TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Early Childhood Growth and Development in Resource-poor LMICs by Incorporating Deworming in Integrated Child Health Care
Brief Summary: Worldwide, over 2 billion people suffer from worm infections in developing countries. These infections are especially damaging to the health of children, resulting in both short-term and lifelong disability. Older children with worm infections are more likely to be stunted, underweight, vulnerable to other illnesses and perform poorly in school compared to non-infected children. Large-scale deworming programs in school-age children are therefore recommended by the World Health Organization (WHO). WHO also recommends deworming of preschool-age children (as of 12 months of age) in these areas; however, the benefits of deworming, especially in the 12-24 month age group, have been inadequately studied. This knowledge is urgently needed as studies show that all children have a similar potential for healthy growth and development, provided that appropriate nutrition and health interventions are given in the critical window of opportunity before the age of two.

Therefore, the investigators are proposing to undertake a randomized controlled trial to determine the effect of deworming program for improving growth and development in children between 12 and 24 months of age. Our results will provide solid rigorous evidence on if, when, and how often, deworming should be integrated into routine child health care packages provided by Ministries of Health in the 130 countries in the world where worm infections are endemic.


Options:
A: CD4 count (every 6 months for 24 months (enrollment and months 6, 12, 18, and 24 )); HIV-1 RNA level (enrollment, 12, and 24 months.)
B: Mean (± standard deviation) weight gain (kg) (from 12 to 24 months of age)
C: parasite cleared and reduced up to 80% at day 42 (42 days)
D: intestinal parasitic infections (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Early Childhood Growth and Development in Resource-poor LMICs by Incorporating Deworming in Integrated Child Health Care
Brief Summary: Worldwide, over 2 billion people suffer from worm infections in developing countries. These infections are especially damaging to the health of children, resulting in both short-term and lifelong disability. Older children with worm infections are more likely to be stunted, underweight, vulnerable to other illnesses and perform poorly in school compared to non-infected children. Large-scale deworming programs in school-age children are therefore recommended by the World Health Organization (WHO). WHO also recommends deworming of preschool-age children (as of 12 months of age) in these areas; however, the benefits of deworming, especially in the 12-24 month age group, have been inadequately studied. This knowledge is urgently needed as studies show that all children have a similar potential for healthy growth and development, provided that appropriate nutrition and health interventions are given in the critical window of opportunity before the age of two.

Therefore, the investigators are proposing to undertake a randomized controlled trial to determine the effect of deworming program for improving growth and development in children between 12 and 24 months of age. Our results will provide solid rigorous evidence on if, when, and how often, deworming should be integrated into routine child health care packages provided by Ministries of Health in the 130 countries in the world where worm infections are endemic.


Options:
A: Severe Anemia
B: Understanding of key findings (30 minutes)
C: Mean (± standard deviation) weight gain (kg) (from 12 to 24 months of age)
D: Mean (± standard deviation) weight gain (kg) (Change between birth and six months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Alzheimer's Disease Multiple Intervention Trial
Brief Summary: The purpose of this study is to conduct a two-year randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention.


Options:
A: 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);; 2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);; 3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
B: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (24 months)
C: Primary Outcome Measure(s) evaluate the efficacy and cost-effectiveness of the intervention in reducing carer burden, improving behaviour problems in elderly persons with dementia and reducing the costs of illness. (by the end of the study)
D: Neuropsychiatric Inventory; Cornell Depression in Dementia Scale; Activities of Daily Living

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Alzheimer's Disease Multiple Intervention Trial
Brief Summary: The purpose of this study is to conduct a two-year randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention.


Options:
A: Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) (Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
B: ADL/IADL (Baseline, t2, t3); Caregiver upset (Baseline, t2, t3); Caregiver confidence (when needed); Behaviors (Baseline, t2, t3)
C: Functional dependence (Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization)
D: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Alzheimer's Disease Multiple Intervention Trial
Brief Summary: The purpose of this study is to conduct a two-year randomized, controlled clinical trial to improve functioning among older adults with Alzheimer's disease by comparing a control group receiving best practices primary care with an intervention group receiving best practice primary care plus a home-based occupational therapy intervention.


Options:
A: The difference of rate of estimated glomerular filtration rate (eGFR) decline (30 months)
B: Neuropsychiatric Inventory; Cornell Depression in Dementia Scale; Activities of Daily Living
C: Depression Severity (2 week)
D: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.


Options:
A: Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate (52 weeks)
B: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)
C: Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks (Baseline and Weeks 2 to 52)
D: All cause mortality at 3 years

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.


Options:
A: Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12)
B: Adjusted Rate of Moderate or Severe Exacerbations (52-week treatment period)
C: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)
D: Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d (26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.


Options:
A: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84 (Baseline and Day 84)
B: Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84 (Baseline and Day 84)
C: Post-dose TGV(FRC) (After 8 Weeks) (8 weeks); Endurance Time (After 8 Weeks) (8 weeks)
D: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week Treatment, Multi-center, Randomized, Doubleblind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.


Options:
A: Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment); Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1) (Week 24 of treatment)
B: Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (64 weeks)
C: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 (Week 26)
D: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks (Week 8)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) Used in the Differentiation of Focal Pancreatic Masses
Brief Summary: The aim of the study is to assess the accuracy of real-time perfusion imaging pattern of pancreatic focal lesions visualized by contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) for the differential diagnosis between chronic pseudotumoral pancreatitis and pancreatic cancer in a prospective multicenter design.

