TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Surgical Masks vs N95 Respirators to Prevent Influenza in Health Care Workers
Brief Summary: The goal of this study is to compare the efficacy of the surgical mask to the N95 respirator in protecting nurses from influenza in the hospital setting. The investigators propose a non-inferiority randomized controlled trial whereby nurses are randomized to either a surgical mask or an N95 respirator when caring for patients with febrile respiratory illness during the influenza season. The hypothesis is that the surgical mask offers similar protection against influenza to that of the N95. The specific objective of the study is to assess whether the rates of influenza (laboratory-confirmed by PCR and HAI assay), as well as secondary outcomes (influenza-like illness, work-related absenteeism, physician visits for respiratory illness, and lower respiratory infection), are similar among nurses using a surgical mask compared to those using an N95 respirator.


Options:
A: Secondary infection with influenza of the household members who are healthy at the start of the study
B: Laboratory-confirmed Influenza Infection (one year)
C: RT-PCR confirmed COVID-19 infection (10 weeks)
D: Prevalance of VAP (14 days); Characteristics of VAP (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feeding Young Children Study (FYCS)- a Randomized Control Trial of a Bottle Weaning Intervention Aimed at Reducing the Risk of Overweight in Low Income Multi-ethnic Toddlers.
Brief Summary: This Integrated Project (Research + Extension) aims to reduce the risk of early childhood overweight through changing bottle-feeding behavior. Excess bottles of whole milk and sweet beverages beyond the advised weaning age of 12 months, "inappropriate bottle-feeding," has been linked to overweight. Our pilot of this intervention reduced bottle use.

COMPONENTS OF THE 'FEEDING YOUNG CHILDREN STUDY' (FYCS):

1. Randomized Controlled Trial (RCT)- of a bottle-weaning intervention in low-income multi-ethnic toddlers, will enroll n=464 12 month olds using \>2 bottles/day from two WIC sites. Bottle use, anthropometrics, dietary intake, and nutrient density outcomes will be assessed at Baseline, and 4 times over a 12 month follow-up.
2. Observational Study- nested within the RCT, will describe dietary intake and nutrient density data (24 hour recalls) for this period of feeding transitions. FYCS fills a gap in knowledge about this population's dietary habits, and their relationship to bottle use.
3. Extension- our Marketing Department will produce: a 5-8 minute 'infomercial' and nutritionist and client guides (freely downloadable) at WIC, maternal/child health, and pediatric websites, and; a public TV segment. We will disseminate findings through a) the National WIC Association, b) nutrition \& pediatric journals, and; c) lay print, media, and websites with assistance from our Public Relations Department.


Options:
A: School-time and total daily MVPA (5 months and 1.5 years)
B: Body Mass Index Z-Score (Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008)
C: Bottle use frequency (Beverage container assessment done at 12,15,18,21 and 24 months)
D: Physical activity (baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention); motor skills (baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Injection Treatment of Slow-Release Corticosteroid to the Sacrospinous Ligament Insertions on Women With Long-Lasting Low Back Pain Starting in Pregnancy.
Brief Summary: To evaluate the pain relief effect of locally injected corticosteroid treatment in women with long-lasting low back pain beginning in pregnancy. We hypothesize that the insertion of the sacrospinous ligament on the ischial spine would be a source of pain and therefore be a target for therapy.

Primary outcome measure is reported pain intensity on visual analogue scale and secondary outcome measures number of pain-drawing locations, pain-provoking test results and tests of function.


Options:
A: Pain Visual Analog Scale (VAS) (10 weeks); confirmatory low back pain test (10 weeks); Confirmatory pelvic pain test (10 weeks)
B: Roland Morris Disability Index (Last study visit prior to birth)
C: Reported pain intensity on visual analogue scale
D: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Postpartum Mood and Weight Concerns to Sustain Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the relative efficacy of a postpartum smoking relapse prevention program, Strategies to Avoid Returning to Smoking (STARTS), and a supportive, nondirective comparison condition (SUPPORT) to increase the proportion of women who remain abstinent through 12 months postpartum. We hypothesize that women randomized to STARTS will maintain higher rates of smoking abstinence at 6 and 12 months postpartum, and expect STARTS to increase the length of time abstinence is sustained relative to SUPPORT.


Options:
A: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)
B: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
C: Abstinence at 12 months postpartum (through 12 months)
D: Self Reported Relapse Rate at 2 Months (2 months after joining the groups for the social networking services.); Self Reported Relapse Rate at 6 Months (6-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Postpartum Mood and Weight Concerns to Sustain Smoking Cessation
Brief Summary: The purpose of this study is to evaluate the relative efficacy of a postpartum smoking relapse prevention program, Strategies to Avoid Returning to Smoking (STARTS), and a supportive, nondirective comparison condition (SUPPORT) to increase the proportion of women who remain abstinent through 12 months postpartum. We hypothesize that women randomized to STARTS will maintain higher rates of smoking abstinence at 6 and 12 months postpartum, and expect STARTS to increase the length of time abstinence is sustained relative to SUPPORT.


