TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence
Brief Summary: The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.


Options:
A: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml (12 weeks +/- 1 week)
B: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
C: Days of abstinence following the programmed lapse (7 days)
D: The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks. (5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence
Brief Summary: The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.


Options:
A: Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt) (weeks 9 through 12)
B: N/A
C: Days of abstinence following the programmed lapse (7 days)
D: Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm) (9 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence
Brief Summary: The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.


Options:
A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Baseline up to 30 days after last dose of study treatment or up to Week 16); Number of Participants With Psychiatric Adverse Events (Baseline up to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Total Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Positive Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 12); Change From Baseline to Week 24 in Positive and Negative Syndrome Scale (PANSS): Negative Symptoms Score (Baseline to Week 24); Change From Baseline to Week 12 in Simpson Angus Rating Scale (SARS) (Baseline to Week 12); Change From Baseline to Week 24 in Simpson Angus Rating Scale (SARS) (Baseline to Week 24); Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Treatment Phase (Week 1 to Week 12 (Treatment phase)); Number of Participants With Suicidal Behavior or Suicical Ideation ("Yes" Response ) on the Columbia Suicide-Severity Rating Scale (C-SSRS) During the Post Treatment Phase (Week 13 to Week 24 (Post treatment phase)); Number of Participants With Shift From Baseline to Week 12 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline (Bsl) to Week 12); Number of Participants With Shift From Baseline to Week 24 in Clinical Global Impressions Scale-Severity (CGI-S) Score (Baseline to Week 24); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 1 (Baseline, Week 1); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 12 (Baseline, Week 12); Number of Participants With Clinical Global Impression of Improvement Scale (CGI-I) Score at Week 24 (Baseline, Week 24)
B: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)
C: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
D: Days of abstinence following the programmed lapse (7 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Peer and Health Educator Support for Cardiovascular Health in African-American Primary Care Patients
Brief Summary: Project Overview:

Poor hypertension control has dire consequences for the African-American population who suffer greater death and disability from heart disease, stroke, and renal failure than whites. To reduce these health disparities it is critical to promote of a healthy lifestyle in regard to diet, exercise, adherence to medications, as well as other behaviors. However, physicians usually fail to address lifestyle behaviors in the context of the harried patient visit. Therefore, the investigators hypothesized that the investigators could reduce cardiovascular risk by providing additional support to persons with poorly controlled hypertension through phone calls from trained peer patients and visits to an office support staff member.

Study Design:

A single-blind, randomized, controlled trial in 280 African-American primary care patients aged 40-75 with poorly controlled hypertension (HTN). The intervention group receives a practice-based team intervention that combines peer coach with office staff (i.e., medical assistant or licensed practice nurse) visits to address lifestyle challenges. Both intervention and control groups receive informational materials and healthy soul food recipes from the American Heart Association. The 6 month intervention alternates monthly phone calls from peer coaches about lifestyle behavioral changes with office-based visits with the support staff member during which patients review and discuss low literacy slide shows about healthy behaviors as well as examine their personal cardiovascular risk profile.


Options:
A: Net Difference in Proportion Treated with Low-dose Diuretics (baseline and at one year)
B: Greater reduction in CHD risk in case group vs. control (6 months)
C: Predicted 10-year CHD risk (4-month follow-up)
D: Multiple CVD risk factor control targets (42 months after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II, Open-Label, Dose-Escalation Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
Brief Summary: The main purpose of this study is to examine the safety and tolerability of CDX-1401 when given in combination with an immune stimulant (resiquimod) to patients with advanced cancers that are known to express the NY-ESO-1 protein.


Options:
A: N/A
B: Overview of Treatment-emergent Adverse Events (TEAEs) (Continuously for up to 16 weeks)
C: Occurrence of adverse events (side effects) (12 weeks (1 cycle of study treatment))
D: Recurrence Free Survival Evaluated by Clinical Event Adjudication Committee (CEAC) (Every 12 weeks up to recurrence or up to 3 months after last administered dose)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study to Assess the Role of Oral Sucrose in Reducing the Pain to Orogastric Tube Insertion in Preterm Neonates
Brief Summary: RESEARCH HYPOTHESIS Orally administered sucrose 2 minutes prior to the procedure of OGT insertion reduces pain associated with the procedure.

