the percentage of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 with no evidence of confirmed bone disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria. Per RECIST v1.1, CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Non-target PR lesions must be non-Progressive Disease (PD), where PD was unequivocal progression of pre-existing lesions., From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months, Secondary Outcome Measures: "Number of Participants With Treatment-Emergent Adverse Events (TEAEs), An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device. TEAEs were those events with onset dates occurring during the on-treatment period. A Serious Adverse Event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE., From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately|Number of Participants With New or Worsening Hematology Laboratory Test Results During the On-Treatment Period, The laboratory results were graded according to the CTCAE v4.03 severity grade whenever applicable. Laboratory test abnormalities were summarized according to worst toxicity grade observed for each laboratory test. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day)., From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately|Number of Participants With New or Worsening Chemistry Laboratory Test Results During the On-Treatment Period, The laboratory results were graded according to the CTCAE v4.03 severity grade whenever applicable. Laboratory test abnormalities were summarized according to worst toxicity grade observed for each laboratory test. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day)., From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately|Serum Lowest (Trough) Concentration (Ctrough) of Avelumab, Ctrough was defined as predose concentration during multiple dosing. The determination method of Ctrough was observing directly from data. The lower limit of quantification (LLQ) was 0.2 mcg/mL. For Cycle 1 Day 1, as the number of observations above lower limit of quantification (NALQ) = 0, summary statistics were not presented., Predose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1|Serum Maximum Concentration (Cmax) for Avelumab, Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data., One hour post-dose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1|Plasma Ctrough for Talazoparib, Ctrough was defined as predose concentration during multiple dosing. The determination method of Ctrough was observing directly from data. The lower limit of quantification (LLQ) was 25 pg/mL. For Cycle 1 Day 1, as the number of observations above lower limit of quantification (NALQ) = 0, summary statistics were not presented. Evaluable participants were participants with non-missing Ctrough concentrations at each specific time point and meeting 2 conditions: participants received 14 consecutive days of talazoparib dose without dosing interruption prior to sample collection (except on Cycle 1 Day 1) and sample collection within 24 hours ± 10% (2 hours and 24 minutes) after the previous days dose and no more than 5 minutes (0.083 hours) after the administration of the dose on the day of PK sample collection. Predose PK samples on Cycle 1 Day 1 must have been collected prior to dose., Predose on Cycle 1 Days 1, 15 and Cycle 3 Day 1|Plasma Post-dose Concentrations for Talazoparib, In this OM, the post-dose concentrations for talazoparib in plasma were reported., Postdose (samples collected within 2 hours post dose plus/minus 12 minutes) on Days 1,15 of Cycle 1, and Day 1 of Cycle 3|Number of Participants by Avelumab Anti-drug Antibody (ADA) Categories, Blood samples were assayed for ADA using a validated assay. ADA never-positive = no positive ADA results at any time point. ADA ever-positive =at least one positive ADA result at any time point. Baseline ADA positive =a positive ADA result at baseline. Treatment-boosted ADA =a positive ADA result at baseline and the titer \\\\>=8×baseline titer at least once after treatment with avelumab. Treatment-induced ADA = participant was ADA-negative at baseline and had at least one positive post-baseline ADA result; or the participant had at least one positive post-baseline ADA result if no baseline sample. Transient ADA response = participants with treatment-induced ADA had (a single positive ADA result or duration between first and last positive result \\\\<16 weeks) and ADA result at the last assessment was not positive. Persistent ADA response =participants with treatment-induced ADA had duration between first and last positive ADA result \\\\>=16 weeks or a positive ADA result at the last assessment., Predose (within 2 hours before start of avelumab infusion) on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1|Number of Participants With Neutralizing Antibodies (Nab) Levels Against Avelumab Ever-Positive, Nab ever-positive was defined as at least one positive Nab result at any time point. Samples positive for ADA with persistent treatment-induced ADA response could be analyzed for Nab., Predose (within 2 hours before start of avelumab infusion) on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1|Percentage of Participants With Confirmed OR as Assessed by The Investigator, For participants with solid tumors, except mCRPC, OR was defined as a CR or PR per RECIST v1.1, both confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. For participants with mCRPC, OR was defined as the percentage of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 with no evidence of confirmed bone disease progression per PCWG3 criteria. Per RECIST v1.1, CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Non-target PR lesions must be non-PD, where PD was unequivocal progression of pre-existing lesions., From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to approximately 24 months|Time to Tumor Response (TTR) as Assessed by BICR, For participants with solid tumors, except mCRPC: TTR was defined for participants with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC: TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a Best Overall Response (BOR) of CR or PR per RECIST v1.1., Baseline up to approximately 24 months|TTR as Assessed by Investigator, For participants with solid tumors, except mCRPC: TTR was defined for participants with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC: TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a BOR of CR or PR per RECIST v1.1., Baseline up to approximately 24 months|Duration of Response (DoR) as Assessed by BICR, For participants with solid tumors, except mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occured first. For participants with mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST v1.1 and no evidence of confirmed bone disease progression by PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occured first. Radiographic progression was defined as soft tissue progression evaluated per RECIST v1.1 or bone disease progression evaluated per PCWG3., Baseline up to approximately 24 months|DoR as Assessed by Investigator, For participants with solid tumors, except mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. For participants with mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST v1.1 and no evidence of confirmed bone disease progression by PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occurred first. Radiographic progression was defined as soft tissue progression evaluated per RECIST v1.1 or bone disease progression evaluated per PCWG3., Baseline up to approximately 24 months|Progression Free Survival (PFS) as Assessed by BICR, For participants with solid tumors, except mCRPC: PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC: PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue evaluated per RECIST v1.1, in bone evaluated per PCWG3, or death, whichever occurred first., Baseline up to approximately 24 months|PFS as Assessed by Investigator, For participants with solid tumors, except mCRPC: PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC: PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue evaluated per RECIST v1.1, in bone evaluated per PCWG3, or death, whichever occurred first., Baseline up to approximately 24 months|Overall Survival (OS) for All Participants, OS was defined as the time from the first dose of study treatment to the date of death. Participants without an event (death) were censored at the date of last contact., Baseline up to approximately 24 months|Time to Prostate-Specific Antigen (PSA) Progression for Participants With mCRPC, For participants with mCRPC, time to PSA progression was defined as the time from the first dose to the date that a \\\\>=25% increase in PSA with an absolute increase of \\\\>=2 μg/L (2 ng/mL) above the nadir (or baseline for participants with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained \\\\>=3 weeks (21 days) later., Baseline up to approximately 24 months|Number of Participants With Confirmed PSA Response, For participants with mCRPC, PSA response was defined as confirmed PSA decline \\\\>=50% compared to baseline. PSA response was calculated as a decline from baseline PSA (ng/mL) to the maximal PSA response with a threshold of 50%. A PSA response must have been confirmed by a second consecutive value at least 3 weeks later., Baseline up to approximately 24 months|Number of Participants With Circulating Tumor Cell (CTC) Count Conversion, For participants with mCRPC, CTC count conversion was defined as a decrease in CTC count from \\\\>=5 CTC per 7.5 mL of blood at baseline to \\\\<5 CTC per 7.5 mL of blood anytime on study., Day 1 of Cycle 1 to Cycle 4|Number of Participants With Cancer Antigen 125 (CA-125) Response, For participants with ovarian cancer, CA-125 response was defined as at least a 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days., Baseline, Day 1 of each treatment Cycle, maximum up to 4.3 years approximately|Number of Participants With Positive Programmed Death Ligand 1 (PD-L1) Expression in Baseline Tumor Tissue, PD-L1 expression on tumor and infiltrating immune cells was measured by immunohistochemistry (IHC). PD-L1 expression level was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest. This OM reported the number of participants classified as positive according to scoring algorithms and cut-offs established from external sources., Baseline|Number of Participants With Different Status for Defects in BRCA1, BRCA2 and ATM, Participants were enrolled in the two cohorts based on BRCA 1/2 and ATM defect status assessed by the local laboratory. The participant BRCA and ATM status was assessed retrospectively by central laboratory, that may differ from the status assessed by the local laboratory. The ATM participants with a negative ATM status per the central laboratory were reported to have a positive ATM status per the local laboratory. Therefore, participants with negative ATM status might have been included in the ATM defect cohort. For defects in BRCA1, BRCA2 and ATM by central laboratory analysis, participants were classified as positive, negative, not analyzable or missing. The number of participants in each category of BRCA 1 defect, BRCA 2 defect, BRCA 1 or BRCA 2 defect and ATM defect were presented., Baseline|Number of Participants by Status of Tumor Mutational Burden (TMB) at Baseline, TMB was defined as the total number of mutations in the tumor genome, or number of mutations per megabase of DNA if derived from targeted sequencing. TMB categories were defined as high, low for a number of mutations per megabase \\\\>=10 and \\\\<10, respectively. The TMB category Not analyzable included participants with available samples but not evaluable. The TMB category Missing included participants with no sample available. The number of participants in each category at only baseline were tabulated., Baseline", Other Outcome Measures: , Sponsor: Pfizer, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 202.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: B9991032|2018-000345-39, Start Date: 2018-06-18, Primary Completion Date: 2022-03-28, Completion Date: 2023-02-03, First Posted: 2018-06-21, Results First Posted: 2023-08-07, Last Update Posted: 2023-09-25, Locations: "Stanford Cancer Center, Palo Alto, California, 94304, United States|Stanford Womens Cancer Center, Palo Alto, California, 94304, United States|Stanford Healthcare, Stanford, California, 94305, United States|Stanford University School of Medicine, Stanford, California, 94305, United States|Atlanta Cancer Care -Alpharetta, Alpharetta, Georgia, 30005, United States|Northside Hospital, Inc. - GCS/Athens, Athens, Georgia, 30606, United States|Northside Hospital, Inc. - GCS/Annex, Atlanta, Georgia, 30341, United States|Atlanta Cancer Care - Atlanta, Atlanta, Georgia, 30342, United States|Northside Hospital, Inc. - Central Research Department, Atlanta, Georgia, 30342, United States|Northside Hospital, Inc. - GCS/Northside, Atlanta, Georgia, 30342, United States|Northside Hospital, Inc. - GCS/Canton, Canton, Georgia, 30114, United States|Atlanta Cancer Care - Cumming, Cumming, Georgia, 30041, United States|Atlanta Cancer Care - Decatur, Decatur, Georgia, 30033, United States|Northside Hospital, Inc.-GCS/Stemmer, Decatur, Georgia, 30033, United States|Atlanta Cancer Care - Stockbridge, Jonesboro, Georgia, 30236, United States|Northside Hospital, Inc.-GCS/Macon, Macon, Georgia, 31217, United States|Northside Hospital, Inc.-GCS/Kennestone, Marietta, Georgia, 30060, United States|Ochsner Clinic Foundation, New Orleans, Louisiana, 70121, United States|Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States|Dana Farber Cancer institute, Boston, Massachusetts, 02215, United States|Siteman Cancer Center - West County, Creve Coeur, Missouri, 63141, United States|Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States|Washington University Infusion Center Pharmacy, Saint Louis, Missouri, 63110, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Siteman Cancer Center - South County, Saint Louis, Missouri, 63129, United States|Siteman Cancer Center - North County, Saint Louis, Missouri, 63136, United States|Siteman Cancer Center - St.Peters, Saint Peters, Missouri, 63376, United States|Memorial Sloan Kettering Cancer Center- Monmouth, Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Cancer Center- Westchester, Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy, Long Island City, New York, 11101, United States|Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, 10016, United States|Laura and Isaac Perlmutter Cancer Center, New York, New York, 10016, United States|NY Investigational Pharmacy, New York, New York, 10016, United States|NYU Langone Medical Center, New York, New York, 10016, United States|NYU Langone Radiology - 32nd Street, New York, New York, 10016, United States|NYU Langone Radiology Ambulatory Care Center East 41st Street, New York, New York, 10017, United States|Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street)., New York, New York, 10021, United States|Rockefeller Outpatient Center, New York, New York, 10022, United States|Rockefeller Outpatient Pavilion (53rd Street), New York, New York, 10022, United States|Evelyn H. Lauder Breast and Imaging Center, New York, New York, 10065, United States|Memorial Hospital, New York, New York, 10065, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|White Plains Hospital, White Plains, New York, 10601, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, 43210, United States|The Ohio State University, Columbus, Ohio, 43210, United States|Stephanie Spielman Comprehensive Breast Cancer, Columbus, Ohio, 43212, United States|Martha Morehouse Medical Plaza, Columbus, Ohio, 43221, United States|OSU Gynecologic Oncology at Mill Run, Hilliard, Ohio, 43026, United States|Stephenson Cancer Center, Oklahoma City, Oklahoma, 73104, United States|Hospital of the University of Pennsylvania/Penn Investigational Drug Services, Philadelphia, Pennsylvania, 19104, United States|Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Penn IDS Central, Philadelphia, Pennsylvania, 19104, United States|Magee-Womens Hospital Womens Cancer Center, Pittsburgh, Pennsylvania, 15213, United States|UPMC Hillman Cancer Center Investigational Drug Service, Pittsburgh, Pennsylvania, 15232, United States|UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, 15232, United States|Tennessee Oncology, PLLC, Chattanooga, Tennessee, 37404, United States|The Sarah Cannon Research Institute, Chattanooga, Tennessee, 37404, United States|Tennessee Oncology, PLLC, Cleveland, Tennessee, 37311, United States|Tennessee Oncology, PLLC, Dickson, Tennessee, 37055, United States|Tennessee Oncology, PLLC, Franklin, Tennessee, 37067, United States|Tennessee Oncology, PLLC, Gallatin, Tennessee, 37066, United States|Tennessee Oncology, PLLC, Hermitage, Tennessee, 37076, United States|Tennessee Oncology, PLLC, Lebanon, Tennessee, 37090, United States|Tennessee Oncology, PLLC, Murfreesboro, Tennessee, 37129, United States|Tennessee Oncology, PLLC, Nashville, Tennessee, 37203, United States|The Sarah Cannon Research Institute, Nashville, Tennessee, 37203, United States|Tennessee Oncology, PLLC, Nashville, Tennessee, 37205, United States|Tennessee Oncology, PLLC, Nashville, Tennessee, 37207, United States|Tennessee Oncology, PLLC, Nashville, Tennessee, 37211, United States|Tennessee Oncology, PLLC, Shelbyville, Tennessee, 37160, United States|Tennessee Oncology, PLLC, Smyrna, Tennessee, 37167, United States|The University of Texas, Houston, Texas, 77030, United States|Institut Jules Bordet, Brussels, 1000, Belgium|UZ Brussel, Brussel, 1090, Belgium|Universitair Ziekenhuis Antwerpen, Edegem, 2650, Belgium|Rigshospitalet, Copenhagen, 2100, Denmark|Odense University Hospital, Odense C, 5000, Denmark|Centre Jean Perrin, Clermont Ferrand, 63000, France|Groupe Hospitalier La Rochelle-Ré-Aunis, La Rochelle, 17000, France|Institut Regional du Cancer de Montpellier - ICM Val dAurelle, Montpellier Cedex 5, 34298, France|Presidio AO-U, Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi, Torette Di Ancona, AN, 60123, Italy|IRCCS-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, FC, 47014, Italy|Azienda Socio-Sanitaria Territoriale Monza, Ospedale San Gerardo, Monza, MB, 20900, Italy|Fondazione IRCCS, Istituto Nazionale dei Tumori, Milano, MI, 20133, Italy|Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico, Milano, MI, 20141, Italy|Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori, Napoli, 80131, Italy|Azienda Policlinico Umberto I, Universita La Sapienza, Oncologia B, Roma, 00161, Italy|Fondazione Policlinico Universitario Agostino Gemelli Unità di Farmacologia Clinica, Roma, 00168, Italy|National Cancer Center Hospital East, Kashiwa, Chiba, 277-8577, Japan|Osaka International Cancer Institute, Osaka-shi, Osaka, 541-8567, Japan|National Cancer Center Hospital, Chuo-ku, Tokyo, 104-0045, Japan|Amsterdam University Medical Centre, location VUmc, Amsterdam, Noord Holland, 1081 HV, Netherlands|Erasmus Universitair Medisch Centrum, Rotterdam, Zuid-holland, 3015 GD, Netherlands|Hospital Universitario Vall dHebron, Barcelona, 08035, Spain|H.G.U. Gregorio Maranon, Madrid, 28009, Spain|Clinica Universidad de Navarra, Madrid, 28027, Spain|H.U. Fundación Jiménez Díaz, Madrid, 28040, Spain|Hospital Universitario Virgen de Valme, Sevilla, 41014, Spain|Barts Health NHS Trust, St Bartholomews Hospital, London, EC1A 7BE, United Kingdom|Sarah Cannon Research Institute UK, London, W1G 6AD, United Kingdom", Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/91/NCT03565991/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/91/NCT03565991/SAP_001.pdf, criteria: "Inclusion Criteria:~* BRCA1, BRCA2 and/or ATM gene defect.~* Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent~* Availability a tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy.~* Progressive disease at study enrollment.~* Minimum age 18 years (in Japan, minimum age 20 years).~* ECOG performance status 0 or 1.~* Adequate bone marrow, renal and liver function.~* For childbearing female patients, negative serum or urine pregnancy test at screening~* Signed and dated informed consent document.~Exclusion Criteria:~* Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.~* Major surgery within 4 weeks prior to study enrollment.~* Current use of immunosuppressive medication at the time of study enrollment.~* Known prior severe hypersensitivity to investigational products or any component in their formulations~* Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.~* Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.~* Prior organ transplantation including allogenic stem-cell transplantation.~* Administration of live attenuated vaccines within 4 weeks of study enrollment.~* Diagnosis of myelodysplastic syndrome.~* Known symptomatic brain metastases requiring steroids.~* Persisting toxicity related to prior therapy Grade \\\\>1.~* Known history of HIV or AIDS.~* Positive HBV or HCV test indicating acute or chronic infection.~* Active infection requiring systemic therapy.~* Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.~* Diagnosis of any other malignancy within 2 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast, bladder, or cervix, or low-grade prostate cancer or other early-stage low-risk cancers.~* Pregnant or breastfeeding female patients; female or male patients who are able to have children who are unable or unwilling to use contraception as outlined in the protocol.", combined_text: Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors Percentage of Participants With Confirmed Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR), For participants with solid tumors, except metastatic Castration Resistant Prostate Cancer (mCRPC), OR was defined as a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1), both confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. For participants with mCRPC, OR was defined as the percentage of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 with no evidence of confirmed bone disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria. Per RECIST v1.1, CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Non-target PR lesions must be non-Progressive Disease (PD), where PD was unequivocal progression of pre-existing lesions., From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months Number of Participants With Treatment-Emergent Adverse Events (TEAEs), An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device. TEAEs were those events with onset dates occurring during the on-treatment period. A Serious Adverse Event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE., From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately|Number of Participants With New or Worsening Hematology Laboratory Test Results During the On-Treatment Period, The laboratory results were graded according to the CTCAE v4.03 severity grade whenever applicable. Laboratory test abnormalities were summarized according to worst toxicity grade observed for each laboratory test. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day)., From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately|Number of Participants With New or Worsening Chemistry Laboratory Test Results During the On-Treatment Period, The laboratory results were graded according to the CTCAE v4.03 severity grade whenever applicable. Laboratory test abnormalities were summarized according to worst toxicity grade observed for each laboratory test. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day)., From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately|Serum Lowest (Trough) Concentration (Ctrough) of Avelumab, Ctrough was defined as predose concentration during multiple dosing. The determination method of Ctrough was observing directly from data. The lower limit of quantification (LLQ) was 0.2 mcg/mL. For Cycle 1 Day 1, as the number of observations above lower limit of quantification (NALQ) = 0, summary statistics were not presented., Predose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1|Serum Maximum Concentration (Cmax) for Avelumab, Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data., One hour post-dose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1|Plasma Ctrough for Talazoparib, Ctrough was defined as predose concentration during multiple dosing. The determination method of Ctrough was observing directly from data. The lower limit of quantification (LLQ) was 25 pg/mL. For Cycle 1 Day 1, as the number of observations above lower limit of quantification (NALQ) = 0, summary statistics were not presented. Evaluable participants were participants with non-missing Ctrough concentrations at each specific time point and meeting 2 conditions: participants received 14 consecutive days of talazoparib dose without dosing interruption prior to sample collection (except on Cycle 1 Day 1) and sample collection within 24 hours ± 10% (2 hours and 24 minutes) after the previous day\\s dose and no more than 5 minutes (0.083 hours) after the administration of the dose on the day of PK sample collection. Predose PK samples on Cycle 1 Day 1 must have been collected prior to dose., Predose on Cycle 1 Days 1, 15 and Cycle 3 Day 1|Plasma Post-dose Concentrations for Talazoparib, In this OM, the post-dose concentrations for talazoparib in plasma were reported., Postdose (samples collected within 2 hours post dose plus/minus 12 minutes) on Days 1,15 of Cycle 1, and Day 1 of Cycle 3|Number of Participants by Avelumab Anti-drug Antibody (ADA) Categories, Blood samples were assayed for ADA using a validated assay. ADA never-positive = no positive ADA results at any time point. ADA ever-positive =at least one positive ADA result at any time point. Baseline ADA positive =a positive ADA result at baseline. Treatment-boosted ADA =a positive ADA result at baseline and the titer \\\\>=8×baseline titer at least once after treatment with avelumab. Treatment-induced ADA = participant was ADA-negative at baseline and had at least one positive post-baseline ADA result; or the participant had at least one positive post-baseline ADA result if no baseline sample. Transient ADA response = participants with treatment-induced ADA had (a single positive ADA result or duration between first and last positive result \\\\<16 weeks) and ADA result at the last assessment was not positive. Persistent ADA response =participants with treatment-induced ADA had duration between first and last positive ADA result \\\\>=16 weeks or a positive ADA result at the last assessment., Predose (within 2 hours before start of avelumab infusion) on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1|Number of Participants With Neutralizing Antibodies (Nab) Levels Against Avelumab Ever-Positive, Nab ever-positive was defined as at least one positive Nab result at any time point. Samples positive for ADA with persistent treatment-induced ADA response could be analyzed for Nab., Predose (within 2 hours before start of avelumab infusion) on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1|Percentage of Participants With Confirmed OR as Assessed by The Investigator, For participants with solid tumors, except mCRPC, OR was defined as a CR or PR per RECIST v1.1, both confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. For participants with mCRPC, OR was defined as the percentage of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 with no evidence of confirmed bone disease progression per PCWG3 criteria. Per RECIST v1.1, CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Non-target PR lesions must be non-PD, where PD was unequivocal progression of pre-existing lesions., From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to approximately 24 months|Time to Tumor Response (TTR) as Assessed by BICR, For participants with solid tumors, except mCRPC: TTR was defined for participants with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC: TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a Best Overall Response (BOR) of CR or PR per RECIST v1.1., Baseline up to approximately 24 months|TTR as Assessed by Investigator, For participants with solid tumors, except mCRPC: TTR was defined for participants with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC: TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a BOR of CR or PR per RECIST v1.1., Baseline up to approximately 24 months|Duration of Response (DoR) as Assessed by BICR, For participants with solid tumors, except mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occured first. For participants with mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST v1.1 and no evidence of confirmed bone disease progression by PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occured first. Radiographic progression was defined as soft tissue progression evaluated per RECIST v1.1 or bone disease progression evaluated per PCWG3., Baseline up to approximately 24 months|DoR as Assessed by Investigator, For participants with solid tumors, except mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. For participants with mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST v1.1 and no evidence of confirmed bone disease progression by PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occurred first. Radiographic progression was defined as soft tissue progression evaluated per RECIST v1.1 or bone disease progression evaluated per PCWG3., Baseline up to approximately 24 months|Progression Free Survival (PFS) as Assessed by BICR, For participants with solid tumors, except mCRPC: PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC: PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue evaluated per RECIST v1.1, in bone evaluated per PCWG3, or death, whichever occurred first., Baseline up to approximately 24 months|PFS as Assessed by Investigator, For participants with solid tumors, except mCRPC: PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC: PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue evaluated per RECIST v1.1, in bone evaluated per PCWG3, or death, whichever occurred first., Baseline up to approximately 24 months|Overall Survival (OS) for All Participants, OS was defined as the time from the first dose of study treatment to the date of death. Participants without an event (death) were censored at the date of last contact., Baseline up to approximately 24 months|Time to Prostate-Specific Antigen (PSA) Progression for Participants With mCRPC, For participants with mCRPC, time to PSA progression was defined as the time from the first dose to the date that a \\\\>=25% increase in PSA with an absolute increase of \\\\>=2 μg/L (2 ng/mL) above the nadir (or baseline for participants with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained \\\\>=3 weeks (21 days) later., Baseline up to approximately 24 months|Number of Participants With Confirmed PSA Response, For participants with mCRPC, PSA response was defined as confirmed PSA decline \\\\>=50% compared to baseline. PSA response was calculated as a decline from baseline PSA (ng/mL) to the maximal PSA response with a threshold of 50%. A PSA response must have been confirmed by a second consecutive value at least 3 weeks later., Baseline up to approximately 24 months|Number of Participants With Circulating Tumor Cell (CTC) Count Conversion, For participants with mCRPC, CTC count conversion was defined as a decrease in CTC count from \\\\>=5 CTC per 7.5 mL of blood at baseline to \\\\<5 CTC per 7.5 mL of blood anytime on study., Day 1 of Cycle 1 to Cycle 4|Number of Participants With Cancer Antigen 125 (CA-125) Response, For participants with ovarian cancer, CA-125 response was defined as at least a 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days., Baseline, Day 1 of each treatment Cycle, maximum up to 4.3 years approximately|Number of Participants With Positive Programmed Death Ligand 1 (PD-L1) Expression in Baseline Tumor Tissue, PD-L1 expression on tumor and infiltrating immune cells was measured by immunohistochemistry (IHC). PD-L1 expression level was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest. This OM reported the number of participants classified as positive according to scoring algorithms and cut-offs established from external sources., Baseline|Number of Participants With Different Status for Defects in BRCA1, BRCA2 and ATM, Participants were enrolled in the two cohorts based on BRCA 1/2 and ATM defect status assessed by the local laboratory. The participant BRCA and ATM status was assessed retrospectively by central laboratory, that may differ from the status assessed by the local laboratory. The ATM participants with a negative ATM status per the central laboratory were reported to have a positive ATM status per the local laboratory. Therefore, participants with negative ATM status might have been included in the ATM defect cohort. For defects in BRCA1, BRCA2 and ATM by central laboratory analysis, participants were classified as positive, negative, not analyzable or missing. The number of participants in each category of BRCA 1 defect, BRCA 2 defect, BRCA 1 or BRCA 2 defect and ATM defect were presented., Baseline|Number of Participants by Status of Tumor Mutational Burden (TMB) at Baseline, TMB was defined as the total number of mutations in the tumor genome, or number of mutations per megabase of DNA if derived from targeted sequencing. TMB categories were defined as high, low for a number of mutations per megabase \\\\>=10 and \\\\<10, respectively. The TMB category \\Not analyzable\\ included participants with available samples but not evaluable. The TMB category \\Missing\\ included participants with no sample available. The number of participants in each category at only baseline were tabulated., Baseline "Inclusion Criteria:~* BRCA1, BRCA2 and/or ATM gene defect.~* Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent~* Availability a tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy.~* Progressive disease at study enrollment.~* Minimum age 18 years (in Japan, minimum age 20 years).~* ECOG performance status 0 or 1.~* Adequate bone marrow, renal and liver function.~* For childbearing female patients, negative serum or urine pregnancy test at screening~* Signed and dated informed consent document.~Exclusion Criteria:~* Prior anti-cancer therapy or radiation therapy within 2 weeks prior to enrolment. Palliative radiotherapy to metastatic lesion(s) permitted providing that it has been completed at least 2 days prior to enrolment and no significant toxicity are expected.~* Major surgery within 4 weeks prior to study enrollment.~* Current use of immunosuppressive medication at the time of study enrollment.~* Known prior severe hypersensitivity to investigational products or any component in their formulations~* Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.~* Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.~* Prior organ transplantation including allogenic stem-cell transplantation.~* Administration of live attenuated vaccines within 4 weeks of study enrollment.~* Diagnosis of myelodysplastic syndrome.~* Known symptomatic brain metastases requiring steroids.~* Persisting toxicity related to prior therapy Grade \\\\>1.~* Known history of HIV or AIDS.~* Positive HBV or HCV test indicating acute or chronic infection.~* Active infection requiring systemic therapy.~* Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study enrollment; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.~* Diagnosis of any other malignancy within 2 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast, bladder, or cervix, or low-grade prostate cancer or other early-stage low-risk cancers.~* Pregnant or breastfeeding female patients; female or male patients who are able to have children who are unable or unwilling to use contraception as outlined in the protocol.", Similarity Score: 0.19022671518843534}'}]
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[{'from': 'human', 'value': '{Study Title: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice, Primary Outcome Measures: Progressive-Free Survival (PFS), PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\\\\>=) 50 percent (%) of previously involved sites from nadir., Approximately up to 5 years, Secondary Outcome Measures: "Overall Response Rate (ORR), ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician., Approximately up to 5 years|Time to First Response, Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response., Approximately up to 5 years|Time to Best Response, Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response., Approximately up to 5 years|Duration of Response, Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \\\\>=50% of previously involved sites from nadir., Approximately up to 5 years|Overall survival (OS), Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death., Approximately up to 5 years|Duration of Ibrutinib Therapy, Duration of ibrutinib therapy in CLL and MCL participants will be reported., Approximately up to 5 years|Duration of a Treatment-Free Period, Duration of treatment-free period in CLL and MCL participants will be reported., Every 6 months (Approximately up to 5 years)|Duration of the First Non-Ibrutinib Subsequent Therapy Period, Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported., Approximately up to 5 years|Participants Daily Dose, Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed., Approximately up to 5 years|Number of Participants Who Require Dose Modifications, Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported., Approximately up to 5 years|Number of Medications Added, Number of medications added in the CLL and MCL treatment will be reported., Approximately up to 5 years", criteria: "Inclusion Criteria:~* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:~ 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or~ 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or~ 3. treatment of participants with relapsed or refractory MCL~* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Has not participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program~* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification~Exclusion Criteria:~* Currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 238, Unnamed: 0: 289, NCT Number: NCT06425991, Study Title: A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma, Study URL: https://clinicaltrials.gov/study/NCT06425991, Acronym: MajesTEC-10, Study Status: RECRUITING, Brief Summary: The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change)., Study Results: NO, Conditions: Relapsed or Refractory Multiple Myeloma, Interventions: DRUG: Teclistamab, Primary Outcome Measures: Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab, Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose)., Cycle 1 (28 days cycle): Predose to Day 7 postdose|Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose, AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose)., Cycle 1 (28 days cycle): Predose to Day 7 postdose|Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1, Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration., Cycle 3 (28 days cycle): Day 1, Secondary Outcome Measures: Number of Participants with Anti-drug Antibodies (ADAs), Number of participants with ADAs to teclistamab will be reported., Up to approximately 3 years|Percentage of Participants With Complete Response (CR) or Better Response, Percentage of participants with CR or better response will be reported. CR or better response rate is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria., Up to approximately 3 years|Number of Participants with Adverse Events (AEs) by Severity, An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event., Up to approximately 3 years|Number of Participants with Serious Adverse Events (SAEs), SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important., Up to approximately 3 years|Number of Participants with Abnormal Laboratory Results, Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported., Up to approximately 3 years|Percentage of Participants With Overall Response (Partial Response [PR] or Better), Percentage of participants with overall response (PR or better) will be reported. Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria., Up to approximately 3 years|Percentage of Participants With Very Good Partial Response (VGPR) or Better Response, Percentage of participants with VGPR or better response will be reported. VGPR or better response rate is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria., Up to approximately 3 years, Other Outcome Measures: , Sponsor: Janssen Research & Development, LLC, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 100.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 64007957MMY1008|64007957MMY1008|2023-508426-10-00|2023-508426-10|2023-508426-20-00, Start Date: 2024-06-07, Primary Completion Date: 2025-07-04, Completion Date: 2027-01-02, First Posted: 2024-05-23, Results First Posted: , Last Update Posted: 2024-10-10, Locations: "Banner MD Anderson Cancer Center, Gilbert, Arizona, 85234, United States|Colorado Blood Cancer Institute, Denver, Colorado, 80218, United States|Cleveland Clinic Florida, Weston, Florida, 33331, United States|Augusta University- Georgia Cancer Center, Augusta, Georgia, 30912, United States|St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Franciscan Health, Indianapolis, Indiana, 46237, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|Baylor University Medical Center, Dallas, Texas, 75246, United States|Flinders Medical Centre, Bedford Park, 5042, Australia|Box Hill Hospital, Box Hill, 3128, Australia|Royal Prince Alfred Hospital, Camperdown, 2050, Australia|Epworth Healthcare, Richmond, 3121, Australia|Princess Margaret Cancer Centre University Health Network, Toronto, Ontario, M5G 1X6, Canada|CHRU de Lille Hopital Claude Huriez, Lille, 59037, France|CHU Nantes, Nantes Cedex 1, 44093, France|CHU de Bordeaux - Hospital Haut-Leveque, Pessac Cedex, 33604, France|CHU Lyon Sud, Pierre-Benite, 69495, France|Klinikum Chemnitz gGmbH, Chemnitz, 09113, Germany|Universitaetsklinikum Hamburg Eppendorf, Hamburg, 20251, Germany|Universitaetsklinikum Heidelberg, Heidelberg, 69120, Germany|Universitatsklinikum Wurzburg, Würzburg, 97080, Germany|Ospedali Riuniti Di Ancona, Ancona, 60126, Italy|Azienda Ospedaliera Spedali Civili di Brescia, Brescia, 25123, Italy|Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, 47014, Italy|Ospedale Santa Chiara AO Universitaria Pisana, Pisa, 56126, Italy|Policlinico Universitario Agostino Gemelli, Rome, 00168, Italy|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Severance Hospital Yonsei University Health System, Seoul, 03722, Korea, Republic of|Asan Medical Center, Seoul, 05505, Korea, Republic of|Samsung Medical Center, Seoul, 06351, Korea, Republic of|The Catholic University of Korea Seoul St Mary s Hospital, Seoul, 06591, Korea, Republic of|Wojewodzki Szpital Specjalistyczny, Biala Podlaska, 21 500, Poland|Uniwersyteckie Centrum Kliniczne, Gdansk, 80-214, Poland|Pratia Onkologia Katowice, Katowice, 40 519, Poland|Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Kielce, 25-734, Poland|Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli, Lublin, 20-090, Poland|Hosp Clinic de Barcelona, Barcelona, 08036, Spain|ICO LHospitalet - Hospital Duran i Reynals, Barcelona, 08908, Spain|Hosp. Univ. 12 de Octubre, Madrid, 28041, Spain|Clinica Univ. de Navarra, Pamplona, 31008, Spain|Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcon, 28223, Spain|Hosp Clinico Univ de Salamanca, Salamanca, 37007, Spain|Hosp. Univ. Marques de Valdecilla, Santander, 39008, Spain|Hammersmith Hospital, London, W12 0HS, United Kingdom|The Christie NHS Foundation Trust Christie Hospital, Manchester, M20 4BX, United Kingdom|Norfolk & Norwich University Hospital, Norwich, NR4 7UY, United Kingdom|Derriford Hospital, Plymouth, PL6 8DH, United Kingdom", Study Documents: , criteria: "Inclusion Criteria:~* Documented diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (\\\\>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \\\\>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \\\\>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio~* Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line~* Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator\\s determination of response by IMWG criteria~* Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2~* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study~Exclusion Criteria:~* Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy~* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients~* Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed~* Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required~* Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study", combined_text: A Study Comparing Pre- and Post-Change Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Maximum Observed Serum Concentration (Cmax) of First Treatment Dose of Teclistamab, Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose)., Cycle 1 (28 days cycle): Predose to Day 7 postdose|Area Under Serum Concentration Versus Time Curve (AUCtau) of Teclistamab First Treatment Dose, AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose)., Cycle 1 (28 days cycle): Predose to Day 7 postdose|Observed Serum Concentration Immediately Prior to the Next Study Treatment Administration (Ctrough) on Cycle 3 Day 1, Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration., Cycle 3 (28 days cycle): Day 1 Number of Participants with Anti-drug Antibodies (ADAs), Number of participants with ADAs to teclistamab will be reported., Up to approximately 3 years|Percentage of Participants With Complete Response (CR) or Better Response, Percentage of participants with CR or better response will be reported. CR or better response rate is defined as participants who achieve a CR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria., Up to approximately 3 years|Number of Participants with Adverse Events (AEs) by Severity, An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event., Up to approximately 3 years|Number of Participants with Serious Adverse Events (SAEs), SAEs are any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, or is medically important., Up to approximately 3 years|Number of Participants with Abnormal Laboratory Results, Number of participants with abnormal laboratory results (such as hematology and chemistry) will be reported., Up to approximately 3 years|Percentage of Participants With Overall Response (Partial Response [PR] or Better), Percentage of participants with overall response (PR or better) will be reported. Overall response (PR or better) is defined as participants who have a PR or better prior to subsequent antimyeloma therapy in accordance with the international myeloma working group (IMWG) criteria., Up to approximately 3 years|Percentage of Participants With Very Good Partial Response (VGPR) or Better Response, Percentage of participants with VGPR or better response will be reported. VGPR or better response rate is defined as participants who achieve a VGPR or better response prior to subsequent antimyeloma therapy in accordance with the IMWG criteria., Up to approximately 3 years "Inclusion Criteria:~* Documented diagnosis of multiple myeloma as defined by the criteria below: (a) Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (\\\\>=) 0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \\\\>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \\\\>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio~* Received 1 to 3 prior lines of antimyeloma therapy, including a minimum of 2 consecutive cycles each of a protease inhibitor (PI), lenalidomide, and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (or minimum of 6 doses if anti CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line~* Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator\\s determination of response by IMWG criteria~* Have an eastern cooperative oncology group (ECOG) performance status score of 0 to 2~* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study~Exclusion Criteria:~* Received any bispecific antibody and/or chimeric antigen receptor T cell (CAR-T) cell therapy~* Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients~* Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use by local health authorities are allowed~* Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology may be required~* Participant had major surgery or had significant traumatic injury within 2 weeks prior to randomization, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study", Similarity Score: 0.18906838794785108}'}]
|
from_dataset
| 0.189068
|
[{'from': 'human', 'value': '{Study Title: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice, Primary Outcome Measures: Progressive-Free Survival (PFS), PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\\\\>=) 50 percent (%) of previously involved sites from nadir., Approximately up to 5 years, Secondary Outcome Measures: "Overall Response Rate (ORR), ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician., Approximately up to 5 years|Time to First Response, Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response., Approximately up to 5 years|Time to Best Response, Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response., Approximately up to 5 years|Duration of Response, Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \\\\>=50% of previously involved sites from nadir., Approximately up to 5 years|Overall survival (OS), Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death., Approximately up to 5 years|Duration of Ibrutinib Therapy, Duration of ibrutinib therapy in CLL and MCL participants will be reported., Approximately up to 5 years|Duration of a Treatment-Free Period, Duration of treatment-free period in CLL and MCL participants will be reported., Every 6 months (Approximately up to 5 years)|Duration of the First Non-Ibrutinib Subsequent Therapy Period, Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported., Approximately up to 5 years|Participants Daily Dose, Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed., Approximately up to 5 years|Number of Participants Who Require Dose Modifications, Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported., Approximately up to 5 years|Number of Medications Added, Number of medications added in the CLL and MCL treatment will be reported., Approximately up to 5 years", criteria: "Inclusion Criteria:~* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:~ 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or~ 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or~ 3. treatment of participants with relapsed or refractory MCL~* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Has not participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program~* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification~Exclusion Criteria:~* Currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 317, Unnamed: 0: 381, NCT Number: NCT04686682, Study Title: A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors, Study URL: https://clinicaltrials.gov/study/NCT04686682, Acronym: , Study Status: RECRUITING, Brief Summary: This is a Phase 1/2a, first-in-human, open-label study of JAB-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study.\\n\\nThese two parts will determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each will be enrolled., Study Results: NO, Conditions: NSCLC|SCLC|CRPC|ESCC|Ovarian Carcinoma|AML|MF|Malignant Tumor, Interventions: DRUG: JAB-8263|DRUG: JAB-8263, Primary Outcome Measures: Number of participants with dose limiting toxicities, Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-8263, Approximately 18 months, Secondary Outcome Measures: "Number of participants with adverse events, All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments, Approximately 18 months|Area under the curve, Area under the plasma concentration time curve of JAB-8263, Approximately 18 months|Cmax, Highest observed plasma concentration of JAB-8263, Approximately 18 months|Tmax, Time of highest observed plasma concentration of JAB-8263, Approximately 18 months|T1/2, Half life of JAB-8263, Approximately 18 months|Objective response rate ( ORR ), For solid tumor study part, ORR is defined as the proportion of participants with complete response or partial response (CR+PR), Approximately 18 months|Duration of response ( DOR ), For solid tumor study part, DOR is defined as the time from the participants initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first., Approximately 18 months|Duration of response ( DCR ), For solid tumor study part, DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD)., Approximately 18 months|CR without minimal residual disease rate (CR MRD-), hematology study part, CR MRD- is defined as proportion of participants with complete response without minimal residual disease., Approximately 18 months|Overall response rate, For hematology study part, Overall response rate is defined as proportion of participants with complete response(CR or CRi), partial remission(PR) or morphologic leukemia-free state(MLFS)., Approximately 18 months|Event-free survival( EFS), For hematology study part, EFS is defined for all patients with AML, measured from the date of entry into the study to the date of primary refractory disease, or relapse from CR, or Cri, or death from any cause., Approximately 18 months", Other Outcome Measures: , Sponsor: Jacobio Pharmaceuticals Co., Ltd., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1|PHASE2, Enrollment: 152.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: JAB-8263-1002, Start Date: 2021-05-07, Primary Completion Date: 2024-01, Completion Date: 2024-09, First Posted: 2020-12-29, Results First Posted: , Last Update Posted: 2023-03-10, Locations: Tianjin, Tianjin, Tianjin, 300020, China, Study Documents: , criteria: "Inclusion Criteria:~* Subjects must meet all the following criteria in order to be included in the research study:~ 1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).~ 2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.~ 3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.~ 4. Subjects with recurrent/refractory AML according to WHO 2016~ 5. Subjects with life expectancy ≥3 months.~ 6. Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1.~ 7. Patients who have sufficient baseline organ function.~Exclusion Criteria:~1. History (≤3 years) of cancer that is histologically distinct from the cancer under study.~2. Known serious allergy to investigational drug or excipients~3. Active brain or spinal metastases~4. History of pericarditis or Grade ≥2 pericardial effusion~5. History of interstitial lung disease.~6. History of Grade ≥2 active infections within 2 weeks~7. Known human immunodeficiency virus (HIV) infection~8. Seropositive for hepatitis B virus (HBV)~9. Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.~10. Any severe and/or uncontrolled medical conditions~11. History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident~12. Impaired cardiac function or clinically significant cardiac diseases~13. QTcF \\\\>470 msec at screening~14. History of medically significant thromboembolic events or bleeding diathesis~15. Unresolved Grade \\\\>1 toxicity~16. History of malignant biliary obstruction~17. Pregnant or breast-feeding", combined_text: A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors Number of participants with dose limiting toxicities, Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-8263, Approximately 18 months Number of participants with adverse events, All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments, Approximately 18 months|Area under the curve, Area under the plasma concentration time curve of JAB-8263, Approximately 18 months|Cmax, Highest observed plasma concentration of JAB-8263, Approximately 18 months|Tmax, Time of highest observed plasma concentration of JAB-8263, Approximately 18 months|T1/2, Half life of JAB-8263, Approximately 18 months|Objective response rate ( ORR ), For solid tumor study part, ORR is defined as the proportion of participants with complete response or partial response (CR+PR), Approximately 18 months|Duration of response ( DOR ), For solid tumor study part, DOR is defined as the time from the participant\\s initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first., Approximately 18 months|Duration of response ( DCR ), For solid tumor study part, DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD)., Approximately 18 months|CR without minimal residual disease rate (CR MRD-), hematology study part, CR MRD- is defined as proportion of participants with complete response without minimal residual disease., Approximately 18 months|Overall response rate, For hematology study part, Overall response rate is defined as proportion of participants with complete response(CR or CRi), partial remission(PR) or morphologic leukemia-free state(MLFS)., Approximately 18 months|Event-free survival( EFS), For hematology study part, EFS is defined for all patients with AML, measured from the date of entry into the study to the date of primary refractory disease, or relapse from CR, or Cri, or death from any cause., Approximately 18 months "Inclusion Criteria:~* Subjects must meet all the following criteria in order to be included in the research study:~ 1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).~ 2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.~ 3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.~ 4. Subjects with recurrent/refractory AML according to WHO 2016~ 5. Subjects with life expectancy ≥3 months.~ 6. Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1.~ 7. Patients who have sufficient baseline organ function.~Exclusion Criteria:~1. History (≤3 years) of cancer that is histologically distinct from the cancer under study.~2. Known serious allergy to investigational drug or excipients~3. Active brain or spinal metastases~4. History of pericarditis or Grade ≥2 pericardial effusion~5. History of interstitial lung disease.~6. History of Grade ≥2 active infections within 2 weeks~7. Known human immunodeficiency virus (HIV) infection~8. Seropositive for hepatitis B virus (HBV)~9. Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.~10. Any severe and/or uncontrolled medical conditions~11. History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident~12. Impaired cardiac function or clinically significant cardiac diseases~13. QTcF \\\\>470 msec at screening~14. History of medically significant thromboembolic events or bleeding diathesis~15. Unresolved Grade \\\\>1 toxicity~16. History of malignant biliary obstruction~17. Pregnant or breast-feeding", Similarity Score: 0.1825709726696368}'}]
|
from_dataset
| 0.182571
|
[{'from': 'human', 'value': '{Study Title: A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice, Primary Outcome Measures: Progressive-Free Survival (PFS), PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (\\\\>=) 50 percent (%) of previously involved sites from nadir., Approximately up to 5 years, Secondary Outcome Measures: "Overall Response Rate (ORR), ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician., Approximately up to 5 years|Time to First Response, Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response., Approximately up to 5 years|Time to Best Response, Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response., Approximately up to 5 years|Duration of Response, Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by \\\\>=50% of previously involved sites from nadir., Approximately up to 5 years|Overall survival (OS), Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death., Approximately up to 5 years|Duration of Ibrutinib Therapy, Duration of ibrutinib therapy in CLL and MCL participants will be reported., Approximately up to 5 years|Duration of a Treatment-Free Period, Duration of treatment-free period in CLL and MCL participants will be reported., Every 6 months (Approximately up to 5 years)|Duration of the First Non-Ibrutinib Subsequent Therapy Period, Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported., Approximately up to 5 years|Participants Daily Dose, Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed., Approximately up to 5 years|Number of Participants Who Require Dose Modifications, Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported., Approximately up to 5 years|Number of Medications Added, Number of medications added in the CLL and MCL treatment will be reported., Approximately up to 5 years", criteria: "Inclusion Criteria:~* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:~ 1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or~ 2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or~ 3. treatment of participants with relapsed or refractory MCL~* Not currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Has not participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program~* Participant must sign a written informed consent form (ICF) allowing data collection and source data verification~Exclusion Criteria:~* Currently participating in another investigational study, clinical study, or any expanded access program at study entry~* Participated in the ibrutinib Autorisation Temporaire d\\Utilisation (ATU) program"}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 420, Unnamed: 0: 515, NCT Number: NCT03001882, Study Title: An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC), Study URL: https://clinicaltrials.gov/study/NCT03001882, Acronym: CheckMate 592, Study Status: COMPLETED, Brief Summary: The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC)., Study Results: YES, Conditions: Non-Small Cell Lung Cancer, Interventions: BIOLOGICAL: Nivolumab|BIOLOGICAL: Ipilimumab, Primary Outcome Measures: Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB), Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).\\n\\nPR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \\\\<10 mm.\\n\\nBlood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum.\\n\\nCR+PR, confidence interval based on the Clopper and Pearson method., From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)|Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (Blood TMB Cut-point = 21-mutations/MB), Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).\\n\\nPR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \\\\<10 mm.\\n\\nBlood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum.\\n\\nCR+PR, confidence interval based on the Clopper and Pearson method., From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)|Objective Response Rate (ORR) Per Investigator by Tissue TMB Within PD-L1 Subgroup (Tissue TMB Cut-point = 10-mutations/MB), Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).\\n\\nPR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \\\\<10 mm.\\n\\nTissue tumor mutational burden (tTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in tumor tissue samples.\\n\\nCR+PR, confidence interval based on the Clopper and Pearson method., From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months), Secondary Outcome Measures: "Objective Response Rate (ORR) for All Treated Participants by Investigator Per RECIST 1.1, Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).\\n\\nPartial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \\\\<10 mm.\\n\\nCR+PR, confidence interval based on the Clopper and Pearson method., From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)|Disease Control Rate (DCR) for Part 1, Disease control rate (DCR) is the percent of treated participants with a best overall response of a complete response (CR), partial response (PR), or stable disease (SD), assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).\\n\\nPR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in short axis to \\\\<10 mm of any pathological lymph nodes (target or non-target). SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking smallest sum diameters as reference. PD is at least a 20% increase in the sum of diameters of target lesions, taking the smallest sum as reference. The sum must also demonstrate an absolute increase of at least 5 mm. (one or more new lesions is also considered progression). CR+PR, confidence interval based on the Clopper and Pearson method., From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)|Duration of Response (DOR) for Part 1, DOR is the time between first confirmed response (Complete/Partial Response) and first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who dont progress or die are censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy without prior reported progression were censored at the last evaluable tumor assessment prior to or on the date of subsequent anti-cancer therapy.\\n\\nPR is at least 30% decrease in the sum of diameters of target lesions, using baseline sum diameters as reference. CR is disappearance of all target lesions and reduction in short axis to \\\\<10 mm of any pathological lymph nodes (target or non-target). Progressive Disease (PD) is at least 20% increase in the sum of diameters of target lesions, taking the smallest sum as reference. The sum must also show an overall increase of \\\\> 5 mm. (one or more new lesions is also progression). Median computed using Kaplan-Meier method., From first dose to the date of the first documented tumor progression or death due to any cause (Up to approximately 67 months)|Time to Response (TTR) for Part 1, TTR is the time taken from first dosing date to the time the criteria for Complete Response (CR)/Partial Response (PR) are first met.\\n\\nPartial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\\<10 mm., From first dose to the time the criteria for Complete Response/Partial Response are first met (Up to approximately 67 months)|Progression Free Survival (PFS), PFS is defined as the time from first dosing date to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause.\\n\\nParticipants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on the date of initiation of subsequent anti-cancer therapy.\\n\\nProgressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking the smallest sum on study as reference. The sum must also show an overall increase of \\\\> 5 mm. (one or more new lesions is also progression).\\n\\nMedian calculated using Kaplan-Meier estimates., From first dose to the date of the first documented tumor progression or death due to any causes (Assessed up to approximately 67 months)|Overall Survival (OS), OS is defined as the time from first dosing date to the date of death. If a participant didnt die, OS will be censored on the last date the participant was known to be alive.\\n\\nMedian based on Kaplan-Meier estimates., From first dose to the date of death (Assessed up to approximately 67 months)|Number of Participants With Adverse Events (AEs) for Study Part 2, An Adverse Event (AE) is any new untoward medical occurrence or worsening preexisting medical condition in a treated participant and that does not necessarily have a causal relationship with treatment.\\n\\nAn AE can be any unfavorable, unintended sign, symptom, or disease temporally associated with the use of treatment, whether or not related to the treatment., From first dose to 30 days after last dosing date (assessed up to approximately 27 months)|Number of Participants With Serious Adverse Events (SAEs) for Study Part 2, A Serious Adverse Event (SAE) results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), or requires inpatient hospitalization or causes prolongation of existing hospitalization., From first dose to 30 days after last dosing date (assessed up to approximately 27 months)|Number of Participants With Select Adverse Events (AEs) for Study Part 2, An Adverse Event (AE) is any new untoward medical occurrence or worsening preexisting medical condition in a treated participant and that does not necessarily have a causal relationship with treatment.\\n\\nAn AE can be any unfavorable, unintended sign, symptom, or disease temporally associated with the use of treatment, whether or not related to the treatment., From first dose to 30 days after last dosing date (up to approximately 27 months)", Other Outcome Measures: , Sponsor: Bristol-Myers Squibb, Collaborators: Yale University, Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 230.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: CA209-592|2018-000462-11, Start Date: 2017-03-29, Primary Completion Date: 2022-02-17, Completion Date: 2023-04-24, First Posted: 2016-12-23, Results First Posted: 2023-06-06, Last Update Posted: 2024-05-20, Locations: Local Institution - 0006, Springdale, Arkansas, 72762, United States|Local Institution - 0001, New Haven, Connecticut, 06520, United States|Local Institution - 0005, Jacksonville, Florida, 32256, United States|Local Institution - 0009, Atlanta, Georgia, 30322, United States|Local Institution - 0003, Saint Louis, Missouri, 63110, United States|Local Institution - 0038, Bronx, New York, 10461, United States|Local Institution - 0002, Cleveland, Ohio, 44195, United States|Local Institution - 0008, Cleveland, Ohio, 44195, United States|Local Institution - 0007, Greenville, South Carolina, 29607, United States|Local Institution - 0004, Nashville, Tennessee, 37203, United States|Local Institution - 0017, La Louvière, Hainaut, 7100, Belgium|Local Institution - 0018, Gent, 9000, Belgium|Local Institution - 0028, Gent, 9000, Belgium|Local Institution - 0027, Liege, 4000, Belgium|Local Institution - 0016, Sint-Niklaas, 9100, Belgium|Local Institution - 0036, Paris Cedex 5, 75248, France|Local Institution - 0033, Pierre Benite, 69495, France|Local Institution - 0034, Strasbourg Cedex, 67091, France|Local Institution - 0039, Toulon, 83000, France|Local Institution - 0015, Essen, 45136, Germany|Local Institution - 0014, Immenstadt, 87509, Germany|Local Institution - 0013, Loewenstein, 74245, Germany|Local Institution - 0012, Stuttgart, 70174, Germany|Local Institution - 0023, Bergamo, 24127, Italy|Local Institution - 0025, Catania, 95123, Italy|Local Institution - 0026, Parma, 43100, Italy|Local Institution - 0024, Perugia, 06129, Italy|Local Institution - 0021, Amsterdam, 1066 CX, Netherlands|Local Institution - 0022, Nijmegen, 6525 GA, Netherlands|Local Institution - 0011, Cluj-Napoca, Cluj, 400015, Romania|Local Institution - 0010, Craiova, 200542, Romania|Local Institution - 0031, Barcelona, 08908, Spain|Local Institution - 0029, Madrid, 28041, Spain|Local Institution - 0030, Madrid, 28046, Spain|Local Institution - 0032, Sevilla, 41009, Spain, Study Documents: Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/82/NCT03001882/Prot_SAP_000.pdf, criteria: "Inclusion Criteria:~* Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease~* Measurable disease by CT or MRI~* Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work~Exclusion Criteria:~* Participants with untreated central nervous system metastases~* Participants with active, known or suspected autoimmune disease~* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)~Other protocol defined inclusion/exclusion criteria apply", combined_text: An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB), Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).\\n\\nPR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \\\\<10 mm.\\n\\nBlood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum.\\n\\nCR+PR, confidence interval based on the Clopper and Pearson method., From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)|Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (Blood TMB Cut-point = 21-mutations/MB), Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).\\n\\nPR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \\\\<10 mm.\\n\\nBlood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum.\\n\\nCR+PR, confidence interval based on the Clopper and Pearson method., From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)|Objective Response Rate (ORR) Per Investigator by Tissue TMB Within PD-L1 Subgroup (Tissue TMB Cut-point = 10-mutations/MB), Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).\\n\\nPR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \\\\<10 mm.\\n\\nTissue tumor mutational burden (tTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in tumor tissue samples.\\n\\nCR+PR, confidence interval based on the Clopper and Pearson method., From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months) Objective Response Rate (ORR) for All Treated Participants by Investigator Per RECIST 1.1, Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).\\n\\nPartial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \\\\<10 mm.\\n\\nCR+PR, confidence interval based on the Clopper and Pearson method., From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)|Disease Control Rate (DCR) for Part 1, Disease control rate (DCR) is the percent of treated participants with a best overall response of a complete response (CR), partial response (PR), or stable disease (SD), assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).\\n\\nPR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in short axis to \\\\<10 mm of any pathological lymph nodes (target or non-target). SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking smallest sum diameters as reference. PD is at least a 20% increase in the sum of diameters of target lesions, taking the smallest sum as reference. The sum must also demonstrate an absolute increase of at least 5 mm. (one or more new lesions is also considered progression). CR+PR, confidence interval based on the Clopper and Pearson method., From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)|Duration of Response (DOR) for Part 1, DOR is the time between first confirmed response (Complete/Partial Response) and first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who don\\t progress or die are censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy without prior reported progression were censored at the last evaluable tumor assessment prior to or on the date of subsequent anti-cancer therapy.\\n\\nPR is at least 30% decrease in the sum of diameters of target lesions, using baseline sum diameters as reference. CR is disappearance of all target lesions and reduction in short axis to \\\\<10 mm of any pathological lymph nodes (target or non-target). Progressive Disease (PD) is at least 20% increase in the sum of diameters of target lesions, taking the smallest sum as reference. The sum must also show an overall increase of \\\\> 5 mm. (one or more new lesions is also progression). Median computed using Kaplan-Meier method., From first dose to the date of the first documented tumor progression or death due to any cause (Up to approximately 67 months)|Time to Response (TTR) for Part 1, TTR is the time taken from first dosing date to the time the criteria for Complete Response (CR)/Partial Response (PR) are first met.\\n\\nPartial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\\<10 mm., From first dose to the time the criteria for Complete Response/Partial Response are first met (Up to approximately 67 months)|Progression Free Survival (PFS), PFS is defined as the time from first dosing date to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause.\\n\\nParticipants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on the date of initiation of subsequent anti-cancer therapy.\\n\\nProgressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking the smallest sum on study as reference. The sum must also show an overall increase of \\\\> 5 mm. (one or more new lesions is also progression).\\n\\nMedian calculated using Kaplan-Meier estimates., From first dose to the date of the first documented tumor progression or death due to any causes (Assessed up to approximately 67 months)|Overall Survival (OS), OS is defined as the time from first dosing date to the date of death. If a participant didn\\t die, OS will be censored on the last date the participant was known to be alive.\\n\\nMedian based on Kaplan-Meier estimates., From first dose to the date of death (Assessed up to approximately 67 months)|Number of Participants With Adverse Events (AEs) for Study Part 2, An Adverse Event (AE) is any new untoward medical occurrence or worsening preexisting medical condition in a treated participant and that does not necessarily have a causal relationship with treatment.\\n\\nAn AE can be any unfavorable, unintended sign, symptom, or disease temporally associated with the use of treatment, whether or not related to the treatment., From first dose to 30 days after last dosing date (assessed up to approximately 27 months)|Number of Participants With Serious Adverse Events (SAEs) for Study Part 2, A Serious Adverse Event (SAE) results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), or requires inpatient hospitalization or causes prolongation of existing hospitalization., From first dose to 30 days after last dosing date (assessed up to approximately 27 months)|Number of Participants With Select Adverse Events (AEs) for Study Part 2, An Adverse Event (AE) is any new untoward medical occurrence or worsening preexisting medical condition in a treated participant and that does not necessarily have a causal relationship with treatment.\\n\\nAn AE can be any unfavorable, unintended sign, symptom, or disease temporally associated with the use of treatment, whether or not related to the treatment., From first dose to 30 days after last dosing date (up to approximately 27 months) "Inclusion Criteria:~* Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease~* Measurable disease by CT or MRI~* Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work~Exclusion Criteria:~* Participants with untreated central nervous system metastases~* Participants with active, known or suspected autoimmune disease~* Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)~Other protocol defined inclusion/exclusion criteria apply", Similarity Score: 0.1782968209641857}'}]
