TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve
Brief Summary: The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.


Options:
A: All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability (24 months)
B: Death (1 Year); Composite of Death and Recurrence Hospitalization. (duration of study)
C: All-cause Death or Disabling Stroke to Two Years (2 Years)
D: Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study (Randomized Controlled Trial - 24 months Continued Access Study - 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve
Brief Summary: The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.


Options:
A: Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study (Randomized Controlled Trial - 24 months Continued Access Study - 12 months)
B: Improvement in mean daily number of steps (Improvement between baseline (during the last preoperative month) and first 3 (and 12) months after discharge.)
C: Death (1 Year); Composite of Death and Recurrence Hospitalization. (duration of study)
D: Change in physical capacity (1,4,12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Continuous Skin to Skin Care (Technique Kangourou: TK) for Low Birth Weight (LBW) Infants and Their Mothers at University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM), Madagascar
Brief Summary: The purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low birth weight (LBW) infants and their mothers started as soon as possible within 24 hours after birth in developing country.

For the purpose of this study, TK is defined as skin-to-skin direct and continuous (24 hours) contact between LBW infants and their mothers or any other people who substitute mothers.


Options:
A: Mortality within 28 days after birth (within 28 days after birth)
B: Axillary temperature 36.5-37.5 degrees Celsius (1-4 hours)
C: N/A
D: Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Detection and Intervention for the Prevention of Psychosis Project
Brief Summary: EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at six sites across the United States. The hypothesis is that very early identification and intervention will be effective in delaying or preventing onset of psychosis and improving social and occupational functioning.


Options:
A: Change in Weight (Baseline, 3-, 6-, 9-, 12-, and 18-months)
B: transition to subthreshold psychosis (and psychosis or schizophrenia)
C: Change in subthreshold psychotic (positive and negative) symptoms (Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment)
D: Psychotic Symptoms (two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Detection and Intervention for the Prevention of Psychosis Project
Brief Summary: EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at six sites across the United States. The hypothesis is that very early identification and intervention will be effective in delaying or preventing onset of psychosis and improving social and occupational functioning.


Options:
A: Incidence of Remission From Attenuated Psychosis Syndrome (APS) Within a 52-week Timeframe (Up to 52 weeks.)
B: Change in subthreshold psychotic (positive and negative) symptoms (Change from pretreatment (assessed for the 3 months prior to randomization) to 12 month reassessment)
C: Psychotic Symptoms (two years)
D: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Detection and Intervention for the Prevention of Psychosis Project
Brief Summary: EDIPP is a multisite trial of early identification and intervention to prevent the onset of psychosis in adolescents and young adults, carried out at six sites across the United States. The hypothesis is that very early identification and intervention will be effective in delaying or preventing onset of psychosis and improving social and occupational functioning.


Options:
A: sucessful employment for one day in the open labour market
B: Psychotic Symptoms (two years)
C: Functional Assessment Short Test (FAST) (Baseline); Functional Assessment Short Test (FAST) (6 months); Functional Assessment Short Test (FAST) (12 months)
D: 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))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
Brief Summary: This is a prospective, multi-center, randomized, single-blind clinical trial conducted in the United States (US). The objective of the study is to evaluate the safety and efficacy of the HF Pressure Measurement System in reducing heart failure (HF) related hospitalizations in a subset of subjects suffering from HF.


Options:
A: The incidence and frequency of COPD exacerbations in each of the intervention groups (December 2008 to March 2009 inclusive); Electronic diary symptoms using the EXACT instrument (Daily recording)
B: Rate of Heart Failure Related (HFR) Hospitalizations (6 months); Freedom From a Device/System-related Complication (DSRC). (6 months); Freedom From Pressure Sensor Failure (6 months)
C: Physical Activity (One year)
D: Time between emergency call and therapy decision

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
Brief Summary: This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.


Options:
A: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
B: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 (Baseline to Week 24)
C: Percentage of Participants With Disease Activity Score 28 Joints (DAS28) Remission at Week 24 (Week 24)
D: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
Brief Summary: This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.


Options:
A: 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)
B: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
C: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 (Baseline to Week 24)
D: Double-blind Withdrawal (DBW) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Antibody Responses by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 169 (Day 169); Re-introduction (RI) Period; Percentage of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by ELISA at Day 253, by DBW Period Groups (Day 253 (short term))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
Brief Summary: This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.


Options:
A: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
B: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 (Baseline to Week 24)
C: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 (Baseline and 52 Weeks); Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 (Baseline and Week 52)
D: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6 (Week 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
Brief Summary: This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 500+ individuals.


