TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study: Does Screening Plus Patient Decision Aids Reduce Unnecessary Surgical Referrals for Total Joint Arthroplasty in Practices With Long Waiting Lists for Surgical Consults?
Brief Summary: Ministries of Health consider wait lists for total joint replacement a top priority. Research priorities to manage wait lists indicate the need to establish benchmarks that consider patient preferences. However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indicators for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. When decision aids are used in combination with assessing surgical eligibility, there may be a reduction in unnecessary referrals for surgery either because the patient is ineligible or because the eligible candidates make informed decisions to forgo this option.

The study objective is to pilot test the feasibility of a trial evaluating the effects of patient decision aids on reducing unnecessary surgical referrals for total joint replacement, when used in combination with a general practitioner run clinic to screen patients with hip or knee osteoarthritis for surgical eligibility.

The investigators expect to provide evidence of feasibility (e.g. ease of recruiting patients, delivering the interventions, measuring patient outcomes) and sample size needed for a larger scale study. This study should also provide evidence for planning implementation of the interventions and standardized training across other centers.


Options:
A: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)
B: Prenatal test use (9 months)
C: Differences in patient-reported satisfaction between treatment groups (6 weeks); Differences in decision regret between treatment groups (6 weeks)
D: Feasibility of Data Collection at Month 12 (Data collection occurred at month 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer
Brief Summary: Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (AGC). The objective of the study is to evaluate the safety and activity of ECX and CX combination chemotherapy given as first-line therapy for AGC.


Options:
A: Failure-free survival (six months)
B: Overall Survival (OS) (2.5 years)
C: Overall Survival (3 years)
D: overall survival (median)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Study of Combination Chemotherapy With Epirubicin , Cisplatin and Capecitabine (ECX) or Cisplatin and Capecitabine (CX) in Advanced Gastric Cancer
Brief Summary: Recently, 3-drug (ECX) and 2-drug (CX) combination chemotherapy involving capecitabine showed promising results in randomized clinical trials for advanced gastric cancer (AGC). The objective of the study is to evaluate the safety and activity of ECX and CX combination chemotherapy given as first-line therapy for AGC.


Options:
A: Failure-free survival (six months)
B: Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I (12 weeks up to 3 years); Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II (12 weeks up to 3 years)
C: 6 Month Progression Free Survival (PFS) (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months)
D: 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.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis
Brief Summary: The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.


Options:
A: The Proportion of Patients Responders to Dex 21-P vs Placebo (From baseline to End of treatment = 6 weeks ± 10 days (in chronic and steroid dependent IBD patients) or 28 weeks ± 5 days (in mesalazine refractory UC patients))
B: Proportion of subjects who were relapse free after 6 months of treatment. (6 months)
C: Change in Mayo Score, Safety (At week 8)
D: Change in Mayo score at Day 57 compared with Screening (Day 57)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Population-Based Intervention to Reduce Prehospital Delays in Patients With Stroke and Transient Ischaemic Attack
Brief Summary: In patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. The aim of the present study was to reduce prehospital delays in a population-based intervention.The intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS). The investigators additionally included a bookmark and sticker with the EMS telephone number. A total of 75,720 inhabitants received the intervention. Between 2004 and 2005, 741 patients with cerebrovascular events were admitted from the control areas (n=24) and 647 from the intervention areas (n=24).


Options:
A: Surveillance methodologies will measure arrival times of acute strokes from stroke symptoms onset to ER among participants for the length of the study, as well as increase in stroke knowledge at one month and one year post stroke event. (at one month and one year post stroke event)
B: Time between symptom onset and hospital admission (Admission to hospital)
C: Stroke Symptom and Response Knowledge Assessment (student) (Up to 3 days from baseline); Assessment of child's communication to parent regarding stroke symptoms. (Up to 7 days from baseline)
D: 180 day rehospitalization rate (at 180 days post-discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Finhyst 2006: Incidence, Methods, Complications and Effect on Quality of Life of Hysterectomies in Finland in 2006
Brief Summary: The purpose of this study is to analyze prospectively all hysterectomies performed in Finland for benign indications including all 46 public hospitals performing hysterectomies and also 7 private clinics. Hypothesis is that vaginal and laparoscopic hysterectomies are safe and cost-effective methods of hysterectomy.


