TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaccination of HIV-uninfected Pregnant Women With Trivalent Influenza Vaccine in the Prevention of Influenza Illness During Early Infancy and in Mothers: Randomized Controlled Phase III Trial Evaluating Safety, Immunogenicity and Efficacy
Brief Summary: Randomised, double blind, placebo controlled trial to assess safety, immunogenicity and efficacy of Trivalent Influenza vaccine in HIV uninfected pregnant women


Options:
A: 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)
B: 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))
C: Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age; local and systemic reactions within 2 weeks of vaccination
D: Influenza Immunization: Pediatric (March 31, 2011); Influenza Immunization: Pregnant Women (by December 31, 2011); Influenza Immunization: Delayed Pediatric (March 31, 2012)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Trivalent Influenza Vaccine in HIV-infected Pregnant Women and Kinetics of Transplacental Anti-influenza Antibody Transfer and Persistence in Young Infants: A Randomized Controlled Phase II Trial Evaluating Safety and Immunogenicity
Brief Summary: This randomized, placebo controlled trial will evaluate the safety and immunogenicity of Trivalent Influenza Vaccine (TIV) in HIV-infected pregnant women, dynamics of transplacental anti-influenza antibody transfer to their newborns and kinetics thereof during early infancy.


Options:
A: Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens (21 days to 180 days after the date of vaccination); The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values (21 Days after vaccination)
B: occurrence of confirmed influenza
C: Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. (Up to 6 days after each vaccination.); Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine. (Upto Day 224 post vaccination)
D: 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))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Trivalent Influenza Vaccine in HIV-infected Pregnant Women and Kinetics of Transplacental Anti-influenza Antibody Transfer and Persistence in Young Infants: A Randomized Controlled Phase II Trial Evaluating Safety and Immunogenicity
Brief Summary: This randomized, placebo controlled trial will evaluate the safety and immunogenicity of Trivalent Influenza Vaccine (TIV) in HIV-infected pregnant women, dynamics of transplacental anti-influenza antibody transfer to their newborns and kinetics thereof during early infancy.


Options:
A: Serum anti pneumococcal polysaccharide IgG antibody at 20 weeks of age; local and systemic reactions within 2 weeks of vaccination
B: 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))
C: Influenza Immunization: Pediatric (March 31, 2011); Influenza Immunization: Pregnant Women (by December 31, 2011); Influenza Immunization: Delayed Pediatric (March 31, 2012)
D: The proportion of influenza vaccination (2 weeks postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Ketamine as an Anaesthetic During Electroconvulsive Therapy (ECT) for Depression: Does it Improve Treatment Outcome?
Brief Summary: The main aim of this research is to ascertain whether Ketamine would be a more effective anaesthetic for Electroconvulsive Therapy (ECT) than the standard anaesthetic. In doing so the investigators aim to examine the effect of ketamine on ratings of depressive symptoms, the number of required ECT treatments, and the effect of this anaesthetic on memory.


Options:
A: Montgomery-Asberg Depression Rating Scale (MADRS) (Measured daily for 12 days, where the endpoint is the primary outcome)
B: Measurements of BOLD signal in the brain area BA25 (Day1 (at infusion))
C: Change in depressive symptoms (After 4th treatment)
D: Part 1: Number of Participants With Moderate Intensity Adverse Events (AEs) (Up to 7 days following the last dose of study drug (Up to 23 days)); Part 1: Number of Participants With Serious Adverse Events (SAEs) (Up to 30 days following the last dose of study drug (Up to 46 days)); Part 1: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 16 days)); Part 2: Number of Participants With AEs (Up to 7 days following the last dose of study drug (Up to 35 days)); Part 2: Number of Participants With AEs Leading to Discontinuation of Study Drug (Up to the last dose of study drug (Up to 28 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Supplementation of Enteral Lipid With Combination of Microlipid and Fish Oil in Infants With Enterostomy
Brief Summary: Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants. Often surgery is needed to remove the dead bowel and create an ostomy (a temporary intestinal opening on the infant's abdomen). Infants with ostomies cannot digest and absorb food well, and must receive nutrition through the blood stream, i.e. parental nutrition (PN). However, prolonged dependence on PN can severely damage the liver and gut. Therefore, giving nutrition through the gut, i.e. enteral nutrition, is the primary treatment for infants with ostomies.

Enteral fats, especially polyunsaturated fatty acids (PUFA), are most beneficial in stimulating gut mucosal adaptation, which begins 24 to 48 hours following bowel resection. In addition, the premature intestine has a rapid growth rate. It is likely that the current clinical practice of giving a relatively low-fat diet to infants with ostomies may not meet their high metabolic needs.

The investigators hypothesize that increasing dietary fat content by early supplementation with MicroLipid® (ML, n-6 PUFA) and fish oil (FO, n-3 PUFA) to preserve the proper balance of n-6 and n-3 PUFA, may (i) improve bowel adaptation and infant growth; (ii) reduce the use of PN; and (iii) prevent liver damage and/or cholestasis (jaundice) in infants with ostomies.


