TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of Using the Inverness Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in HIV-Positive TB Suspects
Brief Summary: The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine lipoarabinomannan (LAM) test in detecting tuberculosis in HIV-infected adults.

A secondary study objective is to determine the accuracy, efficiency, costs, and cost-effectiveness of various combinations of Tuberculosis (TB) diagnostic tests, including the novel Xpert MTB/Rif test.


Options:
A: All-cause mortality (8 weeks)
B: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
C: Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy (2 months)
D: All-cause Mortality (6 months post-HAART initiation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility of Using the Inverness Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in HIV-Positive TB Suspects
Brief Summary: The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine lipoarabinomannan (LAM) test in detecting tuberculosis in HIV-infected adults.

A secondary study objective is to determine the accuracy, efficiency, costs, and cost-effectiveness of various combinations of Tuberculosis (TB) diagnostic tests, including the novel Xpert MTB/Rif test.


Options:
A: Notification Rate Ratio (October 2012 (up to 2 years)); Costs Per Detected Case (October 2012 (up to 2 years))
B: Sensitivity and specificity (10 months)
C: Sensitivity of the lateral-flow urine LAM assay (LF-LAM) (One year); Failure rate of the lateral-flow urine LAM assay (One year); Inter-reader variability of the lateral-flow urine LAM assay (One year); Specificity of the lateral-flow urine LAM assay (LF-LAM) (One year)
D: Difference in TB-related Morbidity (2 months); Difference in TB-related Morbidity (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke: a Randomised, Double-blind, Placebo-controlled Trial
Brief Summary: WAKE-UP is an investigator initiated European multicenter randomized controlled clinical trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset, e.g. due to recognition of stroke symptoms on awakening. Objective of WAKE-UP is to prove efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking up with stroke symptoms or patients with otherwise unknown symptom onset.


Options:
A: Efficacy (90 day after stroke); Safety (90 day after stroke)
B: TMS Symptom Checklist (Adminstered at testing session, 2-4 years after intervention.)
C: Progression in the Fugl-Meyer Motor Scale (M3 (3 months))
D: Treatment response (Week 4 after tenth day of tDCS)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke: a Randomised, Double-blind, Placebo-controlled Trial
Brief Summary: WAKE-UP is an investigator initiated European multicenter randomized controlled clinical trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset, e.g. due to recognition of stroke symptoms on awakening. Objective of WAKE-UP is to prove efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking up with stroke symptoms or patients with otherwise unknown symptom onset.


Options:
A: Assessment of modified Rankin Scale shift analysis at 90 days after onset (90 days)
B: Favourable outcome (day 90)
C: Modified Rankin Scale (mRS) 0-1 (3 months)
D: Efficacy (90 day after stroke); Safety (90 day after stroke)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Lactoferrin for Prevention of Sepsis in Infants
Brief Summary: The investigators propose a clinical trial in premature infants to determine the effect of orally-administered bovine lactoferrin on occurrence of severe infections and to determine whether as a result of decreased infections, infants' growth and development improve after daily lactoferrin supplementation, due to its antimicrobial and anti-inflammatory properties. If successful, the use of lactoferrin as a protective protein could profoundly affect clinical care of neonates both in the developed and developing world.


Options:
A: Number of confirmed episodes of late-onset sepsis. (1 month)
B: Determination of the effect of bovine lactoferrin supplementation on prevention of diarrhea,measured by the number of episodes of diarrhea during a 6 month trial in previously weaned Peruvian children enrolled at 12 to 18 months of age. (6 months)
C: First episode of late-onset sepsis or sepsis-associated death (72hrs to 8 weeks of age)
D: Reduction in incidence of Late-Onset Infection defined by positive cultures and elevated C-reactive protein (CRP) (1-3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Smoking Cessation Quitlines: Pilot Study of Acceptance Therapy
Brief Summary: The purpose of this study is to demonstrate that Acceptance Therapy (ACT's) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).

Implementation outcomes:

* end of treatment and 6-month follow-up data retention rates;
* intervention implementation quality;
* number \& length of calls completed.

Comparison of each arm's implementation


Options:
A: smoking cessation: 7-day point prevalence abstinence (6 months)
B: Smoking Abstinence (24 weeks post quit day)
C: Number of Participants Who Stopped Smoking by 6 Month Post Treatment (6 months)
D: Smoking behavior (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women
Brief Summary: In this study, 400 Hispanic women will be recruited and randomized to one of three interventions:

1. Control (no change);
2. A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
3. A higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening.

