TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Collaborative Care for Substance Use Disorders
Brief Summary: Primary care settings (PCS) are a missed opportunity for delivering evidence-based treatments for opiate and alcohol-use disorders (OAUD). The investigators propose to evaluate the costs and effectiveness of two strategies to increase the delivery of OAUD treatments in PCS, integrated collaborative care (ICC) and education and resources (E\&R). The investigators hypothesize that ICC will be more effective than E\&R in promoting A. Implementation outcomes B. Service system outcomes and C. Patient outcomes.

Results from our study will help providers choose between two different strategies and advance the field of implementation research.


Options:
A: Amount of calcium supplement ingested (8 weeks after ANC consultation, during which recruitment into the study occurred)
B: Proportion of participants with a PrEP prescription at baseline who initiate PrEP (6 months post enrollment); Proportion of participants with a PrEP prescription at baseline who attend at least one follow-up visit and have at least one documented PrEP prescription refill during each 3-month interval (6 months post enrollment); Percentage of participants with a PrEP prescription at baseline who adhere to their PrEP regimen (6 months post enrollment)
C: Framingham cardiovascular disease risk (12 months)
D: unmet need (past 6 months); abstinent from alcohol and opioid use, past 30 days (past 30 days); negative consequences related to substance use (past 3 months); Functioning (past 4 weeks); Engagement (30 days of initiation); initiation (Within 14 days of index visit); heavy alcohol use (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Collaborative Care for Substance Use Disorders
Brief Summary: Primary care settings (PCS) are a missed opportunity for delivering evidence-based treatments for opiate and alcohol-use disorders (OAUD). The investigators propose to evaluate the costs and effectiveness of two strategies to increase the delivery of OAUD treatments in PCS, integrated collaborative care (ICC) and education and resources (E\&R). The investigators hypothesize that ICC will be more effective than E\&R in promoting A. Implementation outcomes B. Service system outcomes and C. Patient outcomes.

Results from our study will help providers choose between two different strategies and advance the field of implementation research.


Options:
A: Illicit Opioid Use (18 weeks)
B: Number of biological samples negative/positive for opioid agonists (Week 1-12 post discharge); Retention (Week 1-12 post discharge); Days of use or abstinence from opioids (Week 1-12 post discharge)
C: unmet need (past 6 months); abstinent from alcohol and opioid use, past 30 days (past 30 days); negative consequences related to substance use (past 3 months); Functioning (past 4 weeks); Engagement (30 days of initiation); initiation (Within 14 days of index visit); heavy alcohol use (6 months)
D: HIV Risk Events (Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Collaborative Care for Substance Use Disorders
Brief Summary: Primary care settings (PCS) are a missed opportunity for delivering evidence-based treatments for opiate and alcohol-use disorders (OAUD). The investigators propose to evaluate the costs and effectiveness of two strategies to increase the delivery of OAUD treatments in PCS, integrated collaborative care (ICC) and education and resources (E\&R). The investigators hypothesize that ICC will be more effective than E\&R in promoting A. Implementation outcomes B. Service system outcomes and C. Patient outcomes.

Results from our study will help providers choose between two different strategies and advance the field of implementation research.


Options:
A: Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS - ADLI) (24 months)
B: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs
C: unmet need (past 6 months); abstinent from alcohol and opioid use, past 30 days (past 30 days); negative consequences related to substance use (past 3 months); Functioning (past 4 weeks); Engagement (30 days of initiation); initiation (Within 14 days of index visit); heavy alcohol use (6 months)
D: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The "START" (a Streamlined ART Initiation Strategy) Study
Brief Summary: START is clinic-level (not individual-patient) intervention to catalyze the process of ART initiation among HIV-infected adults who meet CD4-based criteria for combination ART (e.g., adults with a CD4 T cell level \< 350/ul). The three START components are: (1) real-time point-of-care CD4 testing using the Alere PIMA platform to ascertain treatment eligibility in real time at first presentation to care, (2) targeted knowledge transfer (i.e., dissemination) of recent scientific evidence regarding effects rapid ART initiation on survival to front line health care workers; and 3) feedback and reporting to clinic and providers. There three components represent empirically validated steps in the PRECEED implementation model.


Options:
A: Proportion non-pregnant subjects virally suppressed at routine six-month viral load (10 months after study enrollment); Proportion of pregnant subjects who adhere to ART or the prior PMTCT regimen until delivery (Up to 9 months after study enrollment)
B: Linkage to HIV care within 1 month of HIV testing and retention in care 12 months after testing. (1 month and 12 months after testing)
C: Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients (14 days)
D: Linkage to care (90 days); Viral suppression (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The "START" (a Streamlined ART Initiation Strategy) Study
Brief Summary: START is clinic-level (not individual-patient) intervention to catalyze the process of ART initiation among HIV-infected adults who meet CD4-based criteria for combination ART (e.g., adults with a CD4 T cell level \< 350/ul). The three START components are: (1) real-time point-of-care CD4 testing using the Alere PIMA platform to ascertain treatment eligibility in real time at first presentation to care, (2) targeted knowledge transfer (i.e., dissemination) of recent scientific evidence regarding effects rapid ART initiation on survival to front line health care workers; and 3) feedback and reporting to clinic and providers. There three components represent empirically validated steps in the PRECEED implementation model.


