TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids (HEARTS)
Brief Summary: The purpose of the study is to target inflammation to reduce progression of noncalcified plaque in the coronary arteries using omega-3 fatty acid supplementation compared to standard of care.


Options:
A: Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) (Randomized treatment phase during a mean of 7.4 years); Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) (Randomized treatment phase during a mean of 7.4 years)
B: Change in cognitive function at 36 months determined by a composite score (sum of Z-score of 4 tests: FCRST test (free recall + total recall) score, MMSE orientation score, Wais-R score (Digit Substitution Symbol test), and the Category Naming Test score (Baseline, 6, 12, 24, 36 months)
C: Time to first relapse of atrial fibrillation (After a three weeks loading phase)
D: The primary endpoint is change in coronary noncalcified plaque volume. (Baseline and 30 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake
Brief Summary: The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma such as natural disaster bear a particularly high burden of mental disorders, with depression and Posttraumatic Stress Disorder (PTSD) generally being the top two adult psychiatric diagnoses. In traumatized populations, these disorders do not remit with replacement of material losses or resettlement to safe locations, but rather tend to become chronic conditions with attendant disability. PTSD and depression are risk factors for anger, interpersonal discord and violence, not only among those who have trauma and depression, but also among their spouses and children. This "infectious" model of trauma/violence is critically important in the setting of natural disaster, as increased levels of interpersonal violence within the afflicted community hinder its recovery. To date, there has been little research on the interpersonal effects of mass trauma. The proposed research is a randomized controlled trial of "Interpersonal Therapy" (IPT) versus wait list control (WLC) for survivors of the Sichuan Earthquake living in Shifang, China. IPT, a very effective therapy for depression, has been adapted for PTSD treatment and developing country settings. Measures will evaluate success of the treatment not only in terms of individual depression and PTSD symptoms, but also with respect to interpersonal functioning.

Hypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet criteria for Depression and PTSD at the conclusion of the RCT.

Hypothesis 2: Subjects who received IPT will have greater improvement of social functioning than wait list controls.


Options:
A: Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (baseline, post-intervention and 3-months)
B: PTSD diagnosis and severity score according to the Clinicians Administered PTSD Scale (CAPS) (4 & 9 months after completion of treatment)
C: Clinician Administered PTSD Scale (CAPS) (baseline through week 24)
D: score on Harvard Trauma Questionnaire (at the main study) (before and after the treatment,an expected average of 7 weeks of EMDR treatment); Impact of Event Scale Revised (at the pilot study and the main study) (pre- and post treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of an Employee Wellness Programme in Clothing/Textile Manufacturing Companies: A Randomised Control Trial
Brief Summary: The introduction of a wellness programme for workers employed in a clothing factory will improve quality of life, pain, attendance at work and levels of physical activity.


Options:
A: EQ-5D (Baseline, change in EQ-5D at 6 weeks)
B: Neck pain intensity as assessed by a 10 point Visual Analogue Scale (12 months follow-up); Shoulder pain intensity as assessed by a 10 point Visual Analogue Scale (12 months follow-up)
C: Mean Change in Light-intensity Physical Activity at Work From Baseline to 12 Months (1 year); Mean Change in Sitting Time at Work From Baseline to 12 Months (1 year)
D: Change from baseline in experienced community of practice at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in well-being at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in dietary behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in exercise behaviors at 6 and 12 months. Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline in safety behavior counts at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months); Change from baseline safety behavior consistency at 6 and 12 months, Post intervention maintenance from 12 to 24 months. (Baseline, 6 months, 12 months, 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Brief Summary: The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.


Options:
A: Adjusted Annualized Relapse Rate (ARR) During the Treatment Period (12 months)
B: Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale (Month 12)
C: Cumulative area under the concentration-time curve (AUC), as measured by area under the concentration-time curve from time zero to 336 hours post dose (AUC0-336h) (2 weeks)
D: Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period (Day 1 to Month 4); Injection-Related Adverse Event Rate Per Year in the Extension Period (Month 5 up to Month 10); Injection-Related Adverse Events in the Extension Period (Month 5 up to Month 10)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrating Information Technology Advancements Into Early PTSD Interventions
Brief Summary: After traumatic injuries some people have difficulty returning to the routine of their everyday activities and may experience physical and emotional pain. The purpose of this study is to identify new ways of providing support for physically injured trauma survivors. All study procedures are designed to work around patient needs and be as flexible as possible in order to best fit into patients' post-injury recovery.

