TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: 12-wks Randomised Controlled Trial to Explore the Effect of a Smartphone App. Connected to an Add-on Device System Fitted on pMDI Inhaler on Adherence to Medications Intake and Clinical Outcomes in Difficult-to-treat Asthmatic Patients
Brief Summary: The purpose of this Study is to assess the effect of a smartphone application connected to an add-on device system fitted on Pressured Metered Dose Inhaler (PMDI) on adherence to take medications as prescribed and clinical outcomes in difficult-to-treat asthmatic patients.


Options:
A: Change from Baseline in adherence rate to entire treatment period (From baseline to end of participation (up to 3 months))
B: Recorded Medication Adherence (26 weeks); Self-reported Medication Adherence (6-months)
C: Objective Adherence to ICS (Baseline); Change in objective adherence to ICS (Change from baseline in objective adherence to ICS at 1 month); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control); Feasibility, Acceptability and Usability of the Text Messaging Website (At time of text messaging intervention); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 1 month after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 2 months after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 3 months after receiving text messages)
D: Change in asthma control from baseline at 3 months (3 months); Change in asthma control from baseline at 6 months (6 months); Change in asthma control from baseline at 9 months (9 months); Change in asthma control from baseline at 12 months (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Physiotherapy and Psychological Group Treatment on Physical and Mental Health Among Refugees From Syria With Pain Disorders or Post-traumatic Symptoms
Brief Summary: The war in Syria began in 2011 and refugees from this country have faced stressors including security risks, lack of access and availability of basic services and resources as well as family, community, and socio political tensions. Exposure to stressful events or situations, either short or long lasting, of exceptionally threatening or catastrophic nature is likely to cause pervasive distress in almost anyone, which might disturb daily life function, integration in society and ability to function in work and society, although this stress does not necessarily need to become an established medical diagnose. For a long time now, somatic and mental health systems have been overburdened and inaccessible both in Syria and in transit countries, and there is little available evidence of the effect of interventions targeting common health problems among refugees once established in their host countries.

In this project, the University of Bergen, in close collaboration with the Centre for Migration Health (Bergen municipality) and the Centre for Crisis Psychology, have developed two treatment interventions that are both theoretically sound and practically scalable if shown to be effective.

Among resettled asylum seekers and refugees, the primary aim of the project is to separately study in a quantitative way the effect on both physical and mental health of two different interventions: Physiotherapy activity and awareness intervention for participants with pain disorders and Teaching recovery techniques for participants with post-traumatic symptoms In addition, in a qualitative mode, our secondary aim is to analyse the processes by which the interventions help/do not help the patients to improve their health. Last, as the third aim of the study, cost effectiveness analyses will be conducted.


Options:
A: Post Traumatic Stress Disorder- Reaction Index (RI) (Baseline and Follow-up within one month of treatment completion. For controls follow up was 4 months post baseline.)
B: 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.)
C: Change from baseline post traumatic stress symptoms at 6 months (baseline and 6 month follow up); Change from baseline depression symptoms at 6 months (baseline and 6 month follow up); Change from baseline hope at 6 months (baseline and 6 month follow up)
D: Change in body pain index using Body Pain Inventory (At recruitment, right before and after the intervention and 12 weeks afterwards); Change in Impact of Events Scale (At recruitment, right before and after the intervention and 12 weeks afterwards)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Transtheoretical Model-based Intervention and Motivational Interviewing on the Management of Depression in Hospitalized Patients With Coronary Heart Disease : A Randomized, Controlled Trial
Brief Summary: In the middle of this century, coronary heart disease (CHD) is the most common cause of death in the United States. Chinese health service survey showed that about 1000,0000 \~ 320,000 people were suffering from CHD in the mainland of China in 2008. The high mortality and morbidity of CHD will aggravate the psychological burden of patients, such as depression. Depression is the most psychological problem in CHD patients. The incidence of depression in Chinese population was in the range of 4%\~6%, while it was as high as 14%\~17% in patients with CHD. Depression not only affects the patients' illness, but also reducing their quality of life, the compliance of drugs and lifestyle. In addition, depression is a major risk factor for the mortality and morbidity of cardiovascular disease. Therefore, it's urgently needed to screen and treat the depression of patients with CHD.

At present, the treatment of depression in patients with CHD mainly includes antidepressant, cognitive behavioral therapy， psychological counseling, knowledge education, relaxation therapy and so on. However, the medicine would yield side - effect. Furthermore, the content of psychological interventions are not systematic and dynamic. Moreover, patients' depressive level varies in different periods, the traditional psychological intervention just focused on the ultimate psychological benefits, and cannot analyze some factors and staged results in the process of psycho-behavioral change. Thus, an dynamic and effective intervention to alleviate depression in patients with CHD is imperative.