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[{'from': 'human', 'value': '{Study Title: A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2), Primary Outcome Measures: Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment, DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (\\\\>=) 7 days or Grade 3 neutropenia with fever (greater than \\\\[\\\\>\\\\] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting \\\\>7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for \\\\>7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days), Secondary Outcome Measures: Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment, From baseline up to approximately up to 5 years 5 months|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7, Day-7: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Objective Response Rate (ORR); Combination Treatment, ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\\\<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months), criteria: "Inclusion Criteria:~Participants must meet all of the following criteria to be included in this study:~1. Phase 1b: Unresectable advanced or metastatic solid tumors.~2. Phase 1b expansion cohort and Phase 2: Histological confirmed diagnosis of glioblastoma (expansion cohort and Cohort 1) or melanoma (expansion cohort and Cohort 2).~ Phase 1b expansion cohort glioblastoma participants, Phase 2 Cohort 1:~3. No evidence of active central nervous systems (CNS) hemorrhage on baseline scans other than in those participants with recurrent glioblastoma who are stable Grade 1.~4. Participants having first or second recurrence documented by magnetic resonance imaging (MRI), following primary management with surgical resection or biopsy, radiotherapy and up to two prior systemic treatments.~5. If participants is on corticosteroids, they must be on a stable dose for 1 week prior to first dose of study drug.~6. Measurable disease defined as bidimensionally contrast enhancing lesions with clearly defined margins by computerized tomography (CT) or MRI scan, with a minimal diameter of 1 cm, and visible on two axial slices which are preferably at most 5 millimeter (mm) apart with 0 mm skip.~ Phase 1b expansion cohort melanoma participants, Phase 2 Cohort 2:~7. Radiographic/ photographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Appendix 3) after no more than two prior systemic regimens for unresectable Stage III or Stage IV disease.~8. American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma.~9. Measurable disease meeting the following criteria:~ 1. At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 centimeter (cm) in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI or photography. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.~ 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radio frequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.~ All participants:~10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~11. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 millimeter of mercury (mmHg) at screening and no change in antihypertensive medications within 1 week before the Screening Visit.~12. Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 milligrams per deciliter (mg/dL) or calculated creatinine clearance greater than or equal to 40 milliliters per minute (mL/min) per the Cockcroft and Gault formula (see Appendix 5).~13. Adequate bone marrow function:~ * Absolute neutrophil count greater than or equal to 1500/mm3 (greater than or equal to 1.5 x 10\\\\^3/uL);~ * Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 x 10\\\\^9/L);~ * Hemoglobin greater than or equal to 9.0 g/dL. 14.Adequate blood coagulation function, as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5.~14. Adequate liver function:~ * Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert\\s syndrome;~ * ALP, ALT, and AST less than or equal to 3 x ULN (less than or equal to 5 x ULN if participant has liver metastases).~15. Males or females age greater than or equal to 18 years at the time of informed consent.~16. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \\\\[B-hCG\\\\] at the Screening and Baseline Visit (a separate Baseline assessment is not required if a negative Screening pregnancy test was obtained within 72 hours before the first dose of study drug). Females of child-bearing potential, if not practising total abstinence or having a vasectomized partner with confirmed azoospermia, must agree to use two highly effective methods of contraception: e.g., 1) an intrauterine device (IUD) or intrauterine system (IUS); 2) a barrier method such as a condom or occlusive cup (diaphragm or cervical/vault caps) + spermicide (foam, gel, cream, etc.); 3) oral, injected, or implanted hormonal contraceptives throughout the entire study period and for 30 days after study drug discontinuation. Use of a double-barrier method (i.e., use at the same time of a condom + occlusive cup \\\\[diaphragm or cervical/vault caps\\\\] + spermicide \\\\[foam, gel, cream, etc.\\\\]) is accepted as two highly effective methods of contraception. The only participants who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or participants who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, total hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.~17. Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods described in Inclusion Criterion #18) beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug, unless the male participants are totally abstinent sexually or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile (see Inclusion Criterion #16).~18. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.~Exclusion Criteria:~Participants who meet any of the following criteria will be excluded from this study:~1. Phase 1b Dose Escalation: Participants who discontinued prior TK inhibitor (including VEGFR and c-Met receptor targeted therapy) due to toxicity will be ineligible.~2. Phase 1b Dose Escalation (3+3 portion) participants with primary CNS tumors~3. Phase 1b Dose Escalation participants, melanoma participants in expansion cohort and Phase 2 Cohort 2: Participants with untreated or unstable metastases to the central nervous system (CNS) are excluded. participants who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and have remained asymptomatic for at least 4 weeks prior to commencing treatment are eligible.~4. Phase 2: Prior exposure to VEGF-targeted treatment or c-Met or hepatocyte growth factor (HGF) targeted treatment.~5. Phase 2: Active malignancy (except for glioblastoma (Cohort 1) or unresectable Stage III or Stage IV melanoma (Cohort 2); or melanoma in situ, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) within the past 24 months.~ Phase 1b expansion cohort glioblastoma participants and Phase 2 Cohort 1:~6. More than two recurrences of glioblastoma.~7. Prior bevacizumab treatment.~8. Surgical resection of brain tumor within 4 weeks, or prior stereotactic biopsy within 2 weeks of Screening visit.~9. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field (beyond the high dose region or 80% isodose line), or there is biopsy-proven unequivocal viable tumor on histopathology sampling (e.g., solid tumor areas (i.e. greater than 70% tumor cell nuclei in areas), high or progressive increase in MIB-1 proliferation index compared to prior biopsy, or evidence for histological progression or increased anaplasia in the tumor).~10. Participants who have received enzyme-inducing anti epileptic agents within 14 days before the first dose of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).~ Phase 1b expansion cohort participants with melanoma and Phase 2 Cohort 2:~11. More than two prior systemic regimens for unresectable Stage III or Stage IV disease.~ All participants~12. Prior exposure to E7050 or lenvatinib.~13. Melanoma of intraocular origin.~14. participants who have received any anticancer treatment within 21 days (6 weeks for nitrosureas Cohort 1) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anticancer treatment.~15. Major surgery within 3 weeks prior to the first dose of study drug.~16. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.~17. Inability to take oral medication, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of E7050 or lenvatinib.~18. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.~19. Prolongation of QTc interval to greater than 480 msec.~20. Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin \\\\[LMWH\\\\] is allowed).~21. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.~22. Active infection (any infection requiring antibiotics).~23. Known intolerance or known hypersensitivity to any of the study drugs (or any of the excipients).~24. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.~25. Females who are pregnant or breastfeeding."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 904, Unnamed: 0: 1132, NCT Number: NCT04903873, Study Title: A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors, Study URL: https://clinicaltrials.gov/study/NCT04903873, Acronym: , Study Status: RECRUITING, Brief Summary: Phase 1 (Dose Escalation) of this study will assess the safety, tolerability, dose-limiting toxicity (DLT), and will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EU101 in participants with advanced solid tumors. Phase 2 (Dose Expansion) of the study will assess the antitumor effect of EU101 in two indications including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC)., Study Results: NO, Conditions: Solid Tumor|Renal Cell Cancer Metastatic|Non-Small Cell Lung Cancer|Renal Cell Carcinoma|Prostate Cancer, Interventions: DRUG: EU101, Primary Outcome Measures: "Phase 1: Number of Participants With Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation, Baseline up to 30 months|Phase 1: Number of Participants With Dose Limiting Toxicity (DLT), At the end of Cycle 1 (Each cycle is of 21 Days)|Phase 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Laboratory assessments include hematology, serum chemistry, other blood tests, coagulation, and urine analysis. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 1: Number of Participants With Clinically Significant Abnormalities in Vital Signs, Vital signs will include body temperature, pulse rate, and systolic and diastolic blood pressure measurements. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examination, Physical examination will include head, eyes, ears, nose and throat; heart; lungs; abdomen; skin; cervical and axillary lymph nodes; and neurological and musculoskeletal systems. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 1: Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG), ECG parameters included heart rhythm, pulse rate intervals, QRS, QT intervals, RR intervals and corrected QT(QTc) intervals. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 2: Objective Response Rate (ORR), Objective response rate (ORR), defined as the percentage of participants with a best overall response (BOR) of either a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors by investigators., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physicians decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)", Secondary Outcome Measures: "Phase 1: Objective Response Rate (ORR), Objective response rate (ORR), defined as the percentage of participants with a BOR of either a complete response (CR) or partial response (PR), per RECIST version 1.1 for solid tumors by investigators., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physicians decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)|Phase 1 and 2: Duration of Response (DOR), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physicians decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Disease Control Rate (DCR), DCR will be defined similarly to ORR but also including stable disease (SD) in the categorization of response (i.e, RECIST response of either CR, PR, or SD)., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physicians decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Time to Response (TTR), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physicians decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Time to Progression (TTP), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physicians decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Durable Clinical Benefit (DCB), DCB will be defined similarly to DCR but additionally specifying that the disease control be achieved for at least 12 weeks consecutive (i.e, RECIST response of CR, PR or SD for greater than or equal to \\\\[\\\\>=\\\\] 12 weeks consecutive)., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physicians decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Progression-Free Survival (PFS), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physicians decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Overall survival (OS), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physicians decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Maximum Observed Serum Concentration (Cmax) of EU101, Cmax is defined as maximum observed serum concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Trough Serum Concentration (Ctrough) of EU101, Ctrough is steady-state pre-dose concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of EU101, Tmax is defined as time to reach maximum observed serum concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of EU101, AUC0-24 is defined as the area under the serum concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24)., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of EU101, AUC0-last is defined as area under the serum concentration time-curve from time zero to the time of last measured concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of EU101, AUCinf is defined as area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf)., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Elimination Half-Life Time (T1/2) of EU101, T1/2 is defined as plasma decay half-life is the time measured for the serum concentration to decrease by one half., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Apparent Volume of Distribution (Vd/F) of EU101, Vd/F is defined as volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug., Baseline (Day 1)|Phase 1 and 2: Apparent Oral Clearance of (CL/F) of EU101, Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes., Baseline (Day 1)|Phase 1 and 2: Mean Residence Time (MRT) of EU101, MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time., Baseline (Day 1)|Phase 1 and 2: Renal clearance (CLr) of EU101, CLr is defined as renal clearance is the volume of plasma completely cleared of EU101 by the kidneys per unit time., Baseline (Day 1)|Phase 1 and 2: Number of Participants with Positive Antidrug Antibodies (ADA), The immunogenic potential of EU101 will be assessed by summarizing the number of participants who develop detectable antidrug antibody (ADAs)., Baseline up to 56 months|Phase 2: Number of Participants With AEs and SAEs by Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Time from first dose of study treatment up to 30 months", Other Outcome Measures: , Sponsor: Eutilex, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1|PHASE2, Enrollment: 110.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: EU-CTS101-I-01, Start Date: 2021-05-31, Primary Completion Date: 2025-09, Completion Date: 2025-12, First Posted: 2021-05-27, Results First Posted: , Last Update Posted: 2024-03-15, Locations: Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States|Mary Crowley Center, Dallas, Texas, 75230, United States|National Cancer Center, Ilsan, Korea, Republic of|Samsung Seoul Hospital, Seoul, Korea, Republic of|Seoul Asan, Seoul, Korea, Republic of|Severance Hospital, Seoul, Korea, Republic of, Study Documents: , criteria: "Key Inclusion Criteria:~* Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumors for which no standard therapy exists or standard therapy has failed because of disease progression or unacceptable toxicities. Also includes patients who cannot be treated with standard therapy because of underlying/existing medical condition.~* Cohort 1 (colorectal cancer): a) CRC (including microsatellite instability-high \\\\[MSI-H\\\\] and microsatellite-stable \\\\[MSS\\\\]) regardless of RAS mutation. b) Disease progression within 3 months after last administration of approved standard therapies. c) Prior cytotoxic chemotherapy for metastatic disease include all the following agents: fluoropyrimidine, oxaliplatin, and irinotecan~* Adjuvant chemotherapy-based treatments count as prior therapy, as long as relapse had occurred within 6 months of completion of such therapies, prior anti-epidermal growth factor receptor (EGFR) therapy (cetuximab, panitumumab), anti-angiogenic therapy (bevacizumab, aflibercept, ramucirumab), regorafenib, and TAS-102 are allowed. d) No more than 5 prior therapies for metastatic disease. For participants who had disease recurrence within 6 months of completing adjuvant chemotherapy, the adjuvant regimen can be considered as 1 chemotherapy regimen for metastatic disease~* Cohort 2 (NSCLC): a) NSCLC without known EGFR, anaplastic lymphoma kinase (ALK), and ROS1 genomic tumor aberrations. b) No standard therapy exists or standard therapy has failed. c) No more than 3 prior therapies for metastatic disease~* Phase 2: At least 1 measurable lesion per RECIST version 1.1~* Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2~* Adequate organ and bone marrow function (Hemoglobin \\\\>9.0 g/dL, Absolute neutrophil count ≥1,500/μL, Absolute lymphocyte count ≥600 and ≤2,500/μL, Platelet count ≥100,000/μL, Total bilirubin ≤1.5 × upper limit of normal, Alanine aminotransferase and aspartate aminotransferase ≤2.5 × ULN, Serum creatinine ≤1.5 × ULN or creatinine clearance \\\\>30 mL/min, Prothrombin time and activated partial thromboplastin time ≤1.5 × ULN)~* Life expectancy of at least 12 weeks~* Voluntarily provided a written consent to participate in the study~* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days before study drug administration~* WOCBP and sexually active fertile male patients with partners who are WOCBP must agree to use 2 highly effective methods of contraception throughout the course of the study and for 12 weeks after the last dose of study drug.~Key Exclusion Criteria:~* Primary central nervous system (CNS) tumor (Phase 1), CNS metastasis, and/or carcinomatous meningitis. Participants with prior brain metastases treated at least 4 weeks before the first dose of EU101 that are clinically stable and do not require chronic corticosteroid treatment are allowed. Untreated but asymptomatic and clinically stable brain metastases per investigator\\s discretion are allowed~* Received prior therapy with any anti-CD137 monoclonal antibody (mAb) or agent~* Major surgery requiring general anesthesia within 3 weeks before first dose of EU101 or still recovering from prior surgery~* Active infection that is not controlled or requires intravenous antibiotics in the last 2 weeks~* History of allogeneic tissue or organ transplant~* Active hepatitis B virus or hepatitis C virus infection~* History of any noninfectious hepatitis~* Human immunodeficiency virus (HIV) infection~* Received or receiving systemic corticosteroid therapy or any other form of systemic immunosuppressive medicaion 1 week before first dose of EU101~* Known severe (≥Grade 3) hypersensitivity reactions to antibody, or severe reaction to immuno-oncology agents requiring treatment with steroids~* Konwn or suspected hypersensitivity to EU101 or any component of its formulation~* Current or history of interstitial lung disease, anaphylaxis, uncontrolled asthma, or pneumonitis that has required systemic corticosteroids~* Patients with second primary cancer~* Clinically significant concurrent cardiovascular disease~* Pregnant women, breasfeeding women, WOCBP, or men with partners who are WOCBP who do not agree to use adequate contraceptive measures~* Determined as unable to participate in the study per investigator\\s judgment~Other protocol defined Inclusion/Exclusion criteria may apply", combined_text: A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors Phase 1: Number of Participants With Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation, Baseline up to 30 months|Phase 1: Number of Participants With Dose Limiting Toxicity (DLT), At the end of Cycle 1 (Each cycle is of 21 Days)|Phase 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Laboratory assessments include hematology, serum chemistry, other blood tests, coagulation, and urine analysis. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 1: Number of Participants With Clinically Significant Abnormalities in Vital Signs, Vital signs will include body temperature, pulse rate, and systolic and diastolic blood pressure measurements. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examination, Physical examination will include head, eyes, ears, nose and throat; heart; lungs; abdomen; skin; cervical and axillary lymph nodes; and neurological and musculoskeletal systems. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 1: Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG), ECG parameters included heart rhythm, pulse rate intervals, QRS, QT intervals, RR intervals and corrected QT(QTc) intervals. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 2: Objective Response Rate (ORR), Objective response rate (ORR), defined as the percentage of participants with a best overall response (BOR) of either a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors by investigators., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician\\s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months) Phase 1: Objective Response Rate (ORR), Objective response rate (ORR), defined as the percentage of participants with a BOR of either a complete response (CR) or partial response (PR), per RECIST version 1.1 for solid tumors by investigators., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician\\s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)|Phase 1 and 2: Duration of Response (DOR), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician\\s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Disease Control Rate (DCR), DCR will be defined similarly to ORR but also including stable disease (SD) in the categorization of response (i.e, RECIST response of either CR, PR, or SD)., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician\\s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Time to Response (TTR), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician\\s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Time to Progression (TTP), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician\\s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Durable Clinical Benefit (DCB), DCB will be defined similarly to DCR but additionally specifying that the disease control be achieved for at least 12 weeks consecutive (i.e, RECIST response of CR, PR or SD for greater than or equal to \\\\[\\\\>=\\\\] 12 weeks consecutive)., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician\\s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Progression-Free Survival (PFS), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician\\s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Overall survival (OS), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician\\s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Maximum Observed Serum Concentration (Cmax) of EU101, Cmax is defined as maximum observed serum concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Trough Serum Concentration (Ctrough) of EU101, Ctrough is steady-state pre-dose concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of EU101, Tmax is defined as time to reach maximum observed serum concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of EU101, AUC0-24 is defined as the area under the serum concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24)., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of EU101, AUC0-last is defined as area under the serum concentration time-curve from time zero to the time of last measured concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of EU101, AUCinf is defined as area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf)., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Elimination Half-Life Time (T1/2) of EU101, T1/2 is defined as plasma decay half-life is the time measured for the serum concentration to decrease by one half., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Apparent Volume of Distribution (Vd/F) of EU101, Vd/F is defined as volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug., Baseline (Day 1)|Phase 1 and 2: Apparent Oral Clearance of (CL/F) of EU101, Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes., Baseline (Day 1)|Phase 1 and 2: Mean Residence Time (MRT) of EU101, MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time., Baseline (Day 1)|Phase 1 and 2: Renal clearance (CLr) of EU101, CLr is defined as renal clearance is the volume of plasma completely cleared of EU101 by the kidneys per unit time., Baseline (Day 1)|Phase 1 and 2: Number of Participants with Positive Antidrug Antibodies (ADA), The immunogenic potential of EU101 will be assessed by summarizing the number of participants who develop detectable antidrug antibody (ADAs)., Baseline up to 56 months|Phase 2: Number of Participants With AEs and SAEs by Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Time from first dose of study treatment up to 30 months "Key Inclusion Criteria:~* Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumors for which no standard therapy exists or standard therapy has failed because of disease progression or unacceptable toxicities. Also includes patients who cannot be treated with standard therapy because of underlying/existing medical condition.~* Cohort 1 (colorectal cancer): a) CRC (including microsatellite instability-high \\\\[MSI-H\\\\] and microsatellite-stable \\\\[MSS\\\\]) regardless of RAS mutation. b) Disease progression within 3 months after last administration of approved standard therapies. c) Prior cytotoxic chemotherapy for metastatic disease include all the following agents: fluoropyrimidine, oxaliplatin, and irinotecan~* Adjuvant chemotherapy-based treatments count as prior therapy, as long as relapse had occurred within 6 months of completion of such therapies, prior anti-epidermal growth factor receptor (EGFR) therapy (cetuximab, panitumumab), anti-angiogenic therapy (bevacizumab, aflibercept, ramucirumab), regorafenib, and TAS-102 are allowed. d) No more than 5 prior therapies for metastatic disease. For participants who had disease recurrence within 6 months of completing adjuvant chemotherapy, the adjuvant regimen can be considered as 1 chemotherapy regimen for metastatic disease~* Cohort 2 (NSCLC): a) NSCLC without known EGFR, anaplastic lymphoma kinase (ALK), and ROS1 genomic tumor aberrations. b) No standard therapy exists or standard therapy has failed. c) No more than 3 prior therapies for metastatic disease~* Phase 2: At least 1 measurable lesion per RECIST version 1.1~* Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2~* Adequate organ and bone marrow function (Hemoglobin \\\\>9.0 g/dL, Absolute neutrophil count ≥1,500/μL, Absolute lymphocyte count ≥600 and ≤2,500/μL, Platelet count ≥100,000/μL, Total bilirubin ≤1.5 × upper limit of normal, Alanine aminotransferase and aspartate aminotransferase ≤2.5 × ULN, Serum creatinine ≤1.5 × ULN or creatinine clearance \\\\>30 mL/min, Prothrombin time and activated partial thromboplastin time ≤1.5 × ULN)~* Life expectancy of at least 12 weeks~* Voluntarily provided a written consent to participate in the study~* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days before study drug administration~* WOCBP and sexually active fertile male patients with partners who are WOCBP must agree to use 2 highly effective methods of contraception throughout the course of the study and for 12 weeks after the last dose of study drug.~Key Exclusion Criteria:~* Primary central nervous system (CNS) tumor (Phase 1), CNS metastasis, and/or carcinomatous meningitis. Participants with prior brain metastases treated at least 4 weeks before the first dose of EU101 that are clinically stable and do not require chronic corticosteroid treatment are allowed. Untreated but asymptomatic and clinically stable brain metastases per investigator\\s discretion are allowed~* Received prior therapy with any anti-CD137 monoclonal antibody (mAb) or agent~* Major surgery requiring general anesthesia within 3 weeks before first dose of EU101 or still recovering from prior surgery~* Active infection that is not controlled or requires intravenous antibiotics in the last 2 weeks~* History of allogeneic tissue or organ transplant~* Active hepatitis B virus or hepatitis C virus infection~* History of any noninfectious hepatitis~* Human immunodeficiency virus (HIV) infection~* Received or receiving systemic corticosteroid therapy or any other form of systemic immunosuppressive medicaion 1 week before first dose of EU101~* Known severe (≥Grade 3) hypersensitivity reactions to antibody, or severe reaction to immuno-oncology agents requiring treatment with steroids~* Konwn or suspected hypersensitivity to EU101 or any component of its formulation~* Current or history of interstitial lung disease, anaphylaxis, uncontrolled asthma, or pneumonitis that has required systemic corticosteroids~* Patients with second primary cancer~* Clinically significant concurrent cardiovascular disease~* Pregnant women, breasfeeding women, WOCBP, or men with partners who are WOCBP who do not agree to use adequate contraceptive measures~* Determined as unable to participate in the study per investigator\\s judgment~Other protocol defined Inclusion/Exclusion criteria may apply", Similarity Score: 0.4123409350927331}'}]
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[{'from': 'human', 'value': '{Study Title: A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2), Primary Outcome Measures: Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment, DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (\\\\>=) 7 days or Grade 3 neutropenia with fever (greater than \\\\[\\\\>\\\\] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting \\\\>7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for \\\\>7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days), Secondary Outcome Measures: Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment, From baseline up to approximately up to 5 years 5 months|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7, Day-7: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Objective Response Rate (ORR); Combination Treatment, ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\\\<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months), criteria: "Inclusion Criteria:~Participants must meet all of the following criteria to be included in this study:~1. Phase 1b: Unresectable advanced or metastatic solid tumors.~2. Phase 1b expansion cohort and Phase 2: Histological confirmed diagnosis of glioblastoma (expansion cohort and Cohort 1) or melanoma (expansion cohort and Cohort 2).~ Phase 1b expansion cohort glioblastoma participants, Phase 2 Cohort 1:~3. No evidence of active central nervous systems (CNS) hemorrhage on baseline scans other than in those participants with recurrent glioblastoma who are stable Grade 1.~4. Participants having first or second recurrence documented by magnetic resonance imaging (MRI), following primary management with surgical resection or biopsy, radiotherapy and up to two prior systemic treatments.~5. If participants is on corticosteroids, they must be on a stable dose for 1 week prior to first dose of study drug.~6. Measurable disease defined as bidimensionally contrast enhancing lesions with clearly defined margins by computerized tomography (CT) or MRI scan, with a minimal diameter of 1 cm, and visible on two axial slices which are preferably at most 5 millimeter (mm) apart with 0 mm skip.~ Phase 1b expansion cohort melanoma participants, Phase 2 Cohort 2:~7. Radiographic/ photographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Appendix 3) after no more than two prior systemic regimens for unresectable Stage III or Stage IV disease.~8. American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma.~9. Measurable disease meeting the following criteria:~ 1. At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 centimeter (cm) in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI or photography. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.~ 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radio frequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.~ All participants:~10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~11. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 millimeter of mercury (mmHg) at screening and no change in antihypertensive medications within 1 week before the Screening Visit.~12. Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 milligrams per deciliter (mg/dL) or calculated creatinine clearance greater than or equal to 40 milliliters per minute (mL/min) per the Cockcroft and Gault formula (see Appendix 5).~13. Adequate bone marrow function:~ * Absolute neutrophil count greater than or equal to 1500/mm3 (greater than or equal to 1.5 x 10\\\\^3/uL);~ * Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 x 10\\\\^9/L);~ * Hemoglobin greater than or equal to 9.0 g/dL. 14.Adequate blood coagulation function, as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5.~14. Adequate liver function:~ * Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert\\s syndrome;~ * ALP, ALT, and AST less than or equal to 3 x ULN (less than or equal to 5 x ULN if participant has liver metastases).~15. Males or females age greater than or equal to 18 years at the time of informed consent.~16. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \\\\[B-hCG\\\\] at the Screening and Baseline Visit (a separate Baseline assessment is not required if a negative Screening pregnancy test was obtained within 72 hours before the first dose of study drug). Females of child-bearing potential, if not practising total abstinence or having a vasectomized partner with confirmed azoospermia, must agree to use two highly effective methods of contraception: e.g., 1) an intrauterine device (IUD) or intrauterine system (IUS); 2) a barrier method such as a condom or occlusive cup (diaphragm or cervical/vault caps) + spermicide (foam, gel, cream, etc.); 3) oral, injected, or implanted hormonal contraceptives throughout the entire study period and for 30 days after study drug discontinuation. Use of a double-barrier method (i.e., use at the same time of a condom + occlusive cup \\\\[diaphragm or cervical/vault caps\\\\] + spermicide \\\\[foam, gel, cream, etc.\\\\]) is accepted as two highly effective methods of contraception. The only participants who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or participants who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, total hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.~17. Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods described in Inclusion Criterion #18) beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug, unless the male participants are totally abstinent sexually or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile (see Inclusion Criterion #16).~18. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.~Exclusion Criteria:~Participants who meet any of the following criteria will be excluded from this study:~1. Phase 1b Dose Escalation: Participants who discontinued prior TK inhibitor (including VEGFR and c-Met receptor targeted therapy) due to toxicity will be ineligible.~2. Phase 1b Dose Escalation (3+3 portion) participants with primary CNS tumors~3. Phase 1b Dose Escalation participants, melanoma participants in expansion cohort and Phase 2 Cohort 2: Participants with untreated or unstable metastases to the central nervous system (CNS) are excluded. participants who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and have remained asymptomatic for at least 4 weeks prior to commencing treatment are eligible.~4. Phase 2: Prior exposure to VEGF-targeted treatment or c-Met or hepatocyte growth factor (HGF) targeted treatment.~5. Phase 2: Active malignancy (except for glioblastoma (Cohort 1) or unresectable Stage III or Stage IV melanoma (Cohort 2); or melanoma in situ, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) within the past 24 months.~ Phase 1b expansion cohort glioblastoma participants and Phase 2 Cohort 1:~6. More than two recurrences of glioblastoma.~7. Prior bevacizumab treatment.~8. Surgical resection of brain tumor within 4 weeks, or prior stereotactic biopsy within 2 weeks of Screening visit.~9. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field (beyond the high dose region or 80% isodose line), or there is biopsy-proven unequivocal viable tumor on histopathology sampling (e.g., solid tumor areas (i.e. greater than 70% tumor cell nuclei in areas), high or progressive increase in MIB-1 proliferation index compared to prior biopsy, or evidence for histological progression or increased anaplasia in the tumor).~10. Participants who have received enzyme-inducing anti epileptic agents within 14 days before the first dose of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).~ Phase 1b expansion cohort participants with melanoma and Phase 2 Cohort 2:~11. More than two prior systemic regimens for unresectable Stage III or Stage IV disease.~ All participants~12. Prior exposure to E7050 or lenvatinib.~13. Melanoma of intraocular origin.~14. participants who have received any anticancer treatment within 21 days (6 weeks for nitrosureas Cohort 1) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anticancer treatment.~15. Major surgery within 3 weeks prior to the first dose of study drug.~16. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.~17. Inability to take oral medication, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of E7050 or lenvatinib.~18. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.~19. Prolongation of QTc interval to greater than 480 msec.~20. Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin \\\\[LMWH\\\\] is allowed).~21. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.~22. Active infection (any infection requiring antibiotics).~23. Known intolerance or known hypersensitivity to any of the study drugs (or any of the excipients).~24. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.~25. Females who are pregnant or breastfeeding."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 179, Unnamed: 0: 219, NCT Number: NCT04713891, Study Title: A Study of KF-0210 in Advanced Solid Tumors Patients, Study URL: https://clinicaltrials.gov/study/NCT04713891, Acronym: , Study Status: COMPLETED, Brief Summary: The purpose of this Phase I, Multi-Center, Open-Label Study is to evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and anti-tumor activity of KF-0210 in participants with advanced solid tumors. The study will be conducted in two parts: phase Ia, and phase Ib., Study Results: NO, Conditions: Advanced Solid Tumor|Colorectal Cancer|Lung Cancer|Squamous Cell Carcinoma of the Esophagus|Gastric Cancer|Bladder Cancer, Interventions: DRUG: KF-0210 tablets, 120 mg|DRUG: KF-0210 tablets, 240 mg|DRUG: KF-0210 tablets, 450 mg|DRUG: KF-0210 tablets, 600 mg|DRUG: KF-0210 (dosage RP2D-2) + Atezolizumab|DRUG: KF-0210 (dosage RP2D-1) + Atezolizumab|DRUG: KF-0210 (dosage RP2D) + Atezolizumab, Primary Outcome Measures: "Percentage of patient with adverse events / serious adverse events (AEs/SAEs) [Safety and Tolerability], Adverse events will be assessed according to CTCAE V5.0, and be coded according to the MedDRA Dictionary, From consent through 28 days (±7 days) after the last dose or before starting other anti-tumor treatment (whichever occurs earlier)(up to approximately 1 year))|Dose limiting toxicity (DLT) of KF-0210 [Tolerability], Dose limiting toxicity (DLT) will be considered to be related to KF-0210 according to CTCAE V5.0 including hematology toxicities, non-hematological toxicities and any other toxicities., From Cycle 1 Day 1 to Cycle 1 Day 21, each cycle is 21 days.|Maximum tolerated dose (MTD) of KF-0210 alone [Tolerability], The Maximum tolerated dose (MTD) is defined as the highest dose at which ≤1、6 participants occurred dose limiting toxicity at each dose level., Up to 21 days after first administration in cycle 1, each cycle is 21 days|Change of Body Weight from Baseline [Safety], Body Weight measured in kilogram (kg), On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Body Temperature from Baseline [Safety], Axillary temperature measured in celsius, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Pulse rate from Baseline [Safety], Pulse rate measured per minute, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Systolic pressure from Baseline [Safety], Blood pressure measured in mmHg, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Diastolic pressure from Baseline [Safety], Blood pressure measured in mmHg, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Heart rate from Baseline [Safety], Heart rate in beats per minute (Bpm) through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of R-R interval from Baseline [Safety], R-R interval measured in millisecond through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of P-R interval from Baseline [Safety], P-R interval measured in millisecond through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of QRS complex from Baseline [Safety], QRS complex measured in millisecond through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Chang of QT interval from Baseline [Safety], QT interval measured in millisecond through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of corrected QT (QTc) interval from Baseline [Safety], corrected QT (QTc) interval measured in millisecond through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Fridericias Correction QT (QTcF) interval from Baseline [Safety], Fridericias Correction QT (QTcF) interval measured in millisecond through 12-lead ECG assessment., From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Eastern Cooperative Oncology Group-Performance Status (ECOG PS) from Baseline [Safety], The performance status will be evaluated in accordance with the Eastern Cooperative Oncology Group (ECOG) criteria with the score range in 0 to 5. A score of 0 represents fully normal activity and a score of 5 represents death., On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Total Protein (TP) from Baseline [Safety], Total Protein (TP) measured in g/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Albumin (ALB) from Baseline [Safety], Albumin(ALB) measured in g/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Alanine aminotransferase (ALT) from Baseline [Safety], Alanine aminotransferase (ALT) measured in IU/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Aspartate aminotransferase (AST) from Baseline [Safety], Aspartate aminotransferase (AST) measured in IU/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Alkaline phosphatase (ALP/AKP) from Baseline [Safety], Alkaline phosphatase (ALP/AKP) measured in IU/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Total bilirubin from Baseline [Safety], Total bilirubin measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Direct bilirubin from Baseline [Safety], Direct bilirubin measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Indirect bilirubin from Baseline [Safety], Indirect bilirubin measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Glutamyl transpeptidase from Baseline [Safety], Glutamyl transpeptidase measured in U/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Blood glucose from Baseline [Safety], Blood glucose measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Urea from Baseline [Safety], Urea measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Uric acid from Baseline [Safety], Uric acid measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Creatinine from Baseline [Safety], Creatinine measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Creatinine Kinase from Baseline [Safety], Creatinine Kinase measured in IU/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Total Cholesterol from Baseline [Safety], Total Cholesterol measured in mmol/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Triglycerides from Baseline [Safety], Triglycerides measured in mmol/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Potassium, Sodium, Chloride or Calcium from Baseline [Safety], Potassium, Sodium, Chloride or Calcium measured in mmol/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Leukocyte Count from Baseline [Safety], Leukocyte Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Neutrophil Count from Baseline [Safety], Neutrophil Count in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Percentage of Neutrophil from Baseline [Safety], Percentage of Neutrophil will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Lymphocyte Count from Baseline [Safety], Lymphocyte Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Percentage of Lymphocyte from Baseline [Safety], Percentage of Lymphocyte will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Monocytes Count from Baseline [Safety], Monocytes Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Percentage of Monocytes from Baseline [Safety], Percentage of Monocytes will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Eosinophils Count from Baseline [Safety], Eosinophils Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Percentage of Eosinophils from Baseline [Safety], Percentage of Eosinophils will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Basophil Count from Baseline [Safety], Basophil Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Percentage of Basophil from Baseline [Safety], Percentage of Basophil will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Erythrocyte Count from Baseline [Safety], Erythrocyte Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Hemoglobin from Baseline [Safety], Hemoglobin measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Hematocrit Platelets from Baseline [Safety], Hematocrit Platelets measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Coagulation test-Activated partial thromboplastin time (APTT) from Baseline [Safety], Activated partial thromboplastin time (APTT) measured in seconds, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Coagulation test-Prothrombin time (PT) from Baseline [Safety], Prothrombin time (PT) measured in seconds, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Coagulation test-Fibrinogen(FIB) from Baseline [Safety], Fibrinogen(FIB) measured in mmol/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Coagulation test-Thrombin time (TT) from Baseline [Safety], Thrombin time (TT) measured in seconds, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Urine pH from Baseline [Safety], pH value will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Specific gravity of urine from Baseline [Safety], Specific gravity value will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Occult blood result from Baseline [Safety], The result will be recorded as either positive or negative, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urine Bilirubin result from Baseline [Safety], Urine bilirubin will be measure in µmol/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urine protein from Baseline [Safety], Urine protein will be measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urine Glucose from Baseline [Safety], Urine Glucose will be measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Ketones from Baseline [Safety], Ketones will be measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urobilinogen from Baseline [Safety], Urobilinogen will be measured in EU/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urinary leukocyte from Baseline [Safety], Urinary leukocyte will be counted in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urine erythrocytes from Baseline [Safety], Urine erythrocytes will be counted in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urine Nitrites from Baseline [Safety], Urobilinogen will be measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Clinically significant abnormality in physical examinations, Physical examination includes skin, head, eyes, ears, nose and throat, lymph nodes, heart, chest, abdomen and extremities, and nervous system (speech, cranial nerves, motor ability, tendon reflexes, sensations, free movement), On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)", Secondary Outcome Measures: Maximum observed plasma concentration (Cmax), For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 5, each cycle is 21 days.|Time of maximum plasma concentration (Tmax), For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf), For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-t) of KF-0210, For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Terminal half-life (T1/2) of KF-0210, For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Accumulation ratio (Rac), For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Cmin to Cmax fluctuation between dose time and Tau (DF), For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Blood cytokines/chemokines levels, Biomarker for pharmacodynamic assessment including interferon (IFN-γ), tumor necrosis factor (TNF-α), CXCL10 and CCL5., Up to 21 days after first administration in cycle 1, each cycle is 21 days.|Urine prostaglandin metabolites level, To explore the prostaglandin metabolites in urine, Up to 21 days after first administration in cycle 1, each cycle is 21 days.|Tumor T cell infiltration, Tumor biopsies will be analyzed by immunohistochemistry (IHC) for CD3+ T cells, CD8+ T cells and PD-L1 expression., Up to 21 days after first administration in cycle 1, each cycle is 21 days.|Change in tumor size from baseline, Tumor assessment with CT scan or MRI. The anti-tumor activity will be evaluated according to the RECIST V1.1., From screening through the last dose of treatment, each cycle is 21 days.|Objective response rate (ORR), Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD)., From screening through the last dose of treatment, each cycle is 21 days.|Duration of response (DOR) (days), Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD)., From screening through the last dose of treatment, each cycle is 21 days.|Disease control rate (DCR), Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD)., From screening through the last dose of treatment, each cycle is 21 days.|Progression free survival (PFS), Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD)., From screening through the last dose of treatment, each cycle is 21 days., Other Outcome Measures: , Sponsor: Keythera Pharmaceuticals (Australia) Pty Ltd, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 14.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: KFCS001, Start Date: 2021-03-09, Primary Completion Date: 2022-12-08, Completion Date: 2023-04-27, First Posted: 2021-01-19, Results First Posted: , Last Update Posted: 2024-09-24, Locations: Scientia Clinical Research Limited, Randwick, New South Wales, 2031, Australia, Study Documents: , criteria: "Inclusion Criteria:~1. Age ≥ 18 years old, male and female;~2. Patients are confirmed by available pathology records or current biopsy having advanced, nonresectable, or recurrent and progressing solid tumors since last anti-tumor therapy, and who are unavailable or intolerable for available standard therapy or there is no standard available therapy.~ * Phase Ia (Dose Escalation): Advanced solid tumors;~ * Phase Ib (Expansion Study): Patients must have any of the following tumor type and have not participated in Phase Ia trial of this study: CRC (MSS), LC, SCCE, GC, and BC. Among them, patients with LC, SCCE, or GC must have undergone PD-1/PD-L1 treatment for at least 12 weeks and failed.~3. Must have at least 1 measurable lesion, according RECIST V1.1 criteria (CT-scans or MRI no longer than 4 weeks before signing ICF);~4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;~5. Life expectancy≥ 3 months;~6. Females must not be lactating or pregnant at screening or baseline (negative pregnant test).~Exclusion Criteria:~1. Patients with prior anti-tumor therapy within 4 weeks prior to first dosing of KF-0210, including chemotherapy, biotherapy, endocrine therapy and immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer);~2. Patients with prior definitive radiation therapy within 6 weeks prior to first dosing of KF-0210, and the irradiated lesions showed no signs of progression if it to be considered target lesions. Or patients with prior palliative radiotherapy within 2 weeks prior to first dosing of KF-0210. Or the radiotherapy-related side effects have unresolved before the study entry. Or use of radiopharmaceuticals (strontium, samarium) within 8 weeks prior to first dosing of KF-0210;~3. Patients who have another active malignancy which is likely to require treatment;~4. Patients who have known active central nervous system (CNS) metastases and/or carcinomatous meningitis;~5. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months prior to the first dose of KF-0210; or cardiac arrhythmia requiring medical treatment (including oral anticoagulation);~6. Patients with any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma or history of syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy. Patients with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study;~7. Patients with inflammatory bowel disease or digestive tract diseases (e.g. peptic ulcer disease, including stomach and duodenal ulcer, gastritis and enteritis);~8. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of KF-0210;~9. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids except inhaled or intranasal corticosteroids (with minimal systemic absorption);~10. Current use of NSAIDs, COX-1/COX-2 inhibitors within 4 weeks;~11. Patients who have received surgical or interventional treatment (excluding tumor biopsy, puncture, etc.) within 28 days prior to first dosing of KF-0210;~12. Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is shorter) prior to the first dosing of KF-0210;~13. Use of any live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dosing of KF-0210;~14. Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) grade 1 at the time of starting study treatment with exception of alopecia;~15. Any uncontrolled or severe illness, including but not limited to: ongoing or active infection requiring parenteral antibiotics;~16. Positive screening tests for any one of them: human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg); hepatitis B core antibody (HBcAb) (negative for HBsAg, but HBcAb positive, an HBV-DNA test will be performed and if positive will be excluded), hepatitis C antibody (anti-HCV positive, but negative HCV RNA test is allowed to be included).", combined_text: A Study of KF-0210 in Advanced Solid Tumors Patients Percentage of patient with adverse events / serious adverse events (AEs/SAEs) [Safety and Tolerability], Adverse events will be assessed according to CTCAE V5.0, and be coded according to the MedDRA Dictionary, From consent through 28 days (±7 days) after the last dose or before starting other anti-tumor treatment (whichever occurs earlier)(up to approximately 1 year))|Dose limiting toxicity (DLT) of KF-0210 [Tolerability], Dose limiting toxicity (DLT) will be considered to be related to KF-0210 according to CTCAE V5.0 including hematology toxicities, non-hematological toxicities and any other toxicities., From Cycle 1 Day 1 to Cycle 1 Day 21, each cycle is 21 days.|Maximum tolerated dose (MTD) of KF-0210 alone [Tolerability], The Maximum tolerated dose (MTD) is defined as the highest dose at which ≤1、6 participants occurred dose limiting toxicity at each dose level., Up to 21 days after first administration in cycle 1, each cycle is 21 days|Change of Body Weight from Baseline [Safety], Body Weight measured in kilogram (kg), On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Body Temperature from Baseline [Safety], Axillary temperature measured in celsius, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Pulse rate from Baseline [Safety], Pulse rate measured per minute, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Systolic pressure from Baseline [Safety], Blood pressure measured in mmHg, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Diastolic pressure from Baseline [Safety], Blood pressure measured in mmHg, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Heart rate from Baseline [Safety], Heart rate in beats per minute (Bpm) through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of R-R interval from Baseline [Safety], R-R interval measured in millisecond through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of P-R interval from Baseline [Safety], P-R interval measured in millisecond through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of QRS complex from Baseline [Safety], QRS complex measured in millisecond through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Chang of QT interval from Baseline [Safety], QT interval measured in millisecond through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of corrected QT (QTc) interval from Baseline [Safety], corrected QT (QTc) interval measured in millisecond through 12-lead ECG assessment, From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Fridericia\\s Correction QT (QTcF) interval from Baseline [Safety], Fridericia\\s Correction QT (QTcF) interval measured in millisecond through 12-lead ECG assessment., From screening to the end of treatment/withdrawal (up to approximately 1 year)|Change of Eastern Cooperative Oncology Group-Performance Status (ECOG PS) from Baseline [Safety], The performance status will be evaluated in accordance with the Eastern Cooperative Oncology Group (ECOG) criteria with the score range in 0 to 5. A score of 0 represents fully normal activity and a score of 5 represents death., On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Total Protein (TP) from Baseline [Safety], Total Protein (TP) measured in g/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Albumin (ALB) from Baseline [Safety], Albumin(ALB) measured in g/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Alanine aminotransferase (ALT) from Baseline [Safety], Alanine aminotransferase (ALT) measured in IU/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Aspartate aminotransferase (AST) from Baseline [Safety], Aspartate aminotransferase (AST) measured in IU/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Alkaline phosphatase (ALP/AKP) from Baseline [Safety], Alkaline phosphatase (ALP/AKP) measured in IU/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Total bilirubin from Baseline [Safety], Total bilirubin measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Direct bilirubin from Baseline [Safety], Direct bilirubin measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Indirect bilirubin from Baseline [Safety], Indirect bilirubin measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Glutamyl transpeptidase from Baseline [Safety], Glutamyl transpeptidase measured in U/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Blood glucose from Baseline [Safety], Blood glucose measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Urea from Baseline [Safety], Urea measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Uric acid from Baseline [Safety], Uric acid measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Creatinine from Baseline [Safety], Creatinine measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Creatinine Kinase from Baseline [Safety], Creatinine Kinase measured in IU/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Total Cholesterol from Baseline [Safety], Total Cholesterol measured in mmol/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Triglycerides from Baseline [Safety], Triglycerides measured in mmol/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Potassium, Sodium, Chloride or Calcium from Baseline [Safety], Potassium, Sodium, Chloride or Calcium measured in mmol/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Leukocyte Count from Baseline [Safety], Leukocyte Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Neutrophil Count from Baseline [Safety], Neutrophil Count in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Percentage of Neutrophil from Baseline [Safety], Percentage of Neutrophil will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Lymphocyte Count from Baseline [Safety], Lymphocyte Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Percentage of Lymphocyte from Baseline [Safety], Percentage of Lymphocyte will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Monocytes Count from Baseline [Safety], Monocytes Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Percentage of Monocytes from Baseline [Safety], Percentage of Monocytes will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Eosinophils Count from Baseline [Safety], Eosinophils Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Percentage of Eosinophils from Baseline [Safety], Percentage of Eosinophils will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Basophil Count from Baseline [Safety], Basophil Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Percentage of Basophil from Baseline [Safety], Percentage of Basophil will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Erythrocyte Count from Baseline [Safety], Erythrocyte Count measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Hemoglobin from Baseline [Safety], Hemoglobin measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Hematocrit Platelets from Baseline [Safety], Hematocrit Platelets measured in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Coagulation test-Activated partial thromboplastin time (APTT) from Baseline [Safety], Activated partial thromboplastin time (APTT) measured in seconds, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Coagulation test-Prothrombin time (PT) from Baseline [Safety], Prothrombin time (PT) measured in seconds, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Coagulation test-Fibrinogen(FIB) from Baseline [Safety], Fibrinogen(FIB) measured in mmol/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Coagulation test-Thrombin time (TT) from Baseline [Safety], Thrombin time (TT) measured in seconds, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Urine pH from Baseline [Safety], pH value will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change of Specific gravity of urine from Baseline [Safety], Specific gravity value will be measured, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Occult blood result from Baseline [Safety], The result will be recorded as either positive or negative, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urine Bilirubin result from Baseline [Safety], Urine bilirubin will be measure in µmol/L, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urine protein from Baseline [Safety], Urine protein will be measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urine Glucose from Baseline [Safety], Urine Glucose will be measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Ketones from Baseline [Safety], Ketones will be measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urobilinogen from Baseline [Safety], Urobilinogen will be measured in EU/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urinary leukocyte from Baseline [Safety], Urinary leukocyte will be counted in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urine erythrocytes from Baseline [Safety], Urine erythrocytes will be counted in K/uL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Change in Urine Nitrites from Baseline [Safety], Urobilinogen will be measured in mg/dL, On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)|Clinically significant abnormality in physical examinations, Physical examination includes skin, head, eyes, ears, nose and throat, lymph nodes, heart, chest, abdomen and extremities, and nervous system (speech, cranial nerves, motor ability, tendon reflexes, sensations, free movement), On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year) Maximum observed plasma concentration (Cmax), For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 5, each cycle is 21 days.|Time of maximum plasma concentration (Tmax), For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf), For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-t) of KF-0210, For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Terminal half-life (T1/2) of KF-0210, For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Accumulation ratio (Rac), For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Cmin to Cmax fluctuation between dose time and Tau (DF), For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above)., Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.|Blood cytokines/chemokines levels, Biomarker for pharmacodynamic assessment including interferon (IFN-γ), tumor necrosis factor (TNF-α), CXCL10 and CCL5., Up to 21 days after first administration in cycle 1, each cycle is 21 days.|Urine prostaglandin metabolites level, To explore the prostaglandin metabolites in urine, Up to 21 days after first administration in cycle 1, each cycle is 21 days.|Tumor T cell infiltration, Tumor biopsies will be analyzed by immunohistochemistry (IHC) for CD3+ T cells, CD8+ T cells and PD-L1 expression., Up to 21 days after first administration in cycle 1, each cycle is 21 days.|Change in tumor size from baseline, Tumor assessment with CT scan or MRI. The anti-tumor activity will be evaluated according to the RECIST V1.1., From screening through the last dose of treatment, each cycle is 21 days.|Objective response rate (ORR), Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD)., From screening through the last dose of treatment, each cycle is 21 days.|Duration of response (DOR) (days), Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD)., From screening through the last dose of treatment, each cycle is 21 days.|Disease control rate (DCR), Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD)., From screening through the last dose of treatment, each cycle is 21 days.|Progression free survival (PFS), Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD)., From screening through the last dose of treatment, each cycle is 21 days. "Inclusion Criteria:~1. Age ≥ 18 years old, male and female;~2. Patients are confirmed by available pathology records or current biopsy having advanced, nonresectable, or recurrent and progressing solid tumors since last anti-tumor therapy, and who are unavailable or intolerable for available standard therapy or there is no standard available therapy.~ * Phase Ia (Dose Escalation): Advanced solid tumors;~ * Phase Ib (Expansion Study): Patients must have any of the following tumor type and have not participated in Phase Ia trial of this study: CRC (MSS), LC, SCCE, GC, and BC. Among them, patients with LC, SCCE, or GC must have undergone PD-1/PD-L1 treatment for at least 12 weeks and failed.~3. Must have at least 1 measurable lesion, according RECIST V1.1 criteria (CT-scans or MRI no longer than 4 weeks before signing ICF);~4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;~5. Life expectancy≥ 3 months;~6. Females must not be lactating or pregnant at screening or baseline (negative pregnant test).~Exclusion Criteria:~1. Patients with prior anti-tumor therapy within 4 weeks prior to first dosing of KF-0210, including chemotherapy, biotherapy, endocrine therapy and immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer);~2. Patients with prior definitive radiation therapy within 6 weeks prior to first dosing of KF-0210, and the irradiated lesions showed no signs of progression if it to be considered target lesions. Or patients with prior palliative radiotherapy within 2 weeks prior to first dosing of KF-0210. Or the radiotherapy-related side effects have unresolved before the study entry. Or use of radiopharmaceuticals (strontium, samarium) within 8 weeks prior to first dosing of KF-0210;~3. Patients who have another active malignancy which is likely to require treatment;~4. Patients who have known active central nervous system (CNS) metastases and/or carcinomatous meningitis;~5. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months prior to the first dose of KF-0210; or cardiac arrhythmia requiring medical treatment (including oral anticoagulation);~6. Patients with any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma or history of syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy. Patients with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study;~7. Patients with inflammatory bowel disease or digestive tract diseases (e.g. peptic ulcer disease, including stomach and duodenal ulcer, gastritis and enteritis);~8. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of KF-0210;~9. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids except inhaled or intranasal corticosteroids (with minimal systemic absorption);~10. Current use of NSAIDs, COX-1/COX-2 inhibitors within 4 weeks;~11. Patients who have received surgical or interventional treatment (excluding tumor biopsy, puncture, etc.) within 28 days prior to first dosing of KF-0210;~12. Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is shorter) prior to the first dosing of KF-0210;~13. Use of any live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dosing of KF-0210;~14. Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) grade 1 at the time of starting study treatment with exception of alopecia;~15. Any uncontrolled or severe illness, including but not limited to: ongoing or active infection requiring parenteral antibiotics;~16. Positive screening tests for any one of them: human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg); hepatitis B core antibody (HBcAb) (negative for HBsAg, but HBcAb positive, an HBV-DNA test will be performed and if positive will be excluded), hepatitis C antibody (anti-HCV positive, but negative HCV RNA test is allowed to be included).", Similarity Score: 0.3429668423446584}'}]
