TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)
Brief Summary: 1062 children at the age of 7 months and their families were randomized 1:1 in an intervention arm and a control arm. The intervention families has received child-oriented and individualized nutritional and life-style counseling that aims at decreasing child's exposure to the known environmental atherosclerosis risk factors. The controls children receive information as given at the well-baby clinics and in school health care of children and adolescents. The hypothesis is that the intervention children have healthier food habits and serum serum lipid and lipoprotein concentrations than the controls, fewer of them start smoking, and their physical activity level is higher than that of the controls.


Options:
A: Children's height and weight (HAZ,WAZ and BAZ) (6 months)
B: Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
C: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
D: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: VA Low Vision Intervention Trial
Brief Summary: The primary purpose of this research study is to evaluate the effectiveness of a new outpatient low vision rehabilitation program that is targeted to serve legally blind veterans with central vision loss. The hypothesis is that veterans in the treatment group will self-report less difficulty performing daily activities than veterans in the control group who are on a waiting list for VA low vision or blind rehabilitation programs.


Options:
A: activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) (5 and 17 weeks); distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ)) (5 and 17 weeks)
B: VA LV VFQ-48 Reading Domain Scores (4 months from baseline)
C: Static Balance (Week 0 and Week 8.)
D: Participant enrollment, recruitment and retention. (Ongoing for18 months after start of recruitment.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: VA Low Vision Intervention Trial
Brief Summary: The primary purpose of this research study is to evaluate the effectiveness of a new outpatient low vision rehabilitation program that is targeted to serve legally blind veterans with central vision loss. The hypothesis is that veterans in the treatment group will self-report less difficulty performing daily activities than veterans in the control group who are on a waiting list for VA low vision or blind rehabilitation programs.


Options:
A: VA LV VFQ-48 Reading Domain Scores (4 months from baseline)
B: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]); Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months])
C: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
D: Participants will be given the following assessment tests at 4 different times during the assessment (at baseline, after 6 weeks, after 12 weeks, and after 18 weeks): eye tracking measures, daily performance measures and reading measures.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Brief Summary: The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.


Options:
A: Fugl Mayer motor score for upper extremity (4 weeks)
B: Fugl Meyer Assessment Scale (four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up)
C: Fugl-Meyer Score Change Immediately Following Study Intervention. (After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.); Fugl-Meyer Score Change at 6 Months (FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.)
D: Wolf Motor Function Test (8 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Brief Summary: The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.


Options:
A: Change in 10 meter walk test (Pre Test, 4 weeks, 8 weeks, 3 month follow up)
B: Bilateral Arm Reaching Test (BART) (Change from Baseline to up to 4 months post-randomization); Wolf Motor Function Test (WMFT) (Change from Baseline to up to 4 months post-randomization); Motor Activity Log (MAL) (Change from Baseline to up to 4 months post-randomization); Bilateral Arm Reaching Test (BART) (Change from Baseline to up to 10 months post-randomization); Wolf Motor Function Test (WMFT) (Change from Baseline to up to 10 months post-randomization); Motor Activity Log (MAL) (Change from Baseline to up to 10 months post-randomization)
C: Fugl-Meyer Score Change Immediately Following Study Intervention. (After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.); Fugl-Meyer Score Change at 6 Months (FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.)
D: Fatigue relief (assessed by the Fatigue Severity Scale) (4 months after the stroke)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Brief Summary: The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose therapy program for persons recovering from a recent stroke using mechanically-assisted upper limb movement with a device called MIME. A control group receives additional occupational therapy without the use of MIME.


Options:
A: Change from Baseline in Fugl-Meyer Scale at 28 weeks. (at inclusion, week 4 and week 28); Change from Baseline in Box and Block Test at 28 weeks. (at inclusion, week 4 and week 28.)
B: Fugl-Meyer Score Change Immediately Following Study Intervention. (After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.); Fugl-Meyer Score Change at 6 Months (FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.)
C: Fugl Meyer Assessment Scale (four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up)
D: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment (Baseline to Final Training (6 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Conservative Treatment for Urge Incontinence
Brief Summary: The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women.


Options:
A: Change from baseline in mean number of micturitions per 24 hours after 8 weeks (8 weeks)
B: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)
C: Change in Incontinent Episodes Immediately Post-treatment (Baseline and immediately post-treatment - week 8)
D: Percent Change in Urgency Urinary Incontinence Episodes (Baseline and 2 month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Conservative Treatment for Urge Incontinence
Brief Summary: The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women.


Options:
A: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. (Phase I, II, and III)
B: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
C: International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) (15 weeks)
D: Change in Incontinent Episodes Immediately Post-treatment (Baseline and immediately post-treatment - week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary: A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.


