TrialPanorama/Dataset huggingface dataset:
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: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
B: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
C: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
D: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)

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: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
B: Weight Gain in Treatment Completers (baseline and 12 weeks)
C: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)
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: Rating of urges to smoke 1-week after the target quit (1 week)
B: Biologically-verified 7-day Point Prevalence Smoking Abstinence (End of treatment (week 6))
C: 4-week continuous quit rate (CQR) for Weeks 9-12
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: 7-day smoking abstinence (7 days); 6-month smoking abstinence (6 months); cost-effectiveness (6 months)
B: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
C: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
D: The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (first 3 weeks)

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 (CQR) for Weeks 9-12
B: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
C: Safety (Baseline (week 0), Weeks 1-9, End of trial (Week 10)); Smoking cessation (End of trial (Week 10))
D: 7-day point prevalence of abstinence, 9-12 week continuous abstinence, 9-26 week continuous abstinence (9-12 weeks; 9-26)

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: Comparison of Prolonged Abstinence (up to12 weeks post-quit)
B: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
C: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
D: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy
Brief Summary: Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively


Options:
A: SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
B: Pain After Surgery (12 hours post-surgery)
C: number of patients with improvement in semen parameters and resolution of testicular pain (2 years)
D: pain score (Postoperative first 24 hours); Intraoperative complications (Average of 70 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of a Brief Educational Intervention to Increase Uptake of Influenza Vaccine Among Pregnant Women
Brief Summary: The investigators will conduct a brief educational intervention to pregnant women who have not yet received the influenza vaccine in this pregnancy to improve the uptake of seasonal influenza vaccine.


Options:
A: Humoral immune responses to influenza strains in the vaccine will be measured to assess the immunogenicity of TIV in HIV-infected pregnant women vaccinated between 20-34 weeks of gestational age (1 month post vaccination, delivery (+7 days), 24 weeks post delivery); The proportion of newborns born to HIV-infected mothers with hemagglutination inhibition (HAI) antibody titers of ≥1:40 to TIV strain will be determined and compared to newborns born to TIV-vaccinated HIV-uninfected women (parallel trial) (Delivery (+7 days))
B: The proportion of influenza vaccination (2 weeks postpartum)
C: The number of laboratory-confirmed influenza cases in infants born to mothers who received TIV or placebo will be used to determine efficacy of TIV vaccination of pregnant women against laboratory-confirmed influenza illness in their infants (24 weeks of age); Humoral and cell-mediated immune (CMI) responses to influenza strains in the vaccine will be measured to assess the immunogenicity of TIV in pregnant women vaccinated between 20-34 weeks of gestational age (one month post vaccination, delivery (+7 days), 24 weeks post natal)
D: Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age; local and systemic reactions within 2 weeks of vaccination

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Weight Reduction in Chronic Proteinuric IgA Nephropathy
Brief Summary: The study aims to explore the non-pharmacological treatment of IgA nephropathy by weight reduction. The investigators hypothesized that benefits of weight loss may reduce proteinuria.


Options:
A: Percentage change of 24-hour proteinuria (6 months)
B: Change in Proteinuria (12 weeks minus baseline); Change in Proteinuria (52 weeks minus baseline)
C: Measured glomerular filtration rate (renal function) using the iohexol clearance method in patients with stages 3-4 chronic kidney disease (0, 6, 12 months)
D: Difference in Tacrolimus Exposure (AUC-0-24)) in Obese Patients Who Received an Initial TAC -ER Dose of 0.15 mg/kg Using aBW Versus IBW (Days 1-14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Micafungin Versus Placebo in the Nosocomial Sepsis in Patients Multi-colonized With Candida, Randomized Controlled Trial
Brief Summary: Invasive Candida infections are burdened with a high mortality rate and is very common in intensive care units. This study aims to evaluate the efficacy of empirical treatment with micafungin in adult patients with suspected invasive candidiasis.


Options:
A: Overall Recruitment Rate (32 months)
B: survival to 28 days without proven fungal infection (a fungal infection occurring within 48 hours after inclusion will be considered available for inclusion) (28 days follow-up)
C: course of the colonization index over time. (AT 15 day from ICU admission)
D: Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. (Within 7 days after end of therapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: High Versus Standard Dose Protein for Very Preterm Infants
Brief Summary: Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Optimal dose and optimal mode of administration (standardized or individualized) of enteral protein supplementation to very preterm infants have not been established.

This study aims to compare the effects on weight gain of different modes of enteral protein supplementation.


Options:
A: Weight Gain (Study Day 1 to Study Day 29 (or discharge, whichever happens first))
B: growth during first three weeks of intervention (first three weeks during intervention before 36 weeks of gestation)
C: Daily growth velocity (g/kg/day) (From the beginning of human milk fortification until the end of hospitalization (mean period of treatment 4-5 weeks))
D: Weight gain (From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: High Versus Standard Dose Protein for Very Preterm Infants
Brief Summary: Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Optimal dose and optimal mode of administration (standardized or individualized) of enteral protein supplementation to very preterm infants have not been established.

This study aims to compare the effects on weight gain of different modes of enteral protein supplementation.


Options:
A: Caloric content of human milk (Daily until 36 weeks corrected gestational age)
B: Weight gain (From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA))
C: growth during first three weeks of intervention (first three weeks during intervention before 36 weeks of gestation)
D: growth (from inclusion at postmentrual age <32 weeks until 36 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Brief Summary: The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.


