TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Multi-Center Study of Rapamycin for Treating Kidney Angiomyolipomas in TSC or LAM Patients
Brief Summary: This research study is evaluating a drug called rapamycin as a possible treatment for the lumps (or tumors) that form in the kidneys, called angiomyolipomas, in people who have either TSC or LAM. Kidney angiomyolipomas are tumors that are made up of blood vessels, muscle and fat. Rapamycin has been approved to treat other diseases, but it is investigational for treating kidney angiomyolipomas.

Investigational means that it is being as a possible treatment for kidney angiomyolipomas but is not currently approved by the U.S. Food and Drug Administration (FDA) for treating this disease.


Options:
A: Core Phase: European Medicine Agency (EMA): Seizure Frequency Response Rate (Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)); Core Phase: Food & Drug Administration (FDA): Percentage Change From Baseline in Partial Onset-seizure Frequency (Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase))
B: Objective Response Rate (On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks.)
C: List Learning test (from the BIRT Memory and Information Processing Battery) (6 months); Complex Figure test (from the BIRT Memory and Information Processing Battery) (6 months); CANTAB - Stockings of Cambridge (SOC) (6 months); CANTAB - Spatial Working Memory (SWM) (6 months); Telephone search dual task (from the Test of Everyday Attention) (6 months)
D: Angiomyolipoma Response Rate as Per Central Radiology Review (From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Multi-Center Study of Rapamycin for Treating Kidney Angiomyolipomas in TSC or LAM Patients
Brief Summary: This research study is evaluating a drug called rapamycin as a possible treatment for the lumps (or tumors) that form in the kidneys, called angiomyolipomas, in people who have either TSC or LAM. Kidney angiomyolipomas are tumors that are made up of blood vessels, muscle and fat. Rapamycin has been approved to treat other diseases, but it is investigational for treating kidney angiomyolipomas.

Investigational means that it is being as a possible treatment for kidney angiomyolipomas but is not currently approved by the U.S. Food and Drug Administration (FDA) for treating this disease.


Options:
A: Angiomyolipoma Response Rate as Per Central Radiology Review (From date of randomization until the earliest date of first documented AML progression, date of further anti-AML medication (including open-label Everolimus)/surgery or up to 5.7 years)
B: Objective Response Rate (On treatment, patients were evaluated radiologically for response to therapy up to 52 weeks.)
C: Rapamycin level (6 months); Complete blood count (6 months); Total cholesterol (6 months); Dermatologic sensitivity at site of application (pain, erythema, edema, pruritis) (6 months)
D: Volume of Angiomyolipomata

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: VISN 23 Lung Disease Self Management/Case Management Program
Brief Summary: The purpose of this study is to determine if a program of self management and case management reduces hospitalizations and urgent care visits for patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)
B: Sensitivity, Specificity and Positive Predictive Value of Simple Case Finding tools (12 months)
C: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)
D: 30 day readmission rate (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: VISN 23 Lung Disease Self Management/Case Management Program
Brief Summary: The purpose of this study is to determine if a program of self management and case management reduces hospitalizations and urgent care visits for patients with chronic obstructive pulmonary disease (COPD).


Options:
A: disease-specific health-related quality of life (HRQoL) (two years)
B: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)
C: Difference in COPD admission rates and death over one year between patients treated with supported self-management, in addition to usual care, and those treated with usual care alone? (1 year)
D: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: VISN 23 Lung Disease Self Management/Case Management Program
Brief Summary: The purpose of this study is to determine if a program of self management and case management reduces hospitalizations and urgent care visits for patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Identifying new patient subtypes and endpoints for COPD (3 years)
B: CCQ-recovery time in the event of an exacerbation(Health status recovery time) (6-months)
C: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)
D: Number of hospital admissions for exacerbations of COPD