Options:
A: Hospital rate of permanent colostomy; Hospital rate of local recurrence
B: difference in change in systolic BP between the intervention and usual care groups (6 months)
C: Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients (14 days)
D: Proportion of COX-2 inhibitors prescribed within the entire NSAID class (18 months); Proportion of omeprazole prescribed within the entire proton pump inhibitors class (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Uninational, Multicenter, Two Parallel Groups, Active Controlled Study to Compare the Effect of the Treatment With Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation
Brief Summary: The study design combines a long-term safety and a dose range determination objective. The first 8 weeks of the study were primarily intended for the dose range determination, while the later visits were used for the comparison of long-term safety between the groups.


Options:
A: Symptom Based Weekly Total Sum Score (TSS) Over 52 Weeks (Baseline (Week 0), Week 1, 2, 3, 4, 8, 12, 26, 52); Change From Baseline in Total Sum Score (TSS) at Week 52 (Baseline, Week 52); Short Term Change of Total Sum Score (TSS): Average of Weeks 1 to 8 Minus Baseline (Average of Weeks 1 to 8); Long Term Change of Total Sum Score (TSS): Average of Weeks 26 and 52 Minus Baseline (Average of Weeks 26 and 52); Overall Change of Total Sum Score (TSS): Average of all Diaries Obtained Minus Baseline (Average up to 52 weeks); Dose Range Determination: Mean Dose Based on Sachets Used (Up to 52 weeks.); Dose Range Determination: Mean Dose per Kilogram Body Weight Based on Sachets Used (Up to 52 weeks)
B: Efficacy (4 weeks of observation); Efficacy (7 days)
C: Bowel movement frequency (week 4)
D: therapeutic success (passing ≥ 3 stools per week, with no loosening of stool). (the number and consistency of the stool will be recorded at 6th week of intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: STELLA Trial: Staging of Endometrial and Ovarian Cancer Comparing the Transperitoneal vs. Extraperitoneal Approach for Laparoscopic Lymphadenectomy of Aortic Nodes
Brief Summary: The purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.


Options:
A: Number of harvested lymph nodes (2 years)
B: Number of lymph nodes (After aortic lymphadenectomy is completed)
C: Operative Time (1st 24 hours)
D: Primary outcome: operative time from incision to closure. (Primary outcome: will be obtained immediately at the end of each procedure.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.


Options:
A: Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment. (Through 48 hours acute phase); Exponential Rate of Change in S-K Levels in the Subacute Phase. (Through 12 days subacute phase (Day 3 through Day 15))
B: Change in Serum Potassium From Part A Baseline to Part A Week 4 (Part A Baseline to Part A Week 4); Change in Serum Potassium From Part B Baseline (Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L)
C: Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). (22 Days; Maintenance Phase Days 8 - 29, inclusive.)
D: Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group (Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia
Brief Summary: The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). The study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. The safety of patiromer treatment was also evaluated.


Options:
A: Difference in the Exponential Rate of Change in Serum Potassium (S-K) Levels Versus Placebo During the Initial 48 Hours of Study Drug Treatment (24 and 48 hours post first study drug dose)
B: Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4 (21 to 28 Days)
C: Change in Serum Potassium From Part A Baseline to Part A Week 4 (Part A Baseline to Part A Week 4); Change in Serum Potassium From Part B Baseline (Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L)
D: Number of episodes of serum K ≥ 5.5 mEq/L (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease
Brief Summary: Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD


Options:
A: To assess gut microbiome composition (meta genome sequencing) of preterm infants receiving probiotics versus preterm infants not receiving probiotics (4 time points: 7 days of age, 4 weeks of age, 4 months corrected age and 12 months corrected age)
B: Effect of Saccharomyces boulardii on necrotizing enterocolitis in VLBW infants (up to 6 months)
C: Sepsis (8 weeks)
D: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploring a Patient-centered Approach to Mifepristone Administration in Medical Abortion
Brief Summary: This study will test ways to give women more options and flexibility when they are ending their unwanted pregnancies. The investigators will look at uptake and acceptability of using mifepristone outside of the clinic for pregnancy termination.


