TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double Blind Controlled Trial on the Effect of Treatment in Children With Obstructive Sleep Apnea Syndrome.
Brief Summary: Oral therapy with montelukast may lead to improved polysomnographic findings in children with mild to moderate OSAS with and without allergic rhinitis who a priori require T\&A for OSAS.

- A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will obviate the need for surgical T\&A.


Options:
A: The percentage of children converting from needing T&A surgery before treatment with montelukast to not needing surgery after treatment will be examined. (Duration of Study)
B: Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months. (The primary endpoint measure will occur at 7 months following the baseline visit.)
C: Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25% (2 weeks (10 sessions), 14 weeks)
D: Change in the number of apnea/hypopnea episodes during a sleep study (Start of study, 6 weeks after drug treatment started and 6 weeks after placebo treatment started.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Treating Migraine With Acupuncture
Brief Summary: The purpose of the study is to testify whether acupuncture is effective for migraine, and provide evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."


Options:
A: N/A
B: number of days with migraine (4 weeks); frequency of migraine attacks (4 weeks)
C: Mean monthly number of headache days with moderate or severe intensity (3 months)
D: frequency of migraine attacks (16th week after inclusion)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Treating Migraine With Acupuncture
Brief Summary: The purpose of the study is to testify whether acupuncture is effective for migraine, and provide evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."


Options:
A: Change from Baseline in numerical rating scale of back pain (Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.)
B: The changes in the pain score. (wk52)
C: House-Brackmann scale （Global Score） (a week)
D: number of days with migraine (4 weeks); frequency of migraine attacks (4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)
Brief Summary: In this protocol we will conduct a randomized controlled trial where babies with respiratory distress syndrome (RDS) who have not yet reached criteria for intubation, will be randomized to receive surfactant by LMA or to continue receiving standard therapy of nasal CPAP and supplemental oxygen. All babies will be given surfactant by endotracheal tube if they reach "failure" criteria, which is the standard criterion for surfactant administration (i.e., FiO2= 65% while receiving nasal CPAP).

The objective of this RCT is to determine if surfactant can be successfully administered by LMA, thus perhaps avoiding the need for endotracheal intubation. The hypothesis is that fewer babies in the LMA group would reach failure criteria.


Options:
A: The primary outcome measure is reaching or not reaching failure criterion (FiO2= 65% while receiving nasal CPAP). (96 Hours)
B: Need for Intubation and Mechanical Ventilation in the First Seven Days of Life. (Seven days)
C: Composite outcome of either a) early neonatal death or b) neonatal encephalopathy (Day 7 of life)
D: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
Brief Summary: The purpose of the study is to testify the efficacy of treating functional dyspepsia with acupuncture, and provide evidence for the hypothesis that "Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."


Options:
A: Nepean Dyspepsia Index (4 weeks)
B: number of days with migraine (4 weeks); frequency of migraine attacks (4 weeks)
C: House-Brackmann scale （Global Score） (a week)
D: The changes in the pain score. (wk52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.
Brief Summary: The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.


Options:
A: Duration of labor (48 hours)
B: N/A
C: Neonatal Respiratory Distress Syndrome (RDS) at birth (Measured in the newborn at birth and at 30 days after labor)
D: delaying labor (for more than 48 hours after starting treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Intravenous Local Anesthetic on Bowel Function After Colectomy
Brief Summary: Epidural local anesthetics are the gold standard for shortening duration of bowel dysfunction after bowel surgery. Previous studies suggest that their effect may be in part a result of actions of the local anesthetic outside the epidural space. If local anesthetics could be administered intravenously instead, this might be a safer, easier and less expensive approach. Therefore, this trial will compare the effect on bowel function recovery of intravenous local anesthetics with those administered epidurally.


