TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pregnancy and EARly Lifestyle Improvement Study
Brief Summary: The investigators propose to conduct a randomized controlled trial in 200 overweight/obese pregnant women and their offspring. The prenatal intervention will emphasize improving diet and physical activity. The lifestyle intervention will be delivered within an empowerment theoretical framework through a combination of group sessions, individual counseling, and by monitoring compliance to diet and physical activity to further tailor the intervention. The post-partum intervention sessions will include mothers and their offspring and will focus on breastfeeding, improving physical activity and quality of the diet and feeding practices through the first post-partum year. As part of routine prenatal care, participants in both the control and intervention arms will be given health-related advice. Since the majority of participants are expected to be eligible for the Women, Infants and Children (WIC) program, both groups will also receive assistance through WIC as per their routine policies. Our primary outcome is Gestational Weight Gain (GWG). The major secondary outcome of interest is infant BMI z-score at 12 months of age, and the investigators will also be evaluating several metabolic outcomes in mothers and infants.


Options:
A: Gestational Weight Gain (Delivery)
B: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
C: Percentage of women above the Institute of Medicine Guidelines for gestational weight gain (40 weeks)
D: Gestational weight gain (36 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire), with a loop in the tip, for the prevention of PEP and biliary tree access, in PEP high-risk patients.


Options:
A: Post-ERCP pancreatitis (30 days after ERCP)
B: Percentage of successful selective biliary cannulation
C: The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal (30 days after ERCP); The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis (30 days after ERCP)
D: post ERCP pancreatitis rate (up to 4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Proof-of-concept Phase II Trial Comparing Therapy Based on Tumor Molecular Profiling Versus Conventional Therapy in Patients With Refractory Cancer.
Brief Summary: SHIVA is a proof of concept randomized phase II trial which compares two treatment strategies for patients with refractory cancer.

From a tumor biopsy, a molecular profile of the disease is established (mutations, amplifications, hormone receptor status). If a molecular abnormality is identified for which an approved targeted agent is available, patients are randomized randomized between two arms:

* Targeted therapy based on the molecular profile
* Conventional therapy based on investigator's choice.

A cross-over is proposed at disease progression.


Options:
A: Progression-Free Survival (PFS) (Randomization to measured PD or date of death from any cause (up to Month 25.0))
B: Patient's progression free survival (according RECIST 1.1) of targeted therapy based on molecular profiling versus conventional chemotherapy.
C: Dose Escalation Phase: Maximum Tolerated Dose (MTD) (Cycle 1: Days 1 to 28); Dose Escalation Phase: Number of Participants With at Least 1 Dose Limiting Toxicity (DLT) (Cycle 1: Days 1 to 28); Objective Response Rate (ORR) (At screening and thereafter every 2 cycles of treatment until disease progression (Up to 65.8 weeks)); Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events(SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug (First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks))
D: Overall Survival (From randomization until death, up to 26 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease
Brief Summary: Despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable angina continue to believe that PCI is performed to improve these outcomes. Additionally, recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus there is a compelling need to share with patients the risks and benefits of PCI prior to treatment to reach an informed decision.

This study is designed to answer the question of whether a decision aid can improve patient knowledge, decisional conflict and patient satisfaction with decision-making compared to usual care for the treatment of stable angina.


Options:
A: Evidence of success of decision aid to providers and patients, which leads to improved knowledge, reduced decisional conflict and enhanced satisfaction with the decision, and enhanced adherence to medication. (Directly following intervention.)
B: Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings (Baseline to Three Months)
C: Test if Chest Pain Choice Safely Improves Patient Knowledge. (Directly following intervention (on day 1))
D: Change in Self-Reported Preference for Opioid Pain Reliever (Baseline and Immediate Post-test)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier
Brief Summary: It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.


Options:
A: Reduction in discharge rate of small-for-gestational age very low birth weight infants (6 months corrected age)
B: Caloric content of human milk (Daily until 36 weeks corrected gestational age)
C: Weight Gain (Study Day 1 to Study Day 29 (or discharge, whichever happens first))
D: Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day. (21 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation
Brief Summary: This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking


Options:
A: Quit Rate (4 months)
B: Continuous smoking abstinence rate (Weeks 9 to 12)
C: Varenicline Adherence as Measured by Pill Count (Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12)
D: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation
Brief Summary: This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking


Options:
A: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
B: Quit Rate (4 months)
C: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))
D: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation
Brief Summary: This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: 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)
C: Quit Rate (4 months)
D: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation
Brief Summary: This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: 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))
C: Quit Rate (4 months)
D: 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed (6 months post quit date)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation
Brief Summary: This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking


Options:
A: Continuous Abstinence Rate (CAR) From Week 9 Through Week 12 (Week 9 through Week 12)
B: N/A
C: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)
D: Quit Rate (4 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation
Brief Summary: This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking


Options:
A: Will bupropion reduce relapse to smoking compared to placebo (52 weeks and 76 weeks)
B: Quit Rate (4 months)
C: Percent Treatment Sessions Attended (52 weeks)
D: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation
Brief Summary: This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking


Options:
A: N/A
B: Quit Rate (4 months)
C: 7-day Point Prevalence All Tobacco Abstinence (12 weeks - end of treatment)
D: 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))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Pilot Study of Varenicline vs. Nicotine Patch Delivered by a Telephone Quitline to Promote Smoking Cessation
Brief Summary: This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking


Options:
A: Quit Rate (4 months)
B: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
C: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)
D: Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale (24 hours and 7 days after quit date (week 4))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intrathecal Transplantation of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Patients With ALS
Brief Summary: ALS is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment that has been found to improve survival but only to a modest extent. It lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. It also extends the time before a person needs ventilation support.Stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.


