TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Reduction of Preoperative Anxiety in Children: Electronic Tab vs Midazolam
Brief Summary: Rationale:

The most frequently used means to prevent pre-anaesthetic anxiety in children is a drug premedication. Midazolam, a benzodiazepine, is mainly used. It requires time for action, so coordination between departments and operating room, exposed to the risks of side effects and failure and this variability action. Alternative means were evaluated, such as the presence of parents during anaesthetic mask induction, distraction by clowns, hypnosis or video games.

Electronic tabs are small devices; light, easy to use with age-specific and interactive programs. Our hypothesis is that these electronic tabs are more effective in reducing anxiety and distract children compare to preoperative medication.

Methods: This is a monocentric, randomized, open-label study comparing patients aged 4 to 10 years old programmed for a short term and low level of pain outpatient surgery. My pass score will be measured when arriving at the hospital, at the time of the separation with the parents, at the time of the anaesthetic mask induction and after the surgery.

118 patients will be randomized as follows :

* Arm 1 : Hypnovel® (midazolam)
* Arm 2 : Electronic tab The recruitment is performed by general practitioners in the Lyon area.


Options:
A: Patient's level of anxiety (at day 1)
B: Child pain intensity (2 minutes after completion of the immunization series.)
C: Faces Pain Scale-Revised (5 mins before and immediate after vaccination)
D: Venham's clinical rating scale (Within 1 hour of procedure)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SipSmarter: A Nutrition Literacy Approach to Reducing Sugary Beverages
Brief Summary: The primary aim of this pragmatic randomized-controlled trial was to determine the effectiveness of a scalable 6-month intervention aimed at decreasing SSB consumption (SIPsmartER) when compared to a matched contact physical activity promotion control group (MoveMore).


Options:
A: Change in body weight from baseline (4 weeks)
B: Feasibility for Participant Enrollment and Retention (Baseline to 6-months)
C: Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months (baseline, 6-months)
D: Change in the selection of meal components (Selection of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation); Change in the consumption of meal components (consumption of entrees, milk, fruits, and vegetables) (baseline, up to 3 months post-implementation, and up to 7 months post-implementation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Infantile-onset Spinal Muscular Atrophy
Brief Summary: The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to examine the safety and tolerability of nusinersen administered intrathecally to participants with infantile-onset SMA.


Options:
A: Percentage of Motor Milestones Responders (assessed at the later of the Day 183, Day 302, or Day 394 study visits); Time to Death or Permanent Ventilation (Day 91, Day 182, Day 273, Day 364, Day 394)
B: Safety Labs (-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs); Efficacy, Measured Through Motor Function Assessments (-4wks, 0, 3 mo, 6 mo, 12 mo); Modified Hammersmith Change From Baseline to 6 Months (0 months, 6 months)
C: Motor Function Measure (every 6 months)
D: Laboratory Safety Data (-2 weeks, + 2 weeks, 3 months, 6 months); Anthropometric Measures of Nutritional Status (Body Mass Index [BMI] Z-scores, Weight for Length Ratios, Lean/Fat Mass Via DEXA, Growth Parameters, and Triceps Skinfold Measures) (-2 weeks, time 0, 3 months, 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients With Infantile-onset Spinal Muscular Atrophy
Brief Summary: The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to examine the safety and tolerability of nusinersen administered intrathecally to participants with infantile-onset SMA.


