TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Therapeutic Workplace Maintenance Study
Brief Summary: This application is a competing continuation of a grant in which we developed and pilot tested a computerized Therapeutic Workplace designed to train and employ adults as data entry operators. A randomized trial is planned over 5 years to investigate the Therapeutic Workplace business as a maintenance intervention to sustain long-term abstinence and employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk for contracting or spreading HIV infection will participate in an initial Therapeutic Workplace training phase. Participants who become abstinent and skilled will be randomly assigned to an Abstinence \& Employment, or an Employment Only group. Participants in the Abstinence \& Employment group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary. Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. This study will provide a rigorous evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of cocaine addiction and unemployment; determine the benefits of requiring daily evidence of abstinence to work; and provide information on the extent to which a Therapeutic Workplace business can become self-sustaining. This research could provide firm scientific foundation for the dissemination of Therapeutic Workplace businesses in the long-term treatment of cocaine addiction and unemployment. The main hypothesis being tested is that cocaine abstinence will be reliably maintained during the yearlong intervention evaluation period only in the group exposed to the explicit abstinence maintenance intervention. We expect that cocaine abstinence in the Abstinence and Employment group will be significantly greater than cocaine abstinence in the Employment Only group.


Options:
A: Percentage of Monthly Urine Samples That Are Negative for Cocaine (1 year)
B: N/A
C: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
D: longest continuous period of cocaine abstinence (Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Medication Development for Cocaine Dependence
Brief Summary: Although a great amount of research has been conducted to resolve cocaine dependence, an effective treatment has yet to be discovered. Topiramate is a drug that was found to be useful in treating alcohol dependence. The purpose of this study is to determine the effectiveness of topiramate in treating cocaine dependent individuals.


Options:
A: Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment. (Week 13)
B: Time to Treatment for Emerging Symptoms of a Mood Relapse (Up to 6 months)
C: Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine). (Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment))
D: Proportion of Cocaine Positive Urine Samples Per Treatment Condition (Urine samples collected 3 times weekly from week 1 through 26)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Re-Entry MTC for Offenders With MICA Disorders
Brief Summary: The purpose of this study is to examine the transition of offenders with both mental illness and chemical abuse (MICA) disorders from prison to the community, where continued treatment is generally considered necessary to sustain gains made by prison treatment, and to achieve successful outcomes. The project will determine the effectiveness of a modified therapeutic community (Re-Entry MTC) approach as compared to the case management and parole supervision currently provided. The study will also assess the relative impact on treatment outcomes of the type of treatment received while in prison and of the progress achieved in re-entry treatment.


Options:
A: Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL (Baseline to month 6 post release)
B: CTCR Baseline & Follow-Up Protocol (CTCR Protocol) (Baseline and at 3, 6, 12, and 18 months); Colorado Department of Corrections Record Information System (CDOC-RIS) (At 6, 12, and 18 months); Biological Specimens (At 12 and 18 months); Diagnostic Interview Survey-IV (DIS-IV) (At baseline); Beck Depression Inventory-II (BDI-II) (At baseline and 3, 6, 12, and 18 months); Symptom Checklist 90-R (SCL90-R) (At baseline and 3, 6, 12, and 18 months); Rosenberg Self-Esteem (R-SES) (At baseline and 3, 6, 12, and 18 months); Measures of Social Network (adapted) (At baseline and 3, 6, 12, and 18 months); Client Assessment Inventory (CAI) & Staff Assessment Summary (SAS) (At 3 and 6 months); Therapeutic Community Scale of Essential Elements Questionnaire(SEEQ) (administered monthly over the first six months of the project and quarterly thereafter); Treatment Services Review (TSR) (administered monthly over the first six months of the project and quarterly thereafter); Program Monitoring Form (PMF) (administered monthly over the first six months of the project and quarterly thereafter)
C: N/A
D: Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS. (Changes from baseline until endpoint at week 5)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy
Brief Summary: Allergic diseases represent a major health issue worldwide. Mainstay treatment is allergen avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy, and can modify the course of disease. However, use of this treatment is restricted by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes of allergen administration than the current conventional subcutaneous route (SCIT) have been investigated including sublingual (SLIT). However, the immune parameters of SLIT have not been examined. We propose conducting a randomised, placebo-controlled study of a commercially-available SLIT for house dust mite (HDM) allergy to investigate induction of relevant T cell regulatory immune mechanisms. The first year will be followed by an optional open label extension period. Immunoregulatory cytokine synthesis and T cell phenotype and function (real time PCR and flow cytometry) will be examined. This project will provide important fundamental knowledge on which to base improved and greater application of this potentially curative treatment for allergy. SLIT has the potential advantage of home administration and suitability for patients with asthma who are currently unable to access many of the allergen desensitising regimens.


