TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo With Concomitant Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.
Brief Summary: Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites.

Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).


Options:
A: Number and time of recurrences of therapeutic paracenteses (up to 12 weeks)
B: Composite endpoint of ascites worsening (at week 12)
C: the percentage of responders to the diuretic treatment; the percentage of patients who develop adverse effects to diuretics (within three weeks); the percentage of patients who will respond to the diuretic treatment, the percentage of patients who will develop adverse effects to diuretics (within three weeks)
D: Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours (8 and 24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Study of Intravenous Single Doses of Palonosetron (PALO) With Granisetron Hydrochloride as a Control in Patients Receiving Highly Emetogenic Chemotherapy
Brief Summary: To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as nausea and vomiting induced by highly emetogenic chemotherapy.


Options:
A: Complete response (CR: no emetic episodes and no rescue medication) rate in acute and delayed nausea and vomiting
B: Overall complete response (no emesis and no rescue therapy) (During and post chemotherapy (0-120 h))
C: efficacy (24 to 160 hours); tolerability (24 to 160 hours); cost-effectiveness (24 to 160 hours)
D: The primary efficacy endpoint is the overall complete response rate (no emesis and no use of rescue medication from 0 through 120 hours following initiation of cisplatin-based chemotherapy). (Days 1 through 6.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE IT)
Brief Summary: The aim of this project is to evaluate whether using an implementation intervention promotes use of best practices by rehabilitation professionals and leads to improvements in patient outcomes for individuals with stroke.


Options:
A: Arm function as measured by the Box and Block test; Walking speed as measured by the 6 minutes walk test
B: Difference in the percentage of patients who Door-to-Needle Time≤60min (Up to 24 hours)
C: Change Between the Value of the SF-36 Physical Function Score at 12 Months Minus Value at Baseline to Measure the Change in Health-related Quality of Life and Function (Baseline (pre-randomization) and 12 months)
D: functional gain as measured by motor FIM score (One year post team training intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Subacute Trial of Methylphenidate in Parkinson's Disease
Brief Summary: The purpose of this trial is to determine if methylphenidate (MPD), a drug marketed in the U.S. to treat hyperactivity and narcolepsy, added to levodopa, will increase the beneficial effects of levodopa without bothersome side effects in people with Parkinson's disease (PD).


Options:
A: Change in Total Unified Parkinson's Disease Rating Scale (UPDRS) Score From Baseline (12w, 24w, 36w, 42w, 48w, 54w, 60w, 66w, 72w)
B: Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12 (Baseline and Week 12)
C: Canadian Occupational Performance Measure (COPM) (3 months)
D: Time "on" defined by tapping speed

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vasodilator Therapy and Exercise Tolerance in IPF Patients
Brief Summary: Medicines that decrease blood pressure in the lungs may help idiopathic pulmonary fibrosis (IPF) patients function better. This study will test whether sildenafil improves the ability to exercise in patients with pulmonary fibrosis of unknown cause.


Options:
A: Change in 6-minute Walk Test (0 - 6 months)
B: Peak 6-minute Walk Distance (12 weeks)
C: Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV (From Baseline up to the Final Assessment Visit (FAV) (average of 609 days))
D: Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization (baseline and 12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)
Brief Summary: This study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.


Options:
A: Number of Patients With Treatment Failure (Baseline to end of Period II (up to 4.5 years)); Time to Treatment Failure (Baseline to end of Period II (up to 4.5 years))
B: Changes From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 52 Weeks of Treatment (Baseline and 52 weeks); Changes From Baseline in HbA1c (%) After 76 Weeks of Treatment (Baseline and 76 weeks)
C: Change From Baseline in HbA1c at Week 30 (Week 0 to Week 30)
D: Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 (Baseline and Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy and Safety of Silodosin vs. Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH. Multicentre, Randomised, Double-Blind, Controlled Trial With an Optional Long-Term, Open-Label Extension Phase.
Brief Summary: A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.


