TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.


Options:
A: The Proportion of Responders at Day 29 in the ILA of Glabellar Lines at Maximum Frown. (Day 29)
B: Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales (Week 4)
C: Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown (Week 24); Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity (Up to Week 36)
D: Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales (Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
Brief Summary: Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)


Options:
A: Fetal loss (From 12 weeks to 42 weeks gestational age)
B: Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies (20 weeks gestation)
C: Live Birth (after delivery)
D: Number of miscarriages (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
Brief Summary: Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)


Options:
A: The primary objective of the study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and fetal loss) (6 weeks post-partum)
B: Successful pregnancy outcome
C: ongoing intact pregnancy at 24 weeks of gestation (at 24 weeks of gestation)
D: Fetal loss (From 12 weeks to 42 weeks gestational age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
Brief Summary: Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)


Options:
A: Live Birth (after delivery)
B: To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone. (Duration of pregnancy)
C: Fetal loss (From 12 weeks to 42 weeks gestational age)
D: Pregnancy continuation beyond twelve weeks gestation (ONE YEAR)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
Brief Summary: Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)


Options:
A: Successful pregnancy outcome
B: Pregnancy continuation beyond twelve weeks gestation (ONE YEAR)
C: Live Birth (after delivery)
D: Fetal loss (From 12 weeks to 42 weeks gestational age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: OPuS-2: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX4161 for 12 Weeks as an Oral Prophylaxis Treatment for Attacks of Hereditary Angioedema
Brief Summary: This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in subjects with hereditary angioedema (HAE). Eligible subjects will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.


Options:
A: The mean acute angioedema attack rate (12 weeks)
B: Number of acute angioedema attacks (Over 28 days of treatment)
C: Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf (Duration of the study (2.5 years)); Percent of HAE Attacks With Substantial Relief of the Defining Symptom (Within 4 hours after initial treatment)
D: Frequency of All HAE Attacks (Duration of the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
Brief Summary: This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).


Options:
A: Wet sputum production (45 minutes)
B: Lung Clearance Index (90 minutes post treatment)
C: Change in Absolute FEV1 From Baseline Over 26 Weeks (26 weeks)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
Brief Summary: This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).


Options:
A: Wet sputum production (45 minutes)
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: Percent Mucociliary Clearance at 60 Minutes (60 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
Brief Summary: This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).


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

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
Brief Summary: This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).


Options:
A: Wet sputum production (45 minutes)
B: Percent Mucociliary Clearance at 60 Minutes (60 minutes)
C: 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)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
Brief Summary: This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).


Options:
A: Change of Lung Clearance Index (LCI) (up to 80 minutes)
B: Lung Clearance Index (90 minutes post treatment)
C: Wet sputum production (45 minutes)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
Brief Summary: This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).


Options:
A: Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight (24 hours)
B: Wet sputum production (45 minutes)
C: Mean percentage change in forced expiratory volume in one second (FEV1) (7days)
D: Lung Clearance Index (90 minutes post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant Treatment With the Combination of Vemurafenib, Cobimetinib and Atezolizumab in Limited Metastasis of Malignant Melanoma (AJCC Stage IIIC/IV) and Integrated Biomarker Study: a Single Armed, Two Cohort, Phase II EADO Trial NEO-VC
Brief Summary: Evaluation of the efficacy, safety and biologic effects of neo-adjuvant treatment with vemurafenib + cobimetinib + atezolizumab in patients with limited metastasis of melanoma in stage IIIC/IV melanoma.


Options:
A: Pathological response rate (From baseline to 6 weeks)
B: Percent of patients who actually become resectable and are resected (Following 18 weeks of combined treatment)
C: Assess the pathologic complete response rate (absence of viable tumor on histologic assessment) (5 years)
D: Safety of patients as measured by the adherence to the timelines in the study protocol (6 months); Feasability of patients as measured by the adherence to the timelines in the study protocol (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant Treatment With the Combination of Vemurafenib, Cobimetinib and Atezolizumab in Limited Metastasis of Malignant Melanoma (AJCC Stage IIIC/IV) and Integrated Biomarker Study: a Single Armed, Two Cohort, Phase II EADO Trial NEO-VC
Brief Summary: Evaluation of the efficacy, safety and biologic effects of neo-adjuvant treatment with vemurafenib + cobimetinib + atezolizumab in patients with limited metastasis of melanoma in stage IIIC/IV melanoma.


Options:
A: estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg.
B: Overall Survival (OS) (From the date of randomization until date of death due to any cause (up to approximately 6 years))
C: Percent of patients who actually become resectable and are resected (Following 18 weeks of combined treatment)
D: Safety of patients as measured by the adherence to the timelines in the study protocol (6 months); Feasability of patients as measured by the adherence to the timelines in the study protocol (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Carbetocin Versus Oxytocin in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial
Brief Summary: 200 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).


Options:
A: Proportion of women with post-delivery hemoglobin ≤ 7.8 gm/dL (72 hours (plus or minus 8 hours) after delivery)
B: Need for additional treatment after initial PPH study treatment (all additional interventions recorded following initial uterotonic treatment)
C: Need for other uterotonics (2 minutes after giving the drug.)
D: Need for other uterotonics (2 minutes after giving the drug)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Letrozole and Urinary Purified FSH in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome: A Randomised Controlled Trial
Brief Summary: 210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using computer generated random numbers. Group 1 will receive FSH, group 2 will have Letrozole and group 3 will act as the control group with no intervention.


