TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Self-monitoring of Blood Pressure in Primary Care in Older Diabetic Patients With Uncontrolled Systolic Hypertension
Brief Summary: This study is an open randomized controlled trial of 12-month duration, which compares the use of a home blood pressure (BP) tele-management system to the usual approach of home BP monitoring in older diabetic patients with uncontrolled systolic hypertension. The purpose of this study is to determine whether home blood pressure tele-management system will markedly improve blood pressure control in a primary care setting.


Options:
A: Cholesterol Level (1 year)
B: Blood Pressure Control (Baseline, 6 months, 12 months, 18 months); Mean Systolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months); Mean Diastolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months)
C: Adherence to ART and HIV RNA suppression (6,12 months)
D: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Routine Administration of Folic Acid and Vitamin B12 to Prevent Childhood Infections in Young Indian Children
Brief Summary: Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or without simultaneous administration of vitamin B12 reduces the rates of acute lower respiratory tract infections (ALRI), clinical pneumonia and diarrhea.

Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months will be identified through a survey. Eligible and willing Children aged 6-30 months will be randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child weight and length taken. The baseline blood samples will be collected. The supplements will be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by field workers.


Options:
A: Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia) (6 months); Prevalence of diarrhea (6 months)
B: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester (from 1st to 3rd trimester)
C: Change in concentrations of biomarkers of vitamin B12 in mother-child pairs (Baseline and 6 months postpartum); Vaccine specific immunity in infants (6 months); Cognitive, Language and Motor Composite Score (12 months); Nuroinflammatory cytokines (12 months)
D: Neurodevelopment (12 months of age); Prevalence of vitamin B12 deficiency (1-3 months of age); Prevalence of other vitamin deficiencies (1-3 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Routine Administration of Folic Acid and Vitamin B12 to Prevent Childhood Infections in Young Indian Children
Brief Summary: Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or without simultaneous administration of vitamin B12 reduces the rates of acute lower respiratory tract infections (ALRI), clinical pneumonia and diarrhea.

Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months will be identified through a survey. Eligible and willing Children aged 6-30 months will be randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child weight and length taken. The baseline blood samples will be collected. The supplements will be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by field workers.


Options:
A: Change in length and length-for-age Z-score (36 weeks); Change in weight and weight-for-age Z-score (36 weeks); Incidence of diarrhea (36 weeks); Change in hemoglobin concentration (32 weeks); Change in micronutrient status (32 weeks); Innate and adaptive immune defense (32 weeks)
B: Number of episodes diarrhea (all, severe, prolonged) and pneumonia (ALRI, Clinical pneumonia) (6 months); Prevalence of diarrhea (6 months)
C: Incidence acute diarrheal disease and acute respiratory infection (Up to 16 weeks)
D: Plasma zinc concentration (3 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Haemodialysis
Brief Summary: This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (IV or SC epoetin beta once, twice or thrice weekly, or IV or SC darbepoetin alfa once a week or twice a week).


