TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Lumbar Segmental Stabilization, Strengthening and Stretching in Chronic Low Back Pain: a Comparative Study
Brief Summary: The purpose of this study was to compare the efficacy of three exercise programs in patients with chronic low back pain: Segmental stabilization, superficial strengthening and stretching. Groups were contrasted regarding pain, functional disability and TrA muscle activation capacity. The three groups of exercise improved pain and functional disabilities, and the Segmental stabilization group was better in the ability to recruit TrA muscle.


Options:
A: Pain (visual analogical scale and McGill pain questionnaire) (Six weeks); Functional disability (Oswestry disability questionnaire) (Six weeks); TrA muscle activation capacity (Pressure Biofeedback Unit = PBU) (Six weeks)
B: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)
C: Pain VAS
D: Pain Intensity (2 months after randomisation); Disability (2 months after randomisation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lumbar Segmental Stabilization, Strengthening and Stretching in Chronic Low Back Pain: a Comparative Study
Brief Summary: The purpose of this study was to compare the efficacy of three exercise programs in patients with chronic low back pain: Segmental stabilization, superficial strengthening and stretching. Groups were contrasted regarding pain, functional disability and TrA muscle activation capacity. The three groups of exercise improved pain and functional disabilities, and the Segmental stabilization group was better in the ability to recruit TrA muscle.


Options:
A: Pain (visual analogical scale and McGill pain questionnaire) (Six weeks); Functional disability (Oswestry disability questionnaire) (Six weeks); TrA muscle activation capacity (Pressure Biofeedback Unit = PBU) (Six weeks)
B: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)
C: Pain VAS
D: Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis
Brief Summary: The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?


Options:
A: Reduction in mean oxidative balance ratio at 1 hour of life (Cord blood and at 1 hour of life)
B: Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) (18-21 months corrected for prematurity)
C: composite outcome of death or major disability by 18-24 months corrected age (by 18-24 months corrected age (gestational age plus chronological age))
D: Survival Without Bronchopulmonary Dysplasia (BPD) (36 weeks); Survival Without Severe Retinopathy of Prematurity (ROP) (Threshold Disease or the Need for Surgery) (55 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Control Trial To Compare the Effectiveness of Outpatient Endometrial Ablation Techniques (Novasure vs Thermachoice)in the Treatment of Menorhagia
Brief Summary: STUDY HYPOTHESIS: Does outpatient NovaSureTM endometrial ablation alleviate excessive menstrual bleeding and improve life quality more effectively than outpatient ThermachoiceTM endometrial ablation?


Options:
A: Amenorrhoea (6 months after the intervention.)
B: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) (Baseline MBL over 6 menstrual cycles)
C: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms (during a time period of 90 days under treatment)
D: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms (Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial to Determine the Effect of a Brief Behavioral Intervention in Reducing Drug Misuse Among an Emergency Department Population
Brief Summary: Although screening, brief intervention, and referral to treatment (SBIRT) approaches are effective in reducing alcohol misuse and its associated risk-taking behaviors and negative consequences, there is little research demonstrating the effectiveness of SBIRT for illicit and/or prescription drug misuse. Misusers of illicit and/or prescription drugs frequently seek medical care in emergency departments (EDs), particularly for reasons related to their misuse. As a result, the ED is well suited as a site to conduct an analysis of the effectiveness of SBIRT for this population.

The Brief Intervention for Drug Misuse for the Emergency Department (BIDMED) study is a randomized, controlled, trial that will include adult ED patients at a large, academic, trauma center (Rhode Island Hospital) and a community hospital (The Miriam Hospital) who have a subcritical illness or injury and whose screening indicates illicit and/or prescription drug misuse. BIDMED participants will be randomized to receive screening only (SO) or brief intervention (BI) with appropriate referral to treatment. Participants will complete a battery of blinded baseline assessments using standardized instruments as well as adapted instruments specific to the aims of this study. All participants will undergo blinded follow-up assessments at three, six, and twelve months post-randomization. The primary hypotheses addressed in the BIDMED study are that, compared to participants in the SO arm, participants in the BI arm will show a significantly greater reduction in: (1) drug misuse within the prior 30 days at three months post-randomization, (2) behaviors associated with drug misuse at six months post-randomization; and (3) negative physical health, psychosocial health, and socioeconomic consequences at twelve months post-randomization. As a secondary aim, the impact of BI compared to SO will be assessed on participants contacting, enrolling in, and completing a drug treatment program. In addition, the impact of BI compared to SO on increasing uptake of HIV and hepatitis B/C screening will be measured. A mechanisms of change model that addresses the expected mediators and moderators of change to explain the effects of SBIRT in this setting will also be developed and tested. Further, the epidemiology of illicit and/or prescription drug misuse will be assessed in a random sample of ED patients.


