TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Brief Summary: The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.


Options:
A: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R (Week 16 of Period R)
B: Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria (Week 24)
C: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
D: The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16 (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week Treatment, Multi-center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler
Brief Summary: This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.


Options:
A: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
B: All cause mortality at 3 years
C: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84) (From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84))
D: Trough Forced Expiratory Volume in 1 Second (FEV1). (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week Treatment, Multi-center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler
Brief Summary: This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (after 12 weeks of treatment)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) (End of treatment (Week 12))
C: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84) (From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84))
D: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Pressure as a Primary Mode for Respiratory Distress Syndrome in Preterm Infants
Brief Summary: The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal ventilation when compared to nasal continuous positive airway pressure.(NCPAP)


Options:
A: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)
B: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))
C: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (At 7 days after non-invasive respiratorynsupport.)
D: Trigger Delay (last 5-min of each 15-min trial)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Pressure as a Primary Mode for Respiratory Distress Syndrome in Preterm Infants
Brief Summary: The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal ventilation when compared to nasal continuous positive airway pressure.(NCPAP)


Options:
A: Extubation failure (apnea rate and respiratory failure.)
B: Trigger Delay (last 5-min of each 15-min trial)
C: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (At 7 days after non-invasive respiratorynsupport.)
D: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Pressure as a Primary Mode for Respiratory Distress Syndrome in Preterm Infants
Brief Summary: The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal ventilation when compared to nasal continuous positive airway pressure.(NCPAP)


Options:
A: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))
B: Duration of NIV Support (10 days); Failure of NIV Support (10 days)
C: The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. (1 year)
D: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (At 7 days after non-invasive respiratorynsupport.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Nasal Intermittent Positive Pressure Ventilation Versus Nasal Continuous Positive Pressure as a Primary Mode for Respiratory Distress Syndrome in Preterm Infants
Brief Summary: The purpose of this study is to evaluate the hypothesis that nasal intermittent positive pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will decrease the need for conventional endotracheal ventilation when compared to nasal continuous positive airway pressure.(NCPAP)


Options:
A: The rate of successful extubation with either mode of NCPAP (Day 7 post primary extubation)
B: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))
C: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)
D: Trigger Delay (last 5-min of each 15-min trial)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Post-treatment Care of Breast Cancer Survivors
Brief Summary: The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women.


Options:
A: Subscale quality of life of the questionnaire: EORTC QLQ C30 (After each treatment completion, during follow up; first year every 3 months, second year every 6 months)
B: Fear of Recurrence Level-ACCRE FCR (6-8 weeks after treatment)
C: Change in FACIT-TS questionnaire score (Baseline, 6 months)
D: Patient satisfaction with nurse communication during the Mini-AFTERc intervention (1 week post intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Post-treatment Care of Breast Cancer Survivors
Brief Summary: The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women.


Options:
A: Quality of life; EORTC-QLQ-C30 and EQ 5D (2 years)
B: The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative (Baseline); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive (Baseline); The Expanded Prostate Cancer Index (EPIC) - Bowel Health (Baseline); The Expanded Prostate Cancer Index (EPIC) - Sexual Health (Baseline); The Expanded Prostate Cancer Index (EPIC) - General Health (Baseline); The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean (Baseline); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative (5 Months); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive (5 Months); The Expanded Prostate Cancer Index (EPIC) - Bowel Health (5 Months); The Expanded Prostate Cancer Index (EPIC) - Sexual Health (5 Months); The Expanded Prostate Cancer Index (EPIC) - General Health (5 Months); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative (12 Months); The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive (12 Months); The Expanded Prostate Cancer Index (EPIC) - Bowel Health (12 Months); The Expanded Prostate Cancer Index (EPIC) - Sexual Health (12 Months); The Expanded Prostate Cancer Index (EPIC) - General Health (12 Months); Confidence in Symptom Self-Management (5 months); Confidence in Symptom Self-Management (12 months)
C: Patient satisfaction with follow-up care (up to 60 months after completion of primary treatment); Costs-effectiveness (assessed at 60 months after completion of primary treatment)
D: Change in FACIT-TS questionnaire score (Baseline, 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Post-treatment Care of Breast Cancer Survivors
Brief Summary: The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women.


