TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Systolic Blood Pressure Intervention Trial
Brief Summary: Elevated blood pressure (BP) is an important public health concern. It is highly prevalent, the prevalence may be increasing, and it is a risk factor for several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. The Systolic Blood Pressure Intervention Trial (SPRINT) is a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease (CVD) risk.


Options:
A: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
B: Primary composite outcome (4 years)
C: Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD (8-12 months after stroke onset)
D: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Systolic Blood Pressure Intervention Trial
Brief Summary: Elevated blood pressure (BP) is an important public health concern. It is highly prevalent, the prevalence may be increasing, and it is a risk factor for several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. The Systolic Blood Pressure Intervention Trial (SPRINT) is a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease (CVD) risk.


Options:
A: To evaluate changes from baseline in Left Ventricular Mass at 24M (24 months)
B: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)
C: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Systolic Blood Pressure Intervention Trial
Brief Summary: Elevated blood pressure (BP) is an important public health concern. It is highly prevalent, the prevalence may be increasing, and it is a risk factor for several adverse health outcomes, especially coronary heart disease, stroke, heart failure, chronic kidney disease, and decline in cognitive function. The Systolic Blood Pressure Intervention Trial (SPRINT) is a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease (CVD) risk.


Options:
A: First occurrence of death or nonfatal myocardial infarction (MI) or nonfatal stroke
B: changes in Left Ventricular Hypertrophy (LVH) at Electro Cardio Gramme (ECG). (0, 12, 24 months)
C: Recurrent stroke (five years)
D: Number of Participants With First Occurrence of a Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Stroke, Heart Failure (HF), or CVD Death (6 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial (Pilot)
Brief Summary: The specific aim of the proposed study is to conduct a pilot study involving 160 critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of America, Belgium and France in order to:

Specific Aims

* Confirm that we can achieve a clinically significant difference in calorie and protein intake between the two intervention groups.
* Estimate recruitment rate i.e. number of eligible and enrolled patients per month per site.
* Evaluate the safety, tolerance, and logistics around providing supplemental PN in the study population in the context of a multicenter trial, e.g.

  * To ensure adequate glycemic control in both groups.
  * To ensure that the other metabolic consequences of the feeding strategies are minimized.
  * To establish adequate compliance with study protocols and completion of case report forms

A secondary aim of this pilot study will be:

• To explore the effect of differential effects of calorie and protein delivery on muscle and mass function.


Options:
A: Calorie & Protein Intake 7 Days Post Randomization (7 days post randomization); Calorie & Protein Intake in First 27 Days (first 27 days)
B: Physical function (6 months after randomisation)
C: Number of ventilator-free days (VFD) (Measured at Day 28); Mortality before hospital discharge, with unassisted breathing (Measured at Days 60 and 90)
D: To compare ventilator associated pneumonia rates in patients receiving early enteral feeding without residual gastric volume (RGV) monitoring and in patients with RGV monitoring (until weaning of mechanical ventilation (average : 14 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Home-based Exercise Combined With a Slight Caloric Restriction on Obesity Prevention Among Women
Brief Summary: The study investigated the effectiveness of home-based exercise combined with a slight caloric restriction on weight change during 12 months in non-obese women. In addition the investigators evaluate the effects of baseline insulin resistance on modulation of weight change.

A randomized clinical trial with a factorial design was conducted from 2003 to 2005. Two hundred three middle-aged women (Rio de Janeiro/Brazil), 25-45 years, were randomly assigned to one of two groups: control (CG) and home-based exercise (HB). The HB group received a booklet on aerobic exercise that could be practiced at home (3 times/week - 40 min/session), in low-moderate intensity, during 12 months. Both groups received dietary counseling aimed at a slight energy restriction of 100-300 calories per day.

The HB experienced a greater weight loss in the first 6 months (-1.4 vs. -0.8 kg; p=0.04), but after 12 months there was no differences between groups (-1.1 vs. -1.0; p=0.20). Of the serum biochemical markers, HDL-cholesterol showed major change, with an increase at month 12 of 18.3 mg/dl in the HB compared to 9.5 in the CG (p\<0.01). At baseline the non-IR group (n=121) compared to IR (n=64) had similar values of BMI (26.7 vs. 26.3 p=0.21), but statistically significant lower values of waist, glucose, insulin and HOMA-IR, as expected. When the group non-IR and IR were further stratified by GI diet, there were no differences according to diet in both groups. Women classified as IR at baseline had greater weight loss after 12 months of follow-up (-1.62 kg vs. -1.08 kg; p=0.01), and HB exercise helped to reduce weight only among NIR women (-1.51 vs. -0.68; p=0.04); no differences were observed between intervention groups for IR women (-1.54 vs. -1.66; p=0.24). There were no differences between IR and NIR groups for lipid profile after adjustment for weight changes. During follow-up, changes were more pronounced among those women in the high GI diet. These differences were statistically significant for weight and BMI and were greater among the IR compared to the non-IR. Changes in HOMA-IR after 3 months of follow-up were different comparing non-IR with IR at baseline. The IR had a reduction in the HOMA-IR, whereas in the non-IR this value increased (-0.73 vs. +0.37; p=\<0.001). Also this reduction was greater among high compared to low GI diet (p=0.04).


