TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Sinovuyo Caring Families Project
Brief Summary: It has been established that children in families affected by either intimate partner violence or Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) are at substantially increased risk of poor parenting and child maltreatment. In the sub-Saharan African context of high levels of HIV/AIDS and family violence, it is crucial that parents be supported to establish positive parenting practices and reduce harsh or abusive parenting within their families.This randomized controlled trial will be testing the Sinovuyo Caring Families Program (n = 296), a 12-session (2.5 hour per session) parenting intervention for primary caregivers of children between 2 and 9 years old. Participants will not be restricted to biological parents and include primary caregivers of children between 2 and 9 years old, who live in the same house as the child at least 4 nights per week. Participants will be recruited through systematic household sampling, liaising with Western Cape Department of Social Development and local community-based NGOs. Self-reporting questionnaires and qualitative observational assessment data for intervention and control groups will be collected at pre- and post-test evaluation as well as 12-month follow-up. Primary outcomes will include child behaviour problems, harsh and inconsistent parenting and positive parenting. Secondary outcomes will include parental depression, parental stress, parental monitoring and supervision and parent perceived social support.


Options:
A: Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression). (6 weeks postpartum)
B: Hopkins Symptom Checklist-25 (HSCL-25) (Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment)
C: Depressive symptom change (baseline, 3-, 6-, and 12-month follow up)
D: Eyberg Child Behavior Inventory (Baseline, post- intervention and 12-month post-intervention follow-up); Parenting Young Children Scale (Supporting Positive Behaviour subscale; Setting Limits subscale) (Baseline, post- intervention and 12-month post-intervention follow-up); Sinovuyo Observational Coding System (Baseline, post- intervention and 12-month post-intervention follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO)
Brief Summary: The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.


Options:
A: N/A
B: Insulin sensitivity (Measured at approximately Month 3)
C: total score of the Hamilton Rating Scale for Depression (HAMD) (Twelve weeks)
D: Decreased inflammation during human pregnancy (enrollment (8-16 weeks) to delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcranial Direct Current Stimulation in Rehabilitation of Chronic Stroke Patients: Multicenter Clinical Trial
Brief Summary: In this study, the investigators wondered whether bihemispheric transcranial direct current stimulation (tDCS) would be capable to potentialize the effects of physical therapy on upper limb rehabilitation of chronic stroke patients. Moreover, the study aims to investigate the pattern of physiological variables involved in the recovery of these patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individual physical therapy session.


Options:
A: Change in Fugl-Meyer assessment of paretic upper limb motor function (baseline, after sessions, 30 and 90 days)
B: Postural control (After 5 days)
C: Community Balance and Mobility Scale (Pre treatment and Post treatment (6 weeks))
D: Change of Fugl-Meyer assessment (FMA) score (Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Transcranial Direct Current Stimulation in Rehabilitation of Chronic Stroke Patients: Multicenter Clinical Trial
Brief Summary: In this study, the investigators wondered whether bihemispheric transcranial direct current stimulation (tDCS) would be capable to potentialize the effects of physical therapy on upper limb rehabilitation of chronic stroke patients. Moreover, the study aims to investigate the pattern of physiological variables involved in the recovery of these patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individual physical therapy session.


Options:
A: Change in Fugl-Meyer assessment of paretic upper limb motor function (baseline, after sessions, 30 and 90 days)
B: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
C: Wolf Motor Function test (immediately before and immediately after treatment); Fugl-Meyer Assessment (immediately before and immediately after treatment)
D: Ankle Dorsiflexion Angle. Change From Baseline in Ankle Dorsiflexion Angle During the Swing Phase of Gait (Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Culturaly Adapted Family Intervention for Psychosis
Brief Summary: Aim:

To assess the feasibility of culturally adapted Family Intervention for Psychosis.

Design:

Randomized Control Trial

Setting:

psychiatric department of different hospitals

Participants:

A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm.

