TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Etude Fruits et Légumes à la Maison (FLAM)
Brief Summary: The purpose of this study is to assess whether fruit and vegetables vouchers combined with educational support may increase fruits and vegetables consumption of children aged 3 to 10 living in vulnerable families in Saint-Denis, France.


Options:
A: Eating habits (3 years); Physical activity (3 years); Nature relatedness (3 years)
B: Proportion of small consumers of fruits and vegetables among children (12 months)
C: sugar-sweetened beverages (one time point (baseline only))
D: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Etude Fruits et Légumes à la Maison (FLAM)
Brief Summary: The purpose of this study is to assess whether fruit and vegetables vouchers combined with educational support may increase fruits and vegetables consumption of children aged 3 to 10 living in vulnerable families in Saint-Denis, France.


Options:
A: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
B: Proportion of small consumers of fruits and vegetables among children (12 months)
C: Mean Nutrition Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)); Mean Physical Activity Environment Score (Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up))
D: Growth trajectories (using BMI, waist circumference), body composition (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Multicenter Trial of Two Transfusion Strategies for Patient Receiving Chemotherapy for Acute Leukemia or Hematopoietic Stem Cells With Medico-economic Evaluation of Cost Minimization.
Brief Summary: Patients with acute hematological disease (acute leukemia, aplastic anemia, hematopoietic stem cells autologous or allogeneic ...) and hospitalized in an intensive care unit hematology require compensation of anemia and thrombocytopenia by blood transfusions of red blood packed cells (RBP) or platelet concentrates (PC).The AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) recommendations (2002) specify the need to transfuse 2 RBP in case of symptomatic anemia usually for a hemoglobin between 6 and 10 g / dL. These recommendations allow to transfuse a single RBP for very elderly patients or in cases of associated heart disease (heart failure). A recent development (2012) on post-transfusion pulmonary edema overload recommends transfusion unit by unit for high risk patients.

More recently, a Swiss team has historically compared transfusion policies in 2 139 patients with hematological malignancies. The first group received 2 RBP transfusion in case of symptomatic anemia or hemoglobin level \<6 g / dL. The other group only received 1 RBP at each transfusion. In total 2212 units in 1548 transfusions were performed and the 1 RBP transfusion policy has resulted in a 25% decrease in the number of RBP used without any complication. In a prospective single-center pilot study, we showed that transfusing a single RBP was possible without increasing the side effects of anemia, without complications and allow an overall reduction in consumption of red blood cell units.

Several meta-analyzes reported in intensive care or bleeding situations that a restrictive use of transfusions significantly reduces cardiac events, bleeding, bacterial infections and mortality. The number of patient to be treated to prevent one death is 33.

The main objective is to demonstrate in a randomized trial that the restrictive strategy (transfusion of a single unit at each transfusion) is not inferior to the liberal strategy (transfusion of 2 unit at each transfusion) in terms of severe complication. Transfusion are performed in case of hemoglobin level \<8g/dL.

Key secondary objectives are to reduce the number of RBP used and the cost of hospitalization with a comparison of complications/mortality in the 2 groups.


Options:
A: 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)
B: Timed Up and Go-test (TUG)in seconds. (30 days)
C: Number of severe complications (grade 3 or more) (up to 1 month after the last day of hospitalization)
D: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome: a Randomized Controlled Trial
Brief Summary: The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.


Options:
A: Moderate or severe ovarian hyperstimulation syndrome (Within 4 weeks of HCG adminstration)
B: OHSS (41 days after hCG injection)
C: Rate and degree of OHSS (composite outcome) (14 days)
D: risk of ovarian hyperstimulation syndrome (12 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome: a Randomized Controlled Trial
Brief Summary: The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.


Options:
A: OHSS (41 days after hCG injection)
B: Moderate or severe ovarian hyperstimulation syndrome (Within 4 weeks of HCG adminstration)
C: Percentage and severity of OHSS in two groups (6 days after embryos transfer (ET))
D: risk of ovarian hyperstimulation syndrome (12 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain
Brief Summary: This study investigate the effect of addition morphine to locally instillation bupivacaine on developing chronic neuropathic pain acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.


