TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Physical Activity Intervention to Prevent Obesity and Improve Academic Performance in Children With and Without Attention Deficit Hyperactivity Disorder (ADHD) Risk
Brief Summary: Coordinated project whose objectives are: a) to test the effectiveness of a promotion of physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the academic performance in both children with and without attention deficit hyperactivity disorder (ADHD)


Options:
A: Body fat percentage (One year (interim analysis))
B: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)
C: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)
D: Body mass index (One school year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Physical Activity Intervention to Prevent Obesity and Improve Academic Performance in Children With and Without Attention Deficit Hyperactivity Disorder (ADHD) Risk
Brief Summary: Coordinated project whose objectives are: a) to test the effectiveness of a promotion of physical activity intervention (MOVI-KIDS) on preventing obesity; and b) to improve the academic performance in both children with and without attention deficit hyperactivity disorder (ADHD)


Options:
A: School-time and total daily MVPA (5 months and 1.5 years)
B: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)
C: Body fat percentage (One year (interim analysis))
D: Behavioural determinants of physical activity and nutrition by determinant questionnaire (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Physical activity, physical fitness and sedentarity (questionnaire and accelerometer) (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention); Food intake by 24h recall (at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Intervention of Physical Activity Promotion in Schoolchildren on Preventing Obesity During the Adiposity Rebound Period: a Cross-over Randomized Cluster Trial.
Brief Summary: Coordinated project whose objectives are: a) to assess the effectiveness of a physical activity intervention (MOVI-KIDS) on preventing obesity and improving fitness during the adiposity rebound period; and b) to examine the effectiveness of MOVI-KIDS on reducing the carotid intima-media thickness.


Options:
A: Body fat percentage (One year (interim analysis))
B: Change in Demographic data (Evaluation at three time points: 0 months, 2 months and 8 months); Goal setting tool (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 24-hour dietary intake recall (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 3-day dietary intake record (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 24-hour physical activity recall (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 3-day physical activity record (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in Anthropometric measurements (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in Social Cognitive Theory (SCT) variables (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in blood pressure (BP) measurements (Evaluation at three time points: 0 months, 2 months and 8 months)
C: Mathematical attainment: as measured using the level 13 Progress in Maths test (provided at GL assessment) at the end of the school year (June 2018). (1 hour: Last month of the study (June 2018).)
D: Physical activity level (one school week); Time on task (change in time on task from baseline to 15 minutes post academic lesson); Acute academic achievement (change in math and language arts scores from Baseline to 2 weeks); Long-term math achievement (Change in math achievement scores from Baseline to 7 months); Long-term language arts achievement (Change in language arts achievement from Baseline to 7 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Intervention of Physical Activity Promotion in Schoolchildren on Preventing Obesity During the Adiposity Rebound Period: a Cross-over Randomized Cluster Trial.
Brief Summary: Coordinated project whose objectives are: a) to assess the effectiveness of a physical activity intervention (MOVI-KIDS) on preventing obesity and improving fitness during the adiposity rebound period; and b) to examine the effectiveness of MOVI-KIDS on reducing the carotid intima-media thickness.


Options:
A: Body fat percentage (One year (interim analysis))
B: NeuroCognitive Assessment (Change from baseline, 36 - 40 weeks); Structural Magnetic Resonance Imaging (Change from baseline, 36 - 40 weeks); Functional Magnetic Resonance Imaging (Change from baseline, 36 - 40 weeks); Academic Achievement (Change from baseline, 36 - 40 weeks); Eye Tracking (Change from baseline, 36 - 40 weeks); Task Performance (Change from baseline, 36 - 40 weeks)
C: BMI (6 months)
D: For adults: body weight loss maintenance (6 Month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening: Intervention Phase
Brief Summary: Korean American (KA) women have among the highest breast cancer mortality rates and lowest breast cancer screening rates of U.S. American women across racial/ethical groups. This innovative project seeks to harness mobile phone technology as a means to take preventative health care to a new level among this population. Using the Fogg Behavioral Model this study proposes to develop a mobile phone-based intervention designed to motivate KA women to undergo an annual mammogram (mMammogram). The overall study aim is to develop and assess the feasibility and effectiveness of a 7-day long mMammogram intervention designed to persuade KA women to undergo breast cancer screening.


