TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Performance, Impact, and Operational Challenges of GeneXpert Use for TB Case Finding Among HIV-infected Persons in Botswana During 2012-2013: The Xpert Package Rollout Evaluation Study (XPRES)
Brief Summary: Background: In Botswana, as in the rest of sub-Saharan Africa, undiagnosed TB or TB diagnosed late in the course of disease is thought to be the most common cause of death among HIV-infected persons.

Interventions for Evaluation: The Xpert MTB/RIF assay for the GeneXpert platform (Xpert) has a TB diagnostic sensitivity of 82.4%, significantly superior to that of smear microscopy (44.6%). In line with WHO guidelines, the Botswana Ministry of Health (MOH) and CDC rapidly rolled out the Xpert device and a new Xpert-based diagnostic algorithm in service of 22 HIV care and treatment clinics. To maximize impact of the Xpert device in improving detection of active TB, Xpert rollout was preceded by strengthening of TB screening procedures by: (1) adopting the WHO-recommended 4-symptom TB screen for adults; (2) situating trained TB case-finding nurses in facilities; and (3) training health facility personnel in TB diagnostic algorithms. The combination of these strengthened TB screening procedures and rollout of the Xpert device is referred to as the "Xpert package" in this protocol.

Key Evaluation Objectives: The protocol has two key objectives: (1) to evaluate whether the new MOH-recommended Xpert-based TB diagnostic algorithm for new adult HIV clinic enrollees is more sensitive than the pre-Xpert smear-microscopy-based algorithm in diagnosing culture-positive TB disease; and (2) to evaluate the impact of the whole "Xpert package" on all-cause mortality during the first 6 months of ART, among adult patients.

Design: Stepped-wedge cluster randomized trial. Sample Size: 6,136 patients were prospectively enrolled to meet the first primary objective. A retrospective cohort of 10,131 persons was also enrolled to meet the second objective. Projected power to meet both objectives is \>80%.

Time line: Prospective cohort enrollment started in July 2012 and was complete by March 2014. Retrospective cohort enrollment was complete by March 2015. Patient follow-up and data entry will be complete in March 2016 at which time analysis to answer the first two primary study questions will be possible.


Options:
A: TB diagnostic sensitivity among adults (>12 years old). Sensitivity proportions will be estimated using laboratory data on TB diagnoses (see "Description" below). (Patients will be followed for an average of about 6 months each, and TB diagnostic sensitivity will be estimated at each clinical visit where the patient tests culture-positive for TB, with clinic visits occuring every one to 3 months.); All-cause mortality (Patients will be followed for an average of about 6 months each, with vital status assessed across the 6 month follow-up period.)
B: Survival of newly-diagnosed HIV-infected patients at 1 year (4 years)
C: Treatment time (Up to 8 weeks)
D: Time to TB treatment initiation (8 weeks follow up)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Performance, Impact, and Operational Challenges of GeneXpert Use for TB Case Finding Among HIV-infected Persons in Botswana During 2012-2013: The Xpert Package Rollout Evaluation Study (XPRES)
Brief Summary: Background: In Botswana, as in the rest of sub-Saharan Africa, undiagnosed TB or TB diagnosed late in the course of disease is thought to be the most common cause of death among HIV-infected persons.

Interventions for Evaluation: The Xpert MTB/RIF assay for the GeneXpert platform (Xpert) has a TB diagnostic sensitivity of 82.4%, significantly superior to that of smear microscopy (44.6%). In line with WHO guidelines, the Botswana Ministry of Health (MOH) and CDC rapidly rolled out the Xpert device and a new Xpert-based diagnostic algorithm in service of 22 HIV care and treatment clinics. To maximize impact of the Xpert device in improving detection of active TB, Xpert rollout was preceded by strengthening of TB screening procedures by: (1) adopting the WHO-recommended 4-symptom TB screen for adults; (2) situating trained TB case-finding nurses in facilities; and (3) training health facility personnel in TB diagnostic algorithms. The combination of these strengthened TB screening procedures and rollout of the Xpert device is referred to as the "Xpert package" in this protocol.

Key Evaluation Objectives: The protocol has two key objectives: (1) to evaluate whether the new MOH-recommended Xpert-based TB diagnostic algorithm for new adult HIV clinic enrollees is more sensitive than the pre-Xpert smear-microscopy-based algorithm in diagnosing culture-positive TB disease; and (2) to evaluate the impact of the whole "Xpert package" on all-cause mortality during the first 6 months of ART, among adult patients.

Design: Stepped-wedge cluster randomized trial. Sample Size: 6,136 patients were prospectively enrolled to meet the first primary objective. A retrospective cohort of 10,131 persons was also enrolled to meet the second objective. Projected power to meet both objectives is \>80%.

Time line: Prospective cohort enrollment started in July 2012 and was complete by March 2014. Retrospective cohort enrollment was complete by March 2015. Patient follow-up and data entry will be complete in March 2016 at which time analysis to answer the first two primary study questions will be possible.