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: VISN 23 Lung Disease Self Management/Case Management Program
Brief Summary: The purpose of this study is to determine if a program of self management and case management reduces hospitalizations and urgent care visits for patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Primary study outcomes are patients' self report of the severity of dyspnea and HRQOL. Baseline dyspnea will be quantified with the Baseline Dyspnea Index and Borg scale with regular measures of dyspnea using the Visual Analog Scale (VAS). HRQOL will be (8 weeks)
B: Dyspnea with ADL (3, 6, and 12 months); Exercise and functional performance (3, 6, and 12 months); Exercise adherence (3, 6, and 12 months); Acute COPD exacerbations (3, 6, and 12 months)
C: Adherence to COPD guidelines (Twelve months post intervention)
D: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: VISN 23 Lung Disease Self Management/Case Management Program
Brief Summary: The purpose of this study is to determine if a program of self management and case management reduces hospitalizations and urgent care visits for patients with chronic obstructive pulmonary disease (COPD).


Options:
A: Exercise Duration (Time Walked on the Constant Workrate Treadmill Test) (baseline and 12 weeks)
B: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)
C: Improvement tolerance capacity (4 months and 6 months)
D: Percentage of patients who completed the program (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Preventive Treatment With Sulfadoxine/Pyrimethamine During Pregnancy Among HIV-Positive and HIV-Negative Women: 2-Dose Versus Monthly - Malawi
Brief Summary: In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen administered in the second and third trimester of pregnancy. In this investigation, this two dose strategy was compared to a monthly SP regimen. The objective for the study was to determine the efficacy of the different regimens for HIV positive and HIV negative women in the prevention of placental malaria.


Options:
A: Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
B: Maternal parasitaemia at delivery (Delivery)
C: Prevalence of Placental Malaria (Delivery); Incidence of Malaria in Pregnant Women (Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination); Incidence of Malaria in Infants (Time at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age)); Incidence of Malaria in Infants (Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination)
D: Maternal malaria at delivery (Delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Preventive Treatment With Sulfadoxine/Pyrimethamine During Pregnancy Among HIV-Positive and HIV-Negative Women: 2-Dose Versus Monthly - Malawi
Brief Summary: In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen administered in the second and third trimester of pregnancy. In this investigation, this two dose strategy was compared to a monthly SP regimen. The objective for the study was to determine the efficacy of the different regimens for HIV positive and HIV negative women in the prevention of placental malaria.


Options:
A: PCR corrected clinical and parasitological outcome at day 45
B: Prevalence of parasitaemia on day 28 post treatment.; Prevalence of parasitaemia on day 14 post treatment.
C: Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
D: • Prevalence of placental malaria infection; • Prevalence of maternal peripheral parasitemia

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Preventive Treatment With Sulfadoxine/Pyrimethamine During Pregnancy Among HIV-Positive and HIV-Negative Women: 2-Dose Versus Monthly - Malawi
Brief Summary: In Malawi, the standard of care to prevent malaria during pregnancy at the time of the study was a two dose sulfadoxine-pyrimethamine intermittent protective treatment (SP IPT) regimen administered in the second and third trimester of pregnancy. In this investigation, this two dose strategy was compared to a monthly SP regimen. The objective for the study was to determine the efficacy of the different regimens for HIV positive and HIV negative women in the prevention of placental malaria.


Options:
A: • Prevalence of placental malaria infection; • Prevalence of maternal peripheral parasitemia
B: Prevalence of severe maternal anaemia (Hb < 8g/dl) at 34 to 36 weeks of gestation. (At 34 to 36 weeks of gestation)
C: Placental malaria parasitemia rates measured at time of delivery, stratified by HIV status
D: Proportion of preterm births (once, after delivery); Number of serious adverse events (Cumulative during pregnancy and neonatal period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Blinded, Randomised, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Combined Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children in Their Second Year of Life
Brief Summary: This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.