Options:
A: Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline, 12 weeks)
B: Change in baseline total score on the International Prostate Symptom Score (12 weeks)
C: Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline and 12 weeks)
D: International Prostate Symptom Score (IPSS) (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term, Open-Label, Multicenter, Extension Study of Bosentan in Patients With Pulmonary Hypertension Associated With Sickle Cell Disease Completing a Double-Blind ASSET Study (AC-052-368 or AC 052-369)
Brief Summary: This study will assess the safety and efficacy of bosentan therapy (in a study known as ASSET) for patients who have high blood pressure in the lungs associated with sickle cell disease. That form of hypertension places people at risk for complications, including shortness of breath, pain, pneumonia, and death. Previous studies have shown that bosentan can be helpful in reducing pulmonary hypertension.

Patients ages 16 and older who have completed the 16-week treatment in the ASSET 1 or ASSET 2 study and who are not pregnant or breastfeeding may be eligible for this study. The research will be conducted in about 25 hospitals in the United States and Europe. Up to 30 participants will be enrolled. The screening visit will involve a physical examination, blood sample of about 3 teaspoons for laboratory tests, and a pregnancy test. Patients' doctors will give them bosentan tablets (62.5 mg each), to take one in the morning and one in the evening. After 1 month, patients will be told whether the dose should be increased to 125 mg tablets to take twice a day. Two weeks after the increase in dose, a blood test will be done to analyze the drug's effects on the liver. After the start of treatment, patients will return for visits every 6 months, when there will be a 6-minute walking test to measure exercise capacity and evaluate shortness of breath. There will be follow-up for patients up to the end of the study and for 28 days after the last dose of bosentan is taken, to collect information about side effects.

Some patients on bosentan have had changes in liver function and red blood cell count. Side effects commonly reported are headache, flushed appearance, inflammation of the throat and nasal passages, and gastrointestinal symptoms. If patients have sudden worsening in breathing in the first few weeks after taking bosentan, they should immediately tell their doctors, because it may be necessary to change the treatment.


Options:
A: Peak 6-minute Walk Distance (12 weeks)
B: Digital Micro-vascular Flow (Baseline and 12 weeks)
C: Change from baseline to all assessed time points in 6MWT, in Borg dyspnea index, and in modified NYHA functional class.
D: 6 minute walk distance change from baseline to Week 16 (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term, Open-Label, Multicenter, Extension Study of Bosentan in Patients With Pulmonary Hypertension Associated With Sickle Cell Disease Completing a Double-Blind ASSET Study (AC-052-368 or AC 052-369)
Brief Summary: This study will assess the safety and efficacy of bosentan therapy (in a study known as ASSET) for patients who have high blood pressure in the lungs associated with sickle cell disease. That form of hypertension places people at risk for complications, including shortness of breath, pain, pneumonia, and death. Previous studies have shown that bosentan can be helpful in reducing pulmonary hypertension.

Patients ages 16 and older who have completed the 16-week treatment in the ASSET 1 or ASSET 2 study and who are not pregnant or breastfeeding may be eligible for this study. The research will be conducted in about 25 hospitals in the United States and Europe. Up to 30 participants will be enrolled. The screening visit will involve a physical examination, blood sample of about 3 teaspoons for laboratory tests, and a pregnancy test. Patients' doctors will give them bosentan tablets (62.5 mg each), to take one in the morning and one in the evening. After 1 month, patients will be told whether the dose should be increased to 125 mg tablets to take twice a day. Two weeks after the increase in dose, a blood test will be done to analyze the drug's effects on the liver. After the start of treatment, patients will return for visits every 6 months, when there will be a 6-minute walking test to measure exercise capacity and evaluate shortness of breath. There will be follow-up for patients up to the end of the study and for 28 days after the last dose of bosentan is taken, to collect information about side effects.

Some patients on bosentan have had changes in liver function and red blood cell count. Side effects commonly reported are headache, flushed appearance, inflammation of the throat and nasal passages, and gastrointestinal symptoms. If patients have sudden worsening in breathing in the first few weeks after taking bosentan, they should immediately tell their doctors, because it may be necessary to change the treatment.


Options:
A: Acute Chest Syndrome (Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.)
B: Change from baseline to all assessed time points in 6MWT, in Borg dyspnea index, and in modified NYHA functional class.
C: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
D: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term, Open-Label, Multicenter, Extension Study of Bosentan in Patients With Pulmonary Hypertension Associated With Sickle Cell Disease Completing a Double-Blind ASSET Study (AC-052-368 or AC 052-369)
Brief Summary: This study will assess the safety and efficacy of bosentan therapy (in a study known as ASSET) for patients who have high blood pressure in the lungs associated with sickle cell disease. That form of hypertension places people at risk for complications, including shortness of breath, pain, pneumonia, and death. Previous studies have shown that bosentan can be helpful in reducing pulmonary hypertension.