Options:
A: Drainage volume (7 days)
B: changes in acute pain intensity from the baseline (at 2,4,6,12,24,36 and 48 hour postoperatively)
C: Surgical site infection (30 days)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Risk Suicidal Behavior in Veterans - Assessment of Predictors and Efficacy of Dialectical Behavior Therapy
Brief Summary: Suicide is a pressing problem in the US military, with evidence of increased risk for suicide particularly among soldiers serving in Iraq and Afghanistan. To date, there are very few studies that empirically evaluate treatment efficacy to prevent suicide. One treatment that has been shown empirically to decrease suicidal behavior is Dialectical Behavioral Therapy (DBT), although these studies have been limited to patients with borderline personality disorder (BPD). The current proposal aims to examine the efficacy of DBT in reducing suicidal behavior more broadly in a diagnostically heterogeneous group of veterans with high risk suicidal behavior. One of the difficulties in doing research in suicide prevention is that serious suicidal behavior is a relatively rare event, and alone is not a satisfactory target for treatment studies. It is extremely important, therefore, to identify intermediate symptoms that are closely associated with high risk suicidal behaviors, as targets for treatment. One critical area our proposal addresses is validating new treatment models for suicide in veterans; DBT has been empirically validated to reduce suicidal behavior in individuals with BPD, but has not been tested more broadly to target suicidal behaviors. The second critical area which our proposal addresses is exploring new suicide risk assessment measures. While the investigators do not specifically propose to develop new screening tools, the investigators do propose to identify potentially important domains that specifically differentiate ill high risk suicide veterans from low risk. This information will be useful in future efforts to modify the DBT approach to be more effective for the broader diagnostic group of high risk suicidal veterans.


Options:
A: Counting of suicidal events (6 months)
B: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)
C: Suicide Events (1 year)
D: Non-suicidal self-harm (6 months); Suicidal ideation (6 months); suicide attempts (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: HOme-based moNitORed Exercise for PAD: The HONOR Study
Brief Summary: The purpose of this study is to determine the effects of a home-based exercise intervention on walking ability in people with peripheral artery disease. In 200 patients with peripheral artery disease (PAD), the investigators are conducting a randomized controlled trial to determine whether a patient-centered home-based exercise program improves walking ability, physical activity, mobility, pain, and social functioning, compared to a usual care group.


Options:
A: Six-minute Walk Distance (change from baseline to week 52)
B: Maximum Walking Distance (MWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)); Pain-free Walking Distance (PFWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months)); Functional Walking Distance (FWD) (Changes from before-assignment (T0 - treadmill and T1 - 6min walk test) to T2 (3 months), and to T3 (six-months))
C: Change in Six-Minute Walk Performance at 9-month follow-up (change from baseline to month 9)
D: Depression, as assessed the Patient Health Questionnaire-9 (Baseline, Weeks 2-6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the PACE/PACENET BHL Caregiver Outreach and Telehealth Education Program
Brief Summary: This project will conduct a retrospective clinical database review and a one-time research interview to evaluate outcomes among a sub-set of caregivers (CGs) who were enrolled in the Behavioral Health Laboratory (BHL) Caregiver Outreach and Telehealth Education Program (COTP). The investigators will recruit CGs whose Care Recipients (CR) met criteria for clinically significant cognitive impairment and/or dementia and who received care management services through the COTP.


Options:
A: Revised Memory and Behavior Problems Checklist (6 Months)
B: Beck Depression Inventory II (Beck, Steer & Brown, 1996) (Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention); Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996) (Post-intervention, assessed 4-14 days after final intervention session.)
C: Caregiver Burden Inventory (one year); Proportion of days spent at home by the AD patient in the past year (one year)
D: Parental Self-Efficacy (baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial to Measure the Effects of Twice-Daily Individual, Targeted, Strengthening, Balance and Endurance Exercise Sessions on Mobility, Quality of Life and Healthcare Utilisation for Frail Older Medical In-patients
Brief Summary: This study will help to determine whether frail older medical inpatients will benefit from targeted exercise sessions performed twice daily while in hospital. Half of the patients will complete targeted strengthening, balance and endurance exercises and the other half, stretching and relaxation exercises. The exercise sessions will be assisted and supported by a senior physiotherapist.