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[{'from': 'human', 'value': '{Study Title: A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2), Primary Outcome Measures: Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment, DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (\\\\>=) 7 days or Grade 3 neutropenia with fever (greater than \\\\[\\\\>\\\\] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting \\\\>7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for \\\\>7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days), Secondary Outcome Measures: Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment, From baseline up to approximately up to 5 years 5 months|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7, Day-7: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Objective Response Rate (ORR); Combination Treatment, ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\\\<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months), criteria: "Inclusion Criteria:~Participants must meet all of the following criteria to be included in this study:~1. Phase 1b: Unresectable advanced or metastatic solid tumors.~2. Phase 1b expansion cohort and Phase 2: Histological confirmed diagnosis of glioblastoma (expansion cohort and Cohort 1) or melanoma (expansion cohort and Cohort 2).~ Phase 1b expansion cohort glioblastoma participants, Phase 2 Cohort 1:~3. No evidence of active central nervous systems (CNS) hemorrhage on baseline scans other than in those participants with recurrent glioblastoma who are stable Grade 1.~4. Participants having first or second recurrence documented by magnetic resonance imaging (MRI), following primary management with surgical resection or biopsy, radiotherapy and up to two prior systemic treatments.~5. If participants is on corticosteroids, they must be on a stable dose for 1 week prior to first dose of study drug.~6. Measurable disease defined as bidimensionally contrast enhancing lesions with clearly defined margins by computerized tomography (CT) or MRI scan, with a minimal diameter of 1 cm, and visible on two axial slices which are preferably at most 5 millimeter (mm) apart with 0 mm skip.~ Phase 1b expansion cohort melanoma participants, Phase 2 Cohort 2:~7. Radiographic/ photographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Appendix 3) after no more than two prior systemic regimens for unresectable Stage III or Stage IV disease.~8. American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma.~9. Measurable disease meeting the following criteria:~ 1. At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 centimeter (cm) in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI or photography. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.~ 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radio frequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.~ All participants:~10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~11. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 millimeter of mercury (mmHg) at screening and no change in antihypertensive medications within 1 week before the Screening Visit.~12. Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 milligrams per deciliter (mg/dL) or calculated creatinine clearance greater than or equal to 40 milliliters per minute (mL/min) per the Cockcroft and Gault formula (see Appendix 5).~13. Adequate bone marrow function:~ * Absolute neutrophil count greater than or equal to 1500/mm3 (greater than or equal to 1.5 x 10\\\\^3/uL);~ * Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 x 10\\\\^9/L);~ * Hemoglobin greater than or equal to 9.0 g/dL. 14.Adequate blood coagulation function, as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5.~14. Adequate liver function:~ * Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert\\s syndrome;~ * ALP, ALT, and AST less than or equal to 3 x ULN (less than or equal to 5 x ULN if participant has liver metastases).~15. Males or females age greater than or equal to 18 years at the time of informed consent.~16. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \\\\[B-hCG\\\\] at the Screening and Baseline Visit (a separate Baseline assessment is not required if a negative Screening pregnancy test was obtained within 72 hours before the first dose of study drug). Females of child-bearing potential, if not practising total abstinence or having a vasectomized partner with confirmed azoospermia, must agree to use two highly effective methods of contraception: e.g., 1) an intrauterine device (IUD) or intrauterine system (IUS); 2) a barrier method such as a condom or occlusive cup (diaphragm or cervical/vault caps) + spermicide (foam, gel, cream, etc.); 3) oral, injected, or implanted hormonal contraceptives throughout the entire study period and for 30 days after study drug discontinuation. Use of a double-barrier method (i.e., use at the same time of a condom + occlusive cup \\\\[diaphragm or cervical/vault caps\\\\] + spermicide \\\\[foam, gel, cream, etc.\\\\]) is accepted as two highly effective methods of contraception. The only participants who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or participants who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, total hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.~17. Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods described in Inclusion Criterion #18) beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug, unless the male participants are totally abstinent sexually or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile (see Inclusion Criterion #16).~18. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.~Exclusion Criteria:~Participants who meet any of the following criteria will be excluded from this study:~1. Phase 1b Dose Escalation: Participants who discontinued prior TK inhibitor (including VEGFR and c-Met receptor targeted therapy) due to toxicity will be ineligible.~2. Phase 1b Dose Escalation (3+3 portion) participants with primary CNS tumors~3. Phase 1b Dose Escalation participants, melanoma participants in expansion cohort and Phase 2 Cohort 2: Participants with untreated or unstable metastases to the central nervous system (CNS) are excluded. participants who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and have remained asymptomatic for at least 4 weeks prior to commencing treatment are eligible.~4. Phase 2: Prior exposure to VEGF-targeted treatment or c-Met or hepatocyte growth factor (HGF) targeted treatment.~5. Phase 2: Active malignancy (except for glioblastoma (Cohort 1) or unresectable Stage III or Stage IV melanoma (Cohort 2); or melanoma in situ, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) within the past 24 months.~ Phase 1b expansion cohort glioblastoma participants and Phase 2 Cohort 1:~6. More than two recurrences of glioblastoma.~7. Prior bevacizumab treatment.~8. Surgical resection of brain tumor within 4 weeks, or prior stereotactic biopsy within 2 weeks of Screening visit.~9. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field (beyond the high dose region or 80% isodose line), or there is biopsy-proven unequivocal viable tumor on histopathology sampling (e.g., solid tumor areas (i.e. greater than 70% tumor cell nuclei in areas), high or progressive increase in MIB-1 proliferation index compared to prior biopsy, or evidence for histological progression or increased anaplasia in the tumor).~10. Participants who have received enzyme-inducing anti epileptic agents within 14 days before the first dose of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).~ Phase 1b expansion cohort participants with melanoma and Phase 2 Cohort 2:~11. More than two prior systemic regimens for unresectable Stage III or Stage IV disease.~ All participants~12. Prior exposure to E7050 or lenvatinib.~13. Melanoma of intraocular origin.~14. participants who have received any anticancer treatment within 21 days (6 weeks for nitrosureas Cohort 1) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anticancer treatment.~15. Major surgery within 3 weeks prior to the first dose of study drug.~16. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.~17. Inability to take oral medication, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of E7050 or lenvatinib.~18. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.~19. Prolongation of QTc interval to greater than 480 msec.~20. Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin \\\\[LMWH\\\\] is allowed).~21. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.~22. Active infection (any infection requiring antibiotics).~23. Known intolerance or known hypersensitivity to any of the study drugs (or any of the excipients).~24. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.~25. Females who are pregnant or breastfeeding."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 890, Unnamed: 0: 1115, NCT Number: NCT02964273, Study Title: Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease), Study URL: https://clinicaltrials.gov/study/NCT02964273, Acronym: , Study Status: COMPLETED, Brief Summary: The primary objective of the study is to assess the long term safety of treatment with tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD). The secondary objective is to assess the pharmacodynamics, pharmacokinetics, and efficacy of tolvaptan in the same participant population., Study Results: YES, Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD), Interventions: DRUG: Tolvaptan|DRUG: Tolvaptan Matching-placebo, Primary Outcome Measures: "Phase A: Change From Baseline in Spot Urine Osmolality (Pre-morning Dose), Urine osmolality is a measure of urine concentration, measured by osmometer, which evaluates the freezing point depression of a solution and supplies results as milliosmoles per kilogram of water. Spot urine osmolality was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), and Week 1 for all participants. Sample was taken after the first mornings void and was provided as a mid-stream, clean catch sample. All participants were fasting., Baseline, and Week 1 of Phase A|Phase A: Change From Baseline in Specific Gravity (Pre-morning Dose), Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidneys ability to concentrate urine. Spot urine sample for determination of specific gravity was collected immediately prior to morning dosing for Day 1 (Baseline), and Week 1 for all participants. Sample was taken after the first mornings void and was provided as a mid-stream, clean catch sample. All participants were fasting., Baseline, and Week 1 of Phase A", Secondary Outcome Measures: Phase A: Percent Change From Phase A Baseline in Height-Adjusted Total Kidney Volume (htTKV) as Measured by Magnetic Resonance Imaging (MRI), htTKV is used in participants with autosomal dominant polycystic kidney disease to predict the onset of renal insufficiency., Baseline, and Month 12 of Phase A|Phase A and B: Mean 24-hour Fluid Balance Prior to Week 1, Participants were instructed to record all fluid taken and all urine output for the 24-hour period., Prior to Week 1 in Phase A and B|Phase A: Change From Baseline in Renal Function (Estimated Glomerular Filtration Rate [eGFR] by Schwartz Formula) at Each Clinic Visit in Phase A, Renal function was assessed by estimated eGFR calculated by the Schwartz formula (eGFR = 0.413 × height \\\\[cm\\\\] /serum creatinine mg/dL), expressed as mean change in eGFR at the specified time points. The units for the data reported are milliliter per minute per 1.73 meter square (mL/min/1.73 m\\\\^2). The baseline was the evaluation done at Week 1 in Phase A for this outcome measure., Phase A Baseline, Months 1, 6, and 12|Phase B: Change From Phase B Baseline in Renal Function (eGFR by Schwartz Formula) at Each Clinic Visit in Phase B, Renal function was assessed by estimated eGFR calculated by the Schwartz formula (eGFR = 0.413 × height \\\\[cm\\\\] /serum creatinine mg/dL), expressed as mean change in eGFR at the specified time points., Phase B Baseline, Week 1, Months 1, 6, 12, 18, and 24|Phase B: Percent Change From Phase B Baseline in htTKV as Measured by MRI at Month 12 and Month 24, htTKV is used in participants with autosomal dominant polycystic kidney disease to predict the onset of renal insufficiency., Phase B Baseline, Months 12 and 24|Phase A: 24-hour Urine Volume, Urine volume refers to the quantity of urine produced per unit of time., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: 24-hour Fluid Intake, Daily fluid intake (total water) is defined as the amount of water consumed from foods, plain drinking water, and other beverages., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: 24-hour Fluid Balance, Fluid balance is a term used to describe the balance of the input and output of fluids in the body to allow metabolic processes to function correctly., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: 24-hour Sodium Clearance, Data was categorized and reported based on the total daily dose for the given time point of 0-24 hours., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: 24-hour Creatinine Clearance, Creatinine is produced from the metabolism of protein, when muscles burn energy. Most creatinine is filtered out of the blood by the kidneys and excreted in urine. The creatinine clearance value is determined by measuring the concentration of endogenous creatinine (that which is produced by the body) in both plasma and urine. Data was categorized and reported based on the total daily dose for the given time point of 0-24 hours., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: 24-hour Free Water Clearance, Data was categorized and reported based on the total daily dose for the given time point of 0-24 hours., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: Percentage of Each Tanner Stage by Gender and Age Compared to Normative Populations, Tanner stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Only those categories with at least one participant with event are reported., At Baseline, Months 6 and 12 of Phase A|Phase B: Percentage of Each Tanner Stage by Gender and Age Compared to Normative Populations, Tanner stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Only those categories with at least one participant with event are reported., At Baseline, Months 6, 12, 18, and 24 of Phase B|Phase A: Change From Baseline in Growth Percentile by Gender and Age, The growth percentile was based on the assessment of height and weight., At Baseline, Months 6 and 12 of Phase A|Phase B: Change From Baseline in Growth Percentile by Gender and Age, The growth percentile was based on the assessment of height and weight., At Baseline, Months 6, 12, 18, and 24 of Phase B|Phase A: Change From Baseline in Creatinine Value, Phase A Baseline is the last pre-dose evaluation. The Last Visit is the last available post-baseline evaluation including early term. As prespecified in the protocol, data for safety is reported by the treatment group (Phase A: Tolvaptan and Phase A: Placebo), Baseline, Week 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Follow Up Day 7, End of Treatment, and Last Visit|Phase B: Change From Baseline in Creatinine Value, Phase B Baseline is the last evaluation prior to the first dose in Phase B. The Last Visit is the last available post-baseline evaluation including early term. As prespecified in the protocol, data for safety is reported by the treatment group (Phase B: Prior Tolvaptan and Phase B: Prior Placebo)., Baseline, Week 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, Follow Up Day 7, End of Treatment, and Last Visit|Phase A and B: Percentage of Participants With Potentially Clinically Significant Abnormalities in Vital Signs, Vital sign measurements included measurements of respiratory rate, blood pressure, body temperature and pulse. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance. Only those categories with at least one participant with event are reported. As prespecified in the protocol, data for safety is reported by the treatment group (Phase A: Tolvaptan, Phase A: Placebo, Phase B: Prior Tolvaptan and Phase B: Prior Placebo)., From first dose of study drug up to 14 days post last dose (up to approximately 37 months)|Phase A and B: Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Test Results Including Liver Function Tests (LFTs), Laboratory parameters=haematology,chemistry,urinalysis,\\\\& LFTs.Criteria for laboratory abnormalities along with their test result grade=Increased creatinine level: Baseline(BSL):Grade 0,\\\\>BSL-1.5xBSL:1,\\\\>1.5-3xBSL:2,\\\\>3-6xBSL:3,\\\\>6xBSL:4.Decreased glucose level: \\\\<30:-4,30-\\\\<40:-3, 40-\\\\<55:-2, 55-\\\\<65:-1,\\\\>=65:0; Increased:\\\\<=115:0,\\\\>115-160:1,\\\\>160-250:2,\\\\>250-500:3,\\\\>500:4.Decreased potassium level: \\\\<2.5:-4,2.5-\\\\<3:-3,3-\\\\<lower limit of normal(LLN):-1,LLN:0; Increased:upper limit of normal(ULN):0,\\\\>ULN-5.5:1,\\\\>5.5-6:2,\\\\>6-7:3,\\\\>7:4.Decreased sodium level: \\\\<120:-4,120-124:-3,125-129:-2,130-135:-1,\\\\>=136:0; Increased:\\\\<=145:0,146-150:1,151-155:2,156-160:3,\\\\>160:4. Increased triglyceride level:ULN:0,\\\\>ULN-2.5xULN:1,\\\\>2.5-5xULN:2,\\\\>5-6xULN:3,\\\\>6xULN:4. Decreased Neutrophils:\\\\<0.5:-4,0.5-\\\\<1:-3,1-\\\\<1.5:-2,1.5-\\\\<LLN:-1,LLN:0. Potentially clinically significant increase or decrease was defined as Baseline grade 0,1,-1 and post-baseline grade \\\\>1, \\\\<-1 or Baseline grade \\\\>1,\\\\<-1 and post-baseline grade \\\\>or\\\\<Baseline grade., From first dose of study drug up to 14 days post last dose (up to approximately 37 months)|Phase A and B: Percentage of Participants With Aquaretic Adverse Events (AEs), An AE was defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Aquaretic AEs included Medical Dictionary for Regulatory Activities \\\\[MedDRA\\\\] preferred terms of thirst, polyuria (production of large volumes of dilute urine), nocturia (need to wake up to urinate at night), pollakiuria (abnormally frequent urination), and polydipsia (excessive thirst). As prespecified in the protocol, data for safety is reported by the treatment group (Phase A: Tolvaptan, Phase A: Placebo, Phase B: Prior Tolvaptan and Phase B: Prior Placebo)., From first dose of study drug up to 14 days post last dose (up to approximately 37 months), Other Outcome Measures: , Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc., Collaborators: , Sex: ALL, Age: CHILD, Phases: PHASE3, Enrollment: 91.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT, Other IDs: 156-12-298|2016-000187-42, Start Date: 2016-09-23, Primary Completion Date: 2021-11-17, Completion Date: 2021-11-17, First Posted: 2016-11-16, Results First Posted: 2023-01-03, Last Update Posted: 2023-01-03, Locations: Gent, Oost-Vlaanderen, 9000, Belgium|Leuven, Vlaams Brabant, 3000, Belgium|Brussels, 1200, Belgium|Bruxelles, 1020, Belgium|Montegnee, 4420, Belgium|Cologne, 50937, Germany|Hamburg, 20246, Germany|Hannover, 30625, Germany|Heidelberg, 69120, Germany|Leipzig, 04103, Germany|Tuebingen, 72076, Germany|Milano, 20122, Italy|Napoli, 80129, Italy|Napoli, 80131, Italy|Pavia, 27100, Italy|Birmingham, B4 6NH, United Kingdom|London, SE1 7EH, United Kingdom|London, WC1N 3JH, United Kingdom|Manchester, M13 9WL, United Kingdom|Nottingham, NG7 2UH, United Kingdom, Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/73/NCT02964273/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT02964273/SAP_001.pdf, criteria: "Key Inclusion Criteria:~* Male and female participants aged 4 to 17 years (inclusive) with a diagnosis of ADPKD as defined by the presence of family history and/or genetic criteria AND who have at least 10 renal cysts, each of which measure at least 0.5 cm, confirmed upon magnetic resonance imaging (MRI) inspection; participants under the age of 12 years must have at least 4 cysts that are at least 1 cm in size, confirmed by ultrasound.~* Weight ≥20 kg.~* Participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m\\\\^2 within 31 days prior to randomization (using the Schwartz formula, eGFR = 0.413 × height \\\\[cm\\\\]/serum creatinine milligrams per deciliter \\\\[mg/dL\\\\]).~* Independent in toileting.~* Ability to swallow a tablet.~Key Exclusion Criteria:~* Liver function tests including aspartate aminotransferase (AST), alanine aminotransferase (ALT) \\\\> 1.5 × the upper limit of normal (ULN).~* Nocturnal enuresis.~* Need for chronic diuretic use.~* Participants with advanced diabetes (e.g., glycosylated hemoglobin \\\\>7.5, and/or glycosuria by dipstick, significant proteinuria, retinopathy), evidence of additional significant renal disease(s) (i.e., currently active glomerular nephritides), renal cancer, single kidney, or recent (within 6 months of screening) renal surgery or acute kidney injury.~* Participants having disorders in thirst recognition or inability to access fluids.~* Participants with critical electrolyte imbalances, as determined by the investigator.~* Participants with, or at risk of, significant hypovolemia as determined by investigator.~* Participants with clinically significant anemia, as determined by investigator.~* Participants 12 years of age and older having contraindications to, or interference with MRI assessments (e.g., ferro-magnetic prostheses, aneurysm clips, severe claustrophobia).~* Participants with a history of taking a vasopressin agonist/antagonist.~* Participants taking medications or having concomitant illnesses likely to confound endpoint assessments, including taking approved (i.e., marketed) therapies for the purpose of affecting polycystic kidney disease (PKD) cysts such as tolvaptan, vasopressin antagonists, anti-sense ribonucleic acid (RNA) therapies, rapamycin, sirolimus, everolimus, or somatostatin analogs (i.e., octreotide, sandostatin).~* Participants who have had cyst reduction surgery within 6 weeks of the screening visit.", combined_text: Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) Phase A: Change From Baseline in Spot Urine Osmolality (Pre-morning Dose), Urine osmolality is a measure of urine concentration, measured by osmometer, which evaluates the freezing point depression of a solution and supplies results as milliosmoles per kilogram of water. Spot urine osmolality was determined for urine samples collected immediately prior to morning dosing for Day 1 (Baseline), and Week 1 for all participants. Sample was taken after the first morning\\s void and was provided as a mid-stream, clean catch sample. All participants were fasting., Baseline, and Week 1 of Phase A|Phase A: Change From Baseline in Specific Gravity (Pre-morning Dose), Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney\\s ability to concentrate urine. Spot urine sample for determination of specific gravity was collected immediately prior to morning dosing for Day 1 (Baseline), and Week 1 for all participants. Sample was taken after the first morning\\s void and was provided as a mid-stream, clean catch sample. All participants were fasting., Baseline, and Week 1 of Phase A Phase A: Percent Change From Phase A Baseline in Height-Adjusted Total Kidney Volume (htTKV) as Measured by Magnetic Resonance Imaging (MRI), htTKV is used in participants with autosomal dominant polycystic kidney disease to predict the onset of renal insufficiency., Baseline, and Month 12 of Phase A|Phase A and B: Mean 24-hour Fluid Balance Prior to Week 1, Participants were instructed to record all fluid taken and all urine output for the 24-hour period., Prior to Week 1 in Phase A and B|Phase A: Change From Baseline in Renal Function (Estimated Glomerular Filtration Rate [eGFR] by Schwartz Formula) at Each Clinic Visit in Phase A, Renal function was assessed by estimated eGFR calculated by the Schwartz formula (eGFR = 0.413 × height \\\\[cm\\\\] /serum creatinine mg/dL), expressed as mean change in eGFR at the specified time points. The units for the data reported are milliliter per minute per 1.73 meter square (mL/min/1.73 m\\\\^2). The baseline was the evaluation done at Week 1 in Phase A for this outcome measure., Phase A Baseline, Months 1, 6, and 12|Phase B: Change From Phase B Baseline in Renal Function (eGFR by Schwartz Formula) at Each Clinic Visit in Phase B, Renal function was assessed by estimated eGFR calculated by the Schwartz formula (eGFR = 0.413 × height \\\\[cm\\\\] /serum creatinine mg/dL), expressed as mean change in eGFR at the specified time points., Phase B Baseline, Week 1, Months 1, 6, 12, 18, and 24|Phase B: Percent Change From Phase B Baseline in htTKV as Measured by MRI at Month 12 and Month 24, htTKV is used in participants with autosomal dominant polycystic kidney disease to predict the onset of renal insufficiency., Phase B Baseline, Months 12 and 24|Phase A: 24-hour Urine Volume, Urine volume refers to the quantity of urine produced per unit of time., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: 24-hour Fluid Intake, Daily fluid intake (total water) is defined as the amount of water consumed from foods, plain drinking water, and other beverages., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: 24-hour Fluid Balance, Fluid balance is a term used to describe the balance of the input and output of fluids in the body to allow metabolic processes to function correctly., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: 24-hour Sodium Clearance, Data was categorized and reported based on the total daily dose for the given time point of 0-24 hours., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: 24-hour Creatinine Clearance, Creatinine is produced from the metabolism of protein, when muscles burn energy. Most creatinine is filtered out of the blood by the kidneys and excreted in urine. The creatinine clearance value is determined by measuring the concentration of endogenous creatinine (that which is produced by the body) in both plasma and urine. Data was categorized and reported based on the total daily dose for the given time point of 0-24 hours., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: 24-hour Free Water Clearance, Data was categorized and reported based on the total daily dose for the given time point of 0-24 hours., 24 hours post dose after Month 1 on study medication in Phase A|Phase A: Percentage of Each Tanner Stage by Gender and Age Compared to Normative Populations, Tanner stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Only those categories with at least one participant with event are reported., At Baseline, Months 6 and 12 of Phase A|Phase B: Percentage of Each Tanner Stage by Gender and Age Compared to Normative Populations, Tanner stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Only those categories with at least one participant with event are reported., At Baseline, Months 6, 12, 18, and 24 of Phase B|Phase A: Change From Baseline in Growth Percentile by Gender and Age, The growth percentile was based on the assessment of height and weight., At Baseline, Months 6 and 12 of Phase A|Phase B: Change From Baseline in Growth Percentile by Gender and Age, The growth percentile was based on the assessment of height and weight., At Baseline, Months 6, 12, 18, and 24 of Phase B|Phase A: Change From Baseline in Creatinine Value, Phase A Baseline is the last pre-dose evaluation. The Last Visit is the last available post-baseline evaluation including early term. As prespecified in the protocol, data for safety is reported by the treatment group (Phase A: Tolvaptan and Phase A: Placebo), Baseline, Week 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Follow Up Day 7, End of Treatment, and Last Visit|Phase B: Change From Baseline in Creatinine Value, Phase B Baseline is the last evaluation prior to the first dose in Phase B. The Last Visit is the last available post-baseline evaluation including early term. As prespecified in the protocol, data for safety is reported by the treatment group (Phase B: Prior Tolvaptan and Phase B: Prior Placebo)., Baseline, Week 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, Follow Up Day 7, End of Treatment, and Last Visit|Phase A and B: Percentage of Participants With Potentially Clinically Significant Abnormalities in Vital Signs, Vital sign measurements included measurements of respiratory rate, blood pressure, body temperature and pulse. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance. Only those categories with at least one participant with event are reported. As prespecified in the protocol, data for safety is reported by the treatment group (Phase A: Tolvaptan, Phase A: Placebo, Phase B: Prior Tolvaptan and Phase B: Prior Placebo)., From first dose of study drug up to 14 days post last dose (up to approximately 37 months)|Phase A and B: Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Test Results Including Liver Function Tests (LFTs), Laboratory parameters=haematology,chemistry,urinalysis,\\\\& LFTs.Criteria for laboratory abnormalities along with their test result grade=Increased creatinine level: Baseline(BSL):Grade 0,\\\\>BSL-1.5xBSL:1,\\\\>1.5-3xBSL:2,\\\\>3-6xBSL:3,\\\\>6xBSL:4.Decreased glucose level: \\\\<30:-4,30-\\\\<40:-3, 40-\\\\<55:-2, 55-\\\\<65:-1,\\\\>=65:0; Increased:\\\\<=115:0,\\\\>115-160:1,\\\\>160-250:2,\\\\>250-500:3,\\\\>500:4.Decreased potassium level: \\\\<2.5:-4,2.5-\\\\<3:-3,3-\\\\<lower limit of normal(LLN):-1,LLN:0; Increased:upper limit of normal(ULN):0,\\\\>ULN-5.5:1,\\\\>5.5-6:2,\\\\>6-7:3,\\\\>7:4.Decreased sodium level: \\\\<120:-4,120-124:-3,125-129:-2,130-135:-1,\\\\>=136:0; Increased:\\\\<=145:0,146-150:1,151-155:2,156-160:3,\\\\>160:4. Increased triglyceride level:ULN:0,\\\\>ULN-2.5xULN:1,\\\\>2.5-5xULN:2,\\\\>5-6xULN:3,\\\\>6xULN:4. Decreased Neutrophils:\\\\<0.5:-4,0.5-\\\\<1:-3,1-\\\\<1.5:-2,1.5-\\\\<LLN:-1,LLN:0. Potentially clinically significant increase or decrease was defined as Baseline grade 0,1,-1 and post-baseline grade \\\\>1, \\\\<-1 or Baseline grade \\\\>1,\\\\<-1 and post-baseline grade \\\\>or\\\\<Baseline grade., From first dose of study drug up to 14 days post last dose (up to approximately 37 months)|Phase A and B: Percentage of Participants With Aquaretic Adverse Events (AEs), An AE was defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Aquaretic AEs included Medical Dictionary for Regulatory Activities \\\\[MedDRA\\\\] preferred terms of thirst, polyuria (production of large volumes of dilute urine), nocturia (need to wake up to urinate at night), pollakiuria (abnormally frequent urination), and polydipsia (excessive thirst). As prespecified in the protocol, data for safety is reported by the treatment group (Phase A: Tolvaptan, Phase A: Placebo, Phase B: Prior Tolvaptan and Phase B: Prior Placebo)., From first dose of study drug up to 14 days post last dose (up to approximately 37 months) "Key Inclusion Criteria:~* Male and female participants aged 4 to 17 years (inclusive) with a diagnosis of ADPKD as defined by the presence of family history and/or genetic criteria AND who have at least 10 renal cysts, each of which measure at least 0.5 cm, confirmed upon magnetic resonance imaging (MRI) inspection; participants under the age of 12 years must have at least 4 cysts that are at least 1 cm in size, confirmed by ultrasound.~* Weight ≥20 kg.~* Participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m\\\\^2 within 31 days prior to randomization (using the Schwartz formula, eGFR = 0.413 × height \\\\[cm\\\\]/serum creatinine milligrams per deciliter \\\\[mg/dL\\\\]).~* Independent in toileting.~* Ability to swallow a tablet.~Key Exclusion Criteria:~* Liver function tests including aspartate aminotransferase (AST), alanine aminotransferase (ALT) \\\\> 1.5 × the upper limit of normal (ULN).~* Nocturnal enuresis.~* Need for chronic diuretic use.~* Participants with advanced diabetes (e.g., glycosylated hemoglobin \\\\>7.5, and/or glycosuria by dipstick, significant proteinuria, retinopathy), evidence of additional significant renal disease(s) (i.e., currently active glomerular nephritides), renal cancer, single kidney, or recent (within 6 months of screening) renal surgery or acute kidney injury.~* Participants having disorders in thirst recognition or inability to access fluids.~* Participants with critical electrolyte imbalances, as determined by the investigator.~* Participants with, or at risk of, significant hypovolemia as determined by investigator.~* Participants with clinically significant anemia, as determined by investigator.~* Participants 12 years of age and older having contraindications to, or interference with MRI assessments (e.g., ferro-magnetic prostheses, aneurysm clips, severe claustrophobia).~* Participants with a history of taking a vasopressin agonist/antagonist.~* Participants taking medications or having concomitant illnesses likely to confound endpoint assessments, including taking approved (i.e., marketed) therapies for the purpose of affecting polycystic kidney disease (PKD) cysts such as tolvaptan, vasopressin antagonists, anti-sense ribonucleic acid (RNA) therapies, rapamycin, sirolimus, everolimus, or somatostatin analogs (i.e., octreotide, sandostatin).~* Participants who have had cyst reduction surgery within 6 weeks of the screening visit.", Similarity Score: 0.3343206857016168}'}]
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[{'from': 'human', 'value': '{Study Title: A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2), Primary Outcome Measures: Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment, DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (\\\\>=) 7 days or Grade 3 neutropenia with fever (greater than \\\\[\\\\>\\\\] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting \\\\>7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for \\\\>7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days), Secondary Outcome Measures: Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment, From baseline up to approximately up to 5 years 5 months|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7, Day-7: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Objective Response Rate (ORR); Combination Treatment, ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\\\<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months), criteria: "Inclusion Criteria:~Participants must meet all of the following criteria to be included in this study:~1. Phase 1b: Unresectable advanced or metastatic solid tumors.~2. Phase 1b expansion cohort and Phase 2: Histological confirmed diagnosis of glioblastoma (expansion cohort and Cohort 1) or melanoma (expansion cohort and Cohort 2).~ Phase 1b expansion cohort glioblastoma participants, Phase 2 Cohort 1:~3. No evidence of active central nervous systems (CNS) hemorrhage on baseline scans other than in those participants with recurrent glioblastoma who are stable Grade 1.~4. Participants having first or second recurrence documented by magnetic resonance imaging (MRI), following primary management with surgical resection or biopsy, radiotherapy and up to two prior systemic treatments.~5. If participants is on corticosteroids, they must be on a stable dose for 1 week prior to first dose of study drug.~6. Measurable disease defined as bidimensionally contrast enhancing lesions with clearly defined margins by computerized tomography (CT) or MRI scan, with a minimal diameter of 1 cm, and visible on two axial slices which are preferably at most 5 millimeter (mm) apart with 0 mm skip.~ Phase 1b expansion cohort melanoma participants, Phase 2 Cohort 2:~7. Radiographic/ photographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Appendix 3) after no more than two prior systemic regimens for unresectable Stage III or Stage IV disease.~8. American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma.~9. Measurable disease meeting the following criteria:~ 1. At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 centimeter (cm) in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI or photography. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.~ 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radio frequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.~ All participants:~10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~11. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 millimeter of mercury (mmHg) at screening and no change in antihypertensive medications within 1 week before the Screening Visit.~12. Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 milligrams per deciliter (mg/dL) or calculated creatinine clearance greater than or equal to 40 milliliters per minute (mL/min) per the Cockcroft and Gault formula (see Appendix 5).~13. Adequate bone marrow function:~ * Absolute neutrophil count greater than or equal to 1500/mm3 (greater than or equal to 1.5 x 10\\\\^3/uL);~ * Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 x 10\\\\^9/L);~ * Hemoglobin greater than or equal to 9.0 g/dL. 14.Adequate blood coagulation function, as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5.~14. Adequate liver function:~ * Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert\\s syndrome;~ * ALP, ALT, and AST less than or equal to 3 x ULN (less than or equal to 5 x ULN if participant has liver metastases).~15. Males or females age greater than or equal to 18 years at the time of informed consent.~16. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \\\\[B-hCG\\\\] at the Screening and Baseline Visit (a separate Baseline assessment is not required if a negative Screening pregnancy test was obtained within 72 hours before the first dose of study drug). Females of child-bearing potential, if not practising total abstinence or having a vasectomized partner with confirmed azoospermia, must agree to use two highly effective methods of contraception: e.g., 1) an intrauterine device (IUD) or intrauterine system (IUS); 2) a barrier method such as a condom or occlusive cup (diaphragm or cervical/vault caps) + spermicide (foam, gel, cream, etc.); 3) oral, injected, or implanted hormonal contraceptives throughout the entire study period and for 30 days after study drug discontinuation. Use of a double-barrier method (i.e., use at the same time of a condom + occlusive cup \\\\[diaphragm or cervical/vault caps\\\\] + spermicide \\\\[foam, gel, cream, etc.\\\\]) is accepted as two highly effective methods of contraception. The only participants who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or participants who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, total hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.~17. Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods described in Inclusion Criterion #18) beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug, unless the male participants are totally abstinent sexually or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile (see Inclusion Criterion #16).~18. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.~Exclusion Criteria:~Participants who meet any of the following criteria will be excluded from this study:~1. Phase 1b Dose Escalation: Participants who discontinued prior TK inhibitor (including VEGFR and c-Met receptor targeted therapy) due to toxicity will be ineligible.~2. Phase 1b Dose Escalation (3+3 portion) participants with primary CNS tumors~3. Phase 1b Dose Escalation participants, melanoma participants in expansion cohort and Phase 2 Cohort 2: Participants with untreated or unstable metastases to the central nervous system (CNS) are excluded. participants who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and have remained asymptomatic for at least 4 weeks prior to commencing treatment are eligible.~4. Phase 2: Prior exposure to VEGF-targeted treatment or c-Met or hepatocyte growth factor (HGF) targeted treatment.~5. Phase 2: Active malignancy (except for glioblastoma (Cohort 1) or unresectable Stage III or Stage IV melanoma (Cohort 2); or melanoma in situ, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) within the past 24 months.~ Phase 1b expansion cohort glioblastoma participants and Phase 2 Cohort 1:~6. More than two recurrences of glioblastoma.~7. Prior bevacizumab treatment.~8. Surgical resection of brain tumor within 4 weeks, or prior stereotactic biopsy within 2 weeks of Screening visit.~9. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field (beyond the high dose region or 80% isodose line), or there is biopsy-proven unequivocal viable tumor on histopathology sampling (e.g., solid tumor areas (i.e. greater than 70% tumor cell nuclei in areas), high or progressive increase in MIB-1 proliferation index compared to prior biopsy, or evidence for histological progression or increased anaplasia in the tumor).~10. Participants who have received enzyme-inducing anti epileptic agents within 14 days before the first dose of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).~ Phase 1b expansion cohort participants with melanoma and Phase 2 Cohort 2:~11. More than two prior systemic regimens for unresectable Stage III or Stage IV disease.~ All participants~12. Prior exposure to E7050 or lenvatinib.~13. Melanoma of intraocular origin.~14. participants who have received any anticancer treatment within 21 days (6 weeks for nitrosureas Cohort 1) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anticancer treatment.~15. Major surgery within 3 weeks prior to the first dose of study drug.~16. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.~17. Inability to take oral medication, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of E7050 or lenvatinib.~18. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.~19. Prolongation of QTc interval to greater than 480 msec.~20. Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin \\\\[LMWH\\\\] is allowed).~21. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.~22. Active infection (any infection requiring antibiotics).~23. Known intolerance or known hypersensitivity to any of the study drugs (or any of the excipients).~24. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.~25. Females who are pregnant or breastfeeding."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 558, Unnamed: 0: 688, NCT Number: NCT01287520, Study Title: A Study of LY2090314 in Patients With Advanced or Metastatic Cancer, Study URL: https://clinicaltrials.gov/study/NCT01287520, Acronym: , Study Status: COMPLETED, Brief Summary: The purpose of this study is to determine a recommended Phase 2 dose and dosing regimen of LY2090314 in combination with pemetrexed and carboplatin in patients with advanced/metastatic cancer. Part A of this study will consist of dose escalation of the study regimen, and Part B will consist of an expanded cohort to confirm the dose provided from Part A., Study Results: YES, Conditions: Advanced Cancer, Interventions: DRUG: LY2090314|DRUG: pemetrexed|DRUG: Carboplatin|OTHER: ranitidine, Primary Outcome Measures: "Recommended LY2090314 Dose for Phase 2 Studies (Maximum Tolerated Dose [MTD]), Recommended Phase 2 MTD was determined, when a dose limiting toxicity (DLT) occurred in 1 of 3 participants, the cohort was to be expanded to 6 participants. If a DLT occurred in 2 or more participants, accrual to the cohort was stopped, as the MTD was exceeded. A DLT was defined as an adverse event (AE) occurring in Cycle 1 (28 days) that was possibly related to study drug and met 1 of the following criteria: According to the National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of \\\\>5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval., Baseline up to Day 28 (Cycle 1)", Secondary Outcome Measures: Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314, AUC0-∞ was calculated from the area under the concentration versus time curve from time 0 to infinity of LY2090314 when administered alone., Cycle 1 Day 1 of a 28 day cycle|PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb), AUC0-∞ was calculated from the area under the concentration versus time curves of LY2090314 from time zero to infinity when coadministered with Pem and Carb., Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle|PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314, Cycle 1 Day 1 of a 28-day cycle|PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb), Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle|Number of Participants With Best Overall Tumor Response, Best overall observed tumor response at any point during the study until disease progression/recurrence defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\\<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria., Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days)|Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem), AUC0-∞ was calculated from the area under the concentration versus time curves of Pem given as a single dose with Carb (doublet therapy) and when co-administered with Carb and LY2090314 (triplet therapy)., Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle|PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem), Cmax of Pem given as a single dose with Carb (doublet therapy) and when coadministered with Carb and LY2090314 (triplet therapy)., Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle|PK Parameter: AUC0-∞ of Free Carboplatin (Carb), AUC0-∞ of free Carb was calculated from the area under the concentration versus time curves of Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy)., Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle|PK Parameter: Cmax of Free Carboplatin, Cmax of free Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy)., Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle|Pharmacodynamic (PD) Changes in Beta-Catenin (β-catenin), PD change from baseline to endpoint (up to Cycle 9) in β-catenin levels in peripheral blood mononuclear cells (PBMCs) following the administration of LY2090314 given alone and in combination with Pem and Carb. This outcome measure was not analyzed due to insufficient data., Baseline, Cycle 1 , Day 1 of a 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycles, Other Outcome Measures: , Sponsor: Eli Lilly and Company, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 41.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 11613|I2H-MC-JWYA, Start Date: 2007-11, Primary Completion Date: 2011-04, Completion Date: 2011-04, First Posted: 2011-02-01, Results First Posted: 2019-02-25, Last Update Posted: 2019-02-25, Locations: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tampa, Florida, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Nashville, Tennessee, United States, Study Documents: , criteria: "Inclusion Criteria:~* Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale~* Have a life expectancy of greater than or equal to 12 weeks~* Males and females with reproductive potential agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug~* Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease for which no proven effective therapy exists~* Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)~* Have adequate hematologic, hepatic, and renal function~* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy.~Exclusion Criteria:~* Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication~* Have serious preexisting medical conditions (left to discretion of investigator)~* Have one of the following conduction abnormalities: Corrected time between start of Q wave and end of T wave (QTc) prolongation \\\\>450 millisecond (msec) on screening electrocardiogram (ECG), previous history of QTc prolongation with another medication that required discontinuation, congenital long-QT-syndrome, or left bundle branch block (LBBB)~* Are taking any concomitant medication that may cause QTc prolongation, or induce Torsades de Pointes~* Have systolic blood pressure greater than or equal to 140 millimeters of Mercury (mm Hg), and diastolic blood pressure greater than or equal to 90 mm Hg that is not controlled by medical therapy~* Have serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class II or higher; have history of arrhythmia that is symptomatic or requires treatment~* Have chronic atrial fibrillation and/or bradycardia~* Have uncorrected electrolyte disorders including potassium \\\\<3.4 molar equivalent per liter (mEq/L) (\\\\<3.4 millimole per liter \\\\[mmol/l\\\\]), calcium \\\\<8.4 milligram per deciliter (mg/dL) (2.1 mmol/L), or magnesium \\\\<1.2 mg/dL (\\\\<0.62 mmol/L)~* Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required)~* Have a hematologic malignancy~* Females who are pregnant or lactating", combined_text: A Study of LY2090314 in Patients With Advanced or Metastatic Cancer Recommended LY2090314 Dose for Phase 2 Studies (Maximum Tolerated Dose [MTD]), Recommended Phase 2 MTD was determined, when a dose limiting toxicity (DLT) occurred in 1 of 3 participants, the cohort was to be expanded to 6 participants. If a DLT occurred in 2 or more participants, accrual to the cohort was stopped, as the MTD was exceeded. A DLT was defined as an adverse event (AE) occurring in Cycle 1 (28 days) that was possibly related to study drug and met 1 of the following criteria: According to the National Cancer Institute\\s (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0, ≥Grade 3 nonhematologic toxicity (except for nausea/vomiting without maximal symptomatic/prophylactic treatment) possibly or likely related to the study medication;CTCAE Grade 4 hematological toxicity of \\\\>5 days duration; Febrile neutropenia; CTCAE Grade 4 thrombocytopenia; CTCAE ≥Grade 2 thrombocytopenia plus bleeding; CTCAE ≥Grade 3 prolonged QTc interval., Baseline up to Day 28 (Cycle 1) Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314, AUC0-∞ was calculated from the area under the concentration versus time curve from time 0 to infinity of LY2090314 when administered alone., Cycle 1 Day 1 of a 28 day cycle|PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb), AUC0-∞ was calculated from the area under the concentration versus time curves of LY2090314 from time zero to infinity when coadministered with Pem and Carb., Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle|PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314, Cycle 1 Day 1 of a 28-day cycle|PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb), Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle|Number of Participants With Best Overall Tumor Response, Best overall observed tumor response at any point during the study until disease progression/recurrence defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\\<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria., Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days)|Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem), AUC0-∞ was calculated from the area under the concentration versus time curves of Pem given as a single dose with Carb (doublet therapy) and when co-administered with Carb and LY2090314 (triplet therapy)., Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle|PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem), Cmax of Pem given as a single dose with Carb (doublet therapy) and when coadministered with Carb and LY2090314 (triplet therapy)., Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle|PK Parameter: AUC0-∞ of Free Carboplatin (Carb), AUC0-∞ of free Carb was calculated from the area under the concentration versus time curves of Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy)., Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle|PK Parameter: Cmax of Free Carboplatin, Cmax of free Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy)., Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle|Pharmacodynamic (PD) Changes in Beta-Catenin (β-catenin), PD change from baseline to endpoint (up to Cycle 9) in β-catenin levels in peripheral blood mononuclear cells (PBMCs) following the administration of LY2090314 given alone and in combination with Pem and Carb. This outcome measure was not analyzed due to insufficient data., Baseline, Cycle 1 , Day 1 of a 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycles "Inclusion Criteria:~* Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale~* Have a life expectancy of greater than or equal to 12 weeks~* Males and females with reproductive potential agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug~* Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic disease for which no proven effective therapy exists~* Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)~* Have adequate hematologic, hepatic, and renal function~* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy.~Exclusion Criteria:~* Have received treatment within 30 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication~* Have serious preexisting medical conditions (left to discretion of investigator)~* Have one of the following conduction abnormalities: Corrected time between start of Q wave and end of T wave (QTc) prolongation \\\\>450 millisecond (msec) on screening electrocardiogram (ECG), previous history of QTc prolongation with another medication that required discontinuation, congenital long-QT-syndrome, or left bundle branch block (LBBB)~* Are taking any concomitant medication that may cause QTc prolongation, or induce Torsades de Pointes~* Have systolic blood pressure greater than or equal to 140 millimeters of Mercury (mm Hg), and diastolic blood pressure greater than or equal to 90 mm Hg that is not controlled by medical therapy~* Have serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class II or higher; have history of arrhythmia that is symptomatic or requires treatment~* Have chronic atrial fibrillation and/or bradycardia~* Have uncorrected electrolyte disorders including potassium \\\\<3.4 molar equivalent per liter (mEq/L) (\\\\<3.4 millimole per liter \\\\[mmol/l\\\\]), calcium \\\\<8.4 milligram per deciliter (mg/dL) (2.1 mmol/L), or magnesium \\\\<1.2 mg/dL (\\\\<0.62 mmol/L)~* Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required)~* Have a hematologic malignancy~* Females who are pregnant or lactating", Similarity Score: 0.3298541871824838}'}]
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from_dataset
| 0.329854
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[{'from': 'human', 'value': '{Study Title: A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2), Primary Outcome Measures: Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment, DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (\\\\>=) 7 days or Grade 3 neutropenia with fever (greater than \\\\[\\\\>\\\\] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting \\\\>7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for \\\\>7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days), Secondary Outcome Measures: Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment, From baseline up to approximately up to 5 years 5 months|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7, Day-7: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Objective Response Rate (ORR); Combination Treatment, ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\\\<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months), criteria: "Inclusion Criteria:~Participants must meet all of the following criteria to be included in this study:~1. Phase 1b: Unresectable advanced or metastatic solid tumors.~2. Phase 1b expansion cohort and Phase 2: Histological confirmed diagnosis of glioblastoma (expansion cohort and Cohort 1) or melanoma (expansion cohort and Cohort 2).~ Phase 1b expansion cohort glioblastoma participants, Phase 2 Cohort 1:~3. No evidence of active central nervous systems (CNS) hemorrhage on baseline scans other than in those participants with recurrent glioblastoma who are stable Grade 1.~4. Participants having first or second recurrence documented by magnetic resonance imaging (MRI), following primary management with surgical resection or biopsy, radiotherapy and up to two prior systemic treatments.~5. If participants is on corticosteroids, they must be on a stable dose for 1 week prior to first dose of study drug.~6. Measurable disease defined as bidimensionally contrast enhancing lesions with clearly defined margins by computerized tomography (CT) or MRI scan, with a minimal diameter of 1 cm, and visible on two axial slices which are preferably at most 5 millimeter (mm) apart with 0 mm skip.~ Phase 1b expansion cohort melanoma participants, Phase 2 Cohort 2:~7. Radiographic/ photographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Appendix 3) after no more than two prior systemic regimens for unresectable Stage III or Stage IV disease.~8. American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma.~9. Measurable disease meeting the following criteria:~ 1. At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 centimeter (cm) in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI or photography. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.~ 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radio frequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.~ All participants:~10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~11. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 millimeter of mercury (mmHg) at screening and no change in antihypertensive medications within 1 week before the Screening Visit.~12. Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 milligrams per deciliter (mg/dL) or calculated creatinine clearance greater than or equal to 40 milliliters per minute (mL/min) per the Cockcroft and Gault formula (see Appendix 5).~13. Adequate bone marrow function:~ * Absolute neutrophil count greater than or equal to 1500/mm3 (greater than or equal to 1.5 x 10\\\\^3/uL);~ * Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 x 10\\\\^9/L);~ * Hemoglobin greater than or equal to 9.0 g/dL. 14.Adequate blood coagulation function, as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5.~14. Adequate liver function:~ * Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert\\s syndrome;~ * ALP, ALT, and AST less than or equal to 3 x ULN (less than or equal to 5 x ULN if participant has liver metastases).~15. Males or females age greater than or equal to 18 years at the time of informed consent.~16. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \\\\[B-hCG\\\\] at the Screening and Baseline Visit (a separate Baseline assessment is not required if a negative Screening pregnancy test was obtained within 72 hours before the first dose of study drug). Females of child-bearing potential, if not practising total abstinence or having a vasectomized partner with confirmed azoospermia, must agree to use two highly effective methods of contraception: e.g., 1) an intrauterine device (IUD) or intrauterine system (IUS); 2) a barrier method such as a condom or occlusive cup (diaphragm or cervical/vault caps) + spermicide (foam, gel, cream, etc.); 3) oral, injected, or implanted hormonal contraceptives throughout the entire study period and for 30 days after study drug discontinuation. Use of a double-barrier method (i.e., use at the same time of a condom + occlusive cup \\\\[diaphragm or cervical/vault caps\\\\] + spermicide \\\\[foam, gel, cream, etc.\\\\]) is accepted as two highly effective methods of contraception. The only participants who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or participants who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, total hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.~17. Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods described in Inclusion Criterion #18) beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug, unless the male participants are totally abstinent sexually or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile (see Inclusion Criterion #16).~18. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.~Exclusion Criteria:~Participants who meet any of the following criteria will be excluded from this study:~1. Phase 1b Dose Escalation: Participants who discontinued prior TK inhibitor (including VEGFR and c-Met receptor targeted therapy) due to toxicity will be ineligible.~2. Phase 1b Dose Escalation (3+3 portion) participants with primary CNS tumors~3. Phase 1b Dose Escalation participants, melanoma participants in expansion cohort and Phase 2 Cohort 2: Participants with untreated or unstable metastases to the central nervous system (CNS) are excluded. participants who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and have remained asymptomatic for at least 4 weeks prior to commencing treatment are eligible.~4. Phase 2: Prior exposure to VEGF-targeted treatment or c-Met or hepatocyte growth factor (HGF) targeted treatment.~5. Phase 2: Active malignancy (except for glioblastoma (Cohort 1) or unresectable Stage III or Stage IV melanoma (Cohort 2); or melanoma in situ, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) within the past 24 months.~ Phase 1b expansion cohort glioblastoma participants and Phase 2 Cohort 1:~6. More than two recurrences of glioblastoma.~7. Prior bevacizumab treatment.~8. Surgical resection of brain tumor within 4 weeks, or prior stereotactic biopsy within 2 weeks of Screening visit.~9. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field (beyond the high dose region or 80% isodose line), or there is biopsy-proven unequivocal viable tumor on histopathology sampling (e.g., solid tumor areas (i.e. greater than 70% tumor cell nuclei in areas), high or progressive increase in MIB-1 proliferation index compared to prior biopsy, or evidence for histological progression or increased anaplasia in the tumor).~10. Participants who have received enzyme-inducing anti epileptic agents within 14 days before the first dose of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).~ Phase 1b expansion cohort participants with melanoma and Phase 2 Cohort 2:~11. More than two prior systemic regimens for unresectable Stage III or Stage IV disease.~ All participants~12. Prior exposure to E7050 or lenvatinib.~13. Melanoma of intraocular origin.~14. participants who have received any anticancer treatment within 21 days (6 weeks for nitrosureas Cohort 1) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anticancer treatment.~15. Major surgery within 3 weeks prior to the first dose of study drug.~16. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.~17. Inability to take oral medication, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of E7050 or lenvatinib.~18. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.~19. Prolongation of QTc interval to greater than 480 msec.~20. Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin \\\\[LMWH\\\\] is allowed).~21. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.~22. Active infection (any infection requiring antibiotics).~23. Known intolerance or known hypersensitivity to any of the study drugs (or any of the excipients).~24. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.~25. Females who are pregnant or breastfeeding."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 850, Unnamed: 0: 1065, NCT Number: NCT06137144, Study Title: AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies., Study URL: https://clinicaltrials.gov/study/NCT06137144, Acronym: PRIMAVERA, Study Status: RECRUITING, Brief Summary: This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies., Study Results: NO, Conditions: Lymphoma|Non-Hodgkin|Hodgkin Lymphoma, Interventions: DRUG: AZD3470, Primary Outcome Measures: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), AEs: Number of patients with adverse events by system organ class and preferred term.\\n\\nSAEs: Number of patients with serious adverse events by system organ class and preferred term., From Screening until 28 days after the last dose of study medication.|Incidence of DLTs (Dose Escalation only), In the Dose Escalation cohorts in Part A, the number of participants with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol., From first dose of AZD3470 to end of Cycle 1 (each cycle is 21 days)., Secondary Outcome Measures: Part A and Part B: Response endpoints - Objective Response Rate (ORR)/Complete Response Rate (CRR), ORR is defined as the proportion of participants who have a CR or PR and CRR is defined as the proportion of participants who have a CR.\\n\\nAssessment of ORR/CRR will be done according to the Lugano Classification for cHL., From first dose (Cycle 1 Day 1, each cycle is 21 days) until disease progression or the last evaluable assessment in the absence of progression (assessed approximately up to 2 years).|Part A and Part B: Response endpoints - Duration of Response (DoR), The time from the date of first documented response until the date of documented progression as assessed by the investigator according to the Lugano classification for cHL, or death due to any cause., From first dose (Cycle 1 Day 1, each cycle is 21 days) until disease progression or death, whichever comes first (assessed approximately up to 2 years).|Part A and Part B: Progression-free Survival (PFS), Time from date of first dose (non- randomised study parts) or date of randomization (randomised study parts) until progression as assessed by the investigator according to the Lugano Classification for cHL, or death due to any cause., Non-randomized study parts: from first dose (each cycle is 21 days) until disease progression or death, whichever comes first. Randomized parts: from date of randomization until disease progression or death, whichever comes first (approx up to 2 years).|Part A and Part B: Overall Survival (OS), Time from date of first dose (non-randomised study parts) or date of randomization (randomised study parts) until the date of death due to any cause., Non-randomized study parts: From first dose (Cycle 1 Day 1, each cycle is 21 days) until death. Randomized study parts: from date of randomization until the date of death due to any cause (assessed approximately up to 2 years).|Part A and Part B: Maximum observed plasma drug concentration (Cmax), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A: Dose normalised maximum observed plasma drug concentration (Cmax), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A: Accumulation ratio for maximum observed plasma drug concentration (Cmax), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A and Part B: Minimum observed plasma drug concentration (Cmin), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A and Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A and Part B: Area under the plasma concentration-curve over the dosing interval (AUCtau), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A: Dose normalized area under the plasma concentration-curve over the dosing interval (AUCtau), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A: Accumulation ratio for area under the plasma concentration-curve over the dosing interval (AUCtau), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A: Cumulative amount (%) of drug recovered unchanged in urine during dosing interval (Ae,tau), Assessed to characterize the urine PK profile of AZD3470., From Cycle 1 Day 1 to end of Cycle 1 at predefined intervals throughout the cycle (each cycle is 21 days).|Part A: Renal clearance (Clr), Assessed to characterize the urine PK profile of AZD3470., From Cycle 1 Day 1 to end of Cycle 1 at predefined intervals throughout the cycle (each cycle is 21 days).|Part B: Ratio of maximum observed plasma drug concentration (Cmax) under fed/fasted state, Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion., From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days).|Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax) under fed conditions, Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion., From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days).|Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax) under fasted conditions, Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion., From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days).|Part B: Ratio of area under the plasma concentration-curve over the dosing interval (AUCtau) under fed/fasted state, Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion., From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days)., Other Outcome Measures: , Sponsor: AstraZeneca, Collaborators: , Sex: ALL, Age: CHILD, ADULT, OLDER_ADULT, Phases: PHASE1|PHASE2, Enrollment: 110.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: D9971C00001, Start Date: 2024-01-23, Primary Completion Date: 2026-05-08, Completion Date: 2026-05-08, First Posted: 2023-11-18, Results First Posted: , Last Update Posted: 2024-10-17, Locations: "Research Site, Miami, Florida, 33136, United States|Research Site, Atlanta, Georgia, 30322, United States|Research Site, Boston, Massachusetts, 02215, United States|Research Site, Philadelphia, Pennsylvania, 19104, United States|Research Site, Houston, Texas, 77030, United States|Research Site, Nedlands, 6009, Australia|Research Site, Creteil, 94010, France|Research Site, Lille, 59000, France|Research Site, Pierre Benite, 69310, France|Research Site, Köln, 50937, Germany|Research Site, Alessandria, 15100, Italy|Research Site, Bologna, 40138, Italy|Research Site, Milan, 20141, Italy|Research Site, Seoul, 03080, Korea, Republic of|Research Site, Seoul, 06351, Korea, Republic of|Research Site, LHospitalet de Llobregat, 08908, Spain|Research Site, Madrid, 28041, Spain|Research Site, Manchester, M20 4BX, United Kingdom|Research Site, Oxford, OX3 7LE, United Kingdom", Study Documents: , criteria: "Inclusion criteria~* In Part A (dose escalation), participants must be aged ≥ 18 years at the time of signing the informed consent. In Part B (dose optimization/expansion), participants must be at least 15 years of age.~* Histologically confirmed documented diagnosis of r/r cHL based on criteria established by the World Health Organization~* Willing to provide FFPE baseline tumour tissue to meet the minimum tissue requirement for central MTAP expression determination.~* Participants must have documented r/r active disease, must have previously received at least 3 prior lines of therapy for the treatment of cHL, and must have exhausted all available therapies with demonstrated clinical benefit.~* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~Module 1 (cHL):~* At least 1 radiographically measurable, and/or FDG-avid lymphoma lesion \\\\> 1.5 cm.~* Adequate organ and bone marrow function~* Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.~Exclusion criteria~* Any significant laboratory finding or any severe and uncontrolled medical condition.~* Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression.~* Serologic active HBV or HCV infection.~* Known to have tested positive for HIV.~* Active gastrointestinal disease or other condition that will interfere with oral therapy.~* Any of the following cardiac criteria:~ * Mean resting QTcF \\\\> 470 msec or clinically important abnormalities in rhythm (ventricular arrhythmias and uncontrolled atrial fibrillation)~ * Factors that increase the risk of QTc prolongation or risk of arrhythmic events~ * Cardiac procedures or conditions within the last 6 months: Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) or heart valve intervention vascular stent implantation, acute coronary syndrome / myocardial infarction, uncontrolled angina pectoris, use of therapeutic anti-coagulation for treatment of active thromboembolic events.~ * Severe valvular heart disease~ * Congestive heart failure Grade II to Grade IV~ * Prior or current cardiomyopathy~ * Uncontrolled hypertension~ * Brain perfusion problems such as haemorrhagic or thrombotic stroke (including transient ischemic attacks)~* Unresolved non-haematological toxicity from prior anticancer therapy of Grade \\\\> 1, except alopecia.~* History of another primary malignancy.~* History of significant haemoptysis or haemorrhage within 4 weeks of the first dose of study treatment.~* Requires ongoing immunosuppressive therapy, including systemic corticosteroids.~* Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.", combined_text: AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), AEs: Number of patients with adverse events by system organ class and preferred term.\\n\\nSAEs: Number of patients with serious adverse events by system organ class and preferred term., From Screening until 28 days after the last dose of study medication.|Incidence of DLTs (Dose Escalation only), In the Dose Escalation cohorts in Part A, the number of participants with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol., From first dose of AZD3470 to end of Cycle 1 (each cycle is 21 days). Part A and Part B: Response endpoints - Objective Response Rate (ORR)/Complete Response Rate (CRR), ORR is defined as the proportion of participants who have a CR or PR and CRR is defined as the proportion of participants who have a CR.\\n\\nAssessment of ORR/CRR will be done according to the Lugano Classification for cHL., From first dose (Cycle 1 Day 1, each cycle is 21 days) until disease progression or the last evaluable assessment in the absence of progression (assessed approximately up to 2 years).|Part A and Part B: Response endpoints - Duration of Response (DoR), The time from the date of first documented response until the date of documented progression as assessed by the investigator according to the Lugano classification for cHL, or death due to any cause., From first dose (Cycle 1 Day 1, each cycle is 21 days) until disease progression or death, whichever comes first (assessed approximately up to 2 years).|Part A and Part B: Progression-free Survival (PFS), Time from date of first dose (non- randomised study parts) or date of randomization (randomised study parts) until progression as assessed by the investigator according to the Lugano Classification for cHL, or death due to any cause., Non-randomized study parts: from first dose (each cycle is 21 days) until disease progression or death, whichever comes first. Randomized parts: from date of randomization until disease progression or death, whichever comes first (approx up to 2 years).|Part A and Part B: Overall Survival (OS), Time from date of first dose (non-randomised study parts) or date of randomization (randomised study parts) until the date of death due to any cause., Non-randomized study parts: From first dose (Cycle 1 Day 1, each cycle is 21 days) until death. Randomized study parts: from date of randomization until the date of death due to any cause (assessed approximately up to 2 years).|Part A and Part B: Maximum observed plasma drug concentration (Cmax), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A: Dose normalised maximum observed plasma drug concentration (Cmax), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A: Accumulation ratio for maximum observed plasma drug concentration (Cmax), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A and Part B: Minimum observed plasma drug concentration (Cmin), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A and Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A and Part B: Area under the plasma concentration-curve over the dosing interval (AUCtau), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A: Dose normalized area under the plasma concentration-curve over the dosing interval (AUCtau), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A: Accumulation ratio for area under the plasma concentration-curve over the dosing interval (AUCtau), Assessed to characterize the plasma PK profile of AZD3470., From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months).|Part A: Cumulative amount (%) of drug recovered unchanged in urine during dosing interval (Ae,tau), Assessed to characterize the urine PK profile of AZD3470., From Cycle 1 Day 1 to end of Cycle 1 at predefined intervals throughout the cycle (each cycle is 21 days).|Part A: Renal clearance (Clr), Assessed to characterize the urine PK profile of AZD3470., From Cycle 1 Day 1 to end of Cycle 1 at predefined intervals throughout the cycle (each cycle is 21 days).|Part B: Ratio of maximum observed plasma drug concentration (Cmax) under fed/fasted state, Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion., From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days).|Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax) under fed conditions, Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion., From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days).|Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax) under fasted conditions, Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion., From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days).|Part B: Ratio of area under the plasma concentration-curve over the dosing interval (AUCtau) under fed/fasted state, Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion., From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days). "Inclusion criteria~* In Part A (dose escalation), participants must be aged ≥ 18 years at the time of signing the informed consent. In Part B (dose optimization/expansion), participants must be at least 15 years of age.~* Histologically confirmed documented diagnosis of r/r cHL based on criteria established by the World Health Organization~* Willing to provide FFPE baseline tumour tissue to meet the minimum tissue requirement for central MTAP expression determination.~* Participants must have documented r/r active disease, must have previously received at least 3 prior lines of therapy for the treatment of cHL, and must have exhausted all available therapies with demonstrated clinical benefit.~* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~Module 1 (cHL):~* At least 1 radiographically measurable, and/or FDG-avid lymphoma lesion \\\\> 1.5 cm.~* Adequate organ and bone marrow function~* Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.~Exclusion criteria~* Any significant laboratory finding or any severe and uncontrolled medical condition.~* Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression.~* Serologic active HBV or HCV infection.~* Known to have tested positive for HIV.~* Active gastrointestinal disease or other condition that will interfere with oral therapy.~* Any of the following cardiac criteria:~ * Mean resting QTcF \\\\> 470 msec or clinically important abnormalities in rhythm (ventricular arrhythmias and uncontrolled atrial fibrillation)~ * Factors that increase the risk of QTc prolongation or risk of arrhythmic events~ * Cardiac procedures or conditions within the last 6 months: Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) or heart valve intervention vascular stent implantation, acute coronary syndrome / myocardial infarction, uncontrolled angina pectoris, use of therapeutic anti-coagulation for treatment of active thromboembolic events.~ * Severe valvular heart disease~ * Congestive heart failure Grade II to Grade IV~ * Prior or current cardiomyopathy~ * Uncontrolled hypertension~ * Brain perfusion problems such as haemorrhagic or thrombotic stroke (including transient ischemic attacks)~* Unresolved non-haematological toxicity from prior anticancer therapy of Grade \\\\> 1, except alopecia.~* History of another primary malignancy.~* History of significant haemoptysis or haemorrhage within 4 weeks of the first dose of study treatment.~* Requires ongoing immunosuppressive therapy, including systemic corticosteroids.~* Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.", Similarity Score: 0.3086810146681482}'}]
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from_dataset
| 0.308681