Patients who are eligible for the study are randomly assigned to receive care as usual, or the "new method of treatment," with the study Trauma Support Specialist (TSS). This TSS will be in contact with the patient for the next three months; they may visit the patient at the hospital or at outpatient medical appointments. The TSS will also be available to talk with the patient over the telephone. Overall, the TSS will be working with the patient to help with difficulties returning to his or her routine and overcoming physical and emotional pain experienced after the injury. We believe that patients who receive the "new method of treatment," will be more able to return to daily routines and/or cope with the emotional stress that can occur after an injury. Intervention technology innovations including mHealth applications and web-based links will be included in the investigation.


Options:
A: Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury (The investigators assessed at baseline, 1-, 3-, and 6-month.); Change in Depression Symptoms Over the Course of the Six Months After Injury (The investigators assessed at baseline, 1-, 3-, and 6-month.); Technology Use (Baseline to 6 months); Feasibility/Acceptability of Intervention (Baseline to 6 months)
B: Hospital Anxiety and Depression Scale Score (3 & 6 months post-randomization)
C: PTSD ratings (Measured at Year 1); Substance use (Measured at Year 1); General functioning reports (Measured at Year 1)
D: Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. (Change from baseline at weeks 2, 6 and 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Brief Interventions to Create Smoke-Free Home Policies in Low-Income Households
Brief Summary: The burden of tobacco use falls disproportionately on low-income populations, through high rates of primary smoking and exposure to secondhand smoke. The remarkable progress in creating smoke-free environments in the U.S. over the past two decades has left smoker's homes as one of the primary sources of exposure to secondhand smoke for both children and nonsmoking adults. Intervention research that identifies effective and practical strategies for reaching the minority of households that still allow smoking in the home has considerable potential to reduce smoke exposure, but suitable channels to reach low-income families are limited. The proposed research will develop, evaluate and disseminate a brief smoke-free homes intervention through the established national infrastructure of 2-1-1 call centers. 2-1-1 is a nationally designated 3-digit telephone exchange, similar to 9-1-1 for emergencies or 4-1-1 for directory assistance, that links callers to community-based health and social services.

The proposed research has four specific aims: 1) Conduct formative research on intervention messages and materials for promoting smoke-free homes in low-income populations, applicable to both smokers and nonsmokers as household change agents; 2) Conduct a randomized controlled trial in the Atlanta 2-1-1 service area to evaluate the efficacy of a brief intervention to create smoke-free homes among 2-1-1 callers; 3) Conduct replication studies in Houston and North Carolina 2-1-1 systems to systematically test the intervention in varied populations and tobacco control climates, and 4) Disseminate the research-tested smoke-free homes intervention through a variety of mechanisms including a national grants program to 2-1-1 systems and through the Tobacco Technical Assistance Consortium's linkages to the state and local tobacco control infrastructure in the U.S.


Options:
A: Presence of a total home smoking ban (Change from baseline in reported total home smoking bans at 3-month and 6-month follow-up)
B: Rates of clinician delivering cessation assistance other than advice as assessed by parent surveys at baseline and 12 months after clinic visit; Rates of 7-day abstinence as confirmed biochemically at 12 months after clinic visit
C: Child Urine Cotinine (up to 12 months); Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources (up to 12 months)
D: Child exposure to tobacco smoke - hair nicotine (Baseline, 6 months post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Perineal trauma is common during vaginal birth. The discomfort this causes can interfere with a woman's recovery and early motherhood.Mothers are offered a standard treatment after childbirth, water soaked frozen peri pads (ice packs), to alleviate the discomfort. However, a Cochrane review questions the efficacy of ice packs treatment. An alternative treatment that may be more comfortable and effective for women is warm water soaked black tea bags. Medicinal use of black tea bags has been based on their astringent (shrinking or constricting) properties and have been used for various medical applications.

