TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cytokine Removal in Cardiopulmonary Bypass Patients Using the Cytosorb ™ Filter
Brief Summary: Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in systemic inflammation and the main producers of pro- and antiinflammatory cytokines. Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6 and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory response induces post surgical monocyte immunosuppression which is indicated by an impaired production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral circulation with increased lactate levels, pronounced fluid accumulation, increased need of vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to decrease the inflammatory process have the potential to improve the perioperative course.

Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels for the first 36 hours after surgery and induces a decreased inflammatory response for up to 3 days post surgery.


Options:
A: Mortality at 30 days (30 days post-randomization); Composite (30 days post-randomization)
B: recovery of monocyte subsets (baseline, day1, 3, 5, 7 postoperative)
C: IL-6 (1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours)
D: Difference in occurrence of postoperative cognitive dysfunction between control and intervention group at six days after surgery as determined by using a validated battery of cognitive tests (9 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DB2114951: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy Umeclidinium/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD
Brief Summary: Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of COPD. This is a multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI 62.5/25 microgram \[mcg\] once daily administered via Novel Dry Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12 weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25 mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted approximately 7 days after the end of the study treatment.


Options:
A: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
B: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 24 on Treatment (Baseline and Week 24); Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in the First Second (FEV1) at Week 12 on Treatment (Baseline and Week 12)
C: Percentage of Patients to Experience Any Treatment-emergent Adverse Event (Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52))
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: DB2114951: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy Umeclidinium/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD
Brief Summary: Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of COPD. This is a multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI 62.5/25 microgram \[mcg\] once daily administered via Novel Dry Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12 weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25 mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted approximately 7 days after the end of the study treatment.


Options:
A: Moderate and severe COPD exacerbation rate over 52 weeks of treatment (1 year)
B: 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)
C: FEV1 AUC0-4 (at Week 24); Change From Baseline in Morning Pre-dose Trough FEV1 (at Week 24)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: DB2114951: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy Umeclidinium/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD
Brief Summary: Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of COPD. This is a multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI 62.5/25 microgram \[mcg\] once daily administered via Novel Dry Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12 weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25 mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted approximately 7 days after the end of the study treatment.


Options:
A: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
B: 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)
C: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: DB2114951: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy Umeclidinium/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD
Brief Summary: Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of COPD. This is a multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI 62.5/25 microgram \[mcg\] once daily administered via Novel Dry Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12 weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25 mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted approximately 7 days after the end of the study treatment.


Options:
A: Composite of Pharmacokinetic (PK) Parameters as a measure of systemic exposure. (PK Blood samples will be collected at Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose on Day 1 of each treatment period); Systemic exposure of FF and UMEC and VI following single inhaled doses (four inhalations) of FF/UMEC/VI 100mcg /62.5mcg /25mcg compared with FF/VI 100mcg /25mcg and UMEC/VI 62.5mcg /25mcg (PK Blood samples will be collected at Day 1 Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose.)
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
C: 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)
D: Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (Baseline and Day 169)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Mobile Insulin Titration Intervention (MITI) Study: Innovative Chronic Disease Management of Diabetes
Brief Summary: The purpose of this pilot study is to determine whether text message (and phone) communication can be effectively utilized to adjust long-acting insulin, compared to standard practice.


Options:
A: Medication regimen knowledge (One year)
B: Hemoglobin A1C (Baseline, 6 months and 12 months)
C: Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose (12 weeks)
D: HbA1c (Screen,16weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With Acne Vulgaris
Brief Summary: The study hypothesis are based on the assumption that :

* CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects
* CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile


Options:
A: Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2 (Baseline (Day 1) and Week 2)
B: Part 1: Total Atrophic Acne Scar Count Per Half-face (Week 24)
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: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Motivational Interviewing to Increase Contraception Use Among Young Women: a Randomized Control Trial
Brief Summary: Study design: This is a 2-phase study. During the first phase, the investigators developed a contraceptive counseling intervention based on the principles of Motivational Interviewing, trained counselors, and conducted a small pilot study to develop skills and refine the intervention.

The second phase is this feasibility randomized controlled trial (RCT) to compare outcomes between:

Group 1 - Women randomized to a 20-40 minute contraceptive counseling session based on the principles of motivational interviewing, vs.

Group 2 - Women receiving usual clinic care.

Population: Women, aged 15-29 years, presenting to the University of Chicago family planning clinic for termination of an unintended pregnancy.

Hypothesis: A larger proportion of women who are randomized to receive the MI counseling intervention will be using very effective contraception 3 months after the intervention.


Options:
A: Choice of contraceptive method on day of enrollment. (Day of enrollment)
B: Drinks per drinking day (6 months); Rate of effective contraception (6 months)
C: Use of very effective contraception (up to 3 months after termination of pregnancy appointment)
D: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific Region
Brief Summary: The goal is to build social/cultural, political/economic, and physical/built environments that will promote active play and intake of healthy food to prevent young child obesity in the Pacific Region. Our methods will support local culture in order to achieve this goal in these remote, underserved native populations. CHL will engage the community, and focus on capacity building and sustainable environmental change.

