TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Metformin HCL in Patients With Type 2 Diabetes Intensively Treated With Insulin: a Treatment Strategy for Insulin Resistance in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
Brief Summary: The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.


Options:
A: To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
B: Serum Cobalamin Normalization (61 days)
C: Biochemical response to vitamin B12 substitution (Day 28)
D: Change from Cobalamin level standardization (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Metformin HCL in Patients With Type 2 Diabetes Intensively Treated With Insulin: a Treatment Strategy for Insulin Resistance in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
Brief Summary: The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.


Options:
A: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population (Baseline and every study visit up to 24 weeks); Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population (Baseline and every study visit up to 24 weeks)
B: To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
C: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
D: Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) (Baseline and Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Metformin HCL in Patients With Type 2 Diabetes Intensively Treated With Insulin: a Treatment Strategy for Insulin Resistance in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
Brief Summary: The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.


Options:
A: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
B: Change From Baseline in HbA1c to Week 24 (Baseline, Week 24)
C: Difference in A1c Levels (baseline and 24 weeks); Number of Hypoglycemic Events (between 1rst and 24 weeks of each treatment arm)
D: To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Two Strategies for the Delivery of Intermittent Preventive Treatment in Children (IPTc) in an Area of Seasonal Malaria Transmission
Brief Summary: Antimalarial chemoprophylaxis can reduce morbidity and mortality from malaria in children. However, this approach to malaria control has not been implemented widely because of concerns over its possible effect on the development of resistance and natural immunity. Intermittent preventive treatment (IPT) may be able to achieve some of the beneficial effects of chemoprophylaxis without its drawbacks. Recently, it has been shown that IPT given to Senegalese children under the age of five years on three occasions during the malaria transmission season reduced the incidence of clinical malaria by approximately 90%. However, it is uncertain how this intervention can be most effectively delivered. Therefore, 26 Maternal and Child Health (MCH) trekking clinics in Upper River Division, south of the River Gambia, each with an average catchment population of 400-500 children under 5 years of age, will be randomly allocated to receive IPT from the MCH trekking team or from a IPT dispenser (village health worker, traditional birth attendant or a community mother based in a primary health care village). Treatment with a single dose of sulfadoxine /pyrimethamine (SP) plus three doses of amodiaquine will be given to all study subjects at monthly intervals on three occasions during the months of September, October and November. The primary end points will be the incidence of clinical attacks of malaria detected by passive case detection, and cost-effectiveness of the delivery methods. Important secondary endpoints will be the coverage and the equity of coverage of IPT in preventing malaria morbidity.


Options:
A: Malaria incidence (the number of OPD attendances with clinical malaria that meet the case definitions as indicated below during the surveillance period ) and the number of hospital admissions with malaria during the surveillance period. (during malaria transmission period); Cost-effectiveness of the delivery system. (during the study period)
B: Prevalence of drug resistance
C: Prevalence of anaemia (Hb <112g/L) (March 2006)
D: Clinical episodes of malaria

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind Trial to Assess the Safety and Efficacy of Two Parallel Dose Groups of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients With Gaucher Disease
Brief Summary: Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.

This is the second trial to utilize a recombinant active form of lysosomal enzyme, glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from transformed carrot plant root cell line.


Options:
A: Hemoglobin (Every 3 months for 12 months)
B: PAP: Percent Change From Baseline in Spleen Volume (in Multiples of Normal [MN]) at Week 39 of the Primary Analysis Period With Eliglustat Tartrate Treatment as Compared to Placebo (PAP Baseline (Day 1), Week 39)
C: Spleen Volume (60 months)
D: Change From Baseline in Spleen Volume Measured by MRI. (Baseline and 9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind Trial to Assess the Safety and Efficacy of Two Parallel Dose Groups of Plant Cell Expressed Recombinant Human Glucocerebrosidase (prGCD) in Patients With Gaucher Disease
Brief Summary: Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system.

This is the second trial to utilize a recombinant active form of lysosomal enzyme, glucocerebrosidase, (human prGCD) which is expressed and purified in a bioreactor system from transformed carrot plant root cell line.


Options:
A: Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke (from randomization until study cut-off date (median duration of follow-up: 6.2 years)); Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF) (from randomization until study cut-off date (median duration of follow-up: 6.2 years))
B: Change From Baseline in Spleen Volume Measured by MRI. (Baseline and 9 months)
C: PAP: Percent Change From Baseline in Spleen Volume (in Multiples of Normal [MN]) at Week 39 of the Primary Analysis Period With Eliglustat Tartrate Treatment as Compared to Placebo (PAP Baseline (Day 1), Week 39)
D: Percentage of Participants Demonstrating A Meaningful Clinical Response (Baseline, Year 1)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose-Response/Efficacy of Manipulation for Chronic LBP
Brief Summary: This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.


Options:
A: Sickness leave (2008-2020)
B: Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. (within 12 months)
C: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
D: Modified Von Korff Pain Scale for low back pain (baseline 1&2, 6, 12, 18, 24, 39, 52 weeks); Modified Von Korff Disability Scale (baseline 1&2, 6, 12, 18, 24, 39, 52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of i.v. Bisphosphonate on Health-Related Quality of Life and Skeletal Morbidity for Newly Diagnosed Treatment Demanding Multiple Myeloma. A Prospective Randomised Double Blinded Dose-Effective Study With Cost-Utility Analysis.
Brief Summary: Multiple myeloma is a malignant hematological disease dominated by monoclonal plasma cells in the bone marrow. Major symptoms are related to the bones due to an increased bone resorption and a decreased bone formation leading to bone pain and increased risk of fractures. The normal osteoclasts are responsible for bone degradation through stimulation from the malignant plasma cells. Bisphosphonates have been shown to inhibit the osteoclast activity but may have serious side-effects due to renal toxicity and the optimal dose have not been established.

