TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Depression in Patients With Type II Bipolar Disorder
Brief Summary: This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.


Options:
A: Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).; Modified Social Adjustment Scale (SAS II-B; Bauer, 2001); ***Note: all primary outcomes obtained prospectively every 3 months for 18 months
B: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) (Eight weeks)
C: Time to Withdrawal From Study (Randomization to Study Withdrawal (up to Week 26))
D: Time to a new mood episode after having succeeded the first 6 month of treatment and reached monotherapy with study drug at that point. New episode defined as symptoms requiring treatment or admission (or suicide).

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-Blind, Placebo-Controlled, Single-Centre Study to Provide a Preliminary Evaluation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Intravenous Anti-human Interleukin-5 (Mepolizumab, 750mg and 1500mg) in the Treatment of Eosinophilic Oesophagitis in Adults
Brief Summary: Eosinophils play a key role in the pathogenesis of eosinophilic oesophagitis. Therapies that suppress eosinophil recruitment and activation may give a benefit. Mepolizumab is a humanised monoclonal antibody against interleukin-5 (IL-5). This study will evaluate the ability of mepolizumab to decrease the recruitment and infiltration of eosinophils into the oesophagus, thereby reducing the inflammation and symptoms of EE (eosinophilic oesophagitis) in adult patients.


Options:
A: The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13. (13 weeks)
B: 1. Reduction of eosinophils in the oesophagus 2. Safety and tolerability of mepolizumab
C: Watson Dysphagia Scale Score (WDS) (Two months)
D: evaluate effectiveness of oral montelukast in treatment of EE. (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: MUFObes: MonoUnsaturated Fatty Acids in Obesity - a Comparison Between 3 Different Diets in Weight Maintenance and the Prevention of Lifestyle Diseases in Obese Subjects. A Randomised, Long-term Intervention Study.
Brief Summary: The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.


Options:
A: Change in body weight (measured at Year 2)
B: body weight (prior to and after 4, 8, and 12 months of dieting)
C: Body weight reduction (Month 6)
D: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: MUFObes: MonoUnsaturated Fatty Acids in Obesity - a Comparison Between 3 Different Diets in Weight Maintenance and the Prevention of Lifestyle Diseases in Obese Subjects. A Randomised, Long-term Intervention Study.
Brief Summary: The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.


Options:
A: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
B: body weight (prior to and after 4, 8, and 12 months of dieting)
C: body weight in kilograms as measured by a calibrated scale (0,1,2,3,4,5,and 6 months)
D: Change in Hemoglobin A1C (A1C) (Baseline, 12 weeks and 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MUFObes: MonoUnsaturated Fatty Acids in Obesity - a Comparison Between 3 Different Diets in Weight Maintenance and the Prevention of Lifestyle Diseases in Obese Subjects. A Randomised, Long-term Intervention Study.
Brief Summary: The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.


Options:
A: N/A
B: The primary objective will be to compare the effects of the two different diet recommendations with respect to the one-year change in body weight.
C: 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))
D: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: MUFObes: MonoUnsaturated Fatty Acids in Obesity - a Comparison Between 3 Different Diets in Weight Maintenance and the Prevention of Lifestyle Diseases in Obese Subjects. A Randomised, Long-term Intervention Study.
Brief Summary: The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.


Options:
A: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
B: N/A
C: For adults: body weight loss maintenance (6 Month)
D: Blood pressure (4 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MUFObes: MonoUnsaturated Fatty Acids in Obesity - a Comparison Between 3 Different Diets in Weight Maintenance and the Prevention of Lifestyle Diseases in Obese Subjects. A Randomised, Long-term Intervention Study.
Brief Summary: The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.


Options:
A: Change in body weight (measured at Year 2)
B: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
C: Breast Cancer Recurrence (Lifetime)
D: 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))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: MUFObes: MonoUnsaturated Fatty Acids in Obesity - a Comparison Between 3 Different Diets in Weight Maintenance and the Prevention of Lifestyle Diseases in Obese Subjects. A Randomised, Long-term Intervention Study.
Brief Summary: The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.


