TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Individuals With Diabetes in the Rio Grande Valley
Brief Summary: The purpose of this study is to implement a system of integrated health care that provides a continuum of care for those with diabetes. This study will use a randomized behavioral intervention trial experimental design to compare participants receiving the enhanced delivery of integrated behavioral care with nonparticipants receiving the usual care until after the study period, at which time they will be offered access to expansion services.


Options:
A: Hemoglobin A1c (1 year after date of discharge)
B: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)
C: Rate of Change in Hemoglobin A1c (12 month period)
D: hemoglobin A1c levels (at six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Seroma Reduction and Drain Free Mastectomy
Brief Summary: To prove that omitting drains after mastectomy and flap fixation does not contribute to higher incidence of seroma formation and therefore reducing patient disutility such as seroma aspirations and visits to the outpatient clinic, as well as reducing seroma related wound complications.


Options:
A: Early Complications of Vascular Zone (2 weeks)
B: Seroma aspiration of clinically significant seroma (During first six months post-operative)
C: superficial site infection via southampton scoring system (higher score - worse outcome) (5 days); Wound Dehisence (5 days)
D: Number of Participants With Superficial or Deep Surgical Site Infections (SSIs) (30 days postoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study
Brief Summary: This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.


Options:
A: The primary aim of this study is to show an improvement of the average levels of postextubation PaCO2 in infants less than 18 months of age and post-bypass surgery (Final outcome measure is assessed when 80 patients have been recruited.Outcome measure is assessed at the end of 48 hours postextubation and when the patient is discharged from the ICU.)
B: Number of participants with HFNC success (during hospitalization, approximatly 6 days); Number of participants with CPAP/NPPV success (during hospitalization, approximatly 6 days)
C: Mean esophageal pressure (3.5 hours)
D: Patient respiratory effort and tidal volume (Vt) (1h20)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients
Brief Summary: Elevated blood pressure (BP) consists of a major public health concern especially in low and middle income countries. Besides being a highly prevalent condition, it is also a risk factor for several major cardiovascular events including stroke (which consists of the second leading cause of death in developing countries) and coronary artery disease, and is also related to cognitive decline. The OPTIMAL Stroke trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower target systolic blood pressure (SBP) as compared to the currently recommended target for stroke patients will reduce the occurrence of major cardiovascular events.


Options:
A: Time to symptomatic AF/atrial tachycardia (AT)/atrial flutter (AFl) lasting > 30 seconds more than 3 months post ablation. (at least 3 months post catheter ablation)
B: Stroke event (Up to four years of follow-up)
C: Evidence of clinically defined ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI (Mean follow up of 4 years); Evidence of hemorrhagic stroke; a neurologic deficit associated with intraparenchymal or subarachnoid space lesion on CT/MRI or cerebral hemorrhage demonstrated by surgery or autopsy. (within mean follow-up of 4 years)
D: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a median of 3.5 years ] (From randomization; for approximately a median of 3.5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients
Brief Summary: Elevated blood pressure (BP) consists of a major public health concern especially in low and middle income countries. Besides being a highly prevalent condition, it is also a risk factor for several major cardiovascular events including stroke (which consists of the second leading cause of death in developing countries) and coronary artery disease, and is also related to cognitive decline. The OPTIMAL Stroke trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower target systolic blood pressure (SBP) as compared to the currently recommended target for stroke patients will reduce the occurrence of major cardiovascular events.


Options:
A: change of percent atheroma volume (1.5-year)
B: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a median of 3.5 years ] (From randomization; for approximately a median of 3.5 years)
C: Number of participants with composite of major CVD events (4 years)
D: Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) (Screening to 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Foot Massage on Postpartum Comfort and Pain Level of the Mothers Who Had Vaginal Birth: A Randomised Controlled Trial
Brief Summary: Background and Purpose: This study aims to investigate the effect of foot massage in the postpartum period on the need of receiving analgesic medication after assessing the postpartum comfort and pain status of the mothers who had vaginal delivery.Materials and methods: The study was completed with 66 mothers. As data collection tools, a questionnaire, Postpartum Comfort Scale (PCS), Visual Analogue Scale (VAS) and Drug Follow-up Card (DFC) were used.


Options:
A: Informed Consent Form (5-10 minutes); Postpartum Comfort Scale (PCS) (5-10 minutes); Visual Analog Scale (VAS) (Less than 1 minute); Drug Follow-up Card (DFC) (About 1 minute)
B: Patient Reported Average Pain Score (Average score computed from postpartum day 0, postpartum day 1); Number of Patient Using Each Type of Non-narcotic Pain Medications (Number of patients using each type of non-narcotic medication recorded on postpartum day 0 and postpartum day 1); Any Narcotic Pain Medication Use (Any narcotic medication use from postpartum day 0 and postpartum day 1)
C: Postpartum weight loss (12 months after delivery)
D: Opioid Consumption in MME (within 24 hours of delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Brief Summary: Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia.

The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.


