TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Study for the Multi-Center Placebo-Controlled Double-Blind Clinical Trial for the Evaluation of the Effect of Cilostazol on Pulsatility Index of Transcranial Doppler in the Acute Lacunar Infarction Patients
Brief Summary: RATIONALE:

* Elevation in pulsatility indices (PIs), measured by transcranial Doppler (TCD), has been postulated to reflect downstream increased vascular resistance caused by small-vessel disease (SVD).
* Small arterial vessels are a significant determinant of vascular resistance and PIs are elevated when SVD is present in the intracranial circulation.
* Cilostazol, a phosphodiesterase III inhibitor, has other non-antiplatelet effects, such as vasodilation and neuroprotective effect. It has been shown to be effective in the secondary prevention of stroke especially in the SVD and it may be related to the other non-antiplatelet effects of cilostazol.

OBJECTIVES:

* In this study, we aim to investigate whether cilostazol affects the changes of PIs in patients with acute lacunar infarction using serial TCDs.
* Our hypothesis is that cilostazol has other non-antiplatelet effects such as vasodilation effect and may decrease the vascular resistance in patients with acute lacunar infarction. Hence, cilostazol will decrease the PIs in patients with acute lacunar infarction.


Options:
A: The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death (For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.); The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria (For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.)
B: The primary endpoint is death from any cause or incident, dementia or persistent physical disability. (every 6 months)
C: The Changes of Middle Cerebral Artery (MCA) and Basilar Artery (BA) Pulsatility Index (PI) at 14 and 90 Days From the Baseline Transcranial Doppler (TCD) Study (14 days and 90 days from the baseline TCD study)
D: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Physical Exercise on Endothelial Function in Pregnant Women: Randomized Clinical Trial
Brief Summary: The purpose of this study is to determine the effect of regular aerobic exercise on endothelial function in pregnancy.


Options:
A: Brachial artery flow-mediated dilation (Baseline, 8 weeks, 16 weeks)
B: Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit (nine months)
C: Maternal gestational weight gain (40-42 weeks)
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prognostic Value of the Circadian Pattern of Ambulatory Blood Pressure for Multiple Risk Assessment
Brief Summary: The HYGIA study was designed to investigate prospectively

1. the prognostic value of ambulatory blood pressure (BP) monitoring among subjects primarily evaluated at primary care settings
2. the impact of changes in ambulatory BP during follow-up in cardiovascular, cerebrovascular, metabolic, and renal risk in hypertensive patients
3. the influence of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk in hypertensive patients
4. the prevalence of an altered BP profile as a function of antihypertensive treatment, circadian time of treatment, age, and presence of diabetes, among other factors.


Options:
A: coronary mortality (ICD 10 I20-I25) (up to 15 years from entry into cohort)
B: 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)
C: To evaluate the impact of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk assessment. (Yearly evaluation for at least ten years)
D: Changes in 24 Hour Systolic Blood Pressure (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Study on the Comparison Between Combined Versus Sequential Diuretic Treatment of Moderate Ascites in Nonazotemic Patients With Cirrhosis
Brief Summary: The question whether the sequential diuretic therapy, that means using an antialdosteronic drug at first and adding a loop diuretic in nonresponders, is better than the combination of the two diuretics from the beginning (combined diuretic therapy) in the treatment of ascites in patients with cirrhosis is still open. Therefore, the aim of the study is to compare sequential versus combined diuretic therapy in these patients. One hundred patients will be randomized into two groups. Group A will receive potassium canrenoate at the initial dose of 200 mg/day, then increased up to 400 mg/day. Non responders will be treated with 400 mg/day of potassium canrenoate and furosemide at an initial dose of 50 mg/day, then increased up to 150 mg/day. Group B will receive at first 200 mg/day of potassium canrenoate and 50 mg/day of furosemide, then increased up to 400 mg/day and 150 mg/day, respectively.