Options:
A: Falls (1 year)
B: Number of LTC residents on vitamin D (16 months)
C: Length of Stay (At time of discharge from hospital (an expected average of 8 days post admission))
D: The outcome measure will be rate of patients falls per 1000 patient days (1/2009-6/2009)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial to Measure the Effects of Twice-Daily Individual, Targeted, Strengthening, Balance and Endurance Exercise Sessions on Mobility, Quality of Life and Healthcare Utilisation for Frail Older Medical In-patients
Brief Summary: This study will help to determine whether frail older medical inpatients will benefit from targeted exercise sessions performed twice daily while in hospital. Half of the patients will complete targeted strengthening, balance and endurance exercises and the other half, stretching and relaxation exercises. The exercise sessions will be assisted and supported by a senior physiotherapist.


Options:
A: Independence level in self-care (The level of independence in self-care will be assessed at baseline (admission) and discharge through the Barthel Index)
B: Muscle mass (lean mass) (Change from baseline in muscle mass at 3 month after discharge)
C: Mobility using the de Morton Mobility Index (DEMMI) (Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after discharge)
D: Length of Stay (At time of discharge from hospital (an expected average of 8 days post admission))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of a New Integrated Approach to Management of Eating and Weight Disorders, Namely a Healthy APproach to weIght Management and Food in Eating Disorders Compared to Cognitive Behaviour Therapy Enhanced.
Brief Summary: The investigators have developed a new integrated therapy, namely a Healthy Approach to weIght management and Food in Eating Disorders (HAPIFED). HAPIFED is an enhanced behavioral weight loss therapy integrated with CBT for the management of EDs. HAPIFED uses CBT to treat ED behaviors and body image distress, whilst simultaneously emphasize a healthy lifestyle, the role of food and physical activity in mood regulation, and revised but clinically meaningful goals for weight loss. The investigators propose a randomized controlled trial (RCT) that will compare HAPIFED to CBT-E in people with obesity and either BN or BED. The two main aims will be to reduce symptoms of ED and to improve weight management. The RCT will be conducted in Sydney and in São Paulo with a one year follow-up.


Options:
A: Change in scores on the Oxford Measure of Psychosocial Adjustment & World Health Organization Disability Assessment Schedule, 2.0 (WHODAS 2.0) (Administered at 4 timepoints: (1) baseline; (2) within 15 days of YRI completion; (3) 6 months post-YRI; (4) 12 months post-YRI)
B: Hopkins Symptom Checklist-25 (HSCL-25) (Change from baseline assessment, at 1 week post-intervention assessment (6 weeks after baseline), change from post-assessment at 3 month post-intervention assessment (4-4.5 months after baseline), and change from at 12 month post intervention assessment)
C: Posttraumatic Stress Symptoms measured with the Posttraumatic Diagnostic Scale (9 months)
D: Sustained change weight (for less) of 5% of previous body weight. This is a level known to improve physical health (metabolic) outcomes. (Baseline, 25-weeks (end) treatment, 6 and12 months follow-up.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Transfusion Triggers in Vascular Surgery Trial: Two Different Transfusion Triggers for Postoperative Haemoglobin Separation and Adherence to Transfusion Strategies in Vascular Surgery: a Randomised Clinical Feasibility Trial
Brief Summary: BACKGROUND

* Vascular surgical patients often receive red blood cell (RBC) transfusions in the peri-operative period
* RBC transfusion may lead to improved outcome but on the other hand the intervention may be harmful
* Danish Health and Medicines Authority recommends transfusion of RBC at hemoglobin below 5 mmol/L while local clinical guidelines recommend transfusion of RBC to maintain hemoglobin levels above 6 mmol/L
* A large randomized clinical trial is needed to evaluate the efficacy and safety of RBC transfusion in patients undergoing vascular surgery.
* A trial examining the effect of RBC transfusion on tissue oxygenation is used to test the trial-design and feasibility for a trial evaluating post-operative mortality and morbidity.