Options:
A: N/A
B: The primary endpoints of the study will be a set of inter-related biomarkers for hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk. (two 4-week feeding periods (56 days total))
C: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Duration of Human Papilloma Virus (HPV) Type-Specific Antibody After Administration of Quadrivalent HPV Vaccine (QHPV) to HIV-1 Infected Children Previously Enrolled in IMPAACT P1047
Brief Summary: This study is being done to evaluate how long the immune response from the Human Papilloma Virus (HPV) vaccine you / your child received persists. The immune response occurred after immunization and is what protects you/your child from HPV disease. You / your child received this vaccine as part of an earlier study (P1047). The vaccine is called Human Papillomavirus Vaccine (QHPV Vaccine, also known as GARDASIL®). The study will check to see if the protective effects (called "antibodies") produced by the vaccine have lasted, and for how long these effects will continue to last. You will not be given any medications or vaccines as part of this follow-up study.


Options:
A: To determine the HPV-type specific antibody levels at 2, 3.5, and 5 years after completion of the QHPV vaccine schedule for each of the arms in P1047 (208 weeks (4 Years))
B: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)
C: N/A
D: Occurrence of intraepithelial neoplasia grade 3 or worse (CIN3+). including CIN3, cervical cancer (squamous cell carcinoma or adenocarcinoma). (The time frame is up to 15 years (for the interim analyses: 4, 7 and 10 years). (Start and end of passive follow-up, Cohorts A and B: 01.01.2010 - 31.12. 2024; Cohorts C1 and C2: 01.10.2007/01.10.2008 - 30.09.2021/30.09.2023.))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Discharge Planning for Elderly Patients in the Emergency Department: Use of a Brief Phone Call After Discharge to Improve Medication Utilization and Physician Follow-up
Brief Summary: The investigators hypothesize that the acquisition and correct utilization of medications as well as arranging and attending follow-up appointments will improve as a result of a phone call intervention 1-3 days after elderly patients are discharged from the emergency department (ED).


Options:
A: Whether patient obtained medications prescribed at their discharge from ED (5-8 days after discharge from ED); Whether patient is using medications that were prescribed at their ED discharge correctly (5-8 days after discharge from ED); Whether the patient arranged a follow-up appointment with their primary care provider (5-8 days after discharge from ED); Whether patient attended visit with their primary care provider after discharge from the ED (30-35 days after discharge from ED)
B: Predicted 10-year CHD risk (4-month follow-up)
C: Geriatric Depression Scale (12 months); Physical Performance Test (PPT) (12 months); SF-36 Health Survey (12 months); Mental Mental Status Exam (MMSE) (12 months); Hospitalization (12 month enrollment period); Hospital Days (12 Month Enrollment Period); Emergency Department Visits (12 month Enrollment Period); Medicare Costs (12 Month Enrollment Period)
D: Medication Appropriateness Index (MAI)-Score (6 months from baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis (CRITIC) A Randomized Pharmacokinetic Comparison of Tobramycin in Cystic Fibrosis
Brief Summary: Cystic fibrosis is the most common inherited life limiting condition which affects children. Patients with it develop lung infections which become difficult to clear, and damage the lungs. These are treated with antibiotics (such as tobramycin) into the vein (termed "intravenous antibiotics"). This has without doubt improved survival. However, all treatments have side effects. Tobramycin can cause kidney damage. The investigators have preliminary data that suggests that administering tobramycin in the morning may be safer for the kidneys than administering it in the evening.

The investigators plan to approach children and adults with cystic fibrosis whose doctors have decided to administer a course of intravenous tobramycin. The investigators will randomly allocate them to receive it at either 0800h or 2200h. The investigators will measure the rate at which the body eliminates tobramycin from the bloodstream, by measuring the amount of tobramycin in the blood stream after administering the antibiotic. For each patient the study will last for the duration of the course of antibiotics. This is decided by the doctor looking after the patient (rather than the researcher), and would typically be 14 days. The investigators will also measure substances in the blood and urine ("biomarkers") which are sensitive indicators of low levels of kidney injury. The investigators will monitor lung function and lung bacteria in both the groups to ensure that the patients in both groups improve by the same amount.

If the preliminary data are proved correct, this research will allow investigators to improve the safety profile of tobramycin, one of the most widely prescribed drugs in cystic fibrosis.