Options:
A: alcohol use (6 months); HIV risk taking (6 months)
B: Reduction in past 30 day drug misuse (12 months post-randomization); Reduction in behaviors associated with drug misuse (12 months post-randomization); Reduction negative physical health, psychosocial health, and socioeconomic consequences (12 months post-randomization)
C: past 30 day drug use abstinence (6 months post intervention)
D: Reduction in injury recidivism (August 2011); Reduction in alcohol intake (August 2011); Reduction in alcohol problems (August 2011)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Women's Health Initiative Memory Study of Younger Women
Brief Summary: WHIMS-Y provides valuable information on the long-term effects on risk of cognitive impairment of hormone therapy in a subset of WHI participants in the WHI Hormone Trials. Following cessation of study-prescribed HT cognitive function and impairment were assessed.


Options:
A: Rate of change of carotid intimal medial thickness by ultrasound (Measured at screening, 12, 24, 36, and 48 months)
B: Global disease activity throughout the follow-up period, estimated as the area under the SLEDAI-curve
C: All-cause dementia and Mild Cognitive Impairment (Measured once a year)
D: Rate of change of carotid intimal medial thickness by ultrasound (Measured at screening, 12, 24, 36, and 48 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
Brief Summary: The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure with the assistance of a robot.

Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to result in shorter hospital stays, decreased blood loss and similar surgical outcomes as compared to open abdominal surgery. The decision to use robotic assistance is typically based on surgeon preference and robot availability. The study will compare the outcomes of cost, quality of life, and return to work among women who undergo a laparoscopic sacrocolpopexy utilizing the robot to those using traditional laparoscopic techniques.

This research study is designed to compare the total costs and treatment success of these two surgical techniques. In addition, the study will compare outcomes of post-operative pain, quality of life, sexual function, return to normal activities and satisfaction with treatment outcome.


Options:
A: Mesh attachment interval (Intraoperative placement of mesh - approximately 30 minutes to 2 hours)
B: Number of Participants With Vaginal Mesh or Suture Exposure (1 year)
C: Cumulative Failure (6 Months through 36 Months)
D: Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy (6 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
Brief Summary: The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure with the assistance of a robot.

Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to result in shorter hospital stays, decreased blood loss and similar surgical outcomes as compared to open abdominal surgery. The decision to use robotic assistance is typically based on surgeon preference and robot availability. The study will compare the outcomes of cost, quality of life, and return to work among women who undergo a laparoscopic sacrocolpopexy utilizing the robot to those using traditional laparoscopic techniques.

This research study is designed to compare the total costs and treatment success of these two surgical techniques. In addition, the study will compare outcomes of post-operative pain, quality of life, sexual function, return to normal activities and satisfaction with treatment outcome.


Options:
A: Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy (6 Weeks)
B: Subjective assessment of pain on the morning of post-operative day 1 (One day (the day after surgery))
C: Number of harvested lymph nodes (2 years)
D: Operative Time (Intra operative)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
Brief Summary: The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure with the assistance of a robot.

Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to result in shorter hospital stays, decreased blood loss and similar surgical outcomes as compared to open abdominal surgery. The decision to use robotic assistance is typically based on surgeon preference and robot availability. The study will compare the outcomes of cost, quality of life, and return to work among women who undergo a laparoscopic sacrocolpopexy utilizing the robot to those using traditional laparoscopic techniques.

This research study is designed to compare the total costs and treatment success of these two surgical techniques. In addition, the study will compare outcomes of post-operative pain, quality of life, sexual function, return to normal activities and satisfaction with treatment outcome.


Options:
A: Duration of Surgery (after surgey)
B: Operative Time (1st 24 hours)
C: Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy (6 Weeks)
D: Primary outcome: operative time from incision to closure. (Primary outcome: will be obtained immediately at the end of each procedure.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies
Brief Summary: The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure with the assistance of a robot.

Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to result in shorter hospital stays, decreased blood loss and similar surgical outcomes as compared to open abdominal surgery. The decision to use robotic assistance is typically based on surgeon preference and robot availability. The study will compare the outcomes of cost, quality of life, and return to work among women who undergo a laparoscopic sacrocolpopexy utilizing the robot to those using traditional laparoscopic techniques.

This research study is designed to compare the total costs and treatment success of these two surgical techniques. In addition, the study will compare outcomes of post-operative pain, quality of life, sexual function, return to normal activities and satisfaction with treatment outcome.


