TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Italian Diabetes and Exercise Study 2 - A Long-term Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle
Brief Summary: Current guidelines recommend supervised mixed (aerobic+resistance) physical activity to ensure optimal benefits to control blood glucose, lipids, blood pressure, and other cardiovascular risk and to minimize injuries. However, these guidelines are difficult to put into action for a number of barriers and poor long-term patient compliance. This project will assess the effect of a behavioral intervention strategy on the promotion and maintenance of physical activity in type 2 diabetes.


Options:
A: Body Fat (36 Months)
B: Physical Activity Behavior (3 years)
C: Low Back Pain Disability (6 months); Usual Low Back Pain (6 months)
D: Average daily sedentary minutes (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of Two Injection Techniques Added to Proven Strategies to Reduce Pain in One- to Twelve-month Old Infants Undergoing Immunization
Brief Summary: Immunization injections are a significant source of pain for infants. Tactile stimulation (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it is cost neutral, and has been shown to be effective in children and adults undergoing injections. The aim of this study is to determine the added benefit of tactile stimulation when added to other proven analgesic interventions during routine infant immunization injections.


Options:
A: Hypersensitivity to pain (At 15 month vaccination (Visit 5))
B: N/A
C: pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS) (Immediately after vaccination)
D: Infant Pain as assessed by the Modified Behavioral Pain Scale (First 15 seconds after injection)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Phase 2 Study of HQK-1001 in Sickle Cell Disease
Brief Summary: The purpose of this study is to evaluate the effects of HQK-1001 on Hb F in subjects with sickle cell disease.


Options:
A: The level of Hemoglobin (18 months)
B: Change from baseline in % fetal hemoglobin (Day 1 through Week 48)
C: The Effective Rate of Patients (24 months)
D: Number of Evaluable Patients With an Increase From Baseline in Hemoglobin (Hb) of ≥1.5 g/dL (up to 12 weeks); Change in Total Hemoglobin (Hb) From Baseline to Peak (the Follow-up Time Point With the Highest Value) (up to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Introduction Seminar About Patient Participation, Treatment Options and Decisional Preferences for Psychiatric Outpatients on Waiting List
Brief Summary: Patient participation (PP) in Hospital is a goal defined by the Norwegian Health Authorities and it is a mandatory activity for District Psychiatric out-patient Centres (DPC) in Norway: patients are entitled to have influence on their treatment and should receive sufficient information directed at empowerment. Nevertheless, studies from Norway have found that patients who seek help are dissatisfied with the information they receive and doubt their possibility for real influence on their treatment. One way to improve individual PP might be to give patients sufficient information and education before they start their treatment in the form of an educational group intervention, an introduction seminar (IS); this group intervention is less time and resource consuming than individual interventions.

Aims: The main purpose of this project is to develop and evaluate an IS for patients on a waiting list of DPC. The seminar will educate patients, so they can actively participate in their own treatment and, thereby, choosing treatment, reducing the risk of dropping out of treatment. Another aim is to enable patients to participate in their own treatment, to cope with their problems while they are waiting for treatment by providing them contact with primary health care and user organizations during their waiting time, and to increase adherence.

Methods: The project involves three components: an exploratory study of educational content of the seminar; RCT of that 4-hours program (to examine its effect on treatment preferences and choices, activation, satisfaction, mental health and cost-benefit) and then a post-seminar qualitative evaluation, which will be used to create a broad yet deep understanding of the practical side of the participants'experience and the seminar's effect.


Options:
A: Change of Social Support Scale (Changes from Baseline Social Support Scale at 4 months); Change of Chinese Health Questionnaire-12 (Change from Baseline Chinese Health Questionnaire-12 at 4 months); Change of Brief Psychiatric Rating Scale-18 (Change from Baseline Brief Psychiatric Rating Scale-18 at 4 months); Change of Global Assessment of Function (Change from Baseline Global Assessment of Function at 4 months); Change of Chinese version of the Social Functioning Scale (Change from Baseline Chinese version of the Social Functioning Scale at 4 months)
B: changes in cognitive insight over time (baseline, 3,6 and 12 month)
C: Penn State Worry Questionnaire-Abbreviated (Week 11)
D: Selected Treatment (1 month); Health Care utilization (1 year); Health Care utilization (2 years); coping (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR
Brief Summary: The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of having these events because they have diabetes and/or other cardiovascular risk factors.


Options:
A: Time From Randomisation to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days))
B: Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) (From randomization up to 6 years)
C: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)
D: Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) (Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy
Brief Summary: The goal of this study is to identify a vitamin D supplementation strategy that best promotes the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational age). This is a high risk population that seems to have unique vitamin D needs, and inappropriate supplementation may promote wheezing or allergy. The results of this study will help form nutritional recommendations for the approximately 100,000 black infants born at 30-36 weeks gestational age in the U.S. every year.