Options:
A: Duration of diarrhea (within the first 72 hours during hospitalization)
B: Clinical symptom 2 days after medication; Microbiology study 3 days and one week after medication
C: Number of Participants With Modified Vesikari Scale Score >=9 (14 days)
D: Development of moderate to severe disease in the 2 weeks after the index visit (Measured daily for 14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and MR Imaging Assessments in Patients With Intermittent Claudication Following Injection of Bone Marrow Derived ALDH Bright Cells
Brief Summary: The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells taken from a patient's bone marrow can be placed safely, via intramuscular injections, into their affected calf and lower thigh muscles and improve blood flow and/or peak walking time in patients experiencing pain associated with blocked blood vessels in the leg.


Options:
A: major amputation (six months)
B: The patient is alive, the patient has not undergone any major amputation, complete primary wound healing has been achieved, no ipsilateral relapse has occurred (12 months)
C: Peak Walking Time (PWT) (Assessed at baseline and 6 months); Leg Collateral Count (Via Contrast Enhanced-MR) (Assessed at baseline and 6 months); Peak Hyperemic Popliteal Flow (Phase Contrast MRA) (Assessed at baseline and 6 months); Capillary Perfusion (Assessed at baseline and 6 months)
D: Safety of Intramuscular Injection of CD34-positive cells (6 months and 1 year); Change in Rest Pain (6 months); Ulcer Healing (6 months); Functional Improvement (6 months); Limb Salvage (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and MR Imaging Assessments in Patients With Intermittent Claudication Following Injection of Bone Marrow Derived ALDH Bright Cells
Brief Summary: The purpose of this study is to find out if aldehyde dehydrogenase bright (ALDHbr) cells taken from a patient's bone marrow can be placed safely, via intramuscular injections, into their affected calf and lower thigh muscles and improve blood flow and/or peak walking time in patients experiencing pain associated with blocked blood vessels in the leg.


Options:
A: Change in Peak Walking Time During Treadmill Exercise Tolerance Test From Baseline to 3 Months (Baseline, 3 months)
B: major-amputation-free survival rate (at 6 months)
C: Peak Walking Time (PWT) (Assessed at baseline and 6 months); Leg Collateral Count (Via Contrast Enhanced-MR) (Assessed at baseline and 6 months); Peak Hyperemic Popliteal Flow (Phase Contrast MRA) (Assessed at baseline and 6 months); Capillary Perfusion (Assessed at baseline and 6 months)
D: major amputation (six months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction and Gastric Cancer
Brief Summary: This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram \[mg/kg\] intravenously \[IV\] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.


Options:
A: In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet. (Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization)
B: Overall Survival (OS) (2.5 years)
C: Response Rate (Complete and Partial) in Patients With Measurable Esophageal or GE Junction Adenocarcinoma (Up to 2 years post-treatment)
D: Overall Survival (From Baseline until death from any cause (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.4 [0-42] months vs. 25.0 [0-41] months; Final Analysis: 46.1 [0-70] months vs. 44.4 [0-68] months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Educational Video to Improve Nursing Home Care in End-stage Dementia
Brief Summary: This is a 5-year cluster RCT of a video Advance Care Planning intervention vs. control among 360 nursing home residents with advanced dementia (N=180/arm) in 20 matched nursing homes (10 intervention/10 control). Clinical outcomes will be collected at baseline, and quarterly (up to 12-months) regarding goals of care preferences, advance care planning, and treatments received. The primary outcome is decisions not to be hospitalized at 6 months.


Options:
A: Changes in Neuropsychiatric Inventory (24 weeks); Changes in Cornell's Depression Scale (24 weeks); Changes in UPDRS subscale (24 weeks)
B: Hospital Transfer Rate in Target Cohort (12-month observation period)
C: Relapse by Study Week 32 (0-16 weeks in Phase B (16-32 weeks in study))
D: Documented Decisions to Forgo Hospitalization (by six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China
Brief Summary: We plan to integrate WHO educational material using mobile phone text messaging, target on pregnant women in remote rural areas in China. We hypothsized that text messaging can have major impact on reducing maternal and infant deaths in rural China because text messaging is accessible, acceptable, and affordable.


Options:
A: Neonatal death (28 days)
B: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
C: Initiation of Long acting reversible contraception method (6 months)
D: Adherence to cervical cancer screening (step1) (Up to 20 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China
Brief Summary: We plan to integrate WHO educational material using mobile phone text messaging, target on pregnant women in remote rural areas in China. We hypothsized that text messaging can have major impact on reducing maternal and infant deaths in rural China because text messaging is accessible, acceptable, and affordable.


Options:
A: Exclusive breastfeeding (3 months)
B: Neonatal death (28 days)
C: Frequency of exclusive and total breastfeeding (First year)
D: Postpartum weight retention (no more than 1.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China
Brief Summary: We plan to integrate WHO educational material using mobile phone text messaging, target on pregnant women in remote rural areas in China. We hypothsized that text messaging can have major impact on reducing maternal and infant deaths in rural China because text messaging is accessible, acceptable, and affordable.


Options:
A: Influenza Immunization: Pediatric (March 31, 2011); Influenza Immunization: Pregnant Women (by December 31, 2011); Influenza Immunization: Delayed Pediatric (March 31, 2012)
B: HIV propensity score (0, 6 and 12 months)
C: Antiretroviral Therapy (ART) Adherence Levels (real time (for 9 months))
D: Neonatal death (28 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Mobile Phone Text Messaging to Reduce Maternal and Infant Deaths in Remote Rural Areas in China
Brief Summary: We plan to integrate WHO educational material using mobile phone text messaging, target on pregnant women in remote rural areas in China. We hypothsized that text messaging can have major impact on reducing maternal and infant deaths in rural China because text messaging is accessible, acceptable, and affordable.


Options:
A: Vaccines received (Electronic Health Record) (up to a year of follow up)
B: Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (36 weeks gestation)
C: MEMS Adherence (12 months follow up)
D: Neonatal death (28 days)

Answer: D