Options:
A: Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24 (Week 24)
B: Changes of Symptom-Medication-Score (After 1 year of treatment)
C: Use of inhaled corticosteroid (ICS).
D: Immunological mechanisms of SLIT by phenotyping different subsets of cytokine positive T cells, regulatory T cells, and memory T cells in peripheral blood of subjects before, during and after immunotherapy. (12 and 24 months); -Expression of "immunoregulatory" cytokines by CD4+ T (12 and 24 months); cells (12 and 24 months); - Helper, regulatory and memory T cell subsets (12 and 24 months); (a) Helper T cells (12 and 24 months); (b) Regulatory T cells (12 and 24 months); b1- Regulatory T cell phenotype (12 and 24 months); b2- Regulatory T cell function (12 and 24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy
Brief Summary: Allergic diseases represent a major health issue worldwide. Mainstay treatment is allergen avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy, and can modify the course of disease. However, use of this treatment is restricted by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes of allergen administration than the current conventional subcutaneous route (SCIT) have been investigated including sublingual (SLIT). However, the immune parameters of SLIT have not been examined. We propose conducting a randomised, placebo-controlled study of a commercially-available SLIT for house dust mite (HDM) allergy to investigate induction of relevant T cell regulatory immune mechanisms. The first year will be followed by an optional open label extension period. Immunoregulatory cytokine synthesis and T cell phenotype and function (real time PCR and flow cytometry) will be examined. This project will provide important fundamental knowledge on which to base improved and greater application of this potentially curative treatment for allergy. SLIT has the potential advantage of home administration and suitability for patients with asthma who are currently unable to access many of the allergen desensitising regimens.


Options:
A: change in symptom score active versus placebo
B: determine the proportion of patients who achieve well-controlled asthma with SLIT compared to placebo (September 2009)
C: Immunological mechanisms of SLIT by phenotyping different subsets of cytokine positive T cells, regulatory T cells, and memory T cells in peripheral blood of subjects before, during and after immunotherapy. (12 and 24 months); -Expression of "immunoregulatory" cytokines by CD4+ T (12 and 24 months); cells (12 and 24 months); - Helper, regulatory and memory T cell subsets (12 and 24 months); (a) Helper T cells (12 and 24 months); (b) Regulatory T cells (12 and 24 months); b1- Regulatory T cell phenotype (12 and 24 months); b2- Regulatory T cell function (12 and 24 months)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Active-Comparator-Controlled, Parallel-Group Study to Evaluate the Safety of Etoricoxib in Patients With Osteoarthritis or Rheumatoid Arthritis
Brief Summary: The study is designed to compare the risk of cardiovascular events (heart attacks, strokes) in patients receiving either etoricoxib or diclofenac. It will also compare the gastrointestinal tolerability of the two medicines. The study will be conducted in patients with either rheumatoid or osteo-arthritis.


Options:
A: Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences based on combined data from this trial and MK0663 Protocols 061 & 072 (GI Tolerability in OA Patients and GI Tolerability Study in RA Patients ), respectively.
B: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) (6 month treatment duration)
C: Discontinuations due to clinical and laboratory gastrointestinal adverse experiences
D: Discontinuations due to clinical and laboratory gastrointestinal adverse experiences during a 1 year treatment period.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: New Moves: Obesity Prevention Among Adolescent Girls
Brief Summary: The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. The primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. Secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake.


Options:
A: School-time and total daily MVPA (5 months and 1.5 years)
B: Academic performance (October 2014 - June 2015 (8 months))
C: Percent Body Fat (Baseline and One year)
D: Change from baseline in physical activity as assessed by Actigraph accelerometer (Baseline, 6 months and 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: New Moves: Obesity Prevention Among Adolescent Girls
Brief Summary: The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. The primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. Secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake.