Options:
A: Low-density lipoprotein (LDL)cholesterol (Baseline and 12 months); Blood pressure (baseline and 12 months); Body Mass Index (baseline and 12 months); Psychological Well-Being (Baseline and 12 months)
B: Stage of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Process of change for coronary heart disease patients with depression (2 - days (T0) before discharge.); Decisional balance for coronary heart disease patients with depression (2 - days (T0) before discharge.); Self-efficacy for coronary heart disease patients with depression: scale (2 - days (T0) before discharge.); Hamilton Rating Scale for Depression (2 - days (T0) before discharge.)
C: Hamilton Rating Scale of Depression (HAM-D) (Baseline, Week 4, Week 8, Week 12)
D: Score on the Hamilton Depression Rating Scale-17 item (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Add-on Spironolactone to Losartan Versus Losartan Alone on Peritoneal Membrane Among Continuous Ambulatory Peritoneal Dialysis Patients: An Open-Label Randomized-Controlled Trial
Brief Summary: The ESCAPE-PD (Effects of add-on SpironolaCtone to losartan versus Alone on Peritoneal mEmbrane among continuous ambulatory Peritoneal Dialysis patients) study is a randomized, open-label, single center, active-controlled clinical trial. Adults end-stage kidney disease patients 18 years or older undergoing continuous ambulatory peritoneal dialysis (CAPD) will be enrolled. A total 84 CAPD will be randomly assigned to either the combination of spironolactone and losartan (experimental arm) or losartan alone (control arm). The primary outcomes are the difference in peritoneal dialysate effluent cancer antigen-125 (CA-125) and peritoneal equilibration test (PET) indices (dialysate-to-plasma creatinine ratio, 4-hour ultrafiltration volume, and the concentration of glucose present in the solution at the start of the test). Secondary outcome measures include laboratory and mechanistic outcome measures, nutrition outcomes, health-related quality of life, physical function, clinical events, and safety profiles. Results will be disseminated to suggest a strategy to prevent the peritoneal membrane function among CAPD patients through peer-reviewed publications along with scientific meetings.


Options:
A: permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension (13 weeks)
B: Peritoneal dialysate effluent CA-125 (6 months); PET indices (6 months)
C: Left Ventricular Mass Index (9 months)
D: Reduction of Left Ventricular Hypertrophy (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Multi Center, Randomized, Double-Blind, Vehicle-Controlled, Intra-Participant Study, to Evaluate Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Pediatric and Adult Participants (2 Years and Older) With Mild to Moderate Atopic Dermatitis
Brief Summary: This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older, cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).


Options:
A: VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 (Baseline to Week 8)
B: Change in The Total Lesion Symptom Scale (TLSS) score improvement (Through study completion, an average of 1 year)
C: Pharmacokinetic parameter Cmax will be calculated (Until Day 13); Pharmacokinetic parameter tmax will be calculated (Until Day 13); Pharmacokinetic parameter AUC(0-t) will be calculated (Until Day 13); Pharmacokinetic parameter t1/2 will be calculated (Until Day 13)
D: Change From Baseline in Total Sign Score (TSS) in Target Lesions at Day 15: Crisaborole Ointment 2% Versus Vehicle (Baseline, Day 15)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
Brief Summary: The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.


Options:
A: Dry Eye Symptoms (Week 4)
B: Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12 (Baseline, Month 12)
C: Tear Break-Up Time (1 month); Meibomian Gland Secretion Score (1 month)
D: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L (Single visit); Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm (Single visit); Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds (Single visit); Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 (Single visit); Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 (Single visit); Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 (Single visit); Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 (Single visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes: a Double-blind, Randomised, Cross-over, Placebo Controlled Trial
Brief Summary: Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. The indication for SCS is an ineffective conservative treatment of chronic pain syndromes. The effectiveness of SCS in the case of neuropathic pain is high. The positive result of SCS treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. Long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain.

The efficacy of SCS in different modes of stimulation is evaluated. Patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. It is said that in one type of stimulation they would feel parestesias and in other three they would not. Patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. The test is double-blinded


Options:
A: Patient's Global Impression of Change (PGIC)
B: Visual Analogue Scale (12 months); Oswestry Disability Index (12 months); Adverse Events (12 months); Number of pain medication (12months); Quality of life scale (12months)
C: Changes in pain (6 months)
D: Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes: a Double-blind, Randomised, Cross-over, Placebo Controlled Trial
Brief Summary: Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. The indication for SCS is an ineffective conservative treatment of chronic pain syndromes. The effectiveness of SCS in the case of neuropathic pain is high. The positive result of SCS treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. Long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain.

