TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Management of Superficial Thrombophlebitis
Brief Summary: The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP).


Options:
A: Incidence of confirmed venous thromboembolism at three months. (3 months)
B: Thrombosis Progression and Venous Thromboembolism (VTE) (Day 14); Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months (3 months)
C: Rate of Objectively Confirmed VTE Complications (45 +/- 5 days)
D: To assess the efficacy and safety of low-molecular-weight heparin - dalteparin in patients with ST (3 months); Combined end-point: occurrence of symptomatic or asymptomatic deep vein thrombosis, symptomatic pulmonary embolism or ultrasonographic blood clot progression or relapse of ST (3 months); Clinically relevant bleeding occurring (during treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Computerised Physician Reminder System to Control Cardiovascular Risk Factors in HIV-infected Patients Receiving Antiretroviral Therapy: A Nested Randomised Controlled Cluster Trial Within the Swiss HIV Cohort Study
Brief Summary: There is growing evidence that antiretroviral therapy (ART) increases the risk of coronary heart disease (CHD) through metabolic side effects, such as dyslipidemia, insulin resistance, and type II diabetes. Prevalence of risk factors for CHD in HIV-infected individuals receiving ART in the Swiss HIV Cohort Study (SHCS) is high. This cluster randomised controlled trial is nested into the SHCS and will investigate whether physicians randomised to the routine provision of risk profiles from their patients receiving ART will improve the management of risk factors in HIV-infected patients compared to control physicians not routinely receiving such information. Risk profiles will be generated by the SHCS data center and provided to clinicians in all study centers.


Options:
A: Quality of care process index = ∑ of recommended services received by patient/ ∑ of the recommended services for which the patient was eligible (5 years)
B: Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals (one year)
C: Greater reduction in CHD risk in case group vs. control (6 months)
D: Reduction in total cholesterol in the entire SHCS population (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.


Options:
A: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)
B: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
C: Percentage of patients with ACR 20 response (Week 24)
D: Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration (169 days); Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration (211 days); Plasma concentrations of golimumab following IV administration (169 days); Plasma concentrations of golimumab following SC administration (211 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.


Options:
A: Proportion of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)
B: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)
C: Dose-Normalized AUC[0-Inf] for MTX (24 Hour period); Dose-Normalized AUC[0-24] for MTX (24 Hour period); Dose-Normalized Cmax for MTX (24 Hour period)
D: To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.


Options:
A: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)
B: The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population (Day 1 to Day 365)
C: Change from Baseline in the Disease Activity Score (C-reactive protein) [DAS28(CRP)] for CDP6038 and placebo (Baseline, Week 12)
D: EULAR Good Response (at 24 weeks); ACR50 Response Rate (at 24 weeks); Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score (at 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have not been previously treated with methotrexate.


Options:
A: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)
B: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
C: Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score (76 and 91 weeks)
D: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.


Options:
A: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))
B: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)
C: Percentage of patients with ACR 20 response (Week 24)
D: Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14); Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24 (Baseline (Week 0) and Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Metoclopramide to Aid Establishment of Breastfeeding After Delivery: a Randomized Controlled Trial
Brief Summary: Hypothesis: Early use of oral metoclopramide can hasten and improve the establishment of lactogenesis II in mothers after preterm and term deliveries.

The study hopes to show that metoclopramide can be effective to establish and sustain Lactogenesis II for both preterm and term infants.


Options:
A: Percentage of mothers who exclusively breastfeed their child (At 6 weeks postpartum)
B: successful initiation of lactation as determined by lactogenesis II markers (7 days postpartum)
C: Early lactation difficulties (1 year)
D: success of continuing breastfeeding; amount of supplementation used

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Frequent Hemodialysis Network: Daily Trial
Brief Summary: The Frequent Hemodialysis Network (FHN) Daily Trial is a randomized controlled trial recruiting subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects will be randomized to either conventional hemodialysis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale.


Options:
A: a composite of mortality with the change over 12 months in left ventricular mass (12 months); a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. (12 months)
B: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19))
C: Number of Participants Who Initiated Depression Treatment (within four weeks of engagement interview or control visit); QIDS-C Score (Week 12 of treatment)
D: Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 4); Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 8); Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Frequent Hemodialysis Network: Daily Trial
Brief Summary: The Frequent Hemodialysis Network (FHN) Daily Trial is a randomized controlled trial recruiting subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects will be randomized to either conventional hemodialysis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale.


Options:
A: Number of Randomised Participants With a Major Cardiovascular Event (Non-fatal Stroke, Non-fatal Myocardial Infarction or Cardiovascular Death) (Events were reported continuously during the study. Duration of follow-up ranged from 1 day to 5.6 years)
B: N-balances (20 days)
C: a composite of mortality with the change over 12 months in left ventricular mass (12 months); a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. (12 months)
D: all cause mortality (entire follow up (until dead or end of study, 1-7 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Frequent Hemodialysis Network: Daily Trial
Brief Summary: The Frequent Hemodialysis Network (FHN) Daily Trial is a randomized controlled trial recruiting subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects will be randomized to either conventional hemodialysis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale.


