TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Varenicline Treatment for Smoking Cessation
Brief Summary: This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.


Options:
A: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
B: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
C: Number of Participants Reporting Continuous Smoking Abstinence in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions. (Last 4 weeks of treatment); Mean Percentage of Heavy Drinking Days Comparing Participants in the Extended Varenicline Pretreatment Versus Short-term Varenicline Pretreatment Conditions (First 3 weeks (pretreatment))
D: Days of abstinence following the programmed lapse (7 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Varenicline Treatment for Smoking Cessation
Brief Summary: This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.


Options:
A: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
B: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
C: 7 day point prevalence of cigarette abstinence; measured at Week 13 and on a weekly basis (Weekly, and 13 weeks after beginning study medication (Week 13).)
D: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Varenicline Treatment for Smoking Cessation
Brief Summary: This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.


Options:
A: Percent Compliance With Chantix (Months 1, 2, 3)
B: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
C: Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment (12 weeks)
D: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Varenicline Treatment for Smoking Cessation
Brief Summary: This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.


Options:
A: Rating of urges to smoke 1-week after the target quit (1 week)
B: Smoking behavior (after 5 hrs abstinence)
C: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
D: Smoking Status (at week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Varenicline Treatment for Smoking Cessation
Brief Summary: This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.


Options:
A: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
B: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
C: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
D: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Long-term Varenicline Treatment for Smoking Cessation
Brief Summary: This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of open-label varenicline therapy. At 12 weeks after their target quit date, they will be assigned in a random, double-blind manner to either 40 additional weeks of varenicline or placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks post-treatment.


Options:
A: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)
B: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
C: Changes in Log Brain-wave (EEG) Activity (Power [Microvolts Squared]) From Pre-quit Baseline to 66 Days Post-quit, Assessed at 3, 24, 45, and 66 Days Post-quit. (Mean EEG power [microvolts squared] from at baseline, 3, 24, 45, and 66 days post-quit); Changes in Log of Smoking Withdrawal Scores (Mood, and Depressive Symptoms) From Baseline Across 66 Days of Abstinence (Changes in log withdrawal symptoms from baseline through 66 days of abstinence)
D: Cigarette use (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-delivered Cognitive Behavioural Therapy for Health Anxiety - a Randomized Controlled Trial
Brief Summary: Hypochondriasis (health anxiety) is common, has many negative consequences for the afflicted individual and is associated with high societal costs. Cognitive Behavioural Therapy (CBT) has proven to be effective when administered in live-sessions. The aim of this study is to investigate whether CBT remains effective when administered via a self-help programme on the Internet.


Options:
A: Panic Disorder Severity Scale (PDSS) (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)
B: Health Anxiety Inventory (3 days before treatment start); Health Anxiety Inventory (12 weeks after pre asessment); Health Anxiety Inventory (6 months after post assessment); Health Anxiety Inventory (12 months after post assessment)
C: Panic Disorder Severity Scale (PDSS) (Pre, post at 6-month follow-up)
D: Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) (5-year follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF)
Brief Summary: Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.


Options:
A: Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy (8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval))
B: Ongoing Pregnancy Rate (10 weeks after treatment start)
C: Clinical pregnancy (8 weeks after IUI)
D: Ongoing pregnancy rate (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Phase III Trial Comparing Induction CT With Docetaxel, Cisplatin and 5-FU (TPF) Followed by Concurrent CT-RT to Concurrent CT Alone, in Nasopharyngeal Cancers Staged as T2b, T3, T4 and/or With Lymph Node Involvement (>N1)
Brief Summary: This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.


Options:
A: N/A
B: Overall survival after treatment with the test tri-therapy (TPF: docetaxel plus cisplatin and 5-FU) or the control treatment (PF: Cisplatin plus 5-FU) followed by chemoradiotherapy.
C: overall survival (3 years)
D: Event free-survival (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women
Brief Summary: The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.


