TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Palliative Care in Heart Failure (PAL-HF)
Brief Summary: The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.


Options:
A: Is there a change in patient understanding of prognosis with the addition of a palliative care intervention? (6 months)
B: Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (Baseline); Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (16 weeks); Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) (Baseline); Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) (16 weeks); Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS) (Baseline); Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS) (16 weeks); Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS) (Baseline); Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS) (16 weeks); Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS) (Baseline); Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS) (16 weeks); Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (Baseline); Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (16 weeks); Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (Baseline); Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (16 weeks); Caregiver Burden - Stress - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (Baseline); Caregiver Burden - Stress- as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) (16 weeks)
C: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) (Baseline, 6 months); Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal) (Baseline, 6 months)
D: efficacy of PC-ACP

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Brief Summary: Brief Summary:

The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.


Options:
A: Diarrhoea (<5s) (21 months)
B: Change in target behaviour: zinc use (six weeks post-intervention); Change in target behaviour: correct ORS preparation (six weeks post-intervention); Change in target behaviour: Exclusive breastfeeding (six weeks post-intervention); Change in target behaviour: Handwashing with soap (six weeks post-intervention)
C: Duration of diarrhea (within the first 72 hours during hospitalization)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Brief Summary: Brief Summary:

The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.


Options:
A: Combined prevalence of bacterial and protozoan enteric infections (12 month follow-up)
B: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
C: Diarrhoea (<5s) (21 months)
D: Diarrhea in Children Under 5 (one year after the intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Brief Summary: Brief Summary:

The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.


Options:
A: Diarrhea in Children Under 5 (one year after the intervention)
B: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
C: Reported diarrhoea in children <5 years (7-day recall, assessed 4 times during 3-month follow-up rounds)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Brief Summary: Brief Summary:

The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.


Options:
A: Duration of diarrhea (within the first 72 hours during hospitalization)
B: diarrhea longitudinal prevalence
C: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Brief Summary: Brief Summary:

The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.


Options:
A: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
B: Incidence of Diarrhea (2 weeks)
C: Infant length at 18 months (18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy.); Infant hemoglobin at 18 months (18 months)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Brief Summary: Brief Summary:

The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.


Options:
A: Child's consumption (Within 15 minutes)
B: Acceptability of at least one Ready -to-Use Complementary Food supplement (7 days)
C: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
D: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Brief Summary: Brief Summary:

The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.


Options:
A: Reduction in dysentery and non-dysentery diarrhoeal disease in children under five years old (Duration of the study)
B: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
C: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
D: To assess the prevalence of diarrhea among under five children (four months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: WASH Benefits Bangladesh: A Cluster Randomized Controlled Trial of the Benefits of Water, Sanitation, Hygiene Plus Nutrition Interventions on Child Growth
Brief Summary: Brief Summary:

The purpose of this study is to measure the independent and combined effects of interventions that improve water quality, sanitation, hand washing, and nutrition on child growth and development in the first years of life.


Options:
A: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence Diarrhea Prevalence (Measured 12- and 24-months after intervention)
B: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh (17 months)
C: COVID-19 RNA test positivity (At the end of Cycle 1 (cycle length is 14 days)); Hospital admission for COVID-19 (7 days after the end of Cycle 1 (cycle length is 14 days))
D: Effect of 5 different mouthwashes on the SARS-Cov2 viral load. (Minute 0 (before mouthwash) - Minute 30 (after mouthwash) - Minute 60 (after mouthwash) - Minute 120 (after mouthwash)); Effect of 5 different mouthwashes on the infective SARS-Cov2 viral load in saliva. (Minute 0 (before mouthwash) - Minute 30 (after mouthwash) - Minute 60 (after mouthwash))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
Brief Summary: The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx is radiation therapy. Some patients require chemotherapy with the radiation, and some patients require surgery if the tumour or lymph nodes have not responded after radiation.

This study will compare radiation therapy with a new surgical treatment called transoral robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.


Options:
A: Time to local or locoregional failure or death from any cause (Defined as time from randomization up to 36 month)
B: Overall Survival (5 years)
C: Recurrence-free survival (5 years)
D: Quality of Life (1-year post treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
Brief Summary: The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx is radiation therapy. Some patients require chemotherapy with the radiation, and some patients require surgery if the tumour or lymph nodes have not responded after radiation.

This study will compare radiation therapy with a new surgical treatment called transoral robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.


Options:
A: Progression-free Survival (PFS) Rate (6.2 years)
B: Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C). (16 weeks); Phase III: Surveillance with no progression after two years. (2 years)
C: N/A
D: Quality of Life (1-year post treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
Brief Summary: The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx is radiation therapy. Some patients require chemotherapy with the radiation, and some patients require surgery if the tumour or lymph nodes have not responded after radiation.

This study will compare radiation therapy with a new surgical treatment called transoral robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.


Options:
A: Quality of Life (1-year post treatment)
B: Opreation Duration (1 day)
C: Overall Survival (5 years)
D: Recurrence-free survival (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Onartuzumab (MetMAb) In Combination With 5-Fluorouracil, Folinic Acid, And Oxaliplatin (mFOLFOX6) In Patients With Metastatic HER2-Negative Gastroesophageal Cancer
Brief Summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinue treatment.


