TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism
Brief Summary: The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.


Options:
A: Progression free survival (5 years)
B: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))
C: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
D: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism
Brief Summary: The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.


Options:
A: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (Up to Day 180); Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH) (From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks))
B: Progression Free Survival (during chemotherapy and follow-up)
C: Incidence of venous thromboembolism during treatment (proximal deep vein thrombosis, pulmonary embolism, death related to venous thromboembolism) (20 days)
D: 2-Month Cumulative Incidence of VTE (Assessment with lower extremity ultrasound occured at day 60/ month 2)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: EXpanding Treatment for Existing Neurological Disease (EXTEND)
Brief Summary: The primary goal of the Phase II EXTEND trial is to investigate the effects of open-label hydroxyurea treatment, escalated to maximum tolerated dose, for children with Sickle Cell Anemia and either conditional (170 - 199 cm/sec) or abnormal (≥200 cm/sec) Transcranial Doppler velocities. The primary endpoint will be measured after 18 months of hydroxyurea but treatment will continue until a common study termination date.


Options:
A: Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct (From study entry to study exit)
B: N/A
C: Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).)
D: Maximum Time-Averaged Mean velocity (TAMV) on TCD exam (18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema
Brief Summary: Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only triamcinolone acetonide was available to ophthalmologists. This molecule, developed initially for rheumatological or dermatological use, has been increasingly deployed in ophthalmology, while still off-label.

In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into the vitreous cavity obtained the label for inflammatory macular edema. This protocol is therefore designed to compare the efficacy and safety of peri- and intra-ocular injections of corticosteroids in the treatment of inflammatory macular edema.


Options:
A: Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (36 months)
B: N/A
C: Recurrence of uveitis before and after implantation. (34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation)
D: Evaluation of the effectiveness of a subconjunctival injection of triamcinolone on reducing the central macular thickness versus an intravitreal implant of dexamethasone between patient selection and 2 months after treatment (At 2 months after treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema
Brief Summary: Corticosteroids, whether injected peri- or intra-ocularly, remain indispensable tools of the therapeutic arsenal in treating inflammatory macular edema. However, a few years ago, only triamcinolone acetonide was available to ophthalmologists. This molecule, developed initially for rheumatological or dermatological use, has been increasingly deployed in ophthalmology, while still off-label.

In 2011, the delivery system of dexamethasone from biodegradable and injectable implant into the vitreous cavity obtained the label for inflammatory macular edema. This protocol is therefore designed to compare the efficacy and safety of peri- and intra-ocular injections of corticosteroids in the treatment of inflammatory macular edema.


Options:
A: N/A
B: Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (36 months)
C: Evaluation of the effectiveness of a subconjunctival injection of triamcinolone on reducing the central macular thickness versus an intravitreal implant of dexamethasone between patient selection and 2 months after treatment (At 2 months after treatment)
D: Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Evaluation of Efficacy at 2 Weeks of Duac® Fixed Dose Combination Gel in Treatment of Facial Acne Vulgaris in Japanese Subjects
Brief Summary: This is a multicentre, randomized, single-blind (investigator is blinded), active (the combination therapy of adapalene \[ADA\] and clindamycin \[CLDM\])-controlled and parallel-group study in Japanese subjects with facial acne vulgaris. The purpose of this study is to evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3% (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks.