Options:
A: Initiation of long term contraception with 6 month postpartum (6 month)
B: IUD Usage Rate at 6 Months (6 months after delivery)
C: Evaluation of infant weight, height and size of the tibial (women and children will be evaluated at time frame from day 42 through day 64 post-partum)
D: Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Prospective, Multicenter, Randomized, Open-label Trial to Assess the Efficacy and Safety of GONAL f® at a Dose Based on Subject Baseline Characteristics Determined According to the CONSORT Calculator Compared With a Standard Dose of GONAL f® 150 IU Per Day for Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology (ART)
Brief Summary: The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per day.


Options:
A: Ongoing Pregnancy Rate (10-11 weeks after transfer)
B: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
C: Number of patients obtaining 5-12 oocytes during COH (2 years)
D: Number of Oocytes Retrieved Per Participant (34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Prospective, Multicenter, Randomized, Open-label Trial to Assess the Efficacy and Safety of GONAL f® at a Dose Based on Subject Baseline Characteristics Determined According to the CONSORT Calculator Compared With a Standard Dose of GONAL f® 150 IU Per Day for Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology (ART)
Brief Summary: The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per day.


Options:
A: Number of patients obtaining 5-12 oocytes during COH (2 years)
B: Number of Oocytes Retrieved Per Participant (34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU))
C: Number of Oocytes Retrieved (Day of oocyte retrieval (up to Day 18 after start of stimulation))
D: Number of metaphase II oocytes retrieved during the course of one treatment cycle (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Stroke Telemedicine for Arizona Rural Residents Trial
Brief Summary: The STARR network registry consists of a 4 spoke 1 hub system. Which will consist of prospective collection, recording, and regular analysis of telestroke patient consultation and care data for the purpose of quality measure assessment and improvement and benchmarking against other national and international telestroke programs.


Options:
A: BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.
B: To assess the numbers of patients who receive thrombolytics and the time to treatment in patients evaluated by telemedicine (90 days)
C: State-Trait Anger Inventory (STAXI-2) Anger Expression Index (Baseline); State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale (Post-treatment (2 weeks following last treatment session)); State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale (3-month Follow Up); State-Trait Anger Inventory (STAXI-2) Anger Expression Subscale (6-month Follow Up); Novaco Anger Scale (NAS) (Baseline); Novaco Anger Scale (NAS) (Post-treatment (2 weeks following last treatment session)); Novaco Anger Scale (NAS) (3-Month Follow Up); Novaco Anger Scale (NAS) (6-Month Follow Up)
D: Weight (Measured at Assessment Visits) and Pain Intensity and Pain Related Disability (NRS-I) (baseline, 3, 6, 9, and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive Training to Enhance VA Work Program Outcomes
Brief Summary: The purpose of this study is to determine whether augmenting work services with cognitive remediation can improve vocational outcomes for psychiatrically disabled participants in VA work services.


Options:
A: Change from Baseline in Cognitive Function after 12 Weeks and 28 Weeks (Baseline, 12 Weeks, 28 Weeks and Up to 5 Years Post-Treatment)
B: Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score) (At 6 weeks and At 12 weeks); Change in Performance on the UCSD Performance-based Skills Assessment (Co-Primary Composite Measure) (At 6 weeks and At 12 weeks)
C: Work Activity (6 month and 12 month)
D: Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks (Baseline and after 12 weeks.); Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks (Baseline and after 12 weeks); Change from Baseline in 6-Minute Walk Test (6MWT) score at 12 weeks (Baseline and after 12 weeks); Change from Baseline in Daily Functioning Assessments at 12 weeks (Baseline and after 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Oral Hygiene With 0.12% Chlorhexidine Antiseptic Solution on the Incidence of Nosocomial Pneumonia and Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery
Brief Summary: Hospital infections play an important role in the increase of patients' morbimortality and hospitalization costs, especially in the case of individuals admitted to intensive care units (ICU) during postoperative heart surgery. Analysis of the epidemiological profile of the hospital infections in the pediatric-ICU (P-ICU) of Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, University of São Paulo (HCFMRP-USP) demonstrated a 31.1% incidence of pneumonia (PNM) and a rate of ventilator-associated pneumonia (VAP) of 23.81 per 1000 ventilators-day between March 2004 and February 2005 in the group submitted to cardiac surgery. Knowledge of the pathophysiology and risk factors associated with this infection allows for measures aiming at reducing its incidence. The objective of the present study is to evaluate the effect of oral hygiene with a 0.12% chlorhexidine solution on the incidence of PNM and PAV in children submitted to cardiac surgery.