Options:
A: Safety of hysterectomy (1.1-31.12.2006)
B: Insulin resistance (3 weeks)
C: Duration of Surgery (after surgey)
D: Operative time of the procedure (Range from 90 minutes to 210 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dexmedetomidine vs. Midazolam for Facilitating Extubation in Medical and Surgical ICU Patients: A Randomized, Double-Blind Study
Brief Summary: The purpose of this randomized, double-blind study is to evaluate the utility, safety, and cost of transitioning benzodiazepine sedation to dexmedetomidine in medical or surgical intensive care unit (ICU) patients requiring sedation when tracheal extubation is nearing. Fifty medical or surgical ICU patients requiring sedation with existing benzodiazepine therapy and qualifying for daily awakenings will be randomized in a double-blind manner to receive additional midazolam or dexmedetomidine.


Options:
A: Time From Study Drug Initiation to Tracheal Extubation (Duration of ICU stay, for up to 24 weeks)
B: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
C: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. (2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up); Duration of mechanical ventilation (Start and stop times of mechanical ventilation while the patient is treated in the ICU)
D: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Bevacizumab and Carboplatin for Patients With Platin Resistant Epithelial Ovarian Cancer. A Phase II Study.
Brief Summary: This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients with platin resistant ovarian cancer.


Options:
A: Progression-Free Survival (PFS) (Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months))
B: Progression Free Survival (PFS) - in non-tBRCA HRD positive patients (Approximately 4 years); Progression Free Survival (PFS) - in all non-tBRCA patients (Approximately 4 years)
C: Progression free survival (From date of first treatment until date of verified progression or death. 12 months of follow-up)
D: Overall Survival (Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bevacizumab and Carboplatin for Patients With Platin Resistant Epithelial Ovarian Cancer. A Phase II Study.
Brief Summary: This is a phase II trial to investigate the effect of bevacizumab and carboplatin in patients with platin resistant ovarian cancer.


Options:
A: Progression free survival (From date of first treatment until date of verified progression or death. 12 months of follow-up)
B: Progression-Free Survival (PFS) Comparison (2 Years)
C: ORR (Up to 2 years); PFS (Up to 2 years)
D: Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment (From randomization of the first patient until 32.5 months later, assessed every 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Multicenter, Randomized, Double-Blind, Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
Brief Summary: Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.


Options:
A: Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores (through 96 hours)
B: The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo. (72 hours)
C: Time to First Use of Supplemental Pain Medication (Through 96 hours postdose)
D: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores Through Postoperative Day 4 (0 to 96 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Brief Summary: This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.


Options:
A: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
B: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
C: Mean Fetal Weight at Birth (Immediately after delivery of fetus)
D: Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1) (Month 3 through extension Month 60); Change From Baseline in FEV1 (Baseline through extension follow up Month 3); Annual Rate of Change in FEV1 (Week -2 through extension follow up Month 3 or end of study); Summary of ≥ 15 % Decliners in FEV1 (Month 3 through extension follow up Month 3); Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco) (Week -2 through extension follow up Month 3 or end of study); Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) (Baseline through extension follow up Month 3); Summary of ≥ 20 % Decliners in DLco (Month 3 through extension follow up Month 3)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Brief Summary: This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.


Options:
A: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
B: Number of Participants Assessed for Glucose Control (fasting and 2 hour postprandial blood glucose)
C: 3rd trimester glycated hemoglobin (3rd trimester of pregnancy); total maternal weight gain (during pregnancy); severe maternal hypoglycemia (from enrollment to delivery); preeclampsia (during pregnancy or puerperium); cesarean section (at the end of pregnancy); gestational age at birth (at birth); preterm birth (at birth); birthweight (at birth); macrosomia (at birth); large-for-gestational age newborn (at birth); small-for-gestational age newborn (at birth); neonatal hypoglycemia (in the neonatal period); perinatal mortality (in the perinatal period); insulin treatment (from enrollment to delivery)
D: Mean Fetal Weight at Birth (Immediately after delivery of fetus)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Brief Summary: This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.


