TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
Brief Summary: The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on lung function, incidence of respiratory tract infections, quality of life, quantitative microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of nebulised hypertonic saline will have a beneficial effect on lung function and other clinical outcomes with no adverse effects on infection and inflammation in adults and children with cystic fibrosis.


Options:
A: Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline) (Duration of patient's involvement in study)
B: Change in FEV1 (in liters) from baseline (At the end of the 14 day treatment period); Adverse events such as gastrointestinal complaints, wheezing, hepatitis or shortness of breath (70 weeks)
C: Lung Clearance Index (90 minutes post treatment)
D: Lung function (FEV1, FVC, FEF25-75)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
Brief Summary: The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on lung function, incidence of respiratory tract infections, quality of life, quantitative microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of nebulised hypertonic saline will have a beneficial effect on lung function and other clinical outcomes with no adverse effects on infection and inflammation in adults and children with cystic fibrosis.


Options:
A: Optimal medication adherence to all cardiovascular or non-depression chronic disease medications (12 months)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Lung function (FEV1, FVC, FEF25-75)
D: Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls. (baseline and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
Brief Summary: The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on lung function, incidence of respiratory tract infections, quality of life, quantitative microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of nebulised hypertonic saline will have a beneficial effect on lung function and other clinical outcomes with no adverse effects on infection and inflammation in adults and children with cystic fibrosis.


Options:
A: Lung function (FEV1, FVC, FEF25-75)
B: Percent Mucociliary Clearance at 60 Minutes (60 minutes)
C: mucociliary clearance (6 hours)
D: Comparison of the judgement on global pleasure of the inhalation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the symptom cough between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of saltiness between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.); Comparison of the sensation of throat irritation between the two treatment groups (The outcome measure was assessed at day 1, day 7, day 14, day 21, and day 28 of the four-weeks treatment period. For each time-point we operated a comparison between the two groups.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
Brief Summary: The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on lung function, incidence of respiratory tract infections, quality of life, quantitative microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of nebulised hypertonic saline will have a beneficial effect on lung function and other clinical outcomes with no adverse effects on infection and inflammation in adults and children with cystic fibrosis.


Options:
A: The rate of protocol-defined pulmonary exacerbations requiring treatment with oral, inhaled or intravenous antibiotics between subjects randomized to HS and IS (during the 48 week treatment period)
B: Change in LCI from baseline to end of treatment in hypertonic saline treated patients versus patients receiving placebo (isotonic saline) (Duration of patient's involvement in study)
C: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (days 1, 29, 57 and 85)
D: Lung function (FEV1, FVC, FEF25-75)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis
Brief Summary: The effect of long term inhalation of hypertonic saline in subjects with cystic fibrosis on lung function, incidence of respiratory tract infections, quality of life, quantitative microbiology and sputum cytokine profile. The hypothesis is that regular inhalation of nebulised hypertonic saline will have a beneficial effect on lung function and other clinical outcomes with no adverse effects on infection and inflammation in adults and children with cystic fibrosis.


Options:
A: Reduction in bacterial load (1 year)
B: 24 hour sputum clearance (24 hours / 12 weeks); Quality of Life SGRQ (12 weeks)
C: Lung function (FEV1, FVC, FEF25-75)
D: Number of pulmonary exacerbations (One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerance of CDB-2914 With Levonorgestrel as Emergency Contraception
Brief Summary: Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception

Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception

Subjects are randomized to receive a one-time treatment with either one dose of 50 mg CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)

The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.


Options:
A: Pregnancy (efficacy) (until follow-up about one week after next menses)
B: Number of Participants With Pregnancy (Within 72 hours of unprotected Intercourse)
C: N/A
D: Pregnancy rates in first month after IUD insertion (4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerance of CDB-2914 With Levonorgestrel as Emergency Contraception
Brief Summary: Objective: To compare the efficacy, safety and tolerance of a 50 mg dose of a new antiprogestin, CDB-2914 with a 0.75 mg bid dose of levonorgestrel as emergency contraception

Design: Multicenter, randomized, double blind Phase II study to compare a 50 mg dose of CDB-2914 to a 0.75 mg bid dose of levonorgestrel as emergency contraception

Subjects are randomized to receive a one-time treatment with either one dose of 50 mg CDB-2914 (followed 12 hours later by a placebo) or 2 doses of 0.75 mg of levonorgestrel with follow-up visits at 5-7 days after expected onset of menses and another visit at 12-14 days after expected onset of menses (if needed)

The primary aim is to evaluate the efficacy of CDB-2914 used by subjects as an emergency postcoital contraceptive in comparison to a group of subjects receiving levonorgestrel.


