TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Depressive Symptoms in Physically Ill Youth
Brief Summary: Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease or Ulcerative Colitis and depression. This study will also assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.

Hypothesis

- Individuals who receive CBT will show more improvement than individuals who receive SNDT.


Options:
A: Headache diaries assess headache frequency. (Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits.)
B: Change from baseline in CDRS at 3 months (Month 0, Month 3)
C: Parent Report Measures (4 years)
D: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Depressive Symptoms in Physically Ill Youth
Brief Summary: Children and adolescents with inflammatory bowel disease (IBD) have high rates of depressive symptoms and more trouble with daily functioning than those without physical illness. The proposed study will investigate if cognitive behavioral therapy (CBT) is better than supportive therapy (SNDT) in reducing emotional distress and improving functioning in youth ages 9-17 with Crohn's disease or Ulcerative Colitis and depression. This study will also assess the effect of CBT on IBD-related factors such as disease severity, medication adherence, and physical-health related quality of life.

Hypothesis

- Individuals who receive CBT will show more improvement than individuals who receive SNDT.


Options:
A: N/A
B: Change from baseline in CDRS at 3 months (Month 0, Month 3)
C: Change from Baseline in CDI at 14 weeks (Week 0, Week 14)
D: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial
Brief Summary: The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.


Options:
A: Prospective Randomized Trial of Anterior Colporrhaphy Vs. Cystocele Repair Using Polypropylene Mesh or Porcine Dermis (2 years)
B: Recurrent Stage II or Greater Anterior Vaginal Prolapse (three years)
C: Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (one year)
D: To evaluate the ability of the VCM to treat pelvic organ prolapse as demonstrated by improvement of cystocele as measured by a comparison of POP-Q scores pre and post surgery (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Outcome After Anterior Vaginal Prolapse Repair: A Randomized Controlled Trial
Brief Summary: The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.


Options:
A: Recurrent Stage II or Greater Anterior Vaginal Prolapse (three years)
B: Prolapse by "Pelvic Organ Prolapse Quantification System" (POP-Q), at 12 Months (12 months)
C: Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit (1 year post operatively)
D: Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
Brief Summary: The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows:

1. To determine whether the use of electronic reminder system increases adherence to topical agents.
2. To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes.
3. To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system.
4. To obtain subjects' feedback on the adherence monitoring and reminder system.


Options:
A: Adherence to the trial (6 months); Adherence to the intervention arms (6 months)
B: Symptom burden and quality of life 2-4 weeks post treatment (3 years)
C: The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening). (10 months)
D: Number of Days the Subjects Are Adherent to Using Sunscreen (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
Brief Summary: The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows:

1. To determine whether the use of electronic reminder system increases adherence to topical agents.
2. To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes.
3. To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system.
4. To obtain subjects' feedback on the adherence monitoring and reminder system.


Options:
A: Number of Days the Subjects Are Adherent to Using Sunscreen (6 weeks)
B: Tobacco Abstinence - 6 Month Follow-up (6 months)
C: Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer. (3 months)
D: Average hours of CPAP use per night: experimental pathway vs. traditional pathway (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia Age 65 or Older.
Brief Summary: Primary Objective:

* To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older.

Secondary Objective:

* To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older


Options:
A: Overall Response Rate (ORR) (From 3 cycles (90 days) up to 6 cycles (approximately 180 days))
B: Primary Analysis: Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 30 (Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]).); Final Analysis: PFS Based on Investigator Assessment - Kaplan Meier Landmark Estimates at Month 48 (Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]).)
C: Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B (IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.)
D: Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death (Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)); Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines (Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Zinc in Recurrent Acute Lower Respiratory Infections
Brief Summary: Acute respiratory infections (ARIs) are the most frequent illnesses globally. Despite advances in the recognition and management ARIs, these account for over 20% of all child deaths globally.Trace mineral deficiencies have long been implicated in causation and consequences of many diseases. The importance of adequate zinc intake in human health is well documented and zinc deficiency is a large public health problem, especially among children in developing countries.Various studies suggest that zinc-deficient populations are at increased risk of developing diarrhoeal diseases, respiratory tract infections and growth retardation.Among the individual interventions zinc supplementation with universal coverage ranks 5th in preventing under five mortality in India, preceded only in order by breast feeding; complementary feeding; clean delivery; Hib vaccination; and clean water, sanitation and hygiene.Numerous studies have examined the association between child mortality and zinc deficiency. A number of randomized controlled trials evaluating effect of zinc supplementation have found the intervention to be beneficial in reducing ARI and diarrhoeal mortality and morbidity but few studies have found beneficial effect in diarrhea and no or even contrasting effects on morbidity pattern of acute respiratory infections. Whereas role of zinc in diarrhea is now a well established and specific guidelines and recommendations have been given for zinc supplementation in diarrhea, role of zinc in acute respiratory infections is controversial. The contrasting effect of zinc on diarrhoea and acute lower respiratory infection as reported in several studies is a public health concern, because zinc supplementation is carried out in many nutrition rehabilitation units. Further in many of randomized control trials supplement syrups also contained other vitamins, including vitamin A, known to have effect on respiratory morbidity. Most of the trials evaluating effect of zinc on respiratory morbidity and mortality are community based and children with well known causes of recurrent acute lower respiratory infections have not been excluded from the study pool.