The focus of the CHL community-based program is to promote healthy eating and to increase physical activity. In order to demonstrate effectiveness, the investigators will recruit and measure children in six communities selected in each of our jurisdictions in the Pacific. These represent intervention communities, comparison communities, and temporal communities.


Options:
A: Change in child adiposity from baseline measured via BMI z-score (Enrollment, 6 months, 12 months, 18 months, 24 months); Change in adult adiposity from baseline measured via BMI (Enrollment, 12 months, 24 months)
B: Change in Concentration of Lactobacilli (Baseline, 8 months); Change in Concentration of Mutans Streptococcus (Baseline, 8 months)
C: Increase in parent knowledge, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parent skills, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Decrease in parental high-risk behaviors, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parental-child involvement, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
D: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 24 months); Change in Waist Circumference (Baseline, 78 months); Prevalence of Acanthosis Nigricans (Baseline, 24 months); Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 78 months); Change in Waist Circumference (Baseline, 24 months); Prevalence of Acanthosis Nigricans (Baseline, 78 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific Region
Brief Summary: The goal is to build social/cultural, political/economic, and physical/built environments that will promote active play and intake of healthy food to prevent young child obesity in the Pacific Region. Our methods will support local culture in order to achieve this goal in these remote, underserved native populations. CHL will engage the community, and focus on capacity building and sustainable environmental change.

The focus of the CHL community-based program is to promote healthy eating and to increase physical activity. In order to demonstrate effectiveness, the investigators will recruit and measure children in six communities selected in each of our jurisdictions in the Pacific. These represent intervention communities, comparison communities, and temporal communities.


Options:
A: Growth trajectories (using BMI, waist circumference), body composition (3 months)
B: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
C: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 24 months); Change in Waist Circumference (Baseline, 78 months); Prevalence of Acanthosis Nigricans (Baseline, 24 months); Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 78 months); Change in Waist Circumference (Baseline, 24 months); Prevalence of Acanthosis Nigricans (Baseline, 78 months)
D: Blood pressure (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Children's Healthy Living Program for Remote Underserved Minority Populations in the Pacific Region
Brief Summary: The goal is to build social/cultural, political/economic, and physical/built environments that will promote active play and intake of healthy food to prevent young child obesity in the Pacific Region. Our methods will support local culture in order to achieve this goal in these remote, underserved native populations. CHL will engage the community, and focus on capacity building and sustainable environmental change.

The focus of the CHL community-based program is to promote healthy eating and to increase physical activity. In order to demonstrate effectiveness, the investigators will recruit and measure children in six communities selected in each of our jurisdictions in the Pacific. These represent intervention communities, comparison communities, and temporal communities.


Options:
A: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 24 months); Change in Waist Circumference (Baseline, 78 months); Prevalence of Acanthosis Nigricans (Baseline, 24 months); Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 78 months); Change in Waist Circumference (Baseline, 24 months); Prevalence of Acanthosis Nigricans (Baseline, 78 months)
B: BMI and aerobic fitness (1 schoolyear)
C: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
D: Change in Weight Status (baseline and 2 year follow-up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma
Brief Summary: Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.


Options:
A: Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. (Baseline and 24 months)
B: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)
C: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
D: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma
Brief Summary: Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.


Options:
A: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)
B: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
C: Primary outcomes included IOP and reduction in medication use. (15 month)
D: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma
Brief Summary: Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.


Options:
A: Proportion of Eyes With ≥ 20% Decrease in Intraocular Pressure (IOP) From Baseline to the Hypotensive Medication-free 24-month Postoperative Examination Using Non-responder Imputation for Missing Data (Baseline; Month 24 postoperative)
B: Mean IOP at 6 months (6 months); Surgical complication rates (intraoperative and postoperative up to 12 months)
C: Number of Participants With > 20% Decrease in Mean Diurnal Intraocular Pressure (12 months); Number of Participants With > 20% Decrease in Diurnal Intraocular Pressure (24 months)
D: Change in Intraocular Pressure (Baseline to 5 years); Rate of Complications (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Topical Tranexamic Acid Versus Intravenous Administration to Reduce Blood Transfusion Rate in Total Knee Arthroplasty Surgery: Phase III, Unicentric, Controlled,Double Blind, Randomized Non Inferiority Clinical Trial.
Brief Summary: The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).


Options:
A: Fall in post-operative hemoglobin level after total knee replacement (First 7 days after surgery)
B: Blood transfusion rate (participants will be followed for the duration of hospital stay, an expected average of 5 days)
C: Blood Loss (Post operative day 3)
D: Total blood loss after operation (From the operation to the postoperative day 3 or 4); Decrease of hemoglobin level after operation (From the operation to the postoperative day 14)

Answer: B