TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Total Body Skin Examination on Skin Cancer Detection
Brief Summary: This will be a study where all patients will undergo a two-step procedure:

Step 1 - Physicians examine the problem area of skin ONLY and record result. Step 2 - Physicians perform TBSE and record result. Eventual lesions suggestive of melanoma and non-melanoma skin cancers will be recorded after step 1 or step 2 examination and will be finally biopsied and histopathologically diagnosed. Exceptions to biopsy may include patients with multiple non-melanoma skin cancers (e.g. actinic keratoses or basal cell carcinomas).

Each center will be provided with an electronic data sheet for patients record, or alternatively, with a paper record form.

Endpoints of the study are new parameters concerning the standard of care for skin cancer screening. We expect to conclude that TBSE enables clinicians discovering an increased number of skin cancers thus resulting in earlier detection.


Options:
A: All-cause mortality (Until December 2015)
B: Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment (6 months)
C: Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. (one year)
D: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Total Body Skin Examination on Skin Cancer Detection
Brief Summary: This will be a study where all patients will undergo a two-step procedure:

Step 1 - Physicians examine the problem area of skin ONLY and record result. Step 2 - Physicians perform TBSE and record result. Eventual lesions suggestive of melanoma and non-melanoma skin cancers will be recorded after step 1 or step 2 examination and will be finally biopsied and histopathologically diagnosed. Exceptions to biopsy may include patients with multiple non-melanoma skin cancers (e.g. actinic keratoses or basal cell carcinomas).

Each center will be provided with an electronic data sheet for patients record, or alternatively, with a paper record form.

Endpoints of the study are new parameters concerning the standard of care for skin cancer screening. We expect to conclude that TBSE enables clinicians discovering an increased number of skin cancers thus resulting in earlier detection.


Options:
A: Absence of local recurrence at 3 years after start of treatment
B: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
C: Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. (one year)
D: All-cause mortality (Until December 2015)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy: a Double Blinded Randomized Placebo Controlled Trial.
Brief Summary: The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having laparoscopic surgery to donate a kidney.


Options:
A: Evaluation of analgesic effect by 11-NRS scale (4th postoperative day)
B: Composite of All-cause Mortality and Nonfatal MI (30 days); All-cause Mortality and Nonfatal MI (1 year)
C: Pain 'Right Now' (24 hours after the end of surgery); Morphine Equivalents of Concomitant Pain Medication (24 hours after the end of surgery)
D: Pain 'Right Now' (24 hours after the end of surgery); Morphine Equivalents of Concomitant Pain Medication (24 hours after the end of surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly
Brief Summary: Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.


Options:
A: Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments (12 months)
B: Circulating GH- and IGF-1 concentrations measured every 2 weeks (6 months)
C: Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5) (Week 1 and Week 48)
D: Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. (At 24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction
Brief Summary: Study hypothesis :

The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.

Aims

* To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure
* To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.
* To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.


Options:
A: Incidence of major adverse cardiac event (MACE) (MACE defined as: cardiac death, cardiac arrest, myocardial infarction, sustained ventricular arrhythmias, pulmonary edema, acute heart failure, unstable angina and major bleeding) (Outcome measures will generally be assessed at Baseline, Month 3, Month 6 and Month 12)
B: Longitudinal change in left ventricular function (ejection fraction) (1 year)
C: Safety Will be Evaluated by Number of AE (Total AEs and SAEs within 450 days post-infusion)
D: Change in left ventricular ejection fraction (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction
Brief Summary: Study hypothesis :

The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.

Aims

* To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure
* To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.
* To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.


Options:
A: Longitudinal change in left ventricular function (ejection fraction) (1 year)
B: Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year) (after 3 months and 1 year of treatment)
C: Heart function (one year)
D: change of left ventricular ejection fraction measured by cardiac MRI (6, 12, and 24month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intramyocardial Delivery of Autologous Bone Marrow Cells in Patients With Heart Failure Due to Dilated Cardiomyopathy
Brief Summary: This study is designed to assess the safety and tolerability of Cardiac Repair Cells (CRCs) compared to standard-of-care in patients with dilated cardiomyopathy (DCM).


Options:
A: Safety will be assessed by: post-procedure assessments, physical exam, vital signs, laboratory tests, and adverse events including MACE (Major Adverse Cardiac Event) occurrences. (Outcome measures will generally be assessed at baseline, Month 1, Month 3, Month 6 and Month 12)
B: Safety Will be Evaluated by Number of AE (Total AEs and SAEs within 450 days post-infusion)
C: Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs) (One month post-catheterization)
D: Global Left Ventricular Ejection Fraction change (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: 2B or Not 2B? Shoulder Function After Level 2B Neck Dissection: A Randomized Controlled
Brief Summary: Many types of head and neck cancers will have local spread to the neck. As such selective neck dissection is performed as part of the treatment. The neck is divided into various levels. Selective neck dissection targets areas that are most likely to harbor cancer cells for specific types of head and neck cancers. Level IIB has been particularly controversial in the last few years, as the rate of cancer spread to this area has been shown to be quite low (0-8%). Moreover, because the spinal accessory nerve (involved in shoulder function) runs through this area, there is theoretical risk of causing post-operative shoulder weakness. As such, the question of whether removing level IIB, knowing that there is low chance of it containing disease spread, is worth risking decreased shoulder function. Some would argue that all potential diseased sites should be removed at all costs. While other advocate that a balance between disease cure and function should be maintained. However, what needs to be determined is just what impact does dissecting IIB have on shoulder function. At our institution, the rate of poor shoulder function associated with selective neck dissection has been perceived as being quite low. This study is designed to test this observation.