The investigators will compare which intervention is most effective in encouraging Hispanic women to undergo cervical cancer screening (Pap test)


Options:
A: Change in total weekly minutes of physical activity as measured by the 7-Day PAR (Physical Activity Recall), from Baseline to 6-months and 12-months. (Baseline, 6 months, and 12 months)
B: Change in HIV viral suppression (Assessed at 4 month follow up (FU), 12 month FU)
C: Participant attends cervical cancer screening (Within 7 months of the intervention)
D: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women
Brief Summary: In this study, 400 Hispanic women will be recruited and randomized to one of three interventions:

1. Control (no change);
2. A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening;
3. A higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening.

The investigators will compare which intervention is most effective in encouraging Hispanic women to undergo cervical cancer screening (Pap test)


Options:
A: Receipt of Cervical Cancer screening via Pap Test (past 12-14 months (yes/no).)
B: Participant attends cervical cancer screening (Within 7 months of the intervention)
C: Adherence to cervical cancer screening (step1) (Up to 20 months)
D: The proportion of control and intervention subjects who are current on EACH individual indicated preventive service (Annual for three years); The proportion of control and intervention subjects who are current on ALL indicated preventive services (Annual for three years); The mean score for intervention and control subjects for quality of clinician communication (CAPHS-CGS questions 14-20); and frequency with which patients report sharing medical decisions (CAHPS questions SD 1-3) (Annual for three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation (TDCS): Randomized, Double-Blind, Clinical Trial
Brief Summary: Stroke is one of the main public health problems in America Latina. It can be associated with several neuropsychiatric complications, which include a broad spectrum of emotional distress and cognitive, results in important clinical implications for the prognosis of these patients. Depression is a common complication, affecting around 5-72% of patients and is associated with various cognitive deficits and also with increased mortality - up to 50% more deaths compared to non-depressed patients. Treatment of depression after stroke is important not only to improve depressive symptoms but can also be beneficial for cognitive deficits, activities of daily living. and leads to increased survival for these patients. There are different treatments for depression after stroke, all showing inconclusive results, even though antidepressants have been effective in some groups of patients, tolerability and treatment adherence were not very good-so it is necessary that new therapeutic modalities are presented with good tolerability. In this sense, transcranial direct current stimulation (tDCS) is an interesting technique that can provide interesting results, which proved to be effective for depression in some studies. This study proposes to investigate the effect of tDCS for the treatment of major depressive disorder after stroke. The proposed design is a clinical trial, randomized, double-blind, placebo-controlled study in a subsample of participants in the prospective cohort of stroke: Study of Morbidity and Mortality of stroke. They will be allocated to one of the groups: sham or active tDCS group. Participants will receive ten consecutive days of active or sham stimulation and return at the end of two weeks to evaluate the improvement in depression, cognition and functionality. As objectives, the investigators expect to see a clinical improvement of depression through scales like Hamilton, Beck and MADRS(Montgomery-Asberg Depression Rating Scale), and expect improvement on cognitive tests as MoCA (Montreal Cognitive Assessment), MMSE (mini mental scale exam), FAB (frontal assessment battery) and trail test. Another goal is to see improvement in markers related to depression as BDNF, cortisol, interleukins and heart rate variability. With all this, the investigators hope to offer a new treatment, and effective with few side effects to treat depression after stroke.


Options:
A: General Health Questionnaire (GHQ 28) (T2 (6 months poststroke))
B: Occurrence rate of depression (3 months)
C: Hamilton Rating Scale for Depression (HRSD) (1 year post-treatment)
D: Treatment response (Week 4 after tenth day of tDCS)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]
Brief Summary: The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.


Options:
A: Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84 (Baseline to Day 84)
B: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24); Trough FEV1 Response at Week 24 (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.); Mahler Transitional Dyspnea Index Focal Score at 24 Weeks (Baseline, Week 24); Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis (Baseline, Week 24)
C: Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (28 days)
D: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]
Brief Summary: The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.