Options:
A: Live birth rate (Up to 18 months)
B: Live Birth (as few as 5 months, up to 16 months)
C: Ovulation (6 weeks after starting the intervention)
D: Ovulation Rate (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Letrozole and Urinary Purified FSH in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome: A Randomised Controlled Trial
Brief Summary: 210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using computer generated random numbers. Group 1 will receive FSH, group 2 will have Letrozole and group 3 will act as the control group with no intervention.


Options:
A: Live birth rate (Up to 14 months)
B: Ovulation Rate (3 months)
C: Live birth rate (Up to 18 months)
D: Ovulation (6 weeks after starting the intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Sensorimotor Training on Postural Control and Pain: A Parallel, Single-blinded Randomised Controlled Trial
Brief Summary: This study evaluates the effects of additional sensorimotor training (proprioceptive postural training, PPT) to conventional therapy in the treatment of chronic low-back pain. Half of the participants will receive instructed treadmill training as an active comparator against PPT. All participants receive conventional physiotherapy as prescribed by their treating medical doctors. It is expected that the PPT group will improve in postural control, proprioceptive, as well as pain and function outcomes to a significantly greater extent than the active control group.


Options:
A: Change of self-reported pain on 100mm Visual Analogue Scale (VAS) (Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)); Change of functional status recorded with the Oswestry Disability Index (ODI) (Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days))
B: Change from baseline of Disability using the Roland Morris Disability Questionnaire at 3 months, 1, 2 and 5 years (3 months, 1, 2 and 5 years)
C: Change From Baseline in Oswestry Disability Scale (0-100%) (Baseline and 7 weeks); Change From Baseline in Oswestry Disability Scale (0-100%) (Baseline and 12 Months); Change From Baseline in Numeric Pain Rating Scale (0-10 Points) (Baseline and 7 weeks); Change From Baseline in Numeric Pain Rating Scale (0-10 Points) (Baseline and 12 months)
D: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study
Brief Summary: The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.


Options:
A: long-term QoL follow-up of patients after UGFS and surgical stripping (6-10 years follow-up)
B: Number of Participants With Complete Closure of the Target Vein at 3 Months (3 months)
C: Comparative Duplex Ultrasound (Immediately Post-procedure)
D: Generic Quality of life - Short Form-36 (1 week, 6 weeks, 3 months, 1 year, 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health
Brief Summary: The purpose of this study to assess the effect of maternal vitamin D3 (cholecalciferol) supplementation on maternal HIV progression, small-for-gestational age infants, and infant stunting at 12 months postpartum for HIV-infected Tanzanian pregnant women who are receiving highly active antiretroviral therapy (HAART).


Options:
A: Differences in maternal bone mass changes postpartum between supplemented and placebo groups (2, 5 and 12 months postpartum); Differences in fetal growth and infant bone mass between supplemented and placebo groups (2nd and 3rd trimester gestation and 2 mo postpartum)
B: Proportion of participants experiencing maternal HIV progression (Second Trimester until 12 months post partum); Proportion of small-for-gestational age infants (Birth); Proportion of stunted infants (height-for-age z-score < -2) (12 months postpartum (1 year of age))
C: Prevention of adverse pregnancy outcome, viz preeclampsia, small for gestational age (SGA), preterm labor (18 months)
D: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally: A Randomised Controlled Trial
Brief Summary: 200 women with PPH will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) and group 2 will receive oxytocin 10 IU (Syntocinon®, Novartis, Switzerland). The investigators will not include a control group for ethical reasons.


Options:
A: Uterine Tone (at 10 minutes following administration of the first study drug)
B: The amount of blood loss (6 hours post delivery)
C: Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery. (Before delivery (at onset of labor), after delivery (2 to 4 days after delivery))
D: Need for other uterotonics (2 minutes after giving the drug)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Augmented Versus Routine Approach to Giving Energy Trial: A Randomised Controlled Trial
Brief Summary: Nutrition therapy is an essential standard of care for all critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days.

The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial to determine if augmentation of calorie delivery using energy dense enteral nutrition in mechanically ventilated patients improves 90 day survival when compared to routine care.


Options:
A: Enteral nutrition (14 days); Intra-abdominal pressure (14 days)
B: Number of ventilator-free days (VFD) (Measured at Day 28); Mortality before hospital discharge, with unassisted breathing (Measured at Days 60 and 90)
C: Length of stay in ICU and length of stay in the hospital. (2 years)
D: All cause mortality (Day 90)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Smoking Reduction on Endothelial Glucocalyx and Arterial Wall Properites During Medically-aided Smoking Cessation Program.
Brief Summary: The integrity of endothelial glucocalyx plays a vital role in vascular permeability and inflammation. Smoking cessation is related with improved vascular function and is a key component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of evidence based smoking cessation treatment. This study was designed to determine the effects medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking cessation programs


Options:
A: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
B: Changes in endothelial function between baseline and during medically-aided smoking cessation program. (Baseline, 1 month, 3 months, 6 months and 12 months.)
C: 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)
D: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia Receiving Treatment for More Than 8 Hours Before Delivery. A Randomized Multicenter Clinical Trial .
Brief Summary: There is no evidence that patients receiving magnesium sulfate before birth are required to maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical study in patients with severe preeclampsia who have been treated with impregnation of magnesium sulphate and at least eight hours have received the drug before birth. If the patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other anticonvulsant drugs. This study can be conducted in 12 maternity latin america.


Options:
A: Seizure (Eclampsia) (72 hours postpartum)
B: Maternal Serum Magnesium Level at 4 Hours After Administration (4 hours)
C: Magnesium concentration (00:00, 00:20; 00:40; 1:20; 2:20; 3:00; 4:40; 5:20; 6:00; 6:20; 7:00; 8:00; 9:40; 10:00; 10:40; 12:00)
D: Eclampsia (24 hours postpartum)

Answer: D