TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
Brief Summary: The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.


Options:
A: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
B: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
C: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
D: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
Brief Summary: The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.


Options:
A: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)
B: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
C: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
D: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
Brief Summary: The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.


Options:
A: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
B: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
C: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
D: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
Brief Summary: The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.


Options:
A: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
B: Overall impact of fibromyalgia (Participants will be followed over 24 weeks)
C: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
D: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Exercise and Its Impact on Signs of Inflammation in Women With Fibromyalgia
Brief Summary: The study aims to compare low-intensive and high-intensive physical exercise and its impact on physical function, pain and signs of inflammation.


Options:
A: pain (4 weeks)
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: Measure the effects of exercise-based MI intervention improving exercise adherence. (This is a five year study, each subject will participate in a 9-month study sequence)
D: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrent Sexually Transmitted Infections in Minority Women
Brief Summary: This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections.


Options:
A: Re-infection with a non-viral sexually transmitted infection (1 year)
B: Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer (Follow-up through end of study (4 years)); Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] (Follow-up through end of study (4 years))
C: HIV sero-incidence (24 months post-baseline)
D: Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Base Study (Up to 4 years); Incidence of the Composite Endpoint of Human Papillomavirus (HPV) 16/18-related Cervical Intraepithelial Neoplasia (CIN) 2 or Worse in the Long-term Follow-up (LTFU) Study (Up to 14 years since Vaccine Dose 1); Incidence of the Composite Endpoint of HPV16/18-related CIN 2 or Worse in the Long-term Follow-up (LTFU) Study (up to 22 years post Vaccination Dose 1)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Recurrent Sexually Transmitted Infections in Minority Women
Brief Summary: This trial randomizes young Mexican American and African American women with a sexually transmitted infection to a behavioral intervention (3 three hour weekly sessions) versus control with the goal of preventing recurrent sexually transmitted infections.


Options:
A: Contraceptive use at time of last sexual intercourse (18 months)
B: Re-infection with a non-viral sexually transmitted infection (1 year)
C: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)
D: HIV-1 seroincidence; HSV2 seroprevalence

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Catheter Ablation Versus Standard Conventional Treatment in Patients With Left Ventricular Dysfunction and Atrial Fibrillation
Brief Summary: Atrial fibrillation (AF) is the most common arrhythmia encountered in clinical practice. The incidence and prevalence of AF increase exponentially with increasing age and AF is associated with higher mortality, more frequent hospitalization, and lower quality of life. Furthermore, AF is often associated with heart failure. The majority of AF is initiated by ectopic foci found primarily in the pulmonary veins. It was shown that catheter ablation of those veins could eliminate episodes of AF. In patients with heart failure, catheter ablation could improve cardiac function, symptoms and quality of life. It remains still unknown whether AF ablation is more effective than conventional treatment in terms of mortality and morbidity.


Options:
A: All-cause mortality or worsening heart failure requiring unplanned hospitalization (7 years)
B: Time to Recurrence of AF lasting longer than 15 seconds (1 year)
C: The primary efficacy endpoint is the rate of conversion to sinus rhythm documented by ECG just before the planned electrical cardioversion on D3 i.e. after 48 hours following the first study drug administration.
D: Conversion of AF to SN confirmed in standard 12-lead ECG during observation period after first iv bolus (1.5 hour)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary: The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)


Options:
A: Progression free survival (5 years)
B: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early))
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
D: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary: The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)


Options:
A: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (Day 1 up to 12 Months); Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation (Day 1 up to 12 months)
B: Composite of Recurrent VTE or VTE Death at 36 Months (36 months); Composite of Recurrent VTE or VTE Death at 18 Months (18 months)
C: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early))
D: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary: The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)


Options:
A: Symptomatic DVT (3 months); Symptomatic PE (3 months); Unsuspected PE and DVT (3 months); Worsening of pulmonary vascular or venous obstruction (3 months)
B: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
C: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early))
D: Incidence of Post-thrombotic Syndrome (PTS) (During 2-year follow up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Brief Summary: The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)


Options:
A: Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early))
B: Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (Day 1 up to 12 Months); Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation (Day 1 up to 12 months)
C: Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (3-, 6-, or 12-month study treatment period)
D: Progression of coronary and aortic valve calcification (Agatston, volume & mass score as assessed by cardiac CT) (Cardiac Computertomography (CT) will be performed at screening, after 12 months and at 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
Brief Summary: We will conduct a randomized, controlled trial of routine, pre-natal care practice-site based pre- and post-natal breastfeeding promotion interventions in low-income minority women, with stratification for maternal country of origin. Our primary outcome measure is breastfeeding duration and extent, i.e. "intensity." Our secondary outcomes measures are: a) infant weight, and b) participant/ provider experiences of the intervention.

The Provider Approaches to Improved Rates of Infant Nutrition \& Growth Study (PAIRINGS) trial randomizes women to a Prenatal Care Provider (PNC) + Lactation Consultant (LC) intervention, or Control group. The PNCs will use a brief, computer prompted protocol throughout pregnancy and at follow-up of maternal-infant dyads. The LC will meet women, one-on-one while pregnant, at daily hospital rounds, during well-infant care and (as needed) home visits. Post-partum interviews at 1,3 and 6 months will collect infant feeding data.

Primary Outcomes (Hypotheses): Breastfeeding

1. Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences, by treatment group, in BF intensity. Intensity will be assessed via 7 day recall of the frequency of breastmilk feedings vs. other liquids and solids.
2. Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences, by treatment group, in the rate of exclusive BF.