Options:
A: time from end of surgery to first sign of bowel function (stool or flatus) (follow-up after surgery)
B: Quality of Recovery 40 Score (24 hours post surgery)
C: opiate consumption (hospital discharge/ days 0-7)
D: Postoperative pain measured using Visual analogue scale at postoperative 2hour (post op 2hour)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Dose Ranging Study Evaluating the Efficacy and Safety of GW642444M Administered Once Daily Compared With Placebo for 28 Days in Adolescent and Adult Subjects With Persistent Asthma
Brief Summary: This study is designed to determine if the investigational drug is effective and safe in individuals with asthma


Options:
A: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
B: The primary efficacy measure will be mean change from baseline at Week 8 (last assessment on treatment using last observation carried forward) in tough (AM or PM pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1)
C: Mean Change From Baseline in Clinic Visit Trough FEV1 at Day 28 (Last Observation Carried Forward [LOCF]) (Baseline and Day 28)
D: Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period (Baseline and Day 29 of each treatment period (up to Study Day 197))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Biopsychosocial Education on Quality of Life and Disability of Individuals Suffering From Chronic Low Back Pain
Brief Summary: The purpose of this study is to examine whether the biopsychosocial educational program could improve patients' health-related quality of life at 3-6-12-18-24-30 and 36 - month follow up.


Options:
A: Insomnia Severity Index (ISI) (Baseline); Insomnia Severity Index (ISI) (Post treatment- 2 months post baseline assessment); Insomnia Severity Index (ISI) (9 months post baseline assessment); Insomnia Severity Index (ISI) (18 months post baseline assessment); Global Pain Severity-Graded Chronic Pain Scale (Baseline); Global Pain Severity-Graded Chronic Pain Scale (Post treatment-2 mos. post baseline); Global Pain Severity-Graded Chronic Pain Scale (9 months post baseline assessment); Global Pain Severity- Graded Chronic Pain Scale (18 months post baseline assessment)
B: SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability (before intervention)
C: Change in Pain intensity (Change from baseline pain intensity at 12 months); Change in Depression (Change from baseline depression at 12 months); Change in Catastrophizing (Change from baseline catastrophizing at 12 months); Change in Acceptance (Change from baseline acceptance at 12 months); Change in Disability (Change from baseline disability at 12 months)
D: Change in time spent awake during the night. (Change from baseline to the two study follow-ups (immediately and 3-months following treatment)); Change in mood. (Change from baseline to the two follow-up periods (immediately and 3-months following treatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of Biopsychosocial Education on Quality of Life and Disability of Individuals Suffering From Chronic Low Back Pain
Brief Summary: The purpose of this study is to examine whether the biopsychosocial educational program could improve patients' health-related quality of life at 3-6-12-18-24-30 and 36 - month follow up.


Options:
A: SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability (before intervention)
B: Decreased pain (Baseline, 2 weeks, 4 weeks)
C: Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) (Baseline, Week 16)
D: Percentage of Participants With Reduction in Pain Intensity (Baseline up to Day 29); Change From Baseline in Pain Intensity at Day 29 (Baseline and Day 29)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III 2-arm Trial of Paclitaxel Plus Bevacizumab vs. Capecitabine Plus Bevacizumab for the First-line Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Locally Recurrent or Metastatic Breast Cancer
Brief Summary: First-line treatment of patients with locally recurrent or metastatic, HER2-negative breast cancer who have not received prior chemotherapy for locally recurrent or metastatic disease.


Options:
A: Relapse-free Survival Rates at 2.4 Years (randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years))
B: Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) (Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years); Second-Line PFS (Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years); Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6 (Month 6); Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12 (Month 12); Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18 (Month 18); Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24 (Month 24)
C: Overall Survival (PP Population) (Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years); Overall Survival (ITT Population) (Time from the date of randomization to the date of death or date last known to be alive, assessed up to approximately 6 years)
D: Incidence of grade 3-5 adverse events (Documentation of AE observed during trial treatment and in follow-up until resolution)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
Brief Summary: The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal wound infections.


Options:
A: The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks. (12 weeks)
B: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (6- or 12-month study treatment period)
C: The composite of cardiovascular death, myocardial infarction (MI) and stroke
D: Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 90 (90 days post cardiac surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial to Assess Efficacy and Safety of Orally Administered Miltefosine in Brazilian Patients With Cutaneous Leishmaniasis Compared to the Standard Care as Active Control
Brief Summary: The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).


