TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIb, 24 Week, Randomized, Double-blind, 3 Arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of Two Doses of Umeclidinium Bromide Administered Once-daily Via a Dry Powder Inhaler, Versus Placebo, in Participants With Asthma
Brief Summary: This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25 mcg on lung function versus placebo after 24 weeks of treatment. This study will provide important information regarding the efficacy and safety of UMEC when administered in a separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase IIb, randomized, double-blind, placebo controlled study that will compare the efficacy, safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects with asthma that is not well controlled. Eligible subjects will be requested to participate in the study for a maximum of approximately 31 weeks with 4 phases (pre screening, screening/run-in, randomization/treatment and safety follow-up). The total number of randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to each of the 3 double-blind treatment arms.


Options:
A: Mean Change From Baseline in Clinic Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline (Day 1 pre-dose) and Week 24)
B: Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12 (Baseline and Week 12)
C: 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation (FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period)
D: Change From Baseline in Weighted-mean 24 Hour Serial FEV1 on Day 168/Week 24 (Baseline and Day 168/Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Using m-Health Tools to Reduce the Misuse of Opioid Pain Relievers
Brief Summary: The aim of this study is to pilot test a web-based, patient-centered educational program that encourages the patient to have an informed discussion about pain medication options with their emergency department (ED) provider.


Options:
A: Change in Self-Reported Preference for Opioid Pain Reliever (Baseline and Immediate Post-test)
B: Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings (Baseline to Three Months)
C: Change in severity of depression symptoms: Centre for Epidemiologic Studies Depression Scale (CES-D) (Baseline, 3 months, 6 months)
D: Decision Self Efficacy (post intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Measuring the Health and Wellbeing Impacts of a Scalable Program of Psychosocial Intervention for Refugee Youth
Brief Summary: The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living in urban settlements in Jordan. The study was conducted using two waves of data collection: the first featured an intervention and a matched control group, the second featured a full randomized control trial.


Options:
A: Psychosocial Stress: Insecurity (Regional Measure) (11 weeks); Psychosocial stress: Distress (Regional Measure) (11 weeks); Psychosocial Stress (International Measure) (11 weeks)
B: School Climate (Up to 7 months)
C: General psychological distress - General Health Questionnaire (20-weeks after baseline)
D: HIV sero-incidence (24 months post-baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Measuring the Health and Wellbeing Impacts of a Scalable Program of Psychosocial Intervention for Refugee Youth
Brief Summary: The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living in urban settlements in Jordan. The study was conducted using two waves of data collection: the first featured an intervention and a matched control group, the second featured a full randomized control trial.


Options:
A: Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders. (Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.)
B: Severity of Trauma. This will be the difference in group mean score of severity of depression based on a sum of ratings of various standard depression symptoms from the Hopkins Symptom Checklist and locally defined symptoms. (After 12 counseling , 4-5 months)
C: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
D: Psychosocial Stress: Insecurity (Regional Measure) (11 weeks); Psychosocial stress: Distress (Regional Measure) (11 weeks); Psychosocial Stress (International Measure) (11 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Measuring the Health and Wellbeing Impacts of a Scalable Program of Psychosocial Intervention for Refugee Youth
Brief Summary: The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living in urban settlements in Jordan. The study was conducted using two waves of data collection: the first featured an intervention and a matched control group, the second featured a full randomized control trial.


Options:
A: Reduction in Post-traumatic Stress Reaction Symptoms Among Participants (1-week before intervention, 3-weeks later)
B: depression (pre, post and 6 months post treatment)
C: Depression - Patient Health Questionnaire (1 week post-intervention)
D: Psychosocial Stress: Insecurity (Regional Measure) (11 weeks); Psychosocial stress: Distress (Regional Measure) (11 weeks); Psychosocial Stress (International Measure) (11 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention
Brief Summary: Four aims were pursued: (1) Evaluate the effectiveness of video messaging on adolescent donor designations in comparison to a regionally-matched historical comparison group of adolescents; (2) Compare the differential effectiveness of three commonly-used donation messaging strategies (informational, testimonial, and blended) on donor designations; (3) Examine the impact of donation messaging on changes in secondary outcomes (donation engagement, knowledge, attitudes, beliefs, likelihood of donor designation, discussion with a parent) before and after video intervention; and (4) Assess the commitment of parents to follow their adolescent's donation wishes in the event of death. Our central hypotheses were that integrating donation video messaging into driver education classes would generate a higher proportion of donor designations compared to a historical comparison group and that blended video messaging (informational + testimonials) would yield a higher proportion of donor designations and more change in secondary outcomes.