The investigators will conduct a pilot randomized controlled trial (RCT) of 40 pregnant mothers randomized to either intervention group (tea bags; n=20) or control group (ice packs; n=20). The goal of this pilot is to test the feasibility of a larger RCT by assessing recruitment, testing the protocol, and evaluating a proposed primary outcome objective of analgesic use during hospitalization as an indicator of pain. The investigators expect this pilot study to demonstrate feasibility for a large scale RCT to formally evaluate the efficacy of black tea bags to reduce perineal pain in this patient population.


Options:
A: use of analgesia during hospitalization (24 hours post partum)
B: Patient Reported Average Pain Score (Average score computed from postpartum day 0, postpartum day 1); Number of Patient Using Each Type of Non-narcotic Pain Medications (Number of patients using each type of non-narcotic medication recorded on postpartum day 0 and postpartum day 1); Any Narcotic Pain Medication Use (Any narcotic medication use from postpartum day 0 and postpartum day 1)
C: Rate of change in of the vas scores before and after using this device (24 months)
D: Reduction in the level of perineal pain (3 days); Reduction in perineal swelling (3 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double Blinded Controlled Trial of an Oral Nutritional Supplement Containing AN 777 in Older Hospitalized Patients
Brief Summary: Evaluate effects of an oral nutritional supplement on healthcare outcomes in older hospitalized adults. Also referred to as the NOURISH Study - Nutrition effect On Unplanned Readmissions and Survival in Hospitalized patients.


Options:
A: Return to hospital or death (90 days)
B: Protein intake measured on an individual level over 24h (3 days (hospital), 3 weeks (rehabilitation home))
C: Assessment of nutritional status with the Mini nutritional Assessment (MNA) (Baseline and every 4 weeks, up to 24 weeks)
D: Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale. (Baseline, 6 months, 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Proof of Concept Study in Male and Female Intensive Care Patients to Investigate the Clinical Effect of Repetitive Orally Inhaled Doses of AP301 on Alveolar Liquid Clearance in Acute Lung Injury
Brief Summary: The purpose of this study is to assess the effect of orally inhaled AP301 on alveolar liquid clearance in ALI (acute lung injury) patients with the purpose to assess the treatment associated changes of extravascular lung water (EVLW) within 7 days of treatment.


Options:
A: All cause mortality (28 days)
B: 28 days mortality (28 days)
C: change in extravascular lung water within 7 days of treatment (change from baseline - day 7)
D: Number of Ventilator Free Days (VFD) (Determined 28 days after a subject entered the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe handicap for patients and represents a considerable expense for healthcare system. Neurostimulation has currently not been validated in the treatment of back pain because of technological limitations in implantable spinal cord stimulation (SCS). The lack of a validated technique for back pain relief has prompted the development of newer devices, including leads with increased number of contacts (up to 16) and various geometric arrangements, the objective of which is to cover a larger area while attempting to extend, steer, or focus the electric field of the stimulation within the spinal cord regions. This led companies to design a new generation of multicolumn surgical leads that allow the activation of longitudinal and transverse electric fields (multicolumn spinal cord stimulation, MSCS) in order to provide bilateral paresthesia coverage of back pain.

The objective of this study is to compare the analgesic efficacy of MSCS (using longitudinal and transverse electric stimulation) versus mono-column spinal cord stimulation (CSCS, using axial stimulation, actually represented by quadripolar or octopolar lead) on the treatment of lumbar pain.

A total of 115 patients will be randomized to either CSCS or MSCS. Patients, between 18 and 80 years old suffering from refractory neuropathic pain of radicular origin with associated back pain will be included. Patients will be divided into two groups. One group with MSCS during the 12 months after the new generation electrode implantation and one group with CSCS during 6 months and MSCS between 6 and 12 months after the new generation electrode implantation.

