TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Conditioning in Elderly Patients With Heart Failure
Brief Summary: The purpose of this study is :

* To determine if aerobic exercise conditioning can improve symptoms, cardiovascular function and quality of life in elderly patients with congestive heart failure.
* To describe the baseline clinical characteristics, cardiovascular function and neurohumoral function in elderly patients with congestive heart failure.
* To determine the specific cardiovascular and noncardiovascular mechanisms by which symptoms and quality of life may improve following exercise conditioning in elderly patients with congestive heart failure.


Options:
A: Change in VO2max every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change in Left ventricular ejection fraction every 6 months over the 24 months of outpatient follow-up (every 6 months over the 24 months of outpatient follow-up); Change on 6-min walk test every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on Minnesota index of quality of life every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on heart rate every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on systolic blood pressure every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on diastolic blood pressure every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on body mass index every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up); Change on creatine clearance every 6 months over the 24 months (every 6 months over the 24 months of outpatient follow-up)
B: Peak exercise capacity (16 weeks)
C: 6 Minute Walk Test (up to 3 months)
D: Time until all-cause death or heart-failure hospitalization (Measured over the two years of study follow-up.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia
Brief Summary: To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).


Options:
A: Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 (Baseline (Day 1) through Week 5)
B: Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy (24 weeks)
C: The primary endpoint of the IRON-HF study is to assess the impact of iron supplementation alone (IV or PO) on changes in oxygen maximal consumption (peak VO2) assessed by ergospirometry over a 3-month follow-up period.
D: Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL (Any time between baseline and the end of study or time to intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PRE-DETERMINE: Biologic Markers and MRI SCD Cohort Study
Brief Summary: This is a prospective, multi-center cohort study of patients with a history of coronary artery disease (CAD) and documentation of either a prior myocardial infarction (MI) or mild to moderate left ventricular dysfunction (LVEF 35-50%). The primary objective of this study is to determine whether biologic markers and ECGs can be utilized to advance SCD risk prediction in patients with CHD and LVEF\>30-35%. The overarching goal of the study is to identify a series of markers that alone or in combination specifically predict risk of arrhythmic death as compared to other causes of mortality among this at risk population of coronary heart disease (CHD) patients with preserved left ventricular ejection fraction (LVEF\> 30-35%). If biologic or ECG markers are identified that can specifically predict risk of ventricular arrhythmias, then these markers may serve as relatively inexpensive methods to identify those at risk. The public health impact of identifying markers could be quite substantial, leading to more efficient utilization of ICDs and advances in our understanding of mechanisms underlying SCD.


Options:
A: All cause mortality (5 years)
B: Percentage of Patients Worsened for Clinical Composite Response (12 Months)
C: Sudden and/or arrhythmic cardiac death or resuscitated ventricular fibrillation. (Median follow-up estimated to be 10.7 years)
D: Combination of all-cause mortality and first hospitalization (time to first event), where all-cause mortality is defined as death from all causes.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
Brief Summary: Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.


Options:
A: Time to Relapse (Intent to Treat Population) (Weeks 3-24); Time to Relapse (Per Protocol Population) (Weeks 3-24)
B: CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 (1-24 weeks); CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups (1-24 weeks)
C: Analgesia (6 months)
D: HIV Risk Events (Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo and Active-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
Brief Summary: Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.


Options:
A: opioid use (baseline, 1-month, 3-months, 6-months); HIV risk behavior (baseline, 1-month, 3-months, 6-months)
B: Percent of Participants Using Drugs (2 weeks following discharge)
C: percentage of subjects abstinent from all opioids through the final day of detoxification (up to 12-week trial)
D: CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 (1-24 weeks); CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups (1-24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Nosocomial Escherichia Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: a Randomized, Prospective, Double Blind Study for the Evaluation of Cranberry (Vaccinium Macrocarpon) Gel Capsules
Brief Summary: Indwelling urinary catheters are a primary site for nosocomial infections. The purpose of this study is to evaluate the anti-adhesive properties of Cranberry type A pro anthocyanidine gel capsules in the prevention Escherichia coli infections on indwelling urinary catheters placed in patients following pelvic surgery. The investigators primary working hypothesis is that cranberry treatment decreases E. coli colonization on indwelling urinary catheters, thus preventing nosocomial urinary infections following pelvic surgery.