Options:
A: Weight loss maintenance (6 - 18 months)
B: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
C: Change in FACIT-TS questionnaire score (Baseline, 6 months)
D: Menopausal symptoms (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Post-treatment Care of Breast Cancer Survivors
Brief Summary: The overall goal of this proposal is to improve the post-treatment care of breast cancer survivors and to understand the barriers to optimal post-treatment care in Latina and Non-Hispanic women.


Options:
A: Change in FACIT-TS questionnaire score (Baseline, 6 months)
B: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) (6 months)
C: Change from Baseline in Body Composition (At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis)
D: Fatigue in Breast Cancer Survivors (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effective Aids Treatment and Support in the Free State (FEATS): Adherence and Nutritional Support for Effective and Sustainable Antiretroviral Treatment in Resource Constrained Settings
Brief Summary: The aim of this study is to investigate the benefits of ARV treatment to patients, to the family members of patients on ARV treatment, and to communities at large. The study also aims to investigate the impact of a peer adherence support and a nutritional intervention on measures of treatment success. To this end, 648 patients who had commenced ARV treatment in the past month at twelve selected health care facilities will be recruited into the study. In addition, 204 randomly sampled households from the communities served by the twelve selected clinics will be recruited into the study. Trained enumerators will at baseline conduct semi-structured interviews with patients and households. Following the baseline survey, patients recruited into the study will be randomly assigned to one of three groups:

* Patients receiving ARV treatment and the associated support currently provided in the public sector ARV treatment programme.
* Patients receiving (a) plus bi-weekly visits by an experienced ARV patient who has been trained as a peer adherence supporter
* Patients receiving (a) and (b) plus a weekly nutritional supplement in the form of two 400g cans of meatballs and spaghetti in tomato sauce The group of 'comparison' households comprises the fourth group. Trained enumerators will conduct follow-up interviews with all patients and households at approximately six- and at twelve-months respectively. In addition, the ARV coordinator and other providers working in the ARV treatment programme at each of the twelve selected health care facilities will be interviewed by trained enumerators, at baseline and again at six- and at twelve-months. Clinical data will be obtained from patient files at baseline and at completion of the study. Using these data, various outcomes of importance to the study will be compared between the four study groups, using experimental and non-experimental methods.


Options:
A: Patient Health Questionnaire (PHQ-9) (8 weeks); WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) (8 weeks)
B: 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)
C: Change from baseline Mental health distress at 18 months (Baseline and 18 months post baseline)
D: CD4 count (6-monthly); RNA viral load (6-monthly); Haemoglobin (6-monthly); self-reported adherence (CASE index) (6-monthly); health-related quality of life (EQ-5D/EQ-VAS) (6-monthly); anthropometrics (monthly to 6-monthly); food security (USDA scales) (6-monthly); time allocation/physical activity levels (6-monthly); household welfare (6-monthly)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?
Brief Summary: Improved hand hygiene is known to reduce transmission of both respiratory (RTI) and gastrointestinal infections (GTI) under "semi-closed" conditions such as hospitals, day-care centres and schools. It is not known if similar interventions would have the desired effect in a regular office work. This study is aiming to investigate this possibility by recruiting volunteers from several companies in the Helsinki Region. The two intervention groups will receive detailed instructions e.g. for proper coughing and sneezing, and for regular cleaning of hands with either standard liquid soap or with alcohol-based gel rubbing. Third group will serve as the control and is advised not to change their previous behaviour in this respect. The participants will report weekly possible RTI or GTI symptoms and related days off through internet. The study is planned to run about 18 months to cover the seasonal variation of the epidemics of the causative different viruses.


