TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pennsylvania Adolescent Smoking Study (PASS) - Randomized Controlled Trial Comparing Motivational Interviewing and Structured Brief Advice for the Reduction of Adolescent Cigarette Smoking
Brief Summary: The Pennsylvania Adolescent Smoking Study (PASStudy) will evaluate the effectiveness of Motivational Interviewing (MI) compared to Structured Brief Advice (SBA) to reduce cigarette smoking among adolescents who smoke. MI is a brief 5 session client-centered psychotherapeutic style intended to increase "the probability that a person will enter into, continue and adhere to a specific change strategy." This will be compared with SBA, which implements Best Practice Guidelines (i.e., 5 A's and 5 R's) and assists participants in accessing the best available resources for smoking cessation.


Options:
A: Smoking abstinence as measured by 7-day point prevalence abstinence at 12 months following treatment (12 months)
B: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)
C: Smoking cessation (point prevalence, both self reported as biochemical verified) (12 months)
D: smoking abstinence: self reported abstinence (12 or more months) (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pennsylvania Adolescent Smoking Study (PASS) - Randomized Controlled Trial Comparing Motivational Interviewing and Structured Brief Advice for the Reduction of Adolescent Cigarette Smoking
Brief Summary: The Pennsylvania Adolescent Smoking Study (PASStudy) will evaluate the effectiveness of Motivational Interviewing (MI) compared to Structured Brief Advice (SBA) to reduce cigarette smoking among adolescents who smoke. MI is a brief 5 session client-centered psychotherapeutic style intended to increase "the probability that a person will enter into, continue and adhere to a specific change strategy." This will be compared with SBA, which implements Best Practice Guidelines (i.e., 5 A's and 5 R's) and assists participants in accessing the best available resources for smoking cessation.


Options:
A: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)
B: Abstinence from smoking in the past 30 days at 6 months and 1 year
C: Biochemically verified 7 day point prevalence abstinence from smoking.
D: Conners' Global Index - Parent Version (CGI-P) (Once weekly during the medication trial); Conner's Global Index - Teacher Version (CGI-T) (Once weekly during the medication trial)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pennsylvania Adolescent Smoking Study (PASS) - Randomized Controlled Trial Comparing Motivational Interviewing and Structured Brief Advice for the Reduction of Adolescent Cigarette Smoking
Brief Summary: The Pennsylvania Adolescent Smoking Study (PASStudy) will evaluate the effectiveness of Motivational Interviewing (MI) compared to Structured Brief Advice (SBA) to reduce cigarette smoking among adolescents who smoke. MI is a brief 5 session client-centered psychotherapeutic style intended to increase "the probability that a person will enter into, continue and adhere to a specific change strategy." This will be compared with SBA, which implements Best Practice Guidelines (i.e., 5 A's and 5 R's) and assists participants in accessing the best available resources for smoking cessation.


Options:
A: 7-day point-prevalence abstinence at 2 weeks and 6 month follow-up
B: Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. (Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24)
C: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
D: smoking cessation (6-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Use of a New Written Action Plan Increase Short-term Adherence to Prescribed Medication and Asthma Control in Children Treated for an Asthma Attack in the Emergency Department: A Randomized Controlled Trial.
Brief Summary: The objective of the proposed large, high-intensity, randomised controlled trial is to evaluate the real-life effectiveness of providing a written action plan to asthmatic children discharged from the emergency department (ED) or hospital on the short-term adherence to written recommendations (including medication, attendance to asthma education and medical follow-up). main outcome is adherence to prescribed inhaled preventive medication measured by an electronic counter. Secondary outcomes include attendance to asthma education and to medical follow-up, serving by pharmacy of prescription of oral steroids, as well as asthma control measured by questionnaire (Asthma Quiz for Kidz),2 use of rescue ß2-agonists, relapse to emergency room.


Options:
A: number of subjects who achieved Total asthma Control: Period 2 (Up to Week 24)
B: Adherence rate to daily inhaled steroids, reported as the ratio of the sum of number of recorded over prescribed activation per day during the 28 days following the index visit.
C: N/A
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week Efficacy and Safety Study of Two Doses of Mometasone Furoate/Formoterol Combination Formulation Compared With Mometasone Furoate Monotherapy, in Persistent Asthmatics Previously Treated With High-Dose Inhaled Glucocorticosteroids
Brief Summary: This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during the run-in period. Efficacy will be measured by the area under the curve from 0 to 12 hours \[AUC\](0-12 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).


Options:
A: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Week 12)
C: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
D: Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12 (Week 0 and 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week Efficacy and Safety Study of Two Doses of Mometasone Furoate/Formoterol Combination Formulation Compared With Mometasone Furoate Monotherapy, in Persistent Asthmatics Previously Treated With High-Dose Inhaled Glucocorticosteroids
Brief Summary: This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during the run-in period. Efficacy will be measured by the area under the curve from 0 to 12 hours \[AUC\](0-12 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).


