TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Dose-finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
Brief Summary: The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.


Options:
A: Treatment response, assessed by the proportion of patients with platelet counts of =50, 000/µL (compared with baseline count of <30, 000/µL) after 42 days of treatment.
B: Number of Participants With Splenectomy During 52-Week Treatment Period (52 weeks); Number of Participants With Treatment Failure During 52-Week Treatment Period (52 weeks)
C: Percentage of Responders (Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment)
D: Number of Participants With Adverse Events (From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days); Number of Participants With Anti-romiplostim or Anti-endogenous Thrombopoietin Neutralizing Antibodies (Assessed on day 29 (Part A only), day 43 (Part B only), and day 78)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate Safety, Tolerability, and Immunogenicity of Leish-111f + MPL-SE Vaccine in Combination With Pentavalent Antimony in Treatment of Mucosal Leishmaniasis
Brief Summary: The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given as three injections every 28 days at each of three dose levels of Leish-111f protein, in combination with standard pentavalent antimony therapy in adult patients with mucosal leishmaniasis.


Options:
A: Change of Lesion size (6 months)
B: Proportion and severity of local adverse events of Anfoleish or Vehicle when applied three or two times per day. (At the end of treatment (Day 28)); Clinical cure rates in two regimens of Anfoleish: Three times a day and Two times a day (Day 90)
C: Complete Clinical Response (Until 6 months posttreatment); Failure (Until 3 months posttreatment)
D: Occurrence of dose-limiting toxicity; Adverse events

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-blind, Placebo-controlled, Single Bolus, Multinational, Multi-center, Parallel Group, Dose-ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke
Brief Summary: The purpose of this study is to evaluate desmoteplase (which is a manufactured protein derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of blood through one (or more) of the blood vessels supplying the brain, thereby reopening the blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic stroke.


Options:
A: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)
B: Clinical: Functional handicap (90 days); Proof of concept: Early neurological improvement (22-36 hours)
C: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS (Day 90); Change in lesion volume (Day 30)
D: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS (Day 90); Reperfusion after 4-8 h (8 h); Infarct lesion volume after 30 days (Day 30); Safety & pharmacokinetic outcomes (Day 90)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-blind, Placebo-controlled, Single Bolus, Multinational, Multi-center, Parallel Group, Dose-ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke
Brief Summary: The purpose of this study is to evaluate desmoteplase (which is a manufactured protein derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of blood through one (or more) of the blood vessels supplying the brain, thereby reopening the blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic stroke.


Options:
A: Modified Rankin Scale (mRS) 0-1 (3 months)
B: National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS (Day 90); Change in lesion volume (Day 30)
C: Primary Hypothesis - lesion growth; In patients with penumbra, there will be attenuation of lesion growth (outcome T2 lesion volume - acute DWI volume ) with tPA.
D: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-blind, Placebo-controlled, Single Bolus, Multinational, Multi-center, Parallel Group, Dose-ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke
Brief Summary: The purpose of this study is to evaluate desmoteplase (which is a manufactured protein derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of blood through one (or more) of the blood vessels supplying the brain, thereby reopening the blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic stroke.


Options:
A: National Institutes of Health Stroke Scale (NIHSS) (Change from Baseline to day 90); Modified Rankin Scale (MRS) (Day 90); Barthel Index (BI) score of 75-100. (Day 90)
B: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
C: To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. (3 months)
D: Functional Handicap (Modified Rankin Score) (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Exercise in Lymphoma Patients
Brief Summary: Objectives: The primary objective of this trial is to determine the effect of aerobic exercise training (AET) on change in quality of life (QoL) in lymphoma survivors receiving and not receiving chemotherapy. Secondary objectives are to determine the effects of AET on changes in psychosocial outcomes, cardiopulmonary fitness, body composition, and treatment completion rates.