Options:
A: To compare the overall survival of patients at high risk for developing peritoneal carcinomatosis from colorectal cancer who undergo mandatory second look surgery + HIPEC and CRS (if applicable) vs. similar patients who receive standard of care. (Follow-up will occur every 3 months for two years, every six months for three ye)
B: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))
C: Reduction of rhinovirus-induced common colds. (9 weeks)
D: the episodes due to respiratory tract infections (8 moth); The episodes due to gastroenteritis (8 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?
Brief Summary: Improved hand hygiene is known to reduce transmission of both respiratory (RTI) and gastrointestinal infections (GTI) under "semi-closed" conditions such as hospitals, day-care centres and schools. It is not known if similar interventions would have the desired effect in a regular office work. This study is aiming to investigate this possibility by recruiting volunteers from several companies in the Helsinki Region. The two intervention groups will receive detailed instructions e.g. for proper coughing and sneezing, and for regular cleaning of hands with either standard liquid soap or with alcohol-based gel rubbing. Third group will serve as the control and is advised not to change their previous behaviour in this respect. The participants will report weekly possible RTI or GTI symptoms and related days off through internet. The study is planned to run about 18 months to cover the seasonal variation of the epidemics of the causative different viruses.


Options:
A: The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: (1 month); The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: (1 month); The primary endpoint is the difference in SARS-CoV-2 infection between the two groups after 1 months and is a combined endpoint consisting of primary outcome components 1, 2 and/or 3: (1 month)
B: Reduction of rhinovirus-induced common colds. (9 weeks)
C: Secondary infection with influenza of the household members who are healthy at the start of the study
D: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?
Brief Summary: Improved hand hygiene is known to reduce transmission of both respiratory (RTI) and gastrointestinal infections (GTI) under "semi-closed" conditions such as hospitals, day-care centres and schools. It is not known if similar interventions would have the desired effect in a regular office work. This study is aiming to investigate this possibility by recruiting volunteers from several companies in the Helsinki Region. The two intervention groups will receive detailed instructions e.g. for proper coughing and sneezing, and for regular cleaning of hands with either standard liquid soap or with alcohol-based gel rubbing. Third group will serve as the control and is advised not to change their previous behaviour in this respect. The participants will report weekly possible RTI or GTI symptoms and related days off through internet. The study is planned to run about 18 months to cover the seasonal variation of the epidemics of the causative different viruses.


Options:
A: Diarrhoea (<5s) (21 months)
B: Incidence of Diarrhea (2 weeks)
C: Direct observation of hand washing prior to eating a snack (8 weeks)
D: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: STOPFLU: Is it Possible to Reduce the Number of Days Off in Office Work by Improved Hand-hygiene?
Brief Summary: Improved hand hygiene is known to reduce transmission of both respiratory (RTI) and gastrointestinal infections (GTI) under "semi-closed" conditions such as hospitals, day-care centres and schools. It is not known if similar interventions would have the desired effect in a regular office work. This study is aiming to investigate this possibility by recruiting volunteers from several companies in the Helsinki Region. The two intervention groups will receive detailed instructions e.g. for proper coughing and sneezing, and for regular cleaning of hands with either standard liquid soap or with alcohol-based gel rubbing. Third group will serve as the control and is advised not to change their previous behaviour in this respect. The participants will report weekly possible RTI or GTI symptoms and related days off through internet. The study is planned to run about 18 months to cover the seasonal variation of the epidemics of the causative different viruses.


Options:
A: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)
B: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))
C: Percent of Healthcare Workers Testing Positive for COVID-19. (3 weeks); Percent of Patients Testing Positive for COVID-9. (2 weeks); Percent of Community Participants Testing Positive for COVID-9. (3 weeks)
D: Physical health symptoms (1 day); Lack of physical health symptoms (1 day)

Answer: B