TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase Ib/II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Intravitreal Injections Administered Monthly or Every Other Month to Patients With Geographic Atrophy
Brief Summary: This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy.


Options:
A: Growth rate of geographic atrophy (GA) lesion area from baseline (Month 18)
B: N/A
C: Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48 (Baseline, Week 48); Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48 (Baseline, Week 48)
D: The Change in Best-corrected Visual Acuity (BCVA) From Baseline to Year 2 for All Participants. (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized Clinical Trial of a Silver Eluting Dressing System for Prevention of Lower Extremity Revascularization Wound Complications
Brief Summary: This prospective, multi-institutional randomized clinical trial of a silver ion eluting dressing material compared to standard dry gauze for closed skin incisions after open surgical revascularizations for peripheral vascular occlusive disease. Based on the ability of the silver to lower the bacterial contamination of these vulnerable surgical skin incisions, the investigators hypothesize that immediate application of Acticoat Absorbent® as a post-operative dressing will reduce closed incisional wound complications in patients undergoing lower extremity revascularizations involving infrainguinal skin incisions compared to standard non-silver eluting dressing material.


Options:
A: Wound complication (Within 30 days of index procedure)
B: Device remains localized over corneal incision (24 hours post operative)
C: amount of fluids collected in the operative bed by ultrasonography (participants will be followed for the duration of hospital stay, an expected average of 4 days)
D: Incisional Surgical site infection (30 postoperative days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.


Options:
A: Progression-free Survival (PFS) (From randomization up to 65 months.)
B: To demonstrate that maintenance treatment with bevacizumab + erlotinib following first line chemo- and anti-angiogenetic therapy results in a significant increase in progression free survival (PFS) compared to treatment with only bevacizumab. (3 years)
C: Progression-free survival (PFS) (2 years after last patient in study)
D: Progression-free survival during maintenance therapy (Tumor evaluation every 2 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)
Brief Summary: The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.


Options:
A: Patient self-reported anxiety (First three days on ICU and/or within 24 hours after ICU discharge)
B: Patient Health Questionaire (PHQ-9) (At 3- and 6- months following the death of the patient)
C: length of stay and depression (ICU admission, Day 5, discharge, and 2 months)
D: Hospital Anxiety and Depression Scale (Day 90)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)
Brief Summary: The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.


Options:
A: Hospital Anxiety and Depression Scale (Day 90)
B: Direct Communication About Age-related Concerns: Number of Discussions Related to the Geriatric Assessment That Occur in the Clinic Visit Between the Patient, Oncology Physician, and Caregiver. [Patient-Centered Outcomes Research Institute Specified] (Baseline); Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified] (Within 1-7 days of the baseline audio-recorded clinic consultation)
C: Child Distress - unrelieved symptoms (20 weeks); Trends of PedsQL Total Scores (20 weeks); Trends of MSAS total scores (20 weeks); Trends of MSAS physical scores (20 weeks); Trends of MSAS psychological scores (20 weeks); Trends of PedsQL Physical Subscale Scores (20 weeks); Trends of PedsQL Emotional Subscale Scores (20 weeks)
D: Is there a change in patient understanding of prognosis with the addition of a palliative care intervention? (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)
Brief Summary: The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.


Options:
A: Hospital Anxiety and Depression Scale (Day 90)
B: Percent of Eligible Participants Who Provided Consent (pre-randomization); Percent of Eligible Participants Who Provide Informed Consent and Were Randomized (randomization); Client Satisfaction Questionnaire (CSQ) Score (1 month post-randomization); System Usability Scale (SUS) (1 month post-randomization); Percent of Randomized Participants Who Drop Out of Study (baseline, end of study (approx. 4 months)); Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews (baseline, end of study (approx. 4 months)); Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys (baseline, end of study (approx. 4 months)); Percentage of Self-directed MBT Sessions Attended by Eligible Participants (baseline, end of study (approx. 4 months)); Visual Analog Satisfaction Scale (after intervention completion, up to 8 weeks post-randomization); Number of Participant Clicks on Study Website (baseline, end of study (approx. 4 months))
C: The Number of Feasibility Criteria Successfully Met (3-6 months post discharge from PICU)
D: Change From Baseline, at Weeks 2, 6 and 12 on the Patient Reported Outcome Measurement Information System (PROMIS) - Physical Function Between the Groups. (Change from baseline at weeks 2, 6 and 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Brief Summary: The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary artery disease.