Hypothesis: Neck dissection including level IIb in head and neck cancer patients will not lead to worse shoulder function and quality of life than when level IIb is preserved.


Options:
A: Overall Survival (5 years)
B: Change in Neck Dissection Impairment Index (NDII) score from pre- to post-op. (6 months per patient)
C: blood loss (intraoperative)
D: Quality of Life (1-year post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy
Brief Summary: The purpose of this study is to evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing.


Options:
A: Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer
B: Informed choice (2 weeks post intervention); Involvement in screening decision (2 weeks post intervention)
C: Hemoglobin A1c (6 months)
D: Physical Activity (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Controlled Trial of a Bowel Cancer Screening Decision Aid for Adults With Low Education and Literacy
Brief Summary: The purpose of this study is to evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing.


Options:
A: Test if Chest Pain Choice Safely Improves Patient Knowledge. (Directly following intervention (on day 1))
B: Patient knowledge (Immediately after patient visit)
C: Informed choice (2 weeks post intervention); Involvement in screening decision (2 weeks post intervention)
D: Patient's satisfaction and confidence with the information given. (Within two weeks after receiving the information and after 3 months.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nortriptyline for Idiopathic Gastroparesis: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Trial (NORIG)
Brief Summary: The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether treatment with nortriptyline will improve gastroparesis symptoms compared with placebo.


Options:
A: Decrease From the Baseline GCSI of at Least 50% on Any Two Consecutive Follow-up Visits (at end of treatment, 15 weeks from baseline assessment)
B: Primary outcome variable will compare the reported pain of the "Tampon Test" (mean of Weeks -2, -1, and 0), prior to randomization to the reported pain of "Tampon Test" (mean of Weeks 10, 11, and 12). (The dependent (primary outcome) variable will be defined as the percent change of mean "Tampon test" pain of Weeks (10, 11, and 12) from Weeks (-2, -1 and 0).)
C: Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score (Baseline, Week 13)
D: Change from baseline in the endpoint mean pain score (14 weeks); Fibromyalgia Impact Questionnaire (14 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Centre, Randomized, Double Blind Cross-over Study to Assess the Non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients With Asthma
Brief Summary: The purpose of this study is to compare once and twice daily GW685698 in asthma


Options:
A: Number of Participants With 1 or More Severe Asthma Exacerbations (Baseline to Follow-up (up to 76 weeks of treatment))
B: Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period (Day 28 of the relevant treatment period (up to Study Day 112))
C: The primary efficacy measure will be mean change from baseline at Week 8 (last assessment on treatment using last observation carried forward) in tough (AM or PM pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1)
D: The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) (Baseline to Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks
Brief Summary: This study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control).

Over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. We will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.


Options:
A: Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence (12 months post enrollment)
B: Change in CD4 count (Throughout study)
C: Proportion of women prescribed potentially teratogenic medications with documented use of contraception (1 year)
D: poor asthma control (2006-2009)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preconception Risk Evaluation Via Electronic Medical Record Notification of Teratogenic Risks
Brief Summary: This study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control).

Over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. We will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.


Options:
A: Recruitment rates (Through study completion, an average of 1 year); Enrollment rates (Through study completion, an average of 1 year)
B: Proportion of women prescribed potentially teratogenic medications with documented use of contraception (1 year)
C: Shared Decision-Making Coding System (Change in collaborative decision-making behaviors from baseline (month 0) to post-intervention (month 2)); Shared Decision-Making Coding System (Change in collaborative decision-making behaviors from baseline (month 0) to follow-up at 3-months post-intervention (month 5))
D: Recruitment Rate (Up to one year from when the study starts enrolling participants)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea in a Prospective Cohort of Subjects Aged 67 Years
Brief Summary: The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.

Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population. It is even associated with sleep apnea/hypopnea.


Options:
A: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
B: Smoking cessation (6 month follow-up)
C: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)
D: Percentage of Participants With 30-day Abstinence (6-months post enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea in a Prospective Cohort of Subjects Aged 67 Years
Brief Summary: The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.

Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population. It is even associated with sleep apnea/hypopnea.


Options:
A: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)
B: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
C: Biochemically-validated smoking cessation (middle and late pregnancy)
D: Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (During all the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were

* to develop an implementation model for IPTi in the health care system in Mali
* to assess its impact on the EPI vaccines and other health interventions coverage
* and on molecular makers of resistance to SP


Options:
A: visits by nurse midwife; prenatal exams, tetanus vaccinations, & iron tablets received by pregnant women; infant vaccinations; educational scholarships and fees for children; occurrence of village council meetings; development work in villages
B: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
C: Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate (1 year); Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations (1 year); Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month (1 year)
D: new immunization doses (within 60 days of reminder notification)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were

* to develop an implementation model for IPTi in the health care system in Mali
* to assess its impact on the EPI vaccines and other health interventions coverage
* and on molecular makers of resistance to SP


Options:
A: Malaria incidence (the number of study subjects seen at the OPD clinic with clinical malaria during the surveillance period). (During the surveillance period (September to December 2008))
B: Clinical episodes of malaria
C: Incidence of clinical malaria (2008-2009)
D: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)

Answer: D