AIMS AND OBJECTIVES:

To study the effect of 24% oral sucrose on decreasing the painful response to orogastric tube insertion .


Options:
A: Painful response as assessed by PIPP Scale (Pre procedure,Intra procedure,post 30 sec,post 1 min,post 2 minutes)
B: The primary objective is to show decrease of pain response in the treatment group as measured by the PIPP (Premature Infant Pain Profile) score (PIPP score before, during and after eye exam)
C: Pain scores assessed by the PIPP score (The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.)
D: Pain reaction (first 14 days of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study
Brief Summary: The study is designed to determine the long term, post trial effects of the two interventions studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared with placebo and intensive gliclazide-MR based glucose control as compared to standard guideline based glucose control) in individuals with type 2 diabetes at high risk of cardiovascular events. The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.


Options:
A: Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke (Randomization (day 0) up to 2.9 years)
B: Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis) (2014); Death from any cause (2014)
C: HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment (Baseline and 24 weeks)
D: HbA1c Change From Baseline (Baseline and 12 weeks); Mean 24-hour Systolic Blood Pressure Change From Baseline (Baseline and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study
Brief Summary: The study is designed to determine the long term, post trial effects of the two interventions studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared with placebo and intensive gliclazide-MR based glucose control as compared to standard guideline based glucose control) in individuals with type 2 diabetes at high risk of cardiovascular events. The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.


Options:
A: Major macrovascular events -a composite of non-fatal myocardial infarction, non-fatal stroke and death from any cardiovascular cause (based on investigator diagnosis) (2014); Death from any cause (2014)
B: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
C: Composite of non-fatal stroke, non-fatal myocardial infarction or death from any cardiovascular cause (July 2001 - December 2007); Composite of new or substantially worsening nephropathy or microvascular eye disease. (July 2001 - December 2007)
D: Ischemic Foot Ulcer (Until hospitalization for ischemic foot ulcer or until 31 December 2011)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled
Brief Summary: Primary Objective:

To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.

Secondary Objective:

To compare between treatment groups:

* Plasma glucose (fasting, nocturnal) over time,
* Changes from baseline in HbA1c over time,
* Percentage of patients who reach the target of HbA1c \<7 and \<6.5,
* Use of prandial insulin as rescue medication at month 6,
* Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
* Daily dose of insulin,
* Change in body weight from baseline,
* Evolution of 8-point plasma-glucose (PG) profiles,
* Overall safety,
* Patient reported outcomes (treatment satisfaction).


Options:
A: Body weight loss (after 26 weeks of treatment)
B: HbA1c (Recorded at baseline (week 0), week 12, week 24 and week 36)
C: Change in HbA1c (percentage %) (Baseline to 6 months)
D: The percentage of patients with a 3-step or greater progression in the patient; level recoded integer ETDRS retinopathy scale

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled
Brief Summary: Primary Objective:

To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.

Secondary Objective:

To compare between treatment groups:

* Plasma glucose (fasting, nocturnal) over time,
* Changes from baseline in HbA1c over time,
* Percentage of patients who reach the target of HbA1c \<7 and \<6.5,
* Use of prandial insulin as rescue medication at month 6,
* Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
* Daily dose of insulin,
* Change in body weight from baseline,
* Evolution of 8-point plasma-glucose (PG) profiles,
* Overall safety,
* Patient reported outcomes (treatment satisfaction).


Options:
A: HbA1c (Recorded at baseline (week 0), week 12, week 24 and week 36)
B: Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke. (From randomisation to individual end of observation, up to 4.6 years)
C: Body weight loss (after 26 weeks of treatment)
D: Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia (Baseline to Month 6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Hidradenitis Suppirativa With Etanercept Injection
Brief Summary: Therapy with etanercept, a TNF inhibitor will reverse the inflammation, symptoms and quality of life and allow healing of HS.


