TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Decisional Algorithm to Start Iron Chelation in Minimally Transfused Young Beta-thalassemia Major Patients Naive to Iron Chelation Therapy. A Comparative Randomized Prospective Study
Brief Summary: A prospective randomized study on Safety, Tolerability and Efficacy of oral Low dose DFP (50 mg/kg/day) in minimally transfused B-TM after 5 transfusions when SF reaches 500 ng/m and with either appearance of LPI \> 0.2 or TSAT reaches 50% compared with non treatment arm.

So the aim of this study:

1. To determine the time as well as amount of transfused iron ( calculated in mg iron/kg ) which lead to Serum ferritin reaches 500 ng /ml and LPI appearance \>0.2 as well as TSAT reaches 50 % .
2. Tolerability and safety of early low dose DFP 50mg/kg and effectiveness to postpone or prevent SF from reaching 1000 ng/ml or LPI \>0.6 or TSAT \>70% in comparison to patients not starting chelation therapy
3. Determine adverse events whether drug or non drug related


Options:
A: to assess efficacy of combining DFP and deferasirox compared to combined DFP and DFO in decreasing the serum ferritin level in conditions with severe chronic iron overload. (12 months)
B: To evaluate if fixed starting doses of ICL670, based on transfusion history and subsequent dose titration can provide clinically acceptable chelation as measured by serum ferritin (at baseline and at 52 weeks)
C: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
D: determine the time and number of transfusion units as well as amount of infused iron that will lead to appearance of LPI >0.2 or TSAT>50 % , serum ferritin ≥ 500 ng/ml in the studied thalassemic patients which warrant start of iron chelation (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Medication Adherence in Older African Americans With Diabetes
Brief Summary: This research aims to help older African Americans with diabetes and mild memory problems improve how they take their medications and control their diabetes. This may preserve their independence and health, prevent cognitive and functional decline, and reduce health care costs. As the population ages and becomes more racially diverse, finding ways to achieve these outcomes has great public health importance.


Options:
A: Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose (12 weeks)
B: Percent of Participants With Improvement in Hemoglobin A1c by 0.5%" (6 months)
C: Primary Process Outcome: A composite score counting the number of appropriate processes achieved for patients within appropriate time-frames, including laboratory testing, blood pressure measurements and active prescriptions (24 months); Primary Disease-Related Outcomes: mean BP and mean LDL level. (24 months)
D: Glycated hemoglobin level before and after intervention (1 year after start of the intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis
Brief Summary: The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis


Options:
A: Hemoglobin level (24 weeks)
B: Mean Hb Level of Week 20 and Week 24 (Up to Week 24)
C: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
D: Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 (Baseline (Day 1, Week 0) and Week 28 to Week 52.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Open-label, Active-Controlled Study of the Safety and Efficacy of Roxadustat in the Treatment of Anemia in Dialysis Patients
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.


Options:
A: Change in hemoglobin (Hb) between Baseline (average pretreatment Hb) and the primary evaluation period (average Hb from Weeks 20 to 26, inclusive) (Baseline; Weeks 20 to 26)
B: Maximum Change From Baseline in Hb During Weeks 3-13 (Baseline, Weeks 3-13)
C: Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 (Baseline (Day 1, Week 0), Week 28 to 52)
D: Maximum change in hemoglobin by Week 9 from baseline (Week 9)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Open-Label Study to Assess the Long-Term Safety of Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients 12 Years of Age and Older With Persistent Asthma
Brief Summary: The primary objective of the study is to evaluate the long-term safety of fluticasone propionate (Fp) inhalation powder in 2 strengths and fluticasone propionate/salmeterol inhalation (FS) powder in 2 strengths when administered with the Teva multidose dry powder inhaler (MDPI) device over 26 weeks in patients with persistent asthma.


Options:
A: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
B: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
C: Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline (pre-dose at Day 1) and Week 24)
D: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-Week Open-Label Study to Assess the Long-Term Safety of Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients 12 Years of Age and Older With Persistent Asthma
Brief Summary: The primary objective of the study is to evaluate the long-term safety of fluticasone propionate (Fp) inhalation powder in 2 strengths and fluticasone propionate/salmeterol inhalation (FS) powder in 2 strengths when administered with the Teva multidose dry powder inhaler (MDPI) device over 26 weeks in patients with persistent asthma.


Options:
A: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 6 months); Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period (From Day 1 up to 6 months)
B: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)
C: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)
D: Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12 (Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours); Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 1 (predose, baseline), Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles
Brief Summary: Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The present study will test whether the fractional and total iron absorption from iron supplements (60 mg) administered daily for 14 days differs from that of iron supplements (60 mg) administered every second day for 28 days. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Therefore we will monitor SHep during the whole supplementation period. We hypothesize that the fractional and total iron absorption from the daily administration of 60 mg is lower than that from the administration on every second day due to increased SHep levels when supplements are administered daily.

