TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti-Platelet Derived Growth Factor Receptor-Alpha (PDGFRα) Monoclonal Antibody IMC-3G3 in Patients With Platinum-Refractory or Platinum-Resistant Advanced Ovarian Cancer
Brief Summary: The purpose of this study is to determine if participants with platinum-refractory or platinum-resistant advanced ovarian cancer have a better outcome when treated with Olaratumab (IMC-3G3) in combination with Liposomal Doxorubicin than when treated with Liposomal Doxorubicin alone.


Options:
A: 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))
B: Progression-Free Survival (PFS) (Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months))
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: Overall Survival (OS) (From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).); Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti-Platelet Derived Growth Factor Receptor-Alpha (PDGFRα) Monoclonal Antibody IMC-3G3 in Patients With Platinum-Refractory or Platinum-Resistant Advanced Ovarian Cancer
Brief Summary: The purpose of this study is to determine if participants with platinum-refractory or platinum-resistant advanced ovarian cancer have a better outcome when treated with Olaratumab (IMC-3G3) in combination with Liposomal Doxorubicin than when treated with Liposomal Doxorubicin alone.


Options:
A: Progression-Free Survival (8 Months on average)
B: Primary objective: Determination of the progression-free survival (PFS) of patients treated with topotecan and sorafenib versus topotecan and placebo (18 months)
C: Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 (Week 24)
D: Progression-Free Survival (PFS) (Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti-Platelet Derived Growth Factor Receptor-Alpha (PDGFRα) Monoclonal Antibody IMC-3G3 in Patients With Platinum-Refractory or Platinum-Resistant Advanced Ovarian Cancer
Brief Summary: The purpose of this study is to determine if participants with platinum-refractory or platinum-resistant advanced ovarian cancer have a better outcome when treated with Olaratumab (IMC-3G3) in combination with Liposomal Doxorubicin than when treated with Liposomal Doxorubicin alone.


Options:
A: 2-year Progression-free Survival (2 years)
B: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.)
C: Progression-Free Survival (PFS) (Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months))
D: Overall Objective Response (1 year after end inclusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Mental Training on Childbirth Measured on Pain Experience and Other Birth Outcomes
Brief Summary: Labour pain is a challenge to the parturient woman. Pain relief methods during birth are limited and often associated with side effects. Several studies indicate that a mental trainings method, self hypnosis, has a positive impact on the labour pain and other birth outcomes.

The aim of this randomized controlled study is to examine the effect of a short antenatal course in self hypnosis on the use of epidural analgesia during birth and several other birth outcomes. Data collection includes questionnaires, register data, medical records and biological material.


Options:
A: The use of epidural analgesia during birth (At birth)
B: number of spontaneous vaginal deliveries (after delivery within a month)
C: spontaneous vaginal delivery (day of delivery)
D: Scores for the Wijma Delivery Expectancy Questionnaire (W-DEQ) (Change in W-DEQ scores measured at entry to the study (approximately gestational weeks 20 to 31) and again at gestational week 36.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of the Effect of Five-years Versus Two-years Specialized Assertive Intervention for First Episode Psychosis - the OPUS II Trial
Brief Summary: In a randomized clinical trial, the researchers want to investigate if the positive short-term outcomes (first 1-2 years), achieved with specialized assertive intervention programme (OPUS), can be maintained for five years if the specialized treatment is sustained over the first five years in comparison to only two years of specialized treatment followed by three years of standard treatment.


Options:
A: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)
B: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
C: Prognosis of patients. (6 months)
D: Functioning (social and occupational) (baseline, 12-month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of the Effect of Five-years Versus Two-years Specialized Assertive Intervention for First Episode Psychosis - the OPUS II Trial
Brief Summary: In a randomized clinical trial, the researchers want to investigate if the positive short-term outcomes (first 1-2 years), achieved with specialized assertive intervention programme (OPUS), can be maintained for five years if the specialized treatment is sustained over the first five years in comparison to only two years of specialized treatment followed by three years of standard treatment.


Options:
A: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
B: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)
C: USCD Performance-Based Skills Assessment (2009)
D: Psychotic symptoms at one and two year follow-up; Negative symptoms at one and two year follow-up

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of the Effect of Five-years Versus Two-years Specialized Assertive Intervention for First Episode Psychosis - the OPUS II Trial
Brief Summary: In a randomized clinical trial, the researchers want to investigate if the positive short-term outcomes (first 1-2 years), achieved with specialized assertive intervention programme (OPUS), can be maintained for five years if the specialized treatment is sustained over the first five years in comparison to only two years of specialized treatment followed by three years of standard treatment.


Options:
A: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
B: Functioning (social and occupational) (baseline, 6-month, 12-month, 24-month, 36-month, 48-month)
C: Functioning (social and occupational) (baseline, 12-month)
D: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of the Effect of Five-years Versus Two-years Specialized Assertive Intervention for First Episode Psychosis - the OPUS II Trial
Brief Summary: In a randomized clinical trial, the researchers want to investigate if the positive short-term outcomes (first 1-2 years), achieved with specialized assertive intervention programme (OPUS), can be maintained for five years if the specialized treatment is sustained over the first five years in comparison to only two years of specialized treatment followed by three years of standard treatment.


