TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes
Brief Summary: This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin


Options:
A: Glycosylated Haemoglobin A1c (HbA1c) (after 52 weeks of treatment)
B: Severe hypoglycaemia (9 months)
C: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment (Week 0, Week 52); Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) (Week 0 to Week 104 + 7 days follow up); Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes (Week 0 to Week 104 + 7 days follow up); Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin (Week 0, Week 106)
D: Insulin Detemir-insulin Aspart Cross-reacting Antibodies (week 0, 52 and 104)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Forced Titration Study to Assess the Efficacy and Safety of Omacor, Co-Administered With Open-Label Atorvastatin Therapy, in Hypertriglyceridemic Subjects
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Omacor (omega-3-acid ethyl esters) combined with atorvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in hypertriglyceridemic subjects.


Options:
A: Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 8 During 10 mg Atorvastatin Treatment Period (Baseline and Week 8)
B: Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks.
C: change of ApoB/ApoA1 (after 12 weeks' treatment)
D: Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy (Baseline, Week 12); Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy (Baseline, Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Life 2: Improving Fitness and Function in Elders
Brief Summary: The purpose of this study is to determine whether a 12-month physical activity counseling program, compared to usual care, improves physical performance in a sample of older veterans. The primary physical performance outcome is change in gait speed.


Options:
A: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)
B: Usual Gait Speed (Baseline); Usual Gait Speed (3 month); Usual Gait Speed (12-month); Rapid Gait Speed (Baseline); Rapid Gait Speed (3-month); Rapid Gait Speed (12-month)
C: Brain Natriuretic Peptide values (Baseline, 6 months); Self-care practices measured through Self-Care of Heart Failure Index scores and interviews (baseline, 6 months); Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews (baseline, 6 months)
D: Target goal of HbA1c (< 7.0%) without hypoglycemia (24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: There is uncertainty about the optimal diet in the prevention and treatment of diabetes type 2. Earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber, fruit and vegetables. This study is based on another approach which compares foods that were available during human evolution with more recently introduced ones. The basic tenet from evolutionary biology is that if human physiology is less adapted to a relatively recently introduced diet based on agriculture, this could cause disturbances to human physiology and ultimately lead to diseases. Epidemiological studies indicates that diabetes mellitus type 2 is absent or near absent in populations eating a Palaeolithic ("Old Stone Age") diet which is free from food items produced in agriculture or the food industry. Our study hypothesis is that a Palaeolithic diet is better than the standard diabetes diet recommended today in treating diabetes type 2.

Fifteen patients with diabetes type 2 have been randomized to

1. a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts
2. a standard diabetes diet as recommended by national health authorities.

The patients eat the diet they have been randomized to for three months and then switches to the other diet for another three months. The study is conducted in Primary Health Care stations.


Options:
A: Weigtreduction; Increase in maximum oxygen uptake; Change in foodintake; Change in self-reported activity
B: The primary outcome being measured is the level of activity monitored by the activity monitor. Control and Intervention subjects will be encouraged to wear the activity monitor on a daily basis for the 12 week course of the study. (12 weeks)
C: For adults: body weight loss maintenance (6 Month)
D: area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; HbA1C at baseline, 3 months and 6 months; weight at baseline, 3 months and 6 months; waist circumference at baseline, 3 months and 6 months

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: There is uncertainty about the optimal diet in the prevention and treatment of diabetes type 2. Earlier studies have generally focused on intakes of fat, protein, carbohydrate, fiber, fruit and vegetables. This study is based on another approach which compares foods that were available during human evolution with more recently introduced ones. The basic tenet from evolutionary biology is that if human physiology is less adapted to a relatively recently introduced diet based on agriculture, this could cause disturbances to human physiology and ultimately lead to diseases. Epidemiological studies indicates that diabetes mellitus type 2 is absent or near absent in populations eating a Palaeolithic ("Old Stone Age") diet which is free from food items produced in agriculture or the food industry. Our study hypothesis is that a Palaeolithic diet is better than the standard diabetes diet recommended today in treating diabetes type 2.

