TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Health Outcomes for New Mothers and Babies
Brief Summary: Because adherence to postnatal care guidelines across the United States (U.S.) is poor, newborns and mothers often are placed at undue risk for adverse medical and social outcomes. This study aims to evaluate an alternative model of care and improve healthcare delivery to and reduce health disparities for "well" newborns and mothers after hospital discharge by using single postnatal home nurse visits. The principal investigator has previously shown a reduction in poor outcomes for infants who receive a home visit after discharge when studied retrospectively. The proposed research will build on the previous study and prospectively evaluate the impact of a single home nursing visit on morbidities and health disparities for newborns and mothers in a randomized, controlled trial involving 1154 mother/infant breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk period of infancy and motherhood, where medical and social problems can be recognized, anticipated, and/or treated, and can bridge the gap between hospital care and primary care. The investigators' program, The Nurses for Infants Through Teaching and Assessment after the NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation compared with guidelines-adherent outpatient clinic care.


Options:
A: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
B: Maternal stress and anxiety (Baselibne to 12 weeks); Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques (12 weeks); Breast milk cortisol concentrations at 12 weeks (12 weeks); Infant behaviour measured using a 3-day diary at 12 weeks (12 weeks); Infant weight and body composition measured using stable isotopes at 12 weeks (12 weeks); Physiological changes (maternal saliva cortisol, breast milk cortisol and milk volume) before and after physiological-mini test in intervention group at 2,6 and 12 weeks. (2,6,12 weeks)
C: Average number of childhood injuries (2, 10, 18 and 24 months postpartum)
D: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Health Outcomes for New Mothers and Babies
Brief Summary: Because adherence to postnatal care guidelines across the United States (U.S.) is poor, newborns and mothers often are placed at undue risk for adverse medical and social outcomes. This study aims to evaluate an alternative model of care and improve healthcare delivery to and reduce health disparities for "well" newborns and mothers after hospital discharge by using single postnatal home nurse visits. The principal investigator has previously shown a reduction in poor outcomes for infants who receive a home visit after discharge when studied retrospectively. The proposed research will build on the previous study and prospectively evaluate the impact of a single home nursing visit on morbidities and health disparities for newborns and mothers in a randomized, controlled trial involving 1154 mother/infant breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk period of infancy and motherhood, where medical and social problems can be recognized, anticipated, and/or treated, and can bridge the gap between hospital care and primary care. The investigators' program, The Nurses for Infants Through Teaching and Assessment after the NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation compared with guidelines-adherent outpatient clinic care.


Options:
A: Initiation of LARC by time of standard postpartum visit (4-8 weeks postpartum)
B: Change in receipt of primary care services - self report (2-months and 6-months Postpartum (baseline and 4-months from baseline data collection)); Change in receipt of primary care services - EMR review (2-months and 6-months Postpartum (baseline and 4-months from baseline data collection))
C: Postpartum Clinic Attendance (assessed at 12 weeks postpartum)
D: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Health Outcomes for New Mothers and Babies
Brief Summary: Because adherence to postnatal care guidelines across the United States (U.S.) is poor, newborns and mothers often are placed at undue risk for adverse medical and social outcomes. This study aims to evaluate an alternative model of care and improve healthcare delivery to and reduce health disparities for "well" newborns and mothers after hospital discharge by using single postnatal home nurse visits. The principal investigator has previously shown a reduction in poor outcomes for infants who receive a home visit after discharge when studied retrospectively. The proposed research will build on the previous study and prospectively evaluate the impact of a single home nursing visit on morbidities and health disparities for newborns and mothers in a randomized, controlled trial involving 1154 mother/infant breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk period of infancy and motherhood, where medical and social problems can be recognized, anticipated, and/or treated, and can bridge the gap between hospital care and primary care. The investigators' program, The Nurses for Infants Through Teaching and Assessment after the NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation compared with guidelines-adherent outpatient clinic care.


Options:
A: Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely (3 months)
B: Breastfeeding at 3 months and at 6 months (3 months and six months)
C: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)
D: Gastrointestinal tract infection (12 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Predictors of Antidepressant Treatment Response: The Emory CIDAR
Brief Summary: This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.


Options:
A: Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010) (12 weeks); Self-harm and related hospital use as reported in National Health Service patient records (12 weeks)
B: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm (16 weeks and 68 weeks); Severity of suicidal ideation, level of depressive symptoms (16 weeks and 68 weeks)
C: Remission From Major Depressive Episode in Intent to Treat Sample (Up to 12 Weeks); Remission From Major Depressive Episode Among Participants Who Completed the Intervention (Measured at Weeks 10 and 12)
D: The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts. (At both 12 and 24 months post randomisation.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Predictors of Antidepressant Treatment Response: The Emory CIDAR
Brief Summary: This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.


Options:
A: Suicidal behavior and ideation (Weeks 4, 12, and 24)
B: Remission From Major Depressive Episode in Intent to Treat Sample (Up to 12 Weeks); Remission From Major Depressive Episode Among Participants Who Completed the Intervention (Measured at Weeks 10 and 12)
C: Change in mindfulness (Baseline and after 12-weeks); Change in borderline symptom severity (Baseline and after 12-weeks); Change in overall psychiatric symptom severity (Baseline and after 12-weeks); Change in severity in symptoms of depression (Baseline and after 12-weeks)
D: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Predictors of Antidepressant Treatment Response: The Emory CIDAR
Brief Summary: This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.