Options:
A: Presence/absence of Asymptomatic bacteriuria (15 days post-op)
B: Rate of UTIs (6 months)
C: Length (in days) of the latent period; Neonatal infection; Respiratory distress; Admission to NICU (in days); Neonatal complications rate (NEC, IVH etc); Maternal infections (uterus, UTI)
D: Participants With Clinically-diagnosed and Treated UTI's. (From surgery to post-op visit, approximately 6 weeks post surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Role in Emergent Cerclage of Indomethacin and Antibiotics
Brief Summary: Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage.

The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.


Options:
A: The frequency of spontaneous abortion before 28 weeks (14 weeks)
B: Gestational Latency Achieved Between Cerclage Placement and Time of Delivery (24 weeks)
C: Gestational age at delivery (3-6 months)
D: Delivery before than 37 weeks gestation (Up to 37 weeks gestation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Prospective, Double-Blind Placebo Controlled Study of Oral Ergocalciferol in the Treatment of Pruritis in Hemodialysis Patients
Brief Summary: Pruritis (itching) is common in many people with chronic renal failure on hemodialysis. There may be many different reasons for the pruritis. Efforts to treat the problem have not been very effective.

Vitamin D levels have been found to be low in many hemodialysis patients. Since vitamin D plays an important role in the skin and is effective in treatment of certain skin conditions that involve pruritis, it may have a role in treatment of pruritis in hemodialysis patients.

The objective of the investigators study is to determine the effect of supplementation with oral vitamin D2 (ergocalciferol) on pruritis in hemodialysis patients.


Options:
A: Subjective measurement of reduction in pruritus (3 months)
B: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12 (Week 12)
C: Change From Baseline in Worst-itching 11-point Numerical Rating Scale (NRS) (2 weeks, 4 weeks and 8 week); Change From Baseline in Worst-itching Visual Analog Scale (VAS) (2 weeks, 4 weeks and 8 weeks); Change From Baseline in Itch Severity Score (2 weeks, 4 weeks and 8 weeks); Change From Baseline in Sleep Quality Assessment (2 weeks, 4 weeks and 8 weeks); Change From Baseline in QoL Assessment (Skindex-10) (2 weeks, 4 weeks and 8 weeks); The Mean Value in Treatment Satisfaction (Patient's Global Impression of Change ) (2 weeks, 4 weeks and 8 weeks); Change From Baseline in QoL Assessment (5-D-Itch Scale) (2 weeks, 4 weeks and 8 weeks); The Number of Patients in Excoriation (2 weeks, 4 weeks and 8 weeks)
D: Severity of Pruritis (Baseline and end of study (up to 12 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Helping Problem Drinkers on the Internet
Brief Summary: The main aim of this study is to compare the impact of a minimal and a full Internet-based self-help intervention for problem drinkers in the general population.


Options:
A: Frequency of consumption (6 months and 12 months); Usual number of drinks per occasion (6 months and 12 months); Frequency of consuming 5 or more drinks on one occasion (6 months and 12 months); Typical weekly consumption (6 months and 12 months); Highest number of drinks on one occasion (6 months and 12 months)
B: Binge drinking (30 days)
C: Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care (5 months); Number of brief interventions for excessive alcohol consumption delivered in primary health care settings (5 months)
D: Alcohol Use Disorders Identification Test - Consumption scale (AUDIT-C scale) (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Second-line Treatment of Post-partum Haemorrhage With Intrarectal Misoprostol: a Multicentre, Double Blind, Randomized Placebo-controlled Trial
Brief Summary: Postpartum haemorrhage (PPH) remains the major cause of maternal mortality in France. The most efficient treatment of severe PPH is sulprostone which is associated with cardiac complications. The objective of this study was to assess the efficacy and the safety of intrarectal misoprostol for curative postpartum haemorrhage treatment.