Options:
A: Sum of omega-3 fatty acid levels in membrane phospholipids of RBC (after 4 months of consumption)
B: plasma phospholipid fatty acid composition (28 days after intervention start); visually evoked potentials (48 weeks and 56 weeks postconceptional age)
C: Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis (up to three years)
D: change of weight from day 30 to day 120 (postnatal age 30 to 120 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomised, Placebo and Active Controlled, Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKP.TRIS With TRAM.HCL in Comparison With the Single Agents, on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction
Brief Summary: The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.


Options:
A: Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing. (6 hours)
B: Summed Pain Intensity Difference (SPID)-Calculated From the Pain Intensity Scores Recorded on a 100mm Long Scale With Anchors for "no Pain" (0 mm) and "Worst Pain Imaginable" (100 mm). (48 hours after the first dose)
C: Change in the Patient Demand for the Narcotic Analgesic, Morphine, Post Surgery (24 Hours)
D: Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) (0 to 8 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomised, Placebo and Active Controlled, Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKP.TRIS With TRAM.HCL in Comparison With the Single Agents, on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction
Brief Summary: The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.


Options:
A: SPID8 (Sum of Pain Intensity Differences Over 8 Hours) (over 8 hours after the first dose)
B: Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing. (6 hours)
C: Postoperative pain measurement employing a previous validated visual analogue scale of pain (VAS). (72 hours)
D: SPID8 (Sum of Pain Intensity Differences Over 8 Hours) (over 8 hours after the first dose)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women
Brief Summary: The purpose of this study is to see if using misoprostol makes the intrauterine device insertion easier and less painful in women who have never had a baby.


Options:
A: Patient Perceived Pain on a 100-point Visual Analogue Scale. (Prior to insertion, immediately after insertion, and prior to clinic discharge.)
B: The effect of uterine size or posture on IUD insertion. (Day 1)
C: The Ease of IUD Insertion as Rated by the Provider Using a 100mm Visual Analog Scale (VAS). (Time of IUD insertion)
D: Evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider. (over one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Weight Management Demonstration Project: Healthy Eating and Active Living in TRICARE Households
Brief Summary: The study investigated the effectiveness and cost-effectiveness of a cognitive and behavioral weight management program, complemented by an interactive Web site and brief telephone coaching, implemented among TRICARE non-active-duty beneficiaries.

A total of 1,755 participants from four Midwestern states were randomized to one of three randomized controlled trial groups with increasing intervention intensity: mailed material and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief phone- and Web-based coaching support from health lifestyle coaches (RCT3). The study assessed changes in participants' weight, blood pressure, diet, and physical activity from baseline to 6, 12, and 15 to 18 months. Analyses estimated overall cost savings and calculated the cost-effectiveness ratio of each randomized controlled trial compared with a "do-nothing" alternative as the cost per quality-adjusted life year.


Options:
A: The Generalised Anxiety Disorder 7-item (GAD-7) (Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.)
B: 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)
C: Weight loss (3 months, 6 months, 12 months)
D: Body Mass Index BMI (change in body mass index at baseline); BMI (change in body mass index at 6 months); BMI (change in body mass index at 12 months); BMI (change in body mass index at 18 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Brief Cognitive Behavioral Intervention Designed to Prevent and Reduce Symptoms of Posttraumatic Stress in Mothers of Preterm Infants.
Brief Summary: The purpose of the study includes:

1. To develop a treatment manual and pilot test this treatment intervention which is designed to prevent and reduce psychological distress in parents who have infants hospitalized in the neonatal intensive care unit (NICU).
2. To conduct a treatment intervention study in which parents of NICU infants will receive a 6-12 session treatment designed to reduce psychological distress, and to compare outcomes with parents who do not receive the intervention.

We hope to learn whether or not a simple psychotherapeutic and psychoeducational intervention offered to parents of NICU infants can prevent or minimize the development of symptoms of psychological distress in parents, including symptoms of anxiety and depression and posttraumatic stress disorder (PTSD).