The efficacy of SCS in different modes of stimulation is evaluated. Patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. It is said that in one type of stimulation they would feel parestesias and in other three they would not. Patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. The test is double-blinded


Options:
A: Visual Analogue Scale (12 months); Oswestry Disability Index (12 months); Adverse Events (12 months); Number of pain medication (12months); Quality of life scale (12months)
B: Changes in pain (6 months)
C: Responder rate (1 month post-implant)
D: The Difference in Responders Between Both Groups (6 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes: a Double-blind, Randomised, Cross-over, Placebo Controlled Trial
Brief Summary: Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. The indication for SCS is an ineffective conservative treatment of chronic pain syndromes. The effectiveness of SCS in the case of neuropathic pain is high. The positive result of SCS treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. Long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain.

The efficacy of SCS in different modes of stimulation is evaluated. Patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. It is said that in one type of stimulation they would feel parestesias and in other three they would not. Patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. The test is double-blinded


Options:
A: Global Pain VAS Visual Analogic Scale (VAS) (Month 3)
B: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
C: Visual Analog Scale (VAS) on Back Pain (12 weeks)
D: Visual Analogue Scale (12 months); Oswestry Disability Index (12 months); Adverse Events (12 months); Number of pain medication (12months); Quality of life scale (12months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial
Brief Summary: The RESTORE II randomized controlled trial will examine the efficacy of a 12 week multidisciplinary rehabilitation program consisting of supervised and home-based exercise,1:1 dietetic counselling, and group education sessions for survivors of upper gastrointestinal cancer, namely cancers of the oesophagus, stomach, pancreas, and liver.


Options:
A: FIT Completion (Completed FIT kits sent back within 12 months)
B: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)
C: Surgical Failure (6 months and 1, 2, 3, 4, and 5 years); Recruitment Into E-OPTIMAL (At 24 Months post OPTIMAL Treatment); Retention in E-OPTIMAL (3, 4, and 5 Years Post OPTIMAL Treatment)
D: Change in Cardiorespiratory Fitness from Baseline (Baseline (T0), Immediately after the program intervention (T1), and Three month Follow-up (T2))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Management Program for Hispanic/Latino
Brief Summary: To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.


Options:
A: Glycemic Control (12 months.)
B: Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction (6 months)
C: Behavior change (6 month -12 months post-partum)
D: Hemoglobin A1C (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Syrian REfuGees MeNTal HealTH Care Systems
Brief Summary: To implement Group Problem Management Plus (PM+) in Syrian refugees with this RCT to evaluate feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted Group PM+ intervention for adult Syrian refugees in Turkey.


Options:
A: Hopkins Symptom Checklist-25 (HSCL-25) (Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment)
B: Addiction Severity Index (ASI) - Alcohol (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Addiction Severity Index (ASI) - Drugs (change) (Baseline, 2 months, 4 months, 6 months, 12 months); Change on Urine Drug Test (change) (Baseline, 2 months, 4 months, 6 months, 12 months)
C: Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months. (Baseline, 6 months, and 12 months)
D: Change in BMI (Before intervention and after (12-14 weeks after first assessment))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Syrian REfuGees MeNTal HealTH Care Systems
Brief Summary: To implement Group Problem Management Plus (PM+) in Syrian refugees with this RCT to evaluate feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted Group PM+ intervention for adult Syrian refugees in Turkey.


Options:
A: Change on Beck Depression Inventory-II (Screening; baseline, 6-8 weeks after baseline and 4 months after baseline)
B: Hopkins Symptom Checklist-25 (HSCL-25) (Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment)
C: quantity and frequency of alcohol use (30 days post-treatment)
D: Sustained change weight (for less) of 5% of previous body weight. This is a level known to improve physical health (metabolic) outcomes. (Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Individual Breastfeeding Support With Contingent Incentives for Low-Income Mothers
Brief Summary: This behavioral intervention trial will test whether a standard care breastfeeding intervention from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program plus monthly financial incentives contingent on observed breastfeeding will improve breastfeeding duration among low-income mothers compared to a standard (WIC) care control. Investigators hypothesize that the standard care plus monthly contingent financial incentives intervention will promote longer breastfeeding duration, fewer infant health issues, and greater healthcare cost savings than the standard care (control) intervention.


Options:
A: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)
B: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
C: Number of Participants Breastfeeding Their Infants at 1 Month (1 month); Number of Participants Breastfeeding Their Infants at 3 Months (3 months); Number of Participants Breastfeeding Their Infants at 6 Months (6 months); Number of Participants Breastfeeding Their Infants at 9 Months (9 months); Number of Participants Breastfeeding Their Infants at 12 Months (12 months)
D: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)

Answer: C