TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Child Mental Health: RCT of Home Visiting
Brief Summary: This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home visitation program for families at risk for child abuse, in promoting the health and development of children.


Options:
A: Acceptability of the home-visiting program from the perspective of mothers enrolled (Baseline, 2-months postpartum, 6-months postpartum, 12-months postpartum); Retention in the home-visiting programs (2-months postpartum, 6-months postpartum, 12-months postpartum); Participant satisfaction (6-months postpartum, 12-months postpartum); Adherence (Study enrollment through study completion, an average of 1 year); Home visitor-participant relationship (2-months postpartum, 6-months postpartum, 12-months postpartum)
B: Increase in parental competence at nine intervals over 39 month study period (birth-3 year postpartum)
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 child adiposity from baseline measured via BMI z-score (Enrollment, 6 months, 12 months, 18 months, 24 months); Change in adult adiposity from baseline measured via BMI (Enrollment, 12 months, 24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Child Mental Health: RCT of Home Visiting
Brief Summary: This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home visitation program for families at risk for child abuse, in promoting the health and development of children.


Options:
A: Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months (Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
B: Change in partner violence victimization (summary score) (baseline to 12 months); Change in reproductive coercion (summary score) (baseline to12 months)
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: Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) (Baseline); Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) (6-months post-enrollment); Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) (Baseline); Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention (Baseline); Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention (6-months post-enrollment); Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention (Baseline); Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention (6-months post-enrollment); Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention (Baseline); Implementation and Service Outcome: Adoption of the Women's Health CoOp (WHC) intervention (Baseline); Implementation and Service Outcome: Adoption of the WHC intervention (6-months post-enrollment); Implementation and Service Outcome: Cost (Baseline); Implementation and Service Outcome: Cost (6-months post-enrollment); Implementation and Service Outcome: Feasibility (Throughout the period of the study, up to a maximum of one year); Implementation and Service Outcome: Fidelity (Throughout the study at bimonthly intervals for up to one year); Implementation and Service Outcomes: Sustainability (Throughout the period of the study, up to a maximum of one year); Implementation and Service Outcomes: Sustainability (6 months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Child Mental Health: RCT of Home Visiting
Brief Summary: This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home visitation program for families at risk for child abuse, in promoting the health and development of children.


Options:
A: condom use (4.5 months)
B: Intimate partner violence (One year)
C: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Child Mental Health: RCT of Home Visiting
Brief Summary: This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home visitation program for families at risk for child abuse, in promoting the health and development of children.


Options:
A: Number of significantly improved child and maternal outcomes (2 Years)
B: The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at baseline); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 3 weeks postpartum); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 3 months postpartum); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 6 months postpartum)
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: Depressive symptoms (Measured at baseline); Depressive symptoms (Measured at 3 weeks); Depressive symptoms (Measured at 3 months); Depressive symptoms (Measured at 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Child Mental Health: RCT of Home Visiting
Brief Summary: This study will evaluate the effectiveness of Hawaii's Healthy Start Program (HSP), a home visitation program for families at risk for child abuse, in promoting the health and development of children.


Options:
A: Incident Gender-Based Violence (GBV) (3 months postpartum); Incident GBV (6 months postpartum)
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: 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.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Cognitive Therapy for Depression.
Brief Summary: This study determined the effectiveness of continuation phase cognitive therapy versus antidepressant medication in preventing relapse of depression in people with recurrent depression.


Options:
A: Score on the Hamilton Rating Scale for Depression (measured at Month 24)
B: Depressive Relapse or MDD (Measured at month 8); Depressive Relapse/Recurrence or MDD (Measured at month 20); Depressive Relapse/Recurrence or MDD (Measured at month 32)
C: Hamilton Rating Scale for Depression (Change from Baseline in HAM-D at 8 weeks)
D: Relapse/recurrence of Major Depressive Episode (3, 6, 9, 12, 15 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma
Brief Summary: The purpose of this study is to test the effect of thalidomide in patients with multiple myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor doctor know which of these are given) in addition to the ordinary chemotherapeutic drug against multiple myeloma. We will find out for how long time the patients will stay free of the disease and for how long time they will live, and can evaluate whether thalidomide is a beneficial drug against this disease.


Options:
A: Progression-Free Survival (PFS) (Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.)
B: Time to tumor progression (TTP) (Up to 3 years)
C: overall survival (october 2007)
D: Overall survival

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier
Brief Summary: Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?


Options:
A: Pain response(Premature Infant Pain Profile (PIPP) (Baseline until completion of heelstick)
B: Pain measured on PIPP (Premature Infant Pain Profile) scale (4 week to complete)
C: N/A
D: pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS) (Immediately after vaccination)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier
Brief Summary: Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?


Options:
A: Pain measured on PIPP (Premature Infant Pain Profile) scale (4 week to complete)
B: - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)
C: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)
D: Pain scores assessed by the PIPP score (The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier
Brief Summary: Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?