Options:
A: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within +/- 1 g/dL of Their Reference Hb and Between 10.5 and 12.5 g/dL During Efficacy Evaluation Period (EEP (Week 17 to Week 24))
B: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
C: Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period. (Weeks 16-24)
D: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP) (At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Brief Summary: To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Options:
A: Hospital Length of Stay (Admission to Discharge)
B: Treatment Adherence (10 months)
C: Lung Clearance Index (90 minutes post treatment)
D: Change in forced expiratory volume in 1 second (FEV1) (%predicted) (Baseline to 3 months and Baseline to 6 months); Change in peak oxygen uptake (% predicted) (Baseline to 3 months and Baseline to 6 months); Change in number of steps per day (Baseline to 3 months and Baseline to 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Brief Summary: To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Options:
A: Hospital Length of Stay (Admission to Discharge)
B: Average sputum production, as assessed by sputum wet and dry weights, during each treatment session.
C: Change in sputum viscoelasticity (G*) over a broad frequency range (1-100 rad.s-1) (Baseline - immediately post exercise - 45min post exercise)
D: Wet sputum production (45 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Brief Summary: To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Options:
A: Hospital Length of Stay (Admission to Discharge)
B: Lung Clearance Index (90 minutes post treatment)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Difference in the number of respiratory exacerbations during the 1 year study period (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Brief Summary: To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Options:
A: Mean percentage change in forced expiratory volume in one second (FEV1) (7days)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Hospital Length of Stay (Admission to Discharge)
D: weight of sputum that was expectorated (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Brief Summary: To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Options:
A: Expectorated sputum (gram) (8 weeks)
B: Change in Lung Clearance Index (Immediately pre-intervention and immediately post-intervention); Change in Forced Expiratory Volume in One Second (Immediately pre-intervention and immediately post-intervention); Electronic Impedance Tomography (During intervention); Change in Impulse Oscillation System (Immediately pre-intervention and immediately post-intervention); Sputum Wet Weight (During intervention and for 30 minutes post-intervention)
C: Hospital Length of Stay (Admission to Discharge)
D: Lung Clearance Index (90 minutes post treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Brief Summary: To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Wet sputum production (45 minutes)
C: Hospital Length of Stay (Admission to Discharge)
D: weight of sputum that was expectorated (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Brief Summary: To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Options:
A: Hospital Length of Stay (Admission to Discharge)
B: Cough capacity (6 weeks)
C: Mean percentage change in forced expiratory volume in one second (FEV1) (7days)
D: Change from baseline Posture at 4 weeks (Baseline and after 4 weeks of training); Change from baseline Health-related quality of life at 4 weeks (Baseline and after 4 weeks of training)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Brief Summary: To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Hospital Length of Stay (Admission to Discharge)
C: weight of sputum that was expectorated (12 months)
D: Lung Clearance Index (90 minutes post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Brief Summary: To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Options:
A: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
B: Incremental Shuttle Walk Test Chronic Respiratory Disease questionnaire (July 2011)
C: Sputum Wet and Dry Weight (Produced during each airway clearance therapy session on days 1 and 4)
D: Hospital Length of Stay (Admission to Discharge)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital
Brief Summary: To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Options:
A: Hospital Length of Stay (Admission to Discharge)
B: Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight (24 hours)
C: Change in Lung Clearance Index (Immediately pre-intervention and immediately post-intervention); Change in Forced Expiratory Volume in One Second (Immediately pre-intervention and immediately post-intervention); Electronic Impedance Tomography (During intervention); Change in Impulse Oscillation System (Immediately pre-intervention and immediately post-intervention); Sputum Wet Weight (During intervention and for 30 minutes post-intervention)
D: Mean percentage change in forced expiratory volume in one second (FEV1) (7days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Brief Summary: The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.


Options:
A: Significant increase of overall survival (At follow up 1 year after treatment)
B: Overall 3-year mortality (overall 3-years)
C: Percent Change in D-dimer Value (Baseline, 56 Day)
D: Recurrent (symptomatic) vein thromboembolism, including pulmonary embolism and deep vein thrombosis (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Brief Summary: The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.


Options:
A: Incidence of venous thromboembolism reduction
B: Significant increase of overall survival (At follow up 1 year after treatment)
C: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
D: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, 2-Part, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept, Dose-finding Study Evaluating the Efficacy and Safety of CNTO 136 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate (MTX) therapy.


Options:
A: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) (Week 12)
B: To determine the objective response (Weeks 24)
C: Overall Survival (OS) (From date of treatment start until date of death from any cause, up to 5 years 5 months)
D: Event-free survival (Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Naturopathic Treatment for the Prevention of Cardiovascular Disease: a Pragmatic Randomized Controlled Trial
Brief Summary: This study is designed to test the ability of a comprehensive naturopathic approach to reduce important risk factors for the development of cardiovascular disease. Treatment will take place over the course of one year and the comparator/control group will be followed by their medical doctors and be given conventional care.