Options:
A: Functional Assessment Short Test (FAST) (Baseline); Functional Assessment Short Test (FAST) (6 months); Functional Assessment Short Test (FAST) (12 months)
B: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (3 years)
C: Clinical, neuropsychological, and functional outcomes (Measured at Years 1 and 3)
D: sucessful employment for one day in the open labour market

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment With Two Different Doses of Recombinant Factor XIII Following Cardiopulmonary Bypass Surgery
Brief Summary: This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.


Options:
A: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. (From administration of Haemocomplettan® P until 24 hours later)
B: Total amount of transfused red cell concentrate (24 hours after start of surgery)
C: Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First (measured ongoing from dosing until day 7 or discharge, whichever came first)
D: To determine whether fibrinogen concentrate infusion reduces perioperative blood loss. (within 12 hours.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment With Two Different Doses of Recombinant Factor XIII Following Cardiopulmonary Bypass Surgery
Brief Summary: This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.


Options:
A: Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First (measured ongoing from dosing until day 7 or discharge, whichever came first)
B: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period (up to 20 weeks))
C: Occurrence of a Clinically Significant Thrombocytopenic Event (Treatment period through interim follow-up visit (up to 16 weeks))
D: Response to Drug Based on Platelet Count at the End of Therapy (21 days and/or 42 days of therapy, 15 and 30 days after the end of therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol Use and Sexual Risk: An Intervention
Brief Summary: Adolescents are at great risk for sexually transmitted diseases (STDs) including the human immunodeficiency virus (HIV) (CDC, 2000a; DiLorenzo \& Whaley, 1999). Though the CDC (2000b) reports that overall AIDS incidence is on the decline, there has been no comparable decline in the number of newly diagnosed HIV cases among young people aged 13-19, and young people of color are particularly at risk. Compared to the general adolescent population, adolescents involved with the criminal justice system are younger at first intercourse, have a greater number of sex partners, and lower rates of condom use, resulting in higher rates of unintended pregnancy and STDs (e.g., St. Lawrence et al., 1999). Alcohol use is commonly cited as a reason for lack of condom use among high-risk adolescents such as those involved in the criminal justice system (e.g., Morris et al., 1998) and recent data from our research suggests that it is heavy alcohol use in concert with sexual activity that is most strongly related to lack of condom use (Bryan, Rocheleau, \& Robbins, 2002a). The goal of this research is to design, implement, evaluation, and disseminate a successful HIV/STD risk reduction intervention that is theory-based, empirically targeted to adolescents, and articulated to a criminal justice setting. The study compares a sexual risk reduction intervention with a group motivational interviewing alcohol component to a standard sexual risk reduction intervention and a no treatment control condition. The investigators hope to show that: 1) A three-hour one-time intervention has the capacity to reduce sexual risk behavior up to one year post-release among high risk adolescents in detention, 2) A combined sexual and alcohol risk reduction intervention will result in larger decreases in sexual risk behavior than a sexual risk reduction alone, 3) The interventions will exert their effects through changes in mediators derived from a theoretically-based model of condom use intentions and behaviors, and 4) A sexual risk reduction intervention including an alcohol component will be especially effective for those adolescents with higher levels of existing alcohol problems. Finally, given proven efficacy, the intervention curricula and materials will be disseminated for use in adolescent detention facilities throughout the state.


Options:
A: marijuana use (12 months)
B: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
C: Condom use (one year)
D: alcohol use, alcohol related consequences (3 -12 month period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Alcohol Use and Sexual Risk: An Intervention
Brief Summary: Adolescents are at great risk for sexually transmitted diseases (STDs) including the human immunodeficiency virus (HIV) (CDC, 2000a; DiLorenzo \& Whaley, 1999). Though the CDC (2000b) reports that overall AIDS incidence is on the decline, there has been no comparable decline in the number of newly diagnosed HIV cases among young people aged 13-19, and young people of color are particularly at risk. Compared to the general adolescent population, adolescents involved with the criminal justice system are younger at first intercourse, have a greater number of sex partners, and lower rates of condom use, resulting in higher rates of unintended pregnancy and STDs (e.g., St. Lawrence et al., 1999). Alcohol use is commonly cited as a reason for lack of condom use among high-risk adolescents such as those involved in the criminal justice system (e.g., Morris et al., 1998) and recent data from our research suggests that it is heavy alcohol use in concert with sexual activity that is most strongly related to lack of condom use (Bryan, Rocheleau, \& Robbins, 2002a). The goal of this research is to design, implement, evaluation, and disseminate a successful HIV/STD risk reduction intervention that is theory-based, empirically targeted to adolescents, and articulated to a criminal justice setting. The study compares a sexual risk reduction intervention with a group motivational interviewing alcohol component to a standard sexual risk reduction intervention and a no treatment control condition. The investigators hope to show that: 1) A three-hour one-time intervention has the capacity to reduce sexual risk behavior up to one year post-release among high risk adolescents in detention, 2) A combined sexual and alcohol risk reduction intervention will result in larger decreases in sexual risk behavior than a sexual risk reduction alone, 3) The interventions will exert their effects through changes in mediators derived from a theoretically-based model of condom use intentions and behaviors, and 4) A sexual risk reduction intervention including an alcohol component will be especially effective for those adolescents with higher levels of existing alcohol problems. Finally, given proven efficacy, the intervention curricula and materials will be disseminated for use in adolescent detention facilities throughout the state.