Options:
A: TB diagnostic sensitivity among adults (>12 years old). Sensitivity proportions will be estimated using laboratory data on TB diagnoses (see "Description" below). (Patients will be followed for an average of about 6 months each, and TB diagnostic sensitivity will be estimated at each clinical visit where the patient tests culture-positive for TB, with clinic visits occuring every one to 3 months.); All-cause mortality (Patients will be followed for an average of about 6 months each, with vital status assessed across the 6 month follow-up period.)
B: Diagnostic accuracy (Sensitivity and Specificity) of the Truenat MTB assay (Day 1)
C: All-cause mortality (8 weeks)
D: Treatment time (Up to 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fostering Resilience: An Intervention for Women Physicians at Risk for Burnout
Brief Summary: Physicians in general are at risk for burnout, and this risk is heightened among women, particularly mothers. In a randomized design, central hypotheses in this study are that mothers who attend our 12-week Relational Psychotherapy Mothers Group (RPMG) intervention will show significantly greater decreases in stress, depression, burnout, and associated risk biomarker indices, as compared to comparison controls (who would meet in unstructured gatherings, for an hour a week for 12 weeks). Additionally the investigators hypothesize that the gains would be maintained three months after the intervention is completed.


Options:
A: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
B: level of depression (Baseline to 3 months)
C: Perceived Stress Scale (At the end of five days retreat); Self-compassion (At the end of five days retreat)
D: Professional identity (We will measure the score of professional identity before intervention and immediately after intervention.); Career self-efficacy (We will measure the score of career self-efficacy before intervention and immediately after intervention.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fostering Resilience: An Intervention for Women Physicians at Risk for Burnout
Brief Summary: Physicians in general are at risk for burnout, and this risk is heightened among women, particularly mothers. In a randomized design, central hypotheses in this study are that mothers who attend our 12-week Relational Psychotherapy Mothers Group (RPMG) intervention will show significantly greater decreases in stress, depression, burnout, and associated risk biomarker indices, as compared to comparison controls (who would meet in unstructured gatherings, for an hour a week for 12 weeks). Additionally the investigators hypothesize that the gains would be maintained three months after the intervention is completed.


Options:
A: Job satisfaction (baseline to 3 month)
B: Change in Maslach Burnout Inventory score (6 month); Change in Physician Job Satisfaction Scale score (6 month); change in Empowerment at Work Scale score (6 month); change in Utrecht Work Engagement score (6 months)
C: level of depression (Baseline to 3 months)
D: Patients' unplanned urgent visits to the health care system. (30 days after discharge)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Fostering Resilience: An Intervention for Women Physicians at Risk for Burnout
Brief Summary: Physicians in general are at risk for burnout, and this risk is heightened among women, particularly mothers. In a randomized design, central hypotheses in this study are that mothers who attend our 12-week Relational Psychotherapy Mothers Group (RPMG) intervention will show significantly greater decreases in stress, depression, burnout, and associated risk biomarker indices, as compared to comparison controls (who would meet in unstructured gatherings, for an hour a week for 12 weeks). Additionally the investigators hypothesize that the gains would be maintained three months after the intervention is completed.


Options:
A: level of depression (Baseline to 3 months)
B: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)
C: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
D: Perceived Stress (3 months post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fostering Resilience: An Intervention for Women Physicians at Risk for Burnout
Brief Summary: Physicians in general are at risk for burnout, and this risk is heightened among women, particularly mothers. In a randomized design, central hypotheses in this study are that mothers who attend our 12-week Relational Psychotherapy Mothers Group (RPMG) intervention will show significantly greater decreases in stress, depression, burnout, and associated risk biomarker indices, as compared to comparison controls (who would meet in unstructured gatherings, for an hour a week for 12 weeks). Additionally the investigators hypothesize that the gains would be maintained three months after the intervention is completed.


Options:
A: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)
B: Perceived Stress Scale (PSS) (Week-1(baseline), Week-5 (post-intervention), Week-13 (follow-up))
C: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
D: level of depression (Baseline to 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fostering Resilience: An Intervention for Women Physicians at Risk for Burnout
Brief Summary: Physicians in general are at risk for burnout, and this risk is heightened among women, particularly mothers. In a randomized design, central hypotheses in this study are that mothers who attend our 12-week Relational Psychotherapy Mothers Group (RPMG) intervention will show significantly greater decreases in stress, depression, burnout, and associated risk biomarker indices, as compared to comparison controls (who would meet in unstructured gatherings, for an hour a week for 12 weeks). Additionally the investigators hypothesize that the gains would be maintained three months after the intervention is completed.