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[{'from': 'human', 'value': '{Study Title: A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2), Primary Outcome Measures: Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment, DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (\\\\>=) 7 days or Grade 3 neutropenia with fever (greater than \\\\[\\\\>\\\\] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting \\\\>7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for \\\\>7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days), Secondary Outcome Measures: Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment, From baseline up to approximately up to 5 years 5 months|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7, Day-7: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Objective Response Rate (ORR); Combination Treatment, ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\\\<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months), criteria: "Inclusion Criteria:~Participants must meet all of the following criteria to be included in this study:~1. Phase 1b: Unresectable advanced or metastatic solid tumors.~2. Phase 1b expansion cohort and Phase 2: Histological confirmed diagnosis of glioblastoma (expansion cohort and Cohort 1) or melanoma (expansion cohort and Cohort 2).~ Phase 1b expansion cohort glioblastoma participants, Phase 2 Cohort 1:~3. No evidence of active central nervous systems (CNS) hemorrhage on baseline scans other than in those participants with recurrent glioblastoma who are stable Grade 1.~4. Participants having first or second recurrence documented by magnetic resonance imaging (MRI), following primary management with surgical resection or biopsy, radiotherapy and up to two prior systemic treatments.~5. If participants is on corticosteroids, they must be on a stable dose for 1 week prior to first dose of study drug.~6. Measurable disease defined as bidimensionally contrast enhancing lesions with clearly defined margins by computerized tomography (CT) or MRI scan, with a minimal diameter of 1 cm, and visible on two axial slices which are preferably at most 5 millimeter (mm) apart with 0 mm skip.~ Phase 1b expansion cohort melanoma participants, Phase 2 Cohort 2:~7. Radiographic/ photographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Appendix 3) after no more than two prior systemic regimens for unresectable Stage III or Stage IV disease.~8. American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma.~9. Measurable disease meeting the following criteria:~ 1. At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 centimeter (cm) in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI or photography. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.~ 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radio frequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.~ All participants:~10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~11. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 millimeter of mercury (mmHg) at screening and no change in antihypertensive medications within 1 week before the Screening Visit.~12. Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 milligrams per deciliter (mg/dL) or calculated creatinine clearance greater than or equal to 40 milliliters per minute (mL/min) per the Cockcroft and Gault formula (see Appendix 5).~13. Adequate bone marrow function:~ * Absolute neutrophil count greater than or equal to 1500/mm3 (greater than or equal to 1.5 x 10\\\\^3/uL);~ * Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 x 10\\\\^9/L);~ * Hemoglobin greater than or equal to 9.0 g/dL. 14.Adequate blood coagulation function, as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5.~14. Adequate liver function:~ * Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert\\s syndrome;~ * ALP, ALT, and AST less than or equal to 3 x ULN (less than or equal to 5 x ULN if participant has liver metastases).~15. Males or females age greater than or equal to 18 years at the time of informed consent.~16. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \\\\[B-hCG\\\\] at the Screening and Baseline Visit (a separate Baseline assessment is not required if a negative Screening pregnancy test was obtained within 72 hours before the first dose of study drug). Females of child-bearing potential, if not practising total abstinence or having a vasectomized partner with confirmed azoospermia, must agree to use two highly effective methods of contraception: e.g., 1) an intrauterine device (IUD) or intrauterine system (IUS); 2) a barrier method such as a condom or occlusive cup (diaphragm or cervical/vault caps) + spermicide (foam, gel, cream, etc.); 3) oral, injected, or implanted hormonal contraceptives throughout the entire study period and for 30 days after study drug discontinuation. Use of a double-barrier method (i.e., use at the same time of a condom + occlusive cup \\\\[diaphragm or cervical/vault caps\\\\] + spermicide \\\\[foam, gel, cream, etc.\\\\]) is accepted as two highly effective methods of contraception. The only participants who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or participants who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, total hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.~17. Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods described in Inclusion Criterion #18) beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug, unless the male participants are totally abstinent sexually or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile (see Inclusion Criterion #16).~18. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.~Exclusion Criteria:~Participants who meet any of the following criteria will be excluded from this study:~1. Phase 1b Dose Escalation: Participants who discontinued prior TK inhibitor (including VEGFR and c-Met receptor targeted therapy) due to toxicity will be ineligible.~2. Phase 1b Dose Escalation (3+3 portion) participants with primary CNS tumors~3. Phase 1b Dose Escalation participants, melanoma participants in expansion cohort and Phase 2 Cohort 2: Participants with untreated or unstable metastases to the central nervous system (CNS) are excluded. participants who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and have remained asymptomatic for at least 4 weeks prior to commencing treatment are eligible.~4. Phase 2: Prior exposure to VEGF-targeted treatment or c-Met or hepatocyte growth factor (HGF) targeted treatment.~5. Phase 2: Active malignancy (except for glioblastoma (Cohort 1) or unresectable Stage III or Stage IV melanoma (Cohort 2); or melanoma in situ, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) within the past 24 months.~ Phase 1b expansion cohort glioblastoma participants and Phase 2 Cohort 1:~6. More than two recurrences of glioblastoma.~7. Prior bevacizumab treatment.~8. Surgical resection of brain tumor within 4 weeks, or prior stereotactic biopsy within 2 weeks of Screening visit.~9. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field (beyond the high dose region or 80% isodose line), or there is biopsy-proven unequivocal viable tumor on histopathology sampling (e.g., solid tumor areas (i.e. greater than 70% tumor cell nuclei in areas), high or progressive increase in MIB-1 proliferation index compared to prior biopsy, or evidence for histological progression or increased anaplasia in the tumor).~10. Participants who have received enzyme-inducing anti epileptic agents within 14 days before the first dose of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).~ Phase 1b expansion cohort participants with melanoma and Phase 2 Cohort 2:~11. More than two prior systemic regimens for unresectable Stage III or Stage IV disease.~ All participants~12. Prior exposure to E7050 or lenvatinib.~13. Melanoma of intraocular origin.~14. participants who have received any anticancer treatment within 21 days (6 weeks for nitrosureas Cohort 1) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anticancer treatment.~15. Major surgery within 3 weeks prior to the first dose of study drug.~16. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.~17. Inability to take oral medication, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of E7050 or lenvatinib.~18. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.~19. Prolongation of QTc interval to greater than 480 msec.~20. Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin \\\\[LMWH\\\\] is allowed).~21. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.~22. Active infection (any infection requiring antibiotics).~23. Known intolerance or known hypersensitivity to any of the study drugs (or any of the excipients).~24. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.~25. Females who are pregnant or breastfeeding."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 154, Unnamed: 0: 183, NCT Number: NCT04526691, Study Title: Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02), Study URL: https://clinicaltrials.gov/study/NCT04526691, Acronym: , Study Status: ACTIVE_NOT_RECRUITING, Brief Summary: This study will assess safety and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in participants with advanced or metastatic non-small cell lung cancer., Study Results: NO, Conditions: Advanced or Metastatic NSCLC, Interventions: DRUG: Datopotamab deruxtecan|DRUG: KEYTRUDA®|DRUG: Carboplatin|DRUG: Cisplatin, Primary Outcome Measures: Number of Participants with Dose-limiting Toxicities (DLTs) and Treatment-emergent Adverse Events (TEAEs), Baseline up to Cycle 1 (Days 1 to 21) for DLTs and up to 28 days after last dose for TEAEs, up to approximately 30 months post-dose, Secondary Outcome Measures: Objective Response Rate, Baseline up to BOR (confirmed CR or PR), up to approximately 30 months post-dose|Duration of Response, From first objective response (confirmed CR or PR) to PD or death (whichever occurs first), up to approximately 30 months post-dose|Progression-free Survival, Baseline up PD or death (whichever occurs first), up to approximately 30 months post-dose|Overall Survival, Baseline up to death (any cause), up to approximately 30 months post-dose|Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of Dato-DXd, Total Anti-TROP2 Antibody, and MAAA-1181a, Cycle 1, Day 1: pre-dose, 30 minutes, 3 hours, 5 hours, and 7 hours post-dose; Cycles 1 and 3, Day 2, Day 4, Day 8, and Day 15; Cycles 2-4, Cycle 6, and Cycle 8, Day 1: pre-dose and post-dose (each cycle is 21 days)|Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of Dato-DXd, Total Anti-TROP2 Antibody, and MAAA-1181a, Cycle 1, Day 1: pre-dose, 30 minutes, 3 hours, 5 hours, and 7 hours post-dose; Cycles 1 and 3, Day 2, Day 4, Day 8, and Day 15; Cycles 2-4, Cycle 6, and Cycle 8, Day 1: pre-dose and post-dose (each cycle is 21 days)|Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) of Dato-DXd, Total Anti-TROP2 Antibody, and MAAA-1181a, Area under the plasma concentration-time curve up to last quantifiable time (AUClast) and area under the plasma concentration-time curve during dosing interval (AUCtau) will be assessed., Cycle 1, Day 1: pre-dose, 30 minutes, 3 hours, 5 hours, and 7 hours post-dose; Cycles 1 and 3, Day 2, Day 4, Day 8, and Day 15; Cycles 2-4, Cycle 6, and Cycle 8, Day 1: pre-dose and post-dose (each cycle is 21 days)|Anti-drug Antibodies for Dato-DXd and Pembrolizumab, Baseline up to approximately 30 months post-dose, Other Outcome Measures: , Sponsor: Daiichi Sankyo, Collaborators: Merck Sharp & Dohme LLC, Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 145.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: DS1062-A-U102|2020-006047-25|jRCT2031200193|KEYNOTE-B43|MK-3475-B43, Start Date: 2020-09-15, Primary Completion Date: 2025-06-01, Completion Date: 2025-06-01, First Posted: 2020-08-26, Results First Posted: , Last Update Posted: 2024-08-01, Locations: Mayo Clinic, Scottsdale, Arizona, 85259, United States|City of Hope, Duarte, California, 91010, United States|Johns Hopkins Kimmel Cancer Center, Washington, District of Columbia, 20016, United States|Mayo Clinic, Jacksonville, Florida, 32224, United States|Johns Hopkins Kimmel Cancer Center at Bayview, Baltimore, Maryland, 21224, United States|The Skip Viragh Outpatient Cancer Building, Baltimore, Maryland, 21287, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Quantum Santa Fe, Santa Fe, New Mexico, 87505, United States|NEXT Oncology, San Antonio, Texas, 78229, United States|Instituto Europeo Di Oncologica, Milan, 20141, Italy|Azienda Ospedaliera San Gerardo, Monza, 20052, Italy|Istituto Nazionale Tumori Fondazione G. Pascale di Napoli Struttura di Oncologia, Naples, 80131, Italy|National Cancer Center Hospital East, Chiba, 277-8577, Japan|National Cancer Center Hospital, Tokyo, 104-0045, Japan|Showa Univeristy Hospital, Tokyo, 142-8555, Japan|H. Vall Hebrón (Vall Hebron Institut de Oncologia - VHIO), Barcelona, 08035, Spain|START Madrid - Hospital Universitario Fundacion Jimenez Diaz, Madrid, 28040, Spain|Hospital Universitario 12 de Octubre, Madrid, 28041, Spain|(CIOCC-START) Hospital Universitario HM Sanchinarro, Madrid, 28050, Spain|Hospital Puerta de Hierro, Majadahonda, 28222, Spain|Chung Shan Medical University Hospital, Taichung, 40201, Taiwan|Taichung Veterans General Hospital, Taichung, 40705, Taiwan|National Cheng Kung University Hospital NCKUH, Tainan, 704, Taiwan|National Taiwan University Hospital NTUH, Taipei City, 100, Taiwan, Study Documents: , criteria: "Inclusion Criteria:~* Histologically confirmed at diagnosis of NSCLC that:~ * Is advanced or metastatic.~ * Participants with non-squamous histology must have documented negative test results for actionable EGFR and ALK genomic alterations. Participants with squamous histology are required to undergo testing for EGFR and ALK genomic alterations if they are nonsmokers or under the age of 40 years.~ * Has either documented negative or unknown test results for actionable genomic alterations in ROS1, NTRK, BRAF, RET, MET, or other actionable oncogenic driver kinases.~ * Participants with tumors that harbor KRAS mutations are eligible for this study.~ * Participants with non-actionable genomic alterations in EGFR, ALK, ROS1, NTRK, BRAF, RET, MET, or other kinases are eligible for the study.~* Documentation of radiological disease progression while on or after receiving the most recent treatment regimen, if any, for advanced or metastatic NSCLC.~* Must meet the following prior therapy requirements for advanced or metastatic NSCLC:~ * Dose escalation (all cohorts): Has received ≤2 lines of prior anticancer therapy for locally advanced or metastatic NSCLC.~ * Dose expansion (cohorts with 4.0 mg/kg or 6.0 mg/kg Dato-DXd in combination with 200 mg fixed dose of pembrolizumab): Has not received PD-1/PD-L1, PD-L2, CTLA-4 directed immunotherapy and may or may not have been treated with systemic chemotherapy for advanced or metastatic NSCLC.~ * Dose expansion (cohorts with 4.0 mg/kg or 6.0 mg/kg Dato-DXd in combination with 200 mg fixed dose of pembrolizumab and 4 cycles of AUC 5 carboplatin or cisplatin 75 mg/m\\\\^2): Has not been treated with systemic anticancer therapy for advanced or metastatic NSCLC.~* Willing and able to undergo a mandatory tumor biopsy.~* Archival tumor tissue from initial diagnosis, to the extent that archival tumor tissue is available, for measurement of TROP2 expression levels or other biomarkers.~* Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 Day 1.~* Is not a candidate for surgical resection or chemoradiation with curative intent.~Exclusion Criteria:~* Experienced grade 3 or higher immune-related adverse events (AEs) with prior treatment of anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).~* Received a live vaccine within 30 days prior to the first dose of study treatment.~* Active, known, or suspected autoimmune disease.~* Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications, except for managing AEs.~* Prior organ transplantation, including allogeneic tissue or solid organ transplantation.~* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.~* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.~* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.~* History of another primary malignancy (beyond NSCLC) except for:~ * Malignancy treated with curative intent and with no known active disease for ≥3 years.~ * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.~ * Adequately treated carcinoma in situ without evidence of disease.~ * Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression.", combined_text: Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02) Number of Participants with Dose-limiting Toxicities (DLTs) and Treatment-emergent Adverse Events (TEAEs), Baseline up to Cycle 1 (Days 1 to 21) for DLTs and up to 28 days after last dose for TEAEs, up to approximately 30 months post-dose Objective Response Rate, Baseline up to BOR (confirmed CR or PR), up to approximately 30 months post-dose|Duration of Response, From first objective response (confirmed CR or PR) to PD or death (whichever occurs first), up to approximately 30 months post-dose|Progression-free Survival, Baseline up PD or death (whichever occurs first), up to approximately 30 months post-dose|Overall Survival, Baseline up to death (any cause), up to approximately 30 months post-dose|Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of Dato-DXd, Total Anti-TROP2 Antibody, and MAAA-1181a, Cycle 1, Day 1: pre-dose, 30 minutes, 3 hours, 5 hours, and 7 hours post-dose; Cycles 1 and 3, Day 2, Day 4, Day 8, and Day 15; Cycles 2-4, Cycle 6, and Cycle 8, Day 1: pre-dose and post-dose (each cycle is 21 days)|Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of Dato-DXd, Total Anti-TROP2 Antibody, and MAAA-1181a, Cycle 1, Day 1: pre-dose, 30 minutes, 3 hours, 5 hours, and 7 hours post-dose; Cycles 1 and 3, Day 2, Day 4, Day 8, and Day 15; Cycles 2-4, Cycle 6, and Cycle 8, Day 1: pre-dose and post-dose (each cycle is 21 days)|Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) of Dato-DXd, Total Anti-TROP2 Antibody, and MAAA-1181a, Area under the plasma concentration-time curve up to last quantifiable time (AUClast) and area under the plasma concentration-time curve during dosing interval (AUCtau) will be assessed., Cycle 1, Day 1: pre-dose, 30 minutes, 3 hours, 5 hours, and 7 hours post-dose; Cycles 1 and 3, Day 2, Day 4, Day 8, and Day 15; Cycles 2-4, Cycle 6, and Cycle 8, Day 1: pre-dose and post-dose (each cycle is 21 days)|Anti-drug Antibodies for Dato-DXd and Pembrolizumab, Baseline up to approximately 30 months post-dose "Inclusion Criteria:~* Histologically confirmed at diagnosis of NSCLC that:~ * Is advanced or metastatic.~ * Participants with non-squamous histology must have documented negative test results for actionable EGFR and ALK genomic alterations. Participants with squamous histology are required to undergo testing for EGFR and ALK genomic alterations if they are nonsmokers or under the age of 40 years.~ * Has either documented negative or unknown test results for actionable genomic alterations in ROS1, NTRK, BRAF, RET, MET, or other actionable oncogenic driver kinases.~ * Participants with tumors that harbor KRAS mutations are eligible for this study.~ * Participants with non-actionable genomic alterations in EGFR, ALK, ROS1, NTRK, BRAF, RET, MET, or other kinases are eligible for the study.~* Documentation of radiological disease progression while on or after receiving the most recent treatment regimen, if any, for advanced or metastatic NSCLC.~* Must meet the following prior therapy requirements for advanced or metastatic NSCLC:~ * Dose escalation (all cohorts): Has received ≤2 lines of prior anticancer therapy for locally advanced or metastatic NSCLC.~ * Dose expansion (cohorts with 4.0 mg/kg or 6.0 mg/kg Dato-DXd in combination with 200 mg fixed dose of pembrolizumab): Has not received PD-1/PD-L1, PD-L2, CTLA-4 directed immunotherapy and may or may not have been treated with systemic chemotherapy for advanced or metastatic NSCLC.~ * Dose expansion (cohorts with 4.0 mg/kg or 6.0 mg/kg Dato-DXd in combination with 200 mg fixed dose of pembrolizumab and 4 cycles of AUC 5 carboplatin or cisplatin 75 mg/m\\\\^2): Has not been treated with systemic anticancer therapy for advanced or metastatic NSCLC.~* Willing and able to undergo a mandatory tumor biopsy.~* Archival tumor tissue from initial diagnosis, to the extent that archival tumor tissue is available, for measurement of TROP2 expression levels or other biomarkers.~* Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 Day 1.~* Is not a candidate for surgical resection or chemoradiation with curative intent.~Exclusion Criteria:~* Experienced grade 3 or higher immune-related adverse events (AEs) with prior treatment of anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).~* Received a live vaccine within 30 days prior to the first dose of study treatment.~* Active, known, or suspected autoimmune disease.~* Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications, except for managing AEs.~* Prior organ transplantation, including allogeneic tissue or solid organ transplantation.~* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.~* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.~* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.~* History of another primary malignancy (beyond NSCLC) except for:~ * Malignancy treated with curative intent and with no known active disease for ≥3 years.~ * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.~ * Adequately treated carcinoma in situ without evidence of disease.~ * Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression.", Similarity Score: 0.30537659334455103}'}]
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from_dataset
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[{'from': 'human', 'value': '{Study Title: A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2), Primary Outcome Measures: Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment, DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (\\\\>=) 7 days or Grade 3 neutropenia with fever (greater than \\\\[\\\\>\\\\] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting \\\\>7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for \\\\>7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days), Secondary Outcome Measures: Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment, From baseline up to approximately up to 5 years 5 months|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7, Day-7: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Objective Response Rate (ORR); Combination Treatment, ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\\\<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months), criteria: "Inclusion Criteria:~Participants must meet all of the following criteria to be included in this study:~1. Phase 1b: Unresectable advanced or metastatic solid tumors.~2. Phase 1b expansion cohort and Phase 2: Histological confirmed diagnosis of glioblastoma (expansion cohort and Cohort 1) or melanoma (expansion cohort and Cohort 2).~ Phase 1b expansion cohort glioblastoma participants, Phase 2 Cohort 1:~3. No evidence of active central nervous systems (CNS) hemorrhage on baseline scans other than in those participants with recurrent glioblastoma who are stable Grade 1.~4. Participants having first or second recurrence documented by magnetic resonance imaging (MRI), following primary management with surgical resection or biopsy, radiotherapy and up to two prior systemic treatments.~5. If participants is on corticosteroids, they must be on a stable dose for 1 week prior to first dose of study drug.~6. Measurable disease defined as bidimensionally contrast enhancing lesions with clearly defined margins by computerized tomography (CT) or MRI scan, with a minimal diameter of 1 cm, and visible on two axial slices which are preferably at most 5 millimeter (mm) apart with 0 mm skip.~ Phase 1b expansion cohort melanoma participants, Phase 2 Cohort 2:~7. Radiographic/ photographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Appendix 3) after no more than two prior systemic regimens for unresectable Stage III or Stage IV disease.~8. American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma.~9. Measurable disease meeting the following criteria:~ 1. At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 centimeter (cm) in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI or photography. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.~ 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radio frequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.~ All participants:~10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~11. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 millimeter of mercury (mmHg) at screening and no change in antihypertensive medications within 1 week before the Screening Visit.~12. Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 milligrams per deciliter (mg/dL) or calculated creatinine clearance greater than or equal to 40 milliliters per minute (mL/min) per the Cockcroft and Gault formula (see Appendix 5).~13. Adequate bone marrow function:~ * Absolute neutrophil count greater than or equal to 1500/mm3 (greater than or equal to 1.5 x 10\\\\^3/uL);~ * Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 x 10\\\\^9/L);~ * Hemoglobin greater than or equal to 9.0 g/dL. 14.Adequate blood coagulation function, as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5.~14. Adequate liver function:~ * Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert\\s syndrome;~ * ALP, ALT, and AST less than or equal to 3 x ULN (less than or equal to 5 x ULN if participant has liver metastases).~15. Males or females age greater than or equal to 18 years at the time of informed consent.~16. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \\\\[B-hCG\\\\] at the Screening and Baseline Visit (a separate Baseline assessment is not required if a negative Screening pregnancy test was obtained within 72 hours before the first dose of study drug). Females of child-bearing potential, if not practising total abstinence or having a vasectomized partner with confirmed azoospermia, must agree to use two highly effective methods of contraception: e.g., 1) an intrauterine device (IUD) or intrauterine system (IUS); 2) a barrier method such as a condom or occlusive cup (diaphragm or cervical/vault caps) + spermicide (foam, gel, cream, etc.); 3) oral, injected, or implanted hormonal contraceptives throughout the entire study period and for 30 days after study drug discontinuation. Use of a double-barrier method (i.e., use at the same time of a condom + occlusive cup \\\\[diaphragm or cervical/vault caps\\\\] + spermicide \\\\[foam, gel, cream, etc.\\\\]) is accepted as two highly effective methods of contraception. The only participants who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or participants who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, total hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.~17. Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods described in Inclusion Criterion #18) beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug, unless the male participants are totally abstinent sexually or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile (see Inclusion Criterion #16).~18. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.~Exclusion Criteria:~Participants who meet any of the following criteria will be excluded from this study:~1. Phase 1b Dose Escalation: Participants who discontinued prior TK inhibitor (including VEGFR and c-Met receptor targeted therapy) due to toxicity will be ineligible.~2. Phase 1b Dose Escalation (3+3 portion) participants with primary CNS tumors~3. Phase 1b Dose Escalation participants, melanoma participants in expansion cohort and Phase 2 Cohort 2: Participants with untreated or unstable metastases to the central nervous system (CNS) are excluded. participants who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and have remained asymptomatic for at least 4 weeks prior to commencing treatment are eligible.~4. Phase 2: Prior exposure to VEGF-targeted treatment or c-Met or hepatocyte growth factor (HGF) targeted treatment.~5. Phase 2: Active malignancy (except for glioblastoma (Cohort 1) or unresectable Stage III or Stage IV melanoma (Cohort 2); or melanoma in situ, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) within the past 24 months.~ Phase 1b expansion cohort glioblastoma participants and Phase 2 Cohort 1:~6. More than two recurrences of glioblastoma.~7. Prior bevacizumab treatment.~8. Surgical resection of brain tumor within 4 weeks, or prior stereotactic biopsy within 2 weeks of Screening visit.~9. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field (beyond the high dose region or 80% isodose line), or there is biopsy-proven unequivocal viable tumor on histopathology sampling (e.g., solid tumor areas (i.e. greater than 70% tumor cell nuclei in areas), high or progressive increase in MIB-1 proliferation index compared to prior biopsy, or evidence for histological progression or increased anaplasia in the tumor).~10. Participants who have received enzyme-inducing anti epileptic agents within 14 days before the first dose of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).~ Phase 1b expansion cohort participants with melanoma and Phase 2 Cohort 2:~11. More than two prior systemic regimens for unresectable Stage III or Stage IV disease.~ All participants~12. Prior exposure to E7050 or lenvatinib.~13. Melanoma of intraocular origin.~14. participants who have received any anticancer treatment within 21 days (6 weeks for nitrosureas Cohort 1) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anticancer treatment.~15. Major surgery within 3 weeks prior to the first dose of study drug.~16. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.~17. Inability to take oral medication, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of E7050 or lenvatinib.~18. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.~19. Prolongation of QTc interval to greater than 480 msec.~20. Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin \\\\[LMWH\\\\] is allowed).~21. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.~22. Active infection (any infection requiring antibiotics).~23. Known intolerance or known hypersensitivity to any of the study drugs (or any of the excipients).~24. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.~25. Females who are pregnant or breastfeeding."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 491, Unnamed: 0: 605, NCT Number: NCT01877382, Study Title: A Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or Lymphomas, Study URL: https://clinicaltrials.gov/study/NCT01877382, Acronym: , Study Status: COMPLETED, Brief Summary: This will be a Phase 1, open-label study of milademetan to assess its safety and tolerability, identify a maximum tolerated dose (MTD)/tentative recommended phase 2 dose (RP2D), and assess its pharmacokinetic (PK)/ pharmacodynamic (PDy) properties in participants with advanced solid tumors or lymphomas.\\n\\nApproximately 5 US sites are planned for Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The same sites are planned to participate for both parts., Study Results: YES, Conditions: Advanced Solid Tumor|Lymphoma, Interventions: DRUG: Milademetan|DRUG: Milademetan, Primary Outcome Measures: "Number of Participants With Treatment-emergent Adverse Events (≥10% Overall) in Participants Receiving Milademetan, A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerged during the treatment period (from first dose date until 30 days after the last dosing date), having been absent at pretreatment; or reemerged during treatment, having been present at baseline, but stopped prior to treatment; or worsened in severity after starting treatment relative to the pretreatment state, when the AE was continuous., Screening until end of treatment visit, up to approximately 7 years 2 months|Number of Participants With Dose-Limiting Toxicities In Participants Receiving Milademetan by Preferred Term and Worst Grade by NCI CTCAE, A dose-limiting toxicity (DLT) was defined as any treatment-emergent AE (TEAE) not attributable to the participants disease or a disease-related processes that occurred during the observation period (Cycle 1) in each dose-level cohort and was Grade 3 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0, with a few exceptions., Cycle 1, Day 1 to Day 28 (each cycle, 28 days)|Number of Participants With Melanoma and Diffuse Large B Cell Lymphoma Who Achieved Objective Response, Tumor response was assessed using RECIST Version 1.1 (in solid tumor participants with measurable disease) or treatment response using the revised International Working Group criteria 7 (in participants with lymphoma). For RECIST, complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Objective response rate (ORR) was the sum of CR and PR rates., Screening up to Cycle 3 and beyond, Day 1 (each cycle, 28 days)", Secondary Outcome Measures: Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of Milademetan In Participants Receiving Milademetan, Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods., Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)|Pharmacokinetic Parameter Area Under the Curve (AUC) of Milademetan In Participants Receiving Milademetan, Area under the curve from time 0 to 24 hours (AUC0-24), time 0 to infinity (AUCinf), and to the last measurable concentration (AUClast). Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods., Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)|Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration (Tmax) of Milademetan In Participants Receiving Milademetan, Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods., Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)|Pharmacokinetic Parameter Apparent Clearance (CL/F) of Milademetan In Participants Receiving Milademetan, Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods., Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)|Pharmacokinetic Parameter Elimination Terminal Half Life Half-Life (T1/2) of Milademetan In Participants Receiving Milademetan, Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods., Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)|Mean Fold Change From Baseline in Serum MIC-1 Levels in Participants Receiving Milademetan, Mean fold change in macrophage inhibitory cytokine-1 (MIC-1) levels in serum from baseline are summarized using descriptive statistics by cohort., Cycle 1, Day 15 and Cycle 1, Days 18 to 21 (each cycle is 28 days), Other Outcome Measures: , Sponsor: Daiichi Sankyo, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 107.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: DS3032-A-U101, Start Date: 2013-07-11, Primary Completion Date: 2020-10-08, Completion Date: 2020-12-03, First Posted: 2013-06-13, Results First Posted: 2024-07-18, Last Update Posted: 2024-07-18, Locations: Karmanos Cancer Institute, Detroit, Michigan, 48201, United States|Columbia University College of Physicians and Surgeons, New York, New York, 10032, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Tennessee Oncology, Nashville, Tennessee, 37203, United States|UT MD Anderson Cancer Center, Houston, Texas, 77030, United States, Study Documents: Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/82/NCT01877382/Prot_SAP_000.pdf, criteria: "Inclusion Criteria:~Dose Escalation Cohorts (Part 1)~* Has a histologically or cytologically documented advanced solid tumor or lymphoma that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available.~ * Participants with melanoma who are ineligible to receive or have declined ipilimumab treatment or who are refractory or intolerant to ipilimumab may enroll.~ * Participants with certain tumor types such as those with high prevalence of MDM2 amplification or overexpression (eg, well-differentiated \\\\[WD\\\\]/dedifferentiated \\\\[DD\\\\] liposarcoma) may be preferentially enrolled in Part 1.~Dose Expansion Cohort (Part 2)~* Has a histologically or cytologically documented advanced melanoma or diffuse large B cell lymphoma (DLBCL), with measurable disease that is refractory to standard treatment or for which no standard treatment is available.~ * Participants with melanoma who are ineligible to receive or have declined ipilimumab treatment or who are refractory or intolerant to ipilimumab may enroll.~ * Participants with DLBCL who have failed, been deemed ineligible for, or refused autologous stem cell transplantation may enroll.~* Man or woman ≥ 18 years old.~* Has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.~* Has adequate bone marrow function, defined as:~ * Platelet count ≥ 100 x 10\\\\^9/L~ * Hemoglobin ≥ 9.0 g/dL~ * Absolute neutrophil count ≥ 1.5 x 10\\\\^9/L.~* Has adequate renal function, defined as creatinine clearance ≥ 60 mL/min, as calculated using the modified Cockcroft Gault equation, (\\\\[{140 - age in years} × {actual weight in kg}\\\\] divided by \\\\[{72 × serum creatinine in mg/dL} multiply by 0.85 if female\\\\]), OR creatinine ≤ 1.5 x ULN.~* Has adequate hepatic function, defined as:~ * AST/ALT levels ≤ 3 x ULN (if liver metastases are present, ≤ 5 x ULN)~ * Bilirubin ≤ 1.5 x ULN.~* Has adequate blood clotting function, defined as International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.~* Participant should be able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or comorbidity that would interfere with therapy.~* Participant (male and female) of childbearing/reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug.~* Participant must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IRB \\\\[Institutional Review Board\\\\]-approved Informed consent Form \\\\[ICF\\\\] (including Health Insurance Portability and Accountability Act authorization, if applicable) before performance of any study specific procedures or tests.~* Is willing to provide and there is confirmed availability of pre-existing diagnostic or resected tumor samples, such as paraffin-embedded sections. Providing fresh tumor biopsy is optional for participants in Dose Escalation cohorts.~* Is willing to undergo tumor genotyping for TP53 mutation, insertion, or deletion at screening. Confirmation of TP53 nonmutant status is encouraged, but not required prior to milademetan dosing.~* Is willing to provide additional archived samples for comprehensive genomic and/or proteomic analyses if the participant has a partial response/complete response to milademetan treatment.~* Is willing to undergo pre-treatment tumor biopsies (Part 2 only)~Exclusion Criteria:~* Has a tumor that contains an inactivating mutation, insertion, or deletion in the TP53 gene determined previously or at screening.~* Has a history of primary central nervous system malignancy.~* Has gastrointestinal conditions that could affect the absorption of milademetan in the opinion of the Investigator.~* Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection.~* Has received an allogeneic bone marrow or allogeneic stem cell transplant.~* Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.~* Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 4 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (2 weeks for stereotactic radiotherapy).~* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v4, grade ≤ 1 or baseline. Participants with chronic grade 2 toxicities may be eligible per the discretion of the Investigator and Sponsor (eg, grade 2 chemotherapy-induced neuropathy).~* Had an autologous transplant within 3 months of starting study drug treatment.~* Is receiving concomitant treatment with a strong inducer of CYP3A.~* Had systemic treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 3 weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment; or treatment with small-molecule targeted agents within 2 weeks before study drug treatment. Previous and concurrent use of hormone replacement therapy, the use of gonadotropin releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within 8 weeks before study drug treatment.~* Had therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment.~* Participated in a therapeutic clinical study within 3 weeks before study drug treatment, or current participation in other therapeutic investigational procedures.~* Prolongation of corrected QT interval by Fridericia\\s method (QTcF) at rest, where the mean QTcF interval is \\\\> 450 milliseconds (ms) for males and \\\\> 470 ms for females based on triplicate ECG.~* Pregnant or breastfeeding.~* Substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the participant\\s participation in the clinical study or evaluation of the clinical study results.~* Prior treatment with an MDM2 inhibitor.", combined_text: A Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or Lymphomas Number of Participants With Treatment-emergent Adverse Events (≥10% Overall) in Participants Receiving Milademetan, A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerged during the treatment period (from first dose date until 30 days after the last dosing date), having been absent at pretreatment; or reemerged during treatment, having been present at baseline, but stopped prior to treatment; or worsened in severity after starting treatment relative to the pretreatment state, when the AE was continuous., Screening until end of treatment visit, up to approximately 7 years 2 months|Number of Participants With Dose-Limiting Toxicities In Participants Receiving Milademetan by Preferred Term and Worst Grade by NCI CTCAE, A dose-limiting toxicity (DLT) was defined as any treatment-emergent AE (TEAE) not attributable to the participant\\s disease or a disease-related processes that occurred during the observation period (Cycle 1) in each dose-level cohort and was Grade 3 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0, with a few exceptions., Cycle 1, Day 1 to Day 28 (each cycle, 28 days)|Number of Participants With Melanoma and Diffuse Large B Cell Lymphoma Who Achieved Objective Response, Tumor response was assessed using RECIST Version 1.1 (in solid tumor participants with measurable disease) or treatment response using the revised International Working Group criteria 7 (in participants with lymphoma). For RECIST, complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Objective response rate (ORR) was the sum of CR and PR rates., Screening up to Cycle 3 and beyond, Day 1 (each cycle, 28 days) Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of Milademetan In Participants Receiving Milademetan, Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods., Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)|Pharmacokinetic Parameter Area Under the Curve (AUC) of Milademetan In Participants Receiving Milademetan, Area under the curve from time 0 to 24 hours (AUC0-24), time 0 to infinity (AUCinf), and to the last measurable concentration (AUClast). Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods., Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)|Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration (Tmax) of Milademetan In Participants Receiving Milademetan, Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods., Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)|Pharmacokinetic Parameter Apparent Clearance (CL/F) of Milademetan In Participants Receiving Milademetan, Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods., Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)|Pharmacokinetic Parameter Elimination Terminal Half Life Half-Life (T1/2) of Milademetan In Participants Receiving Milademetan, Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods., Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)|Mean Fold Change From Baseline in Serum MIC-1 Levels in Participants Receiving Milademetan, Mean fold change in macrophage inhibitory cytokine-1 (MIC-1) levels in serum from baseline are summarized using descriptive statistics by cohort., Cycle 1, Day 15 and Cycle 1, Days 18 to 21 (each cycle is 28 days) "Inclusion Criteria:~Dose Escalation Cohorts (Part 1)~* Has a histologically or cytologically documented advanced solid tumor or lymphoma that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available.~ * Participants with melanoma who are ineligible to receive or have declined ipilimumab treatment or who are refractory or intolerant to ipilimumab may enroll.~ * Participants with certain tumor types such as those with high prevalence of MDM2 amplification or overexpression (eg, well-differentiated \\\\[WD\\\\]/dedifferentiated \\\\[DD\\\\] liposarcoma) may be preferentially enrolled in Part 1.~Dose Expansion Cohort (Part 2)~* Has a histologically or cytologically documented advanced melanoma or diffuse large B cell lymphoma (DLBCL), with measurable disease that is refractory to standard treatment or for which no standard treatment is available.~ * Participants with melanoma who are ineligible to receive or have declined ipilimumab treatment or who are refractory or intolerant to ipilimumab may enroll.~ * Participants with DLBCL who have failed, been deemed ineligible for, or refused autologous stem cell transplantation may enroll.~* Man or woman ≥ 18 years old.~* Has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.~* Has adequate bone marrow function, defined as:~ * Platelet count ≥ 100 x 10\\\\^9/L~ * Hemoglobin ≥ 9.0 g/dL~ * Absolute neutrophil count ≥ 1.5 x 10\\\\^9/L.~* Has adequate renal function, defined as creatinine clearance ≥ 60 mL/min, as calculated using the modified Cockcroft Gault equation, (\\\\[{140 - age in years} × {actual weight in kg}\\\\] divided by \\\\[{72 × serum creatinine in mg/dL} multiply by 0.85 if female\\\\]), OR creatinine ≤ 1.5 x ULN.~* Has adequate hepatic function, defined as:~ * AST/ALT levels ≤ 3 x ULN (if liver metastases are present, ≤ 5 x ULN)~ * Bilirubin ≤ 1.5 x ULN.~* Has adequate blood clotting function, defined as International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.~* Participant should be able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or comorbidity that would interfere with therapy.~* Participant (male and female) of childbearing/reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug.~* Participant must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IRB \\\\[Institutional Review Board\\\\]-approved Informed consent Form \\\\[ICF\\\\] (including Health Insurance Portability and Accountability Act authorization, if applicable) before performance of any study specific procedures or tests.~* Is willing to provide and there is confirmed availability of pre-existing diagnostic or resected tumor samples, such as paraffin-embedded sections. Providing fresh tumor biopsy is optional for participants in Dose Escalation cohorts.~* Is willing to undergo tumor genotyping for TP53 mutation, insertion, or deletion at screening. Confirmation of TP53 nonmutant status is encouraged, but not required prior to milademetan dosing.~* Is willing to provide additional archived samples for comprehensive genomic and/or proteomic analyses if the participant has a partial response/complete response to milademetan treatment.~* Is willing to undergo pre-treatment tumor biopsies (Part 2 only)~Exclusion Criteria:~* Has a tumor that contains an inactivating mutation, insertion, or deletion in the TP53 gene determined previously or at screening.~* Has a history of primary central nervous system malignancy.~* Has gastrointestinal conditions that could affect the absorption of milademetan in the opinion of the Investigator.~* Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection.~* Has received an allogeneic bone marrow or allogeneic stem cell transplant.~* Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor.~* Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 4 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (2 weeks for stereotactic radiotherapy).~* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v4, grade ≤ 1 or baseline. Participants with chronic grade 2 toxicities may be eligible per the discretion of the Investigator and Sponsor (eg, grade 2 chemotherapy-induced neuropathy).~* Had an autologous transplant within 3 months of starting study drug treatment.~* Is receiving concomitant treatment with a strong inducer of CYP3A.~* Had systemic treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 3 weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment; or treatment with small-molecule targeted agents within 2 weeks before study drug treatment. Previous and concurrent use of hormone replacement therapy, the use of gonadotropin releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within 8 weeks before study drug treatment.~* Had therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment.~* Participated in a therapeutic clinical study within 3 weeks before study drug treatment, or current participation in other therapeutic investigational procedures.~* Prolongation of corrected QT interval by Fridericia\\s method (QTcF) at rest, where the mean QTcF interval is \\\\> 450 milliseconds (ms) for males and \\\\> 470 ms for females based on triplicate ECG.~* Pregnant or breastfeeding.~* Substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the participant\\s participation in the clinical study or evaluation of the clinical study results.~* Prior treatment with an MDM2 inhibitor.", Similarity Score: 0.30073853091110614}'}]
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[{'from': 'human', 'value': '{Study Title: A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2), Primary Outcome Measures: Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment, DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (\\\\>=) 7 days or Grade 3 neutropenia with fever (greater than \\\\[\\\\>\\\\] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting \\\\>7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for \\\\>7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days), Secondary Outcome Measures: Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment, From baseline up to approximately up to 5 years 5 months|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7, Day-7: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Objective Response Rate (ORR); Combination Treatment, ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\\\<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months), criteria: "Inclusion Criteria:~Participants must meet all of the following criteria to be included in this study:~1. Phase 1b: Unresectable advanced or metastatic solid tumors.~2. Phase 1b expansion cohort and Phase 2: Histological confirmed diagnosis of glioblastoma (expansion cohort and Cohort 1) or melanoma (expansion cohort and Cohort 2).~ Phase 1b expansion cohort glioblastoma participants, Phase 2 Cohort 1:~3. No evidence of active central nervous systems (CNS) hemorrhage on baseline scans other than in those participants with recurrent glioblastoma who are stable Grade 1.~4. Participants having first or second recurrence documented by magnetic resonance imaging (MRI), following primary management with surgical resection or biopsy, radiotherapy and up to two prior systemic treatments.~5. If participants is on corticosteroids, they must be on a stable dose for 1 week prior to first dose of study drug.~6. Measurable disease defined as bidimensionally contrast enhancing lesions with clearly defined margins by computerized tomography (CT) or MRI scan, with a minimal diameter of 1 cm, and visible on two axial slices which are preferably at most 5 millimeter (mm) apart with 0 mm skip.~ Phase 1b expansion cohort melanoma participants, Phase 2 Cohort 2:~7. Radiographic/ photographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Appendix 3) after no more than two prior systemic regimens for unresectable Stage III or Stage IV disease.~8. American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma.~9. Measurable disease meeting the following criteria:~ 1. At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 centimeter (cm) in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI or photography. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.~ 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radio frequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.~ All participants:~10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~11. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 millimeter of mercury (mmHg) at screening and no change in antihypertensive medications within 1 week before the Screening Visit.~12. Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 milligrams per deciliter (mg/dL) or calculated creatinine clearance greater than or equal to 40 milliliters per minute (mL/min) per the Cockcroft and Gault formula (see Appendix 5).~13. Adequate bone marrow function:~ * Absolute neutrophil count greater than or equal to 1500/mm3 (greater than or equal to 1.5 x 10\\\\^3/uL);~ * Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 x 10\\\\^9/L);~ * Hemoglobin greater than or equal to 9.0 g/dL. 14.Adequate blood coagulation function, as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5.~14. Adequate liver function:~ * Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert\\s syndrome;~ * ALP, ALT, and AST less than or equal to 3 x ULN (less than or equal to 5 x ULN if participant has liver metastases).~15. Males or females age greater than or equal to 18 years at the time of informed consent.~16. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \\\\[B-hCG\\\\] at the Screening and Baseline Visit (a separate Baseline assessment is not required if a negative Screening pregnancy test was obtained within 72 hours before the first dose of study drug). Females of child-bearing potential, if not practising total abstinence or having a vasectomized partner with confirmed azoospermia, must agree to use two highly effective methods of contraception: e.g., 1) an intrauterine device (IUD) or intrauterine system (IUS); 2) a barrier method such as a condom or occlusive cup (diaphragm or cervical/vault caps) + spermicide (foam, gel, cream, etc.); 3) oral, injected, or implanted hormonal contraceptives throughout the entire study period and for 30 days after study drug discontinuation. Use of a double-barrier method (i.e., use at the same time of a condom + occlusive cup \\\\[diaphragm or cervical/vault caps\\\\] + spermicide \\\\[foam, gel, cream, etc.\\\\]) is accepted as two highly effective methods of contraception. The only participants who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or participants who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, total hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.~17. Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods described in Inclusion Criterion #18) beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug, unless the male participants are totally abstinent sexually or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile (see Inclusion Criterion #16).~18. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.~Exclusion Criteria:~Participants who meet any of the following criteria will be excluded from this study:~1. Phase 1b Dose Escalation: Participants who discontinued prior TK inhibitor (including VEGFR and c-Met receptor targeted therapy) due to toxicity will be ineligible.~2. Phase 1b Dose Escalation (3+3 portion) participants with primary CNS tumors~3. Phase 1b Dose Escalation participants, melanoma participants in expansion cohort and Phase 2 Cohort 2: Participants with untreated or unstable metastases to the central nervous system (CNS) are excluded. participants who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and have remained asymptomatic for at least 4 weeks prior to commencing treatment are eligible.~4. Phase 2: Prior exposure to VEGF-targeted treatment or c-Met or hepatocyte growth factor (HGF) targeted treatment.~5. Phase 2: Active malignancy (except for glioblastoma (Cohort 1) or unresectable Stage III or Stage IV melanoma (Cohort 2); or melanoma in situ, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) within the past 24 months.~ Phase 1b expansion cohort glioblastoma participants and Phase 2 Cohort 1:~6. More than two recurrences of glioblastoma.~7. Prior bevacizumab treatment.~8. Surgical resection of brain tumor within 4 weeks, or prior stereotactic biopsy within 2 weeks of Screening visit.~9. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field (beyond the high dose region or 80% isodose line), or there is biopsy-proven unequivocal viable tumor on histopathology sampling (e.g., solid tumor areas (i.e. greater than 70% tumor cell nuclei in areas), high or progressive increase in MIB-1 proliferation index compared to prior biopsy, or evidence for histological progression or increased anaplasia in the tumor).~10. Participants who have received enzyme-inducing anti epileptic agents within 14 days before the first dose of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).~ Phase 1b expansion cohort participants with melanoma and Phase 2 Cohort 2:~11. More than two prior systemic regimens for unresectable Stage III or Stage IV disease.~ All participants~12. Prior exposure to E7050 or lenvatinib.~13. Melanoma of intraocular origin.~14. participants who have received any anticancer treatment within 21 days (6 weeks for nitrosureas Cohort 1) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anticancer treatment.~15. Major surgery within 3 weeks prior to the first dose of study drug.~16. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.~17. Inability to take oral medication, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of E7050 or lenvatinib.~18. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.~19. Prolongation of QTc interval to greater than 480 msec.~20. Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin \\\\[LMWH\\\\] is allowed).~21. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.~22. Active infection (any infection requiring antibiotics).~23. Known intolerance or known hypersensitivity to any of the study drugs (or any of the excipients).~24. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.~25. Females who are pregnant or breastfeeding."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 609, Unnamed: 0: 745, NCT Number: NCT02335944, Study Title: Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer., Study URL: https://clinicaltrials.gov/study/NCT02335944, Acronym: , Study Status: TERMINATED, Brief Summary: The purpose of this study was to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of nazartinib (EGF816) in combination with capmatinib (INC280) and to estimate the preliminary anti-tumor activity of nazartinib in combination with capmatinib in participants with advanced non-small cell lung cancer (NSCLC) with documented EGFR mutation., Study Results: YES, Conditions: Non Small Cell Lung Cancer, Interventions: DRUG: Capmatinib|DRUG: Nazartinib, Primary Outcome Measures: "Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs), Number of participants with DLTs in the Phase Ib part. A DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with EGF816 in combination with INC280 during the escalation part of the study (Phase Ib), Up to first 28 days of treatment|Phase II Group 1, 2 and 3: Overall Response Rate (ORR) by Investigators Assessment Per RECIST 1.1, ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) determined by investigators assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). ORR was assessed in Group 1, 2 and 3 (Phase II part).\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., Up to approximately 4 years|Phase II Group 4: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs), Number of participants in Group 4 (Phase II part) with AEs and SAEs. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward event resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE., From start of treatment up to 30 days after last dose of study treatment, assessed up to 3.7 years|Phase II Group 4: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618, Number of participants with at least one dose reduction of INC280, at least one dose interruption of INC280, at least one dose reduction of EGF816 and at least one dose interruption of EGF816 in the Group 4 (Phase II part)., From start of treatment until end of treatment, assessed up to 3.6 years|Phase II Group 4: Dose Intensity, Dose intensity, defined as the ratio of total dose received and actual duration, for participants in Group 4 (Phase II part), From start of treatment until end of treatment, assessed up to 3.6 years|Phase II Group 5: ORR Per RECIST 1.1 Based on Investigators Assessment for INC280 Monotherapy, ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) determined by Investigator assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for participants in Group 5 (Phase II part) while on treatment with INC280 monotherapy.\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., Up to approximately 3 years (while on INC280 monotherapy)", Secondary Outcome Measures: "Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618, Number of participants in Phase Ib with at least one dose reduction of INC280, at least one dose interruption of INC280, at least one dose reduction of EGF816 and at least one dose interruption of EGF816 ., From start of treatment until end of treatment, assessed up to approximately 5 years|Phase II Group 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618, Number of participants in Groups 1, 2 and 3 (Phase II part) with at least one dose reduction of INC280, at least one dose interruption of INC280, at least one dose reduction of EGF816 and at least one dose interruption of EGF816 ., From start of treatment until end of treatment, assessed up to approximately 4 years|Phase Ib: Dose Intensity, Dose intensity, defined as the ratio of total dose received and actual duration, in Phase Ib participants, From start of treatment until end of treatment, assessed up to approximately 5 years|Phase II Group 1, 2 and 3: Dose Intensity, Dose intensity, defined as the ratio of total dose received and actual duration, in Group 1, 2 and 3 (Phase II), From start of treatment until end of treatment, assessed up to approximately 4 years|Phase Ib: Overall Response Rate (ORR) Per RECIST 1.1 Based on Investigators Assessment, ORR is defined as percentage of participants with best overall response of PR+CR determined by Investigators assessment in accordance to RECIST 1.1. ORR was assessed in Phase Ib participants.\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., Up to approximately 5 years|Phase II Group 4: Overall Response Rate (ORR) Per RECIST 1.1 Based on Investigators Assessment, ORR is defined as percentage of participants with best overall response of PR+CR determined by Investigators assessment in accordance to RECIST 1.1. ORR was assessed in Group 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., Up to approximately 4 years|Phase Ib: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigators Assessment, PFS is defined as time from date of first dose of study treatment to date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1.or death due to any cause. The PFS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, PFS is censored at the date of last adequate tumor assessment. PFS was assessed in Phase Ib participants, From date of first dose to first documented disease progression or death, assessed up to approximately 5 years|Phase II Groups 1, 2, 3 and 4: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigators Assessment, PFS is defined as time from date of first dose of study treatment to date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1.or death due to any cause. The PFS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, PFS is censored at the date of last adequate tumor assessment. PFS was assessed in Group 1, 2, 3 and 4 (Phase II), From date of first dose to first documented disease progression or death, assessed up to approximately 4 years|Phase Ib: Time to Response (TTR) Per RECIST 1.1 Based on Investigators Assessment, TTR is defined as the time from the date of the first dose to the date of first documented response (CR or PR) determined by Investigator assessment in accordance to RECIST 1.1. The TTR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. TTR was assessed in Phase Ib participants.\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., From the date of the first dose to the date of first documented response, up to approximately 5 years|Phase II Groups 1, 2, 3 and 4: Time to Response (TTR) Per RECIST 1.1 Based on Investigators Assessment, TTR is defined as the time from the date of the first dose to the date of first documented response (CR or PR) determined by Investigator assessment in accordance to RECIST 1.1. The TTR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. TTR was assessed in Group 1, 2, 3 and 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., From the date of the first dose to the date of first documented response, up to approximately 4 years|Phase Ib: Duration of Response (DOR) Per RECIST 1.1 Based on Investigators Assessment, DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1 or death due to underlying cancer. The DOR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. DOR was assessed in Phase Ib participants CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., From date of first documented response to first documented disease progression or death, assessed up to approximately 5 years|Phase II Groups 1, 2, 3 and 4: Duration of Response (DOR) Per RECIST 1.1 Based on Investigators Assessment, DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1 or death due to underlying cancer. The DOR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. DOR was assessed in Group 1, 2, 3 and 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., From date of first documented response to first documented disease progression or deaths, assessed up to approximately 4 years|Phase Ib: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigators Assessment, DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD) determined by Investigator assessment in accordance to RECIST 1.1. DCR was assessed in Phase Ib participants CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression., Up to approximately 5 years|Phase II Group 1, 2 3 and 4: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigators Assessment, DCR is defined as the percentage of participants with best overall response of CR, PR, or SD determined by Investigator assessment in accordance to RECIST 1.1. DCR was assessed in Group 1, 2, 3 and 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression., Up to approximately 4 years|Phase Ib: Overall Survival (OS), OS is defined as the time from first dose of the study treatment to the date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant was not known to have died, survival was censored at the date of last contact. OS was assessed in Phase Ib participants, From date of first dose to death, assessed up to approximately 5 years|Phase II Groups 1, 2, 3 and 4: Overall Survival (OS), OS is defined as the time from first dose of the study treatment to the date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant was not known to have died, survival was censored at the date of last contact. OS was assessed in Group 1, 2, 3 and 4, From date of first dose to death, assessed up to approximately 4 years|Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase Ib: Peak Plasma Concentration (Cmax) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase Ib: Time to Reach Maximum Concentration (Tmax) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment), Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Peak Plasma Concentration (Cmax) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Time to Reach Maximum Concentration (Tmax) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment), Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase Ib: Peak Plasma Concentration (Cmax) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase Ib: Time to Reach Maximum Concentration (Tmax) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment), Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Peak Plasma Concentration (Cmax) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Time to Reach Maximum Concentration (Tmax) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment), Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Group 5: Duration of Response (DOR) Per RECIST 1.1 Based on Investigators Assessment for INC280 Monotherapy, DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1 for participants in Group 5 (Phase II) while on INC280 monotherapy treatment.\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., From date of first documented response to the date of first documented disease progression or death, assessed up to approximately 3 years (while on INC280 monotherapy)|Phase II Group 5: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigators Assessment for INC280 Monotherapy, DCR is defined as the percentage of participants with best overall response of CR, PR, or SD determined by Investigator assessment in accordance to RECIST 1.1 for participants in Group 5 (Phase II) while on INC280 monotherapy treatment.\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression., Up to approximately 3 years (while on INC280 monotherapy)|Phase II Group 5: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigators Assessment for INC280 Monotherapy, PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1 for participants in Group 5 (Phase II) while on INC280 monotherapy treatment., Up to approximately 3 years (while on INC280 monotherapy)|Phase II Group 5: Number of Participants With Dose Modifications for INC280 Monotherapy as Well as INC280 in Combination With EGF816 Therapy, Number of participants with dose modifications for INC280 monotherapy as well as INC280 in combination with EGF816 therapy, From start of treatment until end of treatment, up to approximately 3 years|Phase II Group 5: Dose Intensity for INC280 Monotherapy as Well as INC280 in Combination With EGF816 Therapy, Dose intensity is defined as the ratio of total dose received and actual duration for INC280 monotherapy as well as INC280 in combination with EGF816 therapy in Group 5 (Phase II), From start of treatment until end of treatment, up to approximately 3 years", Other Outcome Measures: , Sponsor: Novartis Pharmaceuticals, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1|PHASE2, Enrollment: 177.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: CINC280X2105C|2014-000726-37, Start Date: 2015-01-13, Primary Completion Date: 2020-11-10, Completion Date: 2020-11-10, First Posted: 2015-01-12, Results First Posted: 2023-06-18, Last Update Posted: 2023-06-18, Locations: Massachusetts General Hospital Mass General, Boston, Massachusetts, 02114, United States|Novartis Investigative Site, Melbourne, Victoria, 3000, Australia|Novartis Investigative Site, Edmonton, Alberta, T6G 1Z2, Canada|Novartis Investigative Site, Marseille Cedex 05, 13885, France|Novartis Investigative Site, Heidelberg, Baden-Württemberg, 69126, Germany|Novartis Investigative Site, Koeln, Nordrhein-Westfalen, 50937, Germany|Novartis Investigative Site, Bologna, BO, 40138, Italy|Novartis Investigative Site, Modena, MO, 41124, Italy|Novartis Investigative Site, Perugia, PG, 06129, Italy|Novartis Investigative Site, Seoul, Korea, 05505, Korea, Republic of|Novartis Investigative Site, Oslo, NO 0424, Norway|Novartis Investigative Site, Singapore, 119228, Singapore|Novartis Investigative Site, Singapore, 168583, Singapore|Novartis Investigative Site, Barcelona, Catalunya, 08035, Spain|Novartis Investigative Site, La Coruna, Galicia, 15006, Spain|Novartis Investigative Site, Las Palmas De Gran Canarias, Las Palmas De Gran Canaria, 35016, Spain|Novartis Investigative Site, Madrid, 28009, Spain|Novartis Investigative Site, Madrid, 28041, Spain|Novartis Investigative Site, Taipei, Taiwan ROC, 10041, Taiwan, Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/44/NCT02335944/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/44/NCT02335944/SAP_001.pdf, criteria: "Key Inclusion criteria:~- Participants in Phase Ib and Phase II Groups 1 to 4: histologically documented, locally advanced or recurrent (stage IIIB who were not eligible for combined modality treatment) or metastatic (Stage IV) NSCLC.~Participants in Phase II Group 5: stage IIIB/IIIC (not amenable to curative surgery, chemoradiation or radiation) or stage IV NSCLC~* Participants in Phase Ib and Phase II Groups 1 to 4: locally documented EGFR mutation L858R and/or ex19del, or a characterized de novo EGFR T790M mutation (or other rare activating mutations that confer sensitivity to 1st and 2nd generation EGFR inhibitors (e.g. L861Q, G719X, S768I), or a characterized de novo EGFRT790M mutation.~* Presence of at least one measurable lesion according to RECIST v.1.1~* ECOG performance status ≤1~* Participants had to be screened for HBV. Participants who were either HBsAg positive or HBV-DNA positive had to be willing and able to take antiviral therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816.~* Participants had to be screened for HCV. Participants had to have negative hepatitis C antibody (HCV Ab) or were HCV Ab positive but with an undetectable level of HCV-RNA. Note: participants with detectable HCV-RNA were not eligible for the study.~* Phase Ib only: documented progression of disease according to RECIST v1.1 while on continuous treatment with EGFR TKI (e.g.: erlotinib, gefitinib or afatinib).~* Phase II Group 1 (EGFRmut, any T790M, any c-MET, 2/4L antineoplastic, EGFR TKI resistant) only: Participants demonstrated a documented clinical benefit (CR (any duration), PR (any duration), or SD for at least 6 months) on prior EGFR TKI (e.g. erlotinib, gefitinib or afatinib, and subsequently demonstrated progression according to RECIST v1.1.~* Phase II Group 2 (EGFRmut, de novo T790M, any c-MET, 1/3L antineoplastic, EGFR TKI naïve) only: Advanced NSCLC participants who were not previously treated with any therapy known to inhibit EGFR and harbor de novo T790M mutation .~* Phase II Group 3 (EGFRmut, T790M negative, any c-MET, 1L antineoplastic) only: participants had to harbor an EGFR activating mutation and had to be naïve from any line of systemic antineoplastic therapy in the advanced setting.~* Phase II Group 4 (EGFRmut, any T790M, any c-MET, 1L (treatment-naïve), 2//3L antineoplastic): All participants had to harbor an EGFR activating mutation and 2/3L participants had to have failed (defined as intolerance to treatment or documented disease progression) a maximum of 2 prior lines of antineoplastic therapy in the advanced setting~* Phase II Group 5 only: Histologically or cytologically confirmed diagnosis of NSCLC (excluding squamous cell carcinoma) with all the following:~ 1. EGFR mutations known to be associated with EGFR TKI sensitivity. This had to be assessed as part of the participant standard of care by a validated test for EGFR mutations, as per local regulations. Exon 19 del, L858R, either alone or in combination with other EGFR sensitivity mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA) certified USA laboratory or an accredited local laboratory outside the USA had to be documented in the participant source documents before the participant consented for pre-screening for MET amplification status.~ 2. EGFR T790M negative status for participants who had progressed on first or second generation EGFR TKI, or third generation EGFR TKI other than osimertinib, as per tissue-based result from a CLIA-certified USA laboratory or an accredited local laboratory outside of the USA, by a validated test according to local regulations.~ 3. MET gene amplification defined as: Gene copy number (GCN) ≥ 5 per tissue-based result from a CLIA-certified USA laboratory or an accredited local laboratory outside of the USA by a test that is validated according to local regulations with results documented in the participant source documents.~ 4. Histological transformation from NSCLC into small cell lung cancer (SCLC) following previous EGFR TKI treatment were excluded.~* Participants had to have progressed on one prior line of therapy either to first/second generation EGFR TKIs, osimertinib or other third generation EGFR TKIs for advanced/metastatic disease (stage IIIB/IIIC \\\\[not amenable to curative surgery, chemoradiation or radiation or stage IV NSCLC).~* Participants had to have a life expectancy of at least 3 months.~Key exclusion Criteria:~* Phase Ib:~ * More than one previous treatment line with erlotinib, gefitinib or afatinib~ * Previous treatment with any investigational agent known to inhibit EGFR (mutant or wild-type)~ * Participants who had received more than three prior lines of antineoplastic therapies (including EGFR TKI) in advanced setting.~* Phase II Group 1 (EGFRmut, any T790M, any c-MET, 2/4L antineoplastic, EGFR TKI resistant):~ * More than 3 prior lines of systemic antineoplastic therapies (including EGFR TKI) in the advanced setting~ * More than 1 previous treatment line with 1st or 2nd generation EGFR TKI (e.g. erlotinib, gefitinib, afatinib) in the advanced setting~ * Previous treatment with an investigational or marketed 3rd generation EGFR TKI (e.g. AZD9291, CO-1686, ASP8273, EGF816)~ * Previous treatment with an investigational or marketed agent known to inhibit EGFR (e.g. EGF monoclonal antibody therapy, dual TKI inhibitor).~* Phase II Group 2 (EGFRmut, de novo T790M, any c-MET, 1/3L antineoplastic, EGFR TKI naïve):~ * More than two previous treatment lines of systemic antineoplastic therapies in the advanced setting~ * Previous treatment with an investigational or marketed agent that inhibits EGFR. EGFR inhibitors include (but not limited to) all generations of EGFR TKI (e.g.erlotinib, gefitinib, afatinib, AZD9291, CO-1686, ASP8273, EGF816) or other anti-EGFR or EGFR monoclonal antibody therapy or dual TKI inhibitors.~* Phase II Group 3 (EGFRmut, T790M negative, any c-MET, 1L antineoplastic):~ * De novo EGFR T790M mutation identified by central assessment~ * Previous treatment with any systemic antineoplastic therapy in the advanced setting (NSCLC stage IIIB or IV. Participants who received only one cycle of antineoplastic therapy in the advanced setting were allowed).~* Phase II Group 4 (EGFRmut, any T790M, any c-MET, 1/3L antineoplastic):~ * More than 2 prior lines of systemic antineoplastic therapies in the advanced setting~ * Previous treatment with an investigational or marketed 3rd generation EGFR TKI (e.g. AZD9291, CO-1686, ASP8273, EGF816)~ * Previous treatment with an investigational or marketed agent known to inhibit EGFR (e.g. EGF monoclonal antibody therapy, dual TKI inhibitor).~ * Previous treatment with a c-MET inhibitor or HGF-targeting therapy.~ * Participants with symptomatic brain metastases.~* Phase II Group 5: Participants with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.~* Presence or history of another malignancy. Exception: Participants who had been disease-free for 3 years, or participants with a history of adequately treated in-situ carcinoma of the uterine cervix, completely resected basal or squamous cell carcinoma, non-melanomatous cancer of skin, history of stage IA melanoma that had been cured, were eligible.~For Phase II Group 5: Presence or history of a malignant disease other than NSCLC that had been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.~* Undergone a bone marrow or solid organ transplant.~* Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory).~For Group 5: Participants with known history of testing positive for human immunodeficiency virus (HIV) infection, and with a history of Acquired ImmunoDeficiency Syndrome (AIDS) defining opportunistic infections in the last 12 months prior to the first dose of study treatment had to be excluded~* Participants receiving concomitant immunosuppressive agents or chronic corticosteroids used at the time of study entry except for control of brain metastases, topical applications, inhaled sprays, eye drops or local injections~* Participants with clinically significant, uncontrolled cardiovascular disease~* Presence or history of interstitial lung disease or interstitial pneumonitis~* Participants who had not recovered from all toxicities related to prior anticancer therapies to grade ≤1 (CTCAE v 4.03)~* Participants who had out of range laboratory values~* Participants who received live vaccines", combined_text: Study of Safety and Efficacy of EGFR-TKI EGF816 in Combination With cMET Inhibitor INC280 in Adult Patients With EGFR Mutated Non Small Cell Lung Cancer. Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs), Number of participants with DLTs in the Phase Ib part. A DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with EGF816 in combination with INC280 during the escalation part of the study (Phase Ib), Up to first 28 days of treatment|Phase II Group 1, 2 and 3: Overall Response Rate (ORR) by Investigator\\s Assessment Per RECIST 1.1, ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) determined by investigator\\s assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). ORR was assessed in Group 1, 2 and 3 (Phase II part).\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., Up to approximately 4 years|Phase II Group 4: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs), Number of participants in Group 4 (Phase II part) with AEs and SAEs. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Any untoward event resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE., From start of treatment up to 30 days after last dose of study treatment, assessed up to 3.7 years|Phase II Group 4: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618, Number of participants with at least one dose reduction of INC280, at least one dose interruption of INC280, at least one dose reduction of EGF816 and at least one dose interruption of EGF816 in the Group 4 (Phase II part)., From start of treatment until end of treatment, assessed up to 3.6 years|Phase II Group 4: Dose Intensity, Dose intensity, defined as the ratio of total dose received and actual duration, for participants in Group 4 (Phase II part), From start of treatment until end of treatment, assessed up to 3.6 years|Phase II Group 5: ORR Per RECIST 1.1 Based on Investigator\\s Assessment for INC280 Monotherapy, ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) determined by Investigator assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for participants in Group 5 (Phase II part) while on treatment with INC280 monotherapy.\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., Up to approximately 3 years (while on INC280 monotherapy) Phase Ib: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618, Number of participants in Phase Ib with at least one dose reduction of INC280, at least one dose interruption of INC280, at least one dose reduction of EGF816 and at least one dose interruption of EGF816 ., From start of treatment until end of treatment, assessed up to approximately 5 years|Phase II Group 1, 2 and 3: Number of Participants With Dose Reductions and Dose Interruptions of INC280 and EGF618, Number of participants in Groups 1, 2 and 3 (Phase II part) with at least one dose reduction of INC280, at least one dose interruption of INC280, at least one dose reduction of EGF816 and at least one dose interruption of EGF816 ., From start of treatment until end of treatment, assessed up to approximately 4 years|Phase Ib: Dose Intensity, Dose intensity, defined as the ratio of total dose received and actual duration, in Phase Ib participants, From start of treatment until end of treatment, assessed up to approximately 5 years|Phase II Group 1, 2 and 3: Dose Intensity, Dose intensity, defined as the ratio of total dose received and actual duration, in Group 1, 2 and 3 (Phase II), From start of treatment until end of treatment, assessed up to approximately 4 years|Phase Ib: Overall Response Rate (ORR) Per RECIST 1.1 Based on Investigator\\s Assessment, ORR is defined as percentage of participants with best overall response of PR+CR determined by Investigator\\s assessment in accordance to RECIST 1.1. ORR was assessed in Phase Ib participants.\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., Up to approximately 5 years|Phase II Group 4: Overall Response Rate (ORR) Per RECIST 1.1 Based on Investigator\\s Assessment, ORR is defined as percentage of participants with best overall response of PR+CR determined by Investigator\\s assessment in accordance to RECIST 1.1. ORR was assessed in Group 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., Up to approximately 4 years|Phase Ib: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigator\\s Assessment, PFS is defined as time from date of first dose of study treatment to date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1.or death due to any cause. The PFS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, PFS is censored at the date of last adequate tumor assessment. PFS was assessed in Phase Ib participants, From date of first dose to first documented disease progression or death, assessed up to approximately 5 years|Phase II Groups 1, 2, 3 and 4: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigator\\s Assessment, PFS is defined as time from date of first dose of study treatment to date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1.or death due to any cause. The PFS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, PFS is censored at the date of last adequate tumor assessment. PFS was assessed in Group 1, 2, 3 and 4 (Phase II), From date of first dose to first documented disease progression or death, assessed up to approximately 4 years|Phase Ib: Time to Response (TTR) Per RECIST 1.1 Based on Investigator\\s Assessment, TTR is defined as the time from the date of the first dose to the date of first documented response (CR or PR) determined by Investigator assessment in accordance to RECIST 1.1. The TTR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. TTR was assessed in Phase Ib participants.