TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Carbonated Soft Drinks on Body Weight, Fat Distribution and Metabolic Risk Factors
Brief Summary: Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. However, the mechanisms linking drinks intake to obesity are yet to be clarified.

The investigators aim is to investigate the long-term effects of intake of soft drinks, milk and water. The study is a parallel, intervention trial with 80 overweight, healthy volunteers. They will be randomly selected to drink one liter a day of one of the four drinks for six months. The objectives are changes in numerous circulating metabolic risk factors, changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and MR-spectroscopy).

The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.


Options:
A: Initial change in weight (52 weeks)
B: Weight change (0, 3, 6 months)
C: Body Weight (kg) (Six months); MR spectroscopy (Six months); Magnetic resonance imaging (Six months); Dual-energy X-ray absorptiometry (DEXA) scan (Six months)
D: This investigation is an equivalency trial to determine whether weight loss differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers at 12 weeks. (Data will be measured at 12 weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis


Options:
A: Change from baseline in area of infected nail (9 months)
B: Percentage of patients who achieve clinical cure (52 weeks)
C: Percentage of patients who achieve clinical cure (52 weeks)
D: Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail (After 30, 60, 120 and 180 days of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Heart Disease in Underserved Patients
Brief Summary: The study will evaluate the impact of an internet based telemedicine system on cardiovascular risk profile of underserved patient populations. It is our hypothesis that a treatment plan and frequent communication via an internet based Telemedicine system will improve the cardiovascular risk profile of underserved patient populations at increased risk for cardiovascular disease. Our primary endpoint is a reduction over one year in the 10-year CVD risk score (ATP III risk model).


Options:
A: Glycosylated haemogloblin (8 weeks from recruitment at 28 weeks gestation to 36 weeks gestation)
B: Patient satisfaction (At 36-39 weeks gestation); Health care staff satisfaction (At completion of the study estimated to be January 2013); Management decision comparison (At weekly clinic or telemonitoring review from time recruited into study to delivery, estimated at an average of twelve weeks.)
C: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
D: Framingham 10-year risk index (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Heart Disease in Underserved Patients
Brief Summary: The study will evaluate the impact of an internet based telemedicine system on cardiovascular risk profile of underserved patient populations. It is our hypothesis that a treatment plan and frequent communication via an internet based Telemedicine system will improve the cardiovascular risk profile of underserved patient populations at increased risk for cardiovascular disease. Our primary endpoint is a reduction over one year in the 10-year CVD risk score (ATP III risk model).


Options:
A: Estimated Percentage of Participants in Blood Pressure Control at Baseline (Baseline); Estimated Percentage of Participants in Blood Pressure Control at 6 Months (6month); Estimated Percentage of Participants in Blood Pressure Control at 12 Months (12 month); Estimated Percentage of Participants in Blood Pressure Control at 18 Months (18 month); Blood Pressure Averages Systolic & Diastolic (Baseline); Blood Pressure Averages Systolic & Diastolic (12-month)
B: Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants. (Baseline and 18 months)
C: Framingham 10-year risk index (1 year)
D: Change in Mean Systolic Blood Pressure (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Heart Disease in Underserved Patients
Brief Summary: The study will evaluate the impact of an internet based telemedicine system on cardiovascular risk profile of underserved patient populations. It is our hypothesis that a treatment plan and frequent communication via an internet based Telemedicine system will improve the cardiovascular risk profile of underserved patient populations at increased risk for cardiovascular disease. Our primary endpoint is a reduction over one year in the 10-year CVD risk score (ATP III risk model).


Options:
A: Framingham 10-year risk index (1 year)
B: Change from baseline in depression outcome at 6-months (6-months from enrollment)
C: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
D: Number of Days the Subjects Are Adherent to Using Sunscreen (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Heart Disease in Underserved Patients
Brief Summary: The study will evaluate the impact of an internet based telemedicine system on cardiovascular risk profile of underserved patient populations. It is our hypothesis that a treatment plan and frequent communication via an internet based Telemedicine system will improve the cardiovascular risk profile of underserved patient populations at increased risk for cardiovascular disease. Our primary endpoint is a reduction over one year in the 10-year CVD risk score (ATP III risk model).


Options:
A: Estimated Percentage of Participants in Blood Pressure Control at Baseline (Baseline); Estimated Percentage of Participants in Blood Pressure Control at 6 Months (6month); Estimated Percentage of Participants in Blood Pressure Control at 12 Months (12 month); Estimated Percentage of Participants in Blood Pressure Control at 18 Months (18 month); Blood Pressure Averages Systolic & Diastolic (Baseline); Blood Pressure Averages Systolic & Diastolic (12-month)
B: Target goal of HbA1c (< 7.0%) without hypoglycemia (24 weeks)
C: Framingham 10-year risk index (1 year)
D: Change in systolic blood pressure (12-months from baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
Brief Summary: The purpose of this randomized controlled trial is to determine the effects of a user-centric remote patient monitoring system on heart failure management. Patients attending a Heart Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The hypothesis is that the remote monitoring system will improve heart failure outcomes through increased self-care and improved clinical management.


Options:
A: Changes of glycosilated haemoglobin (HbA1c) (At least 12 weeks from baseline (visit 3))
B: 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)
C: Rate of Heart Failure Related (HFR) Hospitalizations (6 months); Freedom From a Device/System-related Complication (DSRC). (6 months); Freedom From Pressure Sensor Failure (6 months)
D: Reduction in systolic blood pressure taken by study team at home visit (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
Brief Summary: The purpose of this randomized controlled trial is to determine the effects of a user-centric remote patient monitoring system on heart failure management. Patients attending a Heart Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The hypothesis is that the remote monitoring system will improve heart failure outcomes through increased self-care and improved clinical management.