Options:
A: change of percent atheroma volume (1.5-year)
B: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
C: coronary mortality (ICD 10 I20-I25) (up to 15 years from entry into cohort)
D: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Brief Summary: The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary artery disease.


Options:
A: To evaluate changes from baseline in Left Ventricular Mass at 24M (24 months)
B: change of percent atheroma volume (1.5-year)
C: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
D: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
Brief Summary: Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI).


Options:
A: • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia (1 year)
B: Compare the efficacy of employing the Gynecare TVT Secur™ with the traditional Gynecare TVT- O™ for treating female stress urinary incontinence. (1 year)
C: Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes. (Up to one year)
D: Objective cure as defined by the cough test at one year from surgery (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Humanized Anti-TNFa Antibody, in Subjects With Active Polyarticular Juvenile Idiopathic Arthritis (JIA) Despite Standard Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.


Options:
A: To demonstrate that a higher proportion of subjects will have an improvement of uveitis on adalimumab versus placebo after 2 months relative to baseline (Final visit could occur at any point up to 78 weeks)
B: Time to Treatment Failure (From baseline until 48 weeks post-randomization)
C: Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48 (Week 16 through Week 48)
D: ACR Pedi 75 response (54 weeks from baseline (0))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas
Brief Summary: AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival. The primary purpose of the study is to determine if AMG 479 and gemcitabine improves overall survival as compared to placebo and gemcitabine.


Options:
A: Overall survival (A subject's survival time will be defined as the time from randomization to the date of his or her death. If the subject has not died, survival will be censored on last date the subject was known to be alive.)
B: Progression-free survival rate at 6 months
C: Determine if the Treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in Combination With Gemcitabine Improves Overall Survival as Compared With Placebo in Combination With Gemcitabine in Subjects With Metastatic Adenocarcinoma of the Pancreas (From randomization up to 20 months)
D: Progression-Free Survival (PFS) (Within the 3 months of study treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Varisolve Polidocanol Endovenous Microfoam (PEM) 0.5% and 1% Compared to Vehicle for the Treatment on Saphenofemoral Junction (SFJ) Incompetence "VANISH-2"
Brief Summary: Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.


Options:
A: Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score) (8 weeks)
B: anatomical success rate (absence or obliteration of GSV on US examination) (3 months, 1 and 5 years)
C: The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks (Baseline to 8 weeks)
D: Intra-procedural Pain (Up to end of intervention); Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment. (At 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open, Randomized, Crossover Phase 2 Pilot Study of Treatment of Stage 3B Renal Failure With Active Vitamin D or a Phosphate Binder to Evaluate the Effect on the FGF23 and PTH Levels.
Brief Summary: Patients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.


Options:
A: Change in left ventricular mass (36 weeks)
B: FGF23 serum level (Change over 2 weeks of treatment)
C: Change From Baseline and Levels at Each Time Point for Serum Phosphorus (Every 4 weeks from baseline to Week 28); Change From Baseline and Levels at Each Time Point for Serum Calcium (Every 4 weeks from baseline to Week 28); Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH) (Every 4 weeks from baseline to Week 28)
D: Composite end-point of Ca, P, Ca*P within K/DOQI recommendation (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Placebo-Controlled Phase II Study of the MEK Inhibitor GSK1120212 Plus Gemcitabine vs Placebo Plus Gemcitabine in Subjects With Metastatic Pancreatic Cancer
Brief Summary: GSK1120212 is a potent and highly selective inhibitor of MEK phosphorylation and kinase activity and has demonstrated potent anti-proliferative activity against human pancreatic cancer cell lines. This study is a Phase II, randomized placebo-controlled trial of the MEK inhibitor GSK1120212 plus gemcitabine vs. placebo plus gemcitabine in subjects with metastatic pancreatic cancer. Eligible subjects will receive intravenous gemcitabine with oral GSK1120212 or placebo. Therapy will continue until treatment discontinuation criteria are met. The primary objective will be to compare the overall survival of subjects in the GSK1120212 plus gemcitabine arm vs. subjects in the placebo plus gemcitabine arm. Secondary objectives include comparison of progression free survival, overall response rate, and duration of response between the two arms. Exploratory research objectives include the evaluation of population pharmacokinetics as well as blood and tissue based biomarkers. Safety will also be monitored throughout dosing.

Once the determined number of survival events has occurred, if subjects are eligible, they will have the option to enter MEK114375, an open-label, Phase Ib rollover study of GSK1120212 monotherapy or GSK1120212 in combination with other anti-cancer treatments.


