TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
Brief Summary: The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy


Options:
A: Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival.
B: Clinical antitumor activity will be assessed as an objective tumor response as defined by RECIST. Tumor response is documented using standard definitions of CR and must be confirmed no less than 4 weeks after the criteria for response are first met. (24 weeks)
C: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
D: Overall Survival (OS) at Primary Endpoint (Randomization until 398 deaths, up to May 2015 (approximately 30 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
Brief Summary: The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy


Options:
A: Progression Free Survival (PFS) (From randomization to disease progression or death (up to approximately 2 years))
B: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
C: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
D: Overall Survival (OS) at Primary Endpoint (Randomization until 398 deaths, up to May 2015 (approximately 30 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia
Brief Summary: The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.


Options:
A: Number of Participants With Drug-related Adverse Events (From first drug administration until 30 days after last drug administration, up to 44 days.)
B: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 (Baseline to Week 26)
C: Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C. (From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks)
D: Time to Relapse or Impending Relapse (Up to 26 weeks post-randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand
Brief Summary: The study will evaluate the impact of a family-based intervention on the well-being of Burmese migrant and displaced children and families living in Tak province, Thailand. The methodology used in the impact evaluation study is a randomized waitlist controlled trial.

The study hypothesizes that participation in a family-based intervention will lead to improved parenting practices and child and family outcomes, as follows.

Primary hypotheses:

1. Parents/caregivers participating in the family-based intervention will report increased knowledge and use of positive parenting skills compared to control;
2. Parents/caregivers participating in the family-based intervention will report less use of physical punishment and other harsh forms of discipline compared to control;
3. Parents/caregivers and children participating in the family-based intervention will report higher levels of family functioning and cohesion compared to control.

Secondary hypotheses:

1. Parents/caregivers and children participating in the family-based intervention will report lower levels of externalizing and internalizing child behaviors compared to control;
2. Parents/caregivers and children participating in the family-based intervention will report higher levels of child resilience and psychosocial well-being compared to control;
3. Parents/caregivers participating in the family-based intervention will report lower levels of alcohol use compared to control.


Options:
A: The primary outcome is the number of outcomes out of 15 outcomes significantly favoring the intervention over the control (Harwood, Weiss & Comulada, 2017) (Baseline to 18 months)
B: Parenting practices (One month and six months post-intervention)
C: The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum (Baseline and 12 and 24-week postpartum follow-up)
D: Developmental Disorders- Children Disability Assessment Schedule (DD-CDAS) (Change in DD-CDAS score at 6 months post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand
Brief Summary: The study will evaluate the impact of a family-based intervention on the well-being of Burmese migrant and displaced children and families living in Tak province, Thailand. The methodology used in the impact evaluation study is a randomized waitlist controlled trial.

The study hypothesizes that participation in a family-based intervention will lead to improved parenting practices and child and family outcomes, as follows.

Primary hypotheses:

1. Parents/caregivers participating in the family-based intervention will report increased knowledge and use of positive parenting skills compared to control;
2. Parents/caregivers participating in the family-based intervention will report less use of physical punishment and other harsh forms of discipline compared to control;
3. Parents/caregivers and children participating in the family-based intervention will report higher levels of family functioning and cohesion compared to control.

Secondary hypotheses:

1. Parents/caregivers and children participating in the family-based intervention will report lower levels of externalizing and internalizing child behaviors compared to control;
2. Parents/caregivers and children participating in the family-based intervention will report higher levels of child resilience and psychosocial well-being compared to control;
3. Parents/caregivers participating in the family-based intervention will report lower levels of alcohol use compared to control.