\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., From the date of the first dose to the date of first documented response, up to approximately 5 years|Phase II Groups 1, 2, 3 and 4: Time to Response (TTR) Per RECIST 1.1 Based on Investigator\\s Assessment, TTR is defined as the time from the date of the first dose to the date of first documented response (CR or PR) determined by Investigator assessment in accordance to RECIST 1.1. The TTR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. TTR was assessed in Group 1, 2, 3 and 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., From the date of the first dose to the date of first documented response, up to approximately 4 years|Phase Ib: Duration of Response (DOR) Per RECIST 1.1 Based on Investigator\\s Assessment, DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1 or death due to underlying cancer. The DOR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. DOR was assessed in Phase Ib participants CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., From date of first documented response to first documented disease progression or death, assessed up to approximately 5 years|Phase II Groups 1, 2, 3 and 4: Duration of Response (DOR) Per RECIST 1.1 Based on Investigator\\s Assessment, DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression determined by Investigator assessment in accordance to RECIST 1.1 or death due to underlying cancer. The DOR distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant has not had an event, duration was censored at the date of last adequate tumor assessment. DOR was assessed in Group 1, 2, 3 and 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., From date of first documented response to first documented disease progression or deaths, assessed up to approximately 4 years|Phase Ib: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigator\\s Assessment, DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease (SD) determined by Investigator assessment in accordance to RECIST 1.1. DCR was assessed in Phase Ib participants CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression., Up to approximately 5 years|Phase II Group 1, 2 3 and 4: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigator\\s Assessment, DCR is defined as the percentage of participants with best overall response of CR, PR, or SD determined by Investigator assessment in accordance to RECIST 1.1. DCR was assessed in Group 1, 2, 3 and 4 (Phase II) CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression., Up to approximately 4 years|Phase Ib: Overall Survival (OS), OS is defined as the time from first dose of the study treatment to the date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant was not known to have died, survival was censored at the date of last contact. OS was assessed in Phase Ib participants, From date of first dose to death, assessed up to approximately 5 years|Phase II Groups 1, 2, 3 and 4: Overall Survival (OS), OS is defined as the time from first dose of the study treatment to the date of death due to any cause. The OS distribution was estimated using the Kaplan-Meier method and associated 95% confidence intervals were calculated. If a participant was not known to have died, survival was censored at the date of last contact. OS was assessed in Group 1, 2, 3 and 4, From date of first dose to death, assessed up to approximately 4 years|Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase Ib: Peak Plasma Concentration (Cmax) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase Ib: Time to Reach Maximum Concentration (Tmax) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment), Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Peak Plasma Concentration (Cmax) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Time to Reach Maximum Concentration (Tmax) of INC280, Pharmacokinetic (PK) parameters were calculated based on INC280 plasma concentrations by using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment), Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase Ib: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase Ib: Peak Plasma Concentration (Cmax) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase Ib: Time to Reach Maximum Concentration (Tmax) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment), Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Peak Plasma Concentration (Cmax) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods., Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Groups 3 and 4: Time to Reach Maximum Concentration (Tmax) of EGF816, Pharmacokinetic (PK) parameters were calculated based on EGF816 plasma concentrations by using non-compartmental methods. Actual time of sample collection was used (not the nominal time point as per scheduled assessment), Pre-dose, 0.5 hours (hr) and 1 hr, 2 hr, 4 hr, 8 hr and 12 hr and 24 hr post-dose on Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle=28 days)|Phase II Group 5: Duration of Response (DOR) Per RECIST 1.1 Based on Investigator\\s Assessment for INC280 Monotherapy, DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1 for participants in Group 5 (Phase II) while on INC280 monotherapy treatment.\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters., From date of first documented response to the date of first documented disease progression or death, assessed up to approximately 3 years (while on INC280 monotherapy)|Phase II Group 5: Disease Control Rate (DCR) Per RECIST 1.1 Based on Investigator\\s Assessment for INC280 Monotherapy, DCR is defined as the percentage of participants with best overall response of CR, PR, or SD determined by Investigator assessment in accordance to RECIST 1.1 for participants in Group 5 (Phase II) while on INC280 monotherapy treatment.\\n\\nCR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\\\< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression., Up to approximately 3 years (while on INC280 monotherapy)|Phase II Group 5: Progression Free Survival (PFS) Per RECIST 1.1 Based on Investigator\\s Assessment for INC280 Monotherapy, PFS is defined as time from date of first dose of study treatment to date of first documented disease progression or death due to any cause determined by Investigator assessment in accordance to RECIST 1.1 for participants in Group 5 (Phase II) while on INC280 monotherapy treatment., Up to approximately 3 years (while on INC280 monotherapy)|Phase II Group 5: Number of Participants With Dose Modifications for INC280 Monotherapy as Well as INC280 in Combination With EGF816 Therapy, Number of participants with dose modifications for INC280 monotherapy as well as INC280 in combination with EGF816 therapy, From start of treatment until end of treatment, up to approximately 3 years|Phase II Group 5: Dose Intensity for INC280 Monotherapy as Well as INC280 in Combination With EGF816 Therapy, Dose intensity is defined as the ratio of total dose received and actual duration for INC280 monotherapy as well as INC280 in combination with EGF816 therapy in Group 5 (Phase II), From start of treatment until end of treatment, up to approximately 3 years "Key Inclusion criteria:~- Participants in Phase Ib and Phase II Groups 1 to 4: histologically documented, locally advanced or recurrent (stage IIIB who were not eligible for combined modality treatment) or metastatic (Stage IV) NSCLC.~Participants in Phase II Group 5: stage IIIB/IIIC (not amenable to curative surgery, chemoradiation or radiation) or stage IV NSCLC~* Participants in Phase Ib and Phase II Groups 1 to 4: locally documented EGFR mutation L858R and/or ex19del, or a characterized de novo EGFR T790M mutation (or other rare activating mutations that confer sensitivity to 1st and 2nd generation EGFR inhibitors (e.g. L861Q, G719X, S768I), or a characterized de novo EGFRT790M mutation.~* Presence of at least one measurable lesion according to RECIST v.1.1~* ECOG performance status ≤1~* Participants had to be screened for HBV. Participants who were either HBsAg positive or HBV-DNA positive had to be willing and able to take antiviral therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816.~* Participants had to be screened for HCV. Participants had to have negative hepatitis C antibody (HCV Ab) or were HCV Ab positive but with an undetectable level of HCV-RNA. Note: participants with detectable HCV-RNA were not eligible for the study.~* Phase Ib only: documented progression of disease according to RECIST v1.1 while on continuous treatment with EGFR TKI (e.g.: erlotinib, gefitinib or afatinib).~* Phase II Group 1 (EGFRmut, any T790M, any c-MET, 2/4L antineoplastic, EGFR TKI resistant) only: Participants demonstrated a documented clinical benefit (CR (any duration), PR (any duration), or SD for at least 6 months) on prior EGFR TKI (e.g. erlotinib, gefitinib or afatinib, and subsequently demonstrated progression according to RECIST v1.1.~* Phase II Group 2 (EGFRmut, de novo T790M, any c-MET, 1/3L antineoplastic, EGFR TKI naïve) only: Advanced NSCLC participants who were not previously treated with any therapy known to inhibit EGFR and harbor de novo T790M mutation .~* Phase II Group 3 (EGFRmut, T790M negative, any c-MET, 1L antineoplastic) only: participants had to harbor an EGFR activating mutation and had to be naïve from any line of systemic antineoplastic therapy in the advanced setting.~* Phase II Group 4 (EGFRmut, any T790M, any c-MET, 1L (treatment-naïve), 2//3L antineoplastic): All participants had to harbor an EGFR activating mutation and 2/3L participants had to have failed (defined as intolerance to treatment or documented disease progression) a maximum of 2 prior lines of antineoplastic therapy in the advanced setting~* Phase II Group 5 only: Histologically or cytologically confirmed diagnosis of NSCLC (excluding squamous cell carcinoma) with all the following:~ 1. EGFR mutations known to be associated with EGFR TKI sensitivity. This had to be assessed as part of the participant standard of care by a validated test for EGFR mutations, as per local regulations. Exon 19 del, L858R, either alone or in combination with other EGFR sensitivity mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA) certified USA laboratory or an accredited local laboratory outside the USA had to be documented in the participant source documents before the participant consented for pre-screening for MET amplification status.~ 2. EGFR T790M negative status for participants who had progressed on first or second generation EGFR TKI, or third generation EGFR TKI other than osimertinib, as per tissue-based result from a CLIA-certified USA laboratory or an accredited local laboratory outside of the USA, by a validated test according to local regulations.~ 3. MET gene amplification defined as: Gene copy number (GCN) ≥ 5 per tissue-based result from a CLIA-certified USA laboratory or an accredited local laboratory outside of the USA by a test that is validated according to local regulations with results documented in the participant source documents.~ 4. Histological transformation from NSCLC into small cell lung cancer (SCLC) following previous EGFR TKI treatment were excluded.~* Participants had to have progressed on one prior line of therapy either to first/second generation EGFR TKIs, osimertinib or other third generation EGFR TKIs for advanced/metastatic disease (stage IIIB/IIIC \\\\[not amenable to curative surgery, chemoradiation or radiation or stage IV NSCLC).~* Participants had to have a life expectancy of at least 3 months.~Key exclusion Criteria:~* Phase Ib:~ * More than one previous treatment line with erlotinib, gefitinib or afatinib~ * Previous treatment with any investigational agent known to inhibit EGFR (mutant or wild-type)~ * Participants who had received more than three prior lines of antineoplastic therapies (including EGFR TKI) in advanced setting.~* Phase II Group 1 (EGFRmut, any T790M, any c-MET, 2/4L antineoplastic, EGFR TKI resistant):~ * More than 3 prior lines of systemic antineoplastic therapies (including EGFR TKI) in the advanced setting~ * More than 1 previous treatment line with 1st or 2nd generation EGFR TKI (e.g. erlotinib, gefitinib, afatinib) in the advanced setting~ * Previous treatment with an investigational or marketed 3rd generation EGFR TKI (e.g. AZD9291, CO-1686, ASP8273, EGF816)~ * Previous treatment with an investigational or marketed agent known to inhibit EGFR (e.g. EGF monoclonal antibody therapy, dual TKI inhibitor).~* Phase II Group 2 (EGFRmut, de novo T790M, any c-MET, 1/3L antineoplastic, EGFR TKI naïve):~ * More than two previous treatment lines of systemic antineoplastic therapies in the advanced setting~ * Previous treatment with an investigational or marketed agent that inhibits EGFR. EGFR inhibitors include (but not limited to) all generations of EGFR TKI (e.g.erlotinib, gefitinib, afatinib, AZD9291, CO-1686, ASP8273, EGF816) or other anti-EGFR or EGFR monoclonal antibody therapy or dual TKI inhibitors.~* Phase II Group 3 (EGFRmut, T790M negative, any c-MET, 1L antineoplastic):~ * De novo EGFR T790M mutation identified by central assessment~ * Previous treatment with any systemic antineoplastic therapy in the advanced setting (NSCLC stage IIIB or IV. Participants who received only one cycle of antineoplastic therapy in the advanced setting were allowed).~* Phase II Group 4 (EGFRmut, any T790M, any c-MET, 1/3L antineoplastic):~ * More than 2 prior lines of systemic antineoplastic therapies in the advanced setting~ * Previous treatment with an investigational or marketed 3rd generation EGFR TKI (e.g. AZD9291, CO-1686, ASP8273, EGF816)~ * Previous treatment with an investigational or marketed agent known to inhibit EGFR (e.g. EGF monoclonal antibody therapy, dual TKI inhibitor).~ * Previous treatment with a c-MET inhibitor or HGF-targeting therapy.~ * Participants with symptomatic brain metastases.~* Phase II Group 5: Participants with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.~* Presence or history of another malignancy. Exception: Participants who had been disease-free for 3 years, or participants with a history of adequately treated in-situ carcinoma of the uterine cervix, completely resected basal or squamous cell carcinoma, non-melanomatous cancer of skin, history of stage IA melanoma that had been cured, were eligible.~For Phase II Group 5: Presence or history of a malignant disease other than NSCLC that had been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.~* Undergone a bone marrow or solid organ transplant.~* Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory).~For Group 5: Participants with known history of testing positive for human immunodeficiency virus (HIV) infection, and with a history of Acquired ImmunoDeficiency Syndrome (AIDS) defining opportunistic infections in the last 12 months prior to the first dose of study treatment had to be excluded~* Participants receiving concomitant immunosuppressive agents or chronic corticosteroids used at the time of study entry except for control of brain metastases, topical applications, inhaled sprays, eye drops or local injections~* Participants with clinically significant, uncontrolled cardiovascular disease~* Presence or history of interstitial lung disease or interstitial pneumonitis~* Participants who had not recovered from all toxicities related to prior anticancer therapies to grade ≤1 (CTCAE v 4.03)~* Participants who had out of range laboratory values~* Participants who received live vaccines", Similarity Score: 0.29878841407247003}'}]
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[{'from': 'human', 'value': '{Study Title: A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2), Primary Outcome Measures: Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment, DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (\\\\>=) 7 days or Grade 3 neutropenia with fever (greater than \\\\[\\\\>\\\\] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting \\\\>7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for \\\\>7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days), Secondary Outcome Measures: Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment, From baseline up to approximately up to 5 years 5 months|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7, Day-7: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Objective Response Rate (ORR); Combination Treatment, ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\\\<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months), criteria: "Inclusion Criteria:~Participants must meet all of the following criteria to be included in this study:~1. Phase 1b: Unresectable advanced or metastatic solid tumors.~2. Phase 1b expansion cohort and Phase 2: Histological confirmed diagnosis of glioblastoma (expansion cohort and Cohort 1) or melanoma (expansion cohort and Cohort 2).~ Phase 1b expansion cohort glioblastoma participants, Phase 2 Cohort 1:~3. No evidence of active central nervous systems (CNS) hemorrhage on baseline scans other than in those participants with recurrent glioblastoma who are stable Grade 1.~4. Participants having first or second recurrence documented by magnetic resonance imaging (MRI), following primary management with surgical resection or biopsy, radiotherapy and up to two prior systemic treatments.~5. If participants is on corticosteroids, they must be on a stable dose for 1 week prior to first dose of study drug.~6. Measurable disease defined as bidimensionally contrast enhancing lesions with clearly defined margins by computerized tomography (CT) or MRI scan, with a minimal diameter of 1 cm, and visible on two axial slices which are preferably at most 5 millimeter (mm) apart with 0 mm skip.~ Phase 1b expansion cohort melanoma participants, Phase 2 Cohort 2:~7. Radiographic/ photographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Appendix 3) after no more than two prior systemic regimens for unresectable Stage III or Stage IV disease.~8. American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma.~9. Measurable disease meeting the following criteria:~ 1. At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 centimeter (cm) in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI or photography. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.~ 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radio frequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.~ All participants:~10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~11. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 millimeter of mercury (mmHg) at screening and no change in antihypertensive medications within 1 week before the Screening Visit.~12. Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 milligrams per deciliter (mg/dL) or calculated creatinine clearance greater than or equal to 40 milliliters per minute (mL/min) per the Cockcroft and Gault formula (see Appendix 5).~13. Adequate bone marrow function:~ * Absolute neutrophil count greater than or equal to 1500/mm3 (greater than or equal to 1.5 x 10\\\\^3/uL);~ * Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 x 10\\\\^9/L);~ * Hemoglobin greater than or equal to 9.0 g/dL. 14.Adequate blood coagulation function, as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5.~14. Adequate liver function:~ * Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert\\s syndrome;~ * ALP, ALT, and AST less than or equal to 3 x ULN (less than or equal to 5 x ULN if participant has liver metastases).~15. Males or females age greater than or equal to 18 years at the time of informed consent.~16. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \\\\[B-hCG\\\\] at the Screening and Baseline Visit (a separate Baseline assessment is not required if a negative Screening pregnancy test was obtained within 72 hours before the first dose of study drug). Females of child-bearing potential, if not practising total abstinence or having a vasectomized partner with confirmed azoospermia, must agree to use two highly effective methods of contraception: e.g., 1) an intrauterine device (IUD) or intrauterine system (IUS); 2) a barrier method such as a condom or occlusive cup (diaphragm or cervical/vault caps) + spermicide (foam, gel, cream, etc.); 3) oral, injected, or implanted hormonal contraceptives throughout the entire study period and for 30 days after study drug discontinuation. Use of a double-barrier method (i.e., use at the same time of a condom + occlusive cup \\\\[diaphragm or cervical/vault caps\\\\] + spermicide \\\\[foam, gel, cream, etc.\\\\]) is accepted as two highly effective methods of contraception. The only participants who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or participants who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, total hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.~17. Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods described in Inclusion Criterion #18) beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug, unless the male participants are totally abstinent sexually or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile (see Inclusion Criterion #16).~18. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.~Exclusion Criteria:~Participants who meet any of the following criteria will be excluded from this study:~1. Phase 1b Dose Escalation: Participants who discontinued prior TK inhibitor (including VEGFR and c-Met receptor targeted therapy) due to toxicity will be ineligible.~2. Phase 1b Dose Escalation (3+3 portion) participants with primary CNS tumors~3. Phase 1b Dose Escalation participants, melanoma participants in expansion cohort and Phase 2 Cohort 2: Participants with untreated or unstable metastases to the central nervous system (CNS) are excluded. participants who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and have remained asymptomatic for at least 4 weeks prior to commencing treatment are eligible.~4. Phase 2: Prior exposure to VEGF-targeted treatment or c-Met or hepatocyte growth factor (HGF) targeted treatment.~5. Phase 2: Active malignancy (except for glioblastoma (Cohort 1) or unresectable Stage III or Stage IV melanoma (Cohort 2); or melanoma in situ, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) within the past 24 months.~ Phase 1b expansion cohort glioblastoma participants and Phase 2 Cohort 1:~6. More than two recurrences of glioblastoma.~7. Prior bevacizumab treatment.~8. Surgical resection of brain tumor within 4 weeks, or prior stereotactic biopsy within 2 weeks of Screening visit.~9. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field (beyond the high dose region or 80% isodose line), or there is biopsy-proven unequivocal viable tumor on histopathology sampling (e.g., solid tumor areas (i.e. greater than 70% tumor cell nuclei in areas), high or progressive increase in MIB-1 proliferation index compared to prior biopsy, or evidence for histological progression or increased anaplasia in the tumor).~10. Participants who have received enzyme-inducing anti epileptic agents within 14 days before the first dose of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).~ Phase 1b expansion cohort participants with melanoma and Phase 2 Cohort 2:~11. More than two prior systemic regimens for unresectable Stage III or Stage IV disease.~ All participants~12. Prior exposure to E7050 or lenvatinib.~13. Melanoma of intraocular origin.~14. participants who have received any anticancer treatment within 21 days (6 weeks for nitrosureas Cohort 1) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anticancer treatment.~15. Major surgery within 3 weeks prior to the first dose of study drug.~16. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.~17. Inability to take oral medication, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of E7050 or lenvatinib.~18. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.~19. Prolongation of QTc interval to greater than 480 msec.~20. Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin \\\\[LMWH\\\\] is allowed).~21. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.~22. Active infection (any infection requiring antibiotics).~23. Known intolerance or known hypersensitivity to any of the study drugs (or any of the excipients).~24. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.~25. Females who are pregnant or breastfeeding."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 939, Unnamed: 0: 1174, NCT Number: NCT04707573, Study Title: Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4, Study URL: https://clinicaltrials.gov/study/NCT04707573, Acronym: , Study Status: COMPLETED, Brief Summary: This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat., Study Results: YES, Conditions: Chronic Kidney Disease, Interventions: DRUG: Vadadustat, Primary Outcome Measures: Number of Participants With Treatment-emergent Adverse Events (TEAEs), An Adverse Event (AE) was defined as any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study following study medication administration, regardless of causal relationship. This also included any clinically significant worsening or re-occurrence of a pre-existing condition, or AE occurring from an overdose of a study drug whether accidental or intentional or AE occurring from abuse of study drug or that has been associated with the discontinuation of the use of study drug., Up to Day 8|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values, Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes., Up to Day 8|Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values, Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes. Number of participants with a clinically significant change from baseline in at least one of the assessed vital signs parameters is reported., Up to Day 8|Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings, A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance., Up to Day 2|Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval, A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected). The baseline was defined as Day 1 pre-dose measurement. If missing, the last measurement prior to dosing was used., Baseline; Day 2|Change From Baseline in Heart Rate, The heart rate evaluation was performed after the participant had been resting comfortably in a supine position for approximately 10 minutes., Baseline; Day 2|Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings, A baseline physical examination was performed at screening. Otherwise, abbreviated physical examinations were conducted and were to include heart, lung, and abdomen. The investigator was responsible for reviewing laboratory results for clinically significant changes., Up to Day 8|Geometric Mean Maximum Observed Plasma Concentration (Cmax) of AKB-6548, Plasma samples were collected from the participants at the defined time points. Cmax was defined as the maximum observed plasma concentration. Cmax was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Median Time to Reach Cmax (Tmax) of AKB-6548, Plasma samples were collected from the participants at the defined time points. Tmax was defined as the time to reach maximum plasma concentration. Tmax was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Mean Terminal Elimination Rate Constant (λz), Plasma samples were collected from the participants at the defined time points. λz was calculated using linear regression of the terminal linear portion of the log concentration vs. time curve. The parameter was calculated by linear least-squares regression analysis using three or more concentrations, excluding Cmax., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Median Terminal Elimination Half-life (T½), Plasma samples were collected from the participants at the defined time points. T½ was defined as apparent terminal elimination half-life. T½ was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Geometric Mean Area Under the Plasma Concentration-time Curve From 0 to Time T Over a Dosing Interval (AUC[0-T]), Plasma samples were collected from the participants at the defined time points. AUC\\\\[0-T) was defined as the area under the plasma concentration-time curve, from time=0 to the last measurable concentration (Ct) up to 24 hours, calculated by the linear trapezoidal method. AUC\\\\[0-T) was calculated using the standard noncompartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Geometric Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]), Plasma samples were collected from the participants at the defined time points. AUC\\\\[0-∞\\\\] was defined as the area under the plasma concentration-time curve from time=0 and extrapolated to infinity. AUC\\\\[0-∞\\\\] was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Geometric Mean Apparent Oral Clearance (CL/F), Plasma samples were collected from the participants at the defined time points. CL/F was defined as apparent oral clearance, calculated as Dose/AUC(0-inf). CL/F was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Geometric Mean Apparent Volume of Distribution During the Terminal Phase (Vd/F), Plasma samples were collected from the participants at the defined time points. Vd/F was defined as the apparent volume of distribution during the terminal phase, calculated as Dose/\\\\[λz \\\\* AUC(0-inf)\\\\]. Vd/F was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2), Secondary Outcome Measures: Change From Baseline in Mean Erythropoietin (EPO), The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values., Baseline; 8, 12, and 24 hours post-dose, Other Outcome Measures: Exploratory: Change From Baseline in Hepcidin at 24 Hours, Baseline; 24 hours post-dose|Exploratory: Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at 24 Hours, Baseline; 24 hours post-dose|Exploratory: Change From Baseline in Transferrin at 24 Hours, Baseline; 24 hours post-dose|Exploratory: Change From Baseline in Cystatin-C at 24 Hours, Baseline; 24 hours post -dose|Exploratory: Change From Baseline in Adiponectin at 24 Hours, Baseline; 24 hours post -dose|Exploratory: Change From Baseline in Ferritin at 24 Hours, Baseline; 24 hours post-dose, Sponsor: Akebia Therapeutics, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 22.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: AKB-6548-CI-0003, Start Date: 2010-07-08, Primary Completion Date: 2010-09-24, Completion Date: 2010-09-24, First Posted: 2021-01-13, Results First Posted: 2022-05-17, Last Update Posted: 2022-06-28, Locations: Research Site, Saint Paul, Minnesota, 55114, United States|Research Site, Knoxville, Tennessee, 37920, United States, Study Documents: , criteria: "Inclusion Criteria:~* 18 to 79 years of age, inclusive~* Chronic Kidney Disease Stage 3 (Estimated Glomerular Filtration Rate \\\\[eGFR\\\\] 30 to 59 milliliters \\\\[mL\\\\]/minute) or Stage 4 participants (eGFR of \\\\<30 mL/minute that were not yet on dialysis). eGFR was calculated using the Modification of Diet in Renal Disease (MDRD).~* Hemoglobin (Hb) \\\\<13.5 grams per deciliter (g/dL) except for Polycystic Kidney Disease (PKD) participants, in which Hb was to be ≤14 g/dL~* Transferrin saturation (TSAT) \\\\>12% and complete blood count (CBC) indicating normocytic red blood cell morphology, unless the medical monitor and investigator agreed that the participant was appropriate for this study~* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.8 x upper limit of normal (ULN)~* Alkaline phosphatase ≤2 x ULN~* Bilirubin ≤1.5 x ULN~* Female participants were not pregnant or breastfeeding. Women of childbearing potential agreed to use an acceptable method of contraception.~* Non-vasectomized male participants agreed to use an acceptable method of contraception~* Understood the procedures and requirements of the study and provided written informed consent and authorization for protected health information disclosure~Exclusion Criteria:~* Any medical or psychological condition that in the opinion of the Investigator would have interfered with the participant\\s ability to provide informed consent or comply with study instructions~* Any clinically significant or uncontrolled medical condition that in the opinion of the Investigator would have placed the participant at undo risk or would have compromised the interpretability of the findings in this study~* A body mass index (BMI) of greater than 40~* Seropositive for human immunodeficiency virus (HIV) or Hepatitis B surface antigen~* Seropositive for Hepatitis C virus (HCV) antibodies unless ALT, AST, bilirubin tests were within normal limits~* History of chronic liver disease~* Uncontrolled hypertension (diastolic blood pressure \\\\[BP\\\\] \\\\> 110 millimeters of mercury \\\\[mm Hg\\\\] or systolic BP \\\\>190 mm Hg at screening)~* New York Heart Association Class III or IV congestive heart failure~* Myocardial infarction, acute coronary syndrome, or stroke within 6 months of dosing~* History of myelodysplastic syndrome~* Participants known to have diabetic gastroparesis that was either symptomatic on therapy or was refractory to therapy~* Any history of malignancy in the previous 5 years except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps~* Evidence of active infection unless the medical monitor and investigator agreed that the participant was appropriate for this study~* History of rheumatoid arthritis or systemic lupus erythematosus (SLE) (History of osteoarthritis or gout did not exclude participants from eligibility in the study.)~* Age-related macular degeneration (AMD), diabetic macular edema or active diabetic proliferative retinopathy that was likely to require treatment during the trial~* History of deep vein thrombosis (DVT) that required active treatment. Superficial thrombosis was not excluded.~* History of ongoing hemolysis or diagnosis of hemolytic syndrome~* Known history of bone marrow fibrosis~* History of hemosiderosis or hemochromatosis~* Androgen therapy within 21 days from the last injection~* Red blood cell transfusion within 12 weeks~* Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 21 days~* Intravenous iron supplementation within the past 21 days~* Currently taking acetaminophen \\\\> 2.6 grams/day~* History of prior organ transplantation, or stem cell or bone marrow transplantation~* Alcohol consumption greater than 14 or more drinks per week within the past year (1 drink = 12 ounce \\\\[oz\\\\] beer, 5 oz wine, or 1.5 oz hard liquor.)~* Use of an investigational medication or participation in an investigational study within 30 days, or 5 half-lives of the investigational product, whichever was longer, preceding Day 1~* Positive urine toxicology screen for a substance of abuse that had not been prescribed for the participant", combined_text: Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4 Number of Participants With Treatment-emergent Adverse Events (TEAEs), An Adverse Event (AE) was defined as any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study following study medication administration, regardless of causal relationship. This also included any clinically significant worsening or re-occurrence of a pre-existing condition, or AE occurring from an overdose of a study drug whether accidental or intentional or AE occurring from abuse of study drug or that has been associated with the discontinuation of the use of study drug., Up to Day 8|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values, Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes., Up to Day 8|Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values, Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes. Number of participants with a clinically significant change from baseline in at least one of the assessed vital signs parameters is reported., Up to Day 8|Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings, A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance., Up to Day 2|Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval, A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected). The baseline was defined as Day 1 pre-dose measurement. If missing, the last measurement prior to dosing was used., Baseline; Day 2|Change From Baseline in Heart Rate, The heart rate evaluation was performed after the participant had been resting comfortably in a supine position for approximately 10 minutes., Baseline; Day 2|Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings, A baseline physical examination was performed at screening. Otherwise, abbreviated physical examinations were conducted and were to include heart, lung, and abdomen. The investigator was responsible for reviewing laboratory results for clinically significant changes., Up to Day 8|Geometric Mean Maximum Observed Plasma Concentration (Cmax) of AKB-6548, Plasma samples were collected from the participants at the defined time points. Cmax was defined as the maximum observed plasma concentration. Cmax was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Median Time to Reach Cmax (Tmax) of AKB-6548, Plasma samples were collected from the participants at the defined time points. Tmax was defined as the time to reach maximum plasma concentration. Tmax was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Mean Terminal Elimination Rate Constant (λz), Plasma samples were collected from the participants at the defined time points. λz was calculated using linear regression of the terminal linear portion of the log concentration vs. time curve. The parameter was calculated by linear least-squares regression analysis using three or more concentrations, excluding Cmax., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Median Terminal Elimination Half-life (T½), Plasma samples were collected from the participants at the defined time points. T½ was defined as apparent terminal elimination half-life. T½ was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Geometric Mean Area Under the Plasma Concentration-time Curve From 0 to Time T Over a Dosing Interval (AUC[0-T]), Plasma samples were collected from the participants at the defined time points. AUC\\\\[0-T) was defined as the area under the plasma concentration-time curve, from time=0 to the last measurable concentration (Ct) up to 24 hours, calculated by the linear trapezoidal method. AUC\\\\[0-T) was calculated using the standard noncompartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Geometric Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]), Plasma samples were collected from the participants at the defined time points. AUC\\\\[0-∞\\\\] was defined as the area under the plasma concentration-time curve from time=0 and extrapolated to infinity. AUC\\\\[0-∞\\\\] was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Geometric Mean Apparent Oral Clearance (CL/F), Plasma samples were collected from the participants at the defined time points. CL/F was defined as apparent oral clearance, calculated as Dose/AUC(0-inf). CL/F was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2)|Geometric Mean Apparent Volume of Distribution During the Terminal Phase (Vd/F), Plasma samples were collected from the participants at the defined time points. Vd/F was defined as the apparent volume of distribution during the terminal phase, calculated as Dose/\\\\[λz \\\\* AUC(0-inf)\\\\]. Vd/F was calculated using the standard non-compartmental method., Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose (Day 2) Change From Baseline in Mean Erythropoietin (EPO), The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values., Baseline; 8, 12, and 24 hours post-dose "Inclusion Criteria:~* 18 to 79 years of age, inclusive~* Chronic Kidney Disease Stage 3 (Estimated Glomerular Filtration Rate \\\\[eGFR\\\\] 30 to 59 milliliters \\\\[mL\\\\]/minute) or Stage 4 participants (eGFR of \\\\<30 mL/minute that were not yet on dialysis). eGFR was calculated using the Modification of Diet in Renal Disease (MDRD).~* Hemoglobin (Hb) \\\\<13.5 grams per deciliter (g/dL) except for Polycystic Kidney Disease (PKD) participants, in which Hb was to be ≤14 g/dL~* Transferrin saturation (TSAT) \\\\>12% and complete blood count (CBC) indicating normocytic red blood cell morphology, unless the medical monitor and investigator agreed that the participant was appropriate for this study~* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.8 x upper limit of normal (ULN)~* Alkaline phosphatase ≤2 x ULN~* Bilirubin ≤1.5 x ULN~* Female participants were not pregnant or breastfeeding. Women of childbearing potential agreed to use an acceptable method of contraception.~* Non-vasectomized male participants agreed to use an acceptable method of contraception~* Understood the procedures and requirements of the study and provided written informed consent and authorization for protected health information disclosure~Exclusion Criteria:~* Any medical or psychological condition that in the opinion of the Investigator would have interfered with the participant\\s ability to provide informed consent or comply with study instructions~* Any clinically significant or uncontrolled medical condition that in the opinion of the Investigator would have placed the participant at undo risk or would have compromised the interpretability of the findings in this study~* A body mass index (BMI) of greater than 40~* Seropositive for human immunodeficiency virus (HIV) or Hepatitis B surface antigen~* Seropositive for Hepatitis C virus (HCV) antibodies unless ALT, AST, bilirubin tests were within normal limits~* History of chronic liver disease~* Uncontrolled hypertension (diastolic blood pressure \\\\[BP\\\\] \\\\> 110 millimeters of mercury \\\\[mm Hg\\\\] or systolic BP \\\\>190 mm Hg at screening)~* New York Heart Association Class III or IV congestive heart failure~* Myocardial infarction, acute coronary syndrome, or stroke within 6 months of dosing~* History of myelodysplastic syndrome~* Participants known to have diabetic gastroparesis that was either symptomatic on therapy or was refractory to therapy~* Any history of malignancy in the previous 5 years except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps~* Evidence of active infection unless the medical monitor and investigator agreed that the participant was appropriate for this study~* History of rheumatoid arthritis or systemic lupus erythematosus (SLE) (History of osteoarthritis or gout did not exclude participants from eligibility in the study.)~* Age-related macular degeneration (AMD), diabetic macular edema or active diabetic proliferative retinopathy that was likely to require treatment during the trial~* History of deep vein thrombosis (DVT) that required active treatment. Superficial thrombosis was not excluded.~* History of ongoing hemolysis or diagnosis of hemolytic syndrome~* Known history of bone marrow fibrosis~* History of hemosiderosis or hemochromatosis~* Androgen therapy within 21 days from the last injection~* Red blood cell transfusion within 12 weeks~* Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 21 days~* Intravenous iron supplementation within the past 21 days~* Currently taking acetaminophen \\\\> 2.6 grams/day~* History of prior organ transplantation, or stem cell or bone marrow transplantation~* Alcohol consumption greater than 14 or more drinks per week within the past year (1 drink = 12 ounce \\\\[oz\\\\] beer, 5 oz wine, or 1.5 oz hard liquor.)~* Use of an investigational medication or participation in an investigational study within 30 days, or 5 half-lives of the investigational product, whichever was longer, preceding Day 1~* Positive urine toxicology screen for a substance of abuse that had not been prescribed for the participant", Similarity Score: 0.2975163016308898}'}]
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from_dataset
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[{'from': 'human', 'value': '{Study Title: A Study of E7050 in Combination With E7080 in Participants With Advanced Solid Tumors (Dose Escalation) and in Participants With Recurrent Glioblastoma or Unresectable Stage III or Stage IV Melanoma After Prior Systemic Therapy (Expansion Cohort and Phase 2), Primary Outcome Measures: Phase 1b: Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)- Combination Treatment, DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Hematological DLTs were Grade 4 neutropenia for greater than or equal to (\\\\>=) 7 days or Grade 3 neutropenia with fever (greater than \\\\[\\\\>\\\\] 38.5 degree Celsius (°C) in axilla), Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or lasting \\\\>7 days and decrease of hemoglobin of Grade 4. Non-hematological DLTS were Grade 3 fatigue, or a 2 point decline in Eastern Cooperative Oncology Group (ECOG) performance status must persist for \\\\>7days, Nausea, vomiting or diarrhea must persist at Grade 3 or 4 despite maximal medical therapy, Grade 4 hypertension or Grade 3 hypertension not able to be controlled by medication and any Grade 3 or higher non-hematological laboratory abnormalities that require hospitalization., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Golvatinib in Combination With Lenvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of golvatinib in Combination with lenvatinib was MTD determined by Dose Escalation Committee (DEC) based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days)|Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Golvatinib, The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a DLTs, with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. The RP2D of lenvatinib in Combination with golvatinib was MTD determined by DEC based on safety, PK and clinical data. DLT was defined as toxicity related to the combination therapy and was graded according to CTCAE v4.0., Cycle 1 (Cycle length= 28 days), Secondary Outcome Measures: Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Values- Combination Treatment, From baseline up to approximately 5 years 5 months|Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)- Combination Treatment, From baseline up to approximately up to 5 years 5 months|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib When Administered as a Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib When Administered as a Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: AUC∞; Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Golvatinib When Administered as Single Agent at Day -7, Day-7: 0-24 hours post-dose|Phase 1b: t1/2; Terminal Elimination Half-life for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: CL/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Golvatinib When Administered as Single Agent at Day -7, Day -7: 0-24 hours post-dose|Phase 1b: Vz/F; Apparent Volume of Distribution at Terminal Phase for Lenvatinib When Administered as Single Agent at Day -8, Day -8: 0-24 hours post dose|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Cmax; Maximum Observed Plasma Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Tmax; Time to Reach the Maximum Plasma Concentration (Cmax) for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUC24; Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Single Dose on Day 1 Cycle 1, Cycle 1 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: AUCt; Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: CLss/F; Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(AUC); Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Rac(Cmax); Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax for Golvatinib and Lenvatinib When Administered in Combination Treatment as Multiple Dose on Day 1 Cycle 2, Cycle 2 Day 1: 0-24 hours post-dose (cycle length is 28 days)|Phase 1b: Objective Response Rate (ORR); Combination Treatment, ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. ORR was defined as the percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\\\<)10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters., From the date of the first dose of study drug to the date of the first documentation of disease progression or death, whichever occurred first (approximately up to 5 years 5 months), criteria: "Inclusion Criteria:~Participants must meet all of the following criteria to be included in this study:~1. Phase 1b: Unresectable advanced or metastatic solid tumors.~2. Phase 1b expansion cohort and Phase 2: Histological confirmed diagnosis of glioblastoma (expansion cohort and Cohort 1) or melanoma (expansion cohort and Cohort 2).~ Phase 1b expansion cohort glioblastoma participants, Phase 2 Cohort 1:~3. No evidence of active central nervous systems (CNS) hemorrhage on baseline scans other than in those participants with recurrent glioblastoma who are stable Grade 1.~4. Participants having first or second recurrence documented by magnetic resonance imaging (MRI), following primary management with surgical resection or biopsy, radiotherapy and up to two prior systemic treatments.~5. If participants is on corticosteroids, they must be on a stable dose for 1 week prior to first dose of study drug.~6. Measurable disease defined as bidimensionally contrast enhancing lesions with clearly defined margins by computerized tomography (CT) or MRI scan, with a minimal diameter of 1 cm, and visible on two axial slices which are preferably at most 5 millimeter (mm) apart with 0 mm skip.~ Phase 1b expansion cohort melanoma participants, Phase 2 Cohort 2:~7. Radiographic/ photographic evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Appendix 3) after no more than two prior systemic regimens for unresectable Stage III or Stage IV disease.~8. American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma.~9. Measurable disease meeting the following criteria:~ 1. At least one lesion of greater than or equal to 1.0 cm in the longest diameter for a non-lymph node or greater than or equal to 1.5 centimeter (cm) in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using CT/MRI or photography. If there is only one target lesion and it is a non-lymph node, it should have a longest diameter of greater than or equal to 1.5 cm.~ 2. Lesions that have had external beam radiotherapy or loco-regional therapies such as radio frequency ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.~ All participants:~10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.~11. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150/90 millimeter of mercury (mmHg) at screening and no change in antihypertensive medications within 1 week before the Screening Visit.~12. Adequate renal function as evidenced by serum creatinine less than or equal to 2.0 milligrams per deciliter (mg/dL) or calculated creatinine clearance greater than or equal to 40 milliliters per minute (mL/min) per the Cockcroft and Gault formula (see Appendix 5).~13. Adequate bone marrow function:~ * Absolute neutrophil count greater than or equal to 1500/mm3 (greater than or equal to 1.5 x 10\\\\^3/uL);~ * Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 x 10\\\\^9/L);~ * Hemoglobin greater than or equal to 9.0 g/dL. 14.Adequate blood coagulation function, as evidenced by an International Normalized Ratio (INR) less than or equal to 1.5.~14. Adequate liver function:~ * Bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert\\s syndrome;~ * ALP, ALT, and AST less than or equal to 3 x ULN (less than or equal to 5 x ULN if participant has liver metastases).~15. Males or females age greater than or equal to 18 years at the time of informed consent.~16. All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin \\\\[B-hCG\\\\] at the Screening and Baseline Visit (a separate Baseline assessment is not required if a negative Screening pregnancy test was obtained within 72 hours before the first dose of study drug). Females of child-bearing potential, if not practising total abstinence or having a vasectomized partner with confirmed azoospermia, must agree to use two highly effective methods of contraception: e.g., 1) an intrauterine device (IUD) or intrauterine system (IUS); 2) a barrier method such as a condom or occlusive cup (diaphragm or cervical/vault caps) + spermicide (foam, gel, cream, etc.); 3) oral, injected, or implanted hormonal contraceptives throughout the entire study period and for 30 days after study drug discontinuation. Use of a double-barrier method (i.e., use at the same time of a condom + occlusive cup \\\\[diaphragm or cervical/vault caps\\\\] + spermicide \\\\[foam, gel, cream, etc.\\\\]) is accepted as two highly effective methods of contraception. The only participants who will be exempt from this requirement are postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or participants who have been sterilized surgically or who are otherwise proven sterile (i.e., bilateral tubal ligation with surgery at least 1 month prior to dosing, total hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing). All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.~17. Male participants who are partners of women of childbearing potential must use a condom + spermicide and their female partners, if of childbearing potential, must use a highly effective method of contraception (see methods described in Inclusion Criterion #18) beginning at least 1 menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug, unless the male participants are totally abstinent sexually or have undergone a successful vasectomy with confirmed azoospermia or unless the female partners have been sterilized surgically or are otherwise proven sterile (see Inclusion Criterion #16).~18. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.~Exclusion Criteria:~Participants who meet any of the following criteria will be excluded from this study:~1. Phase 1b Dose Escalation: Participants who discontinued prior TK inhibitor (including VEGFR and c-Met receptor targeted therapy) due to toxicity will be ineligible.~2. Phase 1b Dose Escalation (3+3 portion) participants with primary CNS tumors~3. Phase 1b Dose Escalation participants, melanoma participants in expansion cohort and Phase 2 Cohort 2: Participants with untreated or unstable metastases to the central nervous system (CNS) are excluded. participants who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and have remained asymptomatic for at least 4 weeks prior to commencing treatment are eligible.~4. Phase 2: Prior exposure to VEGF-targeted treatment or c-Met or hepatocyte growth factor (HGF) targeted treatment.~5. Phase 2: Active malignancy (except for glioblastoma (Cohort 1) or unresectable Stage III or Stage IV melanoma (Cohort 2); or melanoma in situ, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix) within the past 24 months.~ Phase 1b expansion cohort glioblastoma participants and Phase 2 Cohort 1:~6. More than two recurrences of glioblastoma.~7. Prior bevacizumab treatment.~8. Surgical resection of brain tumor within 4 weeks, or prior stereotactic biopsy within 2 weeks of Screening visit.~9. Prior radiotherapy within 12 weeks unless there is a new area of enhancement consistent with recurrent tumor outside of the radiation field (beyond the high dose region or 80% isodose line), or there is biopsy-proven unequivocal viable tumor on histopathology sampling (e.g., solid tumor areas (i.e. greater than 70% tumor cell nuclei in areas), high or progressive increase in MIB-1 proliferation index compared to prior biopsy, or evidence for histological progression or increased anaplasia in the tumor).~10. Participants who have received enzyme-inducing anti epileptic agents within 14 days before the first dose of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone, or oxcarbazepine).~ Phase 1b expansion cohort participants with melanoma and Phase 2 Cohort 2:~11. More than two prior systemic regimens for unresectable Stage III or Stage IV disease.~ All participants~12. Prior exposure to E7050 or lenvatinib.~13. Melanoma of intraocular origin.~14. participants who have received any anticancer treatment within 21 days (6 weeks for nitrosureas Cohort 1) or any investigational agent within 30 days prior to the first dose of study drug or who have not recovered from any acute toxicity related to previous anticancer treatment.~15. Major surgery within 3 weeks prior to the first dose of study drug.~16. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g/24-hour will be ineligible.~17. Inability to take oral medication, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of E7050 or lenvatinib.~18. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment.~19. Prolongation of QTc interval to greater than 480 msec.~20. Bleeding disorder or thrombotic disorder requiring anticoagulant therapy, such as warfarin, or similar agents requiring therapeutic INR monitoring (treatment with low molecular weight heparin \\\\[LMWH\\\\] is allowed).~21. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.~22. Active infection (any infection requiring antibiotics).~23. Known intolerance or known hypersensitivity to any of the study drugs (or any of the excipients).~24. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.~25. Females who are pregnant or breastfeeding."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 479, Unnamed: 0: 587, NCT Number: NCT03005782, Study Title: Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers, Study URL: https://clinicaltrials.gov/study/NCT03005782, Acronym: , Study Status: COMPLETED, Brief Summary: The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma.\\n\\nThe primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR)., Study Results: NO, Conditions: Malignancies, Interventions: DRUG: REGN3767|DRUG: cemiplimab, Primary Outcome Measures: Rate of dose limiting toxicities (Dose Escalation Phase), Baseline to 28 days|Rate of adverse events (Dose Escalation Phase), Baseline to 51 weeks|Rate of serious adverse events (Dose Escalation Phase), Baseline to 51 weeks|Occurrence of death (Dose Escalation Phase), Baseline to 51 weeks|Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Escalation Phase), Baseline to 51 weeks|Area under the curve (AUC) computed from time zero to the time of the last concentration [AUCall] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|AUC computed from time zero to the time of the last positive concentration [AUClast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to week 51|Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase), Baseline to 51 weeks|Mean residence time when the drug concentration profile is based on values up to and including the last positive concentration [MRTlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase), Baseline to 51 weeks|Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase), Baseline to 51 weeks, Secondary Outcome Measures: Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase), Baseline to week 51|Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase), Baseline to week 51|Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase), Baseline to 51 weeks|Best overall response based on irRECIST criteria (Dose Escalation Phase), Baseline to 51 weeks|Best overall response based on Lugano criteria (Dose Escalation Phase), Baseline to 51 weeks|Duration of response based on RECIST criteria (Dose Escalation Phase), Baseline to week 51|Duration of response based on irRECIST criteria (Dose Escalation Phase), Baseline to week 51|Duration of response based on Lugano criteria (Dose Escalation Phase), Baseline to week 51|Disease control rate based on RECIST criteria (Dose Escalation Phase), Baseline to 51 weeks|Disease control rate based on irRECIST criteria (Dose Escalation Phase), Baseline to 51 weeks|Disease control rate based on Lugano criteria (Dose Escalation Phase), Baseline to 51 weeks|Progression free survival based on RECIST (Dose Escalation Phase), Baseline to 51 weeks|Progression free survival based on irRECIST (Dose Escalation Phase), Baseline to 51 weeks|Progression free survival based on Lugano criteria (Dose Escalation Phase), Baseline to 51 weeks|Incidence of adverse events (Dose Expansion Phase), Baseline to 51 weeks|Incidence of serious adverse events (Dose Expansion Phase), Baseline to 51 weeks|Incidence of death (Dose Expansion Phase), From Baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months|Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Expansion Phase), Baseline to 51 weeks|Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase), Baseline to 51 weeks, Other Outcome Measures: , Sponsor: Regeneron Pharmaceuticals, Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 333.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: R3767-ONC-1613|2016-002789-30, Start Date: 2016-11-07, Primary Completion Date: 2024-04-02, Completion Date: 2024-04-02, First Posted: 2016-12-29, Results First Posted: , Last Update Posted: 2024-05-01, Locations: "California Cancer Associates for Research and Excellence, Encinitas, California, 92024, United States|California Cancer Associates For Research And Excellence, Fresno, California, 93720, United States|University of California San Diego (UCSD), La Jolla, California, 92093-0698, United States|The Angeles Clinic, Los Angeles, California, 90025, United States|University of California Davis Health Systems, Sacramento, California, 95817, United States|California Pacific Medical Center (CPMC), San Francisco, California, 94115, United States|University of Colorado Cancer Center, Aurora, Colorado, 80045, United States|Lombardi Comprehensive Cancer Center - MedStar Georgetown University Hospital, Washington, District of Columbia, 20007, United States|Miami Cancer Institute, Miami, Florida, 33176, United States|Orlando Health, Inc, Orlando, Florida, 32806, United States|Winship Cancer Institute at Emory University, Atlanta, Georgia, 30322, United States|University of Kansas Clinical Research Center, Fairway, Kansas, 66205, United States|Dana Farber Cancer Institute, Jamaica Plain, Massachusetts, 02130, United States|Henry Ford Health Hospital, Detroit, Michigan, 48202, United States|Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, 49503, United States|Washington University in Saint Louis, Saint Louis, Missouri, 63110, United States|John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, 07601, United States|Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, 08903, United States|New Mexico Cancer Care Alliance-UNM Cancer Center, Albuquerque, New Mexico, 87131, United States|Roswell Park Cancer Institute, Buffalo, New York, 14263, United States|Northwell Health-Monter Cancer Center, Lake Success, New York, 11042, United States|Laura & Isaac Perlmutter Cancer Center, New York, New York, 10016, United States|Columbia University, New York, New York, 10032, United States|Memorial Sloan-Kettering Cancer Center, New York, New York, 10065, United States|Levine Cancer Institute, Charlotte, North Carolina, 28204, United States|University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, Ohio, 44087, United States|Stephenson Cancer Center, Oklahoma City, Oklahoma, 73104, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|Hollings Cancer Center - Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Sarah Cannon Research Institute, Nashville, Tennessee, 37203, United States|The University of Texas MD Anderson Cancer Center, Houston, Texas, 77030, United States|South Texas Oncology and Hematology, San Antonio, Texas, 78229, United States|Virginia Cancer Care Specialist, PC, Fairfax, Virginia, 22031, United States|The University of Western Australia - The Queen Elizabeth II Medical Centre (QEIIMC) - Sir Charles Gairdner Hospital (SCGH), Perth, Western Australia, 06009, Australia|Royal Brisbane and Womens Hospital, Brisbane, 4029, Australia|Peter Maccallum Cancer Centre (PMCC), Melbourne, 3000, Australia|St. Vincents University Hospital, Dublin, D04 T6F4, Ireland|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Severance Hospital, Yonsei University Health System, Seoul, 03722, Korea, Republic of|Asan Medical Center, Seoul, 05505, Korea, Republic of|Samsung Medical Center, Seoul, 06351, Korea, Republic of|Guys Hospital, London, Europe, SE19RT, United Kingdom|University Of Oxford - Churchill Hospital, Headington, Oxford, OX37LJ, United Kingdom", Study Documents: , criteria: "Key Inclusion Criteria:~* Dose escalation cohorts: Patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit AND who have not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require measurable disease~* Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor~* Eastern Cooperative Oncology Group performance status of 0 or 1~* Adequate organ and bone marrow function~Key Exclusion Criteria:~* Prior treatment with any LAG-3 targeting biologic or small molecule~* Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation~* Untreated or active central nervous system metastases - Ongoing or recent (within 5 years) evidence of significant autoimmune disease~* Corticosteroid therapy (\\\\>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug~* Myocardial infarction within 6 months~Note: Other protocol defined Inclusion / Exclusion criteria apply", combined_text: Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers Rate of dose limiting toxicities (Dose Escalation Phase), Baseline to 28 days|Rate of adverse events (Dose Escalation Phase), Baseline to 51 weeks|Rate of serious adverse events (Dose Escalation Phase), Baseline to 51 weeks|Occurrence of death (Dose Escalation Phase), Baseline to 51 weeks|Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Escalation Phase), Baseline to 51 weeks|Area under the curve (AUC) computed from time zero to the time of the last concentration [AUCall] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|AUC computed from time zero to the time of the last positive concentration [AUClast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to week 51|Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase), Baseline to 51 weeks|Mean residence time when the drug concentration profile is based on values up to and including the last positive concentration [MRTlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase), Baseline to 51 weeks|Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase), Baseline to 51 weeks|Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase), Baseline to 51 weeks Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase), Baseline to week 51|Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase), Baseline to week 51|Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase), Baseline to 51 weeks|Best overall response based on irRECIST criteria (Dose Escalation Phase), Baseline to 51 weeks|Best overall response based on Lugano criteria (Dose Escalation Phase), Baseline to 51 weeks|Duration of response based on RECIST criteria (Dose Escalation Phase), Baseline to week 51|Duration of response based on irRECIST criteria (Dose Escalation Phase), Baseline to week 51|Duration of response based on Lugano criteria (Dose Escalation Phase), Baseline to week 51|Disease control rate based on RECIST criteria (Dose Escalation Phase), Baseline to 51 weeks|Disease control rate based on irRECIST criteria (Dose Escalation Phase), Baseline to 51 weeks|Disease control rate based on Lugano criteria (Dose Escalation Phase), Baseline to 51 weeks|Progression free survival based on RECIST (Dose Escalation Phase), Baseline to 51 weeks|Progression free survival based on irRECIST (Dose Escalation Phase), Baseline to 51 weeks|Progression free survival based on Lugano criteria (Dose Escalation Phase), Baseline to 51 weeks|Incidence of adverse events (Dose Expansion Phase), Baseline to 51 weeks|Incidence of serious adverse events (Dose Expansion Phase), Baseline to 51 weeks|Incidence of death (Dose Expansion Phase), From Baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months|Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Expansion Phase), Baseline to 51 weeks|Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase), Baseline to 51 weeks "Key Inclusion Criteria:~* Dose escalation cohorts: Patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit AND who have not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require measurable disease~* Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor~* Eastern Cooperative Oncology Group performance status of 0 or 1~* Adequate organ and bone marrow function~Key Exclusion Criteria:~* Prior treatment with any LAG-3 targeting biologic or small molecule~* Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation~* Untreated or active central nervous system metastases - Ongoing or recent (within 5 years) evidence of significant autoimmune disease~* Corticosteroid therapy (\\\\>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug~* Myocardial infarction within 6 months~Note: Other protocol defined Inclusion / Exclusion criteria apply", Similarity Score: 0.2808881612697736}'}]
|
from_dataset
| 0.280888
|
[{'from': 'human', 'value': {'Study Title': 'Safety and Tolerability of Open-Labeled Iloperidone in Adolescents', 'Primary Outcome Measures': 'Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period., 1 year', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Patient is willing and able to provide assent and willing to complete all aspects of the study~* Patient\'s parent or legal guardian willing and able to provide consent~* Male or female patients 12 through 17 years of age (inclusive)~* Clinical diagnosis of either schizophrenia or bipolar I disorder~Exclusion Criteria:~* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer~* A positive test for drugs of abuse"'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 884, 'Unnamed: 0': 1108, 'NCT Number': 'NCT03390673', 'Study Title': 'To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects', 'Study URL': 'https://clinicaltrials.gov/study/NCT03390673', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'The purpose of this study is to compare the pharmacokinetics, as well as to evaluate the safety, tolerability and immunogenicity of HD204, US-Avastin and EU-Avastin in healthy male subjects after intravenous administration of a single dose..', 'Study Results': 'NO', 'Conditions': 'Healthy Volunteers', 'Interventions': 'DRUG: HD204|DRUG: Avastin', 'Primary Outcome Measures': 'Area under Curve (AUC, Pharmacokinetics), Sampling will be performed in all patients to compare the PK through values of HD204 and Avastin, up to week 12', 'Secondary Outcome Measures': 'Immunogenicity, Incidence of anti-bevacizumab antibodies, Days 1 (predose), 15, 22,29, 36, 43, 50, 64, 78 and 95(End of treatment)|Incidence of Treatment-Emergent Adverse Events (Safety and tolerability), Safety and tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.03, From Day 1 through study completion (Day 95)', 'Other Outcome Measures': '', 'Sponsor': 'Prestige Biopharma Limited', 'Collaborators': '', 'Sex': 'MALE', 'Age': 'ADULT', 'Phases': 'PHASE1', 'Enrollment': 119.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: SCREENING', 'Other IDs': 'SAMSON-1', 'Start Date': '2018-09-19', 'Primary Completion Date': '2019-03-13', 'Completion Date': '2019-03-13', 'First Posted': '2018-01-04', 'Results First Posted': '', 'Last Update Posted': '2023-02-08', 'Locations': 'Auckland Clinical Studies, Auckland, 1010, New Zealand|Christchurch Clinical Studies Trust Ltd, Christchurch, 8011, New Zealand', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~* Non-smoking healthy male subjects, 18-50 years old inclusive~* Body Mass index is between 19 to 30 kg/m2, inclusive~* NO history of hypersensitivity or allergic reaction to the active ingredient, murine proteins, or excipients, spontaneous or following drug administration.~* For subjects with female partners of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the end of study. Adequate contraception is defined as the usage by the female partner of any form of hormonal contraception or intra-uterine device (which should be established prior to the start of study) plus usage by one of the partners of an additional spermicide-containing barrier method of contraception. The use of a barrier method alone or reliance on abstinence is not considered adequate.~* Subjects must agree not to donate sperm during the study and for 4 months following treatment with the study medication or until scheduled End Of Study (EOS), whichever is longer.~* Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.~Exclusion Criteria:~* Clinically significant abnormalities in physical examination, laboratory test results or electrocardiogram (ECG)~* Systolic blood pressure \\> 140 mmHg or \\< 90 mmHg , or diastolic blood pressure \\> 90 mmHg or \\<50 mmHg~* Proteinuria (with a urine dipstick value of 2+ or above)~* Coagulation abnormalities ( i.e., INR \\> 2x ULN)~* Bleeding diathesis, history of duodenal ulcers, concomitant use of anticoagulants, or any hemorrhage within 6 months prior to study enrollment.~* Surgical procedure within 2 months of screening, or planned surgical procedure within 2 months of EOS~* Positive test result for drugs of abuse or alcohol breathing test.~* Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 or 2.~* Donated or lost \\> 500ml of blood in the previous 3 months~* Taken an investigational drug within 3 months (or 5 half-lives), whichever is longer.~* Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug or non-prescription drugs (with the exception of paracetamol, which is allowed).~* Previously received bevacizumab or any product considered to be biosimilar to bevacizumab, or any other antibody or protein targeting VEGF or VEGFR.~* Unwillingness or inability to comply with the study protocol for any reason.~* Male subject whose partner is pregnant.~* History or evidence of a clinically significant disorder (including cardiovascular, cerebrovascular, endocrine or psychiatric), or immunocompromised condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.~* History of alcohol and/or drug abuse within 12 months of screening."', 'combined_text': 'To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects Area under Curve (AUC, Pharmacokinetics), Sampling will be performed in all patients to compare the PK through values of HD204 and Avastin, up to week 12 Immunogenicity, Incidence of anti-bevacizumab antibodies, Days 1 (predose), 15, 22,29, 36, 43, 50, 64, 78 and 95(End of treatment)|Incidence of Treatment-Emergent Adverse Events (Safety and tolerability), Safety and tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.03, From Day 1 through study completion (Day 95) "Inclusion Criteria:~* Non-smoking healthy male subjects, 18-50 years old inclusive~* Body Mass index is between 19 to 30 kg/m2, inclusive~* NO history of hypersensitivity or allergic reaction to the active ingredient, murine proteins, or excipients, spontaneous or following drug administration.~* For subjects with female partners of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the end of study. Adequate contraception is defined as the usage by the female partner of any form of hormonal contraception or intra-uterine device (which should be established prior to the start of study) plus usage by one of the partners of an additional spermicide-containing barrier method of contraception. The use of a barrier method alone or reliance on abstinence is not considered adequate.~* Subjects must agree not to donate sperm during the study and for 4 months following treatment with the study medication or until scheduled End Of Study (EOS), whichever is longer.~* Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.~Exclusion Criteria:~* Clinically significant abnormalities in physical examination, laboratory test results or electrocardiogram (ECG)~* Systolic blood pressure \\> 140 mmHg or \\< 90 mmHg , or diastolic blood pressure \\> 90 mmHg or \\<50 mmHg~* Proteinuria (with a urine dipstick value of 2+ or above)~* Coagulation abnormalities ( i.e., INR \\> 2x ULN)~* Bleeding diathesis, history of duodenal ulcers, concomitant use of anticoagulants, or any hemorrhage within 6 months prior to study enrollment.~* Surgical procedure within 2 months of screening, or planned surgical procedure within 2 months of EOS~* Positive test result for drugs of abuse or alcohol breathing test.~* Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 or 2.~* Donated or lost \\> 500ml of blood in the previous 3 months~* Taken an investigational drug within 3 months (or 5 half-lives), whichever is longer.~* Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug or non-prescription drugs (with the exception of paracetamol, which is allowed).~* Previously received bevacizumab or any product considered to be biosimilar to bevacizumab, or any other antibody or protein targeting VEGF or VEGFR.~* Unwillingness or inability to comply with the study protocol for any reason.~* Male subject whose partner is pregnant.~* History or evidence of a clinically significant disorder (including cardiovascular, cerebrovascular, endocrine or psychiatric), or immunocompromised condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.~* History of alcohol and/or drug abuse within 12 months of screening."', 'Similarity Score': 0.18185232204928375}}]
|
from_dataset
| 0.181852
|