The study will include patients with focal pancreatic masses evaluated by CEH-EUS and EUS-FNA. The diagnosis is usually unknown in the moment of the initial evaluation, the patients being included based on a suspicion of focal pancreatic masses after transabdominal ultrasound, CT or MR examinations. However, after a complete evaluation, a final diagnosis will be reached based on the combination of EUS-FNA cytology/pathology, surgical pathology and minimum 12 months follow-up.


Options:
A: Value of endoscopic ultrasound elastography for the differential diagnoses of pancreatic masses. (18 months)
B: Compare the degree of cytologic quality in specimen obtained by EUS-FNA with or without suction, pushing the stylet or injecting air. (within 6 months)
C: Contrast enhanced harmonic endoscopic ultrasound (Every six months)
D: Compare the Median Number of Passes Required to Establish a Diagnosis (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability: a Randomised, Controlled, Trial Protocol
Brief Summary: Motion style acupuncture treatment(MSAT) is a treatment method in which the patient is exposed to active or passive movement and exercise during acupuncture, as opposed to conventional acupuncture. The purpose of this study is to investigate the effect of MSAT in the treating pain and severe functional disability in acute LBP patients.


Options:
A: Change from Baseline in numerical rating scale of back pain (Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.)
B: Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire (Baseline and one week after discharge from emergency department)
C: Functional Impairment as Measured on the Roland Morris Disability Questionnaire (1 week)
D: Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake) (Baseline and Day 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability: a Randomised, Controlled, Trial Protocol
Brief Summary: Motion style acupuncture treatment(MSAT) is a treatment method in which the patient is exposed to active or passive movement and exercise during acupuncture, as opposed to conventional acupuncture. The purpose of this study is to investigate the effect of MSAT in the treating pain and severe functional disability in acute LBP patients.


Options:
A: Nepean Dyspepsia Index (4 weeks)
B: number of days with migraine (4 weeks); frequency of migraine attacks (4 weeks)
C: Change from Baseline in numerical rating scale of back pain (Before treatment, At 30 minutes, 2, 4, and 24 weeks after treatment.)
D: The changes in the pain score. (wk52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial
Brief Summary: The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse checking the preventive modalities and/or the presence of comorbidities such as infections ( e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin, antiaggregant,anti-hypertensive treatment...), cancers (e.g.mammography,...), osteoporosis (e.g. bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the impact of an educational program aimed at permitting rheumatoid arthritis patients to auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).


Options:
A: Overall functioning (18 months); Incremental cost-effectiveness ratio (ICER) (18 months)
B: Weight change
C: N/A
D: Comorbidities treatment (6 months later); Auto-DAS: Patient education to calculate his Disease Activity Score (6 months after)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial
Brief Summary: The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse checking the preventive modalities and/or the presence of comorbidities such as infections ( e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin, antiaggregant,anti-hypertensive treatment...), cancers (e.g.mammography,...), osteoporosis (e.g. bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the impact of an educational program aimed at permitting rheumatoid arthritis patients to auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).


Options:
A: Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL (12 months)
B: Health Care Consumption (1 year); Dependence in Activities of Daily Living (1 year); Satisfaction With Health and Social Care (1 year)
C: Comorbidities treatment (6 months later); Auto-DAS: Patient education to calculate his Disease Activity Score (6 months after)
D: Change in HADS-A score from baseline to three months follow-up (Three months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Usefulness of a Center Specialized in the Standardized Management of Rheumatoid Arthritis: The COMEDRA Trial
Brief Summary: The two objectives of this trial are :1 To evaluate the impact of a visit with a nurse checking the preventive modalities and/or the presence of comorbidities such as infections ( e.g. vaccinations), cardiovascular-diseases (e.g. Indication to statin, antiaggregant,anti-hypertensive treatment...), cancers (e.g.mammography,...), osteoporosis (e.g. bone densitometry,..) in patients suffering from Rheumatoid Arthritis 2 To evaluate the impact of an educational program aimed at permitting rheumatoid arthritis patients to auto-evaluate their disease activity by collecting the Disease Activity Score (DAS28-ESR).


Options:
A: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)
B: Change in Depressive symptoms (3, 6 and 12 months.)
C: To investigate whether the use of QOL questionnaires during the assessment and management of lung cancer patients results in improved quality of life
D: Comorbidities treatment (6 months later); Auto-DAS: Patient education to calculate his Disease Activity Score (6 months after)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
Brief Summary: A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients.

The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.


Options:
A: Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) (Baseline to168 days)
B: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) (Baseline, Day 29); Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29) (Baseline, Day 29); Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier (Baseline, Day 29)
C: Change in CFQ-R Respiratory Symptoms Scale (RSS) Score (Day 0 to Day 28)
D: Feasibility of using the CFF National Patient Registry (28 days from time of start of IV antibiotic therapy.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants
Brief Summary: Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are \< 1500 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.


Options:
A: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
B: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
C: Time to reach full feeds (First 40 days after birth)
D: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Role Of Saccharomyces Boulardii in Preventin Necrotizing Enterocolitis in Very Low Birth Weight Infants
Brief Summary: Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are \< 1500 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.


Options:
A: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)
B: Necrotizing enterocolitis (8 weeks)
C: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
D: Human milk glycans (Change from day 2 to day 366)

Answer: C