In a randomized double blinded design it is aim to compare the standard of monthly injections of 90 mg pamidronate with 30 mg.

The primary end-point is physical function estimated by EORTC QLQ-C30 questionnaire at 12 months after starting the treatment in newly diagnosed treatment demanding multiple myeloma. Secondary end-points are skeletal related events, cost-utility analysis, response, response duration and survival and quality of life with respect to fatigue and pain.


Options:
A: Time to next need treatment (6 months)
B: Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) (Up to 34 months)
C: Physical function at 12 months estimated by EORTC QLQ-C30 questionnaire
D: Time to Disease Progression (TTP) (randomization to progression (up to 5 years))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Web-Based Feedback to Improve Blood Pressure Control
Brief Summary: High blood pressure affects 65 million adults in the United States, and more than one third of these individuals do not have adequate control of their blood pressure. Individuals who ask specific questions and discuss important medical issues with their doctors are more likely to receive appropriate medical care than individuals who do not. This study will evaluate the effectiveness of an interactive web site that provides individualized feedback and encourages doctor-patient communication as a way to maintain adequate blood pressure control.


Options:
A: The difference between groups in the change in parent and nurse ratings of specific communication skills and professionalism behaviors from baseline to follow-up (average 5 months later)
B: completing CRC screening test (1 and 6 months post education)
C: Percentage of participants with controlled blood pressure, as defined by the following criteria: less than 130/80 mm Hg for participants with diabetes or chronic kidney disease; less than 140/90 mm Hg for all other participants (Measured at Year 1)
D: The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care. (30 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Antimicrobials in Young Children With Acute Otitis Media (AOM)
Brief Summary: The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23 months, with AOM will be enrolled in the study. They will be treated either with Augmentin (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will be asked to write information about their child in a Patient Diary. A general physical exam, including an ear exam, will be performed 4 times during the study. A mucus sample will be collected from the back of each child's nose. Parents will be asked questions during phone calls and at every visit. If a child has not improved or has worsened, the investigators will prescribe a different antibiotic that is known to kill resistant germs.


Options:
A: Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo (During the first 8 days of follow-up)
B: The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment (The first 7 days on therapy); The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment (The first 7 days on therapy); The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment (During the first 7 days of therapy)
C: Time (days) to disappearance of middle ear effusion (Within 60 days)
D: Proportion of each group that filled the antibiotic prescription

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Antimicrobials in Young Children With Acute Otitis Media (AOM)
Brief Summary: The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23 months, with AOM will be enrolled in the study. They will be treated either with Augmentin (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will be asked to write information about their child in a Patient Diary. A general physical exam, including an ear exam, will be performed 4 times during the study. A mucus sample will be collected from the back of each child's nose. Parents will be asked questions during phone calls and at every visit. If a child has not improved or has worsened, the investigators will prescribe a different antibiotic that is known to kill resistant germs.


Options:
A: Proportion of each group that filled the antibiotic prescription
B: Time (days) to disappearance of middle ear effusion (Within 60 days)
C: Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo (During the first 8 days of follow-up)
D: The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment (The first 7 days on therapy); The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment (The first 7 days on therapy); The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment (During the first 7 days of therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.
Brief Summary: This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pain will be assessed using the visual analogue scale (VAS) and 6-point verbal rating scale (VRS), and patient preference will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Options:
A: Local pain due to s.c. injection (by VAS). (After each injection)
B: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range (Weeks 16-28)
C: Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL) (Week 17 up to Week 24)
D: Hemoglobin Level in blood (Monthly assessment of the levels of hemoglobin in blood at baseline and monthly for six months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Cross-Over Study to Investigate the Comfort of Injection of Renal Anaemia Patients Receiving Subcutaneous NeoRecormon® Compared to Darbepoetin Alfa.
Brief Summary: This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pain will be assessed using the visual analogue scale (VAS) and 6-point verbal rating scale (VRS), and patient preference will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Options:
A: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
B: Median Time to First Cardiovascular Event (Up to 4 years)
C: Local pain due to s.c. injection (by VAS). (After each injection)
D: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range (Weeks 16-28)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Inner-City Anti-IgE Therapy for Asthma (ICAC-08)
Brief Summary: The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone, in inner-city children with mild to severe asthma.


Options:
A: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)
B: Maximum Number of Asthma Symptom Days (Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
C: Change in forced expiratory volume in 1 second (FEV1) (From baseline to Week 12)
D: Incidence of Adverse Events (Days 0 - 150); Incidence of Abnormal Troponin Levels (Days 0, 14, 28, 56, 84, and 150); Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results (Days -14 to -1, 14, 28, 56, 84, and 150); Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results (Days -14 to -1 and 28); Incidence of Serious Adverse Events (Days 0 - 150)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Inner-City Anti-IgE Therapy for Asthma (ICAC-08)
Brief Summary: The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone, in inner-city children with mild to severe asthma.


Options:
A: Mean maximum symptom days per 2 weeks, as assessed by questionnaire (At Visits 3 and 8)
B: Maximum Number of Asthma Symptom Days (Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
C: Asthma exacerbations (Measured at Years 1 and 2)
D: Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5]) (90 Day outcome period); Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4) (90 Day outcome period)

Answer: B