Options:
A: Safety Labs (-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs); Efficacy, Measured Through Motor Function Assessments (-4wks, 0, 3 mo, 6 mo, 12 mo); Modified Hammersmith Change From Baseline to 6 Months (0 months, 6 months)
B: Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (Up to 24 Weeks); Number of participants with clinically significant neurological examination abnormalities (Up tp 24 Weeks); Number of participants with clinically significant vital sign abnormalities (Up to 24 Weeks); Number of participants with clinically significant physical examination abnormalities (Up to 24 Weeks); Number of participants with clinically significant weight abnormalities (Up to 24 Weeks); Number of participants with clinically significant laboratory parameters (Up to 24 Weeks); Number of participants with clinically significant electrocardiograms (ECGs) abnormalities (Up to 24 Weeks); Number of participants who use concomitant medications (Up to 24 Weeks)
C: Percentage of Motor Milestones Responders (assessed at the later of the Day 183, Day 302, or Day 394 study visits); Time to Death or Permanent Ventilation (Day 91, Day 182, Day 273, Day 364, Day 394)
D: Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15 (Baseline and Month 15)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Potential for Improved Analgesia From Combined Medication for Superficial Pain
Brief Summary: This research study is being done to assess if a combination of medications can enhance the relief of superficial pain (pain at the surface of the skin, such as sunburn pain). The investigators also want to find out if certain genes may be linked to individual differences in experienced efficacy of pain killers. The combination of medications under investigation is diclofenac and atropine. Diclofenac has been approved by the U.S. Food and Drug Administration (FDA) to treat pain. Atropine has been approved by the FDA to treat certain types of poisoning, heartbeat problems, and other diseases but atropine is not approved to treat pain. However, atropine has been used for many years in different European countries to treat painful conditions such as stomach cramps.This research study will compare diclofenac and atropine to placebo.


Options:
A: Pain Scores on Standardized Experimental Pain Testing (baseline and 1 hour pain measurement)
B: Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score. (Last week of 3-week treatment period assessed at Visit 5.)
C: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) (From baseline (visit 2) to end of of Double-Blind phase (visit 3))
D: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8 (Baseline and week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Magnesium Balance of Citrate-based Continuous Venovenous Hemofiltration, Effect of Citrate Dose.
Brief Summary: Rationale:

A higher citrate dose during continuous venovenous hemofiltration provides better anticoagulation but possibly a higher risk of citrate accumulation in case of metabolic limitations. A higher citrate dose also increases magnesium loss in ultrafiltrate, while a negative magnesium balance is unwanted.

Objective:

Aim of this study is to determine the magnesium balance of citrate-based continuous veno-venous hemofiltration (CVVH) and to determine whether and to which extent the magnesium balance depends on citrate dose.

Study design and methods:

A prospective randomized study conducted in critically ill patients with acute kidney injury (AKI), treated with CVVH, with either low dose citrate (2.5 mmol/L blood flow in the filter) or high dose citrate (4.5 mmol/L blood flow in the filter) as anti-coagulant, targeting a postfilter ionized Calcium (iCa) of resp. 1.3-1.6 mg/dL (0.325-0.4 mmol/L) and 0.8-1.1 mg/dL (0.2-0.275 mmol/L). Post-filter blood as well as effluent aliquots and bloodconcentrations in the patient are tested for the following variables:

(0 , 2 , 4, 6, 12 and 24 hrs): Total Magnesium (tMg) and total Calcium (tCa), ionized Ca (iCa)(bloodgas analyzer). In addition, hematocrit, albumin, total protein, ureum and creatinine and parathormone (PTH) are determined in arterial blood at 0 and 24 hrs or at the time of protocol exit and citrate concentrations in postfilter and arterial blood at 1 and 24 hrs or at protocol exit.

Sample sites: arterial line, postfilter port (after postdilution and calcium compensation), effluent sample. All flow rates to be noted.

Study population:

Twenty patients admitted to intensive care, requiring continuous renal replacement therapy (CRRT) for AKI.

Intervention:

Anti-coagulation with either low dose citraat (2.5 mmol/L blood flow) or high dose citraat (4.5 mmol/L blood flow) targeting postfilter iCa of resp. 1.3-1.6 and 0.8-1.1 mg/dL. Both regimens are within standard protocolled CVVH treatment in the intensive care department.