[{'from': 'human', 'value': {'Study Title': 'Safety and Tolerability of Open-Labeled Iloperidone in Adolescents', 'Primary Outcome Measures': 'Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period., 1 year', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Patient is willing and able to provide assent and willing to complete all aspects of the study~* Patient\'s parent or legal guardian willing and able to provide consent~* Male or female patients 12 through 17 years of age (inclusive)~* Clinical diagnosis of either schizophrenia or bipolar I disorder~Exclusion Criteria:~* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer~* A positive test for drugs of abuse"'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 169, 'Unnamed: 0': 207, 'NCT Number': 'NCT02923791', 'Study Title': 'A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.', 'Study URL': 'https://clinicaltrials.gov/study/NCT02923791', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will receive doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg). Subjects will receive 5 consecutive daily doses in Period 1 (Days 1-5) and a single dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two study periods. In addition, safety assessments will be conducted throughout the study.', 'Study Results': 'NO', 'Conditions': 'Healthy Volunteers', 'Interventions': 'BIOLOGICAL: Filgrastim Hospira|BIOLOGICAL: US-Approved Neupogen', 'Primary Outcome Measures': 'The proportion of subjects with a negative baseline anti-drug antibody (ADA) test result and confirmed post-dose positive ADA test result at any time during the study., 62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit)', 'Secondary Outcome Measures': 'The proportion of subjects with a negative baseline ADA test result and post-dose positive neutralizing antibody result at any time during the study;, 62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit)', 'Other Outcome Measures': '', 'Sponsor': 'Pfizer', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE1', 'Enrollment': 256.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER', 'Other IDs': 'C1121012|FILGRASTIM IMMUNOGENICITY US|COMPARATIVE IMMUNOGENICITY', 'Start Date': '2016-10', 'Primary Completion Date': '2017-01', 'Completion Date': '2017-01', 'First Posted': '2016-10-05', 'Results First Posted': '', 'Last Update Posted': '2017-02-23', 'Locations': 'SeaView Research, Inc., Coral Gables, Florida, 33134, United States|Seaview Jacksonville LLC, Jacksonville, Florida, 32256, United States|SeaView Research, Inc., Miami, Florida, 33126, United States', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.~2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.~3. Healthy male or female volunteers between 18 and 65 years of age (both inclusive).~4. Body mass index (BMI) between 19 and 30 kg/m2, inclusive, and body weight of not \\< 50 kg or \\>95 kg.~5. Subjects have abstained from the use of tobacco- or nicotine-containing products for at least 90 days prior to dosing and have a negative urine screen for cotinine at Screening.~6. Agrees to abstain from alcohol consumption for at least 48 hours prior to Day 1 of dosing in each study period and throughout the 5 days of study treatment and has a negative urine screen for alcohol at Screening.~7. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:~ 1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status will be confirmed by having a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;~ 2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;~ 3. Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential~Exclusion Criteria:~Subjects with any of the following characteristics/conditions will not be included in the study:~1. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.~2. Participation in other studies involving an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer) prior to study entry and/or during study participation.~3. Acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.~4. Any active systemic or immunologic disease or condition, including but not limited to the following general categories: cardiovascular/pulmonary, hepatorenal, or systemic infection, or lactation.~5. History of malignancy or current malignancy with the exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ within 5 years.~6. Any disease or condition that might interfere with the absorption, distribution, metabolism, or excretion of the study drug or would place the subject at increased risk.~7. Hematologic laboratory abnormalities including leukocytosis (defined as total leukocytes \\>11,000/mcL), leukopenia (defined as total leukocytes \\<4000/mcL), or neutropenia (defined as absolute neutrophil count \\[ANC\\] \\<1500/mcL), or thrombocytopenia (defined as platelet count of \\<150/mcL).~8. Lacks adequate hepatic reserve as defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of normal (ULN) of the reference lab; lack of renal reserve as defined by serum creatinine of ≥1.2 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of ≤ 80 mg/min; or has known history of glomerulonephritis.~9. Clinically significant, as judged by the investigator, vital sign, or 12-lead electrocardiogram (ECG) abnormality.~10. History of biological growth factor exposure, including but not limited to filgrastim and other G-CSFs in the context of treatment, prophylaxis, peripheral blood stem cell mobilization, or previous investigational study setting.~11. Receipt of live vaccination, or exposure to communicable viral diseases such as chicken pox, varicella, or measles within the 4 weeks prior to Screening.~12. Surgery within the 4 months prior to Screening.~13. Use of any prescription medicine (with the exception of contraceptives) within 7 days or at least 5 half-lives, whichever is longer. Use of oral or parenteral anticoagulant or antiplatelet agents and corticosteroids should be specifically queried.~14. Administration of a drug by depot injection (with exception of depot contraception) within 30 days prior to the initial study drug administration or 5 half-lives of that drug, whichever is longer.~15. Use of over the counter medications, including aspirin and non-steroidal anti-inflammatory drugs, or natural preparations (dietary supplement or herbal product) within 7 days or at least 5 half-lives, whichever is longer. Vitamins and calcium supplements are allowed (not to exceed 100% daily value).~16. History of drug or alcohol abuse within 2 years prior to randomization, as determined by the investigator or a positive urine screen for drugs of abuse at Screening. Screening for drugs of abuse will minimally include cannabinoids, opiates, barbiturates, amphetamines, cocaine, and benzodiazepines.~17. Drug sensitivity, allergic reaction to, or known hypersensitivity/idiosyncratic reaction to E. coli-derived proteins, filgrastim, pegfilgrastim, other G-CSFs or any component of the product: subjects with the rare heredity problem of fructose intolerance are excluded due to the excipient sorbitol.~18. History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or pneumonia, sickle cell disorders, chronic neutropenia, thrombocytopenia, or vasculitis.~19. Any clinically significant, as determined by the investigator, abnormal laboratory evaluations, including human immunodeficiency virus antibody (HIVAb), hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) and liver function taken at Screening. Negative HIVAb status will be confirmed at Screening and the results will be maintained confidentially by the study site.~20. Blood donation (including plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing OR had a transfusion of any blood product within 90 days prior to Screening.~21. Pregnant female subjects, breastfeeding female subjects, fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use at least 1 highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 28 days after the last dose of investigational product.~22. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of the protocol."', 'combined_text': 'A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product. The proportion of subjects with a negative baseline anti-drug antibody (ADA) test result and confirmed post-dose positive ADA test result at any time during the study., 62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit) The proportion of subjects with a negative baseline ADA test result and post-dose positive neutralizing antibody result at any time during the study;, 62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit) "Inclusion Criteria:~1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.~2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.~3. Healthy male or female volunteers between 18 and 65 years of age (both inclusive).~4. Body mass index (BMI) between 19 and 30 kg/m2, inclusive, and body weight of not \\< 50 kg or \\>95 kg.~5. Subjects have abstained from the use of tobacco- or nicotine-containing products for at least 90 days prior to dosing and have a negative urine screen for cotinine at Screening.~6. Agrees to abstain from alcohol consumption for at least 48 hours prior to Day 1 of dosing in each study period and throughout the 5 days of study treatment and has a negative urine screen for alcohol at Screening.~7. Female subjects of non-childbearing potential must meet at least 1 of the following criteria:~ 1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status will be confirmed by having a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;~ 2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;~ 3. Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential~Exclusion Criteria:~Subjects with any of the following characteristics/conditions will not be included in the study:~1. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.~2. Participation in other studies involving an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product (whichever is longer) prior to study entry and/or during study participation.~3. Acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.~4. Any active systemic or immunologic disease or condition, including but not limited to the following general categories: cardiovascular/pulmonary, hepatorenal, or systemic infection, or lactation.~5. History of malignancy or current malignancy with the exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ within 5 years.~6. Any disease or condition that might interfere with the absorption, distribution, metabolism, or excretion of the study drug or would place the subject at increased risk.~7. Hematologic laboratory abnormalities including leukocytosis (defined as total leukocytes \\>11,000/mcL), leukopenia (defined as total leukocytes \\<4000/mcL), or neutropenia (defined as absolute neutrophil count \\[ANC\\] \\<1500/mcL), or thrombocytopenia (defined as platelet count of \\<150/mcL).~8. Lacks adequate hepatic reserve as defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5 x the upper limit of normal (ULN) of the reference lab; lack of renal reserve as defined by serum creatinine of ≥1.2 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of ≤ 80 mg/min; or has known history of glomerulonephritis.~9. Clinically significant, as judged by the investigator, vital sign, or 12-lead electrocardiogram (ECG) abnormality.~10. History of biological growth factor exposure, including but not limited to filgrastim and other G-CSFs in the context of treatment, prophylaxis, peripheral blood stem cell mobilization, or previous investigational study setting.~11. Receipt of live vaccination, or exposure to communicable viral diseases such as chicken pox, varicella, or measles within the 4 weeks prior to Screening.~12. Surgery within the 4 months prior to Screening.~13. Use of any prescription medicine (with the exception of contraceptives) within 7 days or at least 5 half-lives, whichever is longer. Use of oral or parenteral anticoagulant or antiplatelet agents and corticosteroids should be specifically queried.~14. Administration of a drug by depot injection (with exception of depot contraception) within 30 days prior to the initial study drug administration or 5 half-lives of that drug, whichever is longer.~15. Use of over the counter medications, including aspirin and non-steroidal anti-inflammatory drugs, or natural preparations (dietary supplement or herbal product) within 7 days or at least 5 half-lives, whichever is longer. Vitamins and calcium supplements are allowed (not to exceed 100% daily value).~16. History of drug or alcohol abuse within 2 years prior to randomization, as determined by the investigator or a positive urine screen for drugs of abuse at Screening. Screening for drugs of abuse will minimally include cannabinoids, opiates, barbiturates, amphetamines, cocaine, and benzodiazepines.~17. Drug sensitivity, allergic reaction to, or known hypersensitivity/idiosyncratic reaction to E. coli-derived proteins, filgrastim, pegfilgrastim, other G-CSFs or any component of the product: subjects with the rare heredity problem of fructose intolerance are excluded due to the excipient sorbitol.~18. History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or pneumonia, sickle cell disorders, chronic neutropenia, thrombocytopenia, or vasculitis.~19. Any clinically significant, as determined by the investigator, abnormal laboratory evaluations, including human immunodeficiency virus antibody (HIVAb), hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) and liver function taken at Screening. Negative HIVAb status will be confirmed at Screening and the results will be maintained confidentially by the study site.~20. Blood donation (including plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing OR had a transfusion of any blood product within 90 days prior to Screening.~21. Pregnant female subjects, breastfeeding female subjects, fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use at least 1 highly effective method of contraception as outlined in the protocol for the duration of the study and for at least 28 days after the last dose of investigational product.~22. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of the protocol."', 'Similarity Score': 0.16551582242570095}}]
|
from_dataset
| 0.165516
|
[{'from': 'human', 'value': {'Study Title': 'Safety and Tolerability of Open-Labeled Iloperidone in Adolescents', 'Primary Outcome Measures': 'Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period., 1 year', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Patient is willing and able to provide assent and willing to complete all aspects of the study~* Patient\'s parent or legal guardian willing and able to provide consent~* Male or female patients 12 through 17 years of age (inclusive)~* Clinical diagnosis of either schizophrenia or bipolar I disorder~Exclusion Criteria:~* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer~* A positive test for drugs of abuse"'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 925, 'Unnamed: 0': 1156, 'NCT Number': 'NCT04307173', 'Study Title': 'Study of Multiple Ascending Dose of KBL693 in Healthy Participants', 'Study URL': 'https://clinicaltrials.gov/study/NCT04307173', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'The study is designed to investigate the safety and tolerability of KBL693 in healthy volunteers. KBL693 has been developed as a potential new treatment for moderate to severe asthma..', 'Study Results': 'NO', 'Conditions': 'Moderate to Severe Asthma', 'Interventions': 'DRUG: KBL693|DRUG: KBL693', 'Primary Outcome Measures': 'Safety and tolerability measure through Adverse Events/Serious Adverse Events, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Measurements at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure, Measured by result of the Vital Sign- blood pressure, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign-heart rate, Measured by result of the Vital Sign- heart rate, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- axillary body temperature, Measured by result of the Vital Sign- axillary body temperature, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- respiratory rate, Measured by result of the Vital Sign- respiratory rate, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through 12-lead ECG, Measured by result of the ECG measurements and findings, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Physical exam, Measured by result of the physical exam which includes general appearance, skin, eyes/ears/nose/throat, head and neck, cardiovascular, respiratory, abdomen, extremities, lymph nodes, musculoskeletal and neurologic, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Routine Stool Examination, Measured by result of the Bristol Stool Examination, Occult blood, Parasites, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results, Measured by clinically significant change from baseline clinical laboratory results, Measurement at Baseline till 28 days', 'Secondary Outcome Measures': 'Difference in the change from baseline in profile of faecal KBL693 between treatment arms, Measured by quantitative analysis method for understanding distribution and excretion of KBL693, Measurements at Baseline till 28 days', 'Other Outcome Measures': '', 'Sponsor': 'KoBioLabs', 'Collaborators': 'Novotech (Australia) Pty Limited', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE1', 'Enrollment': 18.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT', 'Other IDs': 'KBL-CURE-2020-01', 'Start Date': '2020-08-14', 'Primary Completion Date': '2020-10-30', 'Completion Date': '2020-11-12', 'First Posted': '2020-03-13', 'Results First Posted': '', 'Last Update Posted': '2021-02-21', 'Locations': 'Linear Clinical Research, Nedlands, Western Australia, 6009, Australia', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~1. Healthy volunteers (also referred to as participants) who can read and understand, and are willing to sign the informed consent form~2. Willing and able to comply with clinic visits (including confinement to CTU) and study-related procedures~3. Male or female healthy volunteers aged ≥18 and ≤65 years at Screening~4. Body mass index (BMI) of ≥18.0 kg/m2 to ≤32 kg/m2 (both inclusive) at Screening~5. Normal hemodynamic parameters: systolic blood pressure (BP) ≥90 mmHg and ≤140 mmHg; diastolic BP ≥50 mmHg and ≤90 mmHg; heart rate (HR) ≥40 bpm and ≤100 bpm at Screening and Day -1. Measurements may be repeated up to 3 times at the discretion of the investigator.~ Please note: participants with out of range values, which are not clinically significant as per the principal investigator\'s (PI) discretion, will be allowed. The PI may delegate this responsibility to a suitably qualified and trained study team member.~6. The participant is, in the opinion of the PI (or delegate), generally healthy based on assessment of medical history, physical examination, vital signs, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other relevant laboratory tests~7. Baseline laboratory test values within reference ranges based on the blood and urine samples taken at Screening and on Day -1. Out of normal ranges values may be accepted by the PI, if not clinically significant~8. Have regular bowel movements (e.g., once daily)~9. Male participants must agree to practise true abstinence; be surgically sterilised (performed at least 6 months prior); or agree to use of a condom if sexually active with a female partner of childbearing potential, from Screening through 90 days after the final dose of the investigational product (IP).~10. Women of child-bearing potential must agree to practise true abstinence or agree to use effective contraception from Screening through 90 days after the final dose of the IP.~ Effective contraception includes:~ 1. Oral contraceptives (the pill) for at least 1 month prior to Day 1, plus use of a condom~ 2. Depot or injectable birth control or implantable contraception (e.g., Implanon) plus use of a condom~ 3. Intrauterine device plus use of a condom~ 4. Vasectomised male partner (performed at least 6 months prior) who has been documented to no longer produce sperm~11. Women of non-child-bearing potential:~ 1. Must have documented evidence of surgical sterilization at least 6 months prior to Screening visit e.g., tubal ligation, hysterectomy.~ 2. Must be post-menopausal for at least 12 months prior to Screening, as documented by measurement of follicle stimulating hormone level (≥40 mIU/mL).~Exclusion Criteria:~1. Female participants who are pregnant or lactating~2. The participant\'s corrected QT interval (QTcF) (Fridericia\'s correction) is \\>450 msec (males), and \\>470 msec (females) at Screening or on Day -1. An out-of-range or abnormal ECG will be repeated at PI\'s discretion. In total, 3 ECGs should be recorded consecutively at Screening and on Day -1, and the PI (or delegate) must evaluate the triplicate ECG. If the participant\'s QTcF is \\>450 msec (males) or \\>470 msec (females) on at least 2 ECGs or have structural cardiac abnormalities, the participant must be excluded~3. The participant has taken prescription (including antibiotics) or non-prescription medication, herbal remedies, vitamins or minerals, any probiotic drinks and yeast supplements (e.g. Mutaflor®, Bioflor®) within 14 days prior to the first dose of study product unless in the opinion of the PI the medication will not compromise participant safety or interfere with study procedures or data validity. Participant may be rescreened after a washout period of 14 days. Please note use of oral contraceptives and paracetamol up to 2 g/day and/or nonsteroidal anti-inflammatory drugs for symptomatic relief of minor symptoms are allowed~4. Participant has functional GI disorders~5. Participant is a current smoker or has used nicotine containing products within 6 months prior to Screening visit~6. The participant has a substance abuse-related disorder or has a history of drug, alcohol and/or substance abuse deemed significant by the PI~7. The participant has taken any IP within 30 days prior to the first dose of study product or 5 half-lives, whichever is longer~8. The participant has a history of significant hypersensitivity or anaphylaxis involving any drug (including ampicillin, clindamycin or imipenem), any constituent of the IP, food or other precipitating agent (e.g. bee sting). Please note participants with clinically stable mild allergic conditions such as hay fever and mild eczema may be enrolled at the discretion of the PI~9. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus antibody (anti-HCV)at Screening visit.~10. Positive screen for drugs of abuse and cotinine at Screening or on Day -1. Positive screen for alcohol on Day -1.~11. The participant is, in the opinion of the PI, unlikely to comply with the clinical study protocol or is unsuitable for any other reason."', 'combined_text': 'Study of Multiple Ascending Dose of KBL693 in Healthy Participants Safety and tolerability measure through Adverse Events/Serious Adverse Events, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Measurements at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure, Measured by result of the Vital Sign- blood pressure, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign-heart rate, Measured by result of the Vital Sign- heart rate, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- axillary body temperature, Measured by result of the Vital Sign- axillary body temperature, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- respiratory rate, Measured by result of the Vital Sign- respiratory rate, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through 12-lead ECG, Measured by result of the ECG measurements and findings, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Physical exam, Measured by result of the physical exam which includes general appearance, skin, eyes/ears/nose/throat, head and neck, cardiovascular, respiratory, abdomen, extremities, lymph nodes, musculoskeletal and neurologic, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Routine Stool Examination, Measured by result of the Bristol Stool Examination, Occult blood, Parasites, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results, Measured by clinically significant change from baseline clinical laboratory results, Measurement at Baseline till 28 days Difference in the change from baseline in profile of faecal KBL693 between treatment arms, Measured by quantitative analysis method for understanding distribution and excretion of KBL693, Measurements at Baseline till 28 days "Inclusion Criteria:~1. Healthy volunteers (also referred to as participants) who can read and understand, and are willing to sign the informed consent form~2. Willing and able to comply with clinic visits (including confinement to CTU) and study-related procedures~3. Male or female healthy volunteers aged ≥18 and ≤65 years at Screening~4. Body mass index (BMI) of ≥18.0 kg/m2 to ≤32 kg/m2 (both inclusive) at Screening~5. Normal hemodynamic parameters: systolic blood pressure (BP) ≥90 mmHg and ≤140 mmHg; diastolic BP ≥50 mmHg and ≤90 mmHg; heart rate (HR) ≥40 bpm and ≤100 bpm at Screening and Day -1. Measurements may be repeated up to 3 times at the discretion of the investigator.~ Please note: participants with out of range values, which are not clinically significant as per the principal investigator\'s (PI) discretion, will be allowed. The PI may delegate this responsibility to a suitably qualified and trained study team member.~6. The participant is, in the opinion of the PI (or delegate), generally healthy based on assessment of medical history, physical examination, vital signs, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other relevant laboratory tests~7. Baseline laboratory test values within reference ranges based on the blood and urine samples taken at Screening and on Day -1. Out of normal ranges values may be accepted by the PI, if not clinically significant~8. Have regular bowel movements (e.g., once daily)~9. Male participants must agree to practise true abstinence; be surgically sterilised (performed at least 6 months prior); or agree to use of a condom if sexually active with a female partner of childbearing potential, from Screening through 90 days after the final dose of the investigational product (IP).~10. Women of child-bearing potential must agree to practise true abstinence or agree to use effective contraception from Screening through 90 days after the final dose of the IP.~ Effective contraception includes:~ 1. Oral contraceptives (the pill) for at least 1 month prior to Day 1, plus use of a condom~ 2. Depot or injectable birth control or implantable contraception (e.g., Implanon) plus use of a condom~ 3. Intrauterine device plus use of a condom~ 4. Vasectomised male partner (performed at least 6 months prior) who has been documented to no longer produce sperm~11. Women of non-child-bearing potential:~ 1. Must have documented evidence of surgical sterilization at least 6 months prior to Screening visit e.g., tubal ligation, hysterectomy.~ 2. Must be post-menopausal for at least 12 months prior to Screening, as documented by measurement of follicle stimulating hormone level (≥40 mIU/mL).~Exclusion Criteria:~1. Female participants who are pregnant or lactating~2. The participant\'s corrected QT interval (QTcF) (Fridericia\'s correction) is \\>450 msec (males), and \\>470 msec (females) at Screening or on Day -1. An out-of-range or abnormal ECG will be repeated at PI\'s discretion. In total, 3 ECGs should be recorded consecutively at Screening and on Day -1, and the PI (or delegate) must evaluate the triplicate ECG. If the participant\'s QTcF is \\>450 msec (males) or \\>470 msec (females) on at least 2 ECGs or have structural cardiac abnormalities, the participant must be excluded~3. The participant has taken prescription (including antibiotics) or non-prescription medication, herbal remedies, vitamins or minerals, any probiotic drinks and yeast supplements (e.g. Mutaflor®, Bioflor®) within 14 days prior to the first dose of study product unless in the opinion of the PI the medication will not compromise participant safety or interfere with study procedures or data validity. Participant may be rescreened after a washout period of 14 days. Please note use of oral contraceptives and paracetamol up to 2 g/day and/or nonsteroidal anti-inflammatory drugs for symptomatic relief of minor symptoms are allowed~4. Participant has functional GI disorders~5. Participant is a current smoker or has used nicotine containing products within 6 months prior to Screening visit~6. The participant has a substance abuse-related disorder or has a history of drug, alcohol and/or substance abuse deemed significant by the PI~7. The participant has taken any IP within 30 days prior to the first dose of study product or 5 half-lives, whichever is longer~8. The participant has a history of significant hypersensitivity or anaphylaxis involving any drug (including ampicillin, clindamycin or imipenem), any constituent of the IP, food or other precipitating agent (e.g. bee sting). Please note participants with clinically stable mild allergic conditions such as hay fever and mild eczema may be enrolled at the discretion of the PI~9. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus antibody (anti-HCV)at Screening visit.~10. Positive screen for drugs of abuse and cotinine at Screening or on Day -1. Positive screen for alcohol on Day -1.~11. The participant is, in the opinion of the PI, unlikely to comply with the clinical study protocol or is unsuitable for any other reason."', 'Similarity Score': 0.15054812158085623}}]
|
from_dataset
| 0.150548
|
[{'from': 'human', 'value': {'Study Title': 'Safety and Tolerability of Open-Labeled Iloperidone in Adolescents', 'Primary Outcome Measures': 'Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period., 1 year', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Patient is willing and able to provide assent and willing to complete all aspects of the study~* Patient\'s parent or legal guardian willing and able to provide consent~* Male or female patients 12 through 17 years of age (inclusive)~* Clinical diagnosis of either schizophrenia or bipolar I disorder~Exclusion Criteria:~* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer~* A positive test for drugs of abuse"'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 59, 'Unnamed: 0': 65, 'NCT Number': 'NCT00187291', 'Study Title': 'Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study)', 'Study URL': 'https://clinicaltrials.gov/study/NCT00187291', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'The ABCD clinical study is designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in patients with ischemic heart disease, left ventricular dysfunction, and non-sustained tachycardia. Patients undergo both the TWA test and EP study and receive an Implantable Cardioverter Defibrillator (ICD)if either of the tests show the patient is at risk. The patient is then followed for 2 years. The incidence of a ventricular tachyarrhythmia events and total mortality are to be evaluated over the duration of the study.', 'Study Results': 'NO', 'Conditions': 'Ischemic Cardiomyopathy|LV Dysfunction', 'Interventions': 'DEVICE: T-Wave Alternans test', 'Primary Outcome Measures': 'Ventricular tachyarrhythmic events, 12 months', 'Secondary Outcome Measures': 'Total Mortality, 12 months|Ventricular tachyarrhythmic events below rate detection of the ICD, 12 months', 'Other Outcome Measures': '', 'Sponsor': 'Abbott Medical Devices', 'Collaborators': 'Cambridge Heart Inc.|MetroHealth Medical Center', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE3', 'Enrollment': 618.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC', 'Other IDs': 'G010050', 'Start Date': '2001-04', 'Primary Completion Date': '2006-07', 'Completion Date': '2006-07', 'First Posted': '2005-09-16', 'Results First Posted': '', 'Last Update Posted': '2023-07-13', 'Locations': '', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~Patients with no previous history of life threatening ventricular arrhythmias or symptomatic non-sustained VT, and who meet the following inclusion criteria may be enrolled in the study:~1. Ischemic heart disease as documented by any of the following: previous myocardial infarction (documented by 2 out of 3 of the following: history, ECG, and/or cardiac enzymes), prior PTCA or CABG; angina with a positive exercise or pharmacological stress test; angina with a greater than 50% occlusion of any coronary artery, left ventricular dysfunction that can be attributed to angiographically documented coronary artery disease~2. LVEF less than 0.40 as determined by echocardiography, radionuclide or contrast ventriculography within six months of enrollment.~3. Non-sustained ventricular tachycardia within 6 months of enrollment, defined as greater than 3 consecutive premature ventricular contractions having at least three consecutive intervals with a cycle length at or below 550 ms, and with the entire episode lasting less than 30 seconds. This episode should be associated with either no symptoms, or palpitations alone. An episode of NSVT associated with any symptoms (other than palpitations) does not satisfy inclusion criteria for the trial.~4. The patient is 18 years of age or older.~5. In the judgement of the principal investigator, the patient is capable of undergoing a sub-maximal treadmill exercise test to a heart rate of 120 bpm.~6. The patient has signed the latest IRB approved informed consent form.~Exclusion Criteria:~Patients meeting any of the following exclusion criteria will not be eligible for enrollment:~1. The patient is unable to give informed consent.~2. The patient is known to have had a cardiac arrest or sustained life threatening ventricular arrhythmias, other than in the setting of an acutely reversible cause (e.g., acute phase MI, drug intoxication).~3. The patient has had an EPS or TWA test at any time and for any reason prior to being screened and consented for this trial.~4. The patient has unstable coronary artery disease.~5. The patient has contraindications to ICD implantation.~6. A submaximal exercise test is contraindicated.~7. The patient has persistent atrial fibrillation or flutter.~8. The patient is less than 28 days post MI, post CABG, or post coronary angioplasty.~9. The patient has an LVEF 0.40, but no evidence of ischemic heart disease as defined by section 4.1.~10. The patient has NYHA functional Class IV congestive heart failure symptoms at the time of enrollment.~11. The patient is on any class 1 or 3 antiarrhythmic drug.~12. The patient is participating in a study of another investigational device or drug. If, in the opinion of the investigator, this would not interfere with this study, the eligibility of such a patient should be discussed with the primary investigators of the ABCD trial, Drs. Rosenbaum or Costantini.~13. The patient has any other significant medical condition or acute illness that in the opinion of the investigator precludes participation.~14. The patient has a previous history of syncope, unless the episode was clearly not caused by a ventricular tachyarrhythmia.~15. The patient has a life expectancy of less than one year from any cause.~16. The patient has a positive pregnancy test.~17. The patient is not geographically stable or is unable to comply with the follow up schedule."', 'combined_text': 'Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study) Ventricular tachyarrhythmic events, 12 months Total Mortality, 12 months|Ventricular tachyarrhythmic events below rate detection of the ICD, 12 months "Inclusion Criteria:~Patients with no previous history of life threatening ventricular arrhythmias or symptomatic non-sustained VT, and who meet the following inclusion criteria may be enrolled in the study:~1. Ischemic heart disease as documented by any of the following: previous myocardial infarction (documented by 2 out of 3 of the following: history, ECG, and/or cardiac enzymes), prior PTCA or CABG; angina with a positive exercise or pharmacological stress test; angina with a greater than 50% occlusion of any coronary artery, left ventricular dysfunction that can be attributed to angiographically documented coronary artery disease~2. LVEF less than 0.40 as determined by echocardiography, radionuclide or contrast ventriculography within six months of enrollment.~3. Non-sustained ventricular tachycardia within 6 months of enrollment, defined as greater than 3 consecutive premature ventricular contractions having at least three consecutive intervals with a cycle length at or below 550 ms, and with the entire episode lasting less than 30 seconds. This episode should be associated with either no symptoms, or palpitations alone. An episode of NSVT associated with any symptoms (other than palpitations) does not satisfy inclusion criteria for the trial.~4. The patient is 18 years of age or older.~5. In the judgement of the principal investigator, the patient is capable of undergoing a sub-maximal treadmill exercise test to a heart rate of 120 bpm.~6. The patient has signed the latest IRB approved informed consent form.~Exclusion Criteria:~Patients meeting any of the following exclusion criteria will not be eligible for enrollment:~1. The patient is unable to give informed consent.~2. The patient is known to have had a cardiac arrest or sustained life threatening ventricular arrhythmias, other than in the setting of an acutely reversible cause (e.g., acute phase MI, drug intoxication).~3. The patient has had an EPS or TWA test at any time and for any reason prior to being screened and consented for this trial.~4. The patient has unstable coronary artery disease.~5. The patient has contraindications to ICD implantation.~6. A submaximal exercise test is contraindicated.~7. The patient has persistent atrial fibrillation or flutter.~8. The patient is less than 28 days post MI, post CABG, or post coronary angioplasty.~9. The patient has an LVEF 0.40, but no evidence of ischemic heart disease as defined by section 4.1.~10. The patient has NYHA functional Class IV congestive heart failure symptoms at the time of enrollment.~11. The patient is on any class 1 or 3 antiarrhythmic drug.~12. The patient is participating in a study of another investigational device or drug. If, in the opinion of the investigator, this would not interfere with this study, the eligibility of such a patient should be discussed with the primary investigators of the ABCD trial, Drs. Rosenbaum or Costantini.~13. The patient has any other significant medical condition or acute illness that in the opinion of the investigator precludes participation.~14. The patient has a previous history of syncope, unless the episode was clearly not caused by a ventricular tachyarrhythmia.~15. The patient has a life expectancy of less than one year from any cause.~16. The patient has a positive pregnancy test.~17. The patient is not geographically stable or is unable to comply with the follow up schedule."', 'Similarity Score': 0.14669570159944442}}]
|
from_dataset
| 0.146696
|
[{'from': 'human', 'value': {'Study Title': 'Safety and Tolerability of Open-Labeled Iloperidone in Adolescents', 'Primary Outcome Measures': 'Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period., 1 year', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Patient is willing and able to provide assent and willing to complete all aspects of the study~* Patient\'s parent or legal guardian willing and able to provide consent~* Male or female patients 12 through 17 years of age (inclusive)~* Clinical diagnosis of either schizophrenia or bipolar I disorder~Exclusion Criteria:~* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer~* A positive test for drugs of abuse"'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 33, 'Unnamed: 0': 38, 'NCT Number': 'NCT01460394', 'Study Title': 'Normative Data of Brain Network Activation in Adolescents and Young Adults', 'Study URL': 'https://clinicaltrials.gov/study/NCT01460394', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': "Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in two age groups: adolescents and young adults.", 'Study Results': 'NO', 'Conditions': 'Healthy Controls', 'Interventions': '', 'Primary Outcome Measures': 'Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data, The study outcome measure are functional networks of brain activity of healthy adolescents (age 15-18 years) and young adults (19-24 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks, 1 week', 'Secondary Outcome Measures': '', 'Other Outcome Measures': '', 'Sponsor': 'ElMindA Ltd', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'CHILD, ADULT', 'Phases': '', 'Enrollment': 64.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'OBSERVATIONAL', 'Study Design': 'Observational Model: |Time Perspective: p', 'Other IDs': 'ELM-02', 'Start Date': '2011-10', 'Primary Completion Date': '2012-04', 'Completion Date': '2012-04', 'First Posted': '2011-10-26', 'Results First Posted': '', 'Last Update Posted': '2019-10-15', 'Locations': 'Vince and Associates Clinical Research, Overland Park, Kansas, 66212, United States', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~* Age 15-24 years.~* Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).~Exclusion Criteria:~* Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts).~* Currently with lice, open wounds on scalp.~* Any chronic disease.~* Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc.~* Any CNS neurologic disorder, e.g., epilepsy, seizures, etc.~* Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc.~* History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.~* History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.~* Substance abuse in the last 3 months.~* Significant sensory deficits, e.g., deafness or blindness.~* History of any brain trauma."', 'combined_text': 'Normative Data of Brain Network Activation in Adolescents and Young Adults Functional networks of brain activity in healthy individuals measured using analysis of EEG Event Related Potential (ERP) data, The study outcome measure are functional networks of brain activity of healthy adolescents (age 15-18 years) and young adults (19-24 years) established based on an analysis of EEG data recorded while study subjects perform ERP tasks, 1 week "Inclusion Criteria:~* Age 15-24 years.~* Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).~Exclusion Criteria:~* Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts).~* Currently with lice, open wounds on scalp.~* Any chronic disease.~* Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc.~* Any CNS neurologic disorder, e.g., epilepsy, seizures, etc.~* Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc.~* History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.~* History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.~* Substance abuse in the last 3 months.~* Significant sensory deficits, e.g., deafness or blindness.~* History of any brain trauma."', 'Similarity Score': 0.14400800437937863}}]
|
from_dataset
| 0.144008
|
[{'from': 'human', 'value': {'Study Title': 'Safety and Tolerability of Open-Labeled Iloperidone in Adolescents', 'Primary Outcome Measures': 'Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period., 1 year', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Patient is willing and able to provide assent and willing to complete all aspects of the study~* Patient\'s parent or legal guardian willing and able to provide consent~* Male or female patients 12 through 17 years of age (inclusive)~* Clinical diagnosis of either schizophrenia or bipolar I disorder~Exclusion Criteria:~* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer~* A positive test for drugs of abuse"'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 732, 'Unnamed: 0': 915, 'NCT Number': 'NCT06397144', 'Study Title': 'A Study on 2 Different Combination Tablets of Nirmatrelvir Plus Ritonavir to Compare Them With Marketed Paxlovid in Healthy Participants', 'Study URL': 'https://clinicaltrials.gov/study/NCT06397144', 'Acronym': '', 'Study Status': 'NOT_YET_RECRUITING', 'Brief Summary': 'Medicines that may have different names or be made in different ways but have the same effect on the body are called bioequivalent.\n\nThe purpose of this study is to learn about the bioequivalence of nirmatrelvir plus ritonavir after taking 2 different combination tablet forms by mouth. These combination tablets are compared to the tablet formulation that is already in the market. This study will be done under fasted conditions in healthy adult participants.\n\nThis study is seeking participants who are:\n\n* Male and non-pregnant female participants aged 18 years and above.\n* with a body weight of more than 50 kilograms and Body Mass Index (BMI) between 16 to 32 kilograms per meter squared.\n* are healthy as confirmed by medical history, physical examination, laboratory tests.\n\nThe study will also look at the safety and tolerability of nirmatrelvir plus ritonavir combination tablet and marketed tablet formulations in healthy adult participants.\n\nThe study will consist of 4 treatments:\n\nTreatment A: Single oral dose of nirmatrelvir plus ritonavir 150 (1 × 150)/100 milligrams marketed tablets under fasted conditions (Reference 1) Treatment B (low dose strength): Single oral dose of nirmatrelvir plus ritonavir 150/100 milligrams (2 × \\[75/50 milligrams\\]) combination tablets under fasted conditions (Test 1) Treatment C: Single oral dose of nirmatrelvir/ritonavir 300 (2 × 150)/100 milligrams marketed tablets under fasted conditions (Reference 2) Treatment D (high dose strength): Single oral dose of nirmatrelvir/ritonavir 300/100 milligrams (2 × \\[150/50 milligrams\\]) combination tablets under fasted conditions (Test 2)\n\nAll treatments will be given under fasted conditions. Fasted condition means the participants would not have had anything to eat before taking the medicines.\n\nAround 28 participants will be enrolled in the study. Healthy participants will be tested to see if they can be in the study within 28 days before receiving the study medicine. Selected participants will be admitted to the clinical research unit (CRU) one day before receiving the study medicine and will remain in the CRU until discharge after completing all the treatment periods.\n\nOn Day 1 of each period, participants will be given a single dose of study medicine nirmatrelvir/ritonavir 300/100 mg or 150/100 mg by mouth by chance. Study medicine will be given with approximately 240 milliliters of room temperature water under fasted conditions (overnight fast of at least 10 hours and no food until 4 hours after receiving the study medicine). Blood samples will be collected at different times of the day up to 48 hours after taking the study medicine. Participants will be discharged from the CRU on Day 3 of Period 4, after all the study related procedures have been completed.\n\nA follow-up call will be made to participants around 28 to 35 days from receiving the final dose of the study medicine. The study will look at the experiences of participants receiving the study medicine. This will help to understand if the study medicine is safe and effective.', 'Study Results': 'NO', 'Conditions': 'Biological Availability|Healthy Participants', 'Interventions': 'DRUG: Paxlovid|DRUG: Paxlovid|DRUG: Nirmatrelvir/ritonavir|DRUG: Nirmatrelvir/ritonavir', 'Primary Outcome Measures': 'Area under curve (AUC) from time zero to 48 hours post dose (nirmatrelvir), 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours|Peak plasma concentration (Cmax) for nirmatrelvir, 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours', 'Secondary Outcome Measures': 'AUC from time zero to 48 hours post dose (ritonavir), 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours|Cmax for ritonavir, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs), Baseline (Day 0) up to 28 days after last dose of study medication|Number of Participants With Clinically Notable Vital Signs, Baseline (Day 0) up to day 3 of treatment period 4|Number of Participants With Clinically Notable Changes in Clinical laboratory results, Baseline (Day 0) up to day 3 of treatment period 4|Number of Participants With Clinically Notable Abnormality in physical examination, Baseline (Day 0) up to day 3 of treatment period 4', 'Other Outcome Measures': '', 'Sponsor': 'Pfizer', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE1', 'Enrollment': 28.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE', 'Other IDs': 'C4671009', 'Start Date': '2025-02-14', 'Primary Completion Date': '2025-06-10', 'Completion Date': '2025-06-10', 'First Posted': '2024-05-02', 'Results First Posted': '', 'Last Update Posted': '2024-05-02', 'Locations': '', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG (electrocardiogram).~* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.~* Female participants of childbearing potential must have a negative pregnancy test at screening and on Day -1.~* BMI (Body Mass Index) of 16-32 kg/m2; and a total body weight \\>50 kg (110 lb).~* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD (Informed consent Document) and in this protocol.~Exclusion Criteria:~* Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.~* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).~* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).~* History of HIV (Human Immunodeficiency Virus) infection, Hepatitis B, or Hepatitis C; positive testing for HIV, HBsAg (Hepatitis B surface Antigen), HBcAb (Hepatitis B core Antibody) or HCVAb (Hepatitis C Virus Antibody). Hepatitis B vaccination is allowed.~* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator\'s judgment, make the participant inappropriate for the study.~* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.~* Participants who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.~* A positive urine drug test."', 'combined_text': 'A Study on 2 Different Combination Tablets of Nirmatrelvir Plus Ritonavir to Compare Them With Marketed Paxlovid in Healthy Participants Area under curve (AUC) from time zero to 48 hours post dose (nirmatrelvir), 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours|Peak plasma concentration (Cmax) for nirmatrelvir, 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours AUC from time zero to 48 hours post dose (ritonavir), 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours|Cmax for ritonavir, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs), Baseline (Day 0) up to 28 days after last dose of study medication|Number of Participants With Clinically Notable Vital Signs, Baseline (Day 0) up to day 3 of treatment period 4|Number of Participants With Clinically Notable Changes in Clinical laboratory results, Baseline (Day 0) up to day 3 of treatment period 4|Number of Participants With Clinically Notable Abnormality in physical examination, Baseline (Day 0) up to day 3 of treatment period 4 "Inclusion Criteria:~* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG (electrocardiogram).~* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.~* Female participants of childbearing potential must have a negative pregnancy test at screening and on Day -1.~* BMI (Body Mass Index) of 16-32 kg/m2; and a total body weight \\>50 kg (110 lb).~* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD (Informed consent Document) and in this protocol.~Exclusion Criteria:~* Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.~* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).~* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).~* History of HIV (Human Immunodeficiency Virus) infection, Hepatitis B, or Hepatitis C; positive testing for HIV, HBsAg (Hepatitis B surface Antigen), HBcAb (Hepatitis B core Antibody) or HCVAb (Hepatitis C Virus Antibody). Hepatitis B vaccination is allowed.~* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator\'s judgment, make the participant inappropriate for the study.~* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.~* Participants who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.~* A positive urine drug test."', 'Similarity Score': 0.14313610561350382}}]
|
from_dataset
| 0.143136
|
[{'from': 'human', 'value': {'Study Title': 'Safety and Tolerability of Open-Labeled Iloperidone in Adolescents', 'Primary Outcome Measures': 'Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period., 1 year', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Patient is willing and able to provide assent and willing to complete all aspects of the study~* Patient\'s parent or legal guardian willing and able to provide consent~* Male or female patients 12 through 17 years of age (inclusive)~* Clinical diagnosis of either schizophrenia or bipolar I disorder~Exclusion Criteria:~* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer~* A positive test for drugs of abuse"'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 954, 'Unnamed: 0': 1191, 'NCT Number': 'NCT00703573', 'Study Title': 'A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis', 'Study URL': 'https://clinicaltrials.gov/study/NCT00703573', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'The purpose of this study is to evaluate the safety and efficacy of 2 doses of S-777469 in patients with atopic dermatitis.', 'Study Results': 'NO', 'Conditions': 'Atopic Dermatitis', 'Interventions': 'DRUG: S-777469 400 mg|DRUG: S-777469 800 mg|DRUG: Placebo', 'Primary Outcome Measures': "Efficacy of S-777469 was assessed by Physician's Global Assessment (PGA) and Numerical Rating Scale (NRS), Physician's Global Assessment, Change from baseline to 12 weeks|Safety was assessed by repeated clinical evaluation and evaluation of treatment-emergent adverse events. It included vital signs, medical history, concomitant medications, physical examination, 12-lead ECGs, and standard clinical laboratory safety tests, Safety, determined by Adverse event frequency and changes in laboratory values, Baseline to 12 weeks", 'Secondary Outcome Measures': 'Efficacy was assessed by PGA, NRS, Behavioral Rating Scale, Eczema Area and Severity Index Score, Investigator panel treatment-blind comparative review ratings of digital photography of affected areas, and Thymus and Activation-Regulated Chemokine, Assessment of PGA, NRS, Behavioral Rating Scale, Eczema Area and Severity Index Score, Investigator panel treatment-blind comparative review ratings of digital photography of affected areas, and Thymus and Activation-Regulated Chemokine, Changes from baseline to various pre-defined time-points during the 12 week study|Pharmacokinetic analysis of the concentration of unchanged parent drug (S-777469) in trough samples, The concentration of S-777469 will be evaluated to determine when steady state is achieved, From Baseline during Week 1', 'Other Outcome Measures': '', 'Sponsor': 'Shionogi', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE2', 'Enrollment': 209.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT', 'Other IDs': '0721D1424', 'Start Date': '2008-05', 'Primary Completion Date': '2009-05', 'Completion Date': '2009-12', 'First Posted': '2008-06-23', 'Results First Posted': '', 'Last Update Posted': '2018-05-08', 'Locations': 'Hot Springs, Arkansas, 71913, United States|Los Angeles, California, 90045, United States|Oceanside, California, 92056, United States|Riverside, California, 92506, United States|Denver, Colorado, 80210, United States|Coral Gables, Florida, 33134, United States|West Palm Beach, Florida, 33401, United States|Alpharetta, Georgia, 30022, United States|Boise, Idaho, 83704, United States|Arlington Heights, Illinois, 60005, United States|Evansville, Indiana, 47713, United States|South Bend, Indiana, 46617, United States|Fridley, Minnesota, 55432, United States|Omaha, Nebraska, 68144, United States|Berlin, New Jersey, 08009, United States|Paramus, New Jersey, 07652, United States|Stony Brook, New York, 11790, United States|Lake Oswego, Oregon, 97035, United States|Portland, Oregon, 97210, United States|Portland, Oregon, 97223, United States|Portland, Oregon, 973239, United States|Philadelphia, Pennsylvania, 19104, United States|Johnston, Rhode Island, 02919, United States|Goodlettsville, Tennessee, 37072, United States|Knoxville, Tennessee, 37934, United States|Austin, Texas, 78759, United States|College Station, Texas, 77845, United States|Dallas, Texas, 75230, United States|Houston, Texas, 77058, United States|San Antonio, Texas, 78229, United States|West Jordan, Utah, 84088, United States|Lynchburg, Virginia, 24501, United States|Norfolk, Virginia, 23507, United States', 'Study Documents': '', 'criteria': '"Screening Inclusion Criteria:~Each patient must meet all of the following inclusion criteria to be screened and enrolled into the single-blind period:~* Males or females between 18 and 65 years of age at the time of obtaining the written informed consent~* Patient understands the study procedures and agrees to participate in the study by giving written informed consent~* Patient agrees to allow digital photographs of atopic dermatitis (AD)-affected target areas during the study~* Patient satisfies the diagnostic criteria for AD as defined by the criteria of Hanifin and Rajka (Acta Derm Venereol.1980;92\\[suppl\\]:44-47; J Am Acad Dermatol.2003;49\\[6\\]:1088-1095), as follows:~Must have 3 or more basic features:~* Pruritis~* Typical morphology and distribution: flexural lichenification or linearity~* Chronic or chronically relapsing dermatitis~* Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis)~Plus 3 or more minor features:~* Xerosis~* Ichthyosis/palmar hyperlinearity/keratosis pilaris~* Early age of onset~* Tendency toward cutaneous infections (esp. Staphylococcus aureus and Herpes simplex) /impaired cell-mediated immunity~* Tendency toward non-specific hand or foot dermatitis~* Nipple eczema~* Cheilitis~* Recurrent conjunctivitis~* Dennie-Morgan infraorbital fold~* Keratoconus~* Anterior subcapsular cataracts~* Orbital darkening~* Facial pallor/facial erythema~* Pityriasis alba~* Anterior neck folds~* Itch when sweating~* Intolerance to wool and lipid solvents~* Perifollicular accentuation~* Food intolerance~* Course influenced by environmental/emotional factors~* White dermographism/delayed blanch~* Immediate (type I) skin test reactivity (Provide test results within one year of Screening date.)~* Elevated serum IgE.~ * Patient has negative laboratory results for hepatitis B surface antigen and IgG anti- Hepatitis B core, hepatitis C virus antibodies, and human immunodeficiency virus (HIV) antibody tests at screening~ * Serum creatinine and blood urea nitrogen are in the normal range at screening~ * Female patients of child bearing potential must have a negative pregnancy test at screening and Day-14~ * Patient has a negative screen for drugs of abuse at screening~ * Patient does not have a history or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological disease~ * Patient does not have liver function test results \\>1.25 the upper limit of normal NOTE: Under no circumstances should a patient who did not qualify regarding liver function tests (alanine aminotransferase \\[ALT\\] and/or aspartate aminotransferase \\[AST\\]) be re-screened and/or re-qualified~ * Patient does not have QTc \\> 450 (males) or \\> 470 (females) at screening~Randomization Inclusion Criteria:~Patients eligible to be randomized to double-blind treatment must satisfy all of the following inclusion criteria:~* Patient has all of the following at the end of the single-blind period (Day 1, just before randomization to study drug):~ * Physician\'s Global Assessment (PGA) ≥ 2 but ≤ 4.~ * The average of the scores recorded from the evening of Day -3 to the morning of Day 1 (Baseline value) of the Numerical Rating Scale (NRS) is ≥ 4.~ * The average of the scores recorded from the evening of Day -3 to the morning of Day 1 (Baseline value) of the Behavior Rating Scale (BRS) is ≥ 2~* Patient has negative laboratory results for hepatitis B surface antigen, IgE anti-Hepatitis B core, hepatitis C virus antibodies, and HIV antibody tests at screening~* Female patients of child bearing potential must have a negative pregnancy test at screening, single-blind period (Day-14) and baseline (Day 1)~* Serum creatinine and blood urea nitrogen are in the normal range at screening~* Patient has negative screen for drugs of abuse at screening and single-blind (Day-14)~* Use of adequate birth control by men and women, if of reproductive potential and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 2 weeks after the last dose of study drug~ * For females, adequate birth control methods will be defined as: hormonal contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam~ * For males adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam~ * For females, menopause is defined as one year without menses; if in question, a follicle-stimulating hormone of \\>40 U/ml must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable~* Patient has not used any treatments for AD prior to Day 1, using the following time periods:~ * Systemic (inhaled, oral, suppository or immediate release injectable, depot or sustained-release injectable) corticosteroids, cytostatic drugs, or other immunosuppressant drugs: 5 weeks prior to Day 1~ * Topical immunosuppressant drugs: 4 weeks prior to Day 1~ * Phototherapy, specific desensitization therapy, nonspecific disease-modulating therapy and elimination diet therapy: 4 weeks prior to Day 1~ * Any drugs that are known inhibitors or inducers of Cytochrome P450 isozyme cytochrome CYP2C9: 2 weeks prior to Day 1~ * Systemic antibiotics: 4 weeks prior to Day 1~ * Topical steroids or tar preparations: 2 weeks prior to Day 1~ * Antihistamines, histamine-added γ-globulin preparations, desensitization therapy, or other nonspecific disease-modifying therapies: 2 weeks prior to Day 1~ * Herbal preparation, cosmetic or emollient preparations other than those issued during the screening and single-blind periods: 2 weeks prior to Day 1. Use of cosmetic make-up will be allowed~ * Acetaminophen, acetaminophen-containing products, or non-steroidal anti-inflammatories: 2 weeks prior to Day 1~ * Any other investigational drug or device within 8 weeks prior to Day 1~* Patient is willing to completely avoid the use of any prescription or nonprescription treatments for AD , including over-the-counter drugs or any topical preparations, other than those topical emollient preparations provided by the study site during the screening period and thereafter, as needed. Use of hormone replacement therapy (for postmenopausal females) and/or use of hormonal contraceptive(s), intrauterine device, or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam will be allowed. Use of topical antibiotics will be allowed during the study~Exclusion Criteria:~Patients satisfying any of the following exclusion criteria are not eligible for enrollment into the double-blind treatment period:~* Patient is under the age of legal consent, is mentally or legally incapacitated and/or has significant emotional problems at the time of study entry~* Patient has an active dermatologic condition other than AD which may confound the diagnosis or evaluation of AD, such as scabies, allergic contact dermatitis, seborrheic dermatitis, cutaneous lymphoma, or psoriasis~* Patient has a history of malignancy not in remission for \\>5 years, with the exception of cutaneous basal cell carcinoma and cutaneous squamous cell carcinoma~* Presence of comorbid conditions that would preclude participation in the study, including:~ * Immune compromised state, including recent chemotherapy, immunotherapy, or organ transplant~ * History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological disease~ * Signs and symptoms of eczema herpeticum within the preceding 12 months or cellulitis within preceding 3 months~ * Positive results for HIV infection at screening~ * History or clinical manifestations of significant neurological (e.g., epilepsy) or psychiatric disorders (e.g., history of suicide attempt; history of psychiatric episodes resulting in hospitalization)~ * An active intercurrent infection~ * History of clinically significant hypersensitivity, anaphylaxis, or allergies to any drug compound, which resulted in a severe adverse event~ * Liver function tests (ALT, AST) \\>1.25 times the upper limit of normal at Screening. (refer to Covance Lab Manual for reference ranges) Note: Under no circumstances should a patient who did not qualify regarding liver function tests (ALT and/or AST) be re-screened and/or re-qualified~* Patient has any acute or chronic condition or prior therapy that, in the opinion of the Investigator, would limit the patient\'s ability to complete and/or participate in this clinical study or otherwise would make the patient unsuitable for this study~* Patient has a history of drug abuse within 1 year prior to Day 1~* Patient consumes excess amounts of alcohol, defined as exceeding an average of 14 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor, or any combination of them) within 2 months prior to Day -14 (beginning of single-blind period) or is unwilling to comply with the restricted use of alcohol (as defined above, no more than 14 drinks/week) from screening, throughout the study, and until study completion (follow-up visit).~* Patient uses any prohibited concomitant medications at any time during the study~* Patient is pregnant or lactating or intends to become pregnant or, in the case of a male patient, intends to father a child during the study period and for 2 weeks after the last dose of study medication~* Patient has poor peripheral venous access that may limit blood sampling for clinical laboratory or pharmacokinetic analysis~* Patient has participated in any other investigational study drug or device trial in which receipt of an investigational study drug or device occurred within 8 weeks prior to Day 1~* Prior exposure to S-777469~* Any reason which, in the opinion of the Investigator, interferes with the ability of the patient to participate in or complete the trial"', 'combined_text': 'A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis Efficacy of S-777469 was assessed by Physician\'s Global Assessment (PGA) and Numerical Rating Scale (NRS), Physician\'s Global Assessment, Change from baseline to 12 weeks|Safety was assessed by repeated clinical evaluation and evaluation of treatment-emergent adverse events. It included vital signs, medical history, concomitant medications, physical examination, 12-lead ECGs, and standard clinical laboratory safety tests, Safety, determined by Adverse event frequency and changes in laboratory values, Baseline to 12 weeks Efficacy was assessed by PGA, NRS, Behavioral Rating Scale, Eczema Area and Severity Index Score, Investigator panel treatment-blind comparative review ratings of digital photography of affected areas, and Thymus and Activation-Regulated Chemokine, Assessment of PGA, NRS, Behavioral Rating Scale, Eczema Area and Severity Index Score, Investigator panel treatment-blind comparative review ratings of digital photography of affected areas, and Thymus and Activation-Regulated Chemokine, Changes from baseline to various pre-defined time-points during the 12 week study|Pharmacokinetic analysis of the concentration of unchanged parent drug (S-777469) in trough samples, The concentration of S-777469 will be evaluated to determine when steady state is achieved, From Baseline during Week 1 "Screening Inclusion Criteria:~Each patient must meet all of the following inclusion criteria to be screened and enrolled into the single-blind period:~* Males or females between 18 and 65 years of age at the time of obtaining the written informed consent~* Patient understands the study procedures and agrees to participate in the study by giving written informed consent~* Patient agrees to allow digital photographs of atopic dermatitis (AD)-affected target areas during the study~* Patient satisfies the diagnostic criteria for AD as defined by the criteria of Hanifin and Rajka (Acta Derm Venereol.1980;92\\[suppl\\]:44-47; J Am Acad Dermatol.2003;49\\[6\\]:1088-1095), as follows:~Must have 3 or more basic features:~* Pruritis~* Typical morphology and distribution: flexural lichenification or linearity~* Chronic or chronically relapsing dermatitis~* Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis)~Plus 3 or more minor features:~* Xerosis~* Ichthyosis/palmar hyperlinearity/keratosis pilaris~* Early age of onset~* Tendency toward cutaneous infections (esp. Staphylococcus aureus and Herpes simplex) /impaired cell-mediated immunity~* Tendency toward non-specific hand or foot dermatitis~* Nipple eczema~* Cheilitis~* Recurrent conjunctivitis~* Dennie-Morgan infraorbital fold~* Keratoconus~* Anterior subcapsular cataracts~* Orbital darkening~* Facial pallor/facial erythema~* Pityriasis alba~* Anterior neck folds~* Itch when sweating~* Intolerance to wool and lipid solvents~* Perifollicular accentuation~* Food intolerance~* Course influenced by environmental/emotional factors~* White dermographism/delayed blanch~* Immediate (type I) skin test reactivity (Provide test results within one year of Screening date.)~* Elevated serum IgE.~ * Patient has negative laboratory results for hepatitis B surface antigen and IgG anti- Hepatitis B core, hepatitis C virus antibodies, and human immunodeficiency virus (HIV) antibody tests at screening~ * Serum creatinine and blood urea nitrogen are in the normal range at screening~ * Female patients of child bearing potential must have a negative pregnancy test at screening and Day-14~ * Patient has a negative screen for drugs of abuse at screening~ * Patient does not have a history or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological disease~ * Patient does not have liver function test results \\>1.25 the upper limit of normal NOTE: Under no circumstances should a patient who did not qualify regarding liver function tests (alanine aminotransferase \\[ALT\\] and/or aspartate aminotransferase \\[AST\\]) be re-screened and/or re-qualified~ * Patient does not have QTc \\> 450 (males) or \\> 470 (females) at screening~Randomization Inclusion Criteria:~Patients eligible to be randomized to double-blind treatment must satisfy all of the following inclusion criteria:~* Patient has all of the following at the end of the single-blind period (Day 1, just before randomization to study drug):~ * Physician\'s Global Assessment (PGA) ≥ 2 but ≤ 4.~ * The average of the scores recorded from the evening of Day -3 to the morning of Day 1 (Baseline value) of the Numerical Rating Scale (NRS) is ≥ 4.~ * The average of the scores recorded from the evening of Day -3 to the morning of Day 1 (Baseline value) of the Behavior Rating Scale (BRS) is ≥ 2~* Patient has negative laboratory results for hepatitis B surface antigen, IgE anti-Hepatitis B core, hepatitis C virus antibodies, and HIV antibody tests at screening~* Female patients of child bearing potential must have a negative pregnancy test at screening, single-blind period (Day-14) and baseline (Day 1)~* Serum creatinine and blood urea nitrogen are in the normal range at screening~* Patient has negative screen for drugs of abuse at screening and single-blind (Day-14)~* Use of adequate birth control by men and women, if of reproductive potential and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 2 weeks after the last dose of study drug~ * For females, adequate birth control methods will be defined as: hormonal contraceptives, intrauterine device or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam~ * For males adequate birth control methods will be defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam~ * For females, menopause is defined as one year without menses; if in question, a follicle-stimulating hormone of \\>40 U/ml must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable~* Patient has not used any treatments for AD prior to Day 1, using the following time periods:~ * Systemic (inhaled, oral, suppository or immediate release injectable, depot or sustained-release injectable) corticosteroids, cytostatic drugs, or other immunosuppressant drugs: 5 weeks prior to Day 1~ * Topical immunosuppressant drugs: 4 weeks prior to Day 1~ * Phototherapy, specific desensitization therapy, nonspecific disease-modulating therapy and elimination diet therapy: 4 weeks prior to Day 1~ * Any drugs that are known inhibitors or inducers of Cytochrome P450 isozyme cytochrome CYP2C9: 2 weeks prior to Day 1~ * Systemic antibiotics: 4 weeks prior to Day 1~ * Topical steroids or tar preparations: 2 weeks prior to Day 1~ * Antihistamines, histamine-added γ-globulin preparations, desensitization therapy, or other nonspecific disease-modifying therapies: 2 weeks prior to Day 1~ * Herbal preparation, cosmetic or emollient preparations other than those issued during the screening and single-blind periods: 2 weeks prior to Day 1. Use of cosmetic make-up will be allowed~ * Acetaminophen, acetaminophen-containing products, or non-steroidal anti-inflammatories: 2 weeks prior to Day 1~ * Any other investigational drug or device within 8 weeks prior to Day 1~* Patient is willing to completely avoid the use of any prescription or nonprescription treatments for AD , including over-the-counter drugs or any topical preparations, other than those topical emollient preparations provided by the study site during the screening period and thereafter, as needed. Use of hormone replacement therapy (for postmenopausal females) and/or use of hormonal contraceptive(s), intrauterine device, or double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam will be allowed. Use of topical antibiotics will be allowed during the study~Exclusion Criteria:~Patients satisfying any of the following exclusion criteria are not eligible for enrollment into the double-blind treatment period:~* Patient is under the age of legal consent, is mentally or legally incapacitated and/or has significant emotional problems at the time of study entry~* Patient has an active dermatologic condition other than AD which may confound the diagnosis or evaluation of AD, such as scabies, allergic contact dermatitis, seborrheic dermatitis, cutaneous lymphoma, or psoriasis~* Patient has a history of malignancy not in remission for \\>5 years, with the exception of cutaneous basal cell carcinoma and cutaneous squamous cell carcinoma~* Presence of comorbid conditions that would preclude participation in the study, including:~ * Immune compromised state, including recent chemotherapy, immunotherapy, or organ transplant~ * History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological disease~ * Signs and symptoms of eczema herpeticum within the preceding 12 months or cellulitis within preceding 3 months~ * Positive results for HIV infection at screening~ * History or clinical manifestations of significant neurological (e.g., epilepsy) or psychiatric disorders (e.g., history of suicide attempt; history of psychiatric episodes resulting in hospitalization)~ * An active intercurrent infection~ * History of clinically significant hypersensitivity, anaphylaxis, or allergies to any drug compound, which resulted in a severe adverse event~ * Liver function tests (ALT, AST) \\>1.25 times the upper limit of normal at Screening. (refer to Covance Lab Manual for reference ranges) Note: Under no circumstances should a patient who did not qualify regarding liver function tests (ALT and/or AST) be re-screened and/or re-qualified~* Patient has any acute or chronic condition or prior therapy that, in the opinion of the Investigator, would limit the patient\'s ability to complete and/or participate in this clinical study or otherwise would make the patient unsuitable for this study~* Patient has a history of drug abuse within 1 year prior to Day 1~* Patient consumes excess amounts of alcohol, defined as exceeding an average of 14 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor, or any combination of them) within 2 months prior to Day -14 (beginning of single-blind period) or is unwilling to comply with the restricted use of alcohol (as defined above, no more than 14 drinks/week) from screening, throughout the study, and until study completion (follow-up visit).~* Patient uses any prohibited concomitant medications at any time during the study~* Patient is pregnant or lactating or intends to become pregnant or, in the case of a male patient, intends to father a child during the study period and for 2 weeks after the last dose of study medication~* Patient has poor peripheral venous access that may limit blood sampling for clinical laboratory or pharmacokinetic analysis~* Patient has participated in any other investigational study drug or device trial in which receipt of an investigational study drug or device occurred within 8 weeks prior to Day 1~* Prior exposure to S-777469~* Any reason which, in the opinion of the Investigator, interferes with the ability of the patient to participate in or complete the trial"', 'Similarity Score': 0.14228582179967997}}]
|
from_dataset
| 0.142286
|
[{'from': 'human', 'value': {'Study Title': 'Safety and Tolerability of Open-Labeled Iloperidone in Adolescents', 'Primary Outcome Measures': 'Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period., 1 year', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Patient is willing and able to provide assent and willing to complete all aspects of the study~* Patient\'s parent or legal guardian willing and able to provide consent~* Male or female patients 12 through 17 years of age (inclusive)~* Clinical diagnosis of either schizophrenia or bipolar I disorder~Exclusion Criteria:~* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer~* A positive test for drugs of abuse"'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 614, 'Unnamed: 0': 753, 'NCT Number': 'NCT02488044', 'Study Title': 'A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency', 'Study URL': 'https://clinicaltrials.gov/study/NCT02488044', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102. This study is designed to evaluate the safety and tolerability of IV administration of AEB1102 for the treatment of pediatric and adult patients with Arginase I deficiency and hyperargininemia. This study will be conducted in 2 parts: Part 1 (Single Ascending Dose Escalation) and Part 2 (Repeated Dosing). Each part will be preceded by a baseline assessment of arginine levels. All patients who participate in Part 1 may continue AEB1102 dosing in Part 2 if they qualify for continued dosing. A data safety monitoring board (DSMB) will provide independent review of study safety data and recommend whether the sponsor should continue the study as planned, modify the study protocol, or discontinue the study.', 'Study Results': 'NO', 'Conditions': 'Arginase I Deficiency|Hyperargininemia', 'Interventions': 'DRUG: AEB1102', 'Primary Outcome Measures': 'Number of subjects with adverse events, Includes significant changes in hematology, chemistry and coagulation laboratory studies as well as in physical exam and vital signs, weekly throughout the study, up to 14 weeks', 'Secondary Outcome Measures': 'Number of subjects with a decrease from baseline in plasma arginine level, Baseline to 2, 4, 6, 8 weeks|Pharmacokinetic profile including Cmax, AUC, Tmax, T1/2 for each subject, At 15 min, 1, 2, 4, 8, 12, 24, 48, 72, and 120 hours following dose escalation|Number of subjects with a decrease from baseline in plasma guanidino compound levels, Baseline to 2, 4, 6, 8 weeks', 'Other Outcome Measures': '', 'Sponsor': 'Aeglea Biotherapeutics', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'CHILD, ADULT, OLDER_ADULT', 'Phases': 'PHASE1|PHASE2', 'Enrollment': 16.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT', 'Other IDs': 'CAEB1102-101A', 'Start Date': '2016-06', 'Primary Completion Date': '2019-02', 'Completion Date': '2019-02', 'First Posted': '2015-07-02', 'Results First Posted': '', 'Last Update Posted': '2019-06-12', 'Locations': "Stanford University School of Medicine, Stanford, California, 94305, United States|University of Florida, Gainesville, Florida, 32611, United States|Children's Hospital of Michigan, Detroit, Michigan, 48201, United States|Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States|UTSW, Dallas, Texas, 75390, United States|Seattle Children's Hospital, Seattle, Washington, 98105, United States|The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|Centro Hospitalar S. Joao, Porto, Portugal|Great Ormond Street Hospital, London, United Kingdom", 'Study Documents': '', 'criteria': '"Inclusion Criteria:~* Documented diagnosis of Arginase I deficiency~* Adequate organ function: Hgb ≥ 10 g/dL, ANC ≥ 1.5 x 109/L, plt count ≥ 100,000/µL; liver transaminase levels ≤ 2.5x ULN, total bilirubin ≤ 2.0 mg/dL; serum creatinine \\<1.5 x ULN~* If female and of child-bearing potential, has a negative serum pregnancy test within 7 days before enrollment~* If a sexually active (male or female), must be surgically sterile, post-menopausal (female), or must agree to use a physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration~* Patient or legal guardian is able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures and continuation of prescribed diet without modification) prior to any screening procedures~Exclusion Criteria:~* Transfusion of ≥ 2 u RBC within 60 days~* Active infection requiring systemic treatment~* Known infection with HIV, Hep B or Hep C~* Severe hyperammonemia requiring hospitalization within 14 days. Had more than one episode of hyperammonemia requiring hospitalization within the 30 days prior to enrollment.~* Current uncontrolled hyperammonemia~* Has a history of hypersensitivity to PEG or any other component of the AEB1102 (Co-ArgI-PEG) formulation~* If female, is lactating or breast feeding~PART 2 INCLUSION CRITERION:~1. Did not experience any safety or tolerability event in Part 1 which would preclude continued participation and dosing of AEB1102"', 'combined_text': 'A Phase 1/2 Study of AEB1102 in Patients With Arginase I Deficiency Number of subjects with adverse events, Includes significant changes in hematology, chemistry and coagulation laboratory studies as well as in physical exam and vital signs, weekly throughout the study, up to 14 weeks Number of subjects with a decrease from baseline in plasma arginine level, Baseline to 2, 4, 6, 8 weeks|Pharmacokinetic profile including Cmax, AUC, Tmax, T1/2 for each subject, At 15 min, 1, 2, 4, 8, 12, 24, 48, 72, and 120 hours following dose escalation|Number of subjects with a decrease from baseline in plasma guanidino compound levels, Baseline to 2, 4, 6, 8 weeks "Inclusion Criteria:~* Documented diagnosis of Arginase I deficiency~* Adequate organ function: Hgb ≥ 10 g/dL, ANC ≥ 1.5 x 109/L, plt count ≥ 100,000/µL; liver transaminase levels ≤ 2.5x ULN, total bilirubin ≤ 2.0 mg/dL; serum creatinine \\<1.5 x ULN~* If female and of child-bearing potential, has a negative serum pregnancy test within 7 days before enrollment~* If a sexually active (male or female), must be surgically sterile, post-menopausal (female), or must agree to use a physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration~* Patient or legal guardian is able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures and continuation of prescribed diet without modification) prior to any screening procedures~Exclusion Criteria:~* Transfusion of ≥ 2 u RBC within 60 days~* Active infection requiring systemic treatment~* Known infection with HIV, Hep B or Hep C~* Severe hyperammonemia requiring hospitalization within 14 days. Had more than one episode of hyperammonemia requiring hospitalization within the 30 days prior to enrollment.~* Current uncontrolled hyperammonemia~* Has a history of hypersensitivity to PEG or any other component of the AEB1102 (Co-ArgI-PEG) formulation~* If female, is lactating or breast feeding~PART 2 INCLUSION CRITERION:~1. Did not experience any safety or tolerability event in Part 1 which would preclude continued participation and dosing of AEB1102"', 'Similarity Score': 0.14180458212864563}}]