The study will provide important insights about the optimization of iron bioavailability from different supplementation regimens including the performance of SHep, a key regulator of human iron metabolism.


Options:
A: Proportion of Patients With a ≥13 Point Improvement in FIQR Score (Day 42)
B: Iron bio-availability from oral iron supplementation (%) (up to 4 weeks); Serum hepcidin concentrations (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 19, 21, 23, 25 and 27 days)
C: Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy (24 weeks)
D: To assess the efficacy of a single intravenous (IV) administration of FCM (1,000 mg) compared with placebo in improving fatigue symptoms in IDNA women of child bearing age. (Day 56)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care.
Brief Summary: A randomized controlled trial of a texting intervention to increase adherence to preventative asthma medication in four Cincinnati Children's Hospital Medical Center primary care clinics.


Options:
A: Objective Adherence to ICS (Baseline); Change in objective adherence to ICS (Change from baseline in objective adherence to ICS at 1 month); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control); Feasibility, Acceptability and Usability of the Text Messaging Website (At time of text messaging intervention); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 1 month after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 2 months after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 3 months after receiving text messages)
B: Average Number of Days Without Asthma Symptoms (Symptom Free Days) (Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.)
C: Recorded Medication Adherence (26 weeks); Self-reported Medication Adherence (6-months)
D: Change in baseline asthma self efficacy after 3 weeks (participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementing Interventions to Reduce Hospitalizations of Nursing Home Residents
Brief Summary: This project directly addresses the national imperative for innovative strategies to improve care for Medicare beneficiaries and reduce health care costs. The overall objective of the proposed project is to improve the care of older individuals who reside in nursing homes (NHs), and at the same time reduce unnecessary Medicare expenditures. This goal will be accomplished by testing a quality improvement program designed to reduce the number of avoidable hospitalizations of NH residents in a randomized controlled trial.

The primary hypotheses to be tested are:

Hypothesis1: Interventions to Reduce Acute Care Transfers (INTERACT) implementation NHs will have a greater reduction in hospitalization rate than the control and monitoring only NHs during the 12-month implementation compared to a 12-month baseline period.

Hypothesis 2: Reductions in Medicare expenditures for hospitalizations in the INTERACT implementation NHs will be greater than the estimated costs of implementing the intervention.

Hypothesis 3: The effects of INTERACT on hospitalization rates will be greater among patients on the Medicare skilled benefit for post-acute care, than for long-stay patients.

Hypothesis 4: The effects of INTERACT on hospitalization rates will be greatest among those NHs with higher vs. lower intensity (fidelity) of implementing the program.

Hypothesis 5: There will be a greater reduction in measures of hospitalizations for conditions defined as "potentially preventable" than for other transfers and hospitalizations.

Hypothesis 6: Implementation of INTERACT will not be associated with worsening of relevant quality measures in the participating NHs.


Options:
A: Days spent at hospital (24 months); Number of Intervention-related adverse events (6 to 15 months depending on the cluster affiliation)
B: Reductions in hospitalization (1 year)
C: cumulative number of hospitalisation (within 12 months)
D: Reduction of antidepressant (Intervention period of three months for each patient.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy
Brief Summary: Phase IV

Design : Prospective, open-label, randomized three-arms study

Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months

Primary objective To demonstrate that Infliximab scheduled maintenance with or without antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free remission over 2 years, while the latter is non inferior with regards to the mean time spent in remission over the same duration

Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2 years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate.

Number of subjects 225 randomized patients (75 per arm)

Study duration: 3 + 2 years Enrollment: 3 years Follow-up: 2 years


Options:
A: Proportion of patients with response at week 12, i.e. CDAI decrease of 70 or more for patients with luminal disease, or reduction of 50 percent or more from base line in the number of draining fistulas for patients with fistulising disease. (12 weeks); Total expenses related to Crohn's disease during the study (inclusion to week 12). (12 weeks)
B: co-primary efficacy end points (2 ans)
C: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
D: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 (Baseline up to Week 76)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles
Brief Summary: Iron deficiency (ID) with or without anaemia (IDA) is a major public health problem worldwide, especially in women of reproductive age and young children. Iron supplementation is an effective strategy to prevent and treat ID and IDA. There is a lack of data on iron bioavailability from different supplementation regimens and how to optimize bioavailability in a cost-effective and patient-friendly way. The daily supplementation with 1-4 mg Fe/kg body weight for 3 months is reported to be the most effective method to rapidly increase iron stores in subjects with ID and IDA. In IDA patients, medical practitioners often prescribe supplementation regimens with 120 mg iron per day split into 2 doses with 60 mg iron, arguing that the splitting would increase iron bioavailability compared with one single high dose. However, there is no scientific evidence for this assumption; to the contrary, results from a recent study suggest that iron bioavailability from a second supplementation dose of iron after a first supplementation dose of iron is impaired due to increased hepcidin levels. To address this bioavailability issue, the present study will determine iron absorption from 120 mg iron administered for 3 consecutive days and compare it with that from 2 doses of 60 mg iron per day administered for 3 consecutive days. The investigators hypothesize that the iron bioavailability from the single daily dose will be lower than that from the 2 doses. By measuring also hepcidin, this study will provide important insights on the iron bioavailability from a single dose of iron and on the same amount iron split into two doses (b.i.d. administration).