Options:
A: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
B: Cost-effectiveness ratio at 30 days (30 days)
C: Primary outcome measures will be the incidence and severity of postoperative nausea and vomiting as well as paint while the patient is in the CVICU
D: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Transfusion Triggers in Vascular Surgery Trial: Two Different Transfusion Triggers for Postoperative Haemoglobin Separation and Adherence to Transfusion Strategies in Vascular Surgery: a Randomised Clinical Feasibility Trial
Brief Summary: BACKGROUND

* Vascular surgical patients often receive red blood cell (RBC) transfusions in the peri-operative period
* RBC transfusion may lead to improved outcome but on the other hand the intervention may be harmful
* Danish Health and Medicines Authority recommends transfusion of RBC at hemoglobin below 5 mmol/L while local clinical guidelines recommend transfusion of RBC to maintain hemoglobin levels above 6 mmol/L
* A large randomized clinical trial is needed to evaluate the efficacy and safety of RBC transfusion in patients undergoing vascular surgery.
* A trial examining the effect of RBC transfusion on tissue oxygenation is used to test the trial-design and feasibility for a trial evaluating post-operative mortality and morbidity.


Options:
A: Occurrence of a composite endpoint (90 days)
B: Death or Neurodevelopmental Impairment (Birth to 22-26 months corrected age); Death (Birth to 22-26 months corrected age); Neurodevelopmental Impairment (at 22-26 months corrected age); Cognitive Delay (at 22-26 months corrected age); Moderate or Severe Cerebral Palsy (at 22-26 months corrected age); Severe Vision Impairment (at 22-26 months corrected age); Severe Hearing Impairment (at 22-26 months corrected age)
C: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)
D: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Transfusion Triggers in Vascular Surgery Trial: Two Different Transfusion Triggers for Postoperative Haemoglobin Separation and Adherence to Transfusion Strategies in Vascular Surgery: a Randomised Clinical Feasibility Trial
Brief Summary: BACKGROUND

* Vascular surgical patients often receive red blood cell (RBC) transfusions in the peri-operative period
* RBC transfusion may lead to improved outcome but on the other hand the intervention may be harmful
* Danish Health and Medicines Authority recommends transfusion of RBC at hemoglobin below 5 mmol/L while local clinical guidelines recommend transfusion of RBC to maintain hemoglobin levels above 6 mmol/L
* A large randomized clinical trial is needed to evaluate the efficacy and safety of RBC transfusion in patients undergoing vascular surgery.
* A trial examining the effect of RBC transfusion on tissue oxygenation is used to test the trial-design and feasibility for a trial evaluating post-operative mortality and morbidity.


Options:
A: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)
B: Modified Rankin Scale (mRS) (12 months post)
C: A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization. (90 days after randomization)
D: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Transfusion Triggers in Vascular Surgery Trial: Two Different Transfusion Triggers for Postoperative Haemoglobin Separation and Adherence to Transfusion Strategies in Vascular Surgery: a Randomised Clinical Feasibility Trial
Brief Summary: BACKGROUND

* Vascular surgical patients often receive red blood cell (RBC) transfusions in the peri-operative period
* RBC transfusion may lead to improved outcome but on the other hand the intervention may be harmful
* Danish Health and Medicines Authority recommends transfusion of RBC at hemoglobin below 5 mmol/L while local clinical guidelines recommend transfusion of RBC to maintain hemoglobin levels above 6 mmol/L
* A large randomized clinical trial is needed to evaluate the efficacy and safety of RBC transfusion in patients undergoing vascular surgery.
* A trial examining the effect of RBC transfusion on tissue oxygenation is used to test the trial-design and feasibility for a trial evaluating post-operative mortality and morbidity.


Options:
A: 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)
B: Composite end-point of mortality and severe complication (30 days)
C: Mean Post-operative hemoglobin (longitudinal outcome) (Day 0 - 15)
D: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).


Options:
A: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
B: Number of Participants With Treatment Emergent Adverse Events. (84 days of treatment)
C: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline at Week 4)
D: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for ELX/TEZ/IVA Group (From Baseline Through Week 8)

Answer: B