TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38819 for Org 36286 (Corifollitropin Alfa)
Brief Summary: The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).


Options:
A: Pregnancy status at 20 weeks of gestation (one pregnancy period); Take-home baby rate (one pregnancy period)
B: Number of Expectant Mothers Experiencing Adverse Events (AEs) (Up to 1 Year); Number of Expectant Mothers Experiencing Serious AEs (SAEs) (Up to 1 Year); Number of Infants Experiencing AEs (Up to 1 Year); Number of Infants Experiencing SAEs (Up to 1 Year); Take-Home Baby Rate (Birth of a one or more live babies (Up to 1 year))
C: Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs) (Up to one day following delivery (up to 1 year)); Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs) (Up to one day following delivery (up to 1 year)); Number of Infants Born in Current Follow Up Trial Experiencing AEs (Up to 12 weeks following delivery (up to 1 year)); Number of Infants in Current Follow Up Trial Experiencing SAEs (Up to 12 weeks following delivery (up to 1 year)); Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial. (At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)); Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer. (At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year))
D: Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate) (Assessed at least 10 weeks after embryo transfer (up to 1 year)); Mean Number of Oocytes Retrieved (Up to 36 hours after administration of hCG (up to 1 year))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment
Brief Summary: The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.


Options:
A: Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12) (12 weeks post-treatment)
B: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
C: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
D: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 (Posttreatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment
Brief Summary: The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.


Options:
A: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
B: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
C: Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (At Follow-up Week 24)
D: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment
Brief Summary: The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.


Options:
A: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
B: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
C: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
D: Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (At Follow-up Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment
Brief Summary: The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (12 weeks after the last actual dose of study drug)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)
C: Proportion of treated subjects with SVR12, defined as HCV RNA < LOQ at post treatment Week 12, for subjects who are prior null or partial responders to P/R or are treatment-naive (At 12 weeks post-treatment)
D: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia
Brief Summary: The purpose of this study is to refine and evaluate the Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention. PROTECT DC is a program consisting of in-hospital education coupled with community-based "stroke navigators" and is designed to reduce the rate of vascular events or death in a population of underserved individuals with stroke.


Options:
A: Low Density Lipoprotein Value (1 year); Systolic Blood Pressure Value (1 year); Hemoglobin A1C Value (1 year); Pill count of antiplatelet therapy medications (1 year)
B: Change in Systolic Blood Pressure (baseline and 6 months); Change in HDL Level (baseline and 6 months); Change in LDL Level (baseline and 6 months); Change in Triglyceride Level (baseline and 6 months); Change in HbA1c Level (baseline and 6 months); Change in Glycaemia Level (baseline and 6 months); Change in BMI Value (baseline and 6 months)
C: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
D: Blood Pressure (6 months and 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrence of Thromboembolic Events Through Coordinated Treatment in the District of Columbia
Brief Summary: The purpose of this study is to refine and evaluate the Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) intervention. PROTECT DC is a program consisting of in-hospital education coupled with community-based "stroke navigators" and is designed to reduce the rate of vascular events or death in a population of underserved individuals with stroke.


Options:
A: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)
B: Difference in physical activity scale for the elderly (24 months)
C: Low Density Lipoprotein Value (1 year); Systolic Blood Pressure Value (1 year); Hemoglobin A1C Value (1 year); Pill count of antiplatelet therapy medications (1 year)
D: Blood Pressure (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World
Brief Summary: This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.


Options:
A: Final Clinical Cure Rate (Day 42, 98, and 168)
B: Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) (180 days); Safety of WR 279,396 (AEs and SAEs) (180 days)
C: Wound closure time (75 days)
D: Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure (Assessment of cure is made at 2 months after treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World
Brief Summary: This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.


Options:
A: Complete Clinical Response (CCR) of Lesion at Days 50, 100 and 180 (+7 Days) (180 days); Safety of WR 279,396 (AEs and SAEs) (180 days)
B: Final Clinical Cure Rate (Day 42, 98, and 168)
C: Wound closure time
D: Wound closure time (75 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care: A Randomized Controlled Trial
Brief Summary: Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recently, the testing of the level of anticoagulation was performed at medical laboratories or hospitals.

The purpose of this study is to see if patients who test their level of anticoagulation by themselves at home and then call their doctor with the result have better control of their anticoagulation as compared to patients whose anticoagulation is checked only by their physician.


Options:
A: Time to First Event (Death, Stroke, Major Bleed) (Time to event)
B: Anticoagulation-related quality of life (Four months)
C: Mean Percentage of Time in Therapeutic Range (baseline to 3 months)
D: Proportion of INR values which are in therapeutic range

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection
Brief Summary: A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus \[HCV\] viral ribonucleic acid \[RNA\] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) (Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)); Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods (Up to Week 14); Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period (Up to Week 12)
B: Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants (Baseline, Day 7)
C: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)
D: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naive Patients With Chronic Hepatitis C Infection
Brief Summary: A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus \[HCV\] viral ribonucleic acid \[RNA\] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.


Options:
A: Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (At Follow-up Week 24)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
C: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)
D: Sustained Virological Response (SVR12) (60 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial
Brief Summary: Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol shortens the duration of delirium in comparison to placebo added to the treatment with haloperidol.


Options:
A: Duration of delirium (3 months)
B: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
C: Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation (Hospital Discharge)
D: Ventilator-free hours (7 days following randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial
Brief Summary: Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol shortens the duration of delirium in comparison to placebo added to the treatment with haloperidol.


Options:
A: Duration of delirium (3 months)
B: Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation (an average of 4 to 6 hours)
C: The initial day and number of days there is a significant change from baseline in the mean Delirium Observation Screening (DOS) score, and/or delirium is diagnosed according to the DSM-IV criteria. (Assessed within 1 to 7 days after initiation of the study intervention.)
D: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection
Brief Summary: The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).


Options:
A: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 (Posttreatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)
B: Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants (Baseline, Day 7)
C: Sustained Virologic Response (SVR) Rate in Full Analysis Set (FAS) Population. (Follow-up Week 24)
D: Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. (Up to 72 weeks); Number of Participants Experiencing an Adverse Event (AE) (Up to 73 weeks); Number of Participants Discontinuing From Study Treatment Due to AEs (Up to 48 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection
Brief Summary: The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).


Options:
A: Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. (Up to 72 weeks); Number of Participants Experiencing an Adverse Event (AE) (Up to 73 weeks); Number of Participants Discontinuing From Study Treatment Due to AEs (Up to 48 weeks)
B: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) (Weeks 4 and 12); Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24) (Follow-up Week 24); Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died (From start of study treatment (day 1) up to follow-up Week 48)
C: Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT) (Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks))
D: Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants (Baseline, Day 7)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multinational, Randomised, Double-Blind, Fixed-Dose, Bifeprunox Study Combining a 12-Week Placebo-Controlled, Quetiapine-Referenced Phase With a 12-Month Quetiapine-Controlled Phase in Patients With Schizophrenia
Brief Summary: The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.


Options:
A: The difference in change from baseline to the 12-week time point between bifeprunox and placebo using the Positive and Negative Syndrome Scale (PANSS). (12 weeks)
B: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 (Baseline to Week 26)
C: The primary objective of this study is to assess the fixed dose response relationship for efficacy between standard and higher doses of olanzapine (10, 20, and 40 mg/day) in patients with schizophrenia or schizoaffective disorder.
D: Relapse (Every 2 weeks up to 26 weeks)

Answer: A