TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Non-randomized, Non Blinded, Non-controlled Study to Investigate the Impact of Multiple Doses of BAY63-2521 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Interstitial Lung Disease Associated Pulmonary Hypertension.
Brief Summary: The purpose of this study is to assess multiple ascending doses of a new drug (BAY63-2521) given orally, to evaluate if it is safe and can help to improve the well-being, symptoms (e.g. disturbed breathing) and outcome of pulmonary hypertension associated with lung fibrosis. Patients living with pulmonary hypertension associated with interstitial lung disease have a risk of increased number of hospitalisations because of worsening of their condition. Until now there is no approved medication for this disease. The current treatment of pulmonary hypertension associated with interstitial lung disease consists: of oxygen and medical treatment with vasodilators, e.g. so-called Calcium-antagonists. Therefore, there is a need for new drugs in the treatment of pulmonary hypertension associated with interstitial lung disease.


Options:
A: Safety and tolerability (12 weeks treatment)
B: 6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12 (Baseline and week 12)
C: Number of Participants With Treatment-emergent Adverse Events (TEAE) (From administration of first dose of study medication in PATENT-2 up to 2 days after end of treatment with study medication, up to 10 years and 5 months.); Number of Participant With Death (From baseline to end of safety follow-up visit, up to 10 years and 6 months (1 month more than End of study visit))
D: Maximum Change From Baseline in Supine Systolic Blood Pressure (SBP) Within 4 Hours Post-dose at Visit 6 (Week 12) (Pre-dose (baseline) and within 4 hours post-dose at visit 6 (week 12))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
Brief Summary: The aim of this study is to investigate the efficacy of neuroscience-guided computerized cognitive training exercises on the remediation of cognitive deficits and symptoms associated with recent-onset schizophrenia and to examine the influence of subject characteristics, brain structure and function, and pharmacotherapy on the response to remediation.


Options:
A: Cognitive Function Measured by MCCB Composite Score (4-6 month period); Cognitive Function as Measured by the University of California, San Diego, Performance-Based Skills Assessment-Brief (UPSA-B) Scale (4-6 month period)
B: Cognitive Performance, as measured by a neuropsychological battery (Measured at Baseline, Week 8, and 6 Month Follow-Up)
C: Feasibility of a multisite trial using cognitive remediation (Measured at post-treatment)
D: Change from Baseline Social Cognition at 6 months (Baseline (Intake)/6 months follow-up after trianing completion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
Brief Summary: The aim of this study is to investigate the efficacy of neuroscience-guided computerized cognitive training exercises on the remediation of cognitive deficits and symptoms associated with recent-onset schizophrenia and to examine the influence of subject characteristics, brain structure and function, and pharmacotherapy on the response to remediation.


Options:
A: Scale of Prodromal Symptoms Total Score (Baseline); Change in Scale of Prodromal Symptoms Total Score (Change from Baseline at 8 Weeks)
B: Cognitive Performance, as measured by a neuropsychological battery (Measured at Baseline, Week 8, and 6 Month Follow-Up)
C: Brief Assessment of Cognition in Schizophrenia (BACS) (6 and 12 months)
D: transition to subthreshold psychosis (and psychosis or schizophrenia)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.


Options:
A: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)
B: success rate of cervical ripening in labor induction (12 hours after intervention)
C: the percentage of women delivering infants vaginally within 12 hours of augmentation (post vaginal delivery)
D: Vaginal delivery (24 hours); Hyperstimulation syndrome (24 hours); Cesarean section (3 days); Severe neonatal morbidity or perinatal death (28 days); Serious maternal morbidity or maternal death (42)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Titrated Oral Misoprostol Solution to Intravenous Oxytocin for Labor Augmentation: A Randomized Controlled Trial
Brief Summary: The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.


Options:
A: the percentage of women delivering infants vaginally within 12 hours of augmentation (post vaginal delivery)
B: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)
C: Uterine Tachysystole (Up to four hours after administration of study drug)
D: success rate of cervical ripening in labor induction (12 hours after intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DEMO II: A Randomized, Parallel-group, Observer-blinded Clinical Trial of Aerobic Exercise Versus Stretching Exercise for Patients With Light to Moderate Depression
Brief Summary: This trial investigates the biological effect of exercise training on depression. Participants will randomly be allocated to either a aerobic exercise group performing exercise on stationary bikes or a group performing low-impact exercise such as stretching exercises. Both groups will attend sessions three times per week for 3 months. Before and after the intervention the investigators will measure the severity of depression using the Hamilton depression rating scale (HAM-D17).