We conducted a multicenter double blind randomized placebo control trial between June 2004 and December 2007, among consenting women with postpartum haemorrhage and failure to oxytocin treatment.

Our main criteria of judgement was quantification of blood loss and the use of sulprostone between the two groups using either misoprostol intrarectal tablets (5X200mg ) or placebo in similar opaque introducer.


Options:
A: quantification of blood loss (15 minutes after treatment administration)
B: Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery. (Before delivery (at onset of labor), after delivery (2 to 4 days after delivery))
C: Blood loss greater than or equal to 500 mls after enrolment (Blood loss measured for minimum of 1 hour or until active bleeding ceased)
D: Haemoglobin concentration (Hb) of greater than or equal to 2 g/dl from pre- to post-delivery (3-5 days after delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DECISION+: Une Formation Pour Les médecins de Famille Sur la Prise de décision partagée Afin d'Optimiser Les décisions Cliniques Concernant l'Utilisation d'Antibiotiques Pour Les Infections aiguës Des Voies Respiratoires (IAVR)
Brief Summary: Decisions about the use of antibiotics for acute respiratory infections are the most frequently reported reason for consulting a family physician. Although it varies according to the specific type of acute respiratory infections, the use of antibiotics is estimated to be 63% to 67%, well above the expected prevalence of bacterial infections thus suggesting overuse of antibiotics. Consequently, there is an urgent need for helping family physicians and their patients to improve the clinical decision making process regarding the use of antibiotics for acute respiratory infections. We will evaluate the impact of DECISION +, a multifaceted intervention program that includes training in shared decision making, reminders and feedback targeting physicians, and decision support tools targeting patients on the decision to use antibiotics for acute respiratory infections. Results from this study will lay the ground for a national strategy targeting the improvement of the clinical decision making process regarding antibiotic use for acute respiratory infections in primary care. In turn, this will increase quality of care and patient safety.


Options:
A: the antibiotic prescribing rate (within the first 2 weeks after first consultation)
B: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
C: days with significant impairment due to acute respiratory tract infection (14 to 28 days after infection)
D: Antibiotic use; Length of stay in hospital

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: DECISION+: Une Formation Pour Les médecins de Famille Sur la Prise de décision partagée Afin d'Optimiser Les décisions Cliniques Concernant l'Utilisation d'Antibiotiques Pour Les Infections aiguës Des Voies Respiratoires (IAVR)
Brief Summary: Decisions about the use of antibiotics for acute respiratory infections are the most frequently reported reason for consulting a family physician. Although it varies according to the specific type of acute respiratory infections, the use of antibiotics is estimated to be 63% to 67%, well above the expected prevalence of bacterial infections thus suggesting overuse of antibiotics. Consequently, there is an urgent need for helping family physicians and their patients to improve the clinical decision making process regarding the use of antibiotics for acute respiratory infections. We will evaluate the impact of DECISION +, a multifaceted intervention program that includes training in shared decision making, reminders and feedback targeting physicians, and decision support tools targeting patients on the decision to use antibiotics for acute respiratory infections. Results from this study will lay the ground for a national strategy targeting the improvement of the clinical decision making process regarding antibiotic use for acute respiratory infections in primary care. In turn, this will increase quality of care and patient safety.