Options:
A: Recovery from Common Mental Disorder (defined by ICD10) (6 months)
B: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
C: Severity of Trauma. This will be the difference in group mean score of severity of depression based on a sum of ratings of various standard depression symptoms from the Hopkins Symptom Checklist and locally defined symptoms. (After 12 counseling , 4-5 months)
D: Parenting practices (One month and six months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Hatha Yoga for Patients With Colorectal Cancer - a Randomized Controlled Trial
Brief Summary: Hatha Yoga is a traditional practice that encompasses aerobic exercise, breathing techniques, and meditation. It is used in India since centuries to improve well-being and cope with diseases and is gaining more and more interest in Europe and the US. While studies have demonstrated benefits of Hatha Yoga for patients with breast cancer, no studies on patients with colorectal cancer are available yet. The purpose of this study is to investigate the effect of Hatha Yoga in patients with colorectal cancer.


Options:
A: Physical activity (12-weeks)
B: Health-related quality of life (Week 10)
C: Change in psychosocial status (from baseline to 24 month)
D: Patient perception and pattern of change (3 months of training followed by 6 and 12 months of no formal training)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use
Brief Summary: This study seeks to evaluate a low-literacy strategy in a primary health care setting for promoting safe and effective prescription medication use among English and Spanish-speaking patients with diabetes.

The investigators hypothesize that in comparison with patients receiving standard care, the patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies in their medication lists; 3) take their medication regimen more efficiently; 4) have greater adherence to their medication regimen.


Options:
A: Failure to persist with medication regimen (6 months)
B: Medication adherence (One month after patients receive intervention materials)
C: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
D: Antipsychotic dispensing (6 months post-intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Primary Care, EHR- Based Strategy to Promote Safe and Appropriate Drug Use
Brief Summary: This study seeks to evaluate a low-literacy strategy in a primary health care setting for promoting safe and effective prescription medication use among English and Spanish-speaking patients with diabetes.

The investigators hypothesize that in comparison with patients receiving standard care, the patients that received the Electronic Health Record (EHR) strategy will 1) demonstrate better understanding of how to safely dose out their medication regimen; 2) have fewer discrepancies in their medication lists; 3) take their medication regimen more efficiently; 4) have greater adherence to their medication regimen.


Options:
A: Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 3 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 6 months); Change from baseline in Fall Risk Assessment Tool (FRAT) score (Change from baseline in FRAT score at 12 months); Change from baseline in fall rate (Change from baseline in fall rate at 3 months); Change from baseline in fall rate (Change from baseline in fall rate at 6 months); Change from baseline in fall rate (Change from baseline in fall rate at 12 months)
B: Adverse Drug Events (3 and 6 months)
C: Neuropsychiatric symptoms (9 months); Quality of life (9 months)
D: Medication adherence (One month after patients receive intervention materials)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
Brief Summary: The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection.


Options:
A: The Number (Rate) of Patients With Acute Respiratory Infections (first 28 days of life)
B: Interleukin-8 (IL-8) (72 hours)
C: Days of illness symptoms, number, duration and severity of illness episodes, day care absenteeism, and parental work absenteeism (16 weeks)
D: Evaluate the efficacy of fermented milk and rice administered daily for a total duration of 3 months on the appearance of common respiratory and gastrointestinal infections in schoolchildren aged between 12 and 48 months. (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Hellenic Anglo Research Into Morning Or Evening Antihypertensive Drug deliverY Trial
Brief Summary: A randomised crossover trial of anti-hypertensive medication dosing regimen in effective blood pressure control.

To investigate whether there is a difference in 24 hour blood pressure (BP) control when antihypertensive medications are taken in the morning compared with the evening.