The following parameters will be evaluated during this study: overall pain VAS, leg pain VAS, back pain VAS, Oswestry disability index, Montgomery and Asberg Depression Rating scale, Brief Anxiety Scale and the Euro Quality of Life-5 Dimension Health questionnaire and costing in relation to surgery and patient management.


Options:
A: Changes in pain (6 months)
B: Patient's Global Impression of Change (PGIC)
C: Responder Rate (3 months post-activation)
D: Visual Analogic Scale Low Back pain (Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients
Brief Summary: This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734).

The primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).


Options:
A: Small effect of an intervention (immediate after completion of study); Moderate effect of an intervention (immediate after completion of study); Large effect of an intervention (immediate after completion of study)
B: Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period (Week 96)
C: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
D: Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24 (From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Point-of-Choice Prompts to Reduce Prolonged Sitting Time at Work: A Randomised Trial
Brief Summary: The purpose of this study is to determine whether an on-screen prompt put on the work computer every 30 minutes is effective in getting office workers to reduce prolonged periods of sitting at work.


Options:
A: Change from control week and intervention week in total energy expenditure (TEE) (week 1 and week 2); Resting energy expenditure (REE) (Baseline (day 0)); Change from control week and intervention week in physical activity energy expenditure (PAEE) (week 1 and week 2); Change from control week and intervention week in daily time spent in sedentary (SB) (week 1 and week 2); Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities (week 1 and week 2); Change from control week and intervention week in number of breaks in sedentary time (BST) (week 1 and week 2); Change from control week and intervention week in time spent sitting (TSS) (week 1 and week 2); Change from control week and intervention week in time spent standing (TSst) (week 1 and week 2); Change from control week and intervention week in time spent walking (TSW) (week 1 and week 2); Change from control week and intervention week in number of steps (week 1 and week 2)
B: Daily sitting time (baseline and 23 weeks)
C: sitting time (one week); self-reported context-specific sitting time (one week); standing time (one week); breaks from sitting (one week)
D: duration of prolonged sitting (5 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Point-of-Choice Prompts to Reduce Prolonged Sitting Time at Work: A Randomised Trial
Brief Summary: The purpose of this study is to determine whether an on-screen prompt put on the work computer every 30 minutes is effective in getting office workers to reduce prolonged periods of sitting at work.


Options:
A: Incidence of CHD and other lifestyle related diseases after ten years (2012)
B: Physical Activity (Measured 5 times over 13 months, for seven days each time. Time points = baseline, 1-2weeks, 3 months, 6 months and 12 months)
C: duration of prolonged sitting (5 days)
D: change in physical activity (4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Point-of-Choice Prompts to Reduce Prolonged Sitting Time at Work: A Randomised Trial
Brief Summary: The purpose of this study is to determine whether an on-screen prompt put on the work computer every 30 minutes is effective in getting office workers to reduce prolonged periods of sitting at work.


Options:
A: To assess the effectiveness of a 6-month primary care intervention to reduce diary hours of Sitting time in overweight and obese patients, as well as to increase their weekly caloric spend (Baseline-6-9-12 and 18 month)
B: Change from control week and intervention week in total energy expenditure (TEE) (week 1 and week 2); Resting energy expenditure (REE) (Baseline (day 0)); Change from control week and intervention week in physical activity energy expenditure (PAEE) (week 1 and week 2); Change from control week and intervention week in daily time spent in sedentary (SB) (week 1 and week 2); Change from control week and intervention week in light (LIPA), moderate and vigorous (MVPA) intensity activities (week 1 and week 2); Change from control week and intervention week in number of breaks in sedentary time (BST) (week 1 and week 2); Change from control week and intervention week in time spent sitting (TSS) (week 1 and week 2); Change from control week and intervention week in time spent standing (TSst) (week 1 and week 2); Change from control week and intervention week in time spent walking (TSW) (week 1 and week 2); Change from control week and intervention week in number of steps (week 1 and week 2)
C: duration of prolonged sitting (5 days)
D: Physical Activity (Measured 5 times over 13 months, for seven days each time. Time points = baseline, 1-2weeks, 3 months, 6 months and 12 months)

Answer: C