TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, International, Double-Blinded (With In-House Blinding), GARDASIL-Controlled, Dose-Ranging Study of Octavalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine Administered to 16- to 23- Year-Old Women
Brief Summary: This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.


Options:
A: Primary Objective Part 1 (Measured after Month 7); Primary Objective Part 2 (At 18, 24 and 36mths post dose 1); Primary Objective Part 2 (Measured at 36 mths)
B: Number of Subjects Reporting Serious Adverse Events (Throughout the study period (up to Month 7)); Number of Subjects Reporting Solicited Local Symptoms (During the 7-day (Day 0-6) period following each vaccination); Number of Subjects Reporting Solicited General Symptoms (During the 7-day (Day 0-6) period following each vaccination); Number of Subjects Reporting Unsolicited Adverse Events (AEs) (Within 30 days (Day 0-29) after any vaccination); Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Hematological Parameters (At Month 0 and Month 7); Number of Subjects Reporting Medically Significant Adverse Events (Throughout the study period (up to Month7))
C: Number of Subjects Seroprotected Against Diphtheria and Tetanus (One month after vaccination with Boostrix Polio); Titers of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin Toxoid (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies (One month after vaccination with Boostrix Polio); Number of Subjects Seroprotected Against Poliovirus Type 1 (Polio 1), Polio 2 and Polio 3 (One month after vaccination with Boostrix Polio)
D: The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay. (4 weeks post dose 3 injection)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Conventional Infertility Therapy vs. Fast Track to IVF
Brief Summary: The purpose of this randomized prospective clinical trial is to determine whether an infertility treatment that moves quickly to In Vitro Fertilization (IVF) is more cost effective than the usual treatment strategy which includes various combinations of infertility drugs and intrauterine insemination (IUI) prior to utilizing In Vitro Fertilization.


Options:
A: Number of ovulating patients (1-2 months)
B: Determine the cost-effectiveness of fast track to IVF versus conventional infertility treatment by conducting a randomized clinical trial to compare success rates and costs, as well as the associated complications of treatment. (at end of study)
C: Pregnancy rate (6 months follow-up)
D: Whole body insulin action (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Conventional Infertility Therapy vs. Fast Track to IVF
Brief Summary: The purpose of this randomized prospective clinical trial is to determine whether an infertility treatment that moves quickly to In Vitro Fertilization (IVF) is more cost effective than the usual treatment strategy which includes various combinations of infertility drugs and intrauterine insemination (IUI) prior to utilizing In Vitro Fertilization.


Options:
A: Number of ovulating patients (1-2 months)
B: Determine the cost-effectiveness of fast track to IVF versus conventional infertility treatment by conducting a randomized clinical trial to compare success rates and costs, as well as the associated complications of treatment. (at end of study)
C: pregnancy rate (3 momths)
D: Pregnancy rate (6 months follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Placebo-Controlled Trial of Inactivated Poliovirus Vaccine in Cuba
Brief Summary: The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.


Options:
A: Types 1 and 3 poliovirus humoral immune response (12 months)
B: Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value (One month after Poliorix™ booster vaccination.); Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value (Before booster vaccination.); Antibody Titers Against Poliovirus Type 1, 2 and 3 (One month after Poliorix™ booster vaccination.); Antibody Titers Against Poliovirus Type 1, 2 and 3. (Before booster vaccination.)
C: interference and immunugenicity (4 - 6 weeks after vaccination); Safety (up to 10 weeks after first vaccination)
D: Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Placebo-Controlled Trial of Inactivated Poliovirus Vaccine in Cuba
Brief Summary: The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.


Options:
A: Change in the stool poliovirus excretion after mOPV2 challenge (shedding index) (Within 28 days of mOPV2 challenge); Seroconversion and seroprotection to type 1, 2 and 3 poliovirus (At 6 and 14 weeks, and then before and 1 week after mOPV2 challenge)
B: Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity
C: Types 1 and 3 poliovirus humoral immune response (12 months)
D: Number of Subjects Reporting Solicited Local Symptoms (During the 4-day follow-up period after each dose of study vaccine.); Number of Subjects Reporting Solicited General Symptoms (During the 4-day follow-up period after each dose of study vaccine.); Number of Subjects Reporting Unsolicited Adverse Events (AEs) (During the 31-days follow-up period after each dose of the study vaccine.); Number of Subjects Reporting Serious Adverse Events (SAEs) (During the entire study period (from Dose 1 up to one month following last vaccine dose).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome
Brief Summary: Limited evidence suggests that acupuncture may help relieve symptoms of chronic prostatitis/chronic pelvic pain syndrome. This study evaluated if acupuncture twice weekly for 10 weeks would help ameliorate symptoms of CP/CPPS.