Options:
A: Change in QoL between baseline and postintervention. (12 weeks)
B: Change in Physical activity Levels From Baseline to Month 1 and Month 3 (baseline, 1 month, 3 months)
C: Six Minute Walk Distance 6MWD (Change from baseline in 6MWD at 12 weeks)
D: Exercise Tolerance (Exercise tolerance 3 weeks after hospital discharge); Exercise Tolerance (Exercise tolerance 3 months after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Exercise in Lymphoma Patients
Brief Summary: Objectives: The primary objective of this trial is to determine the effect of aerobic exercise training (AET) on change in quality of life (QoL) in lymphoma survivors receiving and not receiving chemotherapy. Secondary objectives are to determine the effects of AET on changes in psychosocial outcomes, cardiopulmonary fitness, body composition, and treatment completion rates.


Options:
A: Change in QoL between baseline and postintervention. (12 weeks)
B: Six Minute Walk Distance 6MWD (Change from baseline in 6MWD at 12 weeks)
C: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)
D: Change from baseline in Exercise Levels (Baseline and within 7 days of completing the 12-week intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study of Neoadjuvant Chemotherapy Followed by Interval Cytoreductive Surgery for Stage III/IV Ovarian, Tubal and Peritoneal Cancers: JCOG0206
Brief Summary: A feasibility study of neoadjuvant chemotherapy (NAC) followed by interval cytoreductive surgery (ICS) and postoperative chemotherapy for stage III/IV mullerian carcinomas such as ovarian, tubal and peritoneal carcinomas.


Options:
A: overall survival (OS) (Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)
B: Evaluation and comparison of early surgical complications of primary surgery and Interval debulking surgery. (thirty days); Evaluation and comparison of late surgical complications of primary surgery and Interval debulking surgery (six months); Evaluation of the progression free survival (PFS) (Thirty-six months)
C: proportion of clinical complete remission
D: Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Phase II Clinical Trial of Activated Protein C (Xigris) Versus Placebo for the Treatment of Acute Lung Injury
Brief Summary: The purpose of this study is to test the efficacy of activated Protein C (Xigris) for improving clinical outcomes in individuals with acute lung injury (ALI).


Options:
A: Incidence of Pre-specified Infusion Associated Adverse Events (24 hours)
B: Mortality rates (measured at time of hospital discharge or 60 days after study entry)
C: Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion (6 hours); Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion (24 hours); Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths) (12 months)
D: Number of ventilator-free days (measured at Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Quitlink : A Leveraging Solution to Tobacco Counseling
Brief Summary: Primary: To test whether the delivery of A3-5 smoking cessation counseling (Assess, Assist, Arrange) in primary care offices is enhanced by a system that couples (1) an expanded vital sign intervention with (2) fax referral of preparation-stage patients for telephone counseling and (3) feedback to the provider. The question will be examined in a randomized trial, with practices as the unit of analysis and with a control intervention consisting of a conventional vital sign intervention. The experiment will therefore compare what intervention and control practices accomplish beyond simply identifying patients who use tobacco.

Secondary: To assess contextual factors that might affect implementation of the intervention and account for its ultimate success or failure. In particular, to assess: (1) environmental and practice-level factors that affect practices' ability to successfully implement and use the intervention and; (2) patient characteristics beyond readiness to change (i.e., age, gender, race/ethnicity) that affect willingness to use the quit line and complete counseling.


Options:
A: Quit line re-enrollment (At 6 months)
B: Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients
C: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)
D: Number of Participants With Cotinine-Validated Abstinence From Smoking (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Quitlink : A Leveraging Solution to Tobacco Counseling
Brief Summary: Primary: To test whether the delivery of A3-5 smoking cessation counseling (Assess, Assist, Arrange) in primary care offices is enhanced by a system that couples (1) an expanded vital sign intervention with (2) fax referral of preparation-stage patients for telephone counseling and (3) feedback to the provider. The question will be examined in a randomized trial, with practices as the unit of analysis and with a control intervention consisting of a conventional vital sign intervention. The experiment will therefore compare what intervention and control practices accomplish beyond simply identifying patients who use tobacco.