The percentage of responders to dthe diuretic treatment, the time to get the resolution of ascites and the rate of adverse effects will be compared between the two Groups of Patients.


Options:
A: 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)
B: Number and time of recurrences of therapeutic paracenteses (up to 12 weeks)
C: Incidence of overcorrection rate at any given period (up to 48 hours)
D: To evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy. (8 and 16 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in COPD Patients
Brief Summary: From the relationship between pathophysiology of chronic obstructive pulmonary disease (COPD), dyspnea, and dynamic hyperinflation during ventilatory increasing, the investigators hypothesize that

1. Positive expiratory pressure (PEP) breathing will reduce dyspnea more than normal breathing during exercise in mild to moderate COPD patients.
2. PEP breathing will improve dynamic hyperinflation during exercise more than normal breathing in mild to moderate COPD patients.
3. PEP breathing will improve cardiorespiratory function during exercise than normal breathing in mild to moderate COPD patients.


Options:
A: Inspiratory Capacity (at 0th, 5th, ~20th minutes of exercises); Borg scale (at 0th and 20th minutes of exercises)
B: Visual Analogue Scale (VAS) - distress due to breathlessness (End of intervention (8 weeks after baseline))
C: Exercise endurance (12 weeks)
D: Primary study outcomes are patients' self report of the severity of dyspnea and HRQOL. Baseline dyspnea will be quantified with the Baseline Dyspnea Index and Borg scale with regular measures of dyspnea using the Visual Analog Scale (VAS). HRQOL will be (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center, Double-blind, Randomized, Placebo-controlled, Two-period/Two-treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation
Brief Summary: Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period/Two-Treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation


Options:
A: The sum of responses in nasal potential difference (NPD) after perfusion with isoproterenol and chloride-free buffer (TCS: Total Chloride Secretion), in the presence of amiloride. (Change from baseline (pre-dose on Day 1) to end-of-treatment (Day 8))
B: Treatment Period 1 (Treatment Cohorts): Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 100)
C: Part A: Observed Plasma Concentrations From 3-4 Hours (C3-4hr) of LUM and IVA (Day 1 and Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of LUM and IVA (Pre-dose at Day 8 and Day 15); Part B : Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 26)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center, Double-blind, Randomized, Placebo-controlled, Two-period/Two-treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation
Brief Summary: Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period/Two-Treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation


Options:
A: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
B: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
C: The sum of responses in nasal potential difference (NPD) after perfusion with isoproterenol and chloride-free buffer (TCS: Total Chloride Secretion), in the presence of amiloride. (Change from baseline (pre-dose on Day 1) to end-of-treatment (Day 8))
D: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline through Week 100)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transdermal Electroacupuncture for Opioid Detoxification
Brief Summary: This single-blind, randomized clinical trial tests whether electroacupuncture, provided as an adjunctive treatment, improves outcomes among patients receiving inpatient opioid detoxification from opioids.


Options:
A: CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 (1-24 weeks); CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups (1-24 weeks)
B: opioid use (baseline, 1-month, 3-months, 6-months); HIV risk behavior (baseline, 1-month, 3-months, 6-months)
C: Percent of Participants Using Drugs (2 weeks following discharge)
D: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 (12 weeks); The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment (12 weeks in Phase 2 period (i.e., 24 weeks into the study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)
Brief Summary: The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.


Options:
A: Complete Clearance of Actinic Keratoses (AK) Lesions (baseline and 57 days)
B: Patients With Complete Clearance of Actinic Keratosis (AKs) (57 days)
C: Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions (57 days)
D: Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. (57 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study With Freeze Dried HL10, Three Dosages of 200 mg/kg Ideal Body Weight Versus Standard Therapy in ALI/ARDS Patients
Brief Summary: The purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given at fixed time intervals compared to standard therapy