Options:
A: Development of Ventilator Acquired Pneumonia (During the period of intubation)
B: Ventilator associated pneumonia (48 hours after tracheal intubation)
C: N/A
D: Intensive Care Unit (ICU) Mortality (14 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Oral Hygiene With 0.12% Chlorhexidine Antiseptic Solution on the Incidence of Nosocomial Pneumonia and Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery
Brief Summary: Hospital infections play an important role in the increase of patients' morbimortality and hospitalization costs, especially in the case of individuals admitted to intensive care units (ICU) during postoperative heart surgery. Analysis of the epidemiological profile of the hospital infections in the pediatric-ICU (P-ICU) of Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, University of São Paulo (HCFMRP-USP) demonstrated a 31.1% incidence of pneumonia (PNM) and a rate of ventilator-associated pneumonia (VAP) of 23.81 per 1000 ventilators-day between March 2004 and February 2005 in the group submitted to cardiac surgery. Knowledge of the pathophysiology and risk factors associated with this infection allows for measures aiming at reducing its incidence. The objective of the present study is to evaluate the effect of oral hygiene with a 0.12% chlorhexidine solution on the incidence of PNM and PAV in children submitted to cardiac surgery.


Options:
A: Development of Ventilator Acquired Pneumonia (During the period of intubation)
B: Ventilator-Associated Pneumonia (VAP) (28 days)
C: Nosocomial Infection
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin（CI-1008）In The Treatment Of Fibromyalgia
Brief Summary: This study, will compare pregabalin with placebo for the duration of 15 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.


Options:
A: Main outcome of the study is long-term safety of pregabalin in patients with fibromyalgia. This is a 1 year open-label extension of the preceding double-blind randomized fibromyalgia protocol A0081056.
B: Wake After Sleep Onset (WASO) at Weeks 5 and 11 (Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET))
C: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline (Baseline, Week 15 or study discontinuation)
D: Mean NRS Pain Score at End of Period. (End of each period, at Weeks 6 and 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Carotid Stent Design on Cerebral Embolization
Brief Summary: The goal of the proposed study is to contrast the relative efficacy of closed-cell stents versus open-cell stents in preventing periprocedural cerebral embolization in high-risk patients with symptomatic and asymptomatic extracranial carotid stenosis undergoing carotid artery stenting (CAS).


Options:
A: composite of major adverse clinical events including death, any stroke, and/or myocardial infarction at 30-days post-procedure (30-days post-procedure); The same 30-day composite of major adverse clinical events plus death and/or ipsilateral stroke between 31-days and 12-months post-procedure. (Between day 31 and 12-months post-procedure.)
B: Any stroke or death within 30 days of the procedure (during de study)
C: Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery. (First 24 hours after implantation of carotid stent)
D: Hierarchical Composite of Stroke, Myocardial Infarction, and Death (30-day post-procedure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Pilot Efficacy Study of the GI Sleeve™ for Pre-Surgical Weight Loss
Brief Summary: The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery.

It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry patients will receive an implant of the EndoBarrier device and the other 10 patients will receive the principle investigator's standard of care diet program. All patients will be treated for 12 weeks with the exception of the last 10 device patients who will continue to 24 weeks if the principle investigator determines that it is safe and in their best interest to continue.

The primary efficacy endpoint is:

* Assessment of the difference in % excess weight loss between the 2 groups

Secondary endpoints are:

* Resolution or Improvement in type II Diabetic status as defined as:
* Resolution = patient is off their diabetes medication and has normal diabetic blood parameters (fasting glucose)
* Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction in dosing or frequency of their diabetic medication
* The percent of patients who achieve at least a 10% excess weight loss will be calculated as a secondary outcome.


Options:
A: Total Weight Change From Baseline at 12 Weeks in kg (12 weeks)
B: Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT. (1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months)
C: Improvement of co-morbidities (1-year after treatment start)
D: To assess the efficacy of bariatric surgery in inducing partial or total remission of type 2 diabetes mellitus, as compared to standard medical anti-diabetic care (STC). (10 years)

Answer: A