TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Drug-Therapy in Patients, 80 Years and Older, in Order to Reduce Drug-Related Morbidity and Usage of Secondary Care - a Randomized Controlled Trial
Brief Summary: The purpose of this study is to measure the effects of an enhanced service where a pharmacists is part of the healthcare team on the ward (focusing on drug-related problems and transferring information between primary and secondary care). Primary outcome measure is visits to hospital during a 12-month follow-up period, and the population is patients 80 years and older.


Options:
A: Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients (1 year)
B: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 18 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 18 months)
C: Medication adherence; Exacerbation of heart failure; Health-related quality of life
D: Effects on hospital visits (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Drug-Therapy in Patients, 80 Years and Older, in Order to Reduce Drug-Related Morbidity and Usage of Secondary Care - a Randomized Controlled Trial
Brief Summary: The purpose of this study is to measure the effects of an enhanced service where a pharmacists is part of the healthcare team on the ward (focusing on drug-related problems and transferring information between primary and secondary care). Primary outcome measure is visits to hospital during a 12-month follow-up period, and the population is patients 80 years and older.


Options:
A: Effects on hospital visits (1 year)
B: Number of patients with probable and definite adverse drug events in hospital (Up to Day 14 of hospital admission)
C: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (At 18 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At inclusion); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 1 month); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 6 months); The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. (At 18 months)
D: Total Number of Medications (Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Drug-Therapy in Patients, 80 Years and Older, in Order to Reduce Drug-Related Morbidity and Usage of Secondary Care - a Randomized Controlled Trial
Brief Summary: The purpose of this study is to measure the effects of an enhanced service where a pharmacists is part of the healthcare team on the ward (focusing on drug-related problems and transferring information between primary and secondary care). Primary outcome measure is visits to hospital during a 12-month follow-up period, and the population is patients 80 years and older.


Options:
A: Effects on hospital visits (1 year)
B: ADEs (Measured 30 and 90 days after hospital discharge); Medication appropriateness (Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index); Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE (Measured 30 and 90 days after hospital discharge); Cost-effectiveness of the minimal or enhanced treatment compared to usual care (Measured 30 and 90 days after hospital discharge)
C: Number of Serious Medication Errors as Determined by Interview and Medical Chart Review (Measured at Day 30)
D: Combined Emergency Department Visits and Inpatient Readmissions (30 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (90 days after discharge from hospital); Combined Emergency Department Visits and Inpatient Readmissions (180 days after discharge from hospital)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy
Brief Summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.


Options:
A: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
B: Time from randomization to the primary action point (monotherapy failure).
C: Proteinuria (at baseline and after 6 and 12 mo of treatment)
D: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) (Baseline , Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase I/II Trial of Valproic Acid and Carnitine in Infants With Spinal Muscular Atrophy Type I (CARNI-VAL Type I)
Brief Summary: This is a multi-center trial to test safety and evaluate early treatment intervention with valproic acid and carnitine in moderating SMA symptoms of Type I infants.


Options:
A: Manual Muscle Test (Medical Research Council scale-MRC), the Hammersmith Motor Ability Score (one year)
B: Motor Function Measure (every 6 months)
C: 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)
D: Percent of Participants Who Achieved Improvement in Motor Milestones as Assessed by Section 2 of the HINE at the Last Visit (Day 1352 or Early Termination)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.
Brief Summary: This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Options:
A: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP) (Weeks -4, -3, -2, -1,and 0; pre-dose (0 hours) during Weeks 18, 20, 22, and 24)
B: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP (EEP (Week 16 to Week 24))
C: Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period (EEP (Week 16 to Week 24))
D: Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period. (Weeks 16-24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Occlusion Prevention for Trabeculectomy Procedures Using Combination Ranibizumab and Mitomycin C (MMC) During Surgery (OCTOPUS Study)
Brief Summary: The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.


Options:
A: The primary efficacy outcome measure is the mean change from baseline in BCVA score (6 months)
B: Assessment of Ocular Adverse Events (6 months)
C: N/A
D: Progression-Free Survival (Assessed every 3 months for 2 years, then every 6 months for 3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Examination of Palonosetron and Hydroxyzine Pre-treatment as a Possible Method to Reduce the Objective Signs of Experimentally-induced Acute Opioid Withdrawal in Humans: a Double-blind, Randomized, Placebo-controlled Crossover Study
Brief Summary: Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. We are interested in knowing if a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved drug, palonosetron) can more effectively treat withdrawal symptoms with or without combination with an antihistamine called hydroxyzine (vistaril).


Options:
A: OOWS Score (Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration))
B: Percentage of patients in each group successfully inducted onto Vivitrol (Completion of 7-day detoxification)
C: Opiate abstinence
D: opioid use (baseline, 1-month, 3-months, 6-months); HIV risk behavior (baseline, 1-month, 3-months, 6-months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIA Study of Subcutaneous 5-aza-2'- Deoxycytidine (Decitabine) in Patients With Thalassemia Intermedia
Brief Summary: Thalassemia intermedia (TI) is an inherited blood disorder that can cause anemia due to low levels of hemoglobin. Decitabine is a medication that may be effective at increasing hemoglobin levels. This study will evaluate the safety and effectiveness of decitabine at increasing hemoglobin levels in people with TI.