Options:
A: Number of Participants With Pregnancy (Within 72 hours of unprotected Intercourse)
B: Pregnancy rates in first month after IUD insertion (4 weeks)
C: N/A
D: Pregnancy (efficacy) (until follow-up about one week after next menses)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-Controlled Pilot Study in Huntington's Disease (CIT-HD)
Brief Summary: This research plan proposes to conduct a double-blind, placebo-controlled pilot clinical trial in 36 adults with mild Huntington's disease (HD) to address the following research aims:

1. To determine the effect of citalopram compared to placebo in patients with early HD on executive function and other outcome variables including functional measures (health-related quality of life, work productivity, and self-reported attention), motor performance, and psychiatric status,
2. To study the relationship between executive function and functional status in patients with early HD after selective serotonin reuptake inhibitor (SSRI) treatment, and
3. To examine the effect of citalopram treatment on volumetric and metabolic (i.e, N-acetyl-aspartate concentration) measures in the neostriatum among patients with recently diagnosed Huntington's disease.


Options:
A: Feasibility - enrollment of 1-2 participants per month (One year)
B: Depression (6 Months)
C: Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 14.); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 28); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 42); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 56); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 70); Major Depression Inventory (MDI) (Depression at one point in the study (not including baseline) out of 6 measurements at app. day 84)
D: Executive Function Composite Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort. (after 15 weeks of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Informatics for Diabetes Education and Telemedicine (IDEATel)
Brief Summary: The IDEATel study is a multicenter randomized controlled trial to evaluate the efficacy, acceptability, and cost-effectiveness of telemedicine case management to provide diabetes care to elderly Medicare beneficiaries residing in medically underserved areas of New York State.


Options:
A: Multiple CVD risk factor control targets (42 months after randomization)
B: Comparison of HbA1c mean between the 3 groups (at 6 months)
C: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)
D: Hemoglobin A1c Levels (5 years); Blood Pressure Levels (5 years); Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Informatics for Diabetes Education and Telemedicine (IDEATel)
Brief Summary: The IDEATel study is a multicenter randomized controlled trial to evaluate the efficacy, acceptability, and cost-effectiveness of telemedicine case management to provide diabetes care to elderly Medicare beneficiaries residing in medically underserved areas of New York State.


Options:
A: Rate of all-cause hospital readmission or death during the 6-month follow-up period. (6 months)
B: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)
C: Hemoglobin A1c Levels (5 years); Blood Pressure Levels (5 years); Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol (5 years)
D: Death (30 days, 3 months, 6 months); readmission (30 days, 3 months, 6 months); need for additional Prednisolone, additional antibiotics , NIV or life support machine (respirator) (30 days, 3 months, 6 months); Self-efficacy (3 days); Cognitive function (3 days and six weeks after discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Informatics for Diabetes Education and Telemedicine (IDEATel)
Brief Summary: The IDEATel study is a multicenter randomized controlled trial to evaluate the efficacy, acceptability, and cost-effectiveness of telemedicine case management to provide diabetes care to elderly Medicare beneficiaries residing in medically underserved areas of New York State.


Options:
A: A1c (6 months and 1 year)
B: Hemoglobin A1c (HbA1c)
C: Hemoglobin A1c
D: Hemoglobin A1c Levels (5 years); Blood Pressure Levels (5 years); Serum Lipids Levels; Low-density Lipoprotein (LDL)-Cholesterol (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Procalcitonin and Survival Study - A Multicentre Single Blinded Randomized Controlled Trial to Investigate if Treatment Guided by Daily Procalcitonin Measurements Can Reduce Mortality in the Intensive Care Unit
Brief Summary: This is a randomised, single blinded, multicentre trial to evaluate whether daily procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to abnormal values and day-to-day changes can reduce the mortality of critically ill patients in the Intensive Care Unit (ICU).


Options:
A: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
B: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
C: mortality/survival (28 day)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Procalcitonin and Survival Study - A Multicentre Single Blinded Randomized Controlled Trial to Investigate if Treatment Guided by Daily Procalcitonin Measurements Can Reduce Mortality in the Intensive Care Unit
Brief Summary: This is a randomised, single blinded, multicentre trial to evaluate whether daily procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to abnormal values and day-to-day changes can reduce the mortality of critically ill patients in the Intensive Care Unit (ICU).


