TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.
Brief Summary: During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.


Options:
A: Mean 48-week Change in DAS28 (48 weeks after baseline assessment)
B: Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 (Day 169); Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population (Days 85, and 169 and postvisits on Days 28, 56, and 85)
C: The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population (Day 1 to Day 365)
D: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.
Brief Summary: During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.


Options:
A: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)
B: Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 (Week 16)
C: N/A
D: Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports (Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug); Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Extension Period: Number of Participants With Laboratory Test Abnormalities (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis (Includes AEs for every visit and up to 999 days after last dose of study drug); Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib (Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study will examine whether the implementation of an outreach program that employs a tracking/reminder/recall/home visiting strategy will have any impact on receipt of immunizations and preventive care among urban adolescents.


Options:
A: Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) (15 months)
B: Change in Vaccination Rate: HPV vaccine initiation among 11-12 year olds (Baseline and 5 months follow-up)
C: The percentage of adolescents who initiate the HPV vaccine series (1 year)
D: Intention to use condom if new partner (Change from Baseline Intention at 3 months); Intention to use condom if new partner (Change from Baseline Intention at 12 months); Intention to use condom if new partner (Change from Baseline Intention at 24 months); Attitude to prevention about HPV (Change from Baseline Attitude at 3 months); Attitude to prevention about HPV (Change from Baseline Attitude at 12 months); Attitude to prevention about HPV (Change from Baseline Attitude at 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study will examine whether the implementation of an outreach program that employs a tracking/reminder/recall/home visiting strategy will have any impact on receipt of immunizations and preventive care among urban adolescents.


Options:
A: Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) (15 months)
B: receipt of vaccine of interest at 28 days (28 days)
C: Change in Infant immunization status; Change in Infant well child care status
D: seasonal influenza vaccination (up to 4 months following reminder notification)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension
Brief Summary: Patients with advanced sarcoidosis often develop pulmonary hypertension. Pulmonary hypertension is a condition where the right side of the heart has to push the blood though the lungs at a higher pressure than normal. Since this pressure is higher, it is harder for the heart to pump the blood through the lungs to the left side of the body. If the blood can not get through the lungs, it can not get pumped through the rest of the body. This leads to weakness and shortness of breath. This type of hypertension does not usually respond to regular blood pressure medicines. The purpose of this study is to determine if bosentan (Tracleer) will help sarcoidosis associated pulmonary hypertension.


Options:
A: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
B: Improvement in six minute walk distance (16 weeks)
C: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
D: Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV (From Baseline up to the Final Assessment Visit (FAV) (average of 609 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Otitis Media Care With EHR-based Clinical Decision Support and Feedback
Brief Summary: This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes Otitis Media (OM) care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians.


Options:
A: Quality of otitis media care. (18 Months)
B: Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score (24 weeks)
C: rate of agreement between the diagnostic criteria applied in daily practice and those validated in the scientific literature
D: Receipt of colorectal cancer screening exam (fecal occult blood test, flexible sigmoidoscopy, or colonoscopy) within 4 months following delivery of an electronic message within the personal health record

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Otitis Media Care With EHR-based Clinical Decision Support and Feedback
Brief Summary: This protocol will prospectively develop a new electronic health record (EHR)-based health information technology (IT) intervention that a) summarizes Otitis Media (OM) care into clinically meaningful episodes-of-care, b) provides clinical decision support based upon evidence-based guidelines to primary care and ENT physicians working within an integrated physician network that uses a common EHR, and c) tests the additive effects on quality and resource utilization of providing feedback to physicians.


Options:
A: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)
B: Changes in decisional conflict (baseline and 3 month post intervention)
C: Quality of otitis media care. (18 Months)
D: Use of IV fluid (Intervention is 3 months per hospital)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hypertension in Hemodialysis Patients
Brief Summary: We will directly test the hypothesis that an initial strategy of lisinopril-based therapy will be more effective than atenolol-based therapy in causing regression of left ventricular hypertrophy (LVH) over one year in patients with hemodialysis hypertension despite similar degree of BP reduction.