Options:
A: Participant smoking status. (6 and 12 month follow-up)
B: Abstinence at 12 months postpartum (through 12 months)
C: Self Reported Relapse Rate at 2 Months (2 months after joining the groups for the social networking services.); Self Reported Relapse Rate at 6 Months (6-months)
D: Percentage of Participants With 30-day Abstinence (6-months post enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)
Brief Summary: The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.


Options:
A: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30 (Baseline and End of treatment (Day 28-30))
B: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (Baseline and end of treatment Course 1 (Day 28)); Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses (Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20))
C: Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24 (Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days))
D: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)
Brief Summary: The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.


Options:
A: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (Baseline and end of treatment Course 1 (Day 28)); Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses (Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20))
B: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)
C: Change in FEV1 From Baseline to End of Treatment at Day 168 (change from baseline to day 168)
D: Proportion of children with radiologically-defined bronchiectasis (at three years of age); The proportion of lung tissue affected by disease (at three years of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)
Brief Summary: The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.


Options:
A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (From start of study until end of the study (up to 168 days)); Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) (Baseline, day 28)
B: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))
C: Relative Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted at Day 28 (Baseline and end of treatment Course 1 (Day 28)); Mean Actual Change From Baseline in FEV1 Percent Predicted Across 3 Treatment Courses (Baseline, and end of treatment Courses 1 (Week 4), 2 (Week 12), and 3 (Week 20))
D: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization (Measured over the 18 month study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin
Brief Summary: The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.


Options:
A: HbA1c (after 26 weeks of treatment)
B: Change in Glycosylated A1c (HbA1c) at Week 26 (week 0, week 26); Change in Glycosylated A1c (HbA1c) at Week 104 (week 0, week 104)
C: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) (Baseline to Week 24)
D: Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52 (Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin
Brief Summary: The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.


Options:
A: Change from baseline in HbA1c at 24 weeks
B: Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) (Baseline and Week 12)
C: Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF]) (Baseline to Week 24)
D: The change of HbA1C (24weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome
Brief Summary: Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.


Options:
A: Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 (4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)); Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6 (7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d))
B: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)
C: Change in Ventricular Lactate Levels in the Brain (Baseline and 2 months)
D: Time to Loss of Therapeutic Response (LTR) (From baseline Visit 3 (week 5) to Visit 7 (week 17))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome
Brief Summary: Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.


Options:
A: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)
B: Composite responder analysis based on pain and patient global status, with or without physical function.
C: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
D: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome
Brief Summary: Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.


Options:
A: Composite responder analysis based on pain and patient global status, with or without physical function.
B: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)
C: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)
D: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Different Acupuncture Methods for Chronic Low Back Pain
Brief Summary: The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.


Options:
A: Pain relief (start and end)
B: 11-point Short Pain Scale (SPS-11) (20 minute)
C: N/A
D: Pain intensity over 8 weeks (area under the curve) (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)
Brief Summary: This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.


Options:
A: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
B: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 (Posttreatment Week 12); Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug (Baseline to Week 12)
C: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
D: Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) (24 weeks after the last planned dose of study treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)
Brief Summary: This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.


Options:
A: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) (Follow-up Week 12)
B: Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) (24 weeks after the last planned dose of study treatment)
C: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
D: Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) (Post-treatment Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)
Brief Summary: This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.


Options:
A: Number of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels 24 Weeks After Last Planned Dose of Study Treatment (24 weeks after last planned dose of study treatment (up to Week 72))
B: Sustained Virologic Response (SVR) Rate (At Follow-up Week (FW) 24)
C: Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) (24 weeks after the last planned dose of study treatment)
D: Sustained Virologic Response (SVR) Rate in the Full Analysis Set (FAS) Population. (At Follow-up Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients
Brief Summary: Prospective randomized double blind controlled trial in prevention of relapse in recently detoxified alcohol dependent patients with levetiracetam and placebo.


Options:
A: The change in percentage of heavy drinking days (5 or more standard drinking units per day for men and 4 or more standard drinking units per day for women) from baseline at 12 weeks or final visit.
B: Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos (During and after treatment)
C: Standard Alcoholic Drinks Per Treatment Period (During each 14 day treatment period)
D: Percent days abstinent; Time to relapse to heavy drinking

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Single Blind, Placebo Controlled, Multicenter Study to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence.
Brief Summary: The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.


Options:
A: The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks (Baseline to 8 weeks)
B: Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score) (8 weeks)
C: Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) (Week 8)
D: Intra-procedural Pain (Up to end of intervention); Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. (At 1 year)

Answer: A