Options:
A: Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2 (Up to Day 46 (for 4 days following ProQuad® Dose 2)); Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2 (Up to Day 70 (up to 28 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2 (Up to Day 84 (up to 42 days after ProQuad® Dose 2)); Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2 (Up to Day 84 (up to 42 days after ProQuad® Dose 2))
B: compare immune responses to measles, mumps, rubella, and varicella antigens following vaccination in children who receive FluMist concurrently with MMRIIÒ and VARIVAXÒ and in children (Day 42)
C: Antibody levels after vaccination.
D: Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups. (31 days following the second dose of Havrix®); Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups (31 days following the second dose of Havrix®); Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups (42 days following the administration of M-M-R®II and VARIVAX®); Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups (42 days following administration of M-M-R®II and VARIVAX®)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years
Brief Summary: The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.


Options:
A: N/A
B: Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population (Baseline to Endpoint (weeks 3-4)); Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population (Baseline to Endpoint (weeks 3-4))
C: Maximum Post-exercise Percent (%) Fall in FEV1 (4 weeks (Weeks 0 to 4 or Weeks 6 to 10))
D: To evaluate distal airway function using high-resolution CT and lung function test (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years
Brief Summary: The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.


Options:
A: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)
B: Daily asthma symptom score
C: Asthma Control (8 weeks (from Week 0 to Week 8))
D: Maximum Post-exercise Percent (%) Fall in FEV1 (4 weeks (Weeks 0 to 4 or Weeks 6 to 10))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder
Brief Summary: This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.


Options:
A: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). (Two years); 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) (Two years)
B: Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. (Baseline and 3 months)
C: Overactive bladder- health related quality of life (OAB HRQOL) (Baseline and at one, six, and 12 weeks)
D: Change from baseline in average number of urinations per patient per day at Week 12

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Behavioral Therapy in Combination With Drug-Darifenacin for Symptoms of Overactive Bladder
Brief Summary: This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.


Options:
A: Change from baseline in average number of urinations per patient per day at Week 12
B: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)
C: Urinary Incontinence (Prevalence) (6 months postpartum (end of intervention))
D: Difference in Incontinence Impact Questionnaire (IIQ-7) scores (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Difference in Overactive Bladder Symptom Score (OABSS) (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Urogenital Distress Inventory (UDI-6) scores (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Differences in daytime frequency (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); incontinence episodes (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Nocturia (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of CPAP on Arterial Hypertension and Cardiovascular Morbi-Mortality in Patients With Sleep Apnea and Without Daytime Sleepiness
Brief Summary: The objective of the study is to evaluate the effect of CPAP over the incidence of cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea.

The hypothesis of the study is the following: The existence of sleep disordered breathing in the general population is associated to an increased incidence of arterial hypertension and to an increased risk of suffering cardiovascular disease. CPAP corrects respiratory disorders during sleep. Treatment with CPAP in subjects with sleep disordered breathing without daytime sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular complications.

The end points of the study are new diagnosis of arterial hypertension and new cardiovascular events.

All patients, after randomization, will be followed for three years.


Options:
A: proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups (CPAP use was evaluated for 4 months)
B: CPAP usage (12-week)
C: CPAP compliance (6 months); Cost-effectiveness (6 months); Quality of life (6 months)
D: Incidence of hypertension; Incidence of cardiovascular events

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of CPAP on Arterial Hypertension and Cardiovascular Morbi-Mortality in Patients With Sleep Apnea and Without Daytime Sleepiness
Brief Summary: The objective of the study is to evaluate the effect of CPAP over the incidence of cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea.

The hypothesis of the study is the following: The existence of sleep disordered breathing in the general population is associated to an increased incidence of arterial hypertension and to an increased risk of suffering cardiovascular disease. CPAP corrects respiratory disorders during sleep. Treatment with CPAP in subjects with sleep disordered breathing without daytime sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular complications.

The end points of the study are new diagnosis of arterial hypertension and new cardiovascular events.

All patients, after randomization, will be followed for three years.


Options:
A: Polysomnography parameters: sleep structure, respiratory, limb movements (onset, 3 and 6 months of treatment)
B: Incidence of hypertension; Incidence of cardiovascular events
C: Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline) (Baseline and 12 weeks (or last observation after baseline)); Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline) (12 weeks (or last observation after baseline))
D: sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness (during treatment while at altitude)

Answer: B