Options:
A: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks. (Baseline and 12 weeks)
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Week 12)
C: FEV1, (Forced expiratory volume in the 1st second).
D: Number of Patients With Drug-related Adverse Events (after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week Efficacy and Safety Study of Two Doses of Mometasone Furoate/Formoterol Combination Formulation Compared With Mometasone Furoate Monotherapy, in Persistent Asthmatics Previously Treated With High-Dose Inhaled Glucocorticosteroids
Brief Summary: This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during the run-in period. Efficacy will be measured by the area under the curve from 0 to 12 hours \[AUC\](0-12 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).


Options:
A: Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period (Day 28 of the relevant treatment period (up to Study Day 112))
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Week 12)
C: FEV1 peak0-3 Change From Baseline (Baseline and 24 weeks)
D: Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24. (Baseline (Day 0) and Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood epilepsy in Bangladesh with particular reference to behavioural side effects.


Options:
A: N/A
B: The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase (112 days)
C: The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.
D: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (Visit 1 to End of Study (approximately 52 weeks))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood epilepsy in Bangladesh with particular reference to behavioural side effects.


Options:
A: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))
B: The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase (112 days)
C: 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment (58 weeks)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood epilepsy in Bangladesh with particular reference to behavioural side effects.


Options:
A: Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) (52 weeks)
B: Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase (Week 31 through Week 109)
C: N/A
D: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (Visit 1 to End of Study (approximately 52 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bracing in Patellofemoral Osteoarthritis: A Clinical Trial
Brief Summary: Osteoarthritis, sometimes called degenerative joint disease, is the most common form of arthritis. It occurs when the cartilage in joints wears down over time. Symptoms can include pain, tenderness, stiffness, and inflammation. Studies have suggested that symptoms of knee osteoarthritis may be caused by abnormalities at the patellofemoral joint, which is the joint between the kneecap, called the patella, and the thigh bone, called the femur. This study will determine whether wearing a knee brace that realigns the patella over the femur is effective in relieving pain and improving function in adults with knee osteoarthritis.


Options:
A: Change in Pain on the VIsual Analog Scale (VAS) (6 weeks); Change in WOMAC Pain Scale (6 weeks)
B: Change in knee pain intensity from baseline at 4 weeks (4 weeks)
C: Changes in the intensity of hip pain before and after the treatment (participants will be assessed before and after intervention (interval: 15-20 minutes))
D: Numerical Pain Rating Scale (NPRS) (Time 0 - baseline); Numerical Pain Rating Scale (NPRS) (Time 1 - after 10min of the baseline); Numerical Pain Rating Scale (NPRS) (Time 2 - after 72 hours of baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one chemotherapy drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying three different combination chemotherapy regimens to compare how well they work when given together with cetuximab in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.


Options:
A: overall survival
B: Progression Free Survival (PFS) (5 years)
C: Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma (Up to 2 years post-treatment)
D: Objective response rate (ORR) (about 10 month (until progression))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase II Study of ECF-C, IC-C, or FOLFOX-C in Metastatic Esophageal and GE Junction Cancer
Brief Summary: RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one chemotherapy drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying three different combination chemotherapy regimens to compare how well they work when given together with cetuximab in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.


Options:
A: Median Progression Free Survival (Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week))
B: Overall Survival (OS) (From randomization up to 627 days)
C: Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma (Up to 2 years post-treatment)
D: Progression Free Survival (PFS) in the Overall Study Population (Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months); Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients] (Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
Brief Summary: The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.


Options:
A: Composite Abuse Scale (CAS)-CAS Victimization Total Score (Assessed at baseline, and again three months later); Safety Behavior Checklist (SBC) (Assessed at baseline, and again three months later); Effectiveness in Obtaining Resources Scale (EOR) (Assessed at baseline, and again three months later)
B: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
C: Change in telomerase activity (pre-intervention (baseline) and post-intervention (5.5 months later))
D: CAPS for PTSD symptoms and ASI for substance use (pre, mid treatment, post, 3-month follow-up, 6-month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
Brief Summary: The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.


Options:
A: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
B: HIV sero-incidence (24 months post-baseline)
C: Recurrence of intimate partner violence (18 months); Health-specific quality of life (18 months); Harms of screening and/or usual care (18 months)
D: disclosure rates for past year exposure to intimate partner violence

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
Brief Summary: The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.


Options:
A: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
B: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
C: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
D: Change in IPV assessments (Screening and at 2 months post-birth.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
Brief Summary: The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.


Options:
A: Severity of Violence Against Women (6 months); Women's Experience with Battering (6 months); Safety Behavior Checklist (6 months); Decisional Conflict Scale (6 months)
B: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
C: Intimate partner violence (One year)
D: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
Brief Summary: The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.


Options:
A: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
B: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
C: Cotinine validated quit rates.
D: Smoking Behavior (Self-report Confirmed by Expired Breath CO) (8 week follow up); Urinary Cotinine (8 week follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
Brief Summary: The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.


Options:
A: Cotinine validated quit rates.
B: Frequency of women receiving the cessation smoking advice (Interviews during the first 12 hours after delivery)
C: Participants' Smoking Status (around the 32nd week of gestation.); The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. (At the baseline and at the 32nd week of gestation)
D: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
Brief Summary: The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.


Options:
A: Intimate partner violence (One year)
B: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
C: PTSD Symptom Scale- I (PSS) (Measured 4 and 12 weeks post-trauma)
D: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)

Answer: B