Options:
A: Percent change in left ventricular volume index (LVVI) at Week 96.
B: Frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment (6 weeks)
C: Occurrence of clinically relevant calcium disturbances (patients are followed for 8 weeks); Occurrence of clinically relevant acid-base disturbances (patients are followed for 8 weeks)
D: The Primary End Point is the Regression of Left Ventricular Hypertrophy (LVH) by Echocardiographic Criteria From Baseline to 1 Year. (Baseline, 6 months, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of IL-1 Trap (Rilonacept) for Treatment of Familial Mediterranean Fever (FMF)
Brief Summary: Familial Mediterranean fever (FMF) is a genetic disease resulting in recurrent attacks of fever, abdominal pain, chest pain, arthritis and rash. There are 5-15% of patients who continue to have FMF attacks despite treatment with colchicine or who cannot tolerate colchicine. Currently there are no alternatives to colchicine. Pyrin, the protein that has a defect in FMF has an important role in the regulation of a molecule called interleukin (IL)-1 beta production and activity. This molecule is very important in the process of inflammation in FMF.

Therefore we propose to use IL-1 Trap (Rilonacept), a medication that binds and neutralizes IL-1.

We will enroll in this study 17 subjects from the age of 4 years, including adults with active FMF despite colchicine therapy. Subjects will receive in random order two 3-month courses of Rilonacept at 2.2 mg/kg (maximum 160 mg) by weekly subcutaneous injection and two 3-month courses of placebo injection. If patients have at least two FMF attacks during a treatment course they will be able to get if they choose the other treatment until the end of that treatment course. Our hypothesis is that Rilonacept will decrease the number of acute FMF attacks and will be safe to use. This study may confirm the importance of IL-1 in the cause of FMF.

Funding source - FDA Office of Orphan Products Development


Options:
A: Number of patients with less than a mean of one FMF attack per month (4 months)
B: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours (Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends)
C: Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) (16 weeks)
D: To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. (attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)); To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. (12 months of entire study length)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of IL-1 Trap (Rilonacept) for Treatment of Familial Mediterranean Fever (FMF)
Brief Summary: Familial Mediterranean fever (FMF) is a genetic disease resulting in recurrent attacks of fever, abdominal pain, chest pain, arthritis and rash. There are 5-15% of patients who continue to have FMF attacks despite treatment with colchicine or who cannot tolerate colchicine. Currently there are no alternatives to colchicine. Pyrin, the protein that has a defect in FMF has an important role in the regulation of a molecule called interleukin (IL)-1 beta production and activity. This molecule is very important in the process of inflammation in FMF.

Therefore we propose to use IL-1 Trap (Rilonacept), a medication that binds and neutralizes IL-1.

We will enroll in this study 17 subjects from the age of 4 years, including adults with active FMF despite colchicine therapy. Subjects will receive in random order two 3-month courses of Rilonacept at 2.2 mg/kg (maximum 160 mg) by weekly subcutaneous injection and two 3-month courses of placebo injection. If patients have at least two FMF attacks during a treatment course they will be able to get if they choose the other treatment until the end of that treatment course. Our hypothesis is that Rilonacept will decrease the number of acute FMF attacks and will be safe to use. This study may confirm the importance of IL-1 in the cause of FMF.

Funding source - FDA Office of Orphan Products Development


Options:
A: To Assess the Efficacy of Rilonacept in Decreasing the Number of Acute FMF Attacks. (attacks were assessed at the end of each 3 month treatment course (overall up to 6 month of rilonacept and 6 months of placebo, each)); To Determine if There is a Medically Important Difference Between the Safety Profiles of Rilonacept vs. Placebo. (12 months of entire study length)
B: Change From Baseline in Patient's Assessment of Pain Using a 5-Point Likert Scale (PAP-LS) in Index Joint to Averaged PAP-LS at 24, 48 and 72 Hours (Pre-dose on Day 1 (Baseline); post-dose at 4, 8, 12, 24, 48, 72 hours and then daily up to Day 13 or until gout flare ends)
C: To measure the effect of canakinumab on the frequency of FMF attacks defined as percentage of patients with at least 50% reduction in the attack frequency during 3 month treatment period. (12 weeks)
D: Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) (16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: 12-step Facilitation for the Dually Diagnosed
Brief Summary: This is a randomized trial testing the efficacy of a modified 12-step facilitation therapy for individuals with serious mental illness and alcohol use disorders, compared to usual treatment. 135 participants are randomized in 2:1 ratio to the modified 12-step facilitation (12 sessions of individual counseling) vs. treatment as usual. The primary hypothesis is that those receiving 12-step facilitation will have better drinking outcomes (percent days abstinence and drinks per drinking day)at end of treatment.