Options:
A: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))
B: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment)
C: Six point drop in NIH-CPSI total Score
D: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blind, Sham Controlled Trial Evaluating the Efficacy of Acupuncture in Relieving Symptoms of Chronic Prostatitis/ Chronic Pelvic Pain Syndrome
Brief Summary: Limited evidence suggests that acupuncture may help relieve symptoms of chronic prostatitis/chronic pelvic pain syndrome. This study evaluated if acupuncture twice weekly for 10 weeks would help ameliorate symptoms of CP/CPPS.


Options:
A: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
B: NIH-CPSI total score and change from baseline (baseline, week 1-8)
C: Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4)); Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach) (Years 1-2, Years 3-4, and Overall (Years 1-4))
D: Six point drop in NIH-CPSI total Score

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: a Randomised Control Trial on Protective Ventilatory Strategy in Potential Organ Donors
Brief Summary: The aim of the study is to verify if a "PROTECTIVE" ventilatory strategy (low tidal volume and high PEEP, application of CPAP during the apnea test and recruitment maneuvers), improves lung function and increases the number of lungs eligible for transplantation.


Options:
A: invasive arterial blood pressure as a Measure of Safety (Day 1)
B: Composite endpoint defined as incidence of major postoperative pulmonary (defined as pneumonia, need for noninvasive ventilation or need for invasive ventilation) and extrapulmonary (SIRS, sepsis and septic shock) complications (during the first seven days after surgery)
C: Lung cytokines in mechanically ventilated patients (30 months)
D: To increase the number of lungs that meet the eligibility criteria for transplantation (end of brain death diagnosis observation period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing an Eight-week Treatment of Aliskiren 75 mg, 150 mg and 300 mg to Placebo in Patients With Essential Hypertension
Brief Summary: This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks


Options:
A: Change from baseline in mean sitting diastolic blood pressure after 8 weeks
B: Change in Normalized Total Aortic Wall Volume (TWV) Between the Trial Arms at the End of the Treatment (Baseline and end of treatment ( 17 to 36 weeks))
C: Core Study: Change From Baseline in Left Ventricular End Systolic Volume (LVESV) as Measured by Echocardiography at End of Study. (Baseline and final visit (after 26 to 36 weeks of treatment)); Extension Study: Percentage of Participants With Deaths, Serious Adverse Events (SAEs), Discontinuation for Adverse Events (AEs) and Discontinuations for Abnormal Lab Values (Extension study (24 weeks))
D: Change from baseline in diastolic blood pressure after 8 weeks

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: REcurrent VEnous Thromboembolism Risk Stratification Evaluation A Study to Develop a Clinical Prediction Rule to Predict Low Recurrence Risk in Patients With Idiopathic Venous Thromboembolism.
Brief Summary: The purpose of this study is to develop a way to predict which patients diagnosed with idiopathic blood clots can safely stop warfarin therapy after six months. We will use patient characteristics, blood test results and imaging test results to identify those patients who have the lowest risk of developing a new blood clot after warfarin is stopped.


Options:
A: Incidence of adjudicated recurrent VTE during study follow-up (8 years)
B: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (Day 1 up to 12 Months); Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation (Day 1 up to 12 months)
C: recurrence of VTE and/or VTE related death (at least 24 months per patient)
D: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3: Randomised Controlled Trial of Rituximab in Active Ulcerative Colitis
Brief Summary: There is broad support for the hypothesis that Ulcerative colitis is an auto-immune disease. Rituximab is an antibody protein that removes a subgroup of white blood cells (B lymphocytes) from the circulation. These cells have the capacity to generate the auto-antibodies that typify auto-immune disease. Although Rituximab has been mainly used for treating B lymphocyte malignancies (lymphoma) it has also been used with promising results in Rheumatoid arthritis and has an excellent safety record. This is a small placebo-controlled trial to assess its efficacy and safety in patients with steroid-resistant active ulcerative colitis.