Options:
A: Condom use (one year)
B: Rearrest
C: Time Line Follow Back and urine screen (Pre and post-treatment, 3 and 6 month follow-ups)
D: Diagnosis of mental health disorder (15 year follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Adaptive Servo-Ventilation Therapeutically More Effective Than Continuous Positive Airway Pressure In Treating Complex Sleep Apnea Syndrome?
Brief Summary: The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over time.


Options:
A: All Cause Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); Cardiovascular Mortality or Unplanned Hospitalisation/Prolongation of Hospitalisation for Worsening Heart Failure (time to first event, assessed for up to 70 weeks); All Cause Mortality or All Cause Unplanned Hospitalisation/Prolongation of Hospitalisation (time to first event, assessed for up to 70 weeks)
B: Left ventricular ejection fraction confirmed by echocardiography (three months)
C: apnea-hypopnea index (at 6 weeks)
D: Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)
Brief Summary: This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.


Options:
A: Patients With Complete Clearance of Actinic Keratosis (AKs) (57 days)
B: Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. (57 days)
C: Complete Clearance of Actinic Keratoses (AK) Lesions (baseline and 57 days)
D: Number of Participants With Recurrence of AK Lesions (Up to one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
Brief Summary: This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.


Options:
A: Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions (57 days)
B: Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. (57 days)
C: Number of Participants With Recurrence of AK Lesions (Up to one year)
D: Patients With Complete Clearance of Actinic Keratosis (AKs) (57 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Multisystemic Therapy to Reduce Health Disparities in Adolescents With Asthma
Brief Summary: Asthma is a chronic lung disease that inflames and narrows the airways. Symptoms can include recurring periods of wheezing, chest tightness, shortness of breath, and coughing. Minority, inner city teens are at increased risk for complications from the disease, possibly because of poor illness management. The purpose of this study is to test the effectiveness of Multisystemic Therapy (MST)-an intensive, home- and community-based psychotherapy-for improving asthma management and overall health and for reducing healthcare costs for inner city African American teens with asthma.


Options:
A: Pulmonary functioning (FEV-1, FVC) (Measured at study entry and Months 7 (post treatment) and 12); Hospital and emergency department utilization (for asthma exacerbation) (Measured at study entry and Months 7 (post treatment) and 12)
B: Night Wakenings Due to Asthma (To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up).)
C: Proportion of Eligible Children who Participate in Study (End of enrollment: estimated 2 years after beginning active enrollment.); Participant Drop-out Rates (After final outcome measures are collected: up to 2 1/2 years from beginning of active enrollment.); Session Completion Rates (After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.); Program Satisfaction Survey (End of Study Participation: up to 5 months from initial enrollment.); Barriers to offering the Intervention in Selected Schools (End of enrollment: estimated 2 years after beginning active enrollment.); Child Depression Inventory (Pre and Post Intervention: baseline, up to 4 months later.); State-Trait Anxiety Inventory for Children (Pre and Post Intervention: baseline, up to 4 months later.); Perceived Stress Scale (Pre and post intervention: baseline, up to 4 months later.); Pediatric Asthma Quality of Life Questionnaire (Pre and Post Intervention: baseline, up to 4 months later.); Asthma Self-Management Scale (Pre and Post Intervention: baseline, up to 4 months later.); KIDCOPE (Pre and Post Intervention: baseline, up to 4 months later.); Measure of Current Status (MOCS - Adapted) (Pre and Post Intervention: baseline, up to 4 months later.); Change in Asthma Health from Baseline (Pre to post-intervention: baseline, up to 4 months later.)
D: Product Evaluation (Once per module (One Evaluation per week for seven weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Overweight and Obesity in Preschool Children, Prevalence and Prevention - Family Based Health Interventions for Child Health
Brief Summary: To evaluate the effects of a family-based intervention program intended for parents of pre-school children (4-6 y) with overweight and obesity (according to Cole et al), and to investigate if treatment has an effect on metabolic parameters. In a randomised controlled trial evaluate the three separate family based intervention programs and to investigate if treatment has an effect by correlating the parameters described above with BMI, before and after the intervention program.


Options:
A: Vegetable Flavor Acceptance [Infants' Intake] (6- to 10-month-old weaned infants (3 separate test days )); Taste Liking Ratings of Vegetable Flavors [Mothers]. (Monthly, 0.5 to 4.5 months); Vegetable Flavor Acceptance (Infants' Rate of Feeding) (6- to 10-month-old weaned infants (3 separate test days))
B: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)
C: Body fat (At the end of the intervention and at a six month follow-up)
D: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)

Answer: B