Patients ages 16 and older who have completed the 16-week treatment in the ASSET 1 or ASSET 2 study and who are not pregnant or breastfeeding may be eligible for this study. The research will be conducted in about 25 hospitals in the United States and Europe. Up to 30 participants will be enrolled. The screening visit will involve a physical examination, blood sample of about 3 teaspoons for laboratory tests, and a pregnancy test. Patients' doctors will give them bosentan tablets (62.5 mg each), to take one in the morning and one in the evening. After 1 month, patients will be told whether the dose should be increased to 125 mg tablets to take twice a day. Two weeks after the increase in dose, a blood test will be done to analyze the drug's effects on the liver. After the start of treatment, patients will return for visits every 6 months, when there will be a 6-minute walking test to measure exercise capacity and evaluate shortness of breath. There will be follow-up for patients up to the end of the study and for 28 days after the last dose of bosentan is taken, to collect information about side effects.

Some patients on bosentan have had changes in liver function and red blood cell count. Side effects commonly reported are headache, flushed appearance, inflammation of the throat and nasal passages, and gastrointestinal symptoms. If patients have sudden worsening in breathing in the first few weeks after taking bosentan, they should immediately tell their doctors, because it may be necessary to change the treatment.


Options:
A: Change from Baseline to Week 16 in 6-Minute Walk Test distance (Week 16); Change from Baseline to Week 16 in Pulmonary Vascular Resistance at rest (Week 16)
B: Change in 6-minute walk distance (Baseline to End-of-Period 1)
C: Change from baseline to all assessed time points in 6MWT, in Borg dyspnea index, and in modified NYHA functional class.
D: Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. (From baseline to Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-Term, Open-Label, Multicenter, Extension Study of Bosentan in Patients With Pulmonary Hypertension Associated With Sickle Cell Disease Completing a Double-Blind ASSET Study (AC-052-368 or AC 052-369)
Brief Summary: This study will assess the safety and efficacy of bosentan therapy (in a study known as ASSET) for patients who have high blood pressure in the lungs associated with sickle cell disease. That form of hypertension places people at risk for complications, including shortness of breath, pain, pneumonia, and death. Previous studies have shown that bosentan can be helpful in reducing pulmonary hypertension.

Patients ages 16 and older who have completed the 16-week treatment in the ASSET 1 or ASSET 2 study and who are not pregnant or breastfeeding may be eligible for this study. The research will be conducted in about 25 hospitals in the United States and Europe. Up to 30 participants will be enrolled. The screening visit will involve a physical examination, blood sample of about 3 teaspoons for laboratory tests, and a pregnancy test. Patients' doctors will give them bosentan tablets (62.5 mg each), to take one in the morning and one in the evening. After 1 month, patients will be told whether the dose should be increased to 125 mg tablets to take twice a day. Two weeks after the increase in dose, a blood test will be done to analyze the drug's effects on the liver. After the start of treatment, patients will return for visits every 6 months, when there will be a 6-minute walking test to measure exercise capacity and evaluate shortness of breath. There will be follow-up for patients up to the end of the study and for 28 days after the last dose of bosentan is taken, to collect information about side effects.

Some patients on bosentan have had changes in liver function and red blood cell count. Side effects commonly reported are headache, flushed appearance, inflammation of the throat and nasal passages, and gastrointestinal symptoms. If patients have sudden worsening in breathing in the first few weeks after taking bosentan, they should immediately tell their doctors, because it may be necessary to change the treatment.


Options:
A: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
B: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
C: Change from baseline to all assessed time points in 6MWT, in Borg dyspnea index, and in modified NYHA functional class.
D: Acute Chest Syndrome (Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR.)

Answer: C
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: Newborn survival (to 28 days) (July 2010 to June 2013)
B: 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)
C: proportion of patients with breastfeeding completed at 6 months (6 months)
D: Exclusive breastfeeding (6 months postpartum)

Answer: B
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: 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)
C: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
D: Frequency of exclusive and total breastfeeding (First year)

Answer: B