Options:
A: Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group. (6 weeks); Pre-/post-intervention changes in IL-6 (6 weeks); Pre-/post-intervention changes in IL-8 (6 weeks); Pre-/post-intervention changes in IL-10 (6 weeks); Pre-/post-intervention changes in TNF-α (6 weeks); Pre-/post-intervention changes in IFN-γ (6 weeks); Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity (6 weeks)
B: level of depression (Baseline to 3 months)
C: Changes in PTSD symptoms(PCL) (Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat); Probable PTSD diagnosis(CAPS) (Four months after combat)
D: Change in Aggression (baseline, post-intervention (week 8), 3-month followup, 6-month followup)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Transobturator Sling Compared With Single-incision Mini-sling for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial
Brief Summary: 1. OBJECTIVE:

   To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment.
2. METHODS:

This prospective single-center randomized controlled trial will involve 100 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value \>.05 rejects the noninferiority hypothesis of the mini-sling.


Options:
A: Subjective Cure of Urinary Incontinence at 12 Months After Surgery (12 months)
B: A change in number of cured patients (Up to 1 year)
C: Comparison of the cure rates between the mini sling and classical transobturator tapes (Up to one year)
D: Subjective cure rate (compared to results of TVT)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Brief Summary: Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.


Options:
A: Non B type tympanogram (one month)
B: Number of visits to health clinic (Two years after randomisation)
C: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
D: Treatment response (1 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Brief Summary: Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.


Options:
A: Number of visits to health clinic (Two years after randomisation)
B: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)
C: Treatment response (1 months)
D: Non B type tympanogram (one month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Brief Summary: Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.


Options:
A: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)
B: Number of visits to health clinic (Two years after randomisation)
C: All measures at 9 to 11 years of age:; Woodcock Reading Mastery Tests-Revised-Normative Update; Number of words in a grade-level passage read correctly in one minute; Dictation Samples subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Writing Samples subtests of the Woodcock-Johnson III Tests of Achievement, Standard Battery; Elision and Rapid Letter Naming subtests of the Comprehensive Test of Phonological Processing; Children's version of the Hearing in Noise Test; Disruptive Behavior Disorders Rating Scale; Child Behavior Checklist, parent report; Child Behavior Checklist, teacher report; Impairment Rating Scales, parent report; Impairment Rating Scales, teacher report; Computerized visual continuous performance test; Computerized auditory continuous performance test; Wechsler Abbreviated Scale of Intelligence; Computational subtest of the Woodcock-Johnson III Tests of Achievement, Standard Battery
D: Treatment response (1 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Brief Summary: Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.


Options:
A: Treatment response (1 months)
B: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)
C: Number of visits to health clinic (Two years after randomisation)
D: Non B type tympanogram (one month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children
Brief Summary: Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.


Options:
A: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment (6 weeks)
B: Treatment response (1 months)
C: - number of acute otitis media; - quality of life issues
D: Proportion of children with middle ear effusion (end of intervention); Proportion of study visits at which middle ear effusion detected (during intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest
Brief Summary: Bleeding is a common complication of cardiac surgery, especially aortic arch surgery involving moderate hypothermic circulatory arrest. Fibrinogen concentrate is increasingly used to treat coagulopathic bleeding in cardiac surgery, although its effectiveness and safety are unknown.

Fibrinogen concentrate was administered to 54 patients when the fibrinogen level was below 1.5 g/L after protamine reversal. Additionally, 30 patients were enrolled as the non-FC-treated group.


Options:
A: To evaluate safety of prophylactic fibrinogen infusion in patients with fibrinogen levels in the lower normal range undergoing cardiac surgery (2 years); Blood loss first 12 postoperative hours (12h)
B: To determine whether fibrinogen concentrate infusion reduces perioperative blood loss. (within 12 hours.)
C: Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First (measured ongoing from dosing until day 7 or discharge, whichever came first)
D: efficacy endpoint (the volumes of allogeneic blood products, volumes of cumulative drainage within 24 h and 48 h and 5 days (from the time of fibrinogen concentrate administration until the 5th postoperative day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation
Brief Summary: Following tooth extraction ridge preservation procedure have been suggested to limit bone resorptive dimensional changes to facilitate prospective implant placement. While this is particularly true for anterior teeth, no evidence is available to establish clinical guidelines in posterior sites, i.e. following molar extraction.

This research project will answer the following question:

What are the dimensional changes of the hard and soft tissues encountered following molar extractions with and without ridge preservation?


Options:
A: Radiographic Bone Changes (3 months after tooth extraction)
B: Percent New Vital Bone Formation (18-20 weeks)
C: % Vital Bone Formation (Histological) (18-20 weeks after ridge preservation)
D: Change in Bone Gain or Loss in Millimeters (Buccopalatal) (From Baseline to 12 weeks); Change in Bone Gain or Loss in Millimeters (Mesiodistal) (From Baseline to 12 weeks); Change in Bone Gain or Loss in Millimeters (Stent to Apex) (From Baseline to 12 weeks); Radiographic Bone Changes (From Baseline to 12 weeks); New Bone Formation (From Baseline to 12 weeks)

Answer: A