Options:
A: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
B: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
C: Antibiotic use; Length of stay in hospital
D: mortality/survival (28 day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Procalcitonin and Survival Study - A Multicentre Single Blinded Randomized Controlled Trial to Investigate if Treatment Guided by Daily Procalcitonin Measurements Can Reduce Mortality in the Intensive Care Unit
Brief Summary: This is a randomised, single blinded, multicentre trial to evaluate whether daily procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to abnormal values and day-to-day changes can reduce the mortality of critically ill patients in the Intensive Care Unit (ICU).


Options:
A: mortality/survival (28 day)
B: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)
C: Antibiotic Prescription Rate (at PED (Pediatric Emergency Department) presentation)
D: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Procalcitonin and Survival Study - A Multicentre Single Blinded Randomized Controlled Trial to Investigate if Treatment Guided by Daily Procalcitonin Measurements Can Reduce Mortality in the Intensive Care Unit
Brief Summary: This is a randomised, single blinded, multicentre trial to evaluate whether daily procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to abnormal values and day-to-day changes can reduce the mortality of critically ill patients in the Intensive Care Unit (ICU).


Options:
A: All cause mortality (28 days)
B: mortality/survival (28 day)
C: Mortality (28 days); Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy. (Between day 1 and D28); Mortality (1 year)
D: Duration of antibiotic treatment for the first episode of infection; Total duration of antibiotic therapy; Antibiotic-free days at 28 days after study enrollment

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Procalcitonin and Survival Study - A Multicentre Single Blinded Randomized Controlled Trial to Investigate if Treatment Guided by Daily Procalcitonin Measurements Can Reduce Mortality in the Intensive Care Unit
Brief Summary: This is a randomised, single blinded, multicentre trial to evaluate whether daily procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to abnormal values and day-to-day changes can reduce the mortality of critically ill patients in the Intensive Care Unit (ICU).


Options:
A: mortality/survival (28 day)
B: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
C: Duration of antibiotic treatment for the first episode of infection; Total duration of antibiotic therapy; Antibiotic-free days at 28 days after study enrollment
D: Proportion of patients who achieve a C(max) for amikacin in tracheal aspirates at least 25 times greater than the reference MIC for hospital-acquired organisms and an AUC (0-24 hr) / MIC ratio that is 100 or greater on Day 1 (Day 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia
Brief Summary: To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.


Options:
A: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Baseline and 24 Weeks); Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Baseline and 24 weeks)
B: Triglycerides (Measured at 24 weeks); Non-HDL-C (Measured at 24 weeks); HDL-C (Measured at 24 weeks); Total Cholesterol (Measured at 24 weeks); Total Cholesterol : HDL-C Ratio (Measured at 24 weeks)
C: N/A
D: Major Vascular Event (During scheduled treatment period (median duration 3.9 years))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
Brief Summary: This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV, STDs and adverse perinatal outcomes in young women during and after pregnancy.


Options:
A: Sexually transmitted disease (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Rapid repeat pregnancy (Measured at Month 12 postpartum); Sexual risk behavior (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Perinatal outcomes (e.g., birth weight, gestational age) (Measured at Months 6 and 12 postpartum)
B: Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer (Follow-up through end of study (4 years)); Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] (Follow-up through end of study (4 years))
C: Percent of teens who have initiated sexual intercourse at 3 years post intervention
D: HIV sero-incidence (24 months post-baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
Brief Summary: This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV, STDs and adverse perinatal outcomes in young women during and after pregnancy.


Options:
A: Improved understanding of preeclampsia (one week)
B: Increase in parent knowledge, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parent skills, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Decrease in parental high-risk behaviors, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parental-child involvement, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
C: Sexually transmitted disease (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Rapid repeat pregnancy (Measured at Month 12 postpartum); Sexual risk behavior (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Perinatal outcomes (e.g., birth weight, gestational age) (Measured at Months 6 and 12 postpartum)
D: Iodine deficiency (36 weeks of pregnancy); Iodine deficiency (24 weeks of pregnancy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Group Prenatal Care for Reducing the Risk of STDs in Pregnant Young Women
Brief Summary: This study will determine the effectiveness of two group prenatal care programs as compared to individual prenatal care in reducing the risk for HIV, STDs and adverse perinatal outcomes in young women during and after pregnancy.


Options:
A: perinatal mortality (Jan 1999-Dec 2003)
B: Neonatal mortality rate (deaths within 28 days of birth)
C: contraception (past 3 months)
D: Sexually transmitted disease (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Rapid repeat pregnancy (Measured at Month 12 postpartum); Sexual risk behavior (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Perinatal outcomes (e.g., birth weight, gestational age) (Measured at Months 6 and 12 postpartum)

Answer: D