Options:
A: PTSD Symptoms (CAPS, SCID, PDS, IESR) (1.5 years)
B: Remission From Major Depressive Episode in Intent to Treat Sample (Up to 12 Weeks); Remission From Major Depressive Episode Among Participants Who Completed the Intervention (Measured at Weeks 10 and 12)
C: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)
D: Change from first investigation in Posttraumatic Symptom Severity at 18 months (Clinician-Administered PTSD Scale; CAPS) (first investigation (t1), after waiting list (3 months, t2), directly after therapy (3 months, t1), 1 year after therapy (15 months, t3))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Predictors of Antidepressant Treatment Response: The Emory CIDAR
Brief Summary: This study will compare different treatments for depression in order to identify which factors predict effectiveness, and will include a companion study which investigates combining treatments and long term effectiveness.


Options:
A: change from baseline in borderline symptoms after a 10 week intervention (10 weeks)
B: Remission From Major Depressive Episode in Intent to Treat Sample (Up to 12 Weeks); Remission From Major Depressive Episode Among Participants Who Completed the Intervention (Measured at Weeks 10 and 12)
C: Number of repeated self-harming acts including suicide attempts (change in number of self-harming acts). (Week 0 (baseline), 17, 28, 52.)
D: The primary outcome will be the composite outcome of the number of in-patient psychiatric hospitalisations, the number of A& E contacts, and the number of suicidal acts. (At both 12 and 24 months post randomisation.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Depression in School Children
Brief Summary: This study will evaluate the effectiveness of the Penn Resiliency Program, a school-based cognitive behavioral depression prevention program for young adolescents.


Options:
A: CAPS-CA (10 days, 2 months, 6 months after intervention); CBCL (10 days, 2 months, 6 months after intervention); DIKJ (10 days, 2 months, 6 months after intervention)
B: psychological symptoms (6 months); coping (6 months)
C: Depressive symptoms (Measured at Year 1)
D: Adolescents' depressive symptoms by self-report (Measured at baseline, post-treatment, and 6-month follow-ups); Adolescents' symptoms of anxiety by self-report (Measured at baseline, post-treatment, and 6-month follow-ups); Adolescents' symptoms of depression and anxiety, including clinical levels of symptoms, as assessed by diagnostic interview (Measured at baseline and 6, 18, and 30-month follow-ups)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open Label, Parallel Group, Active Control Study to Evaluate the Efficacy and Safety of LNG IUS (Mirena®) as Compared to Medroxyprogesterone Acetate During 6 Cycles of Treatment in Patients With Idiopathic Menorrhagia
Brief Summary: The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.


Options:
A: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) (Baseline MBL over 3 menstrual cycles)
B: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms (Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7)
C: The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6) (Baseline and up to 6 months); Percentage of Patients With Successful Treatment (At 6 months)
D: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms (during a time period of 90 days under treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Duloxetine for Chronic Depression: a Double-blind Study
Brief Summary: The investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with chronic depression (dysthymic disorder or dysthymia).

Chronic depression, lasting two or more years, often causes significant suffering and impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin, during which all subjects can be treated with an FDA-approved antidepressant medication.

Eligible subjects may also receive MRI scans, to help the investigators understand how antidepressants work in treating depression.


Options:
A: 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)
B: N/A
C: Hamilton Depression Rating Scale (HDRS) - 24 Total Score (Week 10); Hamilton Depression Rating Scale (HDRS) - 24 Total Score (Baseline)
D: Paid Work Hours at Week 12 (Week 12); Paid Work Hours at Week Baseline (Baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Control and Complications Trial (DCCT)
Brief Summary: Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.

Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.


Options:
A: Number of Participants With Limb Salvage (24 weeks)
B: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26)
C: N/A
D: Full Epithelialization of the Wound (3 months of treatment with vildagliptin); Capillary Density (3 months of treatment with vildagliptin)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Control and Complications Trial (DCCT)
Brief Summary: Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.

Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.


Options:
A: Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period (After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64))
B: Insulin Detemir-insulin Aspart Cross-reacting Antibodies (week 0, 52 and 104)
C: N/A
D: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment (Week 0, Week 52); Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) (Week 0 to Week 104 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (Week 0 to Week 104 + 7 days follow up); Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin (Week 0, Week 106)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Control and Complications Trial (DCCT)
Brief Summary: Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.

Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.


Options:
A: N/A
B: HbA1c Change From Baseline (Baseline and 12 weeks); Mean 24-hour Systolic Blood Pressure Change From Baseline (Baseline and 12 weeks)
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (Time from randomisation up to end of follow-up (scheduled at week 109))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Control and Complications Trial (DCCT)
Brief Summary: Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.

Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.


Options:
A: N/A
B: N/A
C: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)
D: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Control and Complications Trial (DCCT)
Brief Summary: Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.

Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.


Options:
A: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)
B: Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis) (2014); Death from any cause (2014)
C: N/A
D: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)

Answer: C