Secondary: To assess contextual factors that might affect implementation of the intervention and account for its ultimate success or failure. In particular, to assess: (1) environmental and practice-level factors that affect practices' ability to successfully implement and use the intervention and; (2) patient characteristics beyond readiness to change (i.e., age, gender, race/ethnicity) that affect willingness to use the quit line and complete counseling.


Options:
A: Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients
B: The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption. (July 2006-July 2009)
C: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
D: Lowering of blood pressure from hypertension to prehypertension in 50% of study subjects (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Quitlink : A Leveraging Solution to Tobacco Counseling
Brief Summary: Primary: To test whether the delivery of A3-5 smoking cessation counseling (Assess, Assist, Arrange) in primary care offices is enhanced by a system that couples (1) an expanded vital sign intervention with (2) fax referral of preparation-stage patients for telephone counseling and (3) feedback to the provider. The question will be examined in a randomized trial, with practices as the unit of analysis and with a control intervention consisting of a conventional vital sign intervention. The experiment will therefore compare what intervention and control practices accomplish beyond simply identifying patients who use tobacco.

Secondary: To assess contextual factors that might affect implementation of the intervention and account for its ultimate success or failure. In particular, to assess: (1) environmental and practice-level factors that affect practices' ability to successfully implement and use the intervention and; (2) patient characteristics beyond readiness to change (i.e., age, gender, race/ethnicity) that affect willingness to use the quit line and complete counseling.


Options:
A: Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients
B: Smoking abstinence (6 months)
C: Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization (between 6 and 18 months)
D: To assess the primary outcome of provider adherence to tobacco use treatment guidelines, we will conduct patient exit interviews with 80 smokers pre and post-intervention at each of the 18 study sites (2880 smokers pre and post). (prior to and approximately 12 months following each site's enrollment in the study); Compare the effectiveness of the three intervention arms on provider behavior for aiding patient's tobacco cessation (June 2013-June 2017)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III International, Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Nitric Oxide Synthase Inhibition With Tilarginine Acetate Injection in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction, or the TRIUMPH Trial
Brief Summary: Tilarginine Acetate Injection is a new type of drug that temporarily stops the body from making a bodily substance called nitric oxide. The body may produce excess nitric oxide following severe heart damage leading to shock. During a heart attack, and especially after a blocked artery causing the heart attack is reopened, a large amount of nitric oxide is released into the heart muscle and into the blood. Normally small amounts of nitric oxide are good for the heart and blood vessels. However, when released in large amounts, such as during a heart attack, it may be harmful, by adding to the damage of the heart attack and lowering the heart's ability to pump blood to the body. It may cause blood pressure to be lowered and reduce the amount of blood flow to the body's vital organs. This may interfere with the body's organs being able to do their work. If Tilarginine Acetate Injection can stop extra nitric oxide from being made, the performance of the heart and blood flow to the organs may get better, which may result in the improvement of symptoms. The purpose of this study (TRIUMPH) is to investigate the safety and effectiveness of Tilarginine Acetate Injection compared to placebo (an inactive fluid that has no effect on the body but looks exactly like the medication being studied). The study will help determine whether Tilarginine Acetate Injection, by temporarily lowering the amount of nitric oxide released into the vital organs can improve blood pressure and the blood flow to the body's organs.


Options:
A: Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms. (At 5 days)
B: All cause mortality at 30 days post randomization
C: All-cause mortality in the 180 days following randomization.
D: 30-day mortality (30 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score at Day 28 (Day 0 to Day 28)
B: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
C: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)
D: Renal Elimination Rate Constant of Tobramycin (Days 1, 8 and 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
B: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)
C: Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal (Day 0 (baseline), Week 4)
D: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (Baseline and end of treatment Course 1 (Day 28)); Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses (Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Clinically Significant Laboratory Abnormalities. (28 Days)
B: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)
C: Time to an Exacerbation (Baseline to end of study (up to 59 days))
D: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))
B: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)
C: Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 14 (14 days)
D: Number of Participants With Treatment-Emergent Adverse Events (56 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)
B: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)
C: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))
D: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)

Answer: D