Fifteen patients with diabetes type 2 have been randomized to

1. a Palaeolithic diet based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts
2. a standard diabetes diet as recommended by national health authorities.

The patients eat the diet they have been randomized to for three months and then switches to the other diet for another three months. The study is conducted in Primary Health Care stations.


Options:
A: Feasibility measured by recruitment and retention rates (1 year in a 9 year study)
B: Number of women who lose weight when following 1 of 2 different calorie-restricted diets (18 months)
C: area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test at baseline, 3 months and 6 months; HbA1C at baseline, 3 months and 6 months; weight at baseline, 3 months and 6 months; waist circumference at baseline, 3 months and 6 months
D: Change in body weight and lipid profile of diets with different protein composition in overweight and obese women.. (After 3 months of intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
Brief Summary: Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.


Options:
A: Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up (baseline through 12 months follow up)
B: St. George's Respiratory Questionnaire (SGRQ) (three month Follow-Up Visit)
C: Reduction in gas trapping (12 weeks post treatment); SAEs - Safety of treatment and the procedure (2 years)
D: increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
Brief Summary: Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.


Options:
A: Reduction in gas trapping (12 weeks post treatment); SAEs - Safety of treatment and the procedure (2 years)
B: 1. Systemic inflammation 2. Vascular function (Before and 3 months after surgery/no surgery)
C: Forced expiratory volume in 1-second (FEV1) compared to active comparator (Year 1); Quality of Life (SGRQ) (Year 1)
D: Forced Vital Capacity (FVC) (6 months); modified Medical Research Council (mMRC) score (breathlessness) (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Provider and Peer Delivered Youth Smoking Intervention
Brief Summary: The purpose of this study was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents.


Options:
A: The primary outcome is the rate of smoking abstinence after 12 months, measured on the basis of the statements of the whole sample, not only among volunteers. (12 months)
B: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
C: 6-months prolonged smoking abstinence at age 19 and at age 25 (6 months)
D: Abstinence from smoking in the past 30 days at 6 months and 1 year

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
Brief Summary: The purpose of this study is to determine whether semi-annual fluoride varnish applications combined with caregiver counseling are effective in preventing and reducing a severe form of dental decay, known as early childhood caries, in native and non-native children aged 6 months to 5 years.


Options:
A: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline (Baseline); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1 (1 Year); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2 (2 Years); Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3 (3 Years)
B: Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
C: Acceptability of the home-visiting program from the perspective of mothers enrolled (Baseline, 2-months postpartum, 6-months postpartum, 12-months postpartum); Retention in the home-visiting programs (2-months postpartum, 6-months postpartum, 12-months postpartum); Participant satisfaction (6-months postpartum, 12-months postpartum); Adherence (Study enrollment through study completion, an average of 1 year); Home visitor-participant relationship (2-months postpartum, 6-months postpartum, 12-months postpartum)
D: Aim 1: Change in caregiver trauma symptoms (Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months); Aim 1: Change in Caregiver Parenting Stress (Baseline visit, 6 weeks, 12 weeks, 6 months, 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
Brief Summary: The purpose of this study is to determine whether semi-annual fluoride varnish applications combined with caregiver counseling are effective in preventing and reducing a severe form of dental decay, known as early childhood caries, in native and non-native children aged 6 months to 5 years.


Options:
A: Exclusive Breastfeeding at Four Months of Age (Six months after the beginning of the study)
B: Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
C: Children's height and weight (HAZ,WAZ and BAZ) (6 months)
D: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Intervention Program "Obeldicks" for Obese Children and Adolescents
Brief Summary: The intervention program "Obeldicks" was developed for obese children aged 6 to 16 years. This intervention is gender- and age specific. The 12-months intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. Primary outcome measure is change of weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI- hormones, intima media thickness are measured prior to and after the one-year intervention. The changes of these hormones and adipocytokines will allow to answer the questions whether the alterations of these hormones are a cause or consequence of overweight. Additionally, a genetic screening is performed to characterize the participants to probably predict response to intervention.