Options:
A: body weight (prior to and after 4, 8, and 12 months of dieting)
B: weight loss
C: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
D: Breast Cancer Recurrence (Lifetime)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MUFObes: MonoUnsaturated Fatty Acids in Obesity - a Comparison Between 3 Different Diets in Weight Maintenance and the Prevention of Lifestyle Diseases in Obese Subjects. A Randomised, Long-term Intervention Study.
Brief Summary: The purpose of this study is to investigate the effect of three diets different in type and amount of fat in weight maintenance and prevention of life-style diseases in obese subjects.


Options:
A: N/A
B: Change in body weight (measured at Year 2)
C: Changes in body weight; Weight loss maintenance efficacy (>5% and >10%); Body composition (whole body DEXA-scanning); Drop-out rate; Glucose metabolism (Oral Glucose Tolerance Test); Endothelium function (flow-mediated vasodilatation, FMD)
D: Hemoglobin A1c (22 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
Brief Summary: This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with amifostine and chemotherapy may kill more tumor cells.


Options:
A: Asparaginase-Related Toxicity Rate (30-week post-induction asparaginase treatment period)
B: Two Year Event-free Survival (EFS) (Up to Two Year After Enrollment)
C: Risk of relapse (5 years)
D: To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter (March 2012)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Peripheral Effects of Exercise on Cardiovascular Health (STRRIDE II)
Brief Summary: This study will investigate the separate and combined effects of aerobic and resistance training on cardiovascular risk factors in overweight men and women with mild to moderate dyslipidemia.


Options:
A: Major Cardiometabolic Risk Factors: lipoproteins; Ectopic Fat (Visceral Fat, Liver fat); body composition (fat mass, lean body mass; and Insulin Sensitivity (Month 0, Month 4, Year 1, and Year 1 plus 2 weeks)
B: The Primary Endpoint is Success at 180 Days Which is Defined as Alive on the Originally Implanted HeartWare® LVAD or Transplanted or Explanted for Recovery. Patient Must Survive 60 Days Post-explant for Recovery to be Considered Successful. (180 days)
C: Blood pressure at 6 months (6 months)
D: Six minute walking distance (3 months); New York Heart Association (NYHA) functional class (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Trial of a Home-Based Peer Support Program After Coronary Artery Bypass Graft Surgery
Brief Summary: Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. Increased patient acuity and reduced hospital length of stays leave individuals ill prepared for their recovery following discharge. Individuals experience pain, functional impairment and depressive symptoms following discharge, which persist for 8 weeks in 50% of individuals. Unrelieved pain, functional decline and depressive symptoms predispose individuals to adverse events, impaired health-related quality of life (HRQOL), and increased morbidity and mortality.

Existing supports; including printed education materials, community care resources, cardiac rehabilitation programs and nurse-initiated telephone follow-up, fail to address concerns of individuals in this early period following hospital discharge.

Despite the positive health outcomes in other patient populations, valid studies examining the impact of telephone-based peer support to men and women after hospital discharge from CABG surgery were not found. It is anticipated that a home-based peer support program, delivered by telephone, will improve recovery and enhance HRQOL for individuals in the early weeks post hospital discharge from CABG surgery.


Options:
A: Health-related Quality of Life (SF-36v2-acute Form) (9 weeks)
B: Patient Activation Measure questionnaire (Patient Activation Measure measured at 18 months)
C: 1 -Year Survival Probability Rate: Vascular Readmissions or Death (Date of enrollment + 12 months)
D: Changes from baseline in patient self-management (Health Education Impact Questionnaire v3.0) every 6 months until study end. (At baseline (0 years) and followed for 2.5 years, for a total of 2 to 6 assessments per subject)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Trial of a Home-Based Peer Support Program After Coronary Artery Bypass Graft Surgery
Brief Summary: Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. Increased patient acuity and reduced hospital length of stays leave individuals ill prepared for their recovery following discharge. Individuals experience pain, functional impairment and depressive symptoms following discharge, which persist for 8 weeks in 50% of individuals. Unrelieved pain, functional decline and depressive symptoms predispose individuals to adverse events, impaired health-related quality of life (HRQOL), and increased morbidity and mortality.

Existing supports; including printed education materials, community care resources, cardiac rehabilitation programs and nurse-initiated telephone follow-up, fail to address concerns of individuals in this early period following hospital discharge.

