TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Chest Physiotherapy Actual Versus Conventional Techniques in Infants With Acute Viral Bronchiolitis. Random Clinical Trial
Brief Summary: The purpose of this study is to verify the effectiveness of chest physiotherapy (actual versus conventional) on respiratory distress in infants with acute viral bronchiolitis.


Options:
A: Delay for obtention of healing defined by all of these parameters at least 8 hours in a row : pulse oxymétry >94% AND normal feeding AND specific respiratory distress score lower than one as described in the protocol AND normal respiratory rate (obtention)
B: Occurrence of chest retractions as a measure of respiratory distress (30 minutes); Occurrence of wheezing as a measure of respiratory distress (30 minutes); Number of nasal bleeding events as a measure of adverse effects (1 day); Number of vomit episodes as a measure of adverse effects (1 day)
C: Wang clinical severity scale (12 weeks)
D: Respiratory distress (on first evaluation by physiotherapyst ( until 2 hours after hospital admission))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Double-blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma
Brief Summary: This randomized phase III trial studies temozolomide (TMZ) and radiation therapy (RT) to compare how well they work with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may find tumor cells and help kill them. It is not yet known whether temozolomide and radiation therapy are more effective when given together with or without bevacizumab in treating glioblastoma or gliosarcoma.


Options:
A: Overall Survival (Time to event)
B: Percentage of Participants Alive 6 Months After Start of Treatment (6 months); Overall Survival (OS) (Baseline until death (up to 691 days))
C: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)
D: median overall survival (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Double-blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma
Brief Summary: This randomized phase III trial studies temozolomide (TMZ) and radiation therapy (RT) to compare how well they work with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may find tumor cells and help kill them. It is not yet known whether temozolomide and radiation therapy are more effective when given together with or without bevacizumab in treating glioblastoma or gliosarcoma.


Options:
A: Overall survival (12 months)
B: N/A
C: Progression Free Survival (PFS) time (5 years)
D: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Double-blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma
Brief Summary: This randomized phase III trial studies temozolomide (TMZ) and radiation therapy (RT) to compare how well they work with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may find tumor cells and help kill them. It is not yet known whether temozolomide and radiation therapy are more effective when given together with or without bevacizumab in treating glioblastoma or gliosarcoma.


Options:
A: Progression free survival (12 months)
B: Overall survival
C: Overall Survival (During treatment and every three months from end of treatment through end of study or approximately up to 5 years.)
D: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. All patients will receive treatment in a single lung under conscious sedation or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. All study patients will receive standard medical therapy in addition to PLVR.


Options:
A: Forced expiratory volume in 1-second (FEV1) compared to active comparator (Year 1); Quality of Life (SGRQ) (Year 1)
B: St. George's Respiratory Questionnaire (6 months)
C: Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) (12 and 24 weeks following treatment)
D: Quantitative change of lung volume on computed tomography (Before procedure and 12 weeks after procedure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial
Brief Summary: The purpose of the study is to examine the effectiveness of telephone cognitive-behavioral therapy for subthreshold depression and presenteeism in workplace, in comparison with treatment-as-usual (TAU) (which is minimal contact through Employers Assistance Program (EAP)).


Options:
A: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation (Baseline and Week 8 or FOT)
B: Depression severity as measured by Beck Depression Inventory-II (BDI2) (4 months post-randomization); Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month (4 months post-randomization)
C: Hamilton Depression Rating Scale (HAMD-17) (Baseline, 4, 8, 24, 36, 52 week)
D: Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample. (Baseline and Week 14); Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol. (Baseline and Week 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety of Fractional Booster Dose of Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intradermally Versus Full Booster Dose of Inactivated Poliomyelitis Vaccine (IMOVAX Polio) Administered Intramuscularly at 15 to 18 Months of Age in Healthy Toddlers in The Philippines
Brief Summary: The purpose of this study is to investigate the use of a fourth fractional booster dose of sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster dose between 15 to 18 months of age, in terms of immunogenicity and safety.

Objectives:

* To describe in each group the immunogenicity of IMOVAX Polio administered intradermally or intramuscularly, one month after the booster dose given at 15-18 months of age in toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25 study.
* To describe in each group the safety of the booster dose of IMOVAX Polio vaccine administered intradermally or intramuscularly.


Options:
A: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 (At Month 3, one month after the third vaccine dose)
B: The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination (1 Month Post-vaccination)
C: Immunogenicity: To provide information concerning the immunogenicity of IPV vaccine administrated intradermally as a booster vaccination. (30 days post-vaccination); Safety: To provide information concerning the safety after booster intradermal administration of IPV vaccine (30 days post-vaccination and entire study duration)
D: Number of adverse reactions following vaccination (4 days or until adverse reactions have resolved)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Efficacy and Tolerability of Docosahexaenoic Acid (DHA) on Children Affected by Nonalcoholic Fatty Liver Disease (NAFLD).
Brief Summary: The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA) in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).


