TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of the Fax to Quit Program and Wisconsin Tobacco Quitline Utilization by Southeastern Wisconsin Clinics
Brief Summary: The purpose of this study is to evaluate Fax to Quit (F2Q) - a strategy that links state quitlines to health care delivery systems. FQ capitalizes upon the healthcare visit as an opportunity for intervention, consistent with the finding that approximately 70% of smokers visit a primary care physician each year. Successful integration of quitlines into healthcare delivery will transform regular healthcare visits into easily implemented, cost-beneficial avenues via which smokers all across America will be routinely inducted into effective cessation intervention. F2Q will be evaluated as follows:

1. Does F2Q increase contacts and "quality contacts," between the quitline and patients who smoke and receive health care at a participating clinic? A "quality contact" is defined as a quitline referral that results in the individual enrolling in the quitline counseling services. This aim will be assessed by measuring the rates of quitline referrals in 49 clinics before and after F2Q has been implemented.
2. Are contact rates and enrollment rates of F2Q increased by "Enhanced Academic Detailing" at clinic sites (with enhanced academic detailing comprising ongoing training/technical assistance as well as performance feedback)?
3. What are the features of the Fax to Quit (F2Q) and Fax to Quit plus Enhanced Academic Detailing (F2Q + EAD) interventions that key clinic personnel found helpful and easy to implement, as well as features that were unhelpful and difficult? This information will be gathered in qualitative assessments that also will identify clinic strategies and organizational features that facilitated successful implementation.
4. What are the incremental costs of instating and sustaining F2Q and F2Q + EAD and how do these costs compare to other quitline promotional strategies (e.g., paid media, medication give-away programs)?


Options:
A: Self-reported, Smoking Abstinence Rate: 6-month Prolonged Abstinence (12 months after randomization)
B: Motivation to quit smoking, utilization of available resources, smoking cessation rate (1 year)
C: Number of Fax to Quit referrals (One year following enrollment)
D: Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double Blind, Placebo Controlled, Parallel-group Study With Use of Budesonide/Formoterol "As-needed", or Terbutaline "As-needed" or Regular Use of Budesonide + Terbutaline "As-needed", in Patients With Mild Intermittent Asthma
Brief Summary: 1. The primary objective of this study is:

   * To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
2. The secondary objectives of this study are:

   * To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
   * To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event


Options:
A: Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks (Baseline and Visit 6)
B: Time to first severe asthma exacerbation (At each clinic visit)
C: Asthma control assessed by asthma exacerbations (Continuosly throughout the treatment period)
D: Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. (End of 12-week treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Cross-over, Open-labelled Study Evaluating the Acceptance of Test Catheters Compared to SpeediCath Catheters
Brief Summary: The purpose of this study is to evaluate that the test catheter is no less accepted than the SpeediCath (SC) catheter.


Options:
A: UTIs (Urine cultures were done at day 0, 7, 14, 28, 42, and 56 (8 weeks).)
B: Discomfort Measured on a VAS Scale 0 Being no Discomfort, 10 Being Worst Imaginable Discomfort. (14 days)
C: Mean Residual Urine Volume (3 catheterisations on 1 day)
D: Quality of Life (0-100 Point) (6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Trial of Home Mechanical Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease Patients Post Acute Hypercapnic Exacerbation
Brief Summary: This study is designed to investigate the effect of home mechanical ventilation (HMV) in patients with severe chronic obstructive pulmonary disease (COPD). The purpose of the trial is to test the hypothesis that HMV and longterm oxygen therapy (LTOT) increases admission free survival compared with LTOT alone. More specifically, compared with LTOT, HMV and LTOT reduces hospital re-admission in COPD patients who remain persistently hypercapnic following an acute exacerbation requiring non-invasive ventilation (NIV).