Options:
A: Complete clinical cure (six months)
B: Number of Participants Who Obtained Final Clinical Cure of Index Lesion (168 days)
C: Cure rate or complete cicatrization of the ulcer. (6 months after treatment.)
D: Occurrence of dose-limiting toxicity; Adverse events

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Biobehavioral Effects of Mindfulness-Based Stress Reduction in HIV
Brief Summary: The purpose of this study is to investigate whether Mindfulness-Based Stress Reduction (MBSR) vs a one-day MBSR seminar improves immune (CD4+ T lymphocytes) and virological (HIV viral load) status in HIV-1 infected adults. The secondary goal of the study is to determine if MBSR vs a one-day MBSR seminar improves self-reported HIV-related quality of life.


Options:
A: Depression (Measured at pre-intervention, post-intervention, and 4- and 8-month follow-up)
B: Percent Medication Adherence at 3-month Follow-up Assessment (3-month assessment); Percent Medication Adherence at 12-month Follow-up Assessment (12-month follow-up assessment)
C: CD4+ T lymphocytes (counts) (Pre-test and post-test)
D: Substance use (1 year); Unsafe sexual behavior (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly
Brief Summary: The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.

The objective of this study was to compare the proportion of patients with a reduction of mean GH level to \<2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

Following one year of treatment patients could proceed into the study extension.

Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.


Options:
A: Surgical cure by transsphenoidal surgery (Primarily 3 months postoperatively, but up to 10 years postoperatively)
B: Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. (At 24 weeks)
C: Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall (Week 36); Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg (Week 36); Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 (Wek 36); Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 (Week 36); Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status (Week 36); Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF (Week 36)
D: Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge in General Surgical Subjects at Higher Risk for Surgical Wound Infection
Brief Summary: The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery.


Options:
A: Incidence of incisional surgical site infection (SSI)
B: Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 60 (assessed at Postop Day 1, 2, 3, 7, 30 & 60)
C: Surgical site infection (30 days)
D: Surgical site infection following elective colorectal surgery based on surgical site assessment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open-label Phase II Trial Evaluating Deferasirox Compared With Deferoxamine in Patients With Cardiac Iron Overload Due to Chronic Blood Transfusions
Brief Summary: This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions.

The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best for treating iron overload in the heart.

Patients will be treated for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study treatment in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the heart and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.


Options:
A: Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment (12 Month)
B: Change From Baseline in Liver Iron Concentration (LIC) (Change from baseline to Week 52)
C: to assess efficacy of combining DFP and deferasirox compared to combined DFP and DFO in decreasing the serum ferritin level in conditions with severe chronic iron overload. (12 months)
D: Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event (up to 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open-label Phase II Trial Evaluating Deferasirox Compared With Deferoxamine in Patients With Cardiac Iron Overload Due to Chronic Blood Transfusions
Brief Summary: This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions.

The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best for treating iron overload in the heart.

Patients will be treated for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study treatment in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the heart and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.


Options:
A: difference between multiple observations of the serum ferritin concentrations (five-year treatment)
B: To evaluate if fixed starting doses of ICL670, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin (at baseline and at 52 weeks)
C: The prevalence and incidence of complications specific to thalassemia and its treatment among participants (Measured throughout the duration of the study)
D: Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment (12 Month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open-label Phase II Trial Evaluating Deferasirox Compared With Deferoxamine in Patients With Cardiac Iron Overload Due to Chronic Blood Transfusions
Brief Summary: This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions.

The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a medicine called deferasirox (ICL670) with another medicine called deferoxamine (DFO). The study is aimed at finding out which of the two medicines is the best for treating iron overload in the heart.

Patients will be treated for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study treatment in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the heart and the liver will be evaluated using specific magnetic resonance imaging (MRI) assessments.


Options:
A: Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment (12 Month)
B: Core Study: Change in Liver Iron Concentration (LIC) From Baseline to Week 52 (Baseline, Week 52); Extension Study: Percentage of Participants Reaching a Liver Iron Concentration (LIC) < 5 mg Fe/g dw From Core Baseline to End of Extension Study (Core Baseline to End of Extension Study (up to 24 months))
C: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)
D: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)

Answer: A