Options:
A: Number of Evaluable Patients With an Increase From Baseline in Hemoglobin (Hb) of ≥1.5 g/dL (up to 12 weeks); Change in Total Hemoglobin (Hb) From Baseline to Peak (the Follow-up Time Point With the Highest Value) (up to 12 weeks)
B: Clinical effects on heamoglobin changes (6 months)
C: Change in baseline transfusion frequency with increase of pre-transfusion hemoglobin (baseline and 6 month hemoglobin level and transfusion frequency)
D: Change from baseline in % fetal hemoglobin (Day 1 through Week 48)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Longitudinal Cohort Study of Patients With Thalassemia in the Thalassemia Clinical Research Network
Brief Summary: Thalassemias are inherited blood disorders that can cause anemia and other health problems. The goal of this study is to collect information on complications of the disease among people who currently have or previously had thalassemia.


Options:
A: The prevalence and incidence of complications specific to thalassemia and its treatment among participants (Measured throughout the duration of the study)
B: 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)
C: 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)
D: Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event (up to 5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Longitudinal Cohort Study of Patients With Thalassemia in the Thalassemia Clinical Research Network
Brief Summary: Thalassemias are inherited blood disorders that can cause anemia and other health problems. The goal of this study is to collect information on complications of the disease among people who currently have or previously had thalassemia.


Options:
A: 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)
B: difference between multiple observations of the serum ferritin concentrations (five-year treatment)
C: The prevalence and incidence of complications specific to thalassemia and its treatment among participants (Measured throughout the duration of the study)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Weight Loss Technologies for Weight and Blood Pressure Control in Urban Clinics
Brief Summary: Obesity is a serious health problem that is a contributing factor for heart disease and high blood pressure. This study will evaluate a lifestyle modification program that aims to encourage weight loss and improve the health of people with high blood pressure from low income and minority communities.


Options:
A: Mammography Adherence (12 months)
B: Whether the intervention increases the proportion of tobacco users (age 18 and older) who receive help within the domains of A3-5 (Assess, Assist, and/or Arrange) at the index office visit, as reported by exiting patients
C: Smoking abstinence (6 months)
D: Change in body mass index (BMI) (Measured at Year 2)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery
Brief Summary: The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.


Options:
A: To study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery. (3-6 months)
B: Safety parameters reflecting pathophysiological functions of the liver (day -1, 0, 1, and 7); Gastrointestinal tolerance (day 0 before and 6-8h after surgery); Metabolic parameters in serum, liver and muscle tissue (on day -1, 0, 1, and 7)
C: Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) (Number of hours post surgery)
D: Morbidity and mortality after open infrarenal aortic aneurysm repair (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery
Brief Summary: The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.


Options:
A: Safety parameters reflecting pathophysiological functions of the liver (day -1, 0, 1, and 7); Gastrointestinal tolerance (day 0 before and 6-8h after surgery); Metabolic parameters in serum, liver and muscle tissue (on day -1, 0, 1, and 7)
B: To study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery. (3-6 months)
C: improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life. (while in the waiting list for liver transplantation)
D: Recovery of gastrointestinal function: Time to pass flatus/stool (hours following the end of surgery) (Number of hours post surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine is more effective when given alone or together with dalteparin and/or capecitabine in treating patients with pancreatic cancer.

PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots in patients with pancreatic cancer receiving treatment with different combinations of gemcitabine and capecitabine.


Options:
A: Thromboembolic events (during study treatment)
B: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)
C: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
D: Overall survival

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine is more effective when given alone or together with dalteparin and/or capecitabine in treating patients with pancreatic cancer.

PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots in patients with pancreatic cancer receiving treatment with different combinations of gemcitabine and capecitabine.


Options:
A: 2-Month Cumulative Incidence of VTE (Assessment with lower extremity ultrasound occured at day 60/ month 2)
B: Thromboembolic events (during study treatment)
C: Overall 3-year mortality (overall 3-years)
D: Significant increase of overall survival (At follow up 1 year after treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus
Brief Summary: Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.


Options:
A: The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes (12 months)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Change in glycemia at 2h of -1.5 mmol/L (baseline and week 13)
D: HbA1c (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus
Brief Summary: Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.


Options:
A: The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes (12 months)
B: Feasibility (patient perspective) (Week 0 (baseline)); Feasibility (clinician perspective) (Week 8); Acceptability (patient perspective 1 of 2) (Week 8); Acceptability (patient perspective 2 of 2) (Week 8); Satisfaction (patient perspective 1 of 2) (Week 8); Satisfaction (patient perspective 2 of 2) (Week 8)
C: HbA1c (2 years)
D: Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy (14 months)

Answer: C