Options:
A: change of BMI-SDS (20 years)
B: Incidence of CHD and other lifestyle related diseases after ten years (2012)
C: Development of diabetes (Up to 5 years)
D: Development of Diabetes. (Outcomes were assessed from 1996-2008 (approximately 12 years including 6 years of DPP).); Prevalence of Aggregate Microvascular Complication (Outcomes were assessed from 2012-2013 (approximately 2 years).); Total Cancer Except Non-melanoma Skin Cancer (Outcomes were assessed from 1996-2020 (approximately 24 years).); Major Adverse Cardiovascular Events (MACE): Myocardial Infarction (MI), Stroke, or Cardiovascular Death (CVD) (Outcomes were assessed from 1996-2025 (approximately 29 years).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Intervention Program "Obeldicks" for Obese Children and Adolescents
Brief Summary: The intervention program "Obeldicks" was developed for obese children aged 6 to 16 years. This intervention is gender- and age specific. The 12-months intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. Primary outcome measure is change of weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI- hormones, intima media thickness are measured prior to and after the one-year intervention. The changes of these hormones and adipocytokines will allow to answer the questions whether the alterations of these hormones are a cause or consequence of overweight. Additionally, a genetic screening is performed to characterize the participants to probably predict response to intervention.


Options:
A: Weight loss (One year)
B: Improving reproductive and metabolic outcomes of women with PCOS (8 weeks)
C: change of BMI-SDS (20 years)
D: Live Birth Rate (Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
Brief Summary: Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.


Options:
A: Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity (12 weeks after baseline (or last observation carried forward))
B: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)
C: Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 4 (4 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d)); Change From Baseline in Mean Systolic Blood Pressure Following 12-hour Period Post-AM Dose at Visit 6 (7 weeks (1 week of dose-escalation, 3 weeks of 100 mg/d, followed by 1 week at 150 mg/d and 2 weeks of 200 mg/d))
D: Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score (Baseline, Week 13)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
Brief Summary: Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.


Options:
A: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)
B: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)
C: Adverse Events (Baseline (Visit 1) to Week 53 (Visit 9))
D: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
Brief Summary: Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.


Options:
A: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)
B: Time to Loss of Therapeutic Response (LTR) (From baseline Visit 3 (week 5) to Visit 7 (week 17))
C: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)
D: To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome
Brief Summary: Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.


Options:
A: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
B: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)
C: Composite responder analysis based on pain and patient global status, with or without physical function.
D: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care
Brief Summary: The goal of this study is to investigate methods of improving diabetes care for African Americans in primary care clinics. Primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports.


Options:
A: HbA1c, LDL-cholesterol, Systolic Blood Pressure (Visit 1; Visit 2 (after approximately 4 months after visit 1); Visit 3 (after approximately 8 months after visit 1); Visit 4 (after approximately 12 months after visit 1))
B: N/A
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: Rate of LDL cholesterol control (< 100 mg/dL) (12 months); Rate of blood pressure control (< 130/80 mmHg) (12 months); Rate of HbA1c control (<7%) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care
Brief Summary: The goal of this study is to investigate methods of improving diabetes care for African Americans in primary care clinics. Primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports.


Options:
A: Extent of guideline adherence after approximately one year (measured by a specific set of guideline-derived indicators, formulated beforehand by the research group) (half year after intervention); Costs of both Implementation strategies (half year after intervention)
B: Outcome and process measures from the danish diabetes guideline (1/3 2007-1/6 2008)
C: decreased of occured of iatrogenic event in ICU (one month)
D: Rate of LDL cholesterol control (< 100 mg/dL) (12 months); Rate of blood pressure control (< 130/80 mmHg) (12 months); Rate of HbA1c control (<7%) (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care
Brief Summary: The goal of this study is to investigate methods of improving diabetes care for African Americans in primary care clinics. Primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports.


Options:
A: Health of Nations Outcome Scale (HONOS) (Baseline, 6 months, 12 months, 18 months,)
B: completion of colorectal cancer screening (1 year)
C: Patient adherence (12 months)
D: Rate of LDL cholesterol control (< 100 mg/dL) (12 months); Rate of blood pressure control (< 130/80 mmHg) (12 months); Rate of HbA1c control (<7%) (12 months)

Answer: D