Intervention:

Culturally Adapted Family Intervention for Psychosis

Outcome measure:

Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care Well-Being \& Support(CWS)


Options:
A: children's behavior problems and health (Change from baseline to 6-, 12-, 18-, and 24 month follow up)
B: Change in Grief Intensity (Baseline, 2 months post-intervention); Change in Mental Health (Baseline, 2 months post-intervention)
C: Positive and Negative syndrome scale (PANSS) (six months); Experience of Care-giving inventory(ECI) (six months); Carer Wel-Being & Support(CWS) (six months)
D: Change in levels of externalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, Externalizing Scale (Pre-Post (approximately 16 - 20 weeks after pre-assessment)); Change in Prevalence of Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD)) in children: The Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version; MINI-KID-P Clinician-rated (Pre-Post (approximately 16 - 20 weeks after pre-assessment))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Six-month, Open-label, Multi-center Study of the Safety and Efficacy of PRC-063 in Adults and Adolescents With ADHD
Brief Summary: The purpose of this six month, open-label study is to evaluate the long-term safety and efficacy of PRC-063 in adults and adolescents with ADHD.


Options:
A: occurrence of treatment-emergent adverse events (Within 6 months)
B: Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score (Visit 8 (Day 42))
C: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)
D: Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items (end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis
Brief Summary: Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.


Options:
A: Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs (12 weeks after first dose); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 4); Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA (Week 12); Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA (at follow-up Week 24)
B: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
C: Proportion of Participants With Sustained Virologic Response 12 (SVR-12) (12 weeks post-therapy)
D: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis
Brief Summary: Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.


Options:
A: HCV RNA (At each clinic visit, throughout study); Adverse events, laboratory parameters, vital signs (At each clinic visit, throughout study)
B: Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d. (Up to 72 weeks); Number of Participants Experiencing an Adverse Event (AE) (Up to 73 weeks); Number of Participants Discontinuing From Study Treatment Due to AEs (Up to 48 weeks)
C: Proportion of Participants With Sustained Virologic Response 12 (SVR-12) (12 weeks post-therapy)
D: Sustained virological response (24 weeks after end of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson Disease
Brief Summary: The purpose of the study is to determine whether treatment with isradipine is effective in slowing the progression of Parkinson disease disability.


Options:
A: Step Length During Gait (Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks); Walking Speed During Gait (Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks)
B: Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise (9 to 26 weeks)
C: Unified Parkinson's Disease Rating Scale (UPDRS) Part III (30 minutes post-dose at week 12)
D: Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score (Baseline to 36 months of treatment); Adjusted Mean Change in Adjusted UPDRS Score (Baseline to 36 months of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study is to compare between oral misoprostol in solution and vaginal dinoprostone in induction of labour in primiparous women with singleton pregnancy as regards efficiency and safety to both mother and fetus.


Options:
A: induction delivery time (2 hourly)
B: Vaginal delivery (24 hours); Hyperstimulation syndrome (24 hours); Cesarean section (3 days); Severe neonatal morbidity or perinatal death (28 days); Serious maternal morbidity or maternal death (42)
C: The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. (within the first week after delivery)
D: Time to Active Labor (from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study
Brief Summary: The purpose of this study is to demonstrate the treatment success of fexinidazole, at one year follow-up visit, in HAT stage 1 and early stage 2 patients.


Options:
A: Outcome (success or failure) at the test of cure (ToC) visit 12 months after the end of treatment (EOT). (12 months after end of treatment (day 11))
B: N/A
C: Proportion of patients discharged alive from the hospital or the treatment center
D: success or failure at 18 months FU visit (18 months after treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center Phase 2 Study to Assess the Safety, Tolerability and Early Signs of Efficacy of Tid Orally Administered BAY63-2521 in Adult Delta F508 Homozygous Cystic Fibrosis Patients
Brief Summary: Assessment of the safety, tolerability and early signs of efficacy of three times a day orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on treatment with Orkambi


Options:
A: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Baseline up to Week 100)
C: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)
D: Incidence of Treatment-Emergent Adverse Events (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center Phase 2 Study to Assess the Safety, Tolerability and Early Signs of Efficacy of Tid Orally Administered BAY63-2521 in Adult Delta F508 Homozygous Cystic Fibrosis Patients
Brief Summary: Assessment of the safety, tolerability and early signs of efficacy of three times a day orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on treatment with Orkambi


Options:
A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
C: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)
D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center Phase 2 Study to Assess the Safety, Tolerability and Early Signs of Efficacy of Tid Orally Administered BAY63-2521 in Adult Delta F508 Homozygous Cystic Fibrosis Patients
Brief Summary: Assessment of the safety, tolerability and early signs of efficacy of three times a day orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on treatment with Orkambi


Options:
A: Part A: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Day 43 (Part A: Baseline (pre-dose Day 15), Day 43); Part B: Change From Baseline in Total Ventilation Defect Defined by Hyperpolarized Helium 3 Magnetic Resonance Imaging (3He-MRI) at Week 48 (Part B: Baseline (Day -1), Week 48)
B: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)
C: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) (Study 105: Day 1 up to Week 168)
D: exercise capacity (one month, 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Chemotherapy with Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Cholangiocarcinoma and Muscle Invasive Gall Bladder Carcinoma (ACTICCA-1 Trial)
Brief Summary: This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC.