Options:
A: Changes in pain (6 months)
B: The Difference in Responders Between Both Groups (6 Months)
C: Usual pain intensity in lower extremity(ies) (Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
D: Nerve conduction measurements; Pain scores from patient diaries

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Brief Summary: Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia.

The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.


Options:
A: Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods (12 months)
B: Changes in pain (6 months)
C: Patient's Global Impression of Change (PGIC)
D: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Brief Summary: Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia.

The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.


Options:
A: Changes in pain (6 months)
B: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)
C: Composite of Safety and Effectiveness (3 months)
D: Responder Rate (3 months post-activation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Large-Scale Randomized Clinical Trial Assessing Intensive Blood Pressure Control for Reduction of Major Cardiovascular Events in Patients With Diabetes Mellitus (OPTIMAL-DIABETES)
Brief Summary: High blood pressure (BP) is a major public health concern, especially in low and middle income countries. High BP is a highly prevalent condition, and it is usually associated with diabetes mellitus. Both high BP and diabetes are risk factors for major cardiovascular events including cardiovascular death, acute myocardial infarction, stroke, unstable angina and heart failure. In addition, high BP is also related to cognitive decline. The OPTIMAL-DIABETES trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower systolic blood pressure (SBP) target will reduce the occurrence of major cardiovascular events in diabetic patients compared to the standard SBP target.


Options:
A: Change in Lateral Mitral Annular Myocardial Relaxation Velocity (Baseline to 24 weeks after treatment)
B: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure (From randomization; for approximately a median of 3.5 years)
C: change of percent atheroma volume (1.5-year)
D: To evaluate changes from baseline in Left Ventricular Mass at 24M (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Large-Scale Randomized Clinical Trial Assessing Intensive Blood Pressure Control for Reduction of Major Cardiovascular Events in Patients With Diabetes Mellitus (OPTIMAL-DIABETES)
Brief Summary: High blood pressure (BP) is a major public health concern, especially in low and middle income countries. High BP is a highly prevalent condition, and it is usually associated with diabetes mellitus. Both high BP and diabetes are risk factors for major cardiovascular events including cardiovascular death, acute myocardial infarction, stroke, unstable angina and heart failure. In addition, high BP is also related to cognitive decline. The OPTIMAL-DIABETES trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower systolic blood pressure (SBP) target will reduce the occurrence of major cardiovascular events in diabetic patients compared to the standard SBP target.


Options:
A: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a median of 3.5 years ] (From randomization; for approximately a median of 3.5 years)
B: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure (From randomization; for approximately a median of 3.5 years)
C: Stroke event (Up to four years of follow-up)
D: changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). (0, 12, 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reduction of Visual and Auditory Stimuli to Reduce Pain During Venipuncture in Premature Infants. A Randomized Controlled Trial.
Brief Summary: The aim of the study is: To evaluate the efficacy of the reduction of visual and auditory stimuli on pain during venipuncture in premature newborns of 32-36 weeks of gestation.


Options:
A: Standard and Raw Scores of Receptive and Expressive Language on MacArthur-Bates Communicative Development Inventory (CDI): Words and Sentences (18 month follow-up adjusted age for preterm birth)
B: Change in Heart Rate Variability (Pre intervention (baseline), during the intervention and immediately after the intervention)
C: Change in the Premature Infant Pain Profile (PIPP) score (From baseline Pain determination at (just before venipuncture) to 30 seconds after venipuncture)
D: Index of Multisensory Processing (IMP) (At enrollment up to 36 weeks gestation (prior to intervention), and at intervention completion up to 42 weeks gestation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis
Brief Summary: This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).


Options:
A: Changes in adverse events (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal laboratory (at screening and at each study visit up to day 43 which is the final FU visit); Changes in abnormal vital signs, ECG or physical examination (at screening and at each study visit up to day 43 which is the final FU visit)
B: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline through Week 100)
C: Change in Voltage (mVolt) in Nasal Epithelium (Baseline and 2 weeks)
D: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis
Brief Summary: This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).


Options:
A: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 Through Safety Follow-up (up to Day 61 for Part 1, Day 85 for Part 2 and Day 57 for Part 3)); Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline Through Day 29)
B: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline through Week 100)
C: Maximum Observed Concentration (Cmax) of VX-659, TEZ, and IVA (Day 1 and Day 15); Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, and IVA (Day 8 and Day 15); Area Under the Concentration Versus Time Curve From Time 0 to 6 Hours (AUC0-6h) of VX-659, TEZ, and IVA (Day 1 and Day 15)
D: Safety and Tolerability assessments as determined by number of subjects with adverse events (AEs) and serious adverse events (SAEs) (from baseline up to Day 50)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns
Brief Summary: To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients


Options:
A: Change in Maximum Keratometry From Baseline to 6 Months After Treatment (6 months)
B: evaluation of depth of demarcation line (1 month postoperative)
C: Best corrected distant visual acuity (BCDVA) (One year)
D: Best corrected visual acuity (at six months after surgery)

Answer: B