Options:
A: Change in Liver Fat (24 weeks); Change in Liver Fibrosis (24 weeks); Change in Liver Injury (24 weeks)
B: Hepatic steatosis (6 months)
C: Liver status by liver biopsy (steatosis and fibrosis) (months 24)
D: Evaluate the effects of VSL#3 on metabolic, endocrine, lipidomic, metabolomic and inflammatory markers and microbiota variation of pediatric patients with BMI>90° (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa
Brief Summary: The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.


Options:
A: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))
B: Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal (Day 0 (baseline), Week 4)
C: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30 (Baseline and End of treatment (Day 28-30))
D: to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination. (up to 48 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa
Brief Summary: The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.


Options:
A: Clinically Significant Laboratory Abnormalities. (28 Days)
B: to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination. (up to 48 weeks)
C: Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal (Day 0 (baseline), Week 4)
D: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa
Brief Summary: The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.


Options:
A: Time to an Exacerbation (Baseline to end of study (up to 59 days))
B: Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal (Day 0 (baseline), Week 4)
C: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)
D: To better define risk factors for first isolation of Pa from respiratory culture, as well as for emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period); To better define clinical outcomes associated with acquisition of Pa, as well as outcomes associated with emergence of mucoid Pa and antibiotic-resistant Pa. (over the two-to-five-year observational period)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa
Brief Summary: The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.


Options:
A: to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination. (up to 48 weeks)
B: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)
C: Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal (Day 0 (baseline), Week 4)
D: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Before and After Study of the Impact of Lower Chloride Intravenous Fluid Management on Patients' Acid-base Status, Renal Profile,Length of Stay and Mortality.
Brief Summary: The purpose of this study is to determine whether intravenous fluid management using lower chloride solutions (Hartmann's solutions and Plasmalyte®) will result in better outcome when compared to management using high chloride solutions (0.9% saline and Gelofusine®).


Options:
A: Quality of Recovery-40 Score at 24 Hours (24 hours after ED visit)
B: Mortality (90 days)
C: Mean base excess during hospital stay (Six month control period (before) and 6 month intervention period (after))
D: Proportion of Isotonic Crystalloid Which is 0.9% Saline (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT
Brief Summary: The objective of the Program of Rehabilitative Exercise and Education to avert Vascular Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One group will receive a comprehensive education and exercise program (PREVENT); the other group will receive usual care (USUAL CARE). We will measure modifiable vascular risk factors in both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity, walking endurance, and daily physical activity. In addition, we will compare thinking ability, depression, achievement of personal goals for healthy behavior, and health-related goal attainment and health-related quality of life. Finally, we will compare outcomes in urban and rural settings as well as costs of the PREVENT program and USUAL CARE in order to assess sustainability of the PREVENT program.


Options:
A: The family caregiver's burden of care analyzed by Caregiver Burden Scale (2 months)
B: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)
C: Increase in Adherence and Control of Stroke Risk Factors (1, 3, 6, 9 and 12 months)
D: Medication Adherence (3 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT
Brief Summary: The objective of the Program of Rehabilitative Exercise and Education to avert Vascular Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One group will receive a comprehensive education and exercise program (PREVENT); the other group will receive usual care (USUAL CARE). We will measure modifiable vascular risk factors in both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity, walking endurance, and daily physical activity. In addition, we will compare thinking ability, depression, achievement of personal goals for healthy behavior, and health-related goal attainment and health-related quality of life. Finally, we will compare outcomes in urban and rural settings as well as costs of the PREVENT program and USUAL CARE in order to assess sustainability of the PREVENT program.


Options:
A: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)
B: Glucose area under the curve (0 weeks and 2 weeks)
C: Trunk Impairment Scale Norwegian Version (12 weeks); ActiGraph WgtX-BT (13 weeks)
D: modified Rankin Score (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT
Brief Summary: The objective of the Program of Rehabilitative Exercise and Education to avert Vascular Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One group will receive a comprehensive education and exercise program (PREVENT); the other group will receive usual care (USUAL CARE). We will measure modifiable vascular risk factors in both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity, walking endurance, and daily physical activity. In addition, we will compare thinking ability, depression, achievement of personal goals for healthy behavior, and health-related goal attainment and health-related quality of life. Finally, we will compare outcomes in urban and rural settings as well as costs of the PREVENT program and USUAL CARE in order to assess sustainability of the PREVENT program.


Options:
A: systolic blood pressure (primary vascular risk factor being assessed) (baseline, post-intervention, 6 months, 12 months); diastolic blood pressure (baseline, post-intervention, 6 months, 12 months); waist circumference (baseline, post-intervention, 6 months, 12 months); 12-hour fasting lipid profile (baseline, post-intervention, 6 months, 12 months); 12-hour fasting glucose/hemoglobin A1C (baseline, post-intervention, 6 months, 12 months)
B: Blood Pressure (12 months)
C: Difference in physical activity scale for the elderly (24 months)
D: Low Density Lipoprotein Value (1 year); Systolic Blood Pressure Value (1 year); Hemoglobin A1C Value (1 year); Pill count of antiplatelet therapy medications (1 year)

Answer: A