Options:
A: Functions of inflammatory cells (24 hours); Regulation of inflammatory reactions and and opsonization in microorganisms (24 hours); Activity of acute phase protein during acute inflammation (24 hours)
B: Mg balance of CVVH treatment (1 month)
C: Filter Life (72 hours)
D: Circuit lifespan during continuous renal replacement therapy (up till termination as defined above) with each dialyzer (oXiris or M150) (usually 10 - 30 hours from commencement of circuit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Magnesium Balance of Citrate-based Continuous Venovenous Hemofiltration, Effect of Citrate Dose.
Brief Summary: Rationale:

A higher citrate dose during continuous venovenous hemofiltration provides better anticoagulation but possibly a higher risk of citrate accumulation in case of metabolic limitations. A higher citrate dose also increases magnesium loss in ultrafiltrate, while a negative magnesium balance is unwanted.

Objective:

Aim of this study is to determine the magnesium balance of citrate-based continuous veno-venous hemofiltration (CVVH) and to determine whether and to which extent the magnesium balance depends on citrate dose.

Study design and methods:

A prospective randomized study conducted in critically ill patients with acute kidney injury (AKI), treated with CVVH, with either low dose citrate (2.5 mmol/L blood flow in the filter) or high dose citrate (4.5 mmol/L blood flow in the filter) as anti-coagulant, targeting a postfilter ionized Calcium (iCa) of resp. 1.3-1.6 mg/dL (0.325-0.4 mmol/L) and 0.8-1.1 mg/dL (0.2-0.275 mmol/L). Post-filter blood as well as effluent aliquots and bloodconcentrations in the patient are tested for the following variables:

(0 , 2 , 4, 6, 12 and 24 hrs): Total Magnesium (tMg) and total Calcium (tCa), ionized Ca (iCa)(bloodgas analyzer). In addition, hematocrit, albumin, total protein, ureum and creatinine and parathormone (PTH) are determined in arterial blood at 0 and 24 hrs or at the time of protocol exit and citrate concentrations in postfilter and arterial blood at 1 and 24 hrs or at protocol exit.

Sample sites: arterial line, postfilter port (after postdilution and calcium compensation), effluent sample. All flow rates to be noted.

Study population:

Twenty patients admitted to intensive care, requiring continuous renal replacement therapy (CRRT) for AKI.

Intervention:

Anti-coagulation with either low dose citraat (2.5 mmol/L blood flow) or high dose citraat (4.5 mmol/L blood flow) targeting postfilter iCa of resp. 1.3-1.6 and 0.8-1.1 mg/dL. Both regimens are within standard protocolled CVVH treatment in the intensive care department.


Options:
A: bleeding complications (during administration of study anticoagulant); transfusion requirement (during administration of study anticoagulant); filter survival (during hemofiltration)
B: Middle molecular weight molecules clearances (18 months)
C: 60-day All-cause Mortality (60 days)
D: Mg balance of CVVH treatment (1 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Magnesium Balance of Citrate-based Continuous Venovenous Hemofiltration, Effect of Citrate Dose.
Brief Summary: Rationale:

A higher citrate dose during continuous venovenous hemofiltration provides better anticoagulation but possibly a higher risk of citrate accumulation in case of metabolic limitations. A higher citrate dose also increases magnesium loss in ultrafiltrate, while a negative magnesium balance is unwanted.

Objective:

Aim of this study is to determine the magnesium balance of citrate-based continuous veno-venous hemofiltration (CVVH) and to determine whether and to which extent the magnesium balance depends on citrate dose.

Study design and methods:

A prospective randomized study conducted in critically ill patients with acute kidney injury (AKI), treated with CVVH, with either low dose citrate (2.5 mmol/L blood flow in the filter) or high dose citrate (4.5 mmol/L blood flow in the filter) as anti-coagulant, targeting a postfilter ionized Calcium (iCa) of resp. 1.3-1.6 mg/dL (0.325-0.4 mmol/L) and 0.8-1.1 mg/dL (0.2-0.275 mmol/L). Post-filter blood as well as effluent aliquots and bloodconcentrations in the patient are tested for the following variables:

(0 , 2 , 4, 6, 12 and 24 hrs): Total Magnesium (tMg) and total Calcium (tCa), ionized Ca (iCa)(bloodgas analyzer). In addition, hematocrit, albumin, total protein, ureum and creatinine and parathormone (PTH) are determined in arterial blood at 0 and 24 hrs or at the time of protocol exit and citrate concentrations in postfilter and arterial blood at 1 and 24 hrs or at protocol exit.