Options:
A: Surgical Success (24 months); Anatomic Failure (24 months); Urinary Distress Inventory at 6 Months (6 months)
B: Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy (6 Weeks)
C: Stress urinary continence (3 months)
D: anatomic outcomes,graft-related complications between the two materials, changes in pelvic organ prolapse-related quality of life,subjective changes in sexual function,changes in bowel function and the prolapse related pain present after sacral colpopexy (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Haemocomplettan® P in Patients Experiencing Microvascular Bleeding While Undergoing Elective Complex Cardiac Surgery
Brief Summary: Fibrinogen concentrate is increasingly used in cardiac surgery to reverse coagulopathy. Whether its use reduces blood loss, transfusion and occurrence of clinical adverse events remains unknown.


Options:
A: Avoidance of allogeneic blood products transfusion (30 days)
B: Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed (At 1 and 4 hours after the end of infusion); Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR) (30 minutes after end of infusion)
C: To determine whether fibrinogen concentrate infusion reduces perioperative blood loss. (within 12 hours.)
D: fibrinogen concentration (clauss) (45 minutes after the admission on day 1 after trauma)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection
Brief Summary: To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.


Options:
A: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) (Weeks 4 and 12); Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24) (Follow-up Week 24); Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died (From start of study treatment (day 1) up to follow-up Week 48)
B: Change From Baseline at Day 7 in log10 Hepatitis C Virus (HCV) RNA of All Participants (Baseline, Day 7)
C: Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period (Baseline to Week 12 plus 30 days)
D: Safety Outcome Measures (Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection
Brief Summary: To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.


Options:
A: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses (12 weeks after last dose of study drug)
B: Part 1: Rapid Virological Response (RVR) (4 weeks); Part 2: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 52 weeks); Part 3 and 4: Sustained Virological Response (SVR) (From drug administration until 12 weeks after end of treatment, up to 36 weeks)
C: Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR) (Weeks 4 and 12); Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24) (Follow-up Week 24); Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died (From start of study treatment (day 1) up to follow-up Week 48)
D: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) (Posttreatment Week 12); Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) (Up to 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention to Reduce Dietary Sodium in Hemodialysis
Brief Summary: The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis patients, a behavioral intervention to reduce dietary sodium intake. The investigators will assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and health-related quality of life. The primary study hypotheses are that participants will gain less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced consumption of dietary sodium.


Options:
A: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)
B: Knowledge about Living Kidney Donation (3 weeks)
C: ART adherence (Every 3 months up to 12 months); HIV-1 viral load (Every 3 months up to 12 months); Sexual risks (Every 3 months up to 12 months); Clinic visit adherence (Every 3 months up to 12 months)
D: Percent of Participants That Scheduled an Appointment for PrEP Consultation. (3 months); Percent of Participants That Attended an Appointment for PrEP Consultation. (3 months); Percent of Participants That Received a PrEP Prescription. (3 months); Percent of Participants That Filled Their PrEP Prescription. (3 months); Percent of Participants That Initiated PrEP Use. (3 months); Percent of Participants That Adhered to PrEP Over the Past Seven Days for Participants That Initiated PrEP (3 months); Percent of Participants That Attended PrEP Follow-up Appointment. (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intervention to Reduce Dietary Sodium in Hemodialysis
Brief Summary: The purpose of this study is to test, in a randomized clinical trial of 200 hemodialysis patients, a behavioral intervention to reduce dietary sodium intake. The investigators will assess the impact on weight gain between dialysis treatments, blood pressures, symptoms, and health-related quality of life. The primary study hypotheses are that participants will gain less weight in between dialysis treatments, and that dietary recalls will demonstrate reduced consumption of dietary sodium.


Options:
A: Referral for Kidney Transplantation (One Year)
B: Medication Adherence Change from Baseline to 6 Months (6 months); Medication Adherence Change from 6 Months to 12 Months (12 months); Medication Adherence Change from Baseline to 12 Months (12)
C: Time Specific Interdialytic Weight Gain (Baseline) (Baseline); Time Specific Interdialytic Weight Gain (8 Weeks) (8 weeks); Time Specific Interdialytic Weight Gain (12 Weeks) (12 weeks); Time Specific Interdialytic Weight Gain (16 Weeks) (16 weeks); Time Specific Dietary Sodium Intake (Baseline) (Baseline); Time Specific Dietary Sodium Intake (8 Weeks) (8 weeks); Time Specific Dietary Sodium Intake (16 Weeks) (16 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 8 Weeks) (Baseline to 8 weeks); Time Specific Change From Baseline in Dietary Sodium Intake (Baseline to 16 Weeks) (Baseline to 16 weeks)
D: Combined endpoint achievement of target blood pressure and proteinuria (one year); Cumulative duration of hospitalization in short-stay for 1 year (one year); Cumulative duration of unplanned short stay for 1 year (One year); Survival (One Year)

Answer: C