TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Intervention to Enhance CHD Risk Factor Modification: The Heart to Heart Feasibility Study
Brief Summary: Coronary heart disease (CHD) is the leading cause of death in the United States, but fewer than half of all individuals at risk for CHD take advantage of proven strategies to lower their chances of developing this disease. This study will assess the effectiveness of Heart to Heart, a Web-based program, at educating people on ways to incorporate CHD risk-reduction strategies into their lives.


Options:
A: Predicted 10-year CHD risk (4-month follow-up)
B: To determine the effectiveness of a consumer-mediated, Internet-based strategy for identification and intervention in hypercholesterolemia.
C: Quality of care process index = ∑ of recommended services received by patient/ ∑ of the recommended services for which the patient was eligible (5 years)
D: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Intervention to Enhance CHD Risk Factor Modification: The Heart to Heart Feasibility Study
Brief Summary: Coronary heart disease (CHD) is the leading cause of death in the United States, but fewer than half of all individuals at risk for CHD take advantage of proven strategies to lower their chances of developing this disease. This study will assess the effectiveness of Heart to Heart, a Web-based program, at educating people on ways to incorporate CHD risk-reduction strategies into their lives.


Options:
A: Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization (1, 6, and 12 months); Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization (1, 6, and 12 months); Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization (1, 6, and 12 months); Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization (1 month); Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization (1 and 6 months)
B: Shared Decision Making Questionnaire (CollaboRATE) (Level of Shared Decision Making at end of treatment (this will be at approximately week 8))
C: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))
D: Changes in decisional conflict (baseline and 3 month post intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Intervention to Enhance CHD Risk Factor Modification: The Heart to Heart Feasibility Study
Brief Summary: Coronary heart disease (CHD) is the leading cause of death in the United States, but fewer than half of all individuals at risk for CHD take advantage of proven strategies to lower their chances of developing this disease. This study will assess the effectiveness of Heart to Heart, a Web-based program, at educating people on ways to incorporate CHD risk-reduction strategies into their lives.


Options:
A: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
B: Feasibility of subject recruitment; feasibility of delivery of the CHD intervention and surveys in a busy practice setting; feasibility of measuring study outcomes (Measured at the end of the study period (approximately 2 years))
C: Total steps (last 30 days of intervention)
D: Change in dietary and physical activity behavior (self-report) (Baseline to 8 weeks later)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Vitamin D Deficiency in Breastfed Infants
Brief Summary: Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D deficiency during winter. This trial is designed to determine how much supplemental vitamin D breastfed infants need to receive in order to remain free of vitamin D deficiency


Options:
A: Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase (end of winter)
B: The number of days of detectable milk vitamin D concentrations (28 days)
C: Infant Length-for-Age Z-Scores with Prenatal Supplementation (1 year of age); Infant Length-for-Age Z-Scores with Postpartum Supplementation (1 year of age)
D: Vitamin D plasma concentrations (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Vitamin D Deficiency in Breastfed Infants
Brief Summary: Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D deficiency during winter. This trial is designed to determine how much supplemental vitamin D breastfed infants need to receive in order to remain free of vitamin D deficiency


Options:
A: Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase (end of winter)
B: Bacille-Calmette-Guerin (BCG) vaccine efficacy (2 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (6 months); Bacille-Calmette-Guerin (BCG) vaccine efficacy (1 year)
C: To evaluate the effects of supplemental vitamin D in enhancing calcium absorption in healthy children 4 to 8 yrs of age. (End of the study)
D: Serum interleukin-6 (At trial entry and 7 days after daily vitamin D supplementation therapy); Serum tumor necrosis-alpha (At trial entry and 7 days after daily vitamin D supplementation therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Testosterone Dose Response in Surgically Menopausal Women
Brief Summary: TDSM will study the physiology of testosterone in women ages 21-60 who have had surgical menopause (uterus and both ovaries removed). Testosterone is commonly thought of as a "male hormone" thus being that it is the male's primary hormone. Women produce testosterone in much smaller amounts and despite this, testosterone still plays a significant role. Fifty percent of a women's testosterone is made in her adrenal glands (glands that sit on top of the kidneys) and fifty percent is made in her ovaries. When a woman has her ovaries removed it is thought that her testosterone levels decrease rapidly and significantly. This study will be examining testosterone's role in sexual function, general well being, muscle performance, cognitive function, carbohydrate metabolism and muscle and fat distribution.

The study is 14 months long with weekly to monthly visits. The subjects will be placed on the estrogen patch for the duration of the study. They will also be given weekly injections of testosterone or placebo for 6 months. During the testosterone treatment phase the women will be separated into 5 groups. The groups include a dose of testosterone that is very low, low, medium, high and placebo. A placebo looks and feels similar to testosterone; however it does not have testosterone in it. We use this to test if the subject is having a response to the testosterone itself or the thought of receiving testosterone. Neither the subject nor the investigators will know the dose until the end of the study.