Hence the current study was planned to bridge this gap of information and attempts to detect the role of zinc using "zinc only preparations" in reducing respiratory morbidity in children aged 6 to 59 months with recurrent acute lower respiratory infections.


Options:
A: change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year; (six months)
B: Death among children 1-36 months of age
C: Time to cessation of severe pneumonia (Within 2 weeks after enrollment); The period starting from enrolment to the beginning of a 24-hour consecutive period of absence of lower chest indrawing, of hypoxia and of any danger signs. (Recovery from pneumonia within 2 weeks)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Depression in Patients Being Treated for Head and Neck Cancer
Brief Summary: This study will evaluate the effectiveness of escitalopram to prevent depression in head and neck cancer patients receiving treatment.


Options:
A: Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) (Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28)
B: Incidence of depressive disorders in the study population (Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18)
C: Depression (6 Months)
D: Executive Function Composite Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort. (after 15 weeks of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention
Brief Summary: To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.


Options:
A: Bacille-Calmette-Guerin (BCG) vaccine efficacy (2 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (6 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (1 year)
B: Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels (During acute phase postburn)
C: Maternal and Neonatal complications (six months post enrolement)
D: Parental and infant preference for a new vitamin D delivery system over the standard of care supplement in syrup form. (21 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.
Brief Summary: This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.


Options:
A: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)
B: N/A
C: Total number of urinary incontinence episodes per week
D: Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline. (Baseline and Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Transferability of a Successful, Hospital-based, Childhood Obesity Clinic to Primary Care: a Pilot Study
Brief Summary: Obesity affects one in five children in the UK and undoubtedly causes increased ill health with rising levels of childhood and adolescent diabetes, obesity induced liver disease and increased risk of early heart disease. There are few clinics offering effective treatment for childhood obesity. However, the clinic for childhood obesity at Bristol Royal Hospital for Children (BCH) has been successful in around 83% of cases. This pilot study aims to examine the feasibility of transferring the success of the hospital clinic to primary care in preparation for a full RCT. The study will entail training a practice nurse, community dietician and exercise specialist to deliver the same clinical service in primary care as that offered in BCH. Initial work will gather the views of staff delivering the hospital service and those of patients and parents to identify the crucial components of the intervention that are likely to be needed in primary care and to then to refine the intervention.A pilot trial will examine how feasible it is to recruit patients into the service and get some initial idea as to whether weight management is equally good, patient satisfaction and retention improves and what data needs to be collected for a full economic assessment. If found to be effective, the next step will be to use knowledge gained in this study to design and undertake a more extensive, formal study across Bristol in various primary care settings.This larger study will address how such a service can be delivered across a complete spectrum of primary care populations, so that similar services could be developed across the country.


Options:
A: Percent Change From Baseline Weight (Baseline, 2 years)
B: To investigate the feasibility of replicating a successful hospital based, childhood obesity clinic in primary care using trained primary care staff and undertake a pilot trial. (12 months)
C: Weight (baseline, 1, 2, 3 years)
D: Among patients from the targeted diseases group, we aim at improving: a)the proportion of subjects who have an initial intervention planned, according to the CCPGO; b)the proportion of subjects who lose at least 5% of their initial weight. (18 months); Among patients from the regular follow-up group, we aim at improving: a)the proportion of patients who have measured weight, BMI and waist circumference and b)the proportion of overweight or obese subjects who have an initial intervention planned. (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Cetuximab to Evaluate the Efficacy in Patients With Locally Advanced or Metastatic EGFR-EGFR-Positive Pancreatic Cancer. SpaCe Trial
Brief Summary: This is multicenter, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Primary objective: objective response rate. Secondary objectives: safety, time to disease progression, median duration of response, time to treatment failure, overall survival time, correlation between bio-pathological characterization (EGFR, akt, MAPks) objective response and survival


Options:
A: TTF2 (approximate 6 months after first line treatment)
B: Objective response rate (Phase II); Survival (Phase III)
C: Overall survival (A subject's survival time will be defined as the time from randomization to the date of his or her death. If the subject has not died, survival will be censored on last date the subject was known to be alive.)
D: Progression free survival (4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
Brief Summary: To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)


Options:
A: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)
B: 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)
C: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
D: Number of Days Until First On-study Relapse (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
Brief Summary: To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)


Options:
A: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)
B: Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24 (24 months)
C: Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6 (Baseline, Month 6)
D: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
Brief Summary: To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)


Options:
A: ARR - PDEs (Baseline to Month 36)
B: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)
C: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
D: Proportion of Subjects Relapsed (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis
Brief Summary: To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)


Options:
A: Number of Patients Free of Gadolinium-enhanced T1-Weighted Magnetic Resonance Imaging (MRI) Lesions at Both Month 3 and Month 6 (Month 3 and Month 6)
B: Analysis of Changes in CSF CXCL13 Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months); Analysis of Changes in CSF BAFF Induced by Active Treatment (Rituximab) Measured 3 Months After 1st Drug Administration (3 months)
C: ARR - PDEs (Baseline to Month 36)
D: Number of Participants With Treatment-Emergent Adverse Events (AEs) (Day 1 up to Week 561)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures
Brief Summary: This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.


Options:
A: Proportion of Participants With Response to Treatment (Baseline up to Week 16)
B: Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase (Baseline phase (up to 8 weeks prior to treatment phase [Day 1])); Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase (Day 1 up to Week 12)
C: Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase (Day 1 up to Day 14)
D: Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase (Week 0 to Week 14)

Answer: A