Options:
A: 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.)
B: Percentage of Participants Achieving Clinical Response at Week 16 (Baseline, Week 16)
C: N/A
D: Physician global assessment of HS of clear or mild at week 12 (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Wiser Choices In Osteoporosis Choice II
Brief Summary: Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. FRAX combined with a decision aid may promote a shared decision making approach with patients, allowing the clinician and patient to weigh potential fracture risk (without treatment), versus risk reduction with medication (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:

* FRAX
* FRAX + decision aid
* Usual care (no decision aid and no FRAX given to clinician)


Options:
A: Feasibility of Data Collection at Month 12 (Data collection occurred at month 12)
B: decisional conflict scale (Change from baseline in decisional conflict at 3 months)
C: Multiple CVD risk factor control targets (42 months after randomization)
D: Medication start/stop, knowledge, and patient involvement. (Baseline and at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Wiser Choices In Osteoporosis Choice II
Brief Summary: Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. FRAX combined with a decision aid may promote a shared decision making approach with patients, allowing the clinician and patient to weigh potential fracture risk (without treatment), versus risk reduction with medication (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:

* FRAX
* FRAX + decision aid
* Usual care (no decision aid and no FRAX given to clinician)


Options:
A: Predicted 10-year CHD risk (4-month follow-up)
B: Impact of Standard Informed Consent vs CD-ROM Educational Intervention on Knowledge About Microsatellite Instability (MSI) Testing (2 weeks after enrollment)
C: Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge (9 months)
D: Medication start/stop, knowledge, and patient involvement. (Baseline and at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Wiser Choices In Osteoporosis Choice II
Brief Summary: Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. FRAX combined with a decision aid may promote a shared decision making approach with patients, allowing the clinician and patient to weigh potential fracture risk (without treatment), versus risk reduction with medication (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:

* FRAX
* FRAX + decision aid
* Usual care (no decision aid and no FRAX given to clinician)


Options:
A: Medication start/stop, knowledge, and patient involvement. (Baseline and at 6 months)
B: Understanding (Directly proceeding the clinical encounter); Decisional Conflict (Directly proceeding the clinical visit); Treatment Action, adherence (Directly proceeding the clinical encounter, 6 months after the clinical encounter)
C: Decisional Conflict Scale (3 months)
D: Change in Self-Reported Preference for Opioid Pain Reliever (Baseline and Immediate Post-test)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Site-Randomized Controlled Trial for Health Promotion in Girl Scouts: Healthier Troops in a SNAP
Brief Summary: The purpose of the study was to evaluate the effectiveness of an intervention designed to prevent obesity by improving the environmental characteristics of Girl Scouts troop meetings.


Options:
A: N/A
B: Body mass index (one year)
C: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
D: Body mass index percentile ranking (5 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Site-Randomized Controlled Trial for Health Promotion in Girl Scouts: Healthier Troops in a SNAP
Brief Summary: The purpose of the study was to evaluate the effectiveness of an intervention designed to prevent obesity by improving the environmental characteristics of Girl Scouts troop meetings.


Options:
A: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 24 months); Change in Waist Circumference (Baseline, 78 months); Prevalence of Acanthosis Nigricans (Baseline, 24 months); Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 78 months); Change in Waist Circumference (Baseline, 24 months); Prevalence of Acanthosis Nigricans (Baseline, 78 months)
B: Change in the prevalence of overweight and obesity (Baseline, Month 9)
C: BMI z-score (via measured weight and height) of preschooler (~2 years post baseline)
D: Body mass index percentile ranking (5 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Brief Summary: This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.


Options:
A: Overall Survival Time (OS) (Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007)
B: Median Progression Free Survival (PFS) Time (Randomization until PD or death (assessed at baseline and every 8 weeks thereafter until PD, death or end of study [up to approximately 1.5 years]))
C: Progression-Free Survival (PFS) Time (Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression)
D: Investigator-assessed Duration of Progression-free Survival (Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months))

Answer: C