Options:
A: Change in Quality of Life (Baseline, 3 and 6 months)
B: Prevention of Entry Dyspareunia With Non-hormonal Therapy (During Phase II (0-4 weeks) and during Phase III (5-12 weeks)); Location of Pain in Postmenopausal Dyspareunia (Enrollment visit)
C: Physical Function (14 months)
D: Sexuality problems (Baseline); Intimacy problems. (Baseline); Sexuality problems (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Sexuality problems (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Sexuality problems (T3: 3 months after T2 (intervention group)); Intimacy problems. (T1: 10 weeks after start of therapy (intervention group) or 13 weeks after completion of baseline (control group)); Intimacy problems. (T2: 20-24 weeks after start of therapy (intervention group) or 23 weeks after completion of baseline (control group)); Intimacy problems. (T3: 3 months after T2 (intervention group)); Sexuality problems (T4: 6 months after T3 (intervention group)); Intimacy problems (T4: 6 months after T3 (intervention group))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intergenerational Transmission of Illness Behavior
Brief Summary: The purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).


Options:
A: Abdominal Pain Index (Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3)
B: symptoms of recurrent abdominal pain (measured one week following treatment and again in 3, 6 and 12 months); disability (measured one week following treatment and again in 3, 6 and 12 months)
C: Headache diaries assess headache frequency. (Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits.)
D: Adherence (beginning at baseline - week 20)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intergenerational Transmission of Illness Behavior
Brief Summary: The purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).


Options:
A: Parent Report Measures (5 years)
B: symptoms of recurrent abdominal pain (measured one week following treatment and again in 3, 6 and 12 months); disability (measured one week following treatment and again in 3, 6 and 12 months)
C: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))
D: Parent Report Measures (4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intergenerational Transmission of Illness Behavior
Brief Summary: The purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).


Options:
A: Change in FDI (Functional Disability Inventory) Scores at End of Study (Baseline and 6 months (end of study))
B: symptoms of recurrent abdominal pain (measured one week following treatment and again in 3, 6 and 12 months); disability (measured one week following treatment and again in 3, 6 and 12 months)
C: Juvenile Arthritis Quality of Life Questionnaire (JAQQ) (Baseline (prior to randomization) and 3 months after intervention)
D: Headache diaries assess headache frequency. (Completed one month prior to first visit, then weekly up to Week 20, then one month prior to Month 3, 6, 9, and 12 Follow-Up Visits.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intergenerational Transmission of Illness Behavior
Brief Summary: The purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).


Options:
A: Parental asthma-related quality of life (one year); Urgent care events for asthma (One year)
B: Parent report measures (5 years); Teen self-report measures (5 years)
C: symptoms of recurrent abdominal pain (measured one week following treatment and again in 3, 6 and 12 months); disability (measured one week following treatment and again in 3, 6 and 12 months)
D: Metabolic Control: Hemoglobin A1c (HbA1c) (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Comparator Controlled, Double-Blind Study of the Liver Safety of Pioglitazone HCl vs Glyburide With Metformin and Insulin as Part of Step Therapy in Subjects With Type 2 (Non-Insulin Dependent) Diabetes
Brief Summary: The purpose of this study is to determine the liver safety of pioglitazone, once daily (QD), versus glyburide taken with metformin and insulin.


Options:
A: Incidence of liver inflammation or injury greater than 3 times the upper limit of normal, as monitored by serum alanine aminotransaminase elevation. (At All Visits)
B: Change From Baseline in HbA1c at Week 52 (Baseline and Week 52)
C: Change in HbA1c From Baseline to Week 26 (Day 1 (Baseline) and Week 26)
D: HbA1c (after 26 weeks of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Controlled Study of the Efficacy of NdYag for Hidradenitis Suppurativa
Brief Summary: * Determination of the short and long term efficacy of NdYag laser for treatment of Hidradenitis suppurativa, which is an inflamed, deeper follicular disorders.
* Determination of patient tolerance of discomfort associated with NdYag laser treatment for Hidradenitis suppurativa.
* Determination of the impact of this condition on quality of life and if there is any impact of therapy in the dermatology quality of life index.
* Evaluate the histopathologic changes of YAG therapy on affected skin

Second phase of study:

* Prospective, controlled clinical and histologic study of patients with Hurley Stage II HS disease.
* 19 patients of skin types II to VI with Hurley Stage II hidradenitis suppurativa lesions of the axilla and groin. This is a different set of patients than those treated in the first phase of the study above. This study primarily focuses on and further characterizes the histologic changes after laser treatment.


Options:
A: Physician global assessment of HS of clear or mild at week 12 (Week 12)
B: We will be measuring patients' response by the clinical scoring criteria of the Hidradenitis Suppurativa European Research Group (HISERG) scale. (6 months); Examining histologic changes at various time points following 1064 nm Nd:YAG laser treatment of hidradenitis suppurativa. (6 months.)
C: N/A
D: Percentage of Participants Achieving Clinical Response at Week 16 (Baseline, Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Open-label, Non-comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer
Brief Summary: The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.


