TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
Brief Summary: The overall aim of this project is to evaluate the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders.

Smokers with mood and/or anxiety disorder will smoke research cigarettes that will contain either a) nicotine content similar to their preferred usual brand of cigarettes, or b) nicotine content per cigarette that is progressively reduced from approximately 11.6 mg to 0.2 mg per cigarette over 18 weeks.

It is our hypothesis that nicotine intake will decline as a function of cigarette nicotine content in the Reduced Nicotine Content group without significant increases in tobacco smoke exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or protocol non-adherence over time in the Reduced Nicotine Content group as compared with the control group.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
B: Plasma Cotinine Concentration (Measured at the end of the last 3 weeks of randomization trial phase)
C: Smoking Abstinence (12 months)
D: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma
Brief Summary: The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.


Options:
A: Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time) (Between 3 and 7 hours after allergen challenge at Day 86 after the first dose)
B: Rate of asthma exacerbations during the 52-week placebo-controlled period (weeks 0-52)
C: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 48.)
D: Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis (Throughout the study); Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis. (Throughout the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma
Brief Summary: The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.


Options:
A: N/A
B: Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis (Throughout the study); Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis. (Throughout the study)
C: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 48.)
D: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Longitudinal Study of Patients With Opioid-Induced Constipation
Brief Summary: This prospective hybrid longitudinal study was conducted in the United States (US), Canada, the United Kingdom (UK), and Germany. To obtain the most complete and comprehensive understanding of the burden of opioid-induced constipation (OIC) in these countries, this study used a combination of web-based, longitudinal patient survey, retrospective data abstraction from medical records, and a prospective physician survey.

The primary objective of this study was to estimate the rate of inadequate response to laxatives (LIR), which was defined as having sufficient laxative use (at least one laxative use ≥ four times per reference period), and inadequate response (defined as fewer than three bowel movements (BMs) OR at least one of the following symptoms on the Patient Assessment of Constipation Symptoms (PAC-SYM) measure scored as moderate, severe or very severe: BMs too hard, straining to have a BM, feeling like you didn't "finish" a BM, and feeling like you had to pass a BM but could not), in a cohort of non-cancer pain and cancer pain (separately) participants with OIC, by country and overall.

The secondary study objectives are as follows:

1. To estimate the rate of LIR for two subgroups: 1xLIR and 2xLIR. 1xLIR was defined as use of at least one laxative agent ≥ 4 times in the reference period while 2xLIR was defined as the use of at least two laxative agents, each used ≥ 4 times in the reference period;
2. To describe the baseline demographic and clinical characteristics, including prior health status, comorbidities, constipation-related GI symptoms, and concomitant medications of patients with OIC;
3. To describe drug utilization and self-management of OIC;
4. To describe the pre-index and post-index healthcare resource utilization and estimate costs associated with the diagnosis, treatment, and general management of OIC (including laxative use) and events attributed to OIC, including both direct and indirect costs;
5. To describe patient-reported impact of OIC on health-related quality of life, productivity, and pain management;
6. To describe patient-reported treatment satisfaction with laxative use; and
7. To describe physician-reported awareness of OIC and symptoms and understanding of patient-reported impact of OIC.


Options:
A: Rate of LIR among the OIC population (6 months)
B: Rescue-free laxation response (Within 4 hours after at least 2 of the first 4 doses (the first week of treatment).)
C: Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3) (4weeks)
D: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone (4 hours after the dose of subcutaneous methylnaltrexone)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Collaborative-care Rehabilitation to Improve Functional Outcomes After Dysvascular Amputation
Brief Summary: The objective of this study is to examine the feasibility of using a collaborative-care, home-based rehabilitation program to improve functional outcomes for people recovering from lower limb amputation caused by vascular problems and/or diabetes complications. The primary hypothesis is that the rehabilitation program will result in greater improvements in performance-based and participant-reported measures of physical function, compared to standard of care after outpatient rehabilitation.


Options:
A: Timed Up-and-Go Test (Baseline, 12-weeks, and 24 weeks)
B: Pre-intervention:10 Meter Walk Test (10MWT) (Week 12-13); Pre-intervention: 6 Minute Walk Test (6MWT) (Week 12-13); Pre-intervention: Berg Balance Scale Test (Week 12-13); Post-intervention:10 Meter Walk Test (10MWT) (Week 24-25); Post-intervention: 6 Minute Walk Test (6MWT) (Week 24-25); Post-intervention: Berg Balance Scale Test (Week 24-25); Delayed post-intervention:10 Meter Walk Test (10MWT) (Week 40-41); Delayed post-intervention: 6 Minute Walk Test (6MWT) (Week 40-41); Delayed post-intervention: Berg Balance Scale Test (Week 40-41)
C: Community integration (24 weeks)
D: Step Length Symmetry (Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: ENGAGE4HEALTH: A Combination Strategy for Linkage and Retention in HIV Care Among Adults in Mozambique
Brief Summary: Purpose: To compare the effectiveness of a combination intervention strategy (CIS), consisting of point of care (POC) CD4+ testing immediately following HIV diagnosis and accelerated ART initiation for eligible participants delivered by facility personnel, and cellular appointment reminders delivered by study personnel, to the standard of care (SOC) on linkage to and retention in HIV care at 12 months among adults testing positive for HIV in Mozambique. Additionally, the protocol will assess the incremental effectiveness of CIS+ non-cash financial incentives (FI) compared to CIS without FI on study outcomes.


Options:
A: Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study); All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms (Throughout study)
B: Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. (1 month and 12 months after testing)
C: Proportion non-pregnant subjects virally suppressed at routine six-month viral load (10 months after study enrollment); Proportion of pregnant subjects who adhere to ART or the prior PMTCT regimen until delivery (Up to 9 months after study enrollment)
D: Change in the CSF CFUs between the immediate and standard ART initiation groups (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)
Brief Summary: The HEMO-TIN trial is designed to look at both the safety (bleeding risk) and effectiveness (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in hemodialysis patients.


