TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of "Tailored Physical Activity" on the Number of Sick Days: a Randomized Controlled Trial in Health Care Workers That Have Experienced Pain Related to the Spine or Upper Body
Brief Summary: The purpose of this study is to test the effect of "Tailored Physical Activity" on the number of sick-days.

The hypothesis is that "Tailored Physical Activity" is superior in efficacy on sick-days.


Options:
A: Self-reported number of sick-days (3 months)
B: time until full sustainable return-to-work (RTW) (1 year); Total number of sickness absence days (1 year)
C: length of sickness absence (6 months after randomization)
D: Return to work from sick leave (Up to 1,5 years post intervention completion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Group CBT for Chronic PTSD: RCT With Veterans
Brief Summary: The purpose of this study is to examine whether group cognitive behavioral treatment (GCBT) is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a primary diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive group treatment condition. Both treatments will consist of 14, weekly sessions. Assessment of PTSD and related symptoms will be conducted at pre-treatment, mid treatment, post-treatment, and 3-, 6-, - and 12-month follow-up.


Options:
A: Change in PTSD Symptom Scale, Interview Version (PSS-I) following treatment (Baseline to 6-month follow-up (approximately 34 weeks for Spaced PE and PCT, 26 weeks for Massed PE)
B: summing totals of 17 DSM-IV symptoms (10 weeks)
C: PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up (Baseline, Weeks 3, 6, 9 and 17)
D: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence to Web-Based Cessation Programs: A Social Network Approach
Brief Summary: This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT.


Options:
A: Self-reported 30-day Point Prevalence Abstinence (9 months post-randomization)
B: Reproductive rate (30 days)
C: Self-reported 7-day Point Prevalence Abstinence From Smoking That Was Sustained at 60 Days After the Quit Date (60 days after quit date)
D: smoking status (six month followup)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Adherence to Web-Based Cessation Programs: A Social Network Approach
Brief Summary: This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT.


Options:
A: Cotinine validated quit rates.
B: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
C: Self-reported 30-day Point Prevalence Abstinence (9 months post-randomization)
D: Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery. (from the first administration of nicotine/placebo patch until delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA
Brief Summary: The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.


Options:
A: Response Rate (average 6 months)
B: Progression-Free Survival (Site Read, Investigator Assessment) (Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks); Median Progression-Free Survival (Site Read, Investigator Assessment) (Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks)
C: To compare overall survival between ZD1839 and docetaxel
D: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Dietary Factors on Physiological Subjective Stress Responses in Cronically Stressed Subjects: a Randomised Clinical Trial
Brief Summary: The study aims to investigate the role of dietary factors in chronically stressed subjects. Previous studies have shown that milk proteins, B vitamins and probiotics may influence on subjective well-being in stressed subjects.


Options:
A: Subjective well-being (baseline and 4 weeks)
B: Cognitive development and performance (1 year)
C: Vitamin A in the entire body (4 months)
D: Linear growth velocity (6 to 18 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Office Hysteroscopy and Endometrial Snip Improve IUI Outcome? : a Randomized Controlled Trial
Brief Summary: Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI) cycles , in cases of repeated implantation failure. It is found that it will improve the implantation rate.


Options:
A: Clinical pregnancy rate (10 month)
B: Ongoing pregnancy (18 months)
C: Visual analogue scale for pain; Patient satisfaction
D: The time taken for polyp removal (at the time of surgery (day 1 intraoperatively))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Office Hysteroscopy and Endometrial Snip Improve IUI Outcome? : a Randomized Controlled Trial
Brief Summary: Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI) cycles , in cases of repeated implantation failure. It is found that it will improve the implantation rate.


Options:
A: implantation rate (4 weeks)
B: A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. (Approximately 9 months after completion of the last procedure of the last study participant.)
C: Clinical pregnancy rate (10 month)
D: PRIMARY OUTCOME MEASURE:IMPLANTATION RATE; (9 MONTHS)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Does Office Hysteroscopy and Endometrial Snip Improve IUI Outcome? : a Randomized Controlled Trial
Brief Summary: Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI) cycles , in cases of repeated implantation failure. It is found that it will improve the implantation rate.


Options:
A: Clinical pregnancy rate (6 months)
B: Compare Pipelle and Explora Curette Groups With Respect to Patient Perception of Pain Associated With the Procedure as Rated by a 100mm Visual Analog Scale (VAS). (2 minutes after biopsy procedure)
C: Clinical pregnancy rate. (one year); Miscarriage rate. (one year); Multiple pregnancy rates (one year)
D: Clinical pregnancy rate (10 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Non-invasive Brain Stimulation on Motor Recuperation
Brief Summary: tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to improve a variety of functions with superior or inferior limb.


Options:
A: Dynamic sitting balance and trunk control (Change from Baseline at week 5); Stepping (Change from Baseline at week 5)
B: change in motor function before/after tDCS (Baseline (>6 months after stroke), immediately after intervention (30min of tDCS), 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks)
C: Safety of the intervention as assessed by frequency of adverse events (2 weeks)
D: Disability (three months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Non-invasive Brain Stimulation on Motor Recuperation
Brief Summary: tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to improve a variety of functions with superior or inferior limb.