Options:
A: Davidson Trauma Scale (6 months); BDI-II (6 months)
B: Percent of Eligible Participants Who Provided Consent (pre-randomization); Percent of Eligible Participants Who Provide Informed Consent and Were Randomized (randomization); Client Satisfaction Questionnaire (CSQ) Score (1 month post-randomization); System Usability Scale (SUS) (1 month post-randomization); Percent of Randomized Participants Who Drop Out of Study (baseline, end of study (approx. 4 months)); Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews (baseline, end of study (approx. 4 months)); Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys (baseline, end of study (approx. 4 months)); Percentage of Self-directed MBT Sessions Attended by Eligible Participants (baseline, end of study (approx. 4 months)); Visual Analog Satisfaction Scale (after intervention completion, up to 8 weeks post-randomization); Number of Participant Clicks on Study Website (baseline, end of study (approx. 4 months))
C: PTSD Symptom Scale- I (PSS) (Measured 4 and 12 weeks post-trauma)
D: PTSS-14 (Post Traumatic Stress Symptoms) (3 months post discharge from ICU)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence
Brief Summary: This pilot project proposes to monitor real-world alcohol use using a novel technology-cell phone videorecordings in conjunction with breathalyzer recordings-and to conduct a small randomized study of this technology for reinforcing alcohol abstinence. Individuals with frequent alcohol use (N = 30) will be asked to carry a study cell phone plus a handheld breathalyzer for one month. Participants will be randomized to one of two conditions: alcohol monitoring or alcohol monitoring plus contingency management. In both conditions, research assistants will telephone participants on their cell phone an average of 10 times per week to request submission of a breathalyzer sample using the video monitoring function on the cell phone. Samples will be time and date stamped, and the video containing the breathalyzer result will be sent to study staff via the cell phone. Participants will be compensated for each video recorded within one hour of receiving the prompt. Participants randomized to the contingency management condition will receive the same alcohol monitoring described above, and they will also receive reinforcement for each alcohol negative breath sample submitted within one hour of the prompt. Data from this pilot project will be useful for (1) determining the feasibility of assessing alcohol use in the natural environment via breathalyzers and cell phone technology, and (2) estimating effect sizes of a CM intervention that reinforces alcohol abstinence using breathalyzers and cell phone technology. In an exploratory manner, we will also evaluate the reliability and validity of the video monitoring procedure and trends toward changes in psychosocial functioning.


Options:
A: Frequency of consumption (6 months and 12 months); Usual number of drinks per occasion (6 months and 12 months); Frequency of consuming 5 or more drinks on one occasion (6 months and 12 months); Typical weekly consumption (6 months and 12 months); Highest number of drinks on one occasion (6 months and 12 months)
B: Alcohol Use Disorders Identification Test - Consumption scale (AUDIT-C scale) (6 weeks)
C: proportion of negative breath samples submitted (Week 4)
D: Change in estimated Blood Alcohol Concentration (eBAC) (7 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Web-Based Weight Loss & Weight Maintenance Intervention for Older Rural Women
Brief Summary: This project will evaluate an Internet delivery strategy to address weight loss and maintenance among rural midlife and older women.


Options:
A: Carotid Intima Media Thickness (baseline and 12 months); Waist Circumference (baseline and 12 months); High Density Lipoprotein (HDL) (baseline and 12 months); Glucose (baseline and 12 months); Systolic Blood Pressure (baseline and 12 months); Coronary Artery Calcium Score (baseline and 12 months)
B: Primary outcomes are physical activity/exercise and body weight/ composition. Physical activity is assessed by accelerometry and standardized interview/questionnaire methods. Body composition is assessed by DXA (baseline, 4, 12, 16, 24 and 36 months)
C: 1: Differences in Change in Weight between Groups - Body Weight (kg) (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Weight between Groups - waist circumference (cm) (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Kcal intake (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Weekly minutes moderate or greater intensity activity (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Pressure (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months); Differences in Change in Healthy Eating and Activity Outcomes between Groups - Blood Lipids (Phase 1-baseline and 6 months, Phase 2-6 months and 18 months, Phase 3-18 months and 30 months)
D: Minutes of Moderate or Vigorous Physical Activity Per Week After 12-months (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 Monohydrate in the Acute Treatment of Patients With DSM-IV-TR Schizophrenia
Brief Summary: The purpose of this study is to determine whether at least 1 dose level of LY2140023 given to acutely ill patients with schizophrenia will demonstrate significantly greater efficacy as compared to placebo.


Options:
A: Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline (Screen, baseline, Days 4,7,14,21,28,35,42)
B: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)
C: Clinical Utility Index (CUI) (Baseline through Week 6)
D: To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score (28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 Monohydrate in the Acute Treatment of Patients With DSM-IV-TR Schizophrenia
Brief Summary: The purpose of this study is to determine whether at least 1 dose level of LY2140023 given to acutely ill patients with schizophrenia will demonstrate significantly greater efficacy as compared to placebo.


Options:
A: Time to Relapse or Impending Relapse (Up to 26 weeks post-randomization)
B: A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population (baseline, up to 7 weeks of treatment); A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients (baseline, up to 7 weeks of treatment)
C: The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
D: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline, Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Gaining Further Understanding of the Underlying Mechanisms of Myocardial Function
Brief Summary: The main focus of the project is to determine to what degree myocardial energy metabolism is linked to impaired function in human cardiomyocytes, whether exercise training and remote ischemic preconditioning can restore cardiomyocyte function and whether this is linked to improved mitochondrial and cell function.


Options:
A: Composite structural and functional neurological outcome (7 days)
B: Mitochondrial respiration (1 hour)
C: In-hospital death (Postoperative 30 days); Myocardial infarction (Postoperative 30 days); Stroke (Postoperative 30 days); Respiratory failure (Postoperative 30 days); Renal dysfunction (Postoperative 30 days); Renal failure (Postoperative 30 days); Cardiogenic shock (Postoperative 30 days); Gastrointestinal complication (Postoperative 30 days)
D: Cardiopulmonary exercise capacity (time to complete time trail, lactate anaerobic threshold, cardio-pulmonary exercise capacity (7 days)

Answer: B