Options:
A: To determine the effectiveness of SE/IPS in terms of vocational outcomes, such as employment rate, monthly income, job-tenure and working hours compared to stepwise rehabilitation available, for people with SMI in a Swedish context (6 months, 18 months, and 24 months (6 months after end of intervention))
B: The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation
C: Time to return to work (12 months)
D: HAM-D17 (Before and after 3 months intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: DEMO II: A Randomized, Parallel-group, Observer-blinded Clinical Trial of Aerobic Exercise Versus Stretching Exercise for Patients With Light to Moderate Depression
Brief Summary: This trial investigates the biological effect of exercise training on depression. Participants will randomly be allocated to either a aerobic exercise group performing exercise on stationary bikes or a group performing low-impact exercise such as stretching exercises. Both groups will attend sessions three times per week for 3 months. Before and after the intervention the investigators will measure the severity of depression using the Hamilton depression rating scale (HAM-D17).


Options:
A: Endothelium-dependent flow mediated dilation (Baseline / week 32-36 of gestation)
B: HAMD-17
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: HAM-D17 (Before and after 3 months intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Open-Label Trial of Erlotinib (Tarceva) and Bevacizumab in Women With Advanced Ovarian Cancer
Brief Summary: The purpose of this project is to determine if a new combination of drugs, erlotinib (Tarceva™) and bevacizumab is safe and effective for treating women diagnosed with ovarian cancer whose cancer has progressed while on prior standard chemotherapy treatment with a taxane (paclitaxel or docetaxel) and a platinum (cisplatin or carboplatin).


Options:
A: Objective Response (Complete Partial, Stable and Progression) (06.16.2005 to 10.05.2009); Median Response Duration (Weeks) (1 week to 96 weeks)
B: Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose (Week 12); Percentage of Participants Who Remained Progression-free 12 Weeks After Randomization (Week 12 after randomization.)
C: Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually
D: Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.); Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4. (From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
Brief Summary: The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.


Options:
A: Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) (Baseline and Month 36); Change From Baseline in Coronary Artery Calcium Score (Baseline and Month 36)
B: Change From Baseline in Erectile Function Domain Score of the International Index of Erectile Function (IIEF) (Week 0, week 8, week 11, week 14)
C: Change in the Physical Performance Test (Baseline and 6 months)
D: waist-to-hip ratio (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Active-Controlled, Non-Inferiority Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation Using Daily Recombinant FSH as Reference
Brief Summary: To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in initiating multifollicular growth.


Options:
A: number of retrieved oocytes (at the ovarian puncture, 36 hours post HCG administration)
B: live birth rate (10 months for group A, 12 months for group B)
C: 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))
D: clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity (12 weeks after embryo transfer)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Active-Controlled, Non-Inferiority Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation Using Daily Recombinant FSH as Reference
Brief Summary: To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in initiating multifollicular growth.


Options:
A: Number of cumulus-oocyte-complexes retrieved (1 cycle)
B: Pregnancy status at 20 weeks of gestation (one pregnancy period); Take-home baby rate (one pregnancy period)
C: Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Adverse Events (AEs) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Expectant Mothers Experiencing Serious AEs (SAEs) (From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)); Number of Infants Experiencing AEs (Up to 12 weeks after birth); Number of Infants Experiencing SAEs (Up to 12 weeks after birth)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Systems of Support to Increase Colon Cancer Screening and Follow-up
Brief Summary: SOS is a four-arm randomized controlled study of ways to increase screening for colorectal cancer. About 40-50% of the people age 50 and older are not up to date on screening. This is a very important problem because screening both prevents colorectal cancer and decreases colon cancer deaths.

We are studying 3 different levels of support to help people get screened and follow-up after positive screening tests. These involve comparing to usual care stepwise increasing in intensity approaches; an automated approach of mailing information and home screening tests, this plus phone assistance by a medical assistant, both of these plus phone counseling and care management. We will also compare nurse assisted follow-up after a positive screening test compared to usual care

By doing this study we hope to increase colon cancer screening rates, and also follow-up rates for positive screening tests.