Options:
A: Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) (At Week 12); Change in Inflammatory Lesion Count From Baseline to Week 12 (Baseline to Week 12); Change in Noninflammatory Lesion Count From Baseline to Week 12 (Baseline to Week 12)
B: Mean Change From Baseline in Erythema at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Dryness at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Peeling at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Burning/Stinging at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Itching at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Oiliness at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12); Mean Change From Baseline in Skin Overall Comfort at Weeks 1, 2, 4, 8, and 12 (Baseline and Weeks 1, 2, 4, 8, and 12)
C: Success Rate (Week 12); Changes From Baseline in Inflammatory Lesion Counts (Baseline - Week12); Changes From Baseline in Non-Inflammatory Lesion Counts (Baseline - Week 12)
D: Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2 (Baseline (Day 1) and Week 2)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega 3/6 Fatty Acids for Reading in Children: A Randomised, Double-blind, Placebo-controlled Trial in 9-year-old Mainstream Schoolchildren in Sweden
Brief Summary: The primary objective was to assess whether supplementation of Omega 3/6 fatty acids improves mainstream schoolchildren's reading ability. The secondary objective was to assess whether Omega 3/6 improves cognitive functions such as attention, memory, learning, language/communication, problem solving and social ability.This was a 3-month randomised, double-blind, placebo-controlled study followed by one-way crossover (placebo to active treatment) for an additional 3 months. Mainstream schoolchildren aged 9-10 years were initially randomised to receive three Omega 3/6 capsules twice daily or identical placebo. All outcome measures were assessed at baseline, 3 months and 6 months. The primary outcome measure was the LOGOS test, a comprehensive test battery for evaluating reading abilities. Secondary outcome measures were the parent-rated Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV, 5-15 scale (domains of learning, memory, language/communication and problem solving); Social and Communication Disorders Checklist (to evaluate social ability)


Options:
A: Cognitive control task - functional MRI (change over 16 week intervention period (pre/post))
B: Laboratory assessment of inattention and impulsivity with Test of Variables of Attention (TOVA); Blood lipids profile
C: Change in ADHD RS-IV total score (Baseline, month 4, and month 6)
D: Change in reading ability (0, 3 and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Study on the Skin Functional Parameters to Assess Skin Barrier Improvement After the Use of a Commercially Available Oil Bath Containing 84.75% Soybean Oil Compared to no Bath Additive
Brief Summary: Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be compromised. Skin care practices to decrease the risk of development of dry skin and/or to improve dry skin condition have barely been investigated. Bathing with bath oils has been shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore, the aim of this study is to investigate the effect of bathing every other day on the skin barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH (pH) were measured to characterize skin barrier function.


Options:
A: Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm (Day 28 +/- 3)
B: Atopic dermatitis (AD) (AD 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding); Food allergy to any intervention allergen (0-36 months, assessed first at 36 months, with follow-up investigations at intervals up to year 2044, provided funding)
C: Cumulative incidence of provider-diagnosed AD (up to 24 months)
D: Trans Epidermal Water Loss(TEWL) (first 7 days of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Study on the Skin Functional Parameters to Assess Skin Barrier Improvement After the Use of a Commercially Available Oil Bath Containing 84.75% Soybean Oil Compared to no Bath Additive
Brief Summary: Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be compromised. Skin care practices to decrease the risk of development of dry skin and/or to improve dry skin condition have barely been investigated. Bathing with bath oils has been shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore, the aim of this study is to investigate the effect of bathing every other day on the skin barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH (pH) were measured to characterize skin barrier function.


Options:
A: Number of Participants With Peanut Allergy at 60 Months of Age - by Skin Prick Test Stratum (60 months); Number of Participants With Peanut Allergy at 60 Months of Age - Both Strata Combined (60 months)
B: Skin Barrier Function (The Skin Barrier Function will be carried out by measuring trans epidermal water loss 10 minutes before first bath and 10 minutes after first bath.)
C: Presence of eczema (12 months of age.); Confirmed diagnosis of food allergy at 12 months (52 weeks). (12 months of age)
D: Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm (Day 28 +/- 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study
Brief Summary: Chronic Obstructive Pulmonary Disease Transcription Factor and Cytokine Study.


Options:
A: myeloperoxidase in induced sputum (3 weeks)
B: Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (Measured monthly through 13 months)
C: Inflammatory markers (outcome will be assessed up to two months post initial bronchoscopy)
D: To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo (Week 14 post treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Subjects With Elevated Intraocular Pressure
Brief Summary: To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.

Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.


Options:
A: Change in Intraocular Pressure (IOP) Over Nocturnal Time Period (Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9)
B: Intraocular Pressure (IOP) (Study treatment was administered for 28 days, and outcome measures collected on Day 29)
C: Intraocular Pressure (IOP) (Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90))
D: Intraocular Pressure (IOP) (29 Days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Multicomponent Nurse Intervention to Reduce the Incidence and Severity of Delirium in Hospitalized Older Adults: MID-Nurse-P
Brief Summary: Objectives: To analyze if a multicomponent nurse-led intervention randomized clinical trial (MID-Nurse Study) is feasible (Pilot study), and can reduce the incidence, duration, and severity of delirium in hospitalized older adults in an AGU.