|
from_dataset
| 0.141805
|
[{'from': 'human', 'value': {'Study Title': 'Safety and Tolerability of Open-Labeled Iloperidone in Adolescents', 'Primary Outcome Measures': 'Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period., 1 year', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Patient is willing and able to provide assent and willing to complete all aspects of the study~* Patient\'s parent or legal guardian willing and able to provide consent~* Male or female patients 12 through 17 years of age (inclusive)~* Clinical diagnosis of either schizophrenia or bipolar I disorder~Exclusion Criteria:~* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer~* A positive test for drugs of abuse"'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 636, 'Unnamed: 0': 792, 'NCT Number': 'NCT05128344', 'Study Title': 'A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms', 'Study URL': 'https://clinicaltrials.gov/study/NCT05128344', 'Acronym': '', 'Study Status': 'WITHDRAWN', 'Brief Summary': 'The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).', 'Study Results': 'NO', 'Conditions': 'Spasms, Infantile', 'Interventions': 'DRUG: AMZ002 injectable solution, 0.5mg/mL|DRUG: Vigabatrin, oral', 'Primary Outcome Measures': 'Proportion of Participants with Absence of Clinical Spasms as Assessed by Video Electroencephalogram (EEG) at Day 14, At Day 14|Proportion of Participants with Resolution of Hypsarrhythmia or Significant Abnormality Compatible with Infantile Spasms (IS) as Assessed by Video EEG at Day 14, At Day 14', 'Secondary Outcome Measures': 'Time from Treatment Initiation to Absence of Clinical Spasms as Assessed by Parent/Guardian Diary, Baseline up to Day 58|Proportion of Participants with Absence of Clinical Spasms as Assessed by Parent/Guardian Diary at Day 14, At Day 14|Proportion of Participants with Recurrence of Clinical Spasms After Initial Response as Assessed by Video EEG/ by Parent/Guardian Diary, From Day 14 up to Day 58|Time from Initial Response to Recurrence of Clinical Spasms, From Day 14 up to Day 58', 'Other Outcome Measures': '', 'Sponsor': 'Amzell', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'CHILD', 'Phases': 'PHASE3', 'Enrollment': 0.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT', 'Other IDs': 'AMZ002-002|2021-003015-26', 'Start Date': '2023-04', 'Primary Completion Date': '2025-06', 'Completion Date': '2025-12', 'First Posted': '2021-11-22', 'Results First Posted': '', 'Last Update Posted': '2023-04-20', 'Locations': "The Childrens Hospital Colorado, Aurora, Colorado, 80045-7106, United States|Miami Children's Hospital, Miami, Florida, 33155, United States|Advent Health Orlando, Orlando, Florida, 32803, United States|Arnold Palmer Hospital For Children, Orlando, Florida, 32806, United States|Childrens Healthcare of Atlanta, Atlanta, Georgia, 30329, United States|Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, 60611, United States|University of Kentucky Hospital, Lexington, Kentucky, 40536, United States|Children's Brain Institute, Lexington, Massachusetts, 02420, United States|Children's Hospital of Michigan, Detroit, Michigan, 48201-2119, United States|Staten Island University Hospital, North, Staten Island, New York, 10305, United States|Wake Forest Baptist Medical Center - PPDS, Winston-Salem, North Carolina, 27157, United States|UT Southwestern Medical Center, Dallas, Texas, 75207, United States|Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia, Buenos Aires, Argentina|Hospital Italiano de Buenos Aires, Buenos Aires, Argentina|Paediatric Hospital Dr. Juan P. Garrahan, Buenos Aires, Argentina|CHU Bordeaux - Hopital des Enfants, Bordeaux, 33076, France|HFME-Hospices Civils de Lyon, Bron, 69500, France|Hopital Roger Salengro - CHU de Lille, Lille, France|Hopital Necker - Enfants Malades, Paris, France|Hopital de Hautepierre, Strasbourg, France|All India Institute of Medical Sciences, New Delhi, Dehli, 110029, India|Indira Gandhi Institute of Child Health, Bangalore, Karnataka, 560029, India|Amrita Advanced Centre for Epilepsy, Kochi, Kerala, 682041, India|Bharati Vidyapeeth Deemed University - Bharati Hospital, Pune, Maharashtra, 411043, India|Azienda Ospedaliero Universitaria, Ancona, Italy|Pediatric Hospital G. Salesi, Ancona, Italy|AOU Anna Meyer - Clinica di Neurologia Pediatrica, Firenze, Italy|Istituto Pediatrico Giannina Gaslini, Genova, Italy|Ospedale dei Bambini Vittore Buzzi, Milano, Italy|Universita degli Studi di Napoli Federico II, Neapel, Italy|Ospedale Pediatrico Bambino Gesu, Roma, Italy|Policlinico Universitario A.Gemelli, Roma, Italy|Azienda Ospedaliera Universitaria Integrata, Verona, Italy|Neurociencias Estudios Clinicos S.C., Culiacán, Mexico|HSRT, Mexico City, Mexico|Tecnologico De Monterrey - Hospital Zambrano Hellion - Instituto de Neurologia y Neurocirugia, Nuevo León, 66278, Mexico|The University Clinical Center, Gdańsk, Gdansk, Poland|Provincial Specialist Children's Hospital st. Ludwika, Kraków, Krakow, Poland|Medical University of Warsaw, Warsaw, 02-091, Poland|Institute of Mother and Child, Warsaw, Poland|Hospital de la Santa Creu i Sant Pau, Barcelona, 8041, Spain", 'Study Documents': '', 'criteria': '"Inclusion Criteria:~* Participant has been diagnosed with IS within 6 weeks prior to Screening. Diagnostic criteria include both clinical spasms and an EEG pattern consistent with hypsarrhythmia or significant abnormality compatible with IS~* Participant has normal renal function as defined by an estimated glomerular filtration rate (eGFR) greater than \\[\\>\\] 60 milliliter/minute (mL/min)/1.73 m\\^2, calculated as eGFR = 0.413 × (height \\[Centimeter (cm)\\]/serum creatinine \\[milligrams per deciliter {mg/dL}\\])~* Participant\'s legally authorized representative (that is \\[i.e.\\], parent or guardian) must provide written informed consent obtained per Institutional Review Board (IRB) policy and requirements, consistent with the International Council for Harmonisation (ICH)~* Participant\'s parent/guardian is able to understand and willing to comply with study procedures and restrictions~Exclusion Criteria:~* Participant has been diagnosed with tuberous sclerosis~* Participant has acute illness considered clinically significant by the Investigator within 30 days prior to Screening~* Participant has a diagnosis of recent systemic fungal infection; history of ocular herpes simplex; history of or current peptic ulcer; uncontrolled hypertension or congestive heart failure; or any other condition that would be significantly impacted by the study drug~* Participant has a preplanned surgery or procedure(s) that would interfere with the conduct of the study~* Participant has received any prior treatment for IS~* Participant has been previously treated with adrenocorticotropic hormone (ACTH), corticosteroids, or Vigabatrin for seizures;~* Participant has been previously treated with a course of corticosteroids for an indication other than seizures within 30 days prior to Screening~* Participant has a known or suspected allergy to ACTH or Vigabatrin or any component of AMZ002 or Vigabatrin~* Participant has used any other investigational drug within 30 days or 5 half-lives prior to the first dose of AMZ002 or Vigabatrin (whichever is longer)~* Participant\' s parent/guardian is unable to provide written informed consent and/or to complete the daily diary~* Participant has any other disease, condition, or therapy that, in the opinion of the Investigator, might compromise safety or compliance, preclude the participant from successfully completing the study, or interfere with the interpretation of the results"', 'combined_text': 'A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms Proportion of Participants with Absence of Clinical Spasms as Assessed by Video Electroencephalogram (EEG) at Day 14, At Day 14|Proportion of Participants with Resolution of Hypsarrhythmia or Significant Abnormality Compatible with Infantile Spasms (IS) as Assessed by Video EEG at Day 14, At Day 14 Time from Treatment Initiation to Absence of Clinical Spasms as Assessed by Parent/Guardian Diary, Baseline up to Day 58|Proportion of Participants with Absence of Clinical Spasms as Assessed by Parent/Guardian Diary at Day 14, At Day 14|Proportion of Participants with Recurrence of Clinical Spasms After Initial Response as Assessed by Video EEG/ by Parent/Guardian Diary, From Day 14 up to Day 58|Time from Initial Response to Recurrence of Clinical Spasms, From Day 14 up to Day 58 "Inclusion Criteria:~* Participant has been diagnosed with IS within 6 weeks prior to Screening. Diagnostic criteria include both clinical spasms and an EEG pattern consistent with hypsarrhythmia or significant abnormality compatible with IS~* Participant has normal renal function as defined by an estimated glomerular filtration rate (eGFR) greater than \\[\\>\\] 60 milliliter/minute (mL/min)/1.73 m\\^2, calculated as eGFR = 0.413 × (height \\[Centimeter (cm)\\]/serum creatinine \\[milligrams per deciliter {mg/dL}\\])~* Participant\'s legally authorized representative (that is \\[i.e.\\], parent or guardian) must provide written informed consent obtained per Institutional Review Board (IRB) policy and requirements, consistent with the International Council for Harmonisation (ICH)~* Participant\'s parent/guardian is able to understand and willing to comply with study procedures and restrictions~Exclusion Criteria:~* Participant has been diagnosed with tuberous sclerosis~* Participant has acute illness considered clinically significant by the Investigator within 30 days prior to Screening~* Participant has a diagnosis of recent systemic fungal infection; history of ocular herpes simplex; history of or current peptic ulcer; uncontrolled hypertension or congestive heart failure; or any other condition that would be significantly impacted by the study drug~* Participant has a preplanned surgery or procedure(s) that would interfere with the conduct of the study~* Participant has received any prior treatment for IS~* Participant has been previously treated with adrenocorticotropic hormone (ACTH), corticosteroids, or Vigabatrin for seizures;~* Participant has been previously treated with a course of corticosteroids for an indication other than seizures within 30 days prior to Screening~* Participant has a known or suspected allergy to ACTH or Vigabatrin or any component of AMZ002 or Vigabatrin~* Participant has used any other investigational drug within 30 days or 5 half-lives prior to the first dose of AMZ002 or Vigabatrin (whichever is longer)~* Participant\' s parent/guardian is unable to provide written informed consent and/or to complete the daily diary~* Participant has any other disease, condition, or therapy that, in the opinion of the Investigator, might compromise safety or compliance, preclude the participant from successfully completing the study, or interfere with the interpretation of the results"', 'Similarity Score': 0.1354799687776577}}]
|
from_dataset
| 0.13548
|
[{'from': 'human', 'value': {'Study Title': 'Safety and Tolerability of Open-Labeled Iloperidone in Adolescents', 'Primary Outcome Measures': 'Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period., 1 year', 'Secondary Outcome Measures': nan, 'criteria': '"Inclusion Criteria:~* Patient is willing and able to provide assent and willing to complete all aspects of the study~* Patient\'s parent or legal guardian willing and able to provide consent~* Male or female patients 12 through 17 years of age (inclusive)~* Clinical diagnosis of either schizophrenia or bipolar I disorder~Exclusion Criteria:~* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer~* A positive test for drugs of abuse"'}}, {'from': 'gpt', 'value': {'Unnamed: 0.1': 337, 'Unnamed: 0': 407, 'NCT Number': 'NCT02562573', 'Study Title': 'Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome', 'Study URL': 'https://clinicaltrials.gov/study/NCT02562573', 'Acronym': '', 'Study Status': 'COMPLETED', 'Brief Summary': 'This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in type 2 diabetes patients with metabolic syndrome.\n\nA total of 12 patients will initially be enrolled for study participation. A Data Safety Monitoring Board (DSMB) will continuously review data obtained from the 12 patients. When the 12 patients have completed at least one month of study treatment, the DSMB will meet and determine whether additional patients may be enrolled or the study should be stopped. If the safety is deemed acceptable to continue with the study, the study will enroll a maximum of 36 patients.', 'Study Results': 'NO', 'Conditions': 'Type 2 Diabetes|Metabolic Syndrome', 'Interventions': 'DRUG: PBI4050', 'Primary Outcome Measures': 'Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment, 7 months', 'Secondary Outcome Measures': 'Change from baseline on waist circumference, 6 months|Change from baseline on biomarkers, % reduction and/or increase of biomarkers, 6 months|Change from baseline on antidiabetic treatment, Treatment discontinued, dosing change, and/or new medication added, 6 months|Change from baseline on triglycerides, 6 months|Change from baseline on BP, 6 months|Change from baseline on HDL-C, 6 Months|Change from baseline on fasting plasma glucose, 6 months', 'Other Outcome Measures': '', 'Sponsor': 'Liminal BioSciences Ltd.', 'Collaborators': '', 'Sex': 'ALL', 'Age': 'ADULT, OLDER_ADULT', 'Phases': 'PHASE2', 'Enrollment': 24.0, 'Funder Type': 'INDUSTRY', 'Study Type': 'INTERVENTIONAL', 'Study Design': 'Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT', 'Other IDs': 'PBI4050-ATX-9-04', 'Start Date': '2015-05', 'Primary Completion Date': '2016-11', 'Completion Date': '2016-11', 'First Posted': '2015-09-29', 'Results First Posted': '', 'Last Update Posted': '2017-04-11', 'Locations': 'Edmonton, Alberta, Canada', 'Study Documents': '', 'criteria': '"Inclusion Criteria:~1. Patient is 18 years of age or older.~2. Patient has signed written informed consent.~3. Patient has a clinical diagnosis of type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) level between 7% and 10%.~4. Patient has been receiving stable antidiabetic therapy (oral agents with or without basal insulin given once daily in the evening) for a minimum of 3 months before the screening visit.~5. Patient is able and willing to self-monitor blood glucose level at home.~6. Patient has a body mass index (BMI) of at least 27 kg/m2.~7. Patient has metabolic syndrome, having at least 3 of the 5 metabolic syndrome risk factors.~Exclusion Criteria:~1. Patient requires intensive insulin therapy (defined as more than basal insulin given once daily in the evening) in addition to oral hypoglycemic agents for blood glucose control.~2. Patient has recent or on-going infection requiring systemic treatment with an anti-infective agent within 30 days before screening.~3. Patient has had at least one episode of severe hypoglycemia in the past 12 months, defined as having a blood glucose level \\< 3.0 mmol/L and/or requiring third party assistance to treat hypoglycemic episode.~4. Patient has evidence of significant cardiovascular disease, including myocardial infarction, unstable angina, coronary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), stroke, or severe ischemic disease within 3 months before screening.~5. Patient has uncontrolled hypertension with BP \\> 150/95 mm Hg.~6. Patient has a diagnosis of rheumatic or inflammatory disease, such as rheumatoid arthritis (RA), polymyalgia rheumatic (PMR), inflammatory bowel disease (IBD); or other autoimmune or inflammatory disease such as systemic lupus erythematosus (SLE) or psoriasis.~7. Patient is concurrently taking and plans to routinely continue taking anti-inflammatory medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, during the study.~8. Patient is currently using weight loss medications.~9. Patient has significantly elevated liver enzyme levels, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × upper limit of normal (ULN) or total bilirubin above ULN.~10. Patient has a history of chronic alcohol or other substance abuse.~11. Woman who is pregnant, breast-feeding, or planning a pregnancy during the course of the study.~12. Woman of childbearing potential who is unwilling to use adequate birth control throughout the duration of the study.~13. Patient has any condition that, in the investigator\'s opinion, is likely to interfere with study conduct and compliance."', 'combined_text': 'Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic Syndrome Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment, 7 months Change from baseline on waist circumference, 6 months|Change from baseline on biomarkers, % reduction and/or increase of biomarkers, 6 months|Change from baseline on antidiabetic treatment, Treatment discontinued, dosing change, and/or new medication added, 6 months|Change from baseline on triglycerides, 6 months|Change from baseline on BP, 6 months|Change from baseline on HDL-C, 6 Months|Change from baseline on fasting plasma glucose, 6 months "Inclusion Criteria:~1. Patient is 18 years of age or older.~2. Patient has signed written informed consent.~3. Patient has a clinical diagnosis of type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) level between 7% and 10%.~4. Patient has been receiving stable antidiabetic therapy (oral agents with or without basal insulin given once daily in the evening) for a minimum of 3 months before the screening visit.~5. Patient is able and willing to self-monitor blood glucose level at home.~6. Patient has a body mass index (BMI) of at least 27 kg/m2.~7. Patient has metabolic syndrome, having at least 3 of the 5 metabolic syndrome risk factors.~Exclusion Criteria:~1. Patient requires intensive insulin therapy (defined as more than basal insulin given once daily in the evening) in addition to oral hypoglycemic agents for blood glucose control.~2. Patient has recent or on-going infection requiring systemic treatment with an anti-infective agent within 30 days before screening.~3. Patient has had at least one episode of severe hypoglycemia in the past 12 months, defined as having a blood glucose level \\< 3.0 mmol/L and/or requiring third party assistance to treat hypoglycemic episode.~4. Patient has evidence of significant cardiovascular disease, including myocardial infarction, unstable angina, coronary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), stroke, or severe ischemic disease within 3 months before screening.~5. Patient has uncontrolled hypertension with BP \\> 150/95 mm Hg.~6. Patient has a diagnosis of rheumatic or inflammatory disease, such as rheumatoid arthritis (RA), polymyalgia rheumatic (PMR), inflammatory bowel disease (IBD); or other autoimmune or inflammatory disease such as systemic lupus erythematosus (SLE) or psoriasis.~7. Patient is concurrently taking and plans to routinely continue taking anti-inflammatory medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids, during the study.~8. Patient is currently using weight loss medications.~9. Patient has significantly elevated liver enzyme levels, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × upper limit of normal (ULN) or total bilirubin above ULN.~10. Patient has a history of chronic alcohol or other substance abuse.~11. Woman who is pregnant, breast-feeding, or planning a pregnancy during the course of the study.~12. Woman of childbearing potential who is unwilling to use adequate birth control throughout the duration of the study.~13. Patient has any condition that, in the investigator\'s opinion, is likely to interfere with study conduct and compliance."', 'Similarity Score': 0.13545898212703492}}]
|
from_dataset
| 0.135459
|
[{'from': 'human', 'value': '{Study Title: Absolute Bioavailability of Lu AE58054 in Healthy Subjects, Primary Outcome Measures: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV, Intravenous (IV), Day 10|Ratio of (AUC0-24(PM)/AUC0-24(EM)), Poor Metaboliser (PM); Extensive Metaboliser (EM), Day 10, Secondary Outcome Measures: Number and frequency of adverse events, Standard clinical safety assessments, Up to Day 16|Number of subjects with adverse events, Adverse event monitoring, Up to Day 16|Risk of Suicidality, Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions, Up to Day 16, criteria: "Inclusion Criteria:~* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).~* The subjects CYP2D6 genotype must be determined before inclusion into the study.~* Women must not be pregnant or lactating.~Exclusion Criteria:~* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 386, Unnamed: 0: 474, NCT Number: NCT03670082, Study Title: Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State, Study URL: https://clinicaltrials.gov/study/NCT03670082, Acronym: , Study Status: COMPLETED, Brief Summary: The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women, Study Results: NO, Conditions: Healthy, Interventions: DRUG: Lu AF35700|DRUG: Lu AF35700 iv, Primary Outcome Measures: Absolute bioavailability Fabs, Fabs= 100\\\\*(AUC0-72h, po\\\\*Div) / (AUC0-72h, iv\\\\*Dpo) (where D is the dose), 0 to 120 hours, Secondary Outcome Measures: AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours, Area under the plasma concentration-time curve from zero to 72 hours for Lu AF35700, 0 to 120 hours|Cmax: maximum observed plasma concentration, Maximum observed plasma concentration of Lu AF35700, 0 to 120 hours|tmax: time at maximum observed plasma concentration, Time at which maximum observed plasma concentration of Lu AF35700 occurred, 0 to 120 hours, Other Outcome Measures: , Sponsor: H. Lundbeck A/S, Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 10.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 17482A, Start Date: 2018-09-05, Primary Completion Date: 2018-12-21, Completion Date: 2019-01-13, First Posted: 2018-09-13, Results First Posted: , Last Update Posted: 2019-11-01, Locations: Covance, Leeds, United Kingdom, Study Documents: , criteria: "Inclusion Criteria:~* Healthy men and women aged ≥18 and ≤55 years~* Body Mass Index (BMI) of ≥18.5 and ≤30 kg/m2~* Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination~Exclusion Criteria:~* The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating~* The subject must not be a CYP2D6 or a CYP2C19 poor metabolizer~Other inclusion and exclusion criteria may apply.", combined_text: Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State Absolute bioavailability Fabs, Fabs= 100\\\\*(AUC0-72h, po\\\\*Div) / (AUC0-72h, iv\\\\*Dpo) (where D is the dose), 0 to 120 hours AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours, Area under the plasma concentration-time curve from zero to 72 hours for Lu AF35700, 0 to 120 hours|Cmax: maximum observed plasma concentration, Maximum observed plasma concentration of Lu AF35700, 0 to 120 hours|tmax: time at maximum observed plasma concentration, Time at which maximum observed plasma concentration of Lu AF35700 occurred, 0 to 120 hours "Inclusion Criteria:~* Healthy men and women aged ≥18 and ≤55 years~* Body Mass Index (BMI) of ≥18.5 and ≤30 kg/m2~* Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination~Exclusion Criteria:~* The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating~* The subject must not be a CYP2D6 or a CYP2C19 poor metabolizer~Other inclusion and exclusion criteria may apply.", Similarity Score: 0.23833576251306895}'}]
|
from_dataset
| 0.238336
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[{'from': 'human', 'value': '{Study Title: Absolute Bioavailability of Lu AE58054 in Healthy Subjects, Primary Outcome Measures: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV, Intravenous (IV), Day 10|Ratio of (AUC0-24(PM)/AUC0-24(EM)), Poor Metaboliser (PM); Extensive Metaboliser (EM), Day 10, Secondary Outcome Measures: Number and frequency of adverse events, Standard clinical safety assessments, Up to Day 16|Number of subjects with adverse events, Adverse event monitoring, Up to Day 16|Risk of Suicidality, Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions, Up to Day 16, criteria: "Inclusion Criteria:~* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).~* The subjects CYP2D6 genotype must be determined before inclusion into the study.~* Women must not be pregnant or lactating.~Exclusion Criteria:~* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 665, Unnamed: 0: 828, NCT Number: NCT05113940, Study Title: A Study of PF-07258669 In Healthy Adult Participants, Study URL: https://clinicaltrials.gov/study/NCT05113940, Acronym: , Study Status: COMPLETED, Brief Summary: Part A of this study is to evaluate safety, tolerability, and pharmacokinetics (PK) of PF-07258669 after administration of multiple ascending oral doses to healthy adult participants. Optional cohorts of healthy adult Japanese participants and/or older adult participants may also be evaluated if results in other cohorts support further evaluation. Part B of this study is a 2-period, fixed-sequence, multiple-dose, open-label design to evaluate the effect of PF-07258669 on midazolam PK in healthy adult participants. Part B will be conducted if the results of Part A support further evaluation of PF-07258669., Study Results: YES, Conditions: Healthy Participants, Interventions: DRUG: PF-07258669|DRUG: Placebo|DRUG: Midazolam, Primary Outcome Measures: Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study intervention and up to 35 days after last dose of study intervention that were absent before treatment or that worsened after treatment., Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days)|Part A: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality, Laboratory assessments included clinical chemistry, hematology, and urinalysis. Abnormality was determined based on the criteria specified in the sponsor reporting standards. The primary criteria was less than (\\\\<) 0.8\\\\* lower limit of normal (LLN) for lymphocytes and lymphocytes/leukocytes, greater than (\\\\>) 1.2\\\\* upper limit of normal (ULN) for lymphocytes, eosinophils/leukocytes, monocytes, and monocytes/leukocytes; greater than (\\\\>) 3.0\\\\* ULN for alanine aminotransferase, \\\\>1.3\\\\* ULN for urea nitrogen, cholesterol, and triglycerides; \\\\>1.030 for specific gravity (scalar), greater than or equal to (\\\\>=) 1 for ketones, urine protein, urine hemoglobin, urine bilirubin, leukocyte esterase., Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)|Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data, Vital signs included: a) supine systolic blood pressure (SBP): change greater than or equal to (\\\\>=) 30 millimeters of mercury (mmHg) increase, postural difference (supine standing) \\\\>= 20 mmHg, standing systolic SBP (mmHg) less than (\\\\<) 90 mmHg, \\\\>= 160 mmHg, change \\\\>= 30 mmHg increase, change \\\\>= 30 mmHg decrease; b) supine diastolic blood pressure (DBP) \\\\< 50 mmHg, \\\\>= 90 mmHg, change \\\\>= 20 mmHg increase, change \\\\>= 20mmHg decrease; postural difference (supine standing) \\\\>= 10 mmHg; standing \\\\<50 mmHg, value \\\\>=90 mmHg, change \\\\>=20 mmHg increase, change \\\\>=20 mmHg decrease, C) standing pulse rate (PR) greater than (\\\\>) 140 bpm. Baseline for supine BP and pulse rate was defined as the average of the triplicate measurements collected at the pre-dose (0 hour) assessment on Day 1. Baseline for standing BP, standing pulse rate, respiratory rate and oral body temperature were defined as the pre-dose (0 hour) assessment on Day 1., Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)|Part A: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria, ECG criteria: QTc corrected using Fridericia\\s formula (QTCF) interval aggregate in milliseconds (msec): less than or equal to (\\\\<=) change \\\\<= 60 msec. Baseline was defined as the average of the triplicate ECG measurements over the 3 pre-dose measurement times (-1 hour, -0.5 hour, and pre-dose 0 hour; total of 9 ECG measurements) on Day 1., Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)|Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) at Screening, C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported., Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])|Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day -2, C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported., Part A: On Day -2 (2 days prior to dosing)|Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 7, C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported., Part A: On Day 7|Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 14, C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported., Part A: Day 14|Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 21, C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported., Part A: Day 21|Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day at Screening, All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by clinical research unit (CRU) staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours., Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])|Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day -1, All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours., Part A: Day -1 (1 day prior to dosing)|Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 7, All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours., Part A: Day 7|Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 14, All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours., Part A: Day 14|Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone on Day 1 of Period 1, Cmax was defined as the maximum observed plasma concentration., Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1|Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 2 of Period 2, Cmax is the maximum observed plasma concentration., Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2|Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 10 of Period 2, Cmax was defined as the maximum observed plasma concentration., Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10|Part B: Area Under the Plasma Concentration-Time Curve From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam Alone on Day 1 of Period 1, AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration., Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1|Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 2 of Period 2, AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration., Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2|Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 10 of Period 2, AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration., Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10|Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUCinf) of Midazolam Alone on Day 1 of Period 1, AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time., Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1|Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 2 of Period 2, AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time., Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2|Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 10 of Period 2, AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time., Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10, Secondary Outcome Measures: "Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07258669 on Days 1 and 14, Cmax was defined as the maximum plasma concentration., Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14|Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax,dn) of PF-07258669 on Days 1 and 14, Cmax was defined maximum observed serum concentration. Cmax (dn) was calculated as Cmax/dose., Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14|Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (Tau) (AUCtau) of PF-07258669 on Days 1 and 14, Area under the plasma concentration-time profile from time zero to time tau, the dosing interval, where tau = 8 hours., Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14|Part A: Dose Normalized Area Under the Curve From Time 0 to Dosing Interval (Tau) (AUCtau, dn) of PF-07258669 on Days 1 and 14, Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14|Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07258669 on Days 1 and 14, Tmax was defined as the time taken (in hours) to reach the maximum plasma drug concentration., Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14|Part A: Amount of PF-0728669 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau), Aetau was defined as the amount of unchanged drug recovered in urine during the dosing interval., Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14|Part A: Percentage Dose of PF-07258669 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%), Aetau% was defined as the percentage of dose recovered in urine as unchanged drug., Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14|Part A: Renal Clearance (CLr) of PF-07258669, Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau)., Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14|Part B: Number of Participants With TEAEs, An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment., Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)|Part B: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data, Vital signs examination included: supine systolic blood pressure with criteria change \\\\>= 30 mmHg decrease, supine diastolic blood pressure with criteria value \\\\>= 90 mmHg and change \\\\>= 20 mmHg decrease., Part B: Day 1 of Period 1 up to Day 10 of Period 2 (12 days)|Part B: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria, Following ECG parameters were analyzed: QTCF interval with criteria 450 less than (\\\\<) value less than or equal to (\\\\<=) 480. A standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QTc intervals and QRS complex. On Day 1 at -1 hour (h), -0.5h, and 0h prior to the morning dose, triplicate 12-lead ECGs were obtained approximately 2 to 4 minutes apart at each time point. The average of the triplicate ECG measurements over the 3 pre dose measurement times (total of 9 ECG measurements) collected before morning dose administration on Day 1 served as each participants baseline QTc value., Part B: Day 1 of Period 1 up to Day 10 of Period 2 (12 days)|Part B: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality, Laboratory parameters assessed included: hematology (monocytes, monocytes/leukocytes) with primary criteria greater than (\\\\>) 1.2\\\\*upper limit of normal (ULN), clinical chemistry (bilirubin, direct bilirubin and indirect bilirubin with primary criteria \\\\>1.5\\\\*ULN, alanine aminotransferase with primary criteria \\\\>3.0\\\\*ULN, creatine kinase with primary criteria \\\\>2.0\\\\*ULN, urobilinogen with primary criteria greater than or equal to (\\\\>=)1, cholesterol and triglycerides-fasting with primary criteria \\\\>1.3\\\\*ULN), urinalysis (ketones and urine hemoglobin with primary criteria \\\\>=1)., Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)", Other Outcome Measures: , Sponsor: Pfizer, Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 120.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE, Other IDs: C4541003|2021-004037-36, Start Date: 2021-11-08, Primary Completion Date: 2023-07-27, Completion Date: 2023-07-27, First Posted: 2021-11-09, Results First Posted: 2024-10-24, Last Update Posted: 2024-10-24, Locations: Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région DE, B-1070, Belgium, Study Documents: Study Protocol, https://cdn.clinicaltrials.gov/large-docs/40/NCT05113940/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/40/NCT05113940/SAP_001.pdf, criteria: "Inclusion Criteria:~1. For optional cohort of older adult participants only: Male participants and female participants of non childbearing potential must be 65 to 90 years of age, inclusive, at the time of signing the ICD (informed consent document). Attempts will be made to ensure that the age composition of this cohort (eg, approximately 70% of participants ≥70 years of age) is comparable to that of the anticipated patient population in later clinical studies.~2. Female participants of nonchildbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.~ For optional cohort of older adult participants only: Participants must be in a stable condition at admission. These participants must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination, vital signs assessments, 12-lead ECG (electrocardiogram), and clinical laboratory tests. Participants with mild, chronic, stable disease (eg, controlled hypertension, noninsulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator.~3. Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor and to wear eye protection, as appropriate.~4. Body mass index (BMI) of 17.5 to 28.5 kg/m2; and a total body weight \\\\>50 kg (110 lb).~ For optional cohort of older adult participants only: BMI of 17.5 to 32.4 kg/m2; and a total body weight \\\\>50 kg (110 lbs). Efforts will be made to enroll at least 3 older adult participants with BMI \\\\<25 kg/m2, if feasible.~5. Japanese participants only: Participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.~Exclusion Criteria:~1. Evidence or history of clinically significant hematological, renal, endocrine (including, but not limited to, thyroid disease, diabetes insipidus), pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including, but not limited to, primary polydipsia, obsessive compulsive disorder, anxiety disorder, schizophrenia), neurological (including, but not limited to, seizure disorder, traumatic brain injury), immunodeficiency (including, but not limited to, severe infection that required ICU admission, prolonged hospitalization, or prolonged treatment) or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), as well as presence of clinical laboratory abnormalities.~ For optional cohort of older adult participants only: Participants with chronic conditions (eg, hypertension) that are controlled by either diet or stable doses of medications may be included. Recent evidence (ie, within previous 6 months) or history of unstable disease or moderate to severe conditions which would, in the investigator\\s opinion, interfere with the study evaluations or have an impact on the safety of participants.~2. History of symptomatic orthostatic hypotension or symptomatic bradycardia.~3. History of eating disorders (eg, anorexia or bulimia nervosa, binge-eating disorder, avoidant/restrictive food intake disorder).~4. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.~ For optional cohort of older adult participants only: Participants taking daily prescription or non-prescription medications (that are not moderate or strong cytochrome P450 (CYP3A) inducers or inhibitors) for management of acceptable chronic medical conditions are to be on a stable dose, as defined by no change in dose for the 28 days or 5 half-lives (whichever is longer) before the screening visit.~ 1. Use of stable concomitant mediations noted above that are CYP3A substrates may be restricted.~ 2. All medications must be reviewed on a case-by-case basis by the investigator and approved by the sponsor during the screening period for eligibility purposes.~5. Use of moderate or strong cytochrome P450 3A (CYP3A) inhibitors or inducers within 28 days or 5 half-lives (whichever is longer) prior to first dose of study intervention.~6. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).~7. Fasting serum triglycerides \\\\>2× ULN (upper limit of normal).", combined_text: A Study of PF-07258669 In Healthy Adult Participants Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study intervention and up to 35 days after last dose of study intervention that were absent before treatment or that worsened after treatment., Part A: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 49 days)|Part A: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality, Laboratory assessments included clinical chemistry, hematology, and urinalysis. Abnormality was determined based on the criteria specified in the sponsor reporting standards. The primary criteria was less than (\\\\<) 0.8\\\\* lower limit of normal (LLN) for lymphocytes and lymphocytes/leukocytes, greater than (\\\\>) 1.2\\\\* upper limit of normal (ULN) for lymphocytes, eosinophils/leukocytes, monocytes, and monocytes/leukocytes; greater than (\\\\>) 3.0\\\\* ULN for alanine aminotransferase, \\\\>1.3\\\\* ULN for urea nitrogen, cholesterol, and triglycerides; \\\\>1.030 for specific gravity (scalar), greater than or equal to (\\\\>=) 1 for ketones, urine protein, urine hemoglobin, urine bilirubin, leukocyte esterase., Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)|Part A: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data, Vital signs included: a) supine systolic blood pressure (SBP): change greater than or equal to (\\\\>=) 30 millimeters of mercury (mmHg) increase, postural difference (supine standing) \\\\>= 20 mmHg, standing systolic SBP (mmHg) less than (\\\\<) 90 mmHg, \\\\>= 160 mmHg, change \\\\>= 30 mmHg increase, change \\\\>= 30 mmHg decrease; b) supine diastolic blood pressure (DBP) \\\\< 50 mmHg, \\\\>= 90 mmHg, change \\\\>= 20 mmHg increase, change \\\\>= 20mmHg decrease; postural difference (supine standing) \\\\>= 10 mmHg; standing \\\\<50 mmHg, value \\\\>=90 mmHg, change \\\\>=20 mmHg increase, change \\\\>=20 mmHg decrease, C) standing pulse rate (PR) greater than (\\\\>) 140 bpm. Baseline for supine BP and pulse rate was defined as the average of the triplicate measurements collected at the pre-dose (0 hour) assessment on Day 1. Baseline for standing BP, standing pulse rate, respiratory rate and oral body temperature were defined as the pre-dose (0 hour) assessment on Day 1., Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)|Part A: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria, ECG criteria: QTc corrected using Fridericia\\s formula (QTCF) interval aggregate in milliseconds (msec): less than or equal to (\\\\<=) change \\\\<= 60 msec. Baseline was defined as the average of the triplicate ECG measurements over the 3 pre-dose measurement times (-1 hour, -0.5 hour, and pre-dose 0 hour; total of 9 ECG measurements) on Day 1., Part A: Baseline to maximum up to 10 days after administration of the final dose of study intervention (maximum up to 24 days)|Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) at Screening, C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported., Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])|Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day -2, C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported., Part A: On Day -2 (2 days prior to dosing)|Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 7, C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported., Part A: On Day 7|Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 14, C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported., Part A: Day 14|Part A: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 21, C-SSRS is interview-based rating scale to assess suicidal ideation and behavior. C-SSRS was mapped to Columbia-Classification Algorithm of Suicide Assessment(C-CASA) and suicidal behavior events were scored as follows:1.Completed suicide,2.Suicide attempt,3.Interrupted attempt,4.Aborted attempt,5.Preparatory actions toward imminent suicidal behaviors. Participants with response "Yes" to items 4,5 or behavioral question of C-SSRS were assessed by clinician and had their suicidality managed. Suicidal behaviors were scored as1.Completed suicide response "Yes" on "Completed Suicide",2.Suicide attempt had response "Yes" on "Actual Attempt",3.Interrupted attempt, had response "Yes" on "Interrupted attempt",4.Aborted attempt, had response "Yes" on "Aborted attempt",5.Preparatory actions toward imminent suicidal behaviors, had response "Yes" on "Preparatory Acts or Behavior".Here, number of participants with positive response (response of "yes") to suicidal behavior or ideation were reported., Part A: Day 21|Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day at Screening, All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by clinical research unit (CRU) staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours., Part A: At Screening (Day-28 [28 days prior to dosing] to Day -3 [3 days prior to dosing])|Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day -1, All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours., Part A: Day -1 (1 day prior to dosing)|Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 7, All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours., Part A: Day 7|Part A: Number of Participants With 24-Hour Fluid Intake and Urine Output >6 Liters Per Day on Day 14, All fluids consumed by the participants between 0 to 24 hours on days requiring 24-hour fluid intake assessments were recorded by CRU staff. The cumulative fluid intake for the 24-hour period was measured and recorded. Participants were instructed to void urine to empty their bladder at 0 hours. All urine voided after this time was collected up to, and including, a final void of urine at 24 hours., Part A: Day 14|Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam Alone on Day 1 of Period 1, Cmax was defined as the maximum observed plasma concentration., Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1|Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 2 of Period 2, Cmax is the maximum observed plasma concentration., Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2|Part B: Cmax of Midazolam in Combination With PF-07258669 on Day 10 of Period 2, Cmax was defined as the maximum observed plasma concentration., Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10|Part B: Area Under the Plasma Concentration-Time Curve From Time Zero (0) to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam Alone on Day 1 of Period 1, AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration., Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1|Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 2 of Period 2, AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration., Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2|Part B: AUClast of Midazolam in Combination With PF-07258669 on Day 10 of Period 2, AUClast was defined as the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration., Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10|Part B: Area Under the Plasma Concentration-Time Curve From Time 0 to Extrapolated Infinite Time (AUCinf) of Midazolam Alone on Day 1 of Period 1, AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time., Part B/Period 1: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 1|Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 2 of Period 2, AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time., Part B/Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 2|Part B: AUCinf of Midazolam in Combination With PF-07258669 on Day 10 of Period 2, AUCinf was defined as the area under the plasma concentration time profile from time 0 extrapolated to infinite time., Part B/ Period 2: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 16 hours post-dose on Day 10 Part A: Maximum Observed Plasma Concentration (Cmax) of PF-07258669 on Days 1 and 14, Cmax was defined as the maximum plasma concentration., Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14|Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax,dn) of PF-07258669 on Days 1 and 14, Cmax was defined maximum observed serum concentration. Cmax (dn) was calculated as Cmax/dose., Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14|Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to Dosing Interval (Tau) (AUCtau) of PF-07258669 on Days 1 and 14, Area under the plasma concentration-time profile from time zero to time tau, the dosing interval, where tau = 8 hours., Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14|Part A: Dose Normalized Area Under the Curve From Time 0 to Dosing Interval (Tau) (AUCtau, dn) of PF-07258669 on Days 1 and 14, Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 1 and Day 14|Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07258669 on Days 1 and 14, Tmax was defined as the time taken (in hours) to reach the maximum plasma drug concentration., Part A: 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dose on Day 1 and Day 14|Part A: Amount of PF-0728669 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau), Aetau was defined as the amount of unchanged drug recovered in urine during the dosing interval., Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14|Part A: Percentage Dose of PF-07258669 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%), Aetau% was defined as the percentage of dose recovered in urine as unchanged drug., Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14|Part A: Renal Clearance (CLr) of PF-07258669, Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau)., Part A: 0 to 8, 8 to 16, and 16 to 24 hours post dose on Day 14|Part B: Number of Participants With TEAEs, An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment., Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days)|Part B: Number of Participants With Categorical Summary of Post-Baseline Vital Signs Data, Vital signs examination included: supine systolic blood pressure with criteria change \\\\>= 30 mmHg decrease, supine diastolic blood pressure with criteria value \\\\>= 90 mmHg and change \\\\>= 20 mmHg decrease., Part B: Day 1 of Period 1 up to Day 10 of Period 2 (12 days)|Part B: Number of Participants Who Met Defined Electrocardiogram (ECG) Criteria, Following ECG parameters were analyzed: QTCF interval with criteria 450 less than (\\\\<) value less than or equal to (\\\\<=) 480. A standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measures PR, QT, and QTc intervals and QRS complex. On Day 1 at -1 hour (h), -0.5h, and 0h prior to the morning dose, triplicate 12-lead ECGs were obtained approximately 2 to 4 minutes apart at each time point. The average of the triplicate ECG measurements over the 3 pre dose measurement times (total of 9 ECG measurements) collected before morning dose administration on Day 1 served as each participant\\s baseline QTc value., Part B: Day 1 of Period 1 up to Day 10 of Period 2 (12 days)|Part B: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality, Laboratory parameters assessed included: hematology (monocytes, monocytes/leukocytes) with primary criteria greater than (\\\\>) 1.2\\\\*upper limit of normal (ULN), clinical chemistry (bilirubin, direct bilirubin and indirect bilirubin with primary criteria \\\\>1.5\\\\*ULN, alanine aminotransferase with primary criteria \\\\>3.0\\\\*ULN, creatine kinase with primary criteria \\\\>2.0\\\\*ULN, urobilinogen with primary criteria greater than or equal to (\\\\>=)1, cholesterol and triglycerides-fasting with primary criteria \\\\>1.3\\\\*ULN), urinalysis (ketones and urine hemoglobin with primary criteria \\\\>=1)., Part B: Day 1 to maximum up to 35 days after administration of the final dose of study intervention (maximum up to 46 days) "Inclusion Criteria:~1. For optional cohort of older adult participants only: Male participants and female participants of non childbearing potential must be 65 to 90 years of age, inclusive, at the time of signing the ICD (informed consent document). Attempts will be made to ensure that the age composition of this cohort (eg, approximately 70% of participants ≥70 years of age) is comparable to that of the anticipated patient population in later clinical studies.~2. Female participants of nonchildbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.~ For optional cohort of older adult participants only: Participants must be in a stable condition at admission. These participants must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination, vital signs assessments, 12-lead ECG (electrocardiogram), and clinical laboratory tests. Participants with mild, chronic, stable disease (eg, controlled hypertension, noninsulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator.~3. Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor and to wear eye protection, as appropriate.~4. Body mass index (BMI) of 17.5 to 28.5 kg/m2; and a total body weight \\\\>50 kg (110 lb).~ For optional cohort of older adult participants only: BMI of 17.5 to 32.4 kg/m2; and a total body weight \\\\>50 kg (110 lbs). Efforts will be made to enroll at least 3 older adult participants with BMI \\\\<25 kg/m2, if feasible.~5. Japanese participants only: Participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.~Exclusion Criteria:~1. Evidence or history of clinically significant hematological, renal, endocrine (including, but not limited to, thyroid disease, diabetes insipidus), pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including, but not limited to, primary polydipsia, obsessive compulsive disorder, anxiety disorder, schizophrenia), neurological (including, but not limited to, seizure disorder, traumatic brain injury), immunodeficiency (including, but not limited to, severe infection that required ICU admission, prolonged hospitalization, or prolonged treatment) or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), as well as presence of clinical laboratory abnormalities.~ For optional cohort of older adult participants only: Participants with chronic conditions (eg, hypertension) that are controlled by either diet or stable doses of medications may be included. Recent evidence (ie, within previous 6 months) or history of unstable disease or moderate to severe conditions which would, in the investigator\\s opinion, interfere with the study evaluations or have an impact on the safety of participants.~2. History of symptomatic orthostatic hypotension or symptomatic bradycardia.~3. History of eating disorders (eg, anorexia or bulimia nervosa, binge-eating disorder, avoidant/restrictive food intake disorder).~4. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.~ For optional cohort of older adult participants only: Participants taking daily prescription or non-prescription medications (that are not moderate or strong cytochrome P450 (CYP3A) inducers or inhibitors) for management of acceptable chronic medical conditions are to be on a stable dose, as defined by no change in dose for the 28 days or 5 half-lives (whichever is longer) before the screening visit.~ 1. Use of stable concomitant mediations noted above that are CYP3A substrates may be restricted.~ 2. All medications must be reviewed on a case-by-case basis by the investigator and approved by the sponsor during the screening period for eligibility purposes.~5. Use of moderate or strong cytochrome P450 3A (CYP3A) inhibitors or inducers within 28 days or 5 half-lives (whichever is longer) prior to first dose of study intervention.~6. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).~7. Fasting serum triglycerides \\\\>2× ULN (upper limit of normal).", Similarity Score: 0.20974777255363222}'}]
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[{'from': 'human', 'value': '{Study Title: Absolute Bioavailability of Lu AE58054 in Healthy Subjects, Primary Outcome Measures: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV, Intravenous (IV), Day 10|Ratio of (AUC0-24(PM)/AUC0-24(EM)), Poor Metaboliser (PM); Extensive Metaboliser (EM), Day 10, Secondary Outcome Measures: Number and frequency of adverse events, Standard clinical safety assessments, Up to Day 16|Number of subjects with adverse events, Adverse event monitoring, Up to Day 16|Risk of Suicidality, Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions, Up to Day 16, criteria: "Inclusion Criteria:~* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).~* The subjects CYP2D6 genotype must be determined before inclusion into the study.~* Women must not be pregnant or lactating.~Exclusion Criteria:~* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 182, Unnamed: 0: 222, NCT Number: NCT03565094, Study Title: Single Dose of Lu AF28996 to Healthy Young Men, Study URL: https://clinicaltrials.gov/study/NCT03565094, Acronym: , Study Status: COMPLETED, Brief Summary: This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men., Study Results: NO, Conditions: Healthy, Interventions: DRUG: Lu AF28996 solution|DRUG: Lu AF28996 capsule, Primary Outcome Measures: AUC 0-inf, area under the plasma concentration-time curve of Lu AF28996, From dosing to day 12 postdose|Cmax, maximum observed plasma concentration of Lu AF28996, From dosing to day 12 postdose|CL/F, Oral clearance of Lu AF28996, From dosing to day 12 postdose, Secondary Outcome Measures: Number of participants with Treatment-Emergent Adverse Events, Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight and ECG parameters), From dosing to day 12 postdose, Other Outcome Measures: , Sponsor: H. Lundbeck A/S, Collaborators: , Sex: MALE, Age: ADULT, Phases: PHASE1, Enrollment: 39.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: 17695A, Start Date: 2018-05-29, Primary Completion Date: 2019-08-17, Completion Date: 2019-08-21, First Posted: 2018-06-21, Results First Posted: , Last Update Posted: 2019-09-26, Locations: QPS Netherlands BV, Groningen, Netherlands, Study Documents: , criteria: "Inclusion Criterium:~Healthy, young, non-smoking men aged ≥18 and ≤45 years and with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit~Other in- and exclusion criteria may apply", combined_text: Single Dose of Lu AF28996 to Healthy Young Men AUC 0-inf, area under the plasma concentration-time curve of Lu AF28996, From dosing to day 12 postdose|Cmax, maximum observed plasma concentration of Lu AF28996, From dosing to day 12 postdose|CL/F, Oral clearance of Lu AF28996, From dosing to day 12 postdose Number of participants with Treatment-Emergent Adverse Events, Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight and ECG parameters), From dosing to day 12 postdose "Inclusion Criterium:~Healthy, young, non-smoking men aged ≥18 and ≤45 years and with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit~Other in- and exclusion criteria may apply", Similarity Score: 0.1746627505381102}'}]
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| 0.174663
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[{'from': 'human', 'value': '{Study Title: Absolute Bioavailability of Lu AE58054 in Healthy Subjects, Primary Outcome Measures: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV, Intravenous (IV), Day 10|Ratio of (AUC0-24(PM)/AUC0-24(EM)), Poor Metaboliser (PM); Extensive Metaboliser (EM), Day 10, Secondary Outcome Measures: Number and frequency of adverse events, Standard clinical safety assessments, Up to Day 16|Number of subjects with adverse events, Adverse event monitoring, Up to Day 16|Risk of Suicidality, Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions, Up to Day 16, criteria: "Inclusion Criteria:~* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).~* The subjects CYP2D6 genotype must be determined before inclusion into the study.~* Women must not be pregnant or lactating.~Exclusion Criteria:~* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 707, Unnamed: 0: 883, NCT Number: NCT05415644, Study Title: Study of the Bioequivalence and Food Effects of HRX0701 Tablets in Healthy Subjects, Study URL: https://clinicaltrials.gov/study/NCT05415644, Acronym: , Study Status: COMPLETED, Brief Summary: To evaluate the bioequivalence of a single oral dose of HRX0701 tablets and the reference formulations retagliptin phosphate tablets and metformin hydrochloride tablets in healthy subjects in the postprandial state; To evaluate the pharmacokinetic effects of a high-fat diet on retagliptin and metformin after a single oral administration of HRX0701 tablets in healthy subjects., Study Results: NO, Conditions: Type 2 Diabetes Mellitus, Interventions: DRUG: hrx0701 tablets、Metformin hydrochloride tablets、Retagliptin phosphate tablets|DRUG: hrx0701 tablets, Primary Outcome Measures: PK parameters Cmax, in the postprandial plasma of subjects in postprandial plasma, day 1 to day 18|PK parameters AUC0-t in the postprandial plasma of subjects in postprandial plasma, day 1 to day 18|PK parameters AUC0-∞ in the postprandial plasma of subjects in postprandial plasma, day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals reach peak time (Tmax), day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals peak concentration (Cmax), day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-t), day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-∞), day 1 to day 18, Secondary Outcome Measures: Apparent distribution volume (Vz/F), day 1 to day 18|apparent clearance (CL/F), day 1 to day 18|terminal phase half-life (t1/2), day 1 to day 18|retagliptin and metformin in plasma on fasting and after meals, day 1 to day 18|The main metabolites of retagliptin acid PK parameters Cmax, day 1 to day 18|The main metabolites of retagliptin acid AUC0-t, day 1 to day 18|The main metabolites of retagliptin acid AUC0-∞, day 1 to day 18|Adverse events, day 1 to day 25, Other Outcome Measures: , Sponsor: Shandong Suncadia Medicine Co., Ltd., Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 78.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT, Other IDs: HRX0701-101, Start Date: 2022-07-05, Primary Completion Date: 2022-08-08, Completion Date: 2022-08-08, First Posted: 2022-06-13, Results First Posted: , Last Update Posted: 2022-12-21, Locations: Xiangya Third Hospital, Changsha, Hunan, 410013, China, Study Documents: , criteria: "Inclusion Criteria:~1. Male and female subjects aged 18 to 45 years (both ends of the value, subject to the signing of informed consent).~2. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI): 19\\\\~26 kg/m2 (including both ends).~3. Based on medical history, comprehensive physical examination, laboratory tests, 12-lead ECG, chest x-ray, vital signs, etc., the researchers determined that the subjects met the health criteria.~4. Voluntarily sign an informed consent form prior to the commencement of activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to complete this trial in strict compliance with the clinical trial protocol.~Exclusion Criteria:~1. Have a history of any clinically serious disease or a disease or condition that the researcher believes may affect the results of the test, including but not limited to circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, psychiatric and metabolic disease history.~2. People with allergies, including those who are explicitly allergic to the research drug or any ingredient in the research drug, allergic to any food ingredients or have special requirements for diet, and cannot comply with the unified diet.~3. Those who have undergone any surgery within 3 months before screening, or who have not recovered after surgery, or who may have surgery or hospitalization plans during the estimated trial period.~4. Have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or dietary supplements within 2 weeks before the screening period;~5. Those who have consumed grapefruit or fruit juice products within 2 days before administration, any food or beverage containing caffeine (such as coffee, tea, chocolate, cola or other carbonated drinks containing caffeine, etc.), xanthine foods or alcohol.~6. The researcher determines that the subject has a medical condition that affects the absorption, distribution, metabolism and excretion of the drug or can reduce compliance or the researcher deems inappropriate.~7. Screening those who have participated in clinical trials of any drug or medical device within 3 months before screening.~8. Those who donated blood (or lost blood) within 3 months before screening and donated blood (or lost blood) ≥ 400 mL, or received blood transfusions.~9. Those who plan to receive live (attenuated) vaccines during the trial.~10. Have a birth plan at the end of the screening to follow-up period, or refuse to use medically approved contraception.~11. Smokers (average of 5 cigarettes or more per day).~12. An average daily intake of more than 25 g of alcohol in the 1 month prior to screening (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of low-grade liquor);~13. Drug abusers or drug urine screening test positive.~14. Positive for hepatitis B surface antigen (HBsAg) within 1 month before screening or screening period, or positive for anti-hepatitis C virus (HCV), or positive for human immunodeficiency virus (HIV), or positive for syphilis antibody.~15. 12-lead electrocardiogram (ECG) shows abnormalities and is of clinical significance.~16. There are any abnormal laboratory test values that are clinically significant by the researchers; (Note: For abnormal laboratory tests with clinical significance, if there is a clear and reasonable reason, the retest can be retested within one week, and the retest results can be used to determine whether the subject meets the conditions).~17. Subjects may not be able to complete this study for other reasons or those whom the researchers believe should not be included.", combined_text: Study of the Bioequivalence and Food Effects of HRX0701 Tablets in Healthy Subjects PK parameters Cmax, in the postprandial plasma of subjects in postprandial plasma, day 1 to day 18|PK parameters AUC0-t in the postprandial plasma of subjects in postprandial plasma, day 1 to day 18|PK parameters AUC0-∞ in the postprandial plasma of subjects in postprandial plasma, day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals reach peak time (Tmax), day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals peak concentration (Cmax), day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-t), day 1 to day 18|The PK parameters of retagliptin and metformin in the blood plasma on fasting and after meals area under the drug-time curve (AUC0-∞), day 1 to day 18 Apparent distribution volume (Vz/F), day 1 to day 18|apparent clearance (CL/F), day 1 to day 18|terminal phase half-life (t1/2), day 1 to day 18|retagliptin and metformin in plasma on fasting and after meals, day 1 to day 18|The main metabolites of retagliptin acid PK parameters Cmax, day 1 to day 18|The main metabolites of retagliptin acid AUC0-t, day 1 to day 18|The main metabolites of retagliptin acid AUC0-∞, day 1 to day 18|Adverse events, day 1 to day 25 "Inclusion Criteria:~1. Male and female subjects aged 18 to 45 years (both ends of the value, subject to the signing of informed consent).~2. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI): 19\\\\~26 kg/m2 (including both ends).~3. Based on medical history, comprehensive physical examination, laboratory tests, 12-lead ECG, chest x-ray, vital signs, etc., the researchers determined that the subjects met the health criteria.~4. Voluntarily sign an informed consent form prior to the commencement of activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to complete this trial in strict compliance with the clinical trial protocol.~Exclusion Criteria:~1. Have a history of any clinically serious disease or a disease or condition that the researcher believes may affect the results of the test, including but not limited to circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, psychiatric and metabolic disease history.~2. People with allergies, including those who are explicitly allergic to the research drug or any ingredient in the research drug, allergic to any food ingredients or have special requirements for diet, and cannot comply with the unified diet.~3. Those who have undergone any surgery within 3 months before screening, or who have not recovered after surgery, or who may have surgery or hospitalization plans during the estimated trial period.~4. Have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or dietary supplements within 2 weeks before the screening period;~5. Those who have consumed grapefruit or fruit juice products within 2 days before administration, any food or beverage containing caffeine (such as coffee, tea, chocolate, cola or other carbonated drinks containing caffeine, etc.), xanthine foods or alcohol.~6. The researcher determines that the subject has a medical condition that affects the absorption, distribution, metabolism and excretion of the drug or can reduce compliance or the researcher deems inappropriate.~7. Screening those who have participated in clinical trials of any drug or medical device within 3 months before screening.~8. Those who donated blood (or lost blood) within 3 months before screening and donated blood (or lost blood) ≥ 400 mL, or received blood transfusions.~9. Those who plan to receive live (attenuated) vaccines during the trial.~10. Have a birth plan at the end of the screening to follow-up period, or refuse to use medically approved contraception.~11. Smokers (average of 5 cigarettes or more per day).~12. An average daily intake of more than 25 g of alcohol in the 1 month prior to screening (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of low-grade liquor);~13. Drug abusers or drug urine screening test positive.~14. Positive for hepatitis B surface antigen (HBsAg) within 1 month before screening or screening period, or positive for anti-hepatitis C virus (HCV), or positive for human immunodeficiency virus (HIV), or positive for syphilis antibody.~15. 12-lead electrocardiogram (ECG) shows abnormalities and is of clinical significance.~16. There are any abnormal laboratory test values that are clinically significant by the researchers; (Note: For abnormal laboratory tests with clinical significance, if there is a clear and reasonable reason, the retest can be retested within one week, and the retest results can be used to determine whether the subject meets the conditions).~17. Subjects may not be able to complete this study for other reasons or those whom the researchers believe should not be included.", Similarity Score: 0.1685447081614484}'}]
|
from_dataset
| 0.168545
|