Options:
A: The incidence and frequency of COPD exacerbations in each of the intervention groups (December 2008 to March 2009 inclusive); Electronic diary symptoms using the EXACT instrument (Daily recording)
B: 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)
C: Child BMI
D: Smoking abstinence (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
Brief Summary: The purpose of this randomized controlled trial is to determine the effects of a user-centric remote patient monitoring system on heart failure management. Patients attending a Heart Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The hypothesis is that the remote monitoring system will improve heart failure outcomes through increased self-care and improved clinical management.


Options:
A: 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)
B: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
C: medication adherence (one month)
D: Reduction of Non-HDL cholesterol (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Biomarker Modulation by Inhibition of EGFR and/or Src Family Kinases Using Erlotinib and Dasatinib in Head and Neck Lung Cancers
Brief Summary: The central hypothesis to be tested in this study is that dual blockade of EGFR and Src pathways or proteins are distinct compared to inhibition of either kinase alone in head and neck and lung cancers.


Options:
A: Disease free survival (3 years)
B: Disease Free Survival (DFS) (Up to 5 years)
C: Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months); Overall Survival (OS) Rate in All Randomized Participants (Randomization to 18 months post-randomization, up to June 2015); Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint (Randomization until 199 deaths, up to November 2014, approximately 25 months)
D: The primary endpoints are comprised of a panel of tumor proteins to be obtained before after administration of the study drugs. (2-3 week preoperative period of drug administration)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
Brief Summary: This study has two phases:

1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.


Options:
A: Weight change (0, 3, 6 months)
B: Weight loss (One year)
C: Laboratory findings and body composition (2 years)
D: Changes in the acute metabolic and hormonal response (glucose, insulin, leptin, active ghrelin, triglycerides, uric acid) (Baseline and 10 weeks); Changes in fat content of skeletal muscle and liver (Baseline and 10 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
Brief Summary: This study has two phases:

1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.


Options:
A: Live Birth (as few as 5 months, up to 16 months)
B: Whole body insulin action (3 months)
C: Weight loss (One year)
D: Levels of vascular endothelial growth factor(VEGF) and angiotensin-Ⅱ(AT-Ⅱ) (24 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
Brief Summary: This study has two phases:

1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.


Options:
A: To measure if physical exercise and electro-acupuncture restores endocrine, neuroendocrine, metabolic and immunological disturbances related to sympathetic nerve activity as well as psychological distress and improve quality of life in women with PCOS. (One year)
B: 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.)
C: Pregnancy rate (six months)
D: Weight loss (One year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of PCOS (Polycystic Ovary Syndrome)in Morbidly Obese Women - A Randomized Controlled Prospective Dietary Intervention Study
Brief Summary: This study has two phases:

1. In phase 1 of the study (8 weeks),the effect of two different low calorie diets on manifestations of PCOS, including risk factors for the metabolic syndrome and cardiovascular risk profile will be compared.
2. In phase 2 the long term effect (next 44 weeks) on sustained weight-loss and the above mentioned parameters will be compared and evaluated.


Options:
A: Weight loss (One year)
B: Live-birth rate (Up to 2 years)
C: Live Birth (as few as 5 months, up to 16 months)
D: Whole body insulin action (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
Brief Summary: This is a multicenter study in which women are planned to receive either the HPV vaccine or control. Study participation will last approximately 72 months and involves a total of thirteen or fourteen scheduled visits.

Originally, the study was planned for 24 months. It was then extended for 2 more years with 4 additional visits (study end at Month 48).

The protocol posting has been updated as the study was extended by additional 2 years with two or three additional visits (study end at Month 72) for subjects who consent to participate in the extension.


Options:
A: Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18 (4 weeks postdose 3 (Month 7))
B: Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. (From Month 6 up to Month 48)
C: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 (At Month 24); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 (At Month 48); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 (At Month 57); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 (At Month 72)
D: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery
Brief Summary: Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.


Options:
A: Rate of Device Related Serious Adverse Events (Discharge/30 days Post Procedure); Percent of Patients With Complete Occlusion of the Left Atrial Appendage. (3 Months Post Procedure)
B: Freedom From Atrial Fibrillation (Measured at Month 12)
C: Quality of life and maintenance of sinus rhythm at 1 year will be considered as primary end points. (Baseline, 3, 6, and 12 months after operation)
D: Safety - Device related complications (30 days); Efficacy - Occlusion of the LAA (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Autologous Serum Efficacy Study in Patients With Severe Dry Eye
Brief Summary: The purpose of this study is to compare the reduction in symptomatology of patients with severe dry eye treated with autologous serum and conventional artificial tears.


Options:
A: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L (Single visit); Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm (Single visit); Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds (Single visit); Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 (Single visit); Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 (Single visit); Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 (Single visit); Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 (Single visit)
B: C Corneal fluorescein staining (up to 12 weeks)
C: To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears. (5 weeks)
D: Corneal epithelial damage evaluated by fluorescein staining (micron meter squares) with digital photos (28 days treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
Brief Summary: The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.


Options:
A: Extubation failure (apnea rate and respiratory failure.)
B: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (At 7 days after non-invasive respiratorynsupport.)
C: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)
D: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
Brief Summary: The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.


Options:
A: Extubation failure (apnea rate and respiratory failure.)
B: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (3 months)
C: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (At 7 days after non-invasive respiratorynsupport.)
D: Failure of assignmed non-invasive mode post randomization to NIHFV or BP-CPAP (72 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
Brief Summary: The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.


Options:
A: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)
B: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))
C: Duration of NIV Support (10 days); Failure of NIV Support (10 days)
D: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (At 7 days after non-invasive respiratorynsupport.)

Answer: D