Options:
A: Changes in 24 Hour Systolic Blood Pressure (6 months)
B: To evaluate the impact of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk assessment. (Yearly evaluation for at least ten years)
C: Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks; Change from baseline in systolic 24 hour blood pressure after 12 weeks
D: To demonstrate the efficacy of bedtime administration of ramipril in subjects with essential hypertension by testing the hypothesis of superior nocturnal SBP lowering in ABPM measurements compared with ramipril administered on awakening (Three months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Screening and Treatment (IST) or Intermittent Preventive Treatment (IPT) With Dihydroartemisinin-Piperaquine, Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya: a Randomized Controlled Trial
Brief Summary: Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals in the second and third trimesters of pregnancy irrespective of the presence of malaria parasitemia, is currently recommended for HIV-negative women in all areas with stable moderate to high transmission of malaria. Due to increasing resistance to SP, it is no longer used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for IPTp, as well as to explore the strategy of intermittent screening and treatment in pregnancy (ISTp) with DP. This strategy uses increased screening at time of focused antenatal care (FANC) with treatment of women who screen positive.

The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in an area with decreasing malaria transmission and high levels of SP resistance in Kenya.


Options:
A: Maternal parasitaemia at delivery (Delivery)
B: Trial 1 (IPTp MQ vs IPTp SP): Low birth weight. (day 0, birth); Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia. (day 0, delivery)
C: Prevalence of Placental Malaria (Delivery); Incidence of Malaria in Pregnant Women (Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination); Incidence of Malaria in Infants (Time at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age)); Incidence of Malaria in Infants (Time at risk will begin at 24 months of age and will end when study participants reaches 36 months of age or termination)
D: Maternal malaria at delivery (Delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Screening and Treatment (IST) or Intermittent Preventive Treatment (IPT) With Dihydroartemisinin-Piperaquine, Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya: a Randomized Controlled Trial
Brief Summary: Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals in the second and third trimesters of pregnancy irrespective of the presence of malaria parasitemia, is currently recommended for HIV-negative women in all areas with stable moderate to high transmission of malaria. Due to increasing resistance to SP, it is no longer used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for IPTp, as well as to explore the strategy of intermittent screening and treatment in pregnancy (ISTp) with DP. This strategy uses increased screening at time of focused antenatal care (FANC) with treatment of women who screen positive.

The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in an area with decreasing malaria transmission and high levels of SP resistance in Kenya.


Options:
A: N/A
B: Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants (6 to 24 months of age); Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants (Randomization to 24 months of age)
C: Maternal malaria at delivery (Delivery)
D: Efficacy:; The proportion of children with at least one episode of anemia from 3 to 18 months of life; The proportion of children with at least one episode of malaria from 3 to 18 months of life; Safety:; The proportion of children with at least one episode of an adverse event; The proportion of children with at least one episode of a serious adverse event; Rebound:; The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Screening and Treatment (IST) or Intermittent Preventive Treatment (IPT) With Dihydroartemisinin-Piperaquine, Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya: a Randomized Controlled Trial
Brief Summary: Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals in the second and third trimesters of pregnancy irrespective of the presence of malaria parasitemia, is currently recommended for HIV-negative women in all areas with stable moderate to high transmission of malaria. Due to increasing resistance to SP, it is no longer used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for IPTp, as well as to explore the strategy of intermittent screening and treatment in pregnancy (ISTp) with DP. This strategy uses increased screening at time of focused antenatal care (FANC) with treatment of women who screen positive.

The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in an area with decreasing malaria transmission and high levels of SP resistance in Kenya.


Options:
A: Incidence of clinical malaria (2008-2009)
B: Mortality rate in children aged 2-11 months (estimated by birth history questioning) (Up to 12 months of age); Incidence of severe adverse drug reactions following IPTi (as detected by spontaneous, passive reporting system) (All age groups, particular attention in under 2 year olds)
C: Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants (6 to 24 months of age); Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants (Randomization to 24 months of age)
D: Maternal malaria at delivery (Delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations
Brief Summary: This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. "Investigational" means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers.

The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide ("AC") that you might receive if you did not participate in this study.


Options:
A: Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery (Up to approximately 27-30 weeks); Event-free Survival (EFS) as assessed by Investigator (Up to approximately 8 years)
B: Pathological Complete Response (pCR). (At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).)
C: 3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients (No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.)
D: Rate of Pathologic Complete Response (pCR) (3 years)

Answer: D