Options:
A: Pain measured on PIPP (Premature Infant Pain Profile) scale (4 week to complete)
B: pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS) (Immediately after vaccination)
C: initial PAED score (During 1 minutes after PACU admission)
D: recovery after inguinal hernia surgery = time to restore normal activities after surgery (one week)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Narrative Exposure Therapy Compared to Treatment as Usual for Traumatized Refugees and Asylum Seekers in Mid-Norway
Brief Summary: In this study we want to compare Narrative Exposure Therapy to Treatment as Usual for traumatized refugees and asylum seekers in the Mid- Norway region. Clinicians in psychiatric outpatient clinics will deliver the two conditions to asylum seekers and refugees that qualifies for Posttraumatic Stress Disorder. We will investigate if refugees and asylum seekers will improve more with Narrative Exposure Therapy or Treatment as Usual, and if there will be any differences between improvement for asylum seekers compared to improvement for refugees with residential status.


Options:
A: Clinician Administered PTSD Scale (before treatment, 1 month after, 6 months after)
B: Severity of mental health symptoms (previous 4 weeks)
C: Harvard Trauma Questionnaire (HTQ) (Change from baseline after aprox. 6 months treatment)
D: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (4 & 9 months after completion of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise in Hypertension, Randomised Clinical Trial
Brief Summary: Endurance training has a documented effect on hypertension. However, only low to moderate training intensity has so far been studied. High aerobic intensity should, from physiological considerations, prove more effective in also reducing high blood pressure. The present study is a randomised comparison of high versus moderate intensity versus training in groups, and general advice on 24 hour blood pressure in hypertensives. The training period is 12 weeks, with follow-up after 1 year. Maximum oxygen uptake, quality of life, left ventricular function and blood vessel reactivity are also measured.


Options:
A: Aerobic fitness (before and after the 10 week intervention)
B: Changes in MVPA (Moderate-to-Vigorous Physical Activity) bouts of participants from baseline to months 6 and 12 (Baseline, 6 and 12 months)
C: 6-minute walk test at 6 month follow-up (Measured at baseline and Month 6 follow-up)
D: 24 hour blood pressure (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effective Endurance Training in Metabolic Syndrome
Brief Summary: To see how fast and how much physical training can reduce risk factors related to metabolic syndrome


Options:
A: Change of intrahepatic triglyceride contents (12 months)
B: To reduce risk factors related to metabolic syndrome
C: Maximal treadmill walking distance (6 months)
D: Physical activity level (At the begining of the intervention and after 9 months.); Cardiovascular risk. (At the begining of the intervention and after 9 months); Biochemical analysis. (At the begining of the intervention and after 9 months.); Antropometric measurements. (At the begining of the intervention and after 9 months.); Frequency of food consumption (At the begining of the intervention and after 9 months.); Health related quality of life (At the begining of the intervention and after 9 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Eight-week, Randomized, Double-blind, Multi-center, Active-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of an Aliskiren-based Regimen Compared to a Lisinopril-based Regimen in Patients With Uncomplicated Severe Hypertension
Brief Summary: To compare the safety and efficacy of an aliskiren-based regimen to a lisinopril-based regimen in the treatment of severe hypertension


Options:
A: Evaluate safety through adverse events and laboratory abnormalities after 8 weeks
B: Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks
C: Percentage of Participants With Colonic Pathology (54 weeks); Summary of the End of Study Colonoscopy Results (54 weeks)
D: Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) (Baseline and Week 8); Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) (Baseline and Week 8); Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP) (Baseline and Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Eight-week, Randomized, Double-blind, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Ramipril in Patients With Hypertension and Diabetes Mellitus
Brief Summary: To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus


Options:
A: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) (Baseline to 8 weeks)
B: Evaluate safety through adverse events and laboratory abnormalities after 8 weeks
C: Change from baseline in mean sitting diastolic blood pressure after 8 weeks
D: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study (Baseline - end of study (Week 52 or Last observation carried forward (LOCF))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twenty Six-week, Randomized, Double-blind, Parallel Group, Multicenter, Active Controlled, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension
Brief Summary: This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension.


Options:
A: Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)). (baseline to 18 weeks of treatment)
B: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))
C: Change from baseline in diastolic blood pressure after 26 weeks
D: Blood pressure variation and proportion of use of add-on drugs (18 months); Adverse events (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. (18 monyhs)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twenty Six-week, Randomized, Double-blind, Parallel Group, Multicenter, Active Controlled, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension
Brief Summary: This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension.


Options:
A: Change from baseline in diastolic blood pressure after 26 weeks
B: N/A
C: Composite of cardiovascular death, fatal and nonfatal stroke, fatal and nonfatal myocardial infarction (heart attack)
D: Blood Pressure (baseline and six month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twenty Six-week, Randomized, Double-blind, Parallel Group, Multicenter, Active Controlled, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension
Brief Summary: This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension.


Options:
A: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
B: Change from baseline in diastolic blood pressure after 26 weeks
C: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
D: diabetes; death

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Twenty Six-week, Randomized, Double-blind, Parallel Group, Multicenter, Active Controlled, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension
Brief Summary: This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension.


Options:
A: Change from baseline in diastolic blood pressure after 26 weeks
B: stroke; new or recurrent transient ischemic attack; new or recurrent acute myocardial infarction; new occurrence or exacerbation of heart failure; new occurrence or exacerbation angina pectoris; dissecting aneurysm of the aorta; lower limb arterial obstruction; transition to dialysis; doubling of plasma creatinine (Cr) levels
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: Incidence of hypertension, by blood pressure ≥ 140/90 mmHg in individuals without diabetes or ≥ 135/85 mmHg in participants with diabetes. (18 months); Adverse events. (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG (18 months)

Answer: A