Options:
A: 28 days mortality (28 days)
B: Number of Ventilator Free Days (VFD) (Determined 28 days after a subject entered the study)
C: Compare the adverse events between mesenchymal stem cell treatment and placebo groups (From day 0 at the start of treatment to day 28.)
D: Incidence of Pre-specified Infusion Associated Adverse Events (24 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DIANA - Diabetes Mellitus: Neue Wege Der Optimierung Der allgemeinärztlichen Betreuung
Brief Summary: Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In an epidemiological longitudinal study of about 1.150 patients with type 2 diabetes mellitus we investigate determinants and predictors for long-term prognosis. The patients are recruited and supervised in practices of general practitioners of the administrative district of Ludwigsburg/Heilbronn (Baden-Württemberg, Germany). In a subgroup of about 200 patients with a dissatisfactory metabolic status (HbA1c \> 7,5%) a randomised interventional study is performed. The intervention comprises a telephone counseling by the medical secretary of each practice executed in a predefined period of time. The outcome parameters of interest are the change of HbA1c, the development of secondary disorders and adverse events, quality of life and risk factor control, as well as hospitalization and mortality.

The aim of the study was to develop an patient-centred instrument implementable in the routine medical care in order to enhance the prognosis of patients with type-2 diabetes mellitus.


Options:
A: Glycated hemoglobin level before and after intervention (1 year after start of the intervention)
B: Hemoglobin A1c (Change from baseline to 6 months)
C: HbA1c (18 months)
D: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Walnut Supplement on Cardio-Metabolic Risk Factors in Patients With Metabolic Syndrome
Brief Summary: The purpose of this study is to determine whether a daily supplement of 30 grams of walnut is effective in the treatment of metabolic syndrome (MetS).


Options:
A: N/A
B: Endothelial function (8 weeks)
C: Metabolic syndrome status (12 weeks)
D: The primary outcome measure is HDL-C (12 weeks and 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Supplementation With Dual Megadose of Vitamin A in the Post-partum About Vitamin A Levels in Breast Milk, Serum Levels of Vitamin A and Iron in the Binomial Mother-son and Growth and Morbidity of Children Under 6 Months
Brief Summary: The purpose of this study is to evaluate the effect of maternal supplementation with 400,000 IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial mother-child, on growth and morbidity of children in breastfeeding in the first six months of life.


Options:
A: Seric retinol (six months)
B: All-cause, Pregnancy-related Mortality (Deaths during pregnancy through 12 weeks postpartum)
C: Pregnancy-related mortality and all cause mortality (Continuous)
D: Change in carotenoids in serum and breast milk (1 and 3 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Supplementation With Dual Megadose of Vitamin A in the Post-partum About Vitamin A Levels in Breast Milk, Serum Levels of Vitamin A and Iron in the Binomial Mother-son and Growth and Morbidity of Children Under 6 Months
Brief Summary: The purpose of this study is to evaluate the effect of maternal supplementation with 400,000 IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial mother-child, on growth and morbidity of children in breastfeeding in the first six months of life.


Options:
A: Seric retinol (six months)
B: All-cause, Pregnancy-related Mortality (Deaths during pregnancy through 12 weeks postpartum)
C: Vitamin A status changes (After the intervention, which is approximately 3 months.)
D: Mortality, morbidity (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Supplementation With Dual Megadose of Vitamin A in the Post-partum About Vitamin A Levels in Breast Milk, Serum Levels of Vitamin A and Iron in the Binomial Mother-son and Growth and Morbidity of Children Under 6 Months
Brief Summary: The purpose of this study is to evaluate the effect of maternal supplementation with 400,000 IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial mother-child, on growth and morbidity of children in breastfeeding in the first six months of life.


Options:
A: Mortality
B: Mortality; Hospitalisations
C: Skin prick test (Single observation at time of consent - DAY 1)
D: Seric retinol (six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Trial Of The Humanized Anti-GD2 Antibody (HU14.18K322A) In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma
Brief Summary: Relapsed and/or refractory neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma are considered difficult to treat and cure. For this study we are testing the use of a new experimental (investigational) antibody called hu14.18K322A. GD2 is expressed on the surface of most of these tumor types.