Options:
A: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))
B: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 (Baseline to Week 24)
C: Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports (Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug); Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Extension Period: Number of Participants With Laboratory Test Abnormalities (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis (Includes AEs for every visit and up to 999 days after last dose of study drug); Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib (Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period)
D: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 (Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Correlation of Donor Proinflammatory mRNA Profiles With Early Outcomes of Thoracic and Abdominal Transplantation
Brief Summary: Activity of genes in donor tissues that are involved in inflammation are thought to be involved with early organ dysfunction, increased immune responses in transplant recipients, and organ rejection. The purpose of this study is to determine the relationship between genetic expression in donor and recipient tissue with transplant survival. Participants in this study will have received heart, lung, liver, or kidney transplants.


Options:
A: major complications after liver transplantation (During the first year postoperatively)
B: Early graft injury (During the first week postoperatively (absolute and relative delta))
C: Association between proinflammatory mRNA expression in donor samples and subsequent development of early organ dysfunction in the immediate period following transplantation (Within first 7 days after transplant); Association of mRNA expression of proinflammatory mediatros in the transplanted organ in the immediate pre and post-reperfusion period with subsequent incidence of acute rejection and expression of genes involved in cell mediated immunity (12 months after transplant)
D: Patient Survival at One Year Post-Transplantation (Post-Operative Day 1 to Day 365); Graft Survival at One Year Post-Transplantation (Post-Operative Day 1 to Day 365)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study
Brief Summary: The ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone acetonide. 240 patients with a visual acuity \< 0.5 Snellen will be randomised. Patients are treated with either RON, or a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment - a "sham" injection of intravitreal triamcinolone. Patients will be examined regularly over a period of one year.

Best corrected visual acuity for far and near, as well as clinical examinations, fluorescein- and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed pre- and postoperatively.


Options:
A: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months (Baseline and 6 months)
B: The primary efficacy outcome measure is the mean change from baseline in BCVA score (6 months)
C: Proportion of eyes with an improvement of more than 15 letters (approximately > 3 lines of visual acuity gain) after one year as compared to baseline
D: Integrity of retinal layers (End of study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (With Platinum-based Chemotherapy) and Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer
Brief Summary: The purpose of this study is to assess the safety and efficacy of cediranib in combination with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or epithelial cancer, after first line platinum based treatment.


Options:
A: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
B: Overall Response (Up to 3 years); Time to Treatment Failure (Up to 3 years); Overall Survival (Up to 5 years)
C: Progression-free survival (Apr 2013)
D: Radiographic imaging and clinical evaluation will be used for tumor assessment (every 6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (With Platinum-based Chemotherapy) and Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer
Brief Summary: The purpose of this study is to assess the safety and efficacy of cediranib in combination with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or epithelial cancer, after first line platinum based treatment.


Options:
A: Progression free survival (30 months)
B: Progression free survival (up to 18 months)
C: Progression-free survival (Apr 2013)
D: Progression-Free Survival (PFS) (Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (With Platinum-based Chemotherapy) and Concurrent and Maintenance Cediranib in Women With Platinum-sensitive Relapsed Ovarian Cancer
Brief Summary: The purpose of this study is to assess the safety and efficacy of cediranib in combination with standard chemotherapy, in patients who have relapsed with ovarian, fallopian tube or epithelial cancer, after first line platinum based treatment.


Options:
A: Progression-free survival (Apr 2013)
B: Progression Free Survival (2 years)
C: Event Free Survival (The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks)
D: Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST) (From randomization through September 17, 2010 (up to 3 years, 5 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects
Brief Summary: The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.


Options:
A: Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT) (Month 30)
B: Change in body weight
C: Co-primary: Body Weight- Mean Percent Change (Baseline, 56 weeks); Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease (Baseline, 56 weeks)
D: Percent Weight Loss From Baseline to Week 56 (Baseline to 56 weeks); Percentage of Subjects With a Weight Loss of at Least 5% at Week 56 With LOCF (Baseline to 56 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Hydroxyurea and Magnesium Pidolate Alone and in Combination in Hemoglobin SC Disease: A Phase II Trial
Brief Summary: Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is characterized by dense red blood cells. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of pain episodes in people with HbSC.


Options:
A: Hospital Length of Stay (Hours) (From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment)
B: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)
C: Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD. (30 to 54 hours plus 30-day follow-up)
D: Length of stay in the hospital (Time frame determined by outcome)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Hydroxyurea and Magnesium Pidolate Alone and in Combination in Hemoglobin SC Disease: A Phase II Trial
Brief Summary: Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is characterized by dense red blood cells. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of pain episodes in people with HbSC.


Options:
A: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
B: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)
C: Conversion to Abnormal Maximum TAMV (30 months)
D: Number of Malaria Episodes (12 months)

Answer: B