Options:
A: Equivalency of isoforms (3 months)
B: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)
C: 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery (to 7 months postpartum)
D: Number of Infants With Recurrent Wheezing (up to 12 months adjusted age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Wheezing in Black Preterm Infants: Impact of Vitamin D Supplementation Strategy
Brief Summary: The goal of this study is to identify a vitamin D supplementation strategy that best promotes the lung, immune, and overall health of black infants born preterm (28-36 weeks gestational age). This is a high risk population that seems to have unique vitamin D needs, and inappropriate supplementation may promote wheezing or allergy. The results of this study will help form nutritional recommendations for the approximately 100,000 black infants born at 30-36 weeks gestational age in the U.S. every year.


Options:
A: Number of asthma exacerbations per child treated with rescue oral corticosteroids (7 months)
B: Growth (2 years of age); Neurologic and cognitive development (At 2 years of age); Frequency of allergic symptoms and infection (At 2 years of age); Development of immunoregulation (At 2 years of age); Bone mineral density (2 years of age)
C: Number of Infants With Recurrent Wheezing (up to 12 months adjusted age)
D: Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels (During acute phase postburn)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter
Brief Summary: Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.


Options:
A: Length of canalization (Four weeks); Number of punctures (Four weeks); Phlebitis (Four weeks)
B: Device Failures Within 72 Hours (72 hours after device placement)
C: length of use of the catheter measured in number of days (seven days)
D: First pass success (1 day); Number of attempts (1 day); Overall success (1 day); Time to completion (1 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Assessment of an Ultrasound-guided Inserted Peripheral Intravenous Catheter
Brief Summary: Evaluate the safety and efficacy of an an ultrasound-guided inserted peripheral intravenous catheter during a period of seven days.


Options:
A: Initial success rate (immediatetely after first attempt, average attempt takes 15 minutes)
B: Reducing the use of CVC and PVC (through study completion, an average of 7 month)
C: First pass success (1 day); Number of attempts (1 day); Overall success (1 day); Time to completion (1 day)
D: length of use of the catheter measured in number of days (seven days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)
Brief Summary: This is a prospective randomized controlled trial to compare clinical improvement, cost effectiveness and patency rates between new and improved Nitinol stents and open bypass surgery in the superficial femoral artery disease.

Secondary outcomes also include comparing quality of life, re-intervention rate, mortality, morbidity and time to return to work or regular activities.

Patients with superficial femoral artery lesions will be considered. Patients with TASC II A lesions will not be randomized but treated with PTA/stenting as standard of care. Patients with TASC II B and C lesions will be prospectively randomized into either receiving open bypass or stenting.

Patients with TASC D lesions will be treated with open bypass surgery after angiography.

The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on all enrolled the patients.


Options:
A: MWD change score (Measured at 6 months); MWD change score (Measured at 6 months); MWD change score (Measured at 6 months)
B: Primary (and -assisted) patency (5 years); Quality of life (5 years)
C: (re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass (5 year)
D: Clinical improvement (12 Month Post Operatively); Patency rate (12 Month Post Operatively); Cost effectiveness (12 Month Post Operatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.
Brief Summary: The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.


Options:
A: Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 4); Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 12); Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 4); Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS) (Baseline and Week 12); Primary Safety Endpoint: Endometrial Protection - Hyperplasia (Baseline and Month 12)
B: Relief of vaginal symptoms (over 12 months of treatment); Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels
C: Mean change in the symptom identified by the patient to be most bothersome (Randomization to Week 12); Mean change in vaginal pH (Randomization to Week 12); Mean change in maturation index (Randomization to Week 12)
D: Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole (Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Twitter-enabled Mobile Messaging for Smoking Relapse Prevention
Brief Summary: We conducted a two-arm (test vs. control, N=160) randomized controlled trial of small, private, online support groups for quitting smoking with 20 people per group who were seeking to quit smoking. A novel feature was a bot (auto-messenger) that posted a daily cessation-related discussion topic in each group, timed to the group's quit date.


Options:
A: Number of smokers referred to tobacco cessation website (12 months)
B: Our primary outcome measures are patient-reported provider delivered tobacco screening and tobacco cessation advice. (Baseline, 8-months post-intervention, and 24-months post-intervention)
C: Self-reported 7-day Point Prevalence Abstinence From Smoking That Was Sustained at 60 Days After the Quit Date (60 days after quit date)
D: Smoking cessation (14 months post baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Twitter-enabled Mobile Messaging for Smoking Relapse Prevention
Brief Summary: We conducted a two-arm (test vs. control, N=160) randomized controlled trial of small, private, online support groups for quitting smoking with 20 people per group who were seeking to quit smoking. A novel feature was a bot (auto-messenger) that posted a daily cessation-related discussion topic in each group, timed to the group's quit date.