Two schedules of hu14.18K322A antibody will be evaluated in this study, (1) daily for four consecutive days schedule every 28 days and (2) once weekly for 4 weeks schedule every 28 days. Approximately 25-40 participants will be required to define the maximum tolerated dose for each schedule. Participants will continue on treatment for a maximum of 4 to 8 courses or until one or more of the criteria for off-treatment are met.


Options:
A: Event Free Survival (R1: MAT therapy) (Up to three years); Event Free Survival (immunotherapy) (Up to three years); Complete metastatic response (R3: Induction therapy) (Up to 95 days); Event free survival (R3: Induction therapy) (Up to three years)
B: Percentage of Randomized Patients Who Are Responders (Up to the first 6 cycles of treatment); Percentage of Patients in the Dinutuximab Arm Who Are Responders (Up to the first 6 cycles of treatment)
C: Event-Free Survival (EFS) (Three years)
D: Determine maximum tolerated dose and dose-limiting toxicity of the humanized monoclonal anti-GD2 antibody, hu14.18K322A, in research participants with neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma. (within 12 months of the start of therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Strengthened Health Extension Program and Community Based Treatment of Neonatal Infections on Neonatal Mortality in Oromia and South Nation and Nationalities & People Region(SNNPR), Ethiopia
Brief Summary: The purpose of the study is to determine whether community based management of infections with antibiotics administered by health extension workers reduce all cause mortality in neonates after the first day of life compared to current MOH IMNCI model of referral to hospital


Options:
A: All cause Neonatal Mortality (2 years)
B: Newborn survival (to 28 days) (July 2010 to June 2013)
C: Newborn health (the first month after birth)
D: Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment (12 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Strengthened Health Extension Program and Community Based Treatment of Neonatal Infections on Neonatal Mortality in Oromia and South Nation and Nationalities & People Region(SNNPR), Ethiopia
Brief Summary: The purpose of the study is to determine whether community based management of infections with antibiotics administered by health extension workers reduce all cause mortality in neonates after the first day of life compared to current MOH IMNCI model of referral to hospital


Options:
A: mortality (day 28)
B: All cause Neonatal Mortality (2 years)
C: Treatment failure (Day 8 of enrollemnt)
D: Difference in the under-five child mortality rate between the two study arms (36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Strengthened Health Extension Program and Community Based Treatment of Neonatal Infections on Neonatal Mortality in Oromia and South Nation and Nationalities & People Region(SNNPR), Ethiopia
Brief Summary: The purpose of the study is to determine whether community based management of infections with antibiotics administered by health extension workers reduce all cause mortality in neonates after the first day of life compared to current MOH IMNCI model of referral to hospital


Options:
A: All cause Neonatal Mortality (2 years)
B: Treatment failure (within 7 days of enrolment)
C: Treatment failure (Seven days)
D: Neonatal mortality rate

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing Pump vs. Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
Brief Summary: This study will evaluate the safety, biological activity, and pharmacokinetics of PTH delivered by subcutaneous injection compared with an infusion pump. We anticipate pump delivery of PTH will be more physiologic because it mimics normal parathyroid gland secretion of PTH. We expect that pump delivery will simultaneously normalize blood and urine calcium, phosphorus and magnesium levels with minimal or no fluctuations throughout the day. Pump therapy will require lower PTH doses and should normalize markers of bone turnover. We expect the improved metabolic control during pump therapy will be especially evident in patients with more severe forms of hypoparathyrodism where there is an unmet need for improved therapy.


Options:
A: Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. (8 Weeks)
B: The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24. (Week 24 of dosing)
C: Assess the feasability of PTH 1-34 therapy via pump.
D: Increase in maximal voluntary knee extension (6 months)

Answer: C