Options:
A: Fasting Insulin (Baseline); 3 Month Fasting Insulin (3 month); 12 Month Fasting Insulin (12 months); Fasting Glucose (Baseline); 3 Month Fasting Glucose (3 months); 12 Month Fasting Glucose (12 Months)
B: Short-term adherence to CRC screening (From randomization to the end of 2 years); Long-term adherence to CRC screening (From randomization to the end of 9 years)
C: Mammography Adherence (12 months)
D: Composite Assessment of Function and Survival (CAFS) at 12 Months (12 months); Death up to 12 Months (CAFs Individual Component) (12 months); Change From Baseline in ALSFRS-R at 12 Months (CAFs Individual Component) (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Systems of Support to Increase Colon Cancer Screening and Follow-up
Brief Summary: SOS is a four-arm randomized controlled study of ways to increase screening for colorectal cancer. About 40-50% of the people age 50 and older are not up to date on screening. This is a very important problem because screening both prevents colorectal cancer and decreases colon cancer deaths.

We are studying 3 different levels of support to help people get screened and follow-up after positive screening tests. These involve comparing to usual care stepwise increasing in intensity approaches; an automated approach of mailing information and home screening tests, this plus phone assistance by a medical assistant, both of these plus phone counseling and care management. We will also compare nurse assisted follow-up after a positive screening test compared to usual care

By doing this study we hope to increase colon cancer screening rates, and also follow-up rates for positive screening tests.


Options:
A: Total number of split tests performed in study period (three periods). (January - April 2011)
B: The primary outcome is the proportion of patients starting prescription osteoporosis treatment within 3 months of fracture recognition (3 months)
C: colorectal cancer screening (15 months)
D: Short-term adherence to CRC screening (From randomization to the end of 2 years); Long-term adherence to CRC screening (From randomization to the end of 9 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Prospective Randomized Blinded Placebo-controlled Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
Brief Summary: Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.


Options:
A: Average Pain (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up); THE HAMILTON DEPRESSION RATING SCALE (HRDS) (Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up)
B: Analgesic efficiency (36 months)
C: Numeric Rating Scale (NRS) for Pain (baseline); Numeric Rating Scale (NRS) for Pain (day 5); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (baseline); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (day 5); Six-minute Walk Test (baseline); Six-minute Walk Test (day 5); Short Physical Performance Battery (SPPB) (baseline); Short Physical Performance Battery (SPPB) (day 5); Heat Pain Threshold (baseline); Heat Pain Threshold (day 5); Heat Pain Tolerance (baseline); Heat Pain Tolerance (day 5); Pressure Pain Threshold (baseline); Pressure Pain Threshold (day 5); Punctate Mechanical Pain Sensitivity (baseline); Punctate Mechanical Pain Sensitivity (day 5); Conditioned Pain Modulation (CPM) (baseline); Conditioned Pain Modulation (CPM) (day 5)
D: Changes in the Visual Analog Scale for Phantom Limb Pain (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Prospective Randomized Blinded Placebo-controlled Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET
Brief Summary: Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.


Options:
A: Pain severity (up to three months after the end of treatment)
B: Analgesic efficiency (36 months)
C: Numeric Rating Scale (NRS) for Pain (baseline); Numeric Rating Scale (NRS) for Pain (day 5); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (baseline); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale (day 5); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (baseline); Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale (day 5); Six-minute Walk Test (baseline); Six-minute Walk Test (day 5); Short Physical Performance Battery (SPPB) (baseline); Short Physical Performance Battery (SPPB) (day 5); Heat Pain Threshold (baseline); Heat Pain Threshold (day 5); Heat Pain Tolerance (baseline); Heat Pain Tolerance (day 5); Pressure Pain Threshold (baseline); Pressure Pain Threshold (day 5); Punctate Mechanical Pain Sensitivity (baseline); Punctate Mechanical Pain Sensitivity (day 5); Conditioned Pain Modulation (CPM) (baseline); Conditioned Pain Modulation (CPM) (day 5)
D: Change in pain Scores as measured by the Visual Analog Scale (2 months)

Answer: B