Options:
A: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (Baseline and at Week 24)
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
C: Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (12 weeks)
D: Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. (64 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Efficacy Research of Uni- vs Bi-lateral Arm Training Poststroke: Task-Related or Robotic
Brief Summary: This proposed project aims to

* compare the effects of dose-matched unilateral vs bilateral vs unilateral combined with bilateral upper limb rehabilitation based on task-related practice
* compare the effects of unilateral vs bilateral training based on robot-assisted devices
* study the predictors of treatment outcomes and clinimetric properties of the biomechanical measures


Options:
A: Wolf Motor Function Test (8 Weeks)
B: Movement time (Baseline and change from baseline in movement time at 4 weeks); Motor units (Baseline and change from baseline in motor units at 4 weeks); Elbow extension angle (Baseline and change from baseline in elbow extension angle at 4 weeks); Lateral index (Baseline and change from baseline in lateral index at 4 weeks)
C: Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment (Baseline to Final Training (6 weeks))
D: Fugl-Meyer (FM-SEC and FM-WH) (7 months); Motor-Functional Independence Measure (m-FIM) (7 months); Frenchay Arm Test (FA-T) (7 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Efficacy Research of Uni- vs Bi-lateral Arm Training Poststroke: Task-Related or Robotic
Brief Summary: This proposed project aims to

* compare the effects of dose-matched unilateral vs bilateral vs unilateral combined with bilateral upper limb rehabilitation based on task-related practice
* compare the effects of unilateral vs bilateral training based on robot-assisted devices
* study the predictors of treatment outcomes and clinimetric properties of the biomechanical measures


Options:
A: Movement time (Baseline and change from baseline in movement time at 4 weeks); Motor units (Baseline and change from baseline in motor units at 4 weeks); Elbow extension angle (Baseline and change from baseline in elbow extension angle at 4 weeks); Lateral index (Baseline and change from baseline in lateral index at 4 weeks)
B: Fugl-Meyer Score Change Immediately Following Study Intervention. (After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.); Fugl-Meyer Score Change at 6 Months (FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.)
C: Fugl-Meyer (FM-SEC and FM-WH) (7 months); Motor-Functional Independence Measure (m-FIM) (7 months); Frenchay Arm Test (FA-T) (7 months)
D: Fugl-Meyer Assessment (FMA) (An expected average of 4 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial
Brief Summary: Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With HFNC oxygen/air is administered via two small, thin cannulas located just inside the nostrils, but the nostrils are not blocked.

The aim of this study is to compare patient comfort in premature infants treated with nCPAP and HFNC. The investigators hypothesis is that HFNC increases patient comfort.

The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion should be born before 34 weeks of gestation and have moderate respiratory distress, thus be "in need" of nCPAP. During the study period (48 hours) the investigators will consider how the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The child's breathing pattern will be carefully monitored. The study involves no extra painful investigations.

The investigators plan to recruit 20 patients.


Options:
A: Patient comfort (EDIN score) (48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed)
B: The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. (1 year)
C: Mean esophageal pressure (3.5 hours)
D: Compare extubation success rate, defined as % infants remaining extubated for > 72 hrs, among infants managed with HHFNC versus nCPAP (72 hrs)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial
Brief Summary: Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With HFNC oxygen/air is administered via two small, thin cannulas located just inside the nostrils, but the nostrils are not blocked.

The aim of this study is to compare patient comfort in premature infants treated with nCPAP and HFNC. The investigators hypothesis is that HFNC increases patient comfort.

The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion should be born before 34 weeks of gestation and have moderate respiratory distress, thus be "in need" of nCPAP. During the study period (48 hours) the investigators will consider how the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The child's breathing pattern will be carefully monitored. The study involves no extra painful investigations.

The investigators plan to recruit 20 patients.


Options:
A: number of patients needing intubation and mechanical ventilation within 72 hrs from the beginning of the study mode (within 72 hrs from the beginning of the study mode)
B: Death or Chronic Lung Disease (at 36 weeks postmenstrual age); Death (36 weeks adjusted age)
C: Patient comfort (EDIN score) (48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed)
D: The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS. (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Way to Quit - Comparative Efficacy, Acceptance and Effectiveness of Health Incentive Structures
Brief Summary: Using the NIH-funded Way to Health platform, the investigators will conduct this smoking cessation randomized controlled trial (RCT) among CVS employees. The investigators will be able to determine the comparative and absolute efficacy and effectiveness of 4 different incentive structures that are each grounded in behavioral economic principles. Additionally, the investigators will measure rates of and reasons for acceptance of each incentive structure, and examine participant characteristics that modify the efficacy and acceptance of different incentive structures.


Options:
A: Salivary cotinine or anabasine testing (metabolites of nicotine) (at 6 months following the patient selected target quit date.)
B: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens (Week 16)
C: Longest duration of abstinence (Week 24)
D: Biochemical verification of smoking status. (15 months)

Answer: A