Options:
A: Time to progression (The time from randomization until objective tumor progression or death)
B: Overall Survival (OS) (approx. 12 month)
C: Time to Progression (every 8 weeks up to a maximum of 36 months)
D: Progression-free survival (PFS) in all patients (Up to 18 months); Progression-free survival (PFS) in patients with Met-positive tumors (Up to 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Risk Reduction of Symptomatic and Silent Brain Infarctions During Carotid Endarterectomy and Carotid Stenting Due to Ultrasound Activation of Endogenous Fibrinolytic System Using Transcranial Doppler Monitoring
Brief Summary: The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual transcranial Doppler monitoring) using 2 MegaHertz (MHz) diagnostic probe on the reduction of risk of brain infarctions due to the activation of endogenous fibrinolytic system during carotid endarterectomy (CEA) and carotid stenting (CS). 240 patients indicated for CEA (120 patients) and CS (120 patients) will be enrolled into the study in order to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions detected using MRI examination 24 hours after CEA or CS in 5% level of significance. Patients will be randomized - subgroup 1 will undergo a 60minute non-diagnostic transcranial Doppler (TCD) monitoring during CEA or CS, subgroup 2 will undergo interventions without TCD monitoring. The second aim is to compare number of brain infarctions detected using MRI between CEA and CS patients.

Confirmation of the investigators hypothesis that sonothrombolysis is able to activate endogenous fibrinolytic system during CEA or CS with consecutive reduction of the number and volume of brain infarcts, can lead to the increase of the safety of CEA and CS in patients with internal carotid artery stenosis. The investigators can presume that up to 50% of patients indicated for CEA or CS can be treated using these methods in the future.

In the Substudy "Risk of brain infarction after carotid endarterectomy and stenting" the the risk of asymptomatic and symptomatic brain infarctions, changes in cognitive functions, as well as morbidity and mortality at 30 days between patients with symptomatic and asymptomatic severe internal carotid artery (ICA) stenoses undergoing elective CEA and CAS will be compared.

The sample size of the Substudy was based on an expected 80% difference of new ischemic lesions on DWI-MRI between CEA (estimated prevalence, 30%) and CAS (54%). Pre-study calculations showed that a minimum of 73 patients in each group was needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8 assuming that 15% of subjects would be lost to follow-up or refuse to participate in the study.


Options:
A: Any Periprocedural Stroke, Myocardial Infarction, or Death During a 30-day Peri-procedural Period, and Postprocedural Ipsilateral Stroke Thereafter, up to 4-years. (30 days and 4 years)
B: Participants With a New Brain Infarction Detected Using Magnetic Resonance (24 hours after intervention)
C: Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days. (0 to 365 days)
D: Any stroke or death within 30 days of the procedure (during de study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Studies of the Pathophysiologic Mechanisms of Poor Ulcer Healing & Clinical Improvement to the High Ulcer Rebleeding Rate for Patients With Comorbid Illnesses
Brief Summary: Patients with comorbidities have an increased risk of ulcer re-bleeding, especially within the 14 days after first bleeding event. Three-day high dose esomeprazole infusion can prevent peptic ulcer rebleeding after endoscopic therapy. However, the optimal dose of oral esomeprazole is uncertain, especially for high risky patients. This study is to test whether a double dose of oral esomprazole could reduce peptic ulcer rebleeding for patients with Rockall score ≥ 6. Additionally, the second aim of this prospective study was to identify the selection criteria to predict poor fading and residual major stigmata of recent hemorrhage (SRH) or early recurrent bleeding after successful endoscopic hemostasis and high-dose PPI infusion.


Options:
A: recurrent bleeding (within 28 days after the first bleeding event)
B: Intragastric pH > 6 (24 hours)
C: Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo (Within 72 hours)
D: Rebleeding rates and surgical needs

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
Brief Summary: The purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer


Options:
A: Hot flash frequency and intensity (Baseline, 8 weeks, 24 weeks)
B: Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality; Physical:cortisol levels (stress hormone)
C: The efficacy of Mindfulness Based Stress Reduction on mood disorders (up to 5 years follow up)
D: Disease-free Survival (DFS) (Unitil the end of study with a median follow up of 75 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
Brief Summary: The purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer


Options:
A: Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4) (8 weeks, 6 months)
B: The efficacy of Mindfulness Based Stress Reduction on mood disorders (up to 5 years follow up)
C: Changes in depressive symptoms (Pre-treatment (at recruitment; about 2 weeks before starting the experimental condition of 8 weeks), post-treatment (immediately after the experimental condition of 8 weeks), 3-month follow-up and 6-month follow-up)
D: Change in quality of life (T0: before chemotherapy (week 0); T1: in the middle of chemotherapy (i.e. week 4 to 10); T2: three weeks after last cycle of chemotherapy (i.e. week 13 to 20).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose-ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Monthly And Twice Monthly Subcutaneous Dosing For Six Months In Hypercholesterolemic Subjects On A Statin
Brief Summary: To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is \>/=80 mg/dL on background treatment with a statin.


Options:
A: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
B: The incidence of treatment-emergent adverse events in subjects treated with REGN727 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 106 (106 days)
C: Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 (Baseline and weeks 22 and 24); Percent Change From Baseline in LDL-C at Week 24 (Baseline and week 24)
D: Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization (Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.)

Answer: A