   Secondary Outcomes (Hypotheses): Infant Growth
3. Weight-for-Length, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight-for-length z scores at 4,6,9, and 12 month well-child visits.
4. Weight Gain, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight gain from the 4th -12th month of age.
5. Weight-for-Length, by Treatment Group: There will be a significant association between treatment group and weight-for-length z scores at 4,6,9, and 12 month well-child visits
6. Weight Gain, by Treatment Group: There will be a significant association between treatment group and weight gain from the 4th - 12th month of age.


Options:
A: Cardiovascular risk (5 years); Breastfeeding habits (1 years)
B: Exclusive breastfeeding (6 months postpartum)
C: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
D: Breastfeeding intensity at 1,3, and 6 months (1,3, and 6 months after birth of the baby)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
Brief Summary: We will conduct a randomized, controlled trial of routine, pre-natal care practice-site based pre- and post-natal breastfeeding promotion interventions in low-income minority women, with stratification for maternal country of origin. Our primary outcome measure is breastfeeding duration and extent, i.e. "intensity." Our secondary outcomes measures are: a) infant weight, and b) participant/ provider experiences of the intervention.

The Provider Approaches to Improved Rates of Infant Nutrition \& Growth Study (PAIRINGS) trial randomizes women to a Prenatal Care Provider (PNC) + Lactation Consultant (LC) intervention, or Control group. The PNCs will use a brief, computer prompted protocol throughout pregnancy and at follow-up of maternal-infant dyads. The LC will meet women, one-on-one while pregnant, at daily hospital rounds, during well-infant care and (as needed) home visits. Post-partum interviews at 1,3 and 6 months will collect infant feeding data.

Primary Outcomes (Hypotheses): Breastfeeding

1. Breastfeeding Intensity at 1,3, and 6 Months- There will be significant differences, by treatment group, in BF intensity. Intensity will be assessed via 7 day recall of the frequency of breastmilk feedings vs. other liquids and solids.
2. Exclusive Breastfeeding at 1,3, and 6 Months- There will be significant differences, by treatment group, in the rate of exclusive BF.

   Secondary Outcomes (Hypotheses): Infant Growth
3. Weight-for-Length, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight-for-length z scores at 4,6,9, and 12 month well-child visits.
4. Weight Gain, by Breastfeeding Intensity: There will be a significant association between BF intensity and weight gain from the 4th -12th month of age.
5. Weight-for-Length, by Treatment Group: There will be a significant association between treatment group and weight-for-length z scores at 4,6,9, and 12 month well-child visits
6. Weight Gain, by Treatment Group: There will be a significant association between treatment group and weight gain from the 4th - 12th month of age.


Options:
A: Postpartum weight retention (no more than 1.5 years)
B: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)
C: Breastfeeding intensity at 1,3, and 6 months (1,3, and 6 months after birth of the baby)
D: Breastfeeding at 3 months and at 6 months (3 months and six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: PRISMA Study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients)
Brief Summary: This randomized, parallel study compares 2 groups of type 2 non-insulin treated (NIT) diabetes patients using the Accu-Chek Aviva glucometers. One group (Intensive Group) will perform a 4-point daily glucose monitoring profile 3 times a week Monnier-based. These patients will also receive specific glycemic targets and suggestions on how to reach them following lifestyle recommendations. At the same time, investigators will use SMBG results, downloaded from glucometers, to improve patients' therapy. The second group (Control Group), will follow the SMBG standard care usually adopted in their centers. To be eligible, patients do not to have performed a previous intensive SMBG management (the execution of SMBG measurements used to modify lifestyle, diet or physical activity, in a systematic/structured manner and/or to manage therapeutic approach). The anticipated duration of the trial is 12 months, and the target sample size is 1000 individuals.


Options:
A: Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both (Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months)
B: Insulin Prescription Rate - the Number of Insulin-eligible Patients Per 12 Months Who Are Prescribed Insulin in Each Family Physician (FP) Practice (12 months)
C: Change in HbA1c at 12 months (12 months)
D: Change from baseline in HbAlc level; percentage of subjects reaching or maintaining the risk target (represented by a combination of LBGI<=2.5 together with HBGI<=5). (Visit 5 (52 weeks after Visit 1 +/- 2 weeks).)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study PXN110448: A Dose-response Study of XP13512, Compared With Concurrent Placebo Control and LYRICA(Pregabalin), in Subjects With Neuropathic Pain Associated Withdiabetic Peripheral Neuropathy (DPN)
Brief Summary: The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)


Options:
A: Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time (Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9)
B: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
C: Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month after the start of treatment); Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment); Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale (1 month from the start of treatment); Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale (3 months from the start of treatment)
D: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine (baseline, 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study PXN110448: A Dose-response Study of XP13512, Compared With Concurrent Placebo Control and LYRICA(Pregabalin), in Subjects With Neuropathic Pain Associated Withdiabetic Peripheral Neuropathy (DPN)
Brief Summary: The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)


Options:
A: Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment. (Baseline and Post-randomization Day 22); Number of Participants With Treatment-emergent Adverse Events (Randomization to Post-randomization Day 29 (includes dose reduction))
B: Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data (Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit))
C: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine (baseline, 12 weeks)
D: The primary study objective is to assess the relative efficacy of G-ER versus placebo in reducing the mean daily pain score from the baseline week to end of efficacy treatment period (Treatment Week 4) in patients with DPN. (4 weeks)

Answer: B