TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention to Reduce Dietary Sodium in Hemodialysis
Brief Summary: The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis patients, a behavioral intervention to reduce dietary sodium intake. The investigators will assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and health-related quality of life. The primary study hypotheses are that participants will gain less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced consumption of dietary sodium.


Options:
A: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)
B: Stroke (5 years)
C: Net Change in Urinary Albumin-to-Creatinine Ratio (ACR) (Assessed twice at baseline, once at week 12, and twice at week 24)
D: 24-hour Urinary Sodium Excretion (1 month); 24-hour Urinary Salt Excretion (1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention to Reduce Dietary Sodium in Hemodialysis
Brief Summary: The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis patients, a behavioral intervention to reduce dietary sodium intake. The investigators will assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and health-related quality of life. The primary study hypotheses are that participants will gain less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced consumption of dietary sodium.


Options:
A: The difference of rate of estimated glomerular filtration rate (eGFR) decline (30 months)
B: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
C: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)
D: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention to Reduce Dietary Sodium in Hemodialysis
Brief Summary: The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis patients, a behavioral intervention to reduce dietary sodium intake. The investigators will assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and health-related quality of life. The primary study hypotheses are that participants will gain less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced consumption of dietary sodium.


Options:
A: 24-hourly urinary sodium excretion (up to 9 months)
B: Reduction in blood pressure (Six months)
C: 24 hour blood pressure (Two weeks after start of each intervention)
D: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients With DSM-IV-TR Schizophrenia
Brief Summary: This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of efficacy, safety, and tolerability.


Options:
A: PANSS-total score
B: To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score (28 days)
C: Change From Baseline to Week 6 in the PANSS Total Score (Baseline to Week 6)
D: Clinical Utility Index (CUI) (Baseline through Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients With DSM-IV-TR Schizophrenia
Brief Summary: This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of efficacy, safety, and tolerability.


Options:
A: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)
B: The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
C: Clinical Utility Index (CUI) (Baseline through Week 6)
D: Composite MATRICS Consensus Cognitive Battery Score (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Tenofovir-containing Combination Drug Regimen During the Second and Third Trimesters of Pregnancy for Prevention of Mother-to-child Transmission of HIV and HBV in HIV-HBV Co-infected Mothers
Brief Summary: The purpose of this study is to compare a regimen of tenofovir/lamivudine/lopinavir-ritonavir to the WHO-recommended and locally practiced standard of care regimen consisting of zidovudine/lamivudine/lopinavir-ritonavir during the second and third trimesters of pregnancy in HIV and HBV co-infected women. This is a phase II study evaluating the safety of the test regimen in pregnant women and their newborns. While the study is not powered to examine efficacy, preliminary estimates of transmission of HIV and HBV to the infants and of the rate of resistance development will be obtained.


Options:
A: Loss-to-follow-up (delivery, six weeks, 12 and 24 weeks postpartum); Virological suppression (delivery, 12 and 24 months postpartum)
B: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (Week 48)
C: Antepartum Component: Number of Confirmed Infant HIV Infections (Measured at birth or Week 1 study visit); Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events (Measured through the Week 1 postpartum study visit); Antepartum Component: Number of Mothers With Obstetrical Complications (Measured through the Week 1 postpartum study visit); Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) (Measured at birth); Postpartum Component: Incidence of Confirmed Infant HIV Infection (Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first); Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events (Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first); Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death (From study entry until July 7, 2015, an average of 94 weeks of follow-up.)
D: Tenofovir Safety for mothers measured by incidence of serious adverse events (SAEs) (From baseline (14-28 weeks gestation) through 12 months postpartum); Dual Energy X-ray absorptiometry (DXA) scans of bone mineral density (from delivery through 6 months postpartum); Maternal Tenofovir Pharmacokinetics (16 weeks gestation through delivery); Infant Tenofovir Pharmacokinetics (one timepoint within 12 hours of delivery); Tenofovir safety for infants measured by incidence of serious adverse events (SAEs) (from birth through 12 months of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Diabetes Control Through Peer Counseling and Incentives
Brief Summary: The specific aims of this study are to test whether in a cohort of low-income minority veterans with poor diabetes mellitus (DM) control:

1. Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).
2. Financial incentives are an effective means of reducing HbA1c. This is a randomized controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial incentives without peers. Ultimately, contingent on the success of this intervention, the researchers plan to apply for funding for a large scale intervention employing both peer counseling and incentives to improve DM control in low income and minority patients who are at high risk for premature morbidity and mortality.


Options:
A: Hemoglobin A1c (HbA1c) at 6 Months Post Randomization (6 months post randomization)
B: HbA1c (6 months)
C: Hemoglobin A1c (Baseline, 6 months)
D: Hemoglobin A1c (Change in Baseline in HbA1c at 6 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Phase-III-trial of Simultaneous Radiochemotherapy (RCT) of Locally Advanced Head and Neck Cancer in the Stages III and IV A-B: Comparing Dose Reduced Radiotherapy (63,6 Gy) With Paclitaxel/Cisplatin to Standard Radiotherapy (70,2 Gy) With 5-Fluorouracil/Cisplatin
Brief Summary: Reduced RT with Pac/Cis vs. standard RCT with 5-FU/Cis


Options:
A: Overall survival (5 years)
B: Disease free survival (3 years)
C: Overall Survival (3-years)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Compare the Cognitive Effect of Solifenacin 5mg Once-daily and Oxybutynin 5mg Twice-daily After Chronic Dosing Versus Placebo in Subjects 75 Years and Over With Mild Cognitive Impairment - A Double-blind, Randomized, Multi-center Study
Brief Summary: The purpose is to compare solifenacin and oxybutynin with an inactive tablet and assess any potential effects on mental ability.