Options:
A: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention (5 years)
B: Percent Body Fat (Baseline and One year)
C: Targeted fruit and vegetable (TFV) intake (Intake in prior 24 hours; assessed in two follow-up rounds (4-6 mo and 9-11 mo post-implementation) with 10% replicate subsample in each round; data pooled across two follow-up rounds and replicate samples for primary analysis)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: New Moves: Obesity Prevention Among Adolescent Girls
Brief Summary: The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. The primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. Secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake.


Options:
A: MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-2 year intervention); MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-3 year intervention)
B: Improvement of maximal oxygen uptake
C: Body mass index (Baseline, 3 and 6 months)
D: Percent Body Fat (Baseline and One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: New Moves: Obesity Prevention Among Adolescent Girls
Brief Summary: The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. The primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. Secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake.


Options:
A: Percent Body Fat (Baseline and One year)
B: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
C: Nighttime self-regulated sleep duration at 6, 12 and 24 months of age (Up to 24 months)
D: BMI change at 6 month post assessment (Baseline and 6 month post assessment); BMI change at 1 year post assessment (Baseline to 1 year post assessment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: New Moves: Obesity Prevention Among Adolescent Girls
Brief Summary: The New Moves study will evaluate the impact of a school based program for inactive high school girls who are overweight or at risk for being overweight due to low levels of physical activity. The primary study hypothesis is that girls in the intervention schools will significantly decrease their percent body fat as compared to girls in the control schools. Secondary research hypotheses include that girls in the intervention condition will significantly increase their physical activity levels and improve the quality of their dietary intake.


Options:
A: Body mass index (Baseline-adjusted post-intervention scores at 4 months); C-reactive protein (Baseline-adjusted post-intervention scores at 4 months); Interleukin-6 (Baseline-adjusted post-intervention scores at 4 months); Total Cholesterol (Baseline-adjusted post-intervention scores at 4 months)
B: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)
C: Percent Body Fat (Baseline and One year)
D: Adult BMI change (Change from baseline at 2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Anabolic Steroids and Exercise in Hemodialysis Patients
Brief Summary: This is a study to find out whether an exercise program during dialysis or a drug called nandrolone decanoate can increase muscle size and strenght in patients on dialysis.


Options:
A: Primary outcomes included change in lean body mass measured by dual-energy X-ray absorptiometry, quadriceps muscle cross-sectional area (CSA) measured by MRI, and knee extensor muscle strength.
B: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
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: Decrease symptom burden (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis
Brief Summary: The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis.

In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.


Options:
A: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
B: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
C: Antibiotic use; Length of stay in hospital
D: mortality/survival (28 day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis
Brief Summary: The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis.

In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.


Options:
A: Antibiotic days (Total antibiotic days within 30 days after randomization)
B: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)
C: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
D: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis
Brief Summary: The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis.

In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.


Options:
A: Duration of antibiotic therapy for the first episode of infection (28 days); Total antibiotic exposure days per 1,000 days (28 days); Days alive without antibiotics (28 days)
B: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
C: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
D: Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Procalcitonin-Guided Antimicrobial Discontinuation Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Sepsis
Brief Summary: The current study aims to validate the diagnostic use of PCT assessing its capability to individualize and shorten the duration of antibiotic therapy in critically ill patients with suspected or confirmed sepsis.

In particular, no well-designed intervention study has properly examined the following hypothesis: A PCT-guided antibiotic discontinuation strategy enables to reduce antibiotic treatment duration in critically ill patients with suspected or documented sepsis, without harming patient safety.


Options:
A: Exposure to systemic antimicrobial treatment (in duration of antibiotic treatment and total antibiotic exposure)
B: Exposition to antibiotics, defined by antibiotic-free days (assessed 28 days after inclusion); Mortality (at Day 28 and Day 60)
C: mortality/survival (28 day)
D: Duration of antibiotic treatment for the first episode of infection; Total duration of antibiotic therapy; Antibiotic-free days at 28 days after study enrollment

Answer: A