Options:
A: Organ Donation Registration (6 months)
B: enhancing rates of family communication, donor evaluations, and transplantation (6 months)
C: Pursuit of Living Related Transplantation (6 months)
D: Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Field Studies on the Feasibility of Interrupting the Transmission of Soil-transmitted Helminths (STH) DeWorm3 Project
Brief Summary: Over 1.5 billion people are infected with soil-transmitted helminths (STH). Global STH guidelines recommend MDA (mass drug administration) of albendazole or mebendazole to targeted populations, including pre-school age children and school-age children. However mathematical models suggests that current MDA strategies are not sufficient for interrupting disease transmission in most areas. Meanwhile many lymphatic filariasis (LF) programs have successfully treated entire populations with albendazole (in combination with ivermectin or diethylcarbamazine) and are transitioning to a state of post-MDA surveillance. This project will conduct a series of community-based cluster randomized trials in India, Malawi, and Benin to determine if maintaining three years of MDA with albendazole to entire communities following the cessation of LF programs can interrupt STH transmission in focal geographic areas. Additionally, this study aims to compare the efficacy of community-wide MDA versus targeted MDA of children in interrupting the transmission of STH. Nested implementation science research will be used to optimize the intervention, identify contextual factors influencing trial efficacy, and evaluate the feasibility of sustaining and scaling community-wide MDA for STH. These data will provide evidence necessary to inform future guidelines, policies, and operational plans as country partners engage in intensified approaches to eliminate these disabling diseases.


Options:
A: STH transmission interruption (5 years (Three years of drug administration and two years of surveillance))
B: Mean (± standard deviation) weight gain (kg) (Change between birth and six months of age)
C: Severe Anemia
D: Mean Newborn Birth Weight (Within 24 hours of delivery.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Study Comparing Conventional, Burst And High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation
Brief Summary: Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after a spine surgery. Treatment of this chronic condition by further operation or medical management has a heavy financial impact on health care systems.

Many studies have demonstrated the efficacy and economic value of Spinal Cord Stimulation (SCS) for chronic neuropathic pain, and randomized controlled trials (RCTs) have shown SCS to be a clinically effective adjunct to medical management. SCS has the advantages of being reversible and less invasive than surgery and may cause fewer issues over time than long-term pharmacological treatments.

Despite variable levels of success in the literature, approximately 30-55% of the patients treated with traditional SCS for neuropathic pain disorders will not receive adequate long term pain relief. Therefore, technical SCS system refinements, as well as new techniques have emerged.

Two new stimulation waveforms based on traditional SCS technology have appeared to further optimize the outcome for specific painful conditions;

* Burst stimulation mode: which generates constant-current stimuli with 5 spikes at 500 Hz per burst and pulse width and interspike intervals of 1 ms.
* High-frequency stimulation (from 1 to 10 kHz) mode.

Several studies have demonstrated the potential interest of these 2 new waveforms to treat FBSS patients compared to traditional SCS.

The Precision Spectra™ system allows MultiWave Technology by offering a broad spectrum of waveform options (from Tonic Conventional Stimulation (TCS), BURST stimulation to High Frequency stimulation (HF)).

To date, literature data comparing these 3 stimulation patterns is lacking but it is suggested the pain relief in some of non-responsive patients can be "recaptured" by increasing the SCS frequency to 500 Hz by BURST stimulation or beyond by HF stimulation. It seems important to conduct RCT in crossover, thanks to the new Precision SCS Stimulator, to compare the effects of these 3 different SCS modalities in FBSS patients and to determine which concept is the most effective in terms of pain reduction and energy consumption.


Options:
A: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
B: Global Pain VAS Visual Analogic Scale (VAS) (Month 3)
C: Visual Analogic Scale Low Back pain (Month 6)
D: Difference between treatment groups in responder rates. (3 Months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-1)
Brief Summary: This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe 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: Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales (Week 4)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-2)
Brief Summary: This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.