Options:
A: Receipt of colorectal cancer screening exam (fecal occult blood test, flexible sigmoidoscopy, or colonoscopy) within 4 months following delivery of an electronic message within the personal health record
B: Decisional quality (knowledge, decisional conflict, and satisfaction) (Immediately (within 10 minutes) following clinical encounter, and 3- & 6-months post encounter)
C: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
D: Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation. (Phase 1-2 (1- year))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DECISION+: Une Formation Pour Les médecins de Famille Sur la Prise de décision partagée Afin d'Optimiser Les décisions Cliniques Concernant l'Utilisation d'Antibiotiques Pour Les Infections aiguës Des Voies Respiratoires (IAVR)
Brief Summary: Decisions about the use of antibiotics for acute respiratory infections are the most frequently reported reason for consulting a family physician. Although it varies according to the specific type of acute respiratory infections, the use of antibiotics is estimated to be 63% to 67%, well above the expected prevalence of bacterial infections thus suggesting overuse of antibiotics. Consequently, there is an urgent need for helping family physicians and their patients to improve the clinical decision making process regarding the use of antibiotics for acute respiratory infections. We will evaluate the impact of DECISION +, a multifaceted intervention program that includes training in shared decision making, reminders and feedback targeting physicians, and decision support tools targeting patients on the decision to use antibiotics for acute respiratory infections. Results from this study will lay the ground for a national strategy targeting the improvement of the clinical decision making process regarding antibiotic use for acute respiratory infections in primary care. In turn, this will increase quality of care and patient safety.


Options:
A: Quality of Decision Making (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.); Knowledge Transfer (Immediately following each patient's index visit and before they leave the clinic on that day, typically within 10 minutes of completing the clinical encounter.)
B: Informed choice (2 weeks post intervention); Involvement in screening decision (2 weeks post intervention)
C: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
D: Change in Self-Reported Preference for Opioid Pain Reliever (Baseline and Immediate Post-test)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: DECISION+: Une Formation Pour Les médecins de Famille Sur la Prise de décision partagée Afin d'Optimiser Les décisions Cliniques Concernant l'Utilisation d'Antibiotiques Pour Les Infections aiguës Des Voies Respiratoires (IAVR)
Brief Summary: Decisions about the use of antibiotics for acute respiratory infections are the most frequently reported reason for consulting a family physician. Although it varies according to the specific type of acute respiratory infections, the use of antibiotics is estimated to be 63% to 67%, well above the expected prevalence of bacterial infections thus suggesting overuse of antibiotics. Consequently, there is an urgent need for helping family physicians and their patients to improve the clinical decision making process regarding the use of antibiotics for acute respiratory infections. We will evaluate the impact of DECISION +, a multifaceted intervention program that includes training in shared decision making, reminders and feedback targeting physicians, and decision support tools targeting patients on the decision to use antibiotics for acute respiratory infections. Results from this study will lay the ground for a national strategy targeting the improvement of the clinical decision making process regarding antibiotic use for acute respiratory infections in primary care. In turn, this will increase quality of care and patient safety.


Options:
A: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)
B: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)
C: Prescribing rate of antibiotics (up to 03/12)
D: Inappropriate Antibiotic Prescribing for Patients With Acute Respiratory Infections (ARI) (up to 12 months post intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: DECISION+: Une Formation Pour Les médecins de Famille Sur la Prise de décision partagée Afin d'Optimiser Les décisions Cliniques Concernant l'Utilisation d'Antibiotiques Pour Les Infections aiguës Des Voies Respiratoires (IAVR)
Brief Summary: Decisions about the use of antibiotics for acute respiratory infections are the most frequently reported reason for consulting a family physician. Although it varies according to the specific type of acute respiratory infections, the use of antibiotics is estimated to be 63% to 67%, well above the expected prevalence of bacterial infections thus suggesting overuse of antibiotics. Consequently, there is an urgent need for helping family physicians and their patients to improve the clinical decision making process regarding the use of antibiotics for acute respiratory infections. We will evaluate the impact of DECISION +, a multifaceted intervention program that includes training in shared decision making, reminders and feedback targeting physicians, and decision support tools targeting patients on the decision to use antibiotics for acute respiratory infections. Results from this study will lay the ground for a national strategy targeting the improvement of the clinical decision making process regarding antibiotic use for acute respiratory infections in primary care. In turn, this will increase quality of care and patient safety.


Options:
A: N/A
B: Impact on rates of medication errors (1 year)
C: Proportion of visits to primary care clinic associated with antibiotic prescriptions (30 days)
D: Proportion of patients reporting a decision for "immediate antibiotics." (After index consultation)

Answer: D