Options:
A: Mean Fetal Weight at Birth (Immediately after delivery of fetus)
B: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
C: A composite of: pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, and NICU admission > 24 hours. (conception to 28 days after birth)
D: Alive baby (At birth, up to 28 days after birth); Neonatal morbidity (at birth upto 28 days after birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients
Brief Summary: Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.


Options:
A: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12 (Week 12)
B: the longitudinal changes of itching (every week, up to 12 weeks.)
C: The changes in pruritus symptoms assessed by VAS (Week0, week1-12, Week 14)
D: pruritus (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active Control Study to Evaluate the Safety and Efficacy of a Single Intraoperative Administration of SKY0402 For Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty
Brief Summary: The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.


Options:
A: The Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores Through 72 Hours for Subjects Receiving SKY0402 vs. Placebo. (72 hours)
B: Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores (through 72 hours post surgery)
C: Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores (0-24 hours)
D: Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores (through 96 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: High dose atorvastatin may worsen insulin sensitivity.


Options:
A: Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy (baseline(randomization) to 12 weeks)
B: Androgen secretion (0, 3, 6 months); Glucose metabolism (0, (3), 6 months)
C: Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: High dose atorvastatin may worsen insulin sensitivity.


Options:
A: The placebo-corrected change from baseline to week 24 in 6-minute walk distance (Measured at 6 months)
B: N/A
C: C-peptide after a liquid mixed meal stimulation (at randomization, after 12 months, and after 18 months of treatment)
D: Observations of all modifications on semen quality after 5 months of atorvastatin treatment (at month 5); Observations of all modifications on semen quality after 5 months of atorvastatin treatment and after 3 months after its withdrawal (at month 8)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-site, Randomized, Controlled Trial of a Mindfulness-based Cognitive Therapy Intervention for Treating Depression in a Traumatic Brain Injury Population.
Brief Summary: The purpose of this study is to determine whether mindfulness-based cognitive therapy is effective in reducing depression symptoms in individuals who have experienced a traumatic brain injury.

The investigators hypothesize that participants who are given the ten-week intervention will have fewer depression symptoms than the participants in the control group, and this improvement will be maintained at the three-month follow-up assessment.


Options:
A: Hamilton Rating Scale for Depression (HAM-D) (16 weeks, 24 weeks); Symptom Checklist-20 (SCL-20) (16 weeks, 24 weeks)
B: Beck Depression Inventory - II (Baseline data were collected prior to the intervention and post-intervention data were collected 10 weeks later.)
C: Remission of depression (DSM-IV diagnosis no longer met) (baseline); Remission of depression (DSM-IV diagnosis no longer met) (one week after treatment completion); Remission of depression (DSM-IV diagnosis no longer met) (six months after treatment completion); Remission of depression (DSM-IV diagnosis no longer met) (one year after treatment completion)
D: Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status (Six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial for Health Promotion/ Obesity Prevention Targeting Low-income, Urban, African-American Adolescents
Brief Summary: The purpose of Challenge! is to determine if adolescents enrolled in a health promotion/ obesity prevention program will have a healthier BMI-for-age z-score and body composition (body fat %), will consume a healthier diet, and engage in higher levels of physical activity compared to those that did not receive the intervention over time.


Options:
A: changes in body mass index throughout the intervention
B: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
C: Change in error points in one legged-standing test (at baseline and 6 months later after intervention)
D: BMI-for-age z-score and percentiles (measured weight and height, self-reported gender and date of birth)and Body composition (Dual Energy X-ray Absorptiometry, and Bioelectrical Impedance Analysis) (2 years)

Answer: D