[{'from': 'human', 'value': '{Study Title: Absolute Bioavailability of Lu AE58054 in Healthy Subjects, Primary Outcome Measures: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV, Intravenous (IV), Day 10|Ratio of (AUC0-24(PM)/AUC0-24(EM)), Poor Metaboliser (PM); Extensive Metaboliser (EM), Day 10, Secondary Outcome Measures: Number and frequency of adverse events, Standard clinical safety assessments, Up to Day 16|Number of subjects with adverse events, Adverse event monitoring, Up to Day 16|Risk of Suicidality, Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions, Up to Day 16, criteria: "Inclusion Criteria:~* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).~* The subjects CYP2D6 genotype must be determined before inclusion into the study.~* Women must not be pregnant or lactating.~Exclusion Criteria:~* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 792, Unnamed: 0: 998, NCT Number: NCT01659944, Study Title: Study to Evaluate the Effect of Eliglustat on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adults, Study URL: https://clinicaltrials.gov/study/NCT01659944, Acronym: , Study Status: COMPLETED, Brief Summary: The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in healthy adults.\\n\\nThe secondary objective is to assess the safety and tolerability of a single oral dose of metoprolol 50 mg when administered alone and in combination with repeated oral doses of eliglustat 150 mg BID in healthy adults., Study Results: NO, Conditions: Healthy, Interventions: DRUG: Eliglustat|DRUG: Metoprolol, Primary Outcome Measures: Metoprolol area under the plasma concentration time curve from time zero to the last evaluable concentration (AUC0-last), Day 1 and Day 7; predose and up to 48 hours after drug administration|Metoprolol area under the plasma concentration time curve from time zero extrapolated to infinity (AUC0-∞), Day 1 and Day 7; Predose and up to 48 hours after drug administration, Secondary Outcome Measures: Maximum plasma concentration (Cmax) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Time to maximum plasma concentration (Tmax) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Terminal elimination half-life (T1/2) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Trough plasma concentration of eliglustat, Eliglustat plasma concentration observed just prior to administration during repeated dosing., Day 3, Day 4, Day 5, Day 6, Day 7 and Day 8.|Maximum plasma concentration (Cmax) of eliglustat, Day 7, up to 12 hours after drug administration|Time to maximum plasma concentration (Tmax) of eliglustat, Day 7; up to 12 hours after drug administration|Eliglustat area under the plasma concentration time curve during the dosing interval (AUC0-τ), Day 7; up to 12 hours after drug administration|Number of participants with adverse events, Day 1 through to Day 14, Other Outcome Measures: , Sponsor: Genzyme, a Sanofi Company, Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 14.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: |Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE, Other IDs: GZGD04112, Start Date: 2012-05, Primary Completion Date: 2012-06, Completion Date: 2012-07, First Posted: 2012-08-08, Results First Posted: , Last Update Posted: 2015-03-23, Locations: Austin, Texas, United States, Study Documents: , criteria: "Inclusion Criteria:~1. The subject is willing and able to provide signed informed consent.~2. The male or female subject is in good general health and between 18 and 40 years of age, inclusive.~3. The subject has a body weight of 50 to 100 kg (110 to 220 lb) with a body mass index (BMI) ≤32 kg/m2 at screening.~4. The subject\\s physical examination, laboratory, vital sign, and electrocardiogram (ECG) test results are within normal limits at screening and Day -1 or, if abnormal, are not considered clinically significant in the opinion of the Investigator.~5. The subject has been a non-smoker for at least 6 months prior to the time of providing informed consent, and is willing and able to abstain from smoking (and use of other forms of nicotine) until completion of the safety follow-up visit.~6. The subject has not used drugs of abuse for at least 6 months prior to Day -1 and is willing and able to abstain from using drugs of abuse until completion of the safety follow-up visit.~7. The subject is willing and able to abstain from alcohol for 48 hours prior to the first dose of study drug until completion of the safety follow-up visit.~8. The subject is willing and able to abstain from grapefruit, grapefruit juice or any other grapefruit-containing products for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.~9. The subject is willing and able to maintain a normal-fiber diet (i.e., to abstain from excess fiber-rich foods) for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.~10. Female subjects of childbearing potential must have a documented negative pregnancy test at screening, Day -1 and prior to dosing on Day 7 and be willing to use a medically accepted form of contraception (as defined in the protocol) from screening until 30 days after the last dose of study drug. A woman of childbearing potential is defined as any female who has not been amenorrheic for at least 2 years or has not undergone a hysterectomy or surgical sterilization.~Exclusion Criteria:~1. The subject is classified as a cytochrome P450 2D6 (CYP2D6) poor metabolizer (or an indeterminate metabolizer with neither allele known to be active) based on results of CYP2D6 genotyping performed at screening. (Note: Prior CYP2D6 genotyping results may be used for the purpose of determining study eligibility if a copy of the laboratory report is available and the genotyping results can be interpreted with the same classification system used by the study reference laboratory.)~2. The subject has a digestive disorder, including malabsorption, gastroenteritis, pancreatitis, gastroesophageal reflux disease, inflammatory bowel disease (including Crohn\\s disease), or any other digestive disorder which, in the opinion of the Investigator, may affect oral bioavailability (e.g., clinically significant constipation, diverticulitis, or irritable bowel syndrome).~3. The subject has had a gastrointestinal (GI) surgical procedure that might affect drug transit time, (e.g., cholecystectomy, GI bypass surgery, partial or total gastrectomy, or small bowel resection).~4. The subject has any of the following: Clinically significant coronary artery disease including history of myocardial infarction or ongoing signs or symptoms consistent with cardiac ischemia or heart failure; clinically significant arrhythmias or conduction defect such as 2nd or 3rd degree atrioventricular (AV) block, a PR interval ≥200 msec, complete bundle branch block, prolonged QTc interval (e.g., repeated demonstration of a QTc interval ≥430 msec for male subjects and ≥450 msec for female subjects), sustained ventricular tachycardia, heart rate \\\\<55 beats/min, or systolic blood pressure \\\\<110 mmHg.~5. The subject has a clinically significant organic disease, including cardiovascular, renal, hepatic, gastrointestinal, pulmonary, neurologic, endocrine, metabolic, or psychiatric disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precludes participation in the trial.~6. The subject has a disease, clinical finding, or any contraindication that would prohibit the use of metoprolol in a phase 1 study (i.e., risk of disease exacerbation outweighs benefit). Examples of these are clinical findings of glucose intolerance, poor arterial peripheral circulation or bronchospastic disease including asthma.~7. The subject has a history of fainting, postural lightheadedness, or any other postural symptoms.~8. The subject has received any prescription or non-prescription medication (with the exception of nonprescription-strength ibuprofen and acetaminophen, topical non-steroidal preparations, and topical hydrocortisone (up to 1% strength)) or dietary or herbal or fiber supplement within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug without the approval of both the Investigator and Sponsor.~9. The subject has received an immunization within 30 days of providing informed consent.~10. The subject has received an investigational product within 30 days prior to the first dose of study drug or plans to receive any other investigational product at any time during the course of this study.~11. The subject has a history of drug allergies that are clinically significant in the opinion of the Investigator (e.g., significant rash or hives).~12. The subject has a screening laboratory test result above the upper limit of normal for any of the following liver function tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyltransferase (GGT), and total bilirubin.~13. The subject tests positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or hepatitis B surface antigen at screening.~14. The subject tests positive for urine drugs of abuse, urine alcohol, or urine cotinine at screening.~15. The subject donated blood or blood products within 30 days prior to providing informed consent.~16. The subject\\s schedule or travel plans prevent the completion of all required visits.~17. The subject is scheduled for inpatient hospitalization, including elective surgery (inpatient or outpatient), during the study.~18. The subject has a history of cancer, with the exception of basal cell carcinoma.~19. The female subject of childbearing potential is pregnant or lactating.~20. The subject, in the opinion of the Investigator, is unable to adhere to the requirements of the study.", combined_text: Study to Evaluate the Effect of Eliglustat on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adults Metoprolol area under the plasma concentration time curve from time zero to the last evaluable concentration (AUC0-last), Day 1 and Day 7; predose and up to 48 hours after drug administration|Metoprolol area under the plasma concentration time curve from time zero extrapolated to infinity (AUC0-∞), Day 1 and Day 7; Predose and up to 48 hours after drug administration Maximum plasma concentration (Cmax) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Time to maximum plasma concentration (Tmax) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Terminal elimination half-life (T1/2) for metoprolol, Day 1 and Day 7; Predose and up to 48 hours after drug administration|Trough plasma concentration of eliglustat, Eliglustat plasma concentration observed just prior to administration during repeated dosing., Day 3, Day 4, Day 5, Day 6, Day 7 and Day 8.|Maximum plasma concentration (Cmax) of eliglustat, Day 7, up to 12 hours after drug administration|Time to maximum plasma concentration (Tmax) of eliglustat, Day 7; up to 12 hours after drug administration|Eliglustat area under the plasma concentration time curve during the dosing interval (AUC0-τ), Day 7; up to 12 hours after drug administration|Number of participants with adverse events, Day 1 through to Day 14 "Inclusion Criteria:~1. The subject is willing and able to provide signed informed consent.~2. The male or female subject is in good general health and between 18 and 40 years of age, inclusive.~3. The subject has a body weight of 50 to 100 kg (110 to 220 lb) with a body mass index (BMI) ≤32 kg/m2 at screening.~4. The subject\\s physical examination, laboratory, vital sign, and electrocardiogram (ECG) test results are within normal limits at screening and Day -1 or, if abnormal, are not considered clinically significant in the opinion of the Investigator.~5. The subject has been a non-smoker for at least 6 months prior to the time of providing informed consent, and is willing and able to abstain from smoking (and use of other forms of nicotine) until completion of the safety follow-up visit.~6. The subject has not used drugs of abuse for at least 6 months prior to Day -1 and is willing and able to abstain from using drugs of abuse until completion of the safety follow-up visit.~7. The subject is willing and able to abstain from alcohol for 48 hours prior to the first dose of study drug until completion of the safety follow-up visit.~8. The subject is willing and able to abstain from grapefruit, grapefruit juice or any other grapefruit-containing products for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.~9. The subject is willing and able to maintain a normal-fiber diet (i.e., to abstain from excess fiber-rich foods) for 72 hours prior to the first dose of study drug until completion of the safety follow-up visit.~10. Female subjects of childbearing potential must have a documented negative pregnancy test at screening, Day -1 and prior to dosing on Day 7 and be willing to use a medically accepted form of contraception (as defined in the protocol) from screening until 30 days after the last dose of study drug. A woman of childbearing potential is defined as any female who has not been amenorrheic for at least 2 years or has not undergone a hysterectomy or surgical sterilization.~Exclusion Criteria:~1. The subject is classified as a cytochrome P450 2D6 (CYP2D6) poor metabolizer (or an indeterminate metabolizer with neither allele known to be active) based on results of CYP2D6 genotyping performed at screening. (Note: Prior CYP2D6 genotyping results may be used for the purpose of determining study eligibility if a copy of the laboratory report is available and the genotyping results can be interpreted with the same classification system used by the study reference laboratory.)~2. The subject has a digestive disorder, including malabsorption, gastroenteritis, pancreatitis, gastroesophageal reflux disease, inflammatory bowel disease (including Crohn\\s disease), or any other digestive disorder which, in the opinion of the Investigator, may affect oral bioavailability (e.g., clinically significant constipation, diverticulitis, or irritable bowel syndrome).~3. The subject has had a gastrointestinal (GI) surgical procedure that might affect drug transit time, (e.g., cholecystectomy, GI bypass surgery, partial or total gastrectomy, or small bowel resection).~4. The subject has any of the following: Clinically significant coronary artery disease including history of myocardial infarction or ongoing signs or symptoms consistent with cardiac ischemia or heart failure; clinically significant arrhythmias or conduction defect such as 2nd or 3rd degree atrioventricular (AV) block, a PR interval ≥200 msec, complete bundle branch block, prolonged QTc interval (e.g., repeated demonstration of a QTc interval ≥430 msec for male subjects and ≥450 msec for female subjects), sustained ventricular tachycardia, heart rate \\\\<55 beats/min, or systolic blood pressure \\\\<110 mmHg.~5. The subject has a clinically significant organic disease, including cardiovascular, renal, hepatic, gastrointestinal, pulmonary, neurologic, endocrine, metabolic, or psychiatric disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precludes participation in the trial.~6. The subject has a disease, clinical finding, or any contraindication that would prohibit the use of metoprolol in a phase 1 study (i.e., risk of disease exacerbation outweighs benefit). Examples of these are clinical findings of glucose intolerance, poor arterial peripheral circulation or bronchospastic disease including asthma.~7. The subject has a history of fainting, postural lightheadedness, or any other postural symptoms.~8. The subject has received any prescription or non-prescription medication (with the exception of nonprescription-strength ibuprofen and acetaminophen, topical non-steroidal preparations, and topical hydrocortisone (up to 1% strength)) or dietary or herbal or fiber supplement within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug without the approval of both the Investigator and Sponsor.~9. The subject has received an immunization within 30 days of providing informed consent.~10. The subject has received an investigational product within 30 days prior to the first dose of study drug or plans to receive any other investigational product at any time during the course of this study.~11. The subject has a history of drug allergies that are clinically significant in the opinion of the Investigator (e.g., significant rash or hives).~12. The subject has a screening laboratory test result above the upper limit of normal for any of the following liver function tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyltransferase (GGT), and total bilirubin.~13. The subject tests positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or hepatitis B surface antigen at screening.~14. The subject tests positive for urine drugs of abuse, urine alcohol, or urine cotinine at screening.~15. The subject donated blood or blood products within 30 days prior to providing informed consent.~16. The subject\\s schedule or travel plans prevent the completion of all required visits.~17. The subject is scheduled for inpatient hospitalization, including elective surgery (inpatient or outpatient), during the study.~18. The subject has a history of cancer, with the exception of basal cell carcinoma.~19. The female subject of childbearing potential is pregnant or lactating.~20. The subject, in the opinion of the Investigator, is unable to adhere to the requirements of the study.", Similarity Score: 0.16395515348672193}'}]
|
from_dataset
| 0.163955
|
[{'from': 'human', 'value': '{Study Title: Absolute Bioavailability of Lu AE58054 in Healthy Subjects, Primary Outcome Measures: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV, Intravenous (IV), Day 10|Ratio of (AUC0-24(PM)/AUC0-24(EM)), Poor Metaboliser (PM); Extensive Metaboliser (EM), Day 10, Secondary Outcome Measures: Number and frequency of adverse events, Standard clinical safety assessments, Up to Day 16|Number of subjects with adverse events, Adverse event monitoring, Up to Day 16|Risk of Suicidality, Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions, Up to Day 16, criteria: "Inclusion Criteria:~* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).~* The subjects CYP2D6 genotype must be determined before inclusion into the study.~* Women must not be pregnant or lactating.~Exclusion Criteria:~* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 1002, Unnamed: 0: 1246, NCT Number: NCT02353273, Study Title: The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers, Study URL: https://clinicaltrials.gov/study/NCT02353273, Acronym: , Study Status: COMPLETED, Brief Summary: The objective of this study is to evaluate the systemic exposures of WH-1 ointment which includes Salvigenin and Asiaticoside A in subjects with chronic diabetic foot ulcers following topical application of WH-1., Study Results: NO, Conditions: Diabetic Foot, Interventions: DRUG: WH-1 ointment, Primary Outcome Measures: Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ), AUC0-∞, AUC0-t, Cmax:\\n\\n1. Area under the concentration-time curve from time 0 to infinity (AUC0-∞)\\n2. Area under the concentration-time curve from 0 to the time of last quantifiable level (AUC0-t)\\n3. Maximum observed level (Cmax)\\n\\nCmax,ss, AUC0-τ:\\n\\n1. Maximum observed plasma concentration at steady state (Cmax,ss)\\n2. Area under the concentration versus time curve from time zero to the end of a dosing interval (AUC0-τ)., Day1; Day14, Secondary Outcome Measures: Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F), 1. Time to peak concentration (Tmax)\\n2. Mean residence time (MRT)\\n3. Elimination half-life (T1/2)\\n4. Apparent volume of distribution (Vd/F)\\n5. Apparent clearance (CL/F), Day1|Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss), Time to peak concentration at steady state (Tmax,ss), Day14, Other Outcome Measures: , Sponsor: Oneness Biotech Co., Ltd., Collaborators: , Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE1, Enrollment: 12.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: ON101CLPK01, Start Date: 2015-07-22, Primary Completion Date: 2016-07-05, Completion Date: 2016-09-05, First Posted: 2015-02-02, Results First Posted: , Last Update Posted: 2018-03-29, Locations: Clinical Research Division, Taipei, 115, Taiwan, Study Documents: , criteria: "Inclusion Criteria:~1. Male or female is at least 20 years of age;~2. Diabetes mellitus (type I or II) was diagnosed with an HbA1c ≤ 12.0% measured during screening or within three months prior to randomization;~3. The target diabetic foot ulcer must have the following characteristics:~ 1. ≤ Grade 2 per Wagner Ulcer Classification System;~ 2. Lower limbs;~ 3. No-infected;~ 4. A cross-sectional area of between 1 and 25 cm2 post-debridement;~4. If female and of childbearing potential has a negative pregnancy test and is neither breastfeeding or intending to become pregnant during the study;~5. Able and willing to follow with study scheduled visits, comply with study procedures, and sign the informed consent.~Exclusion Criteria:~1. Acute Charcot\\ s neuroarthropathy as determined by clinical and/or radiographic examination;~2. Poor nutritional status defined as an albumin \\\\< 2.5 g/dL;~3. AST and/or ALT \\\\> 3X of the normal upper limit;~4. Clearance of Creatinine (Ccr) \\\\< 30 ml/min;~5. Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids within 4 weeks prior to enroll;~6. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject\\ s medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance~7. Subjects who have received an experimental agent within 30 days, prior to enroll.~8. Subjects who have received WH-1 ointment within 30 days, prior to enroll.~9. Subjects who have history of smoking (define as more than 20 cigarettes per day) within 3 months prior to admission to the Hospital site.~10. Judged by the investigator not to be suitable for the study for any other reason.", combined_text: The Pharmacokinetic Study of WH-1 Ointment in Subjects With Chronic Diabetic Foot Ulcers Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below. (AUC0-∞, AUC0-t, Cmax)(Cmax,ss, AUC0-τ), AUC0-∞, AUC0-t, Cmax:\\n\\n1. Area under the concentration-time curve from time 0 to infinity (AUC0-∞)\\n2. Area under the concentration-time curve from 0 to the time of last quantifiable level (AUC0-t)\\n3. Maximum observed level (Cmax)\\n\\nCmax,ss, AUC0-τ:\\n\\n1. Maximum observed plasma concentration at steady state (Cmax,ss)\\n2. Area under the concentration versus time curve from time zero to the end of a dosing interval (AUC0-τ)., Day1; Day14 Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax, MRT, T1/2, Vd/F, CL/F), 1. Time to peak concentration (Tmax)\\n2. Mean residence time (MRT)\\n3. Elimination half-life (T1/2)\\n4. Apparent volume of distribution (Vd/F)\\n5. Apparent clearance (CL/F), Day1|Pharmacokinetic parameters of Salvigenin and Asiaticoside A as listed below, if appropriate. (Tmax,ss), Time to peak concentration at steady state (Tmax,ss), Day14 "Inclusion Criteria:~1. Male or female is at least 20 years of age;~2. Diabetes mellitus (type I or II) was diagnosed with an HbA1c ≤ 12.0% measured during screening or within three months prior to randomization;~3. The target diabetic foot ulcer must have the following characteristics:~ 1. ≤ Grade 2 per Wagner Ulcer Classification System;~ 2. Lower limbs;~ 3. No-infected;~ 4. A cross-sectional area of between 1 and 25 cm2 post-debridement;~4. If female and of childbearing potential has a negative pregnancy test and is neither breastfeeding or intending to become pregnant during the study;~5. Able and willing to follow with study scheduled visits, comply with study procedures, and sign the informed consent.~Exclusion Criteria:~1. Acute Charcot\\ s neuroarthropathy as determined by clinical and/or radiographic examination;~2. Poor nutritional status defined as an albumin \\\\< 2.5 g/dL;~3. AST and/or ALT \\\\> 3X of the normal upper limit;~4. Clearance of Creatinine (Ccr) \\\\< 30 ml/min;~5. Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids within 4 weeks prior to enroll;~6. A psychiatric condition (e.g., suicidal ideation), current or chronic alcohol or drug abuse problem, determined from the subject\\ s medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance~7. Subjects who have received an experimental agent within 30 days, prior to enroll.~8. Subjects who have received WH-1 ointment within 30 days, prior to enroll.~9. Subjects who have history of smoking (define as more than 20 cigarettes per day) within 3 months prior to admission to the Hospital site.~10. Judged by the investigator not to be suitable for the study for any other reason.", Similarity Score: 0.16041715317878427}'}]
|
from_dataset
| 0.160417
|
[{'from': 'human', 'value': '{Study Title: Absolute Bioavailability of Lu AE58054 in Healthy Subjects, Primary Outcome Measures: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV, Intravenous (IV), Day 10|Ratio of (AUC0-24(PM)/AUC0-24(EM)), Poor Metaboliser (PM); Extensive Metaboliser (EM), Day 10, Secondary Outcome Measures: Number and frequency of adverse events, Standard clinical safety assessments, Up to Day 16|Number of subjects with adverse events, Adverse event monitoring, Up to Day 16|Risk of Suicidality, Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions, Up to Day 16, criteria: "Inclusion Criteria:~* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).~* The subjects CYP2D6 genotype must be determined before inclusion into the study.~* Women must not be pregnant or lactating.~Exclusion Criteria:~* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 132, Unnamed: 0: 155, NCT Number: NCT02281591, Study Title: Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine, Study URL: https://clinicaltrials.gov/study/NCT02281591, Acronym: , Study Status: COMPLETED, Brief Summary: Single centre, open-label, randomised study in four parallel groups of healthy volunteers, Study Results: YES, Conditions: Epilepsy, Interventions: DRUG: BIA 2-093|DRUG: S-licarbazepine|DRUG: R-licarbazepine, Primary Outcome Measures: Cmax - the Maximum Plasma Concentration, Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|Tmax - the Time of Occurrence of Cmax, Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose., Secondary Outcome Measures: AUC0-t - the Area Under the Plasma Concentration-time Curve to Last Measurable Time Point, Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose., Other Outcome Measures: , Sponsor: Bial - Portela C S.A., Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 32.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT, Other IDs: BIA-2093-115, Start Date: 2006-06, Primary Completion Date: 2006-07, Completion Date: 2006-07, First Posted: 2014-11-02, Results First Posted: 2014-12-03, Last Update Posted: 2014-12-03, Locations: Scope International Life Sciences AG,, Hamburg, D-22525, Germany, Study Documents: , criteria: "Inclusion Criteria~* Male or female subjects aged between 18 and 45 years, inclusive.~* Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.~* Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.~* Subjects who had clinical laboratory tests clinically acceptable at screening and admission.~* Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.~* Subjects who were negative for drugs of abuse and alcohol at screening and admission.~* Subjects who were non-smokers or who smoke \\\\< 10 cigarettes or equivalent per day.~* Subjects who are able and willing to give written informed consent.~* (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.~* (If female) She had a negative pregnancy test at screening and admission to Phase A.~Exclusion Criteria:~* Subjects who did not conform to the above inclusion criteria, OR~* Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.~* Subjects who had a clinically relevant surgical history.~* Subjects who had a clinically relevant family history.~* Subjects who had a history of relevant atopy.~* Subjects who had a history of relevant drug hypersensitivity (especially carbamazepine or oxcarbazepine).~* Subjects who had a history of alcoholism or drug abuse.~* Subjects who consumed more than 14 units of alcohol a week.~* Subjects who had a significant infection or known inflammatory process on screening or admission.", combined_text: Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine Cmax - the Maximum Plasma Concentration, Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|Tmax - the Time of Occurrence of Cmax, Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose. AUC0-t - the Area Under the Plasma Concentration-time Curve to Last Measurable Time Point, Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose. "Inclusion Criteria~* Male or female subjects aged between 18 and 45 years, inclusive.~* Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.~* Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.~* Subjects who had clinical laboratory tests clinically acceptable at screening and admission.~* Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.~* Subjects who were negative for drugs of abuse and alcohol at screening and admission.~* Subjects who were non-smokers or who smoke \\\\< 10 cigarettes or equivalent per day.~* Subjects who are able and willing to give written informed consent.~* (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.~* (If female) She had a negative pregnancy test at screening and admission to Phase A.~Exclusion Criteria:~* Subjects who did not conform to the above inclusion criteria, OR~* Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.~* Subjects who had a clinically relevant surgical history.~* Subjects who had a clinically relevant family history.~* Subjects who had a history of relevant atopy.~* Subjects who had a history of relevant drug hypersensitivity (especially carbamazepine or oxcarbazepine).~* Subjects who had a history of alcoholism or drug abuse.~* Subjects who consumed more than 14 units of alcohol a week.~* Subjects who had a significant infection or known inflammatory process on screening or admission.", Similarity Score: 0.15982748719060524}'}]
|
from_dataset
| 0.159827
|
[{'from': 'human', 'value': '{Study Title: Absolute Bioavailability of Lu AE58054 in Healthy Subjects, Primary Outcome Measures: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV, Intravenous (IV), Day 10|Ratio of (AUC0-24(PM)/AUC0-24(EM)), Poor Metaboliser (PM); Extensive Metaboliser (EM), Day 10, Secondary Outcome Measures: Number and frequency of adverse events, Standard clinical safety assessments, Up to Day 16|Number of subjects with adverse events, Adverse event monitoring, Up to Day 16|Risk of Suicidality, Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions, Up to Day 16, criteria: "Inclusion Criteria:~* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).~* The subjects CYP2D6 genotype must be determined before inclusion into the study.~* Women must not be pregnant or lactating.~Exclusion Criteria:~* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 494, Unnamed: 0: 608, NCT Number: NCT00945282, Study Title: Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults., Study URL: https://clinicaltrials.gov/study/NCT00945282, Acronym: , Study Status: COMPLETED, Brief Summary: GSK has in-licensed a novel NNRTI-class candidate (GSK2248761, IDX12899) for the treatment of subjects with HIV-1 infection from Idenix Pharmaceuticals. Idenix Pharmaceuticals completed a proof-of-concept study evaluating GSK2248761 monotherapy over seven days in forty treatment-naïve subjects infected with HIV-1. GSK2248761 doses sequentially evaluated were 800 mg QD, 400 mg QD, 200 mg QD and 100mg QD.\\n\\nThis study will evaluate a lower dose, or doses, of GSK2248761 to better characterize the dose-response and concentration-response curves. The results from this study will be used to select doses for future clinical studies in HIV-1 infected subjects., Study Results: YES, Conditions: Infection, Human Immunodeficiency Virus, Interventions: DRUG: GSK2248761|DRUG: Lopinavir/ritonavir|DRUG: HAART|DRUG: Placebo|DRUG: GSK2248761, Primary Outcome Measures: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs), An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An 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 disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury., Up to 38 days|Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count, The data for hematology parameters for Basophils, eosinophils, lymphocytes, monocytes, and white blood cell count from the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Hemoglobin, The data for hematology parameter hemoglobin from the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Platelet Count, The data for hematology parameter platelet count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Red Blood Cell Count, The data for hematology parameter red blood cell count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Parameters- Total Neutrophil, The data for hematology parameter total neutrophil count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Mean Corpuscle Hemoglobin (MCH), The data for hematology parameter MCH, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Mean Corpuscle Volume (MCV), The change from baseline data for hematology parameter MCV, was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Hematocrit, The data for hematology parameter Hematocrit, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters-Mean Corpuscle Hemoglobin Concentration, The data for hematology parameter Mean Corpuscle Hemoglobin concentration, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein, The data for clinical chemistry parameters Albumin and total protein, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin., The data for clinical chemistry parameters- Blood urea nitrogen, triglycerides, glucose, creatinine, calcium, cholesterol, total bilirubin, and direct bilirubin. The change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, The data for clinical chemistry paramaters- alkaline phosphatase, alanine amino transferase, aspartate amino transferase, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate, The data for clinical chemistry parameters- sodium, potassium and carbon dioxide or bicarbonate, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Phosphorus, The data for clinical chemistry paramaters- phosphorous, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Uric Acid, The data for clinical chemistry parameters Uric acid, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Thyroxine, Free, The data for clinical chemistry parameters Thyroxine, free the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3., The data for clinical chemistry parameters Thyroxine total, thyroxine binding globulin, Total T3 the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Number of Participants With Abnormal Electrocardiogram (ECG) Findings, Triplicate 12-lead ECGs were collected at different timepoints, after participants were supine for 5 minutes, during the study using an ECG machine that automatically calculated the heart rate (HR) and measures PR, QRS, QT, and QTc intervals. The three consecutive determinations were collected 5 plus or minus 2 minutes apart and all three tracings were recorded. The participants with abnormal values categorized as abnormal clinically significant (CS) and not clinically significant (NCS) were reported., Day 1, Day 4, Day 7, Day 8 and follow-up|Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Vital sign measurements for SBP and DBP after sitting for 5 minutes were measured. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 1, 4, 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in HR, Vital sign measurements for HR after sitting for 5 minutes were measured. The average mean values were measured. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 1 (4-hour), Day 4 (Pre-dose and 4 hour), Day 7 (pre-dose and 4-hour), Day 8 and follow up (Day 14)|Change From Baseline Through Day 8 in Plasma HIV-1 RNA, The quantitative analysis of plasma was done to evaluate the amount of HIV-1 RNA at Day 1,2,3,4,5,6,7, 8 and End of treatment visit. The quantification was done using a Polymerase chain reactor (PCR). The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose Day 1) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose Day 1) to Day 8|Change From Baseline to Nadir in Plasma HIV-1 RNA, The quantification of plasma HIV-1 RNA, was conducted for the change from baseline to on treatment nadir (maximum change) before starting HAART or Kaletra monotherapy on Day 8. The quantification was done using a PCR. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose Day 1) to Day 8|HIV-1 Rate of Decline by Treatment, The rate of decrease in the viral load of HIV-1 virus in response to individual treatment was measured. The viral load data was assumed to have a log normal prior distribution and followed linear decline with non-informative conjugate prior densities. The rate of decline (slope of the day) for each treatment was measured using a PCR from Day 1 to Day 8. The slope has been reported as mean., Day 1 to Day 8|GSK2248761 Pharmacokinetic (PK) Parameters Following Dose Administration on Day 1: Area Under the Plasma Concentration Time Curve 0 to Infinite (AUC[0-∞]) and Area Under the Plasma Concentration Time Curve (AUC [0-24]), AUC (0-24), measured the plasma concentration of GSK2248761 against time, from time zero (pre-dose) to 24 hrs post-dose AUC (0-24) and from time zero to extrapolated infinite time AUC (0-∞). Serial blood samples were collected on Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis., Day 1 (Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)|GSK2248761 PK Parameters Following Dose Administration on Day 1: Maximum Observed Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24), Cmax represents the maximum concentration of GSK2248761 in the plasma. C24 is defined as the measure of plasma drug concentration of GSK2248761, 24 hours post dose, determined on Day 1. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis.Data for dose normalized Cmax and C24 was reported., Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours)|GSK2248761 PK Parameters Following Dose Administration on Day 7: Predose Concentration (C0), Concentration at End of Dosing Interval (Cτ), Minimum Observed Concentration During One Dosing Interval (Cmin) and Cmax, The C0 was defined as the concentration of drug in plasma, before dose administration on Day 7. Cτ, was defined as the concentration of drug in the plasma at the end of dosing interval. The Cmin was defined as the minimum concentration of the drug in plasma during one dosing interval on Day 7. Cmax represents the maximum concentration of GSK2248761 in the plasma on Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis., Day 7 (Pre -dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)|GSK2248761 PK Parameters Following Dose Administration on Day 1: Time to Maximum Observed Concentration (Tmax), Terminal Half-life (t1/2), Absorption Lag Time (Tlag), Tmax is defined as the, time of maximum measured GSK2248761 concentration in the plasma, on Day 1. The t1/2 was defined as the time measured for plasma concentration to decrease by one half. The tlag was defined as the time taken for the drug GSK2248761, to appear in the systemic circulation following administration. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis., Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose)|GSK2248761 PK Parameters Following Dose Administration on Day 1: Apparent Clearance (CL/F), The Clearance factor was defined as the volume of plasma cleared of the drug GSK2248761, per unit time. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis., Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)|GSK2248761 PK Parameters Following Dose Administration on Day 7: AUC(0-τ), AUC(0-τ) is the AUC to the end of dosing period. For Day 7, it is the AUC measured at the end of the dosing period at Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis., Day 7 (Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose)|GSK2248761 PK Parameters Following Dose Administration on Day 7: Tmax, Tmax is defined as the, time of maximum measured GSK2248761 concentration in the plasma, on Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis, Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose)|GSK2248761 PK Parameters Following Dose Administration on Day 7: t1/2, The t1/2 was defined as the time measured for plasma concentration to decrease by one half. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis, Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose)|Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day1 and Day 8., Whole venous blood samples were obtained from each participant for the analysis of lymphocyte subsets by flow cytometry (total lymphocyte counts, percentage, CD4+ cell counts, and CD8+ cell counts) at Screening, Day 1 and Day 8. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values (Day 1 and Day 8). Baseline was defined as Screening., Baseline (Screening), Day 1 and Day 8, Secondary Outcome Measures: Percent Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day 1 and Day 8, Data for CD4+ and CD8+ cells was collected at Screening, Day 1 and Day 8. The percent change from baseline was reported at Day 1 and Day 8. Baseline was defined as Screening. The percent change from baseline was calculated as post-randomization value minus the baseline value., Baseline (Screening), Day 1 and Day 8|Accumulation Ratio for AUC , Cmax, Cτ, and Time Invariance Ratio Following Repeat Administration, The accumulation ratio is based on the parameters, Cmax, AUC(0-tau), AUC(0-24), C(tau), C24, AND AUC(0-inf). The accumulation ratio Ro was the ratio of AUC(0-tau) on Day 7 to that of AUC(0-24) on Day 1; the accumulation ratio R (Cmax) was the ratio of Cmax on Day 7 to that of Cmax on Day 1; the accumulation ratio R(Ctau) was the ratio of Ctau on Day 7 to the ratio of C24 on Day 1 and the Time Invariance Ratio Rs was defined as the ratio of AUC(0-tau) on Day 7 to that of AUC(0-inf) on Day 1. The ratio has been reported as number., (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) on Day 1 and Day 7|Change From Baseline in Reverse Transcriptase Sequences of HIV-1 at Day 8, None of the participants had non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations at codons 90, 98, 100, 101, 103, 106, 108, 138, 179, 181, 188, 190, 225, or 230 at either Day 1 or Day 8. No mutation selected by GSK2248761 in vitro was observed for any participant at either Day 1 or Day 8. This data for "Change from baseline in reverse transcriptase sequences of HIV-1 at Day 8" not collected., Baseline (Screening) and Day 8|Assessment of the Achievement of Pre-dose GSK2248761 Steady State Concentration Following Repeat Dose Administration on Day 2 Through 7, The pre-dose GSK2248761 steady state concentration, following repeated dose administration from Day 2 through Day 7 was assessed. Serial dose sampling was done on each day of Day 2, 3, 4, 5 and Day 6 and for Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose), before the administration of the study drug daily., Day 7 (Pre - dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose) and Days 2, 3, 4. 5 and 6: pre-dose only|PK Data of Day 1 AUC(0-inf) and Day 7 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality, Data for IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg for Day 1 and Day 2 were taken from the Idenix NV-05A-002 study which were combined with GSK2248761 30 mg once daily data from this study, to assess the dose proportionality. The dose proportionality occurred when increase in the administered doses were accompanied by proportional increases in measure of exposure of the drug in the plasma PK parameters like AUC, Cmax, Ctau and other factors. The dose proportionality effects of IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg, following repeat dose administration on Day 7 for the PK parameter AUC(0-tau) has been reported., (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) From Day 1 to Up to Day 7|PK Data of Cmax and Ctau at Different Doses for the Assessment of Dose Proportionality, Data for IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg for Day 1 and Day 2 were taken from the Idenix NV-05A-002 study which were combined with GSK2248761 30 mg once daily data from this study, to assess the dose proportionality. The dose proportionality occurred when increase in the administered doses were accompanied by proportional increases in measure of exposure of the drug in the plasma PK parameters like AUC, Cmax, Ctau and other factors. Data for Ctau on Day 1 is presented for concentration at 24 hours post-dose on Day 1., (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) From Day 1 to Up to Day 7, Other Outcome Measures: , Sponsor: ViiV Healthcare, Collaborators: GlaxoSmithKline, Sex: ALL, Age: ADULT, OLDER_ADULT, Phases: PHASE2, Enrollment: 8.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT, Other IDs: 113020, Start Date: 2009-10-20, Primary Completion Date: 2009-11-28, Completion Date: 2009-11-28, First Posted: 2009-07-24, Results First Posted: 2018-11-29, Last Update Posted: 2018-11-29, Locations: GSK Investigational Site, Buenos Aires, B1602DBG, Argentina, Study Documents: , criteria: "Inclusion Criteria:~* Male or Female, 21 to 65 years of age.~* Female of non-childbearing potential defined as: being post-menopausal, defined as 12 months of spontaneous amenorrhea and having a serum FSH level \\\\>40 MIU/ml at Screening OR have had a documented bilateral tubal ligation or hysterectomy of at least 6 months prior to study initiation, bilateral oophorectomy or bilateral tubal ligation.~* Plasma HIV-1 RNA value \\\\>= 5000 copies/mL.~* CD4+ count \\\\>= 200 cells/mm3.~* Is antiretroviral treatment-naïve and agrees not to start antiretroviral therapy prior to clinic check-in (Day-1).~* Subject agrees to start a standard HAART regimen on Day 8 of the study or Kaletra monotherapy for 28 days within 24 hours after the last dose of study medication.~* Capable of giving written informed consent, which includes being willing and able to comply with the requirements and restrictions listed in the consent form.~Exclusion Criteria:~* Subject is pregnant as determined by a positive urine/serum pregnancy test at Screening and Day -1.~* Lactating females.~* Male subjects of reproductive potential and unwilling to use double barrier method of contraception (e.g., condom plus spermicide) and continue to use an adequate method of birth control for at least 30 days after the last dose of the study drug.~* Has a positive screening Hepatitis B surface antigen, positive screening Hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) on subsequent testing. If the Hepatitis C antibody is positive but the HCV RNA is undetectable, the subject may be included in the study.~* History of regular alcohol consumption within 6 months of Screening as defined as: an average weekly intake of \\\\>21 units for males or \\\\>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\\\\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits~* Has a positive pre-study drug screen. Drugs that will be screened for include amphetamines, barbiturates, cocaine and PCP.~* History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the Principal Investigator, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.~Note: Study drugs include GSK2248761 placebo or the follow-up HAART or Kaletra therapy.~* Received an immunomodulating agent (e.g., interleukin-2) or immunotherapeutic vaccine within 30 days before Day -1.~* Requires a medication that is a known substrate, inhibitor and/or inducer of CYP3A4.~* Has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dosing day.~* Has ever had an AIDS-defining illness.~* Has a history of or has a currently active clinically important disease other than HIV-1 infection that, in the opinion of the Investigator, may put the subject at risk because of participation in this study (including renal and hepatic impairment, active infections including tuberculosis or opportunistic infection, malignancy and cardiac dysfunction).~* Has an intestinal malabsorption (e.g., structural defects, digestive failure, enzyme deficiencies, etc).~* Has a pre-existing NNRTI drug resistance based on genotyping at Screening.~* Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.~* Subject has any of the following laboratory parameters at Screening (a single repeat is allowed for eligibility determination): Hemoglobin \\\\<8.5 g/dL, Neutrophil count \\\\<1000 cells/mm3, Platelet count \\\\<100,000 cells/mm3, Serum creatinine \\\\> the upper limit of normal (ULN), AST or ALT \\\\<= 2.5 x ULN.~* Exclusion Criteria for Screening ECG (A single repeat is allowed for eligibility determination): Exclusion Criteria for Screening ECG: Heart rate: (males) \\\\<45 and \\\\>100 bpm (females) \\\\<50 and \\\\>100 bpm, QRS duration: \\\\>120 msec, QTc interval (Bazett): \\\\> 450 msec. Non-sustained (\\\\>= 3 consecutive beats) or sustained ventricular tachycardia. Sinus Pauses \\\\>2.5 seconds. 2nd degree (Type II) or higher AV block. Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization)).", combined_text: Safety and Tolerability Study to Evaluate Lower Dose of GSK2248761 in Antiretroviral Treatment-Naive HIV-1 Infected Adults. Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs), An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An 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 disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury., Up to 38 days|Change From Baseline in Hematology Paramaters- Basophils, Eosinophils, Lymphocytes, Monocytes, White Blood Cell Count, The data for hematology parameters for Basophils, eosinophils, lymphocytes, monocytes, and white blood cell count from the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Hemoglobin, The data for hematology parameter hemoglobin from the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Platelet Count, The data for hematology parameter platelet count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Red Blood Cell Count, The data for hematology parameter red blood cell count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Parameters- Total Neutrophil, The data for hematology parameter total neutrophil count, for the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Mean Corpuscle Hemoglobin (MCH), The data for hematology parameter MCH, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Mean Corpuscle Volume (MCV), The change from baseline data for hematology parameter MCV, was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters- Hematocrit, The data for hematology parameter Hematocrit, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Hematology Paramaters-Mean Corpuscle Hemoglobin Concentration, The data for hematology parameter Mean Corpuscle Hemoglobin concentration, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Albumin and Total Protein, The data for clinical chemistry parameters Albumin and total protein, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Parameters- Blood Urea Nitrogen, Triglycerides, Glucose, Creatinine, Calcium, Cholesterol, Total Bilirubin, and Direct Bilirubin., The data for clinical chemistry parameters- Blood urea nitrogen, triglycerides, glucose, creatinine, calcium, cholesterol, total bilirubin, and direct bilirubin. The change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, The data for clinical chemistry paramaters- alkaline phosphatase, alanine amino transferase, aspartate amino transferase, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters-sodium, Potassium and Carbondioxide or Bicarbonate, The data for clinical chemistry parameters- sodium, potassium and carbon dioxide or bicarbonate, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Phosphorus, The data for clinical chemistry paramaters- phosphorous, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Uric Acid, The data for clinical chemistry parameters Uric acid, the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Thyroxine, Free, The data for clinical chemistry parameters Thyroxine, free the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in Clinical Chemistry Paramaters- Thyroxine Total, Thyroxine Binding Globulin, Total T3., The data for clinical chemistry parameters Thyroxine total, thyroxine binding globulin, Total T3 the change from baseline was reported. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 2, 4 , 7 , Day 8 and Follow-up (Day 14)|Number of Participants With Abnormal Electrocardiogram (ECG) Findings, Triplicate 12-lead ECGs were collected at different timepoints, after participants were supine for 5 minutes, during the study using an ECG machine that automatically calculated the heart rate (HR) and measures PR, QRS, QT, and QTc intervals. The three consecutive determinations were collected 5 plus or minus 2 minutes apart and all three tracings were recorded. The participants with abnormal values categorized as abnormal clinically significant (CS) and not clinically significant (NCS) were reported., Day 1, Day 4, Day 7, Day 8 and follow-up|Change From Baseline in Vital Signs-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Vital sign measurements for SBP and DBP after sitting for 5 minutes were measured. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 1, 4, 7 , Day 8 and Follow-up (Day 14)|Change From Baseline in HR, Vital sign measurements for HR after sitting for 5 minutes were measured. The average mean values were measured. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose \\\\[Screening, Day -1 or Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose at Day -1 or Day 1) and Day 1 (4-hour), Day 4 (Pre-dose and 4 hour), Day 7 (pre-dose and 4-hour), Day 8 and follow up (Day 14)|Change From Baseline Through Day 8 in Plasma HIV-1 RNA, The quantitative analysis of plasma was done to evaluate the amount of HIV-1 RNA at Day 1,2,3,4,5,6,7, 8 and End of treatment visit. The quantification was done using a Polymerase chain reactor (PCR). The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose Day 1) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose Day 1) to Day 8|Change From Baseline to Nadir in Plasma HIV-1 RNA, The quantification of plasma HIV-1 RNA, was conducted for the change from baseline to on treatment nadir (maximum change) before starting HAART or Kaletra monotherapy on Day 8. The quantification was done using a PCR. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. Baseline (pre-dose Day 1\\\\]) was defined as last available scheduled assessment prior to time of the first dose unless it is specified otherwise., Baseline (pre-dose Day 1) to Day 8|HIV-1 Rate of Decline by Treatment, The rate of decrease in the viral load of HIV-1 virus in response to individual treatment was measured. The viral load data was assumed to have a log normal prior distribution and followed linear decline with non-informative conjugate prior densities. The rate of decline (slope of the day) for each treatment was measured using a PCR from Day 1 to Day 8. The slope has been reported as mean., Day 1 to Day 8|GSK2248761 Pharmacokinetic (PK) Parameters Following Dose Administration on Day 1: Area Under the Plasma Concentration Time Curve 0 to Infinite (AUC[0-∞]) and Area Under the Plasma Concentration Time Curve (AUC [0-24]), AUC (0-24), measured the plasma concentration of GSK2248761 against time, from time zero (pre-dose) to 24 hrs post-dose AUC (0-24) and from time zero to extrapolated infinite time AUC (0-∞). Serial blood samples were collected on Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis., Day 1 (Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)|GSK2248761 PK Parameters Following Dose Administration on Day 1: Maximum Observed Concentration (Cmax) and Concentration at 24 Hours Post Dose (C24), Cmax represents the maximum concentration of GSK2248761 in the plasma. C24 is defined as the measure of plasma drug concentration of GSK2248761, 24 hours post dose, determined on Day 1. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis.Data for dose normalized Cmax and C24 was reported., Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours)|GSK2248761 PK Parameters Following Dose Administration on Day 7: Predose Concentration (C0), Concentration at End of Dosing Interval (Cτ), Minimum Observed Concentration During One Dosing Interval (Cmin) and Cmax, The C0 was defined as the concentration of drug in plasma, before dose administration on Day 7. Cτ, was defined as the concentration of drug in the plasma at the end of dosing interval. The Cmin was defined as the minimum concentration of the drug in plasma during one dosing interval on Day 7. Cmax represents the maximum concentration of GSK2248761 in the plasma on Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis., Day 7 (Pre -dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)|GSK2248761 PK Parameters Following Dose Administration on Day 1: Time to Maximum Observed Concentration (Tmax), Terminal Half-life (t1/2), Absorption Lag Time (Tlag), Tmax is defined as the, time of maximum measured GSK2248761 concentration in the plasma, on Day 1. The t1/2 was defined as the time measured for plasma concentration to decrease by one half. The tlag was defined as the time taken for the drug GSK2248761, to appear in the systemic circulation following administration. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis., Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose)|GSK2248761 PK Parameters Following Dose Administration on Day 1: Apparent Clearance (CL/F), The Clearance factor was defined as the volume of plasma cleared of the drug GSK2248761, per unit time. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 1 and used for analysis., Day 1 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose)|GSK2248761 PK Parameters Following Dose Administration on Day 7: AUC(0-τ), AUC(0-τ) is the AUC to the end of dosing period. For Day 7, it is the AUC measured at the end of the dosing period at Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis., Day 7 (Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose)|GSK2248761 PK Parameters Following Dose Administration on Day 7: Tmax, Tmax is defined as the, time of maximum measured GSK2248761 concentration in the plasma, on Day 7. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis, Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose)|GSK2248761 PK Parameters Following Dose Administration on Day 7: t1/2, The t1/2 was defined as the time measured for plasma concentration to decrease by one half. Serial blood samples were collected on Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose on Day 7 and used for analysis, Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose)|Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day1 and Day 8., Whole venous blood samples were obtained from each participant for the analysis of lymphocyte subsets by flow cytometry (total lymphocyte counts, percentage, CD4+ cell counts, and CD8+ cell counts) at Screening, Day 1 and Day 8. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values (Day 1 and Day 8). Baseline was defined as Screening., Baseline (Screening), Day 1 and Day 8 Percent Change From Baseline in CD4+ and CD8+ T-lymphocyte Cell Count at Day 1 and Day 8, Data for CD4+ and CD8+ cells was collected at Screening, Day 1 and Day 8. The percent change from baseline was reported at Day 1 and Day 8. Baseline was defined as Screening. The percent change from baseline was calculated as post-randomization value minus the baseline value., Baseline (Screening), Day 1 and Day 8|Accumulation Ratio for AUC , Cmax, Cτ, and Time Invariance Ratio Following Repeat Administration, The accumulation ratio is based on the parameters, Cmax, AUC(0-tau), AUC(0-24), C(tau), C24, AND AUC(0-inf). The accumulation ratio Ro was the ratio of AUC(0-tau) on Day 7 to that of AUC(0-24) on Day 1; the accumulation ratio R (Cmax) was the ratio of Cmax on Day 7 to that of Cmax on Day 1; the accumulation ratio R(Ctau) was the ratio of Ctau on Day 7 to the ratio of C24 on Day 1 and the Time Invariance Ratio Rs was defined as the ratio of AUC(0-tau) on Day 7 to that of AUC(0-inf) on Day 1. The ratio has been reported as number., (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) on Day 1 and Day 7|Change From Baseline in Reverse Transcriptase Sequences of HIV-1 at Day 8, None of the participants had non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance mutations at codons 90, 98, 100, 101, 103, 106, 108, 138, 179, 181, 188, 190, 225, or 230 at either Day 1 or Day 8. No mutation selected by GSK2248761 in vitro was observed for any participant at either Day 1 or Day 8. This data for "Change from baseline in reverse transcriptase sequences of HIV-1 at Day 8" not collected., Baseline (Screening) and Day 8|Assessment of the Achievement of Pre-dose GSK2248761 Steady State Concentration Following Repeat Dose Administration on Day 2 Through 7, The pre-dose GSK2248761 steady state concentration, following repeated dose administration from Day 2 through Day 7 was assessed. Serial dose sampling was done on each day of Day 2, 3, 4, 5 and Day 6 and for Day 7 (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose), before the administration of the study drug daily., Day 7 (Pre - dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose) and Days 2, 3, 4. 5 and 6: pre-dose only|PK Data of Day 1 AUC(0-inf) and Day 7 AUC(0-tau) at Different Doses for the Assessment of Dose Proportionality, Data for IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg for Day 1 and Day 2 were taken from the Idenix NV-05A-002 study which were combined with GSK2248761 30 mg once daily data from this study, to assess the dose proportionality. The dose proportionality occurred when increase in the administered doses were accompanied by proportional increases in measure of exposure of the drug in the plasma PK parameters like AUC, Cmax, Ctau and other factors. The dose proportionality effects of IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg, following repeat dose administration on Day 7 for the PK parameter AUC(0-tau) has been reported., (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) From Day 1 to Up to Day 7|PK Data of Cmax and Ctau at Different Doses for the Assessment of Dose Proportionality, Data for IDX899 100 mg, IDX899 200 mg, IDX899 400 mg and IDX899 800 mg for Day 1 and Day 2 were taken from the Idenix NV-05A-002 study which were combined with GSK2248761 30 mg once daily data from this study, to assess the dose proportionality. The dose proportionality occurred when increase in the administered doses were accompanied by proportional increases in measure of exposure of the drug in the plasma PK parameters like AUC, Cmax, Ctau and other factors. Data for Ctau on Day 1 is presented for concentration at 24 hours post-dose on Day 1., (Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose ) From Day 1 to Up to Day 7 "Inclusion Criteria:~* Male or Female, 21 to 65 years of age.~* Female of non-childbearing potential defined as: being post-menopausal, defined as 12 months of spontaneous amenorrhea and having a serum FSH level \\\\>40 MIU/ml at Screening OR have had a documented bilateral tubal ligation or hysterectomy of at least 6 months prior to study initiation, bilateral oophorectomy or bilateral tubal ligation.~* Plasma HIV-1 RNA value \\\\>= 5000 copies/mL.~* CD4+ count \\\\>= 200 cells/mm3.~* Is antiretroviral treatment-naïve and agrees not to start antiretroviral therapy prior to clinic check-in (Day-1).~* Subject agrees to start a standard HAART regimen on Day 8 of the study or Kaletra monotherapy for 28 days within 24 hours after the last dose of study medication.~* Capable of giving written informed consent, which includes being willing and able to comply with the requirements and restrictions listed in the consent form.~Exclusion Criteria:~* Subject is pregnant as determined by a positive urine/serum pregnancy test at Screening and Day -1.~* Lactating females.~* Male subjects of reproductive potential and unwilling to use double barrier method of contraception (e.g., condom plus spermicide) and continue to use an adequate method of birth control for at least 30 days after the last dose of the study drug.~* Has a positive screening Hepatitis B surface antigen, positive screening Hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) on subsequent testing. If the Hepatitis C antibody is positive but the HCV RNA is undetectable, the subject may be included in the study.~* History of regular alcohol consumption within 6 months of Screening as defined as: an average weekly intake of \\\\>21 units for males or \\\\>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\\\\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits~* Has a positive pre-study drug screen. Drugs that will be screened for include amphetamines, barbiturates, cocaine and PCP.~* History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the Principal Investigator, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.~Note: Study drugs include GSK2248761 placebo or the follow-up HAART or Kaletra therapy.~* Received an immunomodulating agent (e.g., interleukin-2) or immunotherapeutic vaccine within 30 days before Day -1.~* Requires a medication that is a known substrate, inhibitor and/or inducer of CYP3A4.~* Has received an investigational drug or participated in any other research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dosing day.~* Has ever had an AIDS-defining illness.~* Has a history of or has a currently active clinically important disease other than HIV-1 infection that, in the opinion of the Investigator, may put the subject at risk because of participation in this study (including renal and hepatic impairment, active infections including tuberculosis or opportunistic infection, malignancy and cardiac dysfunction).~* Has an intestinal malabsorption (e.g., structural defects, digestive failure, enzyme deficiencies, etc).~* Has a pre-existing NNRTI drug resistance based on genotyping at Screening.~* Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.~* Subject has any of the following laboratory parameters at Screening (a single repeat is allowed for eligibility determination): Hemoglobin \\\\<8.5 g/dL, Neutrophil count \\\\<1000 cells/mm3, Platelet count \\\\<100,000 cells/mm3, Serum creatinine \\\\> the upper limit of normal (ULN), AST or ALT \\\\<= 2.5 x ULN.~* Exclusion Criteria for Screening ECG (A single repeat is allowed for eligibility determination): Exclusion Criteria for Screening ECG: Heart rate: (males) \\\\<45 and \\\\>100 bpm (females) \\\\<50 and \\\\>100 bpm, QRS duration: \\\\>120 msec, QTc interval (Bazett): \\\\> 450 msec. Non-sustained (\\\\>= 3 consecutive beats) or sustained ventricular tachycardia. Sinus Pauses \\\\>2.5 seconds. 2nd degree (Type II) or higher AV block. Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization)).", Similarity Score: 0.1597060820955274}'}]
|
from_dataset
| 0.159706
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[{'from': 'human', 'value': '{Study Title: Absolute Bioavailability of Lu AE58054 in Healthy Subjects, Primary Outcome Measures: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV, Intravenous (IV), Day 10|Ratio of (AUC0-24(PM)/AUC0-24(EM)), Poor Metaboliser (PM); Extensive Metaboliser (EM), Day 10, Secondary Outcome Measures: Number and frequency of adverse events, Standard clinical safety assessments, Up to Day 16|Number of subjects with adverse events, Adverse event monitoring, Up to Day 16|Risk of Suicidality, Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions, Up to Day 16, criteria: "Inclusion Criteria:~* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).~* The subjects CYP2D6 genotype must be determined before inclusion into the study.~* Women must not be pregnant or lactating.~Exclusion Criteria:~* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 71, Unnamed: 0: 79, NCT Number: NCT05732194, Study Title: Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers, Study URL: https://clinicaltrials.gov/study/NCT05732194, Acronym: , Study Status: RECRUITING, Brief Summary: The study will be conducted as a single-center, randomized, double-blind, placebo-controlled, ascending dose study in up to 4 sequential cohorts of healthy subjects. Each cohort will enroll 8 subjects: 6 subjects will receive ITI-333 and 2 subjects will receive placebo once daily for 14 days., Study Results: NO, Conditions: Healthy Volunteers, Interventions: DRUG: ITI-333|OTHER: Placebo, Primary Outcome Measures: Pharmacokinetics: AUC0-tau, Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval, predose and multiple timepoints up to 24 hours postdose on Days 1 and 14|Pharmacokinetics: Cmax, Maximum plasma concentration of ITI-333 and its metabolites over a dosing interval, predose and multiple timepoints up to 24 and 72 hours postdose on Days 1 and 14, respectively|Pharmacokinetics: Tmax, Time of maximum plasma concentration of ITI-333 and its metabolites over a dosing interval, predose and multiple timepoints up to 24 and 72 hours postdose on Days 1 and 14, respectively|Percentage of subjects with treatment-emergent adverse events, up to 30 days after last dose|Change from baseline in systolic and diastolic blood pressure, Up to Day 24|Change from baseline in SpO2, Up to Day 24|Change from baseline in ECG QT interval, Up to Day 24|Change from baseline in aspartate aminotransferase, Up to Day 24|Change from baseline in alanine aminotransferase, Up to Day 24, Secondary Outcome Measures: , Other Outcome Measures: , Sponsor: Intra-Cellular Therapies, Inc., Collaborators: National Institute on Drug Abuse (NIDA), Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 32.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT, Other IDs: ITI-333-002|1UG3DA047699-02, Start Date: 2023-01-18, Primary Completion Date: 2023-09, Completion Date: 2023-09, First Posted: 2023-02-16, Results First Posted: , Last Update Posted: 2023-03-03, Locations: Clinical Site 1, Miami, Florida, 33014-3616, United States, Study Documents: , criteria: "Key Inclusion Criteria:~* Healthy male and female subjects between 18 and 45 years old (inclusive);~* BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;~* Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator.~Key Exclusion Criteria:~* Clinically significant abnormality within 2 years of Screening that in the Investigator\\s opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;~* Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) \\\\< 96% and respiratory rate \\\\< 12 breaths per min;~* History of psychiatric condition that in the Investigator\\s opinion may be detrimental to participation in the study;~* CRP, ESR, or fibrinogen that are above normal reference ranges at Screening or Day 1.", combined_text: Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITI 333 in Healthy Volunteers Pharmacokinetics: AUC0-tau, Area under the plasma drug concentration-time curve (AUC) from time zero to the end of dosing interval, predose and multiple timepoints up to 24 hours postdose on Days 1 and 14|Pharmacokinetics: Cmax, Maximum plasma concentration of ITI-333 and its metabolites over a dosing interval, predose and multiple timepoints up to 24 and 72 hours postdose on Days 1 and 14, respectively|Pharmacokinetics: Tmax, Time of maximum plasma concentration of ITI-333 and its metabolites over a dosing interval, predose and multiple timepoints up to 24 and 72 hours postdose on Days 1 and 14, respectively|Percentage of subjects with treatment-emergent adverse events, up to 30 days after last dose|Change from baseline in systolic and diastolic blood pressure, Up to Day 24|Change from baseline in SpO2, Up to Day 24|Change from baseline in ECG QT interval, Up to Day 24|Change from baseline in aspartate aminotransferase, Up to Day 24|Change from baseline in alanine aminotransferase, Up to Day 24 "Key Inclusion Criteria:~* Healthy male and female subjects between 18 and 45 years old (inclusive);~* BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;~* Willingness to remain in the clinic for the inpatient portion of the study and return for follow-up visit(s) as required by protocol and as deemed necessary by the Investigator.~Key Exclusion Criteria:~* Clinically significant abnormality within 2 years of Screening that in the Investigator\\s opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, GI, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;~* Clinically significant abnormal findings in vital sign assessments, including blood oxygen saturation (SpO2) \\\\< 96% and respiratory rate \\\\< 12 breaths per min;~* History of psychiatric condition that in the Investigator\\s opinion may be detrimental to participation in the study;~* CRP, ESR, or fibrinogen that are above normal reference ranges at Screening or Day 1.", Similarity Score: 0.15352482130129963}'}]
|
from_dataset
| 0.153525
|
[{'from': 'human', 'value': '{Study Title: Absolute Bioavailability of Lu AE58054 in Healthy Subjects, Primary Outcome Measures: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV, Intravenous (IV), Day 10|Ratio of (AUC0-24(PM)/AUC0-24(EM)), Poor Metaboliser (PM); Extensive Metaboliser (EM), Day 10, Secondary Outcome Measures: Number and frequency of adverse events, Standard clinical safety assessments, Up to Day 16|Number of subjects with adverse events, Adverse event monitoring, Up to Day 16|Risk of Suicidality, Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions, Up to Day 16, criteria: "Inclusion Criteria:~* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).~* The subjects CYP2D6 genotype must be determined before inclusion into the study.~* Women must not be pregnant or lactating.~Exclusion Criteria:~* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.~Other inclusion and exclusion criteria may apply."}'}, {'from': 'gpt', 'value': '{Unnamed: 0.1: 478, Unnamed: 0: 586, NCT Number: NCT00833482, Study Title: Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants, Study URL: https://clinicaltrials.gov/study/NCT00833482, Acronym: , Study Status: COMPLETED, Brief Summary: This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100 mg once daily (QD), in healthy participants with functional CYP2C19 alleles. The study also reviews the effects of atazanavir/ritonavir, 300/100 mg QD, on the pharmacokinetics of voriconazole, 200 mg, BID in healthy participants with functional CYP2C19 alleles., Study Results: YES, Conditions: Human Immunodeficiency Virus Type 1 (HIV-1)|HIV Infections, Interventions: DRUG: Voriconazole|DRUG: Atazanavir|DRUG: Ritonavir, Primary Outcome Measures: Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in Participants Who Are Extensive Metabolizers (EM), EM participants are those with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|Time to Maximum Concentration (Tmax) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants, EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|Area Under the Plasma Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] of Atazanavir Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants, EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|Tmax of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants, Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|Cmax and Cmin of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants, Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|AUC(TAU)of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants, AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle, Secondary Outcome Measures: Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants, Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants, Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants, AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE, AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization., Days 1 to 31 (discharge), continuously|Number of Participants With Marked Abnormalities in Serum Chemistry Test Results, LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: AST and ALT: If \\\\>1.25\\\\*ULN, or if preRX\\\\>ULN, use \\\\>1.25\\\\*preRX. Total and direct bilirubin: If \\\\>1.1\\\\*ULN or if preRX\\\\>ULN, use \\\\>1.25\\\\*preRX. Creatinine: If \\\\>1.33\\\\*preRX. Serum glucose, fasting: If preRX\\\\<LLN, use \\\\<.8\\\\*preRX or \\\\>ULN; if preRX\\\\>ULN, use \\\\>2\\\\*preRX or \\\\<LLN. Creatinine kinase: If \\\\>1.5\\\\*ULN or preRX\\\\>ULN, use \\\\>1.5\\\\*or preRX. Lactose dehydrogenase: If \\\\>1.25\\\\*ULN or preRX\\\\>ULN, use \\\\>1.5\\\\*preRX., Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results, LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: Neutrophils + bands: If \\\\<.85\\\\*LLN or \\\\>1.15\\\\*ULN or ULN or if preRX\\\\<LLN, use \\\\<0.85\\\\*preRX or \\\\>ULN; if preRX\\\\>ULN, use \\\\>1.15\\\\*preRX or \\\\<LLN. Lymphocytes, relative: If \\\\<0.85\\\\*LLN or \\\\>1.15\\\\*ULN, or if preRX \\\\<LLN, use \\\\<0.85\\\\*preRX or \\\\>ULN; if preRX \\\\>ULN, use \\\\>1.15\\\\*preRX or \\\\<LLN. Blood, urine: If \\\\>= 2+, or if preRX \\\\>=1+, use \\\\>=2\\\\*preRX. White blood cells, urine: If \\\\>=2+, or if preRX \\\\>=2+, use \\\\>=4+. Red blood cells, urine: If \\\\>=2+ or if preRX \\\\>=2+, use \\\\>=4+. Not all categories were evaluated for each arm., Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator, volt=voltage; LVH=left ventricular hypertrophy, Within 21 days of Day 1 and on Days -1, 21, and 31 (at discharge)|Number of Participants With Abnormalities in Vital Signs, Within 21 days of Day 1 and on Days -1, 1, 3, 11, 21, and 31 (at discharge), Other Outcome Measures: , Sponsor: Bristol-Myers Squibb, Collaborators: , Sex: ALL, Age: ADULT, Phases: PHASE1, Enrollment: 185.0, Funder Type: INDUSTRY, Study Type: INTERVENTIONAL, Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: , Other IDs: AI424-383|2009-009095-13, Start Date: 2009-09, Primary Completion Date: 2010-07, Completion Date: 2011-02, First Posted: 2009-02-02, Results First Posted: 2012-10-25, Last Update Posted: 2012-10-25, Locations: West Coast Clinical Trials, Llc, Cypress, California, 90630, United States|Local Institution, Nijmegen, 6425 GA, Netherlands, Study Documents: , criteria: "Inclusion Criteria:~* Healthy participants as determined by no clinically significant deviation from normal~* Body Mass Index (BMI) of 18 to 32 kg/m\\\\^2, inclusive. BMI=weight(kg)/height (m)\\\\^2~* Women who are not of childbearing potential (WOCBP)(ie, who are postmenopausal or surgically sterile) and men, ages 18 to 45 years, inclusive~Exclusion Criteria:~* WOCBP~* Sexually active fertile men not using effective birth control if their partners are WOCBP~* Proven or suspected acute hepatitis (within 12 months prior to the 1st dose)~* Any significant acute or chronic medical illness~* Any gastrointestinal surgery that could impact on the absorption of study drug~* Smoking more than 5 cigarettes per day~* History of any hemolytic disorders (including drug-induced hemolysis)~* History of acute or chronic pancreatitis~* History of hypochlorhydria or achlorhydria~* Men and women weighing \\\\<40 kg~* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 or HIV-2 antibody~* Patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption", combined_text: Drug Interactions Between Voriconazole and Atazanavir Coadministered as Atazanavir/Ritonavir in Healthy Participants Maximum Observed Plasma Concentration (Cmax) and Minimum Observed Plasma Concentration (Cmin) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in Participants Who Are Extensive Metabolizers (EM), EM participants are those with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|Time to Maximum Concentration (Tmax) of Atazanavir, Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants, EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|Area Under the Plasma Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] of Atazanavir Administered as Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants, EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|Tmax of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants, Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|Cmax and Cmin of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants, Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle|AUC(TAU)of Voriconazole, Administered With and Without Atazanavir/Ritonavir, in EM Participants, AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdoseDays 3 and 30 of a 30-day cycle Cmax and Cmin of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants, Cmax=maximum observed plasma concentration; Cmin=minimum observed plasma concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|Tmax of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants, Tmax=time to maximum concentration; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|AUC(TAU) of Ritonavir, Administered As Atazanavir/Ritonavir With and Without Voriconazole, in EM Participants, AUC(TAU)=area under the plasma concentration-time curve in 1 dosing interval; EM=extensive metabolizers, or participants with functional CYP2C19 alleles., Predose and at 1, 2, 3, 4, 5, 7, 9,13, and 24 hours postdose on Days 20 and 30 of a 30-day cycle|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Any AE, AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization., Days 1 to 31 (discharge), continuously|Number of Participants With Marked Abnormalities in Serum Chemistry Test Results, LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: AST and ALT: If \\\\>1.25\\\\*ULN, or if preRX\\\\>ULN, use \\\\>1.25\\\\*preRX. Total and direct bilirubin: If \\\\>1.1\\\\*ULN or if preRX\\\\>ULN, use \\\\>1.25\\\\*preRX. Creatinine: If \\\\>1.33\\\\*preRX. Serum glucose, fasting: If preRX\\\\<LLN, use \\\\<.8\\\\*preRX or \\\\>ULN; if preRX\\\\>ULN, use \\\\>2\\\\*preRX or \\\\<LLN. Creatinine kinase: If \\\\>1.5\\\\*ULN or preRX\\\\>ULN, use \\\\>1.5\\\\*or preRX. Lactose dehydrogenase: If \\\\>1.25\\\\*ULN or preRX\\\\>ULN, use \\\\>1.5\\\\*preRX., Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|Number of Participants With Marked Abnormalities in Hematology Laboratory Test and Urinalysis Results, LLN=lower limit of normal; ULN=upper limit of normal; preRX=pretreatment. Safety criteria: Neutrophils + bands: If \\\\<.85\\\\*LLN or \\\\>1.15\\\\*ULN or ULN or if preRX\\\\<LLN, use \\\\<0.85\\\\*preRX or \\\\>ULN; if preRX\\\\>ULN, use \\\\>1.15\\\\*preRX or \\\\<LLN. Lymphocytes, relative: If \\\\<0.85\\\\*LLN or \\\\>1.15\\\\*ULN, or if preRX \\\\<LLN, use \\\\<0.85\\\\*preRX or \\\\>ULN; if preRX \\\\>ULN, use \\\\>1.15\\\\*preRX or \\\\<LLN. Blood, urine: If \\\\>= 2+, or if preRX \\\\>=1+, use \\\\>=2\\\\*preRX. White blood cells, urine: If \\\\>=2+, or if preRX \\\\>=2+, use \\\\>=4+. Red blood cells, urine: If \\\\>=2+ or if preRX \\\\>=2+, use \\\\>=4+. Not all categories were evaluated for each arm., Within 21 days of Day 1 and on Days 3, 10, 20, 26, and 31 (at discharge)|Number of Participants With Investigator-identified Abnormalities in Electrocardiogram Results Not Present Prior to Administration of Study Drug and Considered Not Relevant and Not AEs by Investigator, volt=voltage; LVH=left ventricular hypertrophy, Within 21 days of Day 1 and on Days -1, 21, and 31 (at discharge)|Number of Participants With Abnormalities in Vital Signs, Within 21 days of Day 1 and on Days -1, 1, 3, 11, 21, and 31 (at discharge) "Inclusion Criteria:~* Healthy participants as determined by no clinically significant deviation from normal~* Body Mass Index (BMI) of 18 to 32 kg/m\\\\^2, inclusive. BMI=weight(kg)/height (m)\\\\^2~* Women who are not of childbearing potential (WOCBP)(ie, who are postmenopausal or surgically sterile) and men, ages 18 to 45 years, inclusive~Exclusion Criteria:~* WOCBP~* Sexually active fertile men not using effective birth control if their partners are WOCBP~* Proven or suspected acute hepatitis (within 12 months prior to the 1st dose)~* Any significant acute or chronic medical illness~* Any gastrointestinal surgery that could impact on the absorption of study drug~* Smoking more than 5 cigarettes per day~* History of any hemolytic disorders (including drug-induced hemolysis)~* History of acute or chronic pancreatitis~* History of hypochlorhydria or achlorhydria~* Men and women weighing \\\\<40 kg~* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 or HIV-2 antibody~* Patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption", Similarity Score: 0.15098460005229566}'}]
|
from_dataset
| 0.150985
|
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