Options:
A: N/A
B: Mammogram receipt (1 week)
C: Gain in phosphorus knowledge as assessed by the chronic kidney disease Knowledge Assessment Tool (CKDKAT) of nutrition. (4 to 8 weeks post intial questionnaire/survey); Compliance with dietary phosphorous will be measured by serum phosphorous level. (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorous will be measured by serum calcium level (4 to 8 weeks after initial questionaire/survey appointment); Compliance with dietary phosphorous will be measured by para thyroid hormone (PTH) level (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorous will be measured by serum calcium phosphorus product. (4 to 8 weeks after initial questionnaire/survey appointment); Compliance with dietary phosphorus intake will be measured by using 24 hour recall diary. (4 to 8 weeks after initial questionnaire/survey appointment)
D: Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT (Up to 1 week after the transplant education day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening: Intervention Phase
Brief Summary: Korean American (KA) women have among the highest breast cancer mortality rates and lowest breast cancer screening rates of U.S. American women across racial/ethical groups. This innovative project seeks to harness mobile phone technology as a means to take preventative health care to a new level among this population. Using the Fogg Behavioral Model this study proposes to develop a mobile phone-based intervention designed to motivate KA women to undergo an annual mammogram (mMammogram). The overall study aim is to develop and assess the feasibility and effectiveness of a 7-day long mMammogram intervention designed to persuade KA women to undergo breast cancer screening.


Options:
A: Measles vaccination coverage (10 months)
B: Intention to treat analysis (13 months)
C: Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing (Up to 12 Months); Uptake of male circumcision referral among HIV-uninfected men with either promotion at point of HIV testing, SMS follow-up or lay-counselor follow-up visits (Up to 9 months); Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral (Up to 12 months)
D: Mammogram receipt (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Phone Multimedia Messaging Intervention for Breast Cancer Screening: Intervention Phase
Brief Summary: Korean American (KA) women have among the highest breast cancer mortality rates and lowest breast cancer screening rates of U.S. American women across racial/ethical groups. This innovative project seeks to harness mobile phone technology as a means to take preventative health care to a new level among this population. Using the Fogg Behavioral Model this study proposes to develop a mobile phone-based intervention designed to motivate KA women to undergo an annual mammogram (mMammogram). The overall study aim is to develop and assess the feasibility and effectiveness of a 7-day long mMammogram intervention designed to persuade KA women to undergo breast cancer screening.


Options:
A: Exclusive breastfeeding duration (Six months)
B: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
C: MEMS Adherence (12 months follow up)
D: Mammogram receipt (1 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
Brief Summary: This study is a 12-week, randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in adolescents with autism spectrum disorder (ASD). The investigators will also conduct pre- and post-treatment neuroimaging (functional magnetic resonance imaging \[fMRI\] and hydrogen magnetic resonance spectroscopy \[HMRS\]) to assess neural functional deficits in adolescents with autism spectrum disorder compared to healthy volunteer adolescents. This pre- and post-neuroimaging will also be used to assess any effects of memantine therapy on neural function in adolescents with autism spectrum disorder. The investigators hypothesize that short-term memantine monotherapy will be safe, well-tolerated, and effective in improving the core symptoms of autism spectrum disorder in adolescents with autism spectrum disorder. Additionally, the investigators hypothesize that following memantine therapy, adolescents with autism spectrum disorder will exhibit a decrease in glutamate (Glu) concentration in the anterior cingulate cortex (ACC) and a change towards normalization in altered functional connectivity of the anterior cingulate cortex and medial temporal lobes, consistent with improvement in social impairments in autism spectrum disorder. The investigators hypothesize that compared to healthy volunteer participants, participants with autism spectrum disorder will significantly differ on neuroimaging measures at baseline but that following memantine therapy, the difference between autism spectrum disorder and healthy volunteer neuroimaging data will decrease.


Options:
A: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)
B: Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. (Baseline; Week 4)
C: ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase) (8 weeks)
D: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
Brief Summary: This study is a 12-week, randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in adolescents with autism spectrum disorder (ASD). The investigators will also conduct pre- and post-treatment neuroimaging (functional magnetic resonance imaging \[fMRI\] and hydrogen magnetic resonance spectroscopy \[HMRS\]) to assess neural functional deficits in adolescents with autism spectrum disorder compared to healthy volunteer adolescents. This pre- and post-neuroimaging will also be used to assess any effects of memantine therapy on neural function in adolescents with autism spectrum disorder. The investigators hypothesize that short-term memantine monotherapy will be safe, well-tolerated, and effective in improving the core symptoms of autism spectrum disorder in adolescents with autism spectrum disorder. Additionally, the investigators hypothesize that following memantine therapy, adolescents with autism spectrum disorder will exhibit a decrease in glutamate (Glu) concentration in the anterior cingulate cortex (ACC) and a change towards normalization in altered functional connectivity of the anterior cingulate cortex and medial temporal lobes, consistent with improvement in social impairments in autism spectrum disorder. The investigators hypothesize that compared to healthy volunteer participants, participants with autism spectrum disorder will significantly differ on neuroimaging measures at baseline but that following memantine therapy, the difference between autism spectrum disorder and healthy volunteer neuroimaging data will decrease.