Options:
A: Intra-Dialytic Hypotension (60 days)
B: composite of 12 month mortality and the change over 12 months in left ventricular mass by cine-MRI, (12 months); a composite of 12 month mortality and the change over 12 months in the SF-36 RAND physical health composite (12 months)
C: a composite of mortality with the change over 12 months in left ventricular mass (12 months); a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. (12 months)
D: Interdialytic weight gain (Each dialysis treatment (3x per week) - 2 years of treatment data); Pre-dialysis Blood Pressure (Each dialysis treatment (3x per week)- 2 years of treatment data)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Brief Summary: The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.


Options:
A: ADHD Severity (baseline and 20 weeks); Substance Use (20 weeks)
B: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks (Baseline and up to 7 weeks)
C: SKAMP deportment rating scale (Week 8)
D: Clinicians Manuals from Russell A. Barkley as Disruptive Behavior Disorders Rating Scale--Parent Form (Form 4), Disruptive Behavior Disorders Rating Scale--Teacher Form (Form 5) and Clinical Interview--Parent Report Form (Form 6) (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Brief Summary: The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.


Options:
A: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
B: Attention Deficit Hyperactivity Disorder Total Symptom Score (End of placebo dose week, End of low dose week, End of medium dose week , End of high dose week)
C: ADHD Severity (baseline and 20 weeks); Substance Use (20 weeks)
D: Change in pain ratings (0-100) to a suprathreshold heat pain stimulus (3.5 Minutes after end of infusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label, Parallel-group, International, Multicenter Study Evaluating Persistency of Response to Omalizumab During 32 Weeks Treatment Given as Add on to Optimized Asthma Therapy in Adult and Adolescent Patients With Severe Persistent Allergic Asthma, Who Remain Inadequately Controlled Despite GINA (2004) Step 4 Therapy
Brief Summary: Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.


Options:
A: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) (Weeks 16 and 32)
B: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)
C: Annualized Rate of On-treatment Exacerbations Per Year (Baseline (Week 0) to Week 172); Number of Participants With Any On-treatment Adverse Event (AE) or On-treatment Serious AE (SAE) (Baseline (Week 0) to Week 172)
D: Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control (Week 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label, Parallel-group, International, Multicenter Study Evaluating Persistency of Response to Omalizumab During 32 Weeks Treatment Given as Add on to Optimized Asthma Therapy in Adult and Adolescent Patients With Severe Persistent Allergic Asthma, Who Remain Inadequately Controlled Despite GINA (2004) Step 4 Therapy
Brief Summary: Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.


Options:
A: N/A
B: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) (Weeks 16 and 32)
C: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)
D: Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils (Baseline and 16 weeks); Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells (Baseline and 16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label, Parallel-group, International, Multicenter Study Evaluating Persistency of Response to Omalizumab During 32 Weeks Treatment Given as Add on to Optimized Asthma Therapy in Adult and Adolescent Patients With Severe Persistent Allergic Asthma, Who Remain Inadequately Controlled Despite GINA (2004) Step 4 Therapy
Brief Summary: Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.


Options:
A: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 52 or early withdrawal (EW))
B: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) (Weeks 16 and 32)
C: Maximum Number of Asthma Symptom Days (Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
D: Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) (Baseline, 12 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the optimum radiation dose comparing of 30 to 20 Gy in the same context.


Options:
A: Freedom from first progression at 5 years (After a median of 5 years from start of the study)
B: Overall survival; Reduction of late treatment-related toxicity; Maintenance of failure-free survival rate
C: N/A
D: Survival (12 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study is designed to (1) compare the efficacy of the BEACOPP regimen with that of ABVD as a 4-cycle chemotherapy combined with an involved field irradiation and (2) to define the optimum radiation dose comparing of 30 to 20 Gy in the same context.


Options:
A: Progression Free Survival (5 years)
B: N/A
C: Event-free survival (from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death)
D: Freedom from first progression at 5 years (After a median of 5 years from start of the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.


Options:
A: Progression free survival (PFS) (5 years)
B: Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD (36 Months); 36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation. (at 36 months)
C: To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue. (4 years)
D: Progression Free Survival (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study is designed to find the optimum radiation dose and number of cycles for an ABVD chemotherapy combined with an involved field irradiation. It is to be tested whether the reduction from 4 to 2 cycles of ABVD and/or the reduction of the radiation dose from 30 to 20 Gy is feasible without a loss of efficacy.


Options:
A: Progression free survival (PFS) (5 years)
B: Progression-free Survival by Independent Review (Up to approximately 4 years)
C: Event-free survival (treatments evaluation)
D: Progression-free survival (up to 5 years after randomisation)

Answer: A