Options:
A: Clinically Significant Laboratory Abnormalities. (28 Days)
B: Time to Recurrence of Pseudomonas (P.) Aeruginosa (Any Genotype) in Sputum or Deep Throat Cough Swab (From 1 month after the end of treatment (Day 56 for the 28-day treatment group and Month 3 for the 56-day treatment group) until the end of the study (Month 27))
C: Renal Elimination Rate Constant of Tobramycin (Days 1, 8 and 14)
D: Number of Participants With Treatment-Emergent Adverse Events (56 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence
Brief Summary: This study is a randomized controlled trial of a brief intervention for women Emergency Department patients with involvement in both Intimate Partner Violence (IPV) and problem drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief motivational intervention, delivered by social workers in the Emergency Department setting, in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with resources. Social work graduate students and/or staff will be trained to provide brief motivational enhancement therapy (MET) intervention for decreasing heavy drinking and IPV-related injury in women Emergency Department patients.


Options:
A: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
B: The proportion of condom protected acts of vaginal and anal intercourse (Up to 12 months)
C: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
D: Drug abstinence

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence
Brief Summary: This study is a randomized controlled trial of a brief intervention for women Emergency Department patients with involvement in both Intimate Partner Violence (IPV) and problem drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief motivational intervention, delivered by social workers in the Emergency Department setting, in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with resources. Social work graduate students and/or staff will be trained to provide brief motivational enhancement therapy (MET) intervention for decreasing heavy drinking and IPV-related injury in women Emergency Department patients.


Options:
A: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
B: Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization (Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months)
C: Reduction of 15% in alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the PFI group . In the self-help material group we expect that 5 - 10% will reduce their consumption equivalent. (12 months)
D: alcohol intake (six months and one year); injury recidivism (six months and one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence
Brief Summary: This study is a randomized controlled trial of a brief intervention for women Emergency Department patients with involvement in both Intimate Partner Violence (IPV) and problem drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief motivational intervention, delivered by social workers in the Emergency Department setting, in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with resources. Social work graduate students and/or staff will be trained to provide brief motivational enhancement therapy (MET) intervention for decreasing heavy drinking and IPV-related injury in women Emergency Department patients.


Options:
A: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
B: Change in Intimate Partner Violence Victimization from Baseline (12 months)
C: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
D: Discussion-opportunity about risk of partner abuse during physician-patient medical encounter (audiotaped data); Detection of partner abuse during physician-patient medical encounter (audio taped data)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence
Brief Summary: This study is a randomized controlled trial of a brief intervention for women Emergency Department patients with involvement in both Intimate Partner Violence (IPV) and problem drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief motivational intervention, delivered by social workers in the Emergency Department setting, in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with resources. Social work graduate students and/or staff will be trained to provide brief motivational enhancement therapy (MET) intervention for decreasing heavy drinking and IPV-related injury in women Emergency Department patients.


Options:
A: Discussion of family psychosocial problem; Referral of family psychosocial problem; Contacting community resources
B: Intimate partner violence (One year)
C: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)
D: Past year experience of physical violence by an intimate partner (among women partnered in past year) (4 years after intervention implementation); Past year experience of sexual violence by an intimate partner (among women partnered in the past year) (4 years after intervention implementation); Acceptability of violence against women (4 years after intervention implementation); Acceptability of a woman refusing sex (4 years after intervention implementation); Community response to women experiencing physical and/or sexual IPV in past year (among women reporting physical/sexual IPV in past year) (4 years after intervention implementation); Past year concurrent sexual partner (among men partnered in past year) (4 years after intervention implementation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence
Brief Summary: This study is a randomized controlled trial of a brief intervention for women Emergency Department patients with involvement in both Intimate Partner Violence (IPV) and problem drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief motivational intervention, delivered by social workers in the Emergency Department setting, in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with resources. Social work graduate students and/or staff will be trained to provide brief motivational enhancement therapy (MET) intervention for decreasing heavy drinking and IPV-related injury in women Emergency Department patients.


Options:
A: Change in PTSD symptoms (PTSD Symptom Scale Interview) (Change in PTSD symptoms from baseline to 3 months post intervention)
B: Change in Pittsburgh Sleep Quality Index total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU); Change in Modified PTSD Symptom Scale - Self Report total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU)
C: Drug Abuse Screening Test (DAST-10) (6 months); Alcohol Use Disorders Identification Test (AUDIT) (6 months); Cigarettes (Estimated Number) (14 days preceding 6 week, 3 month and 6 month follow-up); Amount of Alcohol Use (14 days prior to 6 week, 3 month, 6 month follow-up); Marijuana Use Frequency (14 days prior to 6 week, 3 month, 6 month follow-up)
D: Effectiveness of brief intervention for decreasing problem drinking and partner violence (Weekly for 3 months; then 6 and 12 months)

Answer: D