Options:
A: Incidence of CHD and other lifestyle related diseases after ten years (2012)
B: All cause mortality (3, 5, and 10 years)
C: Metabolic syndrome (1 year); General Cardiovascular Risk Profile: Framingham Heart Study (1 year)
D: Composite outcome of multiple cardiovascular risk factors (2 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effective Treatment for Prescription Opioid Abuse
Brief Summary: There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.


Options:
A: Opiate abstinence
B: percentage of subjects abstinent from all opioids through the final day of detoxification (up to 12-week trial)
C: opiate use
D: Opioid use as determined by the Timeline Follow Back measure (from 2006-2009 to 2011-2016)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effective Treatment for Prescription Opioid Abuse
Brief Summary: There has been an alarming increase in abuse of prescription opioids in recent years. This project aims to develop an effective outpatient treatment for prescription opioid (PO) abuse that combines an intensive behavioral therapy with a pharmacotherapy regimen of buprenorphine detoxification and naltrexone maintenance.


Options:
A: 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))
B: percentage of subjects abstinent from all opioids through the final day of detoxification (up to 12-week trial)
C: opiate use
D: Percent of Participants Using Drugs (2 weeks following discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Effect of Aprepitant on Cyclophosphamide Pharmacokinetics
Brief Summary: RATIONALE: Antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and vomiting in patients undergoing chemotherapy.

PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to placebo in preventing nausea and vomiting in patients undergoing chemotherapy for breast cancer.


Options:
A: No Emetic Episodes and No Rescue Medication (>24 to 120 hours post chemotherapy)
B: Plasma levels of study drugs will be taken on Day 1 & 8. (taken on Day 1 & 8.)
C: Effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide pharmacokinetics as measured by plasma AUC (05/2005 to 10/2010)
D: Complete Response Rates Among Standard of Care and Combination Therapy Groups. (14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 20 Week Double-Blind Randomized Trial of Clomiphene Citrate and Letrozole for the Treatment of Infertility in Women With Polycystic Ovary Syndrome
Brief Summary: The primary research hypothesis is that ovulation induction with an aromatase inhibitor (letrozole) is more likely to result in live birth than ovulation induction with a selective estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety hypothesis will also be incorporated into the primary research hypothesis in which we hypothesize both treatments are equally safe for mother and child.

Secondary research hypotheses include:

1. Treatment with letrozole is more likely to result in singleton pregnancy compared to treatment with clomiphene citrate. Singleton pregnancy is defined as presence of a single intrauterine gestational sac with a single fetal pole and observable heart motion.
2. Treatment with letrozole will less likely result in a first trimester intrauterine fetal demise than treatment with clomiphene citrate. A first trimester IUFD is defined as a pregnancy that ends before 13 weeks gestation.
3. Treatment with letrozole is more likely to result in ovulation (increased ovulation rate) compared to treatment with clomiphene citrate. Ovulation is defined as a midluteal progesterone level ≥ 3 ng/mL.
4. The shortest time to pregnancy will be with letrozole.
5. Age, body mass index, SHBG, testosterone, LH, Anti-Mullerian Hormone (AMH), and degree of hirsutism and acne will be significant predictors of ovulation and conception regardless of treatment.
6. Improvement in SHBG, testosterone, AMH, and LH levels will be significant predictors of ovulation and conception regardless of treatment.
7. DNA polymorphisms in estrogen action genes will predict response to study drug.
8. Quality of Life will be better on letrozole than clomiphene.
9. Letrozole will be more cost effective at achieving singleton pregnancies than clomiphene.


Options:
A: Live Birth (as few as 5 months, up to 16 months)
B: Live birth rate (Up to 18 months)
C: Pregnancy rate (14 moths)
D: Ovulation (6 weeks after starting the intervention)

Answer: A