Options:
A: Progression-free survival (12 months)
B: Occurence of Grade 3 or 4 toxicities according to NCI-common terminology criteria for adverse events v3.0 (One year)
C: Disease free survival (DFS) (Disease free survival rate at 24 months (DFSR@24))
D: overall survival (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS
Brief Summary: Between 8% and 12% of Canadians suffer from asthma. Although there are effective and inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic diseases.The purpose of this study is to determine whether enhancing the role of community pharmacists in asthma management using interactive short messaging service (SMS) with asthma patients is a cost-effective model that will improve adherence to inhaled corticosteroid medications compared to usual care.


Options:
A: Quality of life. (12 months)
B: Proportion of patients achieving hypertension control (6 months after enrollment); change in systolic and diastolic blood pressure (6 months after enrollment)
C: Comparison of difference in change in systolic BP between enhanced care and usual care (24 weeks)
D: Adherence to inhaled corticosteroid medication (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS
Brief Summary: Between 8% and 12% of Canadians suffer from asthma. Although there are effective and inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic diseases.The purpose of this study is to determine whether enhancing the role of community pharmacists in asthma management using interactive short messaging service (SMS) with asthma patients is a cost-effective model that will improve adherence to inhaled corticosteroid medications compared to usual care.


Options:
A: Percent of patients that are at least 80% adherent (Medication possession rate > 0.8) to antihypertensives and statins (One year from inclusion)
B: Quality of life. (12 months)
C: Adherence of medical regimen/treatment to all of the Guideline Advantage criteria that apply. (12 months for each participant)
D: Adherence to inhaled corticosteroid medication (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS
Brief Summary: Between 8% and 12% of Canadians suffer from asthma. Although there are effective and inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic diseases.The purpose of this study is to determine whether enhancing the role of community pharmacists in asthma management using interactive short messaging service (SMS) with asthma patients is a cost-effective model that will improve adherence to inhaled corticosteroid medications compared to usual care.


Options:
A: Emergency department visits - 1st time point (12months prior to baseline interview); Emergency Department Visits -2nd time point (Interval between baseline interview and 12 month interview); Emergency Department Visits - 3rd time point (Interval between 12 month and 24 month telephone interview)
B: Parental asthma-related quality of life (one year); Urgent care events for asthma (One year)
C: change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference (6 months)
D: Adherence to inhaled corticosteroid medication (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS
Brief Summary: Between 8% and 12% of Canadians suffer from asthma. Although there are effective and inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic diseases.The purpose of this study is to determine whether enhancing the role of community pharmacists in asthma management using interactive short messaging service (SMS) with asthma patients is a cost-effective model that will improve adherence to inhaled corticosteroid medications compared to usual care.


Options:
A: Adherence to inhaled corticosteroid medication (12 months)
B: Parental asthma-related quality of life (one year); Urgent care events for asthma (One year)
C: Emergency department visits - 1st time point (12months prior to baseline interview); Emergency Department Visits -2nd time point (Interval between baseline interview and 12 month interview); Emergency Department Visits - 3rd time point (Interval between 12 month and 24 month telephone interview)
D: change in asthma control between baseline and six months as measured by ACQ.24 The ACQ measures clinical goals of asthma management on a scale: 0 (good control) to 6, is responsive to change,24 with a intra-individual minimum important difference (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: EmPhAsIS: Empowering Pharmacists in Asthma Management Through Interactive SMS
Brief Summary: Between 8% and 12% of Canadians suffer from asthma. Although there are effective and inexpensive treatments, adherence to asthma treatment is amongst the lowest for all chronic diseases.The purpose of this study is to determine whether enhancing the role of community pharmacists in asthma management using interactive short messaging service (SMS) with asthma patients is a cost-effective model that will improve adherence to inhaled corticosteroid medications compared to usual care.


Options:
A: Adherence to inhaled corticosteroid medication (12 months)
B: Modified Medication Possession Ratio (Measured over 19 months)
C: Change in Percentage of participants using controller medications for asthma from baseline to 12 month follow-up (Baseline, 12)
D: Adherence rate (at three months)

Answer: A