Options:
A: Acceptability (Study months 21 through 34)
B: Substance use and function questionnaire (2 years)
C: Global Assessment of Function (9 months and 21 months)
D: Percent days abstinent from alcohol (12, 24, 36, and 48 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phosphorus Improvement Pilot Study
Brief Summary: Specific Aim: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.

Hypothesis: Educating dialysis patients regarding phosphate containing additives will result in improved serum phosphorus levels.


Options:
A: Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention (1 month)
B: Number of Steps Completed in Transplant Process (18-24 months)
C: enhancing rates of family communication, donor evaluations, and transplantation (6 months)
D: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phosphorus Improvement Pilot Study
Brief Summary: Specific Aim: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.

Hypothesis: Educating dialysis patients regarding phosphate containing additives will result in improved serum phosphorus levels.


Options:
A: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)
B: total phosphate bound per gum piece fasting (15 min, 30 min, 45 min, 60 min post chewing); total phosphate bound per piece of gum post meal (5 min, 15 min, 30 min, 45 minutes post meal)
C: serum phosphorus (change from baseline to mean during 2 weeks active therapy)
D: The change in plasma phosphorus after 8 weeks of niacinamide versus placebo (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phosphorus Improvement Pilot Study
Brief Summary: Specific Aim: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.

Hypothesis: Educating dialysis patients regarding phosphate containing additives will result in improved serum phosphorus levels.


Options:
A: Number of Steps Completed in Transplant Process (18-24 months)
B: Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT (Up to 1 week after the transplant education day)
C: Referral for Kidney Transplantation (One Year)
D: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination With AMG 386 or Placebo in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma
Brief Summary: This is a phase 2, randomized, double blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with Cisplatin \& Capecitabine in the treatment of subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.


Options:
A: Progression Free Survival (PFS) (22 months)
B: Time to progression (The time from randomization until objective tumor progression or death)
C: Overall Survival (OS)- Phase 3 (Date of randomization until death (up to 2 years 3 months)); Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study) (Date of randomization until death (up to 1 year))
D: Overall Survival (OS) (2.5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination With AMG 386 or Placebo in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma
Brief Summary: This is a phase 2, randomized, double blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with Cisplatin \& Capecitabine in the treatment of subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.


Options:
A: Progression free survival (PFS), as measured by RECIST per local review (Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study.)
B: Progression Free Survival (PFS) (22 months)
C: Progression-free Survival (Treatment will continue until disease progression or intolerable toxicity, up to 2 years)
D: Overall survival (every course for first three courses, then every other course)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adolescent Adherence to Hormonal Contraception
Brief Summary: The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.


Options:
A: Highly-effective contraceptive use (6 months postpartum)
B: ART Adherence at 20 Weeks as Determined by VAS, Viral Load (20week [End of study]); ART Adherence at 20 Weeks as Determined by Pill Counts, ACTG Adherence Questionnaire, and VAS Scores (20week [End of study]); ART Adherence at 20 Weeks as Determined by Viral Load Count (20 week [End of study]); ART Adherence at 20 Weeks as Determined by Log of Viral Load Count (20week [End of study])
C: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
D: Rate of Enrollment (Month 12); Acceptability of the mHealth application (Month 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adolescent Adherence to Hormonal Contraception
Brief Summary: The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.


Options:
A: Sequence-verified HIV-transmission from index to partner participant (March 2009)
B: Contraceptive use at time of last sexual intercourse (18 months)
C: pregnancy
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adolescent Adherence to Hormonal Contraception
Brief Summary: The purpose of this study is to determine whether contraceptive compliance by young women can be improved through expanded counseling by a health educator at the initial clinic visit as compared with standard care.


Options:
A: N/A
B: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
C: Average number of missed pills per cycle (3 months)
D: Contraceptive use at time of last sexual intercourse (18 months)

Answer: B