Options:
A: Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants (Baseline (BL); Week 12); CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants (Baseline; Week 12)
B: Baseline Average Number of Daily Incontinence Episodes (Baseline); Change From Baseline in Average Daily Number of Incontinence Episodes (Baseline to Week 12)
C: Change From Baseline in Cognitive Function Composite Score - Power of Attention (Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.); Change From Baseline in Cognitive Function Composite Score - Continuity of Attention (Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.); Change From Baseline in Cognitive Function Composite Score - Quality of Working Memory (Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.); Change From Baseline in Cognitive Function Composite Score - Quality of Episodic Secondary Memory (Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.); Change From Baseline in Cognitive Function Composite Score - Speed of Memory (Assessed at each treatment period baseline visit (the day prior to the first dose of each treatment; Days -1, 42, 84) and at the end of each treatment period (Days 21, 63 and 105). At each visit, tests were performed at 2 and 6 hours post-dose.)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Brief Summary: Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.


Options:
A: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8) (Baseline (BL) and Day 85)
B: Change From Baseline Trough in 24-Hour Weighted Mean FEV1 on Treatment Day 84 (Baseline (Day 1) and Day 84)
C: Time to All-Cause Mortality (Up to 3 years); Time to First COPD Exacerbation (Up to 3 years)
D: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Brief Summary: Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.


Options:
A: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
B: Time to All-Cause Mortality (Up to 3 years); Time to First COPD Exacerbation (Up to 3 years)
C: Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF) (AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.)
D: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Brief Summary: Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.


Options:
A: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Trough FEV1 Response Determined After a Treatment Period of 24 Weeks. (Baseline and 24 weeks); Time to First Severe Asthma Exacerbation During the 48-week Treatment of the Pooled Data From the Two Twin Trials 205.416 (NCT00772538) and the Present 205.417 (NCT00776984). (48 weeks)
B: Time to All-Cause Mortality (Up to 3 years); Time to First COPD Exacerbation (Up to 3 years)
C: Change in Mean Weekly Morning Peak Expiratory Flow From Baseline to the End of the Trial (baseline and after 16 weeks of treatment)
D: Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF) (AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Brief Summary: Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.


Options:
A: Change in trough FEV1 after 12 weeks of treatment. (week 12)
B: Time to All-Cause Mortality (Up to 3 years); Time to First COPD Exacerbation (Up to 3 years)
C: Inflammation: localisation, numbers and profile of neutrophils, eosinophils, macrophages, and CD8+T cells in bronchial biopsy specimens after 6 months and 2.5 years treatment.
D: Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1) (Change from Baseline to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Brief Summary: Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.


Options:
A: The primary efficacy endpoint was the change in trough FEV1 after 48 weeks of treatment. (after 48 weeks of treatment)
B: morning peak expiratory flow rate (PEFR) (50 weeks)
C: Time to All-Cause Mortality (Up to 3 years); Time to First COPD Exacerbation (Up to 3 years)
D: sputum IL-6

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function: a Randomized Controlled Trial in Bangladesh
Brief Summary: This study is a randomized placebo-controlled trial of oral weekly vitamin D3 (cholecalciferol) supplementation during the third trimester of pregnancy among women in Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence that improving vitamin D status among pregnant women in Bangladesh will enhance the resistance of the infant offspring to infection.

The aims of the study are to assess the effect of supplementation on 1) maternal and infant vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers of neonatal immune function.


Options:
A: Serum 25-hydroxyvitamin D concentration (Maternal: during 3rd trimester; Neonatal (cord blood))
B: Persistent wheeze 0 to 3 years of age (3 years)
C: Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase (end of winter)
D: Number of Infants With Recurrent Wheezing (up to 12 months adjusted age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Antenatal Vitamin D Supplementation on Maternal-fetal Vitamin D Status and Neonatal Immune Function: a Randomized Controlled Trial in Bangladesh
Brief Summary: This study is a randomized placebo-controlled trial of oral weekly vitamin D3 (cholecalciferol) supplementation during the third trimester of pregnancy among women in Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence that improving vitamin D status among pregnant women in Bangladesh will enhance the resistance of the infant offspring to infection.

The aims of the study are to assess the effect of supplementation on 1) maternal and infant vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers of neonatal immune function.


Options:
A: Serum 25-hydroxyvitamin D concentration (Maternal: during 3rd trimester; Neonatal (cord blood))
B: 25-hydroxyvitamin D concentration (6 scheduled timepoints during supplementation period); Serum calcium concentration (albumin-corrected) (6 scheduled timepoints during supplementation period); Urine calcium: creatinine ratio (7-8 scheduled timepoints during supplementation period)
C: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)
D: Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement (12, 16, 28 weeks and at maternal delivery and neonatal birth)

Answer: A