Options:
A: Overall Survival (From randomization until death due to any cause or until the data cutoff of 15-March-2013 (up to 24 months))
B: Ascertain the median survival of advanced pancreatic cancer patients treated with Gefitinib and docetaxel.
C: Progression free survival (4 years)
D: Progression free survival (Up to 3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended Letrozole Regimen Versus Clomiphene Citrate for Superovulation in Patients With Unexplained Infertility Undergoing Intrauterine Insemination
Brief Summary: The aim of this randomized controlled trial is to compare the efficacy of extended letrozole regimen (2.5mg/day from cycle day 1 to 9) with clomiphene citrate (100 mg/day from cycle day 3 to 7) in women with unexplained infertility undergoing superovulation and intrauterine insemination .


Options:
A: ongoing pregnancy rate (12 weeks)
B: Multiple Gestation Rate Following Recruitment of Multiple Follicular Development With an AI, as Compared to CC and FSH. (Participants were followed for the duration of their treatment and, if pregnant through 6 weeks post-delivery, up to 66 weeks)
C: Clinical pregnancy rate (5 weeks after intrauterine insemination)
D: pregnancy rate (on average 30 days if not pregnant and 12 weeks if pregnant)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
Brief Summary: The purpose of this study is to investigate the benefit of several micro nutrients of antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in cell-free mRNA.


Options:
A: Birth weight; 3-month infant mortality
B: ongoing pregnancy on the 20th week of gestational age (20th week of gestational age)
C: Preeclampsia (40 weeks); Preeclampsia (9 months)
D: Fetal loss, low birth weight and pre-term birth. (Delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Effects of Chitin-Glucan on Oxidized Low-Density Lipoprotein (LDL)
Brief Summary: Cardiovascular diseases (CVDs), especially atherosclerotic coronary heart disease and stroke, are the leading causes of death globally. Important risk factors for CVDs include elevated serum levels of total cholesterol, low-density lipoprotein(LDL)-cholesterol, triglycerides, and low high-density lipoprotein (HDL)-cholesterol. Elevated "oxidized" LDL, a pro-inflammatory villain, has also emerged as an important risk factor for the development of CVDs. There is a growing need to identify safe and effective nutritional interventions that offer a clinical benefit aimed at reducing one more of the risk factors for CVDs. Data from many studies in humans have shown various health benefits provided by dietary fiber intake, including an inverse association with the risk of developing cardiovascular disease. The primary purpose of this study is to determine whether daily consumption for 6 weeks of chitin-glucan, a fiber purified from a microorganism, is effective at reducing the amount of oxidized LDL in humans with borderline-to-high LDL-cholesterol. The effects of chitin-glucan on other cardiovascular risk factors will also be evaluated.


Options:
A: weight loss (12 weeks)
B: Change in Fat Mass at 12 Weeks (Value at 12 weeks minus value at baseline)
C: Oxidized LDL (After 4 and 6 weeks)
D: Primary Outcome Measures Described Below (December 2011)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: I Change Adherence & Raise Expectations
Brief Summary: The iCARE study, a clustered-randomized controlled trial, is evaluating an adherence promotion intervention for adolescents that Cystic Fibrosis (CF) care teams will implement. Half the centers will receive the Comprehensive Adherence Program (CAP) for 2 years. CAP consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention). The other half of the centers will receive CAP in year 2 of the study. Participants are patients age 11-20 years old who are diagnosed with CF and have been prescribed at least one of the following medications for at least 6 months prior to signing the informed consent: azithromycin, hypertonic saline, Pulmozyme®, TOBI®, or inhaled compounded tobramycin. Rate of refilling prescriptions is the primary outcome with lung function decline rates, exacerbation rates, and patient reported measures including health related quality of life and CF knowledge and skills, as secondary outcomes.

A central goal of this study is to test the effectiveness of the comprehensive adherence program (CAP), described above, versus standard care (SC) for adolescents and young adults seen in outpatient CF clinics.


Options:
A: Change in lung function (48 weeks)
B: Medication Adherence (12 Months)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Lung function (FEV1, FVC, FEF25-75)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Brief Summary: This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.


Options:
A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 (Month 6); Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 (Baseline, Month 6); Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 (Baseline, Month 3); Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 (Month 6)
B: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)
C: Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR) (Day 1 of Period 1, Day 43 of Period 1)
D: Mean 48-week Change in DAS28 (48 weeks after baseline assessment)

Answer: B