Design: Parallel-group Double-blind Randomized Clinical Trial (Pilot Study). Setting: AGU "Complejo Hospitalario Universitario from Albacete" (Albacete, Spain).

Participants: 50 patients ≥ 65 years hospitalized in the AGU (21 intervention group, 29 control group).

Interventions: After risk factor analysis, all participants in the intervention group (IG) received a daily multicomponent intervention (orientation, sensorial deficit, sleep, mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain) by the intervention nurses. The control group (CG) received usual care.

Measurements: Delirium presence was determined daily with the Confusion Assessment Method (CAM), and delirium severity with the Delirium Rating Scale-Revised-98 (DRS). Mortality, days of hospitalization, use of physical restraint measures, and use of drugs for delirium control (neuroleptics and benzodiacepines) were also recorded.


Options:
A: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
B: Compliance with recommendations for intraoperative temperature management (1 day); Compliance with recommendations for intraoperative blood glucose management (1 day); Assess the usability of the Anesthesiology Control Tower (ACT) for an operating suite (2 years)
C: Instrumental and Physical Functionality (Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)); Re-Admission to Hospital (Assessed 3 months and 12 months after the time of hospital discharge (T1, T2).); Institutionalisation (Assessed 12 months after the time of hospital discharge (T2).)
D: Delirium incidence (% participants) (Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of a Multicomponent Nurse Intervention to Reduce the Incidence and Severity of Delirium in Hospitalized Older Adults: MID-Nurse-P
Brief Summary: Objectives: To analyze if a multicomponent nurse-led intervention randomized clinical trial (MID-Nurse Study) is feasible (Pilot study), and can reduce the incidence, duration, and severity of delirium in hospitalized older adults in an AGU.

Design: Parallel-group Double-blind Randomized Clinical Trial (Pilot Study). Setting: AGU "Complejo Hospitalario Universitario from Albacete" (Albacete, Spain).

Participants: 50 patients ≥ 65 years hospitalized in the AGU (21 intervention group, 29 control group).

Interventions: After risk factor analysis, all participants in the intervention group (IG) received a daily multicomponent intervention (orientation, sensorial deficit, sleep, mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain) by the intervention nurses. The control group (CG) received usual care.

Measurements: Delirium presence was determined daily with the Confusion Assessment Method (CAM), and delirium severity with the Delirium Rating Scale-Revised-98 (DRS). Mortality, days of hospitalization, use of physical restraint measures, and use of drugs for delirium control (neuroleptics and benzodiacepines) were also recorded.


Options:
A: Participant Reduced Symptom Burden (From Baseline to 4 Days Later (Daily assessments at 2 hours [+/- 3 hours] after the completion of 4-Hour infusion))
B: Delirium incidence (% participants) (Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
C: Recruitment rate (Up to 12 months)
D: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus
Brief Summary: In this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily activity disorders enroll in this study. These patients should have at least a course of therapy without proper response. After proper informing patients and taking testimonial patients enter to study. Then patients randomized in case and control group. In case group, patients took montelukast 10 milligram daily and in control group took placebo for 30 days. Other antipruritic or antiinflammatory medication has been stopped one week prior to starting treatment. Calcium, phosphorous, urea, creatinine, highly sensitive CRP (hsCRP), Parathyroid Hormone (PTH), hemoglobin and kt/V were measured at beginning and at end of study. pruritus severity assessed by Detailed Pruritus Score that introduced by Duo and Visual Analogue Score in beginning and at end of study in both group. Sleep disorder score and its severity added to crude score at beginning and end of study and change of measures analyzed.


Options:
A: Change From Baseline in the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score During Week 8 (Baseline, Week 8)
B: the longitudinal changes of itching (every week, up to 12 weeks.)
C: Change from Baseline in Detailed score proposed by Duo for pruritus (Change from Baseline in Detailed score at 1months)
D: Investigator Global Assessment (Disease severity assessed at baseline and 4 weeks, week 4 reported)

Answer: C