Despite the positive health outcomes in other patient populations, valid studies examining the impact of telephone-based peer support to men and women after hospital discharge from CABG surgery were not found. It is anticipated that a home-based peer support program, delivered by telephone, will improve recovery and enhance HRQOL for individuals in the early weeks post hospital discharge from CABG surgery.


Options:
A: Health-related Quality of Life (SF-36v2-acute Form) (9 weeks)
B: Within patient change in the Paffenbarger Exercise and Physical Activity Index (basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout)
C: nicotinic weaning (1year); weight loss at least 5% (1 year); waist reduction at least 4% (1 year); physical activity at least 30 minute per day (3h per week) (1 year)
D: time from ACS symptom onset to admission to emergency department (two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Trial of a Home-Based Peer Support Program After Coronary Artery Bypass Graft Surgery
Brief Summary: Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who are older and sicker than in previous years. Increased patient acuity and reduced hospital length of stays leave individuals ill prepared for their recovery following discharge. Individuals experience pain, functional impairment and depressive symptoms following discharge, which persist for 8 weeks in 50% of individuals. Unrelieved pain, functional decline and depressive symptoms predispose individuals to adverse events, impaired health-related quality of life (HRQOL), and increased morbidity and mortality.

Existing supports; including printed education materials, community care resources, cardiac rehabilitation programs and nurse-initiated telephone follow-up, fail to address concerns of individuals in this early period following hospital discharge.

Despite the positive health outcomes in other patient populations, valid studies examining the impact of telephone-based peer support to men and women after hospital discharge from CABG surgery were not found. It is anticipated that a home-based peer support program, delivered by telephone, will improve recovery and enhance HRQOL for individuals in the early weeks post hospital discharge from CABG surgery.


Options:
A: VO2peak (baseline, after 12 weeks and after 1 year)
B: Reduction of the SCORE Risk Score (6 months after the intervention)
C: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
D: Health-related Quality of Life (SF-36v2-acute Form) (9 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of PONV by Acupressure. A Study of the Effect of a Recently Generated Danish Bracelet Vital-Band(R) Which Stimulates the Acupressure Point P6
Brief Summary: The purpose of this study is to determine whether stimulation to the akupressurpoint P6 with a recently developed bracelet are effective preventing postoperative nausea and vomiting


Options:
A: N/A
B: the mean infusion rate of intraoperative remifentanil and propofol (during operation)
C: Postoperative nausea and vomiting (24 hours)
D: Postoperative nausea and vomiting

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Study of Wide Excision Alone Versus Wide Excision With Intraoperative Lymphatic Mapping and Selective Lymph Node Dissection in the Treatment of Patients With Cutaneous Invasive Melanoma.
Brief Summary: Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their melanoma. If the melanoma meets study requirements, the subject is randomized to receive either (1) no further surgical procedures as part of the study or (2) a Selective Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then followed for 10 years.


Options:
A: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
B: Relapse-free Survival (RFS) (Approximately 3.5 years)
C: Overall Survival (OS) (From the date of randomization until date of death due to any cause (up to approximately 6 years))
D: To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. (10 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Study of Wide Excision Alone Versus Wide Excision With Intraoperative Lymphatic Mapping and Selective Lymph Node Dissection in the Treatment of Patients With Cutaneous Invasive Melanoma.
Brief Summary: Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their melanoma. If the melanoma meets study requirements, the subject is randomized to receive either (1) no further surgical procedures as part of the study or (2) a Selective Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then followed for 10 years.


Options:
A: Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. (Within the first week after surgical excision of suspected BCC lesion)
B: To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. (10 years)
C: Sensitivity and Specificity (Within 120 days of Data Lock)
D: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants (From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Study of Wide Excision Alone Versus Wide Excision With Intraoperative Lymphatic Mapping and Selective Lymph Node Dissection in the Treatment of Patients With Cutaneous Invasive Melanoma.
Brief Summary: Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their melanoma. If the melanoma meets study requirements, the subject is randomized to receive either (1) no further surgical procedures as part of the study or (2) a Selective Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then followed for 10 years.


Options:
A: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
B: distant-metastasis free-survival (DMFS) (from randomization)
C: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
D: To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. (10 years)

Answer: D