Options:
A: Change in baseline total score on the International Prostate Symptom Score (12 weeks)
B: International Prostate Symptom Score (IPSS) (12 weeks)
C: Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline and 12 weeks)
D: Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline, 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Brief Summary: A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.


Options:
A: Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline and 12 weeks)
B: Change in baseline total score on the International Prostate Symptom Score (12 weeks)
C: Change From Baseline in Total International Prostate Symptom Score (IPSS) at 12 Weeks (Baseline, 12 weeks)
D: International Prostate Symptom Score (IPSS) (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing Pharmacological Therapies for Pregnant Smokers
Brief Summary: Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.


Options:
A: Biochemically-validated smoking cessation (middle and late pregnancy)
B: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)
C: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
D: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing Pharmacological Therapies for Pregnant Smokers
Brief Summary: Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.


Options:
A: Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days (32-34 weeks gestation (Visit 6))
B: Biochemically-validated smoking cessation (middle and late pregnancy)
C: Cotinine validated quit rates.
D: Biochemically validated quit rates (6 weeks after treatment, end of pregnancy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing Pharmacological Therapies for Pregnant Smokers
Brief Summary: Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.


Options:
A: Prolonged Abstinence (7 weeks, 6 months and 12 months)
B: Biochemically-validated smoking cessation (middle and late pregnancy)
C: Point Prevalence Abstinence (52-week); Week 24 Point Prevalence Abstinence (24-week)
D: sustained smoking abstinence (during the study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing Pharmacological Therapies for Pregnant Smokers
Brief Summary: Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.


Options:
A: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
B: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
C: Biochemically-validated smoking cessation (middle and late pregnancy)
D: Smoking Behavior (Self-report Confirmed by Expired Breath CO) (8 week follow up); Urinary Cotinine (8 week follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing Pharmacological Therapies for Pregnant Smokers
Brief Summary: Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.


Options:
A: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
B: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
C: Biochemically-validated smoking cessation (middle and late pregnancy)
D: Summarization of safety data in smokers treated with either varenicline or placebo.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing Pharmacological Therapies for Pregnant Smokers
Brief Summary: Nicotine dependence has not been sufficiently addressed in current state-of-the-science cessation interventions for pregnant smokers. The weight of the evidence from the general population of smokers suggests that nicotine replacement therapies may be beneficial cessation aids for pregnant smokers who are unable to stop smoking. The tremendous potential of these therapies for promoting smoking cessation among pregnant women creates a pressing need for decision tools and protocols to encourage treatment adherence that is essential for rigorous evaluation of the effectiveness of OTC NRT when provided as part of prenatal care. The results of this research could be directly translated to the improvement of obstetrical care providers' clinical practices. Medically supervised use of OTC NRT by pregnant smokers is an alternative to continued smoking that has the potential to substantially increase rates of smoking cessation during pregnancy.


Options:
A: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
B: Biochemically-validated smoking cessation (middle and late pregnancy)
C: Frequency of women receiving the cessation smoking advice (Interviews during the first 12 hours after delivery)
D: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Mulitcentre, Double-blind, Randomised, Fixed-dose Evaluation of the Safety and Efficacy of Lamictal (Lamotrigine) Compared to Placebo as an add-on Therapy to Lithium or Another Mood Stabiliser in the Treatment of Bipolar Depression, Followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Patients With Bipolar Disorder
Brief Summary: This is a study that, in the first 16 weeks, investigates whether lamotrigine versus placebo offers effect on depressive episodes for patients with bipolar disorder (also known as manic depressive disorder) who use lithium. In the following 50 weeks it is investigated whether these patients experience effect on their depressive and/ or (hypo)manic episodes.


Options:
A: Score on the MADRS depression rating scale at week 8 compared to baseline
B: Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).; Modified Social Adjustment Scale (SAS II-B; Bauer, 2001); ***Note: all primary outcomes obtained prospectively every 3 months for 18 months
C: Bipolar Inventory of Symptoms Scale (BISS) (Change from Baseline to 26 weeks)
D: Time to Withdrawal From Study (Randomization to Study Withdrawal (up to Week 26))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists
Brief Summary: The RATIO registry is a French registry designed by a multidisciplinary group to collect data on opportunistic and severe bacterial infections and lymphoma in patients treated with TNF-a antagonists ( infliximab, etanercept and adalimumab). A total of 486 medical units in metropolitan France participate in the RATIO registry. All diagnosis are retained after validation by 2 qualified infectious disease or haematologist physicians (on the basis of the standardized case report form, the hospitalisation summary, and the microbiological and radiological results). Risk factors for developing these conditions when treated by TNF-a antagonists will be identified in a case control study. Incidence of these diseases will be calculated.


Options:
A: Aortic Vascular Inflammation as Measured by FDG-PET/CT (baseline, 12 weeks)
B: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R (Week 16 of Period R)
C: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
D: N/A

Answer: D