Sample sites: arterial line, postfilter port (after postdilution and calcium compensation), effluent sample. All flow rates to be noted.

Study population:

Twenty patients admitted to intensive care, requiring continuous renal replacement therapy (CRRT) for AKI.

Intervention:

Anti-coagulation with either low dose citraat (2.5 mmol/L blood flow) or high dose citraat (4.5 mmol/L blood flow) targeting postfilter iCa of resp. 1.3-1.6 and 0.8-1.1 mg/dL. Both regimens are within standard protocolled CVVH treatment in the intensive care department.


Options:
A: Time to Occurrence of Selected Prismaflex® System Alarms/Conditions (Up to 120 hours post CRRT treatment initiation)
B: Middle molecular weight molecules clearances (18 months)
C: Mg balance of CVVH treatment (1 month)
D: Number of filters used per hour (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Individuals With Type 2 Diabetes
Brief Summary: The primary goal is to evaluate whether a home telehealth system that enables the participant to monitor their body weight, blood glucose values and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk in individuals with type 2 diabetes mellitus (T2DM), as compared to usual practice.


Options:
A: HBA1c Glycosylated hemoglobin (one year for every patient)
B: change in hemoglobin A1c (6 and 12 months)
C: Change from baseline in blood glucose level (Baseline and 12 months); Change from baseline in blood pressure (Baseline and 12 months); Change from baseline in body mass index (Baseline and 12 months)
D: Proportion of Participants that Receive Annual Eye Exam (Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications
Brief Summary: A multicentre, open-label, non-interventional study to observe treatment patterns in patients with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to chorioidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a 24 months observational period under real life conditions.


Options:
A: Change from Baseline in Visual Acuity (VA) to Month 12 (Baseline, Month 12); Change from Baseline in Visual Acuity (VA) to Month 24 (Baseline, Month 24)
B: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye at Month 12 (Baseline through the end of study (Month 12))
C: Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year (Baseline, Year 1)
D: Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12 (Baseline through the end of study (Month 12)); Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]); Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study (Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months])

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications
Brief Summary: A multicentre, open-label, non-interventional study to observe treatment patterns in patients with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to chorioidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a 24 months observational period under real life conditions.


Options:
A: Visual acuity; Central macular thickness
B: Central subfield macular thickness (CSFT) change (Monthly from baseline to Week 48)
C: N/A
D: Change from Baseline in Visual Acuity (VA) to Month 12 (Baseline, Month 12); Change from Baseline in Visual Acuity (VA) to Month 24 (Baseline, Month 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind Phase II/III Trial of Oral Isoquercetin to Prevent Venous Thromboembolic Events in Cancer Patients.
Brief Summary: This research study is evaluating a drug called isoquercetin to prevent venous thrombosis (blood clots), in participants who have pancreas, non small cell lung cancer or colorectal cancer.


Options:
A: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
B: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
C: Percent Change in D-dimer Value (Baseline, 56 Day)
D: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy
Brief Summary: The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously untreated multiple myeloma who are ineligible for high dose chemotherapy and autologous stem cell transplant (ASCT).


Options:
A: Percentage of Participants Who Achieved Complete Response (CR) - European Group for Blood and Marrow Transplantation (EBMT) Criteria (Up to disease progression, approximately 3 years)
B: Time to tumor progression (TTP) (Up to 3 years)
C: Progression Free Survival (PFS) (From randomization to either disease progression or death whichever occurs first (up to 2.4 years))
D: overall survival (october 2007)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Does the Addition of Growth Hormone to the Invitro Fertilization/ Intracytoplasmic Sperm Injection Antagonist Protocol Improve Outcome in Poor Responders? A Randomized Controlled Trial
Brief Summary: The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.


Options:
A: Numbers of oocytes retrieved and number of fertilized oocytes (2 years)
B: Live birth rate (12 months)
C: Clinical pregnancy rates (15 months)
D: Live birth rate (Up to 9 months)

Answer: D