Options:
A: Need for stopping the meeting for coagulation of the circuit of dialysis: -either complete coagulation of the circuit (during dialises); or coagulation partial of the circuit (a clot is noted in the lines or the trap with bubbles (during dialeses); -or increase in the venous pressure (statement) of the circuit of more than 50 that is to say increase in the venous pressure (statement) of the circuit of more than 50 % beyond its initial value (during the dialeses)
B: Rate of major, clinically important non-major or minor bleeding (26 weeks)
C: change in dialysis adequacy (every midweek dialysis session through study duration, ie 2x4 weeks)
D: The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD (2 weeks after CD exposure, 2 weeks after AD exposure)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transversus Abdominis Plane (TAP) Block Versus Intrathecal Morphine for Caesarean Section - Randomised Controlled Trial
Brief Summary: Analgesia after cesarean section is still not satisfactory for many women. Even if pain reduction is sufficient with the technique of intrathecal morphine injection, side effects such as nausea and pruritus are common.

Since several years, an alternative technique has been studied, the "transversus abdominis plane (TAP)"-block. Here a local anesthetic is injected in the abdominal wall muscles, and this has been shown to give a similar analgesic effect compared to intrathecal morphine, with potentially less side effects.

With this study, we want to evaluate if the TAP-block yields indeed less side effects when compared with intrathecal morphine.

The study will be a prospective study with the patients randomized to either a group with intrathecal morphine or a group with TAP-block.


Options:
A: cumulative incidence of nausea and/or vomiting at 24 hours (24 hours)
B: Intraoperative Nausea and Vomiting (Intraoperatively)
C: Occurrence of Intra-operative and Post-operative Vomiting (During surgery (1 hour) and thru 72 hours after surgery)
D: Incidence of Post-operative Nausea and/or Vomiting (48 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Duloxetine 60mg Once Daily in Patients With Chronic Pain Due to Osteoarthritis in China
Brief Summary: The purpose of this study is to assess the efficacy and safety of duloxetine once daily compared with placebo on the reduction of pain due to osteoarthritis (OA) in knee or hip in participants in China.


Options:
A: Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score (Baseline, Week 13)
B: Composite responder analysis based on pain and patient global status, with or without physical function.
C: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
D: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Duloxetine 60mg Once Daily in Patients With Chronic Pain Due to Osteoarthritis in China
Brief Summary: The purpose of this study is to assess the efficacy and safety of duloxetine once daily compared with placebo on the reduction of pain due to osteoarthritis (OA) in knee or hip in participants in China.


Options:
A: Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores (Baseline, Week 13)
B: Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score (Baseline, Week 13)
C: Pain reduction (16 weeks)
D: Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score (Baseline, Week 14)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.


Options:
A: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
B: Change in Voltage (mVolt) in Nasal Epithelium (Baseline and 2 weeks)
C: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))
D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.


Options:
A: Safety as Determined by Adverse Events (AEs) (Start of study drug through the Follow-up Visit (Up to Day 56)); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 1-5b (Baseline through Day 28); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 6 (Baseline through Day 28); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 7 (Baseline through Day 28)
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
C: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
D: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.


Options:
A: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))
B: Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24 (Baseline, Through Week 24)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.


Options:
A: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline through Week 100)
B: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 100)
C: Part A: Maximum Observed Plasma Concentration (Cmax) of ELX, TEZ, and IVA (Part A: Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of ELX, TEZ, and IVA (Part A: Day 15); Part A: Area Under the Concentration Versus Time Curve From 0 to 24 Hours (AUC0-24h) of ELX, TEZ, and IVA (Part A: Day 15); Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Part B: Day 1 Through Safety Follow-up Visit (up to Week 28))
D: Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 105 (Study 105)); Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs (Day 1 up to Week 105 (Study 105))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Interventions to Achieve Universal Access to PMTCT Services and Reduce Mother-to-Child Transmission of HIV in Dar es Salaam, Tanzania
Brief Summary: The purpose of this study is to determine the effectiveness, cost-effectiveness, feasibility and acceptability of an enhanced community health worker (CHW) intervention and outreach system to improve antenatal care and PMTCT uptake and retention, and to decrease mother-to-child HIV transmission.


Options:
A: Proportion of infants born to HIV-infected mothers who have acquired HIV (During the first 2 years of life); Proportion of HIV-exposed infants tested for HIV (During the first 2 years of life); Proportion of pregnant women making at least four antenatal clinic visits (Between the first week of gestation and delivery); Proportion of pregnant women delivering at a healthcare facility (At delivery); Proportion of HIV-positive women receiving PMTCT (Between the first antenatal care visit and 1 week after stopping breastfeeding)
B: N/A
C: Neonatal mortality rate (deaths within 28 days of birth)
D: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Artificial Kidney Initiation in Kidney Injury, a Multicenter Randomised Trial
Brief Summary: The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:

1. an "early" strategy where RRT is started immediately when a RIFLE F status is documented
2. a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration \> 40 mmol /L, serum potassium concentration \> 6 mmol /L, serum potassium concentration \> 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH \< 7.15 in the context of pure metabolic acidosis (PaCO2 \<35 mmHg) or in the context of mixed acidosis with PaCO2\> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow\> 5L/min in spontaneously breathing patients or FiO2\> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2\> 95%, despite diuretic therapy.

The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.


Options:
A: Feasibility of protocol adherence (14 days)
B: Overall survival (60 days)
C: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
D: Death from all causes at 90 days after randomisation. (Within 90 days after randomisation)

Answer: B