Options:
A: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))
B: Number of Participants With Dose Limiting Toxicities of Cediranib Maleate in Combination With Olaparib (Phase I) (At 28 days); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Metastatic Triple-negative Breast Cancer (Phase I) (At 28 Days); Progression-free Survival (PFS) at the Maximum Tolerated Dose/Recommended Phase 2 Dose of Cediranib Maleate With Olaparib Compared to That of Olaparib Alone (Phase II) (Time from start of treatment to time of objective disease progression, assessed up to 5 years); The Maximum Tolerated Dose (MTD) of Cediranib in Combination With Olaparib Tablet Formulation in the Treatment of Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer (Phase I-T). (At 28 days)
C: Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) (Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.)
D: Objective Response Rate as Evaluated by Response Evaluation Criteria In Solid Tumors ( RECIST) (Response is evaluated from randomization to objective disease progression per RECIST criteria or death due to any cause in the absence of progression (conducted when a minimum of 78 progression free survival events had occurred))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Open-label, Non-comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer
Brief Summary: The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.


Options:
A: Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST) (Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.)
B: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
C: Progression free survival (PFS) (To assess from the time of randomization until the date of objective disease progression or death (by any cause in the absence of progression) or approximately up to 2.5 years.)
D: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treprostinil for Untreated Symptomatic PAH Trial: A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension
Brief Summary: Multi-center, double-blind, placebo-controlled, randomized, parallel study comparing continuous intravenous (IV) Remodulin® to placebo in patients with pulmonary arterial hypertension either primary (PPH) or associated with human immunodeficiency virus (HIV) infection or collagen vascular disease).


Options:
A: Peak 6-minute Walk Distance (12 weeks)
B: change from baseline in 6-min-walk distance (6-MWD) (12 weeks)
C: Six-minute walk distance (Twelve Weeks)
D: Tolerability: Adverse events (AE) and safety variables, Variables to describe clinical effects: NYHA class, Walking distance (6-min walk), Mahler Dyspnea Index, EuroQoL, Karnofsky Index, Hemodynamic and gas exchange; Mortality and lung/heart-lung transplantation, Acute effects of iloprost inhalation on hemodynamics and gas exchange

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of CEP-701, an Orally Available JAK2 Tyrosine Kinase Inhibitor, as a Therapy for Patients With Myelofibrosis
Brief Summary: The goal of this clinical research study is to find out if CEP-701 can help control myelofibrosis (MF). The safety of CEP-701 will also be studied.


Options:
A: Percent Change From Baseline in Spleen Volume at Week 24 by Final Titrated Dose (Baseline and Week 24); Percent Change From Baseline in Total Symptom Score (TSS) as Measured by the Modified Myelofibrosis Symptom Assessment Form (MFSAF) V2.0 Diary at Week 24 by Final Titrated Dose (Baseline and Week 24); Percentage of Participants With Treatment-emergent Adverse Events (TEAE) (Up to Week 156); Percentage of Participants With New Onset Grade 4 Thrombocytopenia Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE V4.03) (Up to Week 156); Percentage of Participants With New Onset Grade 2 or Higher Hemorrhage as Assessed by CTCAE V4.03 (Up to Week 156)
B: Overall Response Rate (Assessed at the end of cycle 3)
C: Number of Participants With Objective Response (Response assessed after each 3 cycles (cycle = 30 days))
D: Number of Participants With Adverse Events (AEs) (From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.); Percentage of Participants With Clinical Improvement (CI) Over Time (Week 12, 24, 36, 48 and 60)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)
Brief Summary: This study will evaluate the effectiveness of tailored cognitive behavioral therapy in treating post-traumatic stress disorder in people with additional mental illnesses.


Options:
A: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)
B: Change in severity of borderline personality disorder assessed with the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview (Assessed at baseline, and at 8, 16 and 24 months post-randomization)
C: Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs (Measured post-treatment and at 6- and 12-month follow-ups); Depression, anxiety, and other psychiatric symptoms (Measured post-treatment and at 6- and 12-month follow-ups); PTSD diagnoses and symptom severity (Measured post-treatment and at 6- and 12-month follow-ups)
D: Change in Number of Deaths by Suicide and/or Re-Presentations to Any Emergency Department (ED) in Ontario for Self-Harm - Data from the Institute for Clinical Evaluative Sciences (ICES) (Baseline; 12 Months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)
Brief Summary: This study will evaluate the effectiveness of tailored cognitive behavioral therapy in treating post-traumatic stress disorder in people with additional mental illnesses.


Options:
A: The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 40 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from Baseline in BPFS-C at 10 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 20 weeks); The Borderline Personality Feature Scale for Children (BPFS-C) (Change from baseline at 30 weeks)
B: Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs (Measured post-treatment and at 6- and 12-month follow-ups); Depression, anxiety, and other psychiatric symptoms (Measured post-treatment and at 6- and 12-month follow-ups); PTSD diagnoses and symptom severity (Measured post-treatment and at 6- and 12-month follow-ups)
C: Remission From Major Depressive Episode in Intent to Treat Sample (Up to 12 Weeks); Remission From Major Depressive Episode Among Participants Who Completed the Intervention (Measured at Weeks 10 and 12)
D: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)

Answer: B