Options:
A: Change in Peak VO2 (mL/kg/min) from baseline to Week 24 (Week 24)
B: Change in six minute walk test from baseline to week 24 (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: Iron bio-availability (%) from oral iron supplementation (3x 120 mg) (3 days); Serum hepcidin concentrations on the 1st day of iron supplementation (1 day); Iron bio-availability (%) from oral iron supplementation (6x 60 mg) (6 days); Serum hepcidin concentrations on the 2nd day of iron supplementation (2 days); Serum hepcidin concentrations on the 3rd day of iron supplementation (3 days); Serum hepcidin concentrations on the 4th day of iron supplementation (4 days); Serum hepcidin concentrations on the 5th day of iron supplementation (5 days); Serum hepcidin concentrations on the 6th day of iron supplementation (6 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Controlled Clinical Trial: Impact of Remote Ischemic Preconditioning Preceding Coronary Artery Bypass Grafting on Inducing Neuroprotection
Brief Summary: Coronary artery disease (CAD) is the leading cause of death worldwide. Patients with severe CAD are often treated with coronary artery bypass grafting (CABG). Novel treatment strategies need to be pursued to respond to the continuous increase in the risk profile of contemporary CABG patients. Surgical myocardial revascularization is commonly performed with the use of cardiopulmonary bypass (CPB). Neurological impairment following CABG may take on the form of a new-onset motor deficit or postoperative cognitive dysfunction. The former is rare, but potentially devastating. Conversely, declines in attention, memory and fine motor skills can frequently be documented.

Ischemic preconditioning is a phenomenon of an endogenous protective response to organ ischemia, which is triggered by brief cycles of nonlethal ischemia and reperfusion in tissues known to be more resistant to ischemic insults. In clinical practice remote ischemic preconditioning (RIPC) is achieved by inflicting short periods of ischemia with intermittent restitution of flow to the upper extremity. This intervention has been shown to be effective in the reduction of myocardial injury in cardiac surgical patients. The hypothesis tested in this research proposal is that RIPC will decrease the extent of postoperative neurological injury following CABG.

In this research project, 70 patients scheduled for an elective CABG will be recruited at a single center. They will be randomly allocated to either undergo RIPC (intervention arm) or a sham procedure (control arm). Inflating a blood pressure cuff to 200 mmHg for 5 min will induce RIPC, thereby inducing a brief period of ischemia. This will be followed by a 5-minute arm reperfusion. In total, three cycles of arm ischemia and reperfusion will be induced in this fashion.

All patients will undergo pre- and post-procedural magnetic resonance imaging (MRI) of the brain, as well as neurocognitive testing. The array of MRI tools that will be used for the quantification of brain injury will include fluid attenuated inversion recovery, diffusion weighted and susceptibility weighted imaging, coupled with resting state functional MRI.

The investigators aim to determine whether RIPC can reduce the adverse impact of CPB on neurological outcome as evaluated by MRI detectable brain ischemia and neurocognition.


Options:
A: Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG surgery and its area under the curve (AUC). (72 hours postoperatively after CABG surgery)
B: Composite structural and functional neurological outcome (7 days)
C: cognitive function (preoperative, 1 week and 6 months after surgery)
D: Mitochondrial respiration (1 hour)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Podiatry Intervention to Reduce Falls in Care Home Residents: Development, Feasibility and Acceptability Study With Exploratory Randomised Controlled Trial
Brief Summary: This is an exploratory pilot Randomised Controlled Trial (RCT) to investigate the effects of a multifaceted podiatry intervention designed to reduce falls in care homes. The investigators hypothesise that the intervention will reduce the high falls rates present in care homes for older people, compared to usual care.

The results will inform the sample size calculation for a full-scale definitive RCT


Options:
A: Bone Mineral Density (BMD) of the Total Hip and Spine (Baseline, 12 months, 24 month)
B: Patient falls over 15 months
C: Number of LTC residents on vitamin D (16 months)
D: Change in falls rate (3 months from baseline measures, 6 months from baseline, 9 months from baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Intra-arterial Autologous Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke. A Phase II, Open-label, Multicenter, Randomized and Controlled Clinical Trial.
Brief Summary: This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.


Options:
A: Barthel index score (six month post randomization)
B: Categorical shift in modified Rankin scale (mRS) (90 days after the cell treatment)
C: Disability (6 months)
D: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) (6 months)

Answer: C