Options:
A: Self-reported 7-day Point Prevalence Abstinence From Smoking That Was Sustained at 60 Days After the Quit Date (60 days after quit date)
B: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)
C: 7-day point prevalence abstinence at 3 months (3 months post baseline); 7-day point prevalence abstinence at 6 months (6 months post baseline); 7-day point prevalence abstinence at 12 months (12 months post baseline)
D: End-of-intervention Varenicline Adherence (4 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Twitter-enabled Mobile Messaging for Smoking Relapse Prevention
Brief Summary: We conducted a two-arm (test vs. control, N=160) randomized controlled trial of small, private, online support groups for quitting smoking with 20 people per group who were seeking to quit smoking. A novel feature was a bot (auto-messenger) that posted a daily cessation-related discussion topic in each group, timed to the group's quit date.


Options:
A: Self-reported 7-day Point Prevalence Abstinence From Smoking That Was Sustained at 60 Days After the Quit Date (60 days after quit date)
B: Smoking cessation (14 months post baseline)
C: smoking quit rate change from baseline at 3-month follow-up (3-month follow-up); smoking quit rate change from baseline at 6-month follow-up (6-month follow-up)
D: Child Urine Cotinine (3 months and 12 months); Cigarettes/Day (3 months and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS): a Randomised Controlled Trial Using ePrescribing Data
Brief Summary: We hypothesise that feedback and feedback + psychology informed intervention delivered to primary care medical practices will reduce high-risk prescribing to patients compared to a simple educational intervention alone. The specific objectives are :

1. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified primary outcome of a composite measure of high-risk antipsychotic, non-steroidal anti-inflammatory drug, and antiplatelet drug prescribing
2. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified secondary outcomes of the six individual measures constituting the composite
3. To assess the cost-effectiveness of the intervention


Options:
A: Number of patients with medications discontinued, reduced dose or changed. (baseline, 3, 6 and 12 months); Number of discontinued medications, changed or changing doses. (baseline, 3, 6 and 12 months)
B: Composite measure of proportion of patients at risk of an adverse event from specified prescribing. (Change in proportion of patients prescribed a high risk drug between baseline and 12 months after the intervention)
C: acute care utilization (90 days)
D: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of a Complex Intervention on Reducing the Prevalence of Smoking Among Adolescents: a Cluster Randomized Control Trial
Brief Summary: In this multicenter cluster randomized controlled trial stratified by school baseline prevalence of smoking will be randomly allocated to the control or intervention group. Control schools will receive normal smoking education and intrvention schools will receive a four year class-based curriculum intervention (22 Classroom lessons), reinforcement of smoke-free school policy, smoking cessation in parents, pupils, and teachers and information and annual meeting with parents.

Study participants will be children aged 12 to 15 years old ; they will be followed to 2 years after high school. External evaluator and analyst will be blinded to school allocation.

The aim of this study is to analyze the effectiveness of a complex intervention to reduce the prevalence of smoking at 3º ESO (14-15 yrs-old) and 2 years after high school (17-18 yrs-old) .


Options:
A: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
B: Smoking prevalence of adolescents in each group (six years)
C: change in adiposity (baseline and 12 weeks); change in blood pressure (baseline and 12 weeks); change in metabolic function (baseline and 12 weeks)
D: Change in body mass index (BMI) (Baseline, Month 3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment
Brief Summary: Dementia is serious problem and around 700 000 people are affected in the UK alone. Currently there is no cure however early diagnosis and effective treatment offers hope for reducing the impact. Dementia sufferers require care due to physical disability, cognitive deficits, social isolation and emotional symptoms (depression). Delaying the onset of dementia will improve quality of life for patients and reduce the cost of residential care (£42 000 per person per year).

People with mild cognitive impairment (MCI) are at high risk of developing dementia. They have impaired cognitive abilities, such as memory, but still manage their everyday activities. Studies show that 8 out of 10 people with MCI will have developed dementia 6 years after diagnosis.

Regular physical activities and performing a variety of cognitive activities reduce the risk of dementia and improves abilities and quality of life in healthy people. Therefore a combination of these activities may reduce the risk of developing dementia in MCI. The investigators want to see if they can develop a program which combines these activities in a fun and social way that gets people active and keeps them active. The aims are to improve fitness, cognition and quality of life. The investigators plan to use computers and the internet to help with the activities and to make them available to people who are isolated. Physical activity will involve walking from home, cognitive activities will be computer based games and puzzles and socialising will involve regular varied group-based activities. Participants (128) will be recruited from the UCL Derwent Memory Clinic and will complete a 26 week program. They will then be followed up yearly to monitor their progress. The main outcome of the study is engagement in the activities. The investigators will also measure fitness, cognition, quality of life and conversion to dementia.


Options:
A: Change in cognitive function summary score (12 weeks)
B: Neuropsychological testing (Baseline, 12 weeks, and 24 weeks); Oddball task (Baseline, 12 weeks, and 24 weeks); Wisconsin task (Baseline, 12 weeks, and 24 weeks); Speed of processing task (Baseline, 12 weeks, and 24 weeks); Spatial working memory (WM) (Baseline, 12 weeks, and 24 weeks)
C: Activity Compliance (Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks)
D: Reduction of frailty (12 months); Frailty score (continuous variable) (12 months); Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). (12 months)

Answer: C