Options:
A: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (Baseline; Week 4)
B: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
C: Rate of Recruitment (19 months)
D: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorder
Brief Summary: This study is a 12-week, randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment of social impairment in adolescents with autism spectrum disorder (ASD). The investigators will also conduct pre- and post-treatment neuroimaging (functional magnetic resonance imaging \[fMRI\] and hydrogen magnetic resonance spectroscopy \[HMRS\]) to assess neural functional deficits in adolescents with autism spectrum disorder compared to healthy volunteer adolescents. This pre- and post-neuroimaging will also be used to assess any effects of memantine therapy on neural function in adolescents with autism spectrum disorder. The investigators hypothesize that short-term memantine monotherapy will be safe, well-tolerated, and effective in improving the core symptoms of autism spectrum disorder in adolescents with autism spectrum disorder. Additionally, the investigators hypothesize that following memantine therapy, adolescents with autism spectrum disorder will exhibit a decrease in glutamate (Glu) concentration in the anterior cingulate cortex (ACC) and a change towards normalization in altered functional connectivity of the anterior cingulate cortex and medial temporal lobes, consistent with improvement in social impairments in autism spectrum disorder. The investigators hypothesize that compared to healthy volunteer participants, participants with autism spectrum disorder will significantly differ on neuroimaging measures at baseline but that following memantine therapy, the difference between autism spectrum disorder and healthy volunteer neuroimaging data will decrease.


Options:
A: Treatment Responder (12 Weeks (from Baseline [Week 0] to Endpoint [Week 12]))
B: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)
C: cortical metrics (a mathematical plot of tactile responsivity in 3 dimensions) (8 weeks)
D: Clinical Global Impression-Scale(CGI-S) (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Community Case Management of Common Childhood Diseases: Mozambique and Uganda
Brief Summary: The aim of the inSCALE project is to test the effect of innovative approaches to increase coverage of integrated community case management, which provides community based-care for diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate care for these three most common childhood illnesses


Options:
A: Number of weight management visits/ practitioner Full Time Equivalent(FTE) (Data will be collected monthly and analyzed at 6, 12 and 18 Months); Change in BMI (3,6,12,and 18 month where possible); Change in Self-reported health measures-SF12 (3,6,12 months and 18 months where possible)
B: Change in uptake of shared decision-making from the patients' perspective (All clinics: baseline, 8 months, 16 months, 24 months)
C: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)
D: Change in Body Mass Index (3 and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Community Case Management of Common Childhood Diseases: Mozambique and Uganda
Brief Summary: The aim of the inSCALE project is to test the effect of innovative approaches to increase coverage of integrated community case management, which provides community based-care for diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate care for these three most common childhood illnesses


Options:
A: Delay before expertise by a dermatologist (3 months)
B: systolic blood pressure (change from baseline to 12-month of follow-up)
C: Appropriate treatment of malaria, pneumonia and diarrhoea in children under five years of age (1 year)
D: Specialist referral rate per 100 patients seen (to medical specialties available through eConsult) (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label, Single Centre, Phase II Pilot Study of Neoadjuvant Dabrafenib + Trametinib in Patients With Resectable American Joint Committee on Cancer (AJCC) Stage IIIB-C BRAF V600 Mutation Positive Melanoma
Brief Summary: This is an open label, single centre, phase II study of neoadjuvant drug treatment with dabrafenib + trametinib in patients with resectable American Joint Committee on Cancer (AJCC) Stage IIIB-C BRAF V600 mutation positive melanoma.

The main aim of this study is to find out if giving of a new combined drug treatment to patients with melanoma that has spread to the lymph nodes BEFORE they have surgery, will result in improved clinical and pathological response of the melanoma tissue after 12 weeks treatment.


Options:
A: The proportion of viable melanoma tissue, compared to baseline, in dissected lymph node and / or in-transit tumour tissue after 12 weeks of neoadjuvant treatment. (12 weeks)
B: The feasibility of treating patients with unresectable melanoma and palpable lymph node metastases that harbor the BRAF mutation with neoadjuvant vemurafenib. (24 months)
C: Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population (Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.); Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population (Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years.); Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population (At years 1, 2, and 3)
D: Recurrence-Free Survival (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study of Tivozanib as Maintenance Therapy, Post-Chemotherapy, in Patients With Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Brief Summary: This research study is evaluating a drug called tivozanib as a possible treatment for ovarian, fallopian tube or primary peritoneal cancer.

Angiogenesis is the formation of new blood vessels. Tumors need blood vessels to grow and spread. Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a tumor's blood supply so that it does not get the blood and nutrients it needs to grow.

In this research study, the Investigators are looking to see whether tivozanib works as a maintenance therapy for ovarian, fallopian tube or primary peritoneal carcinoma in participants who have achieved a complete response following chemotherapy. Maintenance therapy is given after a disease has responded to previous treatment. It is given to help prevent the spread or recurrence of the tumor.


Options:
A: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
B: To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications (Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter.)
C: Progression-Free Survival (PFS) Comparison (2 Years)
D: Proportion of patients with objective response rate with recurrent endometrial cancer with mutated ARID1A (3 years); Proportion of patients with objective response rate with recurrent ovarian cancer with mutated ARID1A (3 years)

Answer: C