Options:
A: Days from trial intervention to either hospital admission or death (1 year)
B: Time to death or repeat AHRF with need of NIV (1 year)
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Vitamin D Supplementation to Male HIV Sero-positive Patients
Brief Summary: The investigators want to investigate if HIV sero-positive males benefit from vitamin D supplementation. The study runs in 16 weeks and the participants are treated with one of three placebo controlled regimes (tablets):

1. Calcium
2. Calcium and 25-hydroxy-vitamin D
3. Calcium and 25-hydroxy-vitamin D and 1,25-dihydroxyvitamin D

The endpoints are:

* Serum vitamin D
* Parathyroid hormone
* ionized calcium
* T-lymphocyte fractions (naïve, mature, Tregs)
* Osteocalcin (bone metabolism)


Options:
A: To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover. (Baseline, Week 4, Week 12); To measure the safety of 50,000 IU dose of vitamin D3 (Baseline, Week 4, and Week 8)
B: The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip (Weeks 0 and 48)
C: Development of a new or recurrent disease progression event, including all-cause death. (within 24 months after randomization)
D: serum-vitamin D metabolites (week 0); serum-vitamin D metabolites (week 2); serum-vitamin D metabolites (week 4); serum-vitamin D metabolites (week 8); serum-vitamin D metabolites (week 12); serum-vitamin D metabolites (week 16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Controlled Trial of Mindfulness-based Stress Reduction (MBSR) Among Women Operated for Breast Cancer
Brief Summary: The number of Danish women treated for breast cancer rise every year, though survival rates have improved, women can still expect to experience the diverse late effects reported by this group of patients. Mindfulness labels the ability to be aware of the present moment - thereby avoiding speculations about both past and present. Mindfulness based stress-reduction (MBSR) is an 8-week program, covering 24 contact-hours and 45 minutes daily home practice. The program aims at developing participants' coping resources and developing participants' mindful awareness. Thus the program consists of guided meditations, guided body scan(a specific awareness exercise)and through meditation, yoga and psychoeducation concerning stress and stress-reactions, while meditation and bodyscan is practiced at home by the use of specific audio-CDs guiding the patient. The MBSR-program have shoved promising results among patients with anxiety-disorders, depression and chronic pain. Smaller studies have also found positive effects of the program among cancer patients. The investigators want to evaluate the effect of the MBSR program on levels of anxiety and depression as well as the possible influence of mindfulness training on health behaviors and existential concerns. The study are based on the following hypotheses:

* report of anxiety and depression will decrease among cases
* better compliance will lead to more decrease in levels of anxiety and depression
* cases will make lifestyle changes suitable with recommendations for BC patients in post-treatment phase of the illness
* decreased level of anxiety and depression will reflect improved spiritual well-being
* improved spiritual wellbeing will lead to decreased report of physical symptoms

All participants in this randomized controlled trial will fill out questionnaires at enrollment and as 1, 6 and 12 months follow-up. Based on results from this trial clinicians and patients will be able to make decisions regarding post-treatment psychosocial intervention and researchers will have initial evidence of the effect of the intervention and thus possible indications for research on mindfulness among patients diagnosed with cancer at other stages or sites.


Options:
A: SCL-90r Depression and anxiety subscales (baseline - 12 months)
B: Disease-free Survival (DFS) (Unitil the end of study with a median follow up of 75 months)
C: The efficacy of Mindfulness Based Stress Reduction on mood disorders (up to 5 years follow up)
D: Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality; Physical:cortisol levels (stress hormone)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Controlled Trial of Mindfulness-based Stress Reduction (MBSR) Among Women Operated for Breast Cancer
Brief Summary: The number of Danish women treated for breast cancer rise every year, though survival rates have improved, women can still expect to experience the diverse late effects reported by this group of patients. Mindfulness labels the ability to be aware of the present moment - thereby avoiding speculations about both past and present. Mindfulness based stress-reduction (MBSR) is an 8-week program, covering 24 contact-hours and 45 minutes daily home practice. The program aims at developing participants' coping resources and developing participants' mindful awareness. Thus the program consists of guided meditations, guided body scan(a specific awareness exercise)and through meditation, yoga and psychoeducation concerning stress and stress-reactions, while meditation and bodyscan is practiced at home by the use of specific audio-CDs guiding the patient. The MBSR-program have shoved promising results among patients with anxiety-disorders, depression and chronic pain. Smaller studies have also found positive effects of the program among cancer patients. The investigators want to evaluate the effect of the MBSR program on levels of anxiety and depression as well as the possible influence of mindfulness training on health behaviors and existential concerns. The study are based on the following hypotheses:

* report of anxiety and depression will decrease among cases
* better compliance will lead to more decrease in levels of anxiety and depression
* cases will make lifestyle changes suitable with recommendations for BC patients in post-treatment phase of the illness
* decreased level of anxiety and depression will reflect improved spiritual well-being
* improved spiritual wellbeing will lead to decreased report of physical symptoms

All participants in this randomized controlled trial will fill out questionnaires at enrollment and as 1, 6 and 12 months follow-up. Based on results from this trial clinicians and patients will be able to make decisions regarding post-treatment psychosocial intervention and researchers will have initial evidence of the effect of the intervention and thus possible indications for research on mindfulness among patients diagnosed with cancer at other stages or sites.