Options:
A: Fever (48hours); Unconsciousness (48hours); vomiting (48hours)
B: Fever (48hours); Unconscious (48hours); Vomiting (48hours)
C: Forced vital capacity (Every 3 months)
D: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks (baseline and 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Cannabinoid-Based Therapy and Approaches to Quantify Pain in Sickle Cell Disease
Brief Summary: Our primary objective is to assess whether inhaling vaporized cannabis ameliorates chronic pain in patients with sickle cell disease (SCD). As these patients will all be on chronic opioid analgesics, the investigators will also assess the possible synergistic affect between inhaled cannabis and opioids. The investigators will also assess the clinical safety of the concomitant use of cannabinoids and these opioids in patients with SCD by monitoring the short-term side effects associated with combined therapy. Finally, the investigators will evaluate the short-term effects of inhaled cannabis on markers of inflammation and disease progression in patients with SCD.

Hypotheses are as follows:

1. Inhaled cannabis will significantly reduce chronic pain in patients with SCD.
2. Inhaled cannabis will significantly alter the short-term side effects experienced by patients who take opioids for SCD.
3. Inhaled cannabis will significantly alter markers of inflammation and disease progression in patients with SCD compared to placebo.


Options:
A: In vitro response of HbAA and HbSS erythroid cells to NRF2 activation by sulforaphane. (3 months); Safety, physiological effects and cellular effects of daily consumption of broccoli sprout homogenate in a cohort of Hb SS/SB0 thalassemia adult SCD patients (1-2 years)
B: Treatment Differences of the Change in Qualitative Splenic Function From Baseline (Before initiation of treatment and at 2 years)
C: Pain Rating Using Visual Analog Scale at Day 1 and Day 5 (Day 1 and Day 5)
D: The primary endpoint of the study will be the level of fetal hemoglobin after three months (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
Brief Summary: This is a Phase 1, open-label, dose-escalation trial of avelumab \[antibody targeting programmed death ligand 1 (anti PD-L1)\] with consecutive parallel group expansion in participants with selected tumor indications. New recruitment is open for all active cohorts.

Active cohorts: Escalation revised dosing regimen cohort.

Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .


Options:
A: Overall Survival (OS) (From randomization to the date of death (Up to 40 Months))
B: Overall Survival (OS) (From date of randomisation until death from any cause, assessed up to 58 months)
C: Survival (24 months)
D: Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) (Dose Escalation: Baseline up to Week 3); Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (Ovarian Cancer Efficacy Expansion: Baseline up to Day 620); Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931); Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871); Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) (HNSCC Efficacy Expansion: Baseline up to Day 1072)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Study of Use of Internet Mediated Walking Program and Pedometer in COPD
Brief Summary: Persons with COPD are randomized to pedometer versus pedometer plus Internet mediated website to promote walking and physical activity. Primary outcome is daily step counts. Intervention lasts 3 months.


Options:
A: Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose (Day 43, 60 minutes post-dose after 6 weeks of each treatment)
B: Daily Step Counts (pre and 3 months post)
C: Change from baseline of time spent in at least moderate physical activity (3>METS equivalent) (8 weeks)
D: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation
Brief Summary: This study has three main aims. Aim 1: To provide initial data on the efficacy of combined Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Aim 2: To explore the possibility that SGR+VN will be particularly efficacious among smokers with higher background levels of Cue Reactivity (CR), as assessed at the start of the study, using a classic experimental smoking CR paradigm. Aim 3: To explore possible mechanisms underlying the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy, cue-induced cravings) of treatment effects.


Options:
A: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
B: Continuous Nicotine Abstinence (8 weeks)
C: urine carcinogen biomarker of exposure, NNAL (week 24)
D: Comparison of Prolonged Abstinence (up to12 weeks post-quit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation
Brief Summary: This study has three main aims. Aim 1: To provide initial data on the efficacy of combined Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Aim 2: To explore the possibility that SGR+VN will be particularly efficacious among smokers with higher background levels of Cue Reactivity (CR), as assessed at the start of the study, using a classic experimental smoking CR paradigm. Aim 3: To explore possible mechanisms underlying the effects of SGR+VN, by assessing potential mediators (i.e., self-efficacy, cue-induced cravings) of treatment effects.


Options:
A: A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment. (2 years)
B: Biochemically/pharmacologically-confirmed 12-month continuous abstinence as evidenced by self-reports of nonsmoking status in all interviews (i.e., at 3, 6, and 12 months) (12 months)
C: Days to Relapse (4 weeks)
D: Comparison of Prolonged Abstinence (up to12 weeks post-quit)

Answer: D