Options:
A: Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months)
B: Changes in cortical excitability measures (Measured for approximately 6 weeks)
C: change in motor function before/after tDCS (Baseline (>6 months after stroke), immediately after intervention (30min of tDCS), 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks)
D: electromyography (EMG ) activity of Tibialis Anterior Muscle. (1 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Examining Adolescent Assessment, Feedback, Incentive, and Exchange (AFIX)
Brief Summary: The North Carolina Immunization Branch will evaluate the use of the CDC program to improve adolescent vaccination practices (called Assessment, Feedback, Incentives, and eXchanges, or AFIX). This evaluation is the first of its kind in the nation and may have a profound impact on prevention.

AFIX has four major components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement.

This program will evaluate the effectiveness of AFIX visits on affecting provider practices to increase adolescent (age 11-18) immunization. Visits include discussion of that practice's immunization rates and strategies for improving rates. The investigators will compare the changes, from baseline to 5 months, in immunization for practices receiving virtual visits (webinars), in-person visits, and no visits (control group). Thirty practices will be randomly assigned to each intervention type. The main outcomes of this study are practice-wide uptake rates of several adolescent vaccines (Tdap, HPV, and MCV4) as well as pre- and post-AFIX visit surveys focusing on recall tactics utilized by each practice. Data will be collected on practices with at least 200 adolescent patients (note: there is no patient-level data collected in this study).


Options:
A: Intention to use condom if new partner (Change from Baseline Intention at 3 months); Intention to use condom if new partner (Change from Baseline Intention at 12 months); Intention to use condom if new partner (Change from Baseline Intention at 24 months); Attitude to prevention about HPV (Change from Baseline Attitude at 3 months); Attitude to prevention about HPV (Change from Baseline Attitude at 12 months); Attitude to prevention about HPV (Change from Baseline Attitude at 24 months)
B: Vaccine coverage by delivery strategy (Month 12); Vaccine coverage (dose 2) by delivery strategy (Month 5); Vaccine coverage (dose 1) by delivery strategy (Month 3)
C: Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV) (15 months)
D: Change in Vaccination Rate: HPV vaccine initiation among 11-12 year olds (Baseline and 5 months follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study
Brief Summary: This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP.

Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.

The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.


Options:
A: Responder Rate (25 weeks)
B: Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period (Up to 25 weeks)
C: Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period (6 months)
D: Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score (at Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pragmatic, Randomized Optimal Platelet and Plasma Ratios
Brief Summary: Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR)is a Phase III trial designed to evaluate the difference in 24-hour and 30-day mortality among subjects predicted to receive massive transfusion (\[MT\] (defined as receiving 10 units or more red blood cells (RBCs) within the first 24 hours). The goal of PROPPR is to improve the basis on which clinicians make decisions about transfusion protocols for massively bleeding patients.

PROPPR is a Resuscitation Outcomes Consortium (ROC) Protocol. ROC is funded by the National Heart, Lung, and Blood Institute (NHLBI), the United States' Department of Defense (DoD) and the Defence Research and Development Canada. PROPPR will be conducted as a Phase III trial at Level I Adult Trauma Centers in North America.


Options:
A: Point Of Care (POC) Transfusion Algorithm Cardiac Study (2.5 years)
B: 24-hour Mortality (First 24 hours after ED admission); 30-day Mortality (First 30 days after ED admission); Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE) (From time of ED admission, for up to 72 hours)
C: Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures (Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26)
D: Bleeding Scores (intra-operatively and up to 24 hours postoperatively)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pragmatic, Randomized Optimal Platelet and Plasma Ratios
Brief Summary: Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR)is a Phase III trial designed to evaluate the difference in 24-hour and 30-day mortality among subjects predicted to receive massive transfusion (\[MT\] (defined as receiving 10 units or more red blood cells (RBCs) within the first 24 hours). The goal of PROPPR is to improve the basis on which clinicians make decisions about transfusion protocols for massively bleeding patients.

PROPPR is a Resuscitation Outcomes Consortium (ROC) Protocol. ROC is funded by the National Heart, Lung, and Blood Institute (NHLBI), the United States' Department of Defense (DoD) and the Defence Research and Development Canada. PROPPR will be conducted as a Phase III trial at Level I Adult Trauma Centers in North America.


Options:
A: Volume of transfused plasma during surgery (5 years)
B: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
C: 24-hour Mortality (First 24 hours after ED admission); 30-day Mortality (First 30 days after ED admission); Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE) (From time of ED admission, for up to 72 hours)
D: Procedure-related relevant bleeding, occurring within 24 hours after the procedure. (24 hours after the procedure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cohort Study to Evaluate Effects of Prophylactic Treatment for Respiratory Syncytial (RS) Virus Infection in Respiratory Tract During Infancy on Subsequent Atopic Asthma in Preterm Infants
Brief Summary: The primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections during the infancy.

The secondary objective is to determine whether the incidence of recurrent wheezing after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy.


Options:
A: Cumulative incidence of recurrent wheezing confirmed by physicians (two years)
B: Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI) (From Day 1 through Day 151)
C: Readmission to either infirmary/observation or hospital or PICU during 3 weeks of follow-up after discharge (3 weeks)
D: The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy (For three years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study to Determine Protective Efficacy Against Otitis Media and Assess Safety of an Investigational Pneumococcal Vaccine 2189242A in Healthy Infants
Brief Summary: The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.


Options:
A: Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)); Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course (Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months))
B: Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) (Any time from 2 weeks after Dose 3 up to 31 August 2010)
C: Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria (Any time from 2 weeks after the administration of dose 3 up to Month 22)
D: Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination (At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine); Antibody Concentration Against Protein D (PD) - Primary Vaccination (At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine)

Answer: C