Options:
A: Proportion of women who select home-use of mifepristone (1-2 weeks); Satisfaction with Method (1-2 weeks)
B: Efficacy defined as complete abortion without recourse to surgical abortion. (2 weeks)
C: successful menstrual regulation without the need for a surgical evacuation (14 days)
D: Proportion of participants who would choose outside of center administration of mifepristone again (1-2 weeks); Proportion of participants who would recommend outside-of-center administration to a friend (1-2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial
Brief Summary: To evaluate the efficacy of a papain-based gel in caries removal.


Options:
A: Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control. (1year control data for all treatments primo 2008)
B: restauration evaluation (18 months)
C: Failure Rate of the Three Treatment Arms Judged Clinically (2 years)
D: Pulp sensitivity (Once a year during at least five years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence
Brief Summary: An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This randomized trial of an intervention to assess and prevent intimate partner violence during pregnancy and the post-partum builds upon the David Olds model of nurse home visitation (Nurse Family Partnership or NFP) for high risk mothers and infants that has shown to be effective in multiple settings in preventing child abuse and enhancing maternal and child health and psychosocial outcomes. However, prior research has shown that the NFP intervention is not as effective in homes where there is intimate partner violence (IPV). Although the NFP by itself has reduced IPV in one setting, it has not in another. The proposed study will test the efficacy of an enhanced NFP intervention, the ECI or Enhanced Choice Intervention among women referred to an existing NFP program in Portland, Oregon. The ECI is based on a choice or empowerment model whereby women can choose among interventions related to her goal for her current intimate relationship. If IPV or emotional abuse or controlling behaviors are assessed, the intervention is based on two interventions shown to be effective in assessing for and reducing repeat IPV (the Sullivan Advocacy Intervention and the McFarlane and Parker brochure driven intervention). For women desiring to enhance marital quality, the Markman and Stanley PREP model that has been shown to enhance relationship quality will be offered. The PREP model also has some preliminary evidence of preventing IPV. For women with other risk factors for IPV in their own or their partners' history (e.g. exposure to parental IPV, child abuse, substance abuse), community resource linkage (beyond referral) strategies as with the NFP model will be used to obtain community resources to address these risk factors. 250 women referred to the Multnomah County Health Department will be randomized to the experimental (NFP plus ECI) or control condition (NFP) and visited according to the regular NFP schedule during pregnancy and until the infant is 24 months old. The intervention will concentrate on the prenatal and immediate (first 6 months) post partum period with regular IPV, emotional abuse and controlling behavior assessments throughout the NFP period. Baseline and outcome measurement (CTS2, WEB, TPMI, depression - Edinborough, \& parenting stress), will occur at 3 months before delivery, 9 months \& 21 months post-partum with multivariate MANOVA, SEM and growth curve analyses.


Options:
A: depression (On completion of intervention and six months post-intervention)
B: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
C: Decreased Intimate Partner Physical Violence from Baseline to Two-Year Follow-Up. (baseline, one year follow-up, and two year follow-up)
D: Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months (Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination
Brief Summary: Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.


Options:
A: Premature Infant Pain Profile (PIPP) scale rate (0-21) (15 seconds before and Within 30 seconds after heel lance)
B: Pain scores assessed by the PIPP score (The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.)
C: The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score (PIPP score before, during and after eye exam)
D: Premature Infant Pain Profile (two hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Web-Delivered Acceptance Therapy for Smoking Cessation
Brief Summary: The goal of this study is to determine whether the ACT website provides higher quit rates than a current standard smoking cessation website.


Options:
A: Smoking Abstinence Rate (Baseline up to 6 weeks)
B: 30-day point prevalence abstinence (12 month post randomization)
C: Perceived Stress Scale (At the end of five days retreat); Self-compassion (At the end of five days retreat)
D: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Web-Delivered Acceptance Therapy for Smoking Cessation
Brief Summary: The goal of this study is to determine whether the ACT website provides higher quit rates than a current standard smoking cessation website.


Options:
A: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
B: 30-day point prevalence abstinence (12 month post randomization)
C: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)
D: Smoking Abstinence (End of Treatment (8 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Moderate to Severe Bronchiolitis: Standard Therapy Versus Therapy With NaCl 3%
Brief Summary: Our study will investigate inhalation therapy of NaCl 3% compared to standard therapy with no inhalation in the treatment of moderate to severe bronchiolitis. The impact on length of hospital stay will be analyzed.


Options:
A: Length of Stay in the Study-LOS--Intention to Treat Analysis (Time of first study treatment until time of discharge); Length of Stay in the Study-LOS by Per Protocol Analysis (Time of first study treatment until time of discharge)
B: length of hospital stay (2 years)
C: Hospitalization Days (Participants will be followed for the duration of hospitalization, an expected average of 4 days)
D: Time to 'fit for discharge' (This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.)

Answer: B