Options:
A: change from baseline in perceived health status at six months (baseline and six months)
B: Incidence of spontaneous dreams and recallable dreams while using different general anaesthesiological methods? (2009 - 2011)
C: expanded polytetrafluoroethylene (ePTFE) tubes assessed for hydroxyproline deposited per unit length of the tube as well as total protein (7 days following surgery)
D: SCL-90r Depression and anxiety subscales (baseline - 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PNU-100480 (PF-02341272) After Administration Of Multiple Escalating Oral Doses To Healthy Adult Subjects
Brief Summary: The purpose of this study is to assess the safety, tolerability and pharmacokinetics of multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium that causes tuberculosis (TB) will also be measured. The effect of adding an additional tuberculosis (TB) agent (given for 2 days) in addition to PNU-100480 will be evaluated. Linezolid open label to determine activity in whole blood assay (WBA).


Options:
A: To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy. (Week 8); To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens. (Weekly or more frequent)
B: To evaluate the safety and tolerability of ascending oral doses of PNU-100480 administered as extemporaneously prepared suspension (EPS) over 14 and 28 days in healthy adult volunteers. (Monitor adverse events daily; safety eval pre-dose, specified times , discharge, follow-up/as needed)
C: Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media (0 - 12 weeks)
D: Efficacy: Percentage of relapses by 24 months following treatment cure; Safety: Percentage of adverse events

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Brief Summary: A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale \[NIHSS\] score less than or equal to 3).

TIAs are common \[25\], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years \[32\], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA \[33\], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis \[33\]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.


Options:
A: Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (Up to 90 days); Major Hemorrhage (Up to 90 days)
B: Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (3 months)
C: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)
D: Comparison of the frequency of mRS 0, 1, 2 at 90 days (at 90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Brief Summary: A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale \[NIHSS\] score less than or equal to 3).

TIAs are common \[25\], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years \[32\], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA \[33\], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis \[33\]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.


Options:
A: Comparison of the frequency of mRS 0, 1, 2 at 90 days (at 90 days)
B: Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) (Up to 124 weeks)
C: Any stroke at 90 days; Stroke severity
D: Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (Up to 90 days); Major Hemorrhage (Up to 90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Brief Summary: A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale \[NIHSS\] score less than or equal to 3).

TIAs are common \[25\], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years \[32\], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA \[33\], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis \[33\]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.


Options:
A: Telephone Modified Rankin Scale (Centralised, Blinded Assessment) (90 days)
B: Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy (End of trial follow-up); Change in blood pressure (End of trial follow-up); Change in LDL cholesterol (End of trial follow-up)
C: Adjudicated Recurrent Stroke (From randomisation until full follow up period, approximately 43 months.); First Major Bleed (Adjudicated) (Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)
D: Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (Up to 90 days); Major Hemorrhage (Up to 90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Cell Storage Duration Study
Brief Summary: The RECESS study will compare the effects of transfusing red blood cell units stored \<= 10 days vs. red blood cell units stored \>= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.


Options:
A: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
B: Measure of Non-transferrin-bound Iron (four hours after transfusion)
C: Mortality at Day 90 (90 Day)
D: The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow. (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Cell Storage Duration Study
Brief Summary: The RECESS study will compare the effects of transfusing red blood cell units stored \<= 10 days vs. red blood cell units stored \>= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.


Options:
A: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
B: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)
C: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)
D: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Red Cell Storage Duration Study
Brief Summary: The RECESS study will compare the effects of transfusing red blood cell units stored \<= 10 days vs. red blood cell units stored \>= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.


Options:
A: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
B: Measure of Non-transferrin-bound Iron (four hours after transfusion)
C: Effect of blood storage age on the resolution of lactic acidosis in children with severe malarial anemia at Mulago hospital (4hrs)
D: Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. (Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.)

Answer: A