Options:
A: Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales (Week 4)
B: 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)
C: The Proportion of Responders at Day 29 in the ILA of Glabellar Lines at Maximum Frown. (Day 29)
D: Percentage of Subjects Who Achieved ≥ 2 Point Improvement Independently and Concurrently on Investigator and Patient Rating Scales (Week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial
Brief Summary: The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a 2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The purpose of this trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (\<130 mmHg, intensive treatment) than currently recommended (\<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of old. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.


Options:
A: Primary composite outcome (4 years)
B: Cholesterol Level (1 year)
C: Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (Baseline); Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (6 months); Framingham Risk Percent (Estimate of 10 Year Risk of Cardiovascular Disease in Percent) (12 months)
D: MEMS Adherence (12 months follow up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial
Brief Summary: The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a 2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The purpose of this trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (\<130 mmHg, intensive treatment) than currently recommended (\<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of old. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.


Options:
A: Change in Lateral Mitral Annular Myocardial Relaxation Velocity (Baseline to 24 weeks after treatment)
B: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a median of 3.5 years ] (From randomization; for approximately a median of 3.5 years)
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: Primary composite outcome (4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial
Brief Summary: The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a 2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The purpose of this trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (\<130 mmHg, intensive treatment) than currently recommended (\<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of old. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.


Options:
A: Primary composite outcome (4 years)
B: composite cardiovascular events (participants will be followed for the duration of the study, an expected median follow-up 3.07 years)
C: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
D: Composite of fatal and non-fatal stroke (During the study period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategy of Systolic Blood Pressure Intervention in the Elderly Hypertensive Patients: A Prospective Randomized Open-Label Blinded-Endpoint Trial
Brief Summary: The Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) is a 2-arm, multi-center, prospective, randomized, open-labeled, blinded-endpoint trial. The purpose of this trial is to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal (\<130 mmHg, intensive treatment) than currently recommended (\<150 mmHg, standard treatment) will reduce CVD risk among persons between 60-80 years of old. Furthermore, this trial will also examine the effect of blood pressure APP management strategy via WeChat network on medication compliance, blood pressure control and CVD benefits.


Options:
A: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure (From randomization; for approximately a median of 3.5 years)
B: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
C: Primary composite outcome (4 years)
D: First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Addition of Contingency Management to Stop Smoking Services for Patients Undergoing Treatment for Opiate Addiction: a Randomised Controlled Pilot Study
Brief Summary: The purpose of this study is to see whether contingency management (CM) can be successfully added as an adjunct treatment to standard stop smoking services in outpatients undergoing treatment for opiate addiction. Forty tobacco smoking patients undergoing treatment for opiate addiction will be stratified to a CM intervention for either smoking abstinence or attendance at the clinic, whilst also receiving usual stop smoking services cessation treatment. The intervention will run for five weeks and participants will be followed up six months after the beginning of the study.


Options:
A: Number of participants completing treatment in each condition (6 weeks)
B: Biologically confirmed tobacco cessation (6 months)
C: Biochemical verification of smoking status. (15 months)
D: Urinary Cotinine (3 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Auricular Acupressure for Hemodialysis Patients With Insomnia: Study Protocol for a Multi-centre Double-blind, Randomized Controlled Trial
Brief Summary: Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. A randomized controlled clinical trial is planned to evaluate the effect and safety of AAT in MHD patients with insomnia.


Options:
A: IRLS severity scale (24 and 48 wks)
B: clinical response rate (at 8 weeks from baseline)
C: Bedtime (Mean Bedtimes over 21 days for each period)
D: The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument. (12 months from randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of The Effect of Fecal Microbiota Transplantation on Ulcerative Colitis and Its Mechanism
Brief Summary: Ulcerative colitis is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of ulcerative colitis is closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be related to intestinal flora. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease，but the efficacy of ulcerative colitis by fecal microbiota transplantation needs to be further explored.


Options:
A: clinical remission (12 weeks)
B: Incidence of treatment-emergent adverse events (3 months)
C: The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis (9 weeks)
D: Clinical remission (Up to one year)

Answer: B