Options:
A: Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) (Week 12 (Day IP-85)); Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 (Month 12 (Day MP-365)); Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation (Day OL-1 through the end of the OL); OL; Number of Participants With AEs of Special Interest (Day OL-1 through Day OL-729); OL; Number of Participants With Physical Examination Findings (Day OL-1 through Day OL-729); OL; Number of Participants With Marked Hematology Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities (Day OL-1 through Day OL-729); OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities (Day OL-1 through Day OL-729)
B: Remission defined as a decrease in Mayo score to ≤ 2 points at week 4 (week 4)
C: Proportion of subject who were relapse free after 6 months of treatment (6 months)
D: Percentage of Participants Who Achieved Clinical Remission Based on the Central Read of the Mayo Score (MS), at Week 8 (Week 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3: Randomised Controlled Trial of Rituximab in Active Ulcerative Colitis
Brief Summary: There is broad support for the hypothesis that Ulcerative colitis is an auto-immune disease. Rituximab is an antibody protein that removes a subgroup of white blood cells (B lymphocytes) from the circulation. These cells have the capacity to generate the auto-antibodies that typify auto-immune disease. Although Rituximab has been mainly used for treating B lymphocyte malignancies (lymphoma) it has also been used with promising results in Rheumatoid arthritis and has an excellent safety record. This is a small placebo-controlled trial to assess its efficacy and safety in patients with steroid-resistant active ulcerative colitis.


Options:
A: Remission defined as a decrease in Mayo score to ≤ 2 points at week 4 (week 4)
B: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
C: Number of Participants With Clinical Response at Week 6 (Baseline, Week 6)
D: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion for Hospital-Based Smoking Cessation
Brief Summary: This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned to receive bupropion, an antidepressant, and cognitive-behavioral counseling, are more likely to have quit smoking at the end of treatment and at 6 months compared with smokers randomly assigned to receive placebo and cognitive-behavioral counseling. Because depression is more prevalent among smokers and because smokers who are prone to depression may become depressed when they quit, the hypothesis is that the proportion of quitters who receive the active drug/antidepressant will be greater than the proportion of quitters who receive the placebo drug at 6 months.


Options:
A: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)
B: Smoking status at 6 months after enrollment (6 months)
C: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
D: Treatment Satisfaction (End of treatment (seven weeks after baseline))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion for Hospital-Based Smoking Cessation
Brief Summary: This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned to receive bupropion, an antidepressant, and cognitive-behavioral counseling, are more likely to have quit smoking at the end of treatment and at 6 months compared with smokers randomly assigned to receive placebo and cognitive-behavioral counseling. Because depression is more prevalent among smokers and because smokers who are prone to depression may become depressed when they quit, the hypothesis is that the proportion of quitters who receive the active drug/antidepressant will be greater than the proportion of quitters who receive the placebo drug at 6 months.


Options:
A: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
B: Smoking status at 6 months after enrollment (6 months)
C: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
D: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion for Hospital-Based Smoking Cessation
Brief Summary: This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned to receive bupropion, an antidepressant, and cognitive-behavioral counseling, are more likely to have quit smoking at the end of treatment and at 6 months compared with smokers randomly assigned to receive placebo and cognitive-behavioral counseling. Because depression is more prevalent among smokers and because smokers who are prone to depression may become depressed when they quit, the hypothesis is that the proportion of quitters who receive the active drug/antidepressant will be greater than the proportion of quitters who receive the placebo drug at 6 months.


Options:
A: Smoking status at 6 months after enrollment (6 months)
B: Percent Treatment Sessions Attended (52 weeks)
C: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
D: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion for Hospital-Based Smoking Cessation
Brief Summary: This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned to receive bupropion, an antidepressant, and cognitive-behavioral counseling, are more likely to have quit smoking at the end of treatment and at 6 months compared with smokers randomly assigned to receive placebo and cognitive-behavioral counseling. Because depression is more prevalent among smokers and because smokers who are prone to depression may become depressed when they quit, the hypothesis is that the proportion of quitters who receive the active drug/antidepressant will be greater than the proportion of quitters who receive the placebo drug at 6 months.


Options:
A: Smoking Status (at week 48)
B: Smoking status at 6 months after enrollment (6 months)
C: tobacco abstinence (6 months)
D: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bupropion for Hospital-Based Smoking Cessation
Brief Summary: This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned to receive bupropion, an antidepressant, and cognitive-behavioral counseling, are more likely to have quit smoking at the end of treatment and at 6 months compared with smokers randomly assigned to receive placebo and cognitive-behavioral counseling. Because depression is more prevalent among smokers and because smokers who are prone to depression may become depressed when they quit, the hypothesis is that the proportion of quitters who receive the active drug/antidepressant will be greater than the proportion of quitters who receive the placebo drug at 6 months.


Options:
A: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: Smoking status at 6 months after enrollment (6 months)
D: 7 Day Point Prevalent Abstinence (PPA) (6 month post-enrollment); Professional Dental Care Utilization in Past 6 Months (6 months post-enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy
Brief Summary: The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.


Options:
A: Change in a mania rating scale at endpoint
B: Change from baseline to endpoint in a mania rating scale
C: Scores in the SNAP-IV (ADHD); Scores in the Young Mania Rating Scale (BD); Weight
D: Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 (Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]))

Answer: D