TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
Brief Summary: Cranberries have been proved to reduce the rate of urinary tract infections in a population of women with recurrent urinary tract infections in previous studies. The purpose of the study is to examine the efficacy of cranberries in pregnant women with preterm premature rupture of membranes in a)prolonging the latent period (=the time period between the time the water broke and delivery of the fetus) and b)reduction of infectious morbidity of both the mother and infant.


Options:
A: E.Coli Bacteriuria Plus Pyuria (One month)
B: Presence/absence of Asymptomatic bacteriuria (15 days post-op)
C: Length (in days) of the latent period; Neonatal infection; Respiratory distress; Admission to NICU (in days); Neonatal complications rate (NEC, IVH etc); Maternal infections (uterus, UTI)
D: UTI Recurrence (Variable for each participant over course of up to one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Motivational Interviews for ETOH+ Teens in the ER
Brief Summary: The purpose of this study is to compare the effectiveness of a brief family intervention in reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17 years old) who are treated in a hospital emergency department for an alcohol-related event.


Options:
A: Change in the number of drinks per week and the number of drinks per drinking day (Baseline, 3 months & 12 months)
B: At-risk drinking at 6 month followup (6 months); At-risk drinking at 12 month followup (12 months)
C: Reduction of 15% in alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the PFI group . In the self-help material group we expect that 5 - 10% will reduce their consumption equivalent. (12 months)
D: Alcohol use (3 months); Alcohol use (6 months); Alcohol use (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Motivational Interviews for ETOH+ Teens in the ER
Brief Summary: The purpose of this study is to compare the effectiveness of a brief family intervention in reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17 years old) who are treated in a hospital emergency department for an alcohol-related event.


Options:
A: Substance use will be assessed using items extracted from the Monitoring the Future Study. (Three years); Adolescent unsafe sexual behavior will be measured using Jemmott, Jemmott, and Fong's (1998) 37-item Sexual Behavior instrument. (Three years)
B: Comparison of susceptibility rate differences between the control and intervention groups (6 Months Post Intervention)
C: Diagnosis of mental health disorder (15 year follow-up)
D: Alcohol use (3 months); Alcohol use (6 months); Alcohol use (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Family Motivational Interviews for ETOH+ Teens in the ER
Brief Summary: The purpose of this study is to compare the effectiveness of a brief family intervention in reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17 years old) who are treated in a hospital emergency department for an alcohol-related event.


Options:
A: Alcohol Consumption (6, 9, and 12 months)
B: Primary outcome variables include alcohol misuse and violent behaviors. (12-months)
C: Alcohol use (3 months); Alcohol use (6 months); Alcohol use (12 months)
D: marijuana use (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing With Traditional Nitrogen Calorie Parenteral Nutrition Support, the Impact of Low Calorie and Low Nitrogen Intake on the Clinical Outcome of Gastrointestinal Postoperative Patients, Multicentre Post-Marketing Clinical Study
Brief Summary: The study is designed to investigate the influence of parenteral nutrition (PN) with low nitrogen and calorie supply on the clinical outcome of patients after an operation compared to that of traditional PNs.


Options:
A: Septic complication (average of one week)
B: Infectious complications (POD+1 to POD+14)
C: Ventilator-free days (day 28)
D: Documented Infection Rate (20 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The aim of this study is to describe and analyse the effects of multifactorial trial on the incidence of falls and injurious falls and on different risk factors of falling among the home-dwelling aged.


Options:
A: Number of falls and injurious falls in 12 months
B: The number of fallers who have fallen at least once during the 9-month study period (9 months)
C: Incidence of falls and injurious falls
D: Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hypnotics in the Treatment of Psychiatric Disorders
Brief Summary: This study will evaluate the safety and effectiveness of treatment with both a sleeping pill and antidepressant medication in improving sleep and psychological functioning in people with depression and insomnia.


Options:
A: Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings (9 weeks); Relation to Self/Others (RSO) Basis-32 Subscale Ratings (9 weeks); Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (9 weeks)
B: Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS). (Baseline (Day 0) to Week 12)
C: diagnostic yield of PSG (during overnight study); total sleep time (during overnight study); wake after sleep onset (during overnight study); sleep latency (during overnight study); sleep efficiency (during overnight study); total arousal index (during overnight study); respiratory disturbance index at highest CPAP level (during overnight study)
D: Mean Change From Baseline in Subject-Reported Total Sleep Time (TST) Averaged Over the 12 Week Double Blind Study Period. (Baseline (week 0), Day 1 (post first dose)-12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
Brief Summary: The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.


Options:
A: Normalized Net Incremental Area Under the Curve (AUC) for the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) Between Randomization and Week 12 (Baseline, Week 2, Week 4, Week 8, Week 12)
B: The primary end point was the proportion of patients with a 20% improvement response according to the ASAS criteria, at week 54.
C: Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) (16 weeks)
D: ASAS 40 at week 12

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies for the Prevention of HIV Infection and the Enhancement of Reproductive Health Among Adolescents in Rural Tanzania: MEMA Kwa Vijana Trial
Brief Summary: The MEMA kwa Vijana Project is a community randomised trial which aims to assess the impact of a targeted intervention on adolescent sexual and reproductive health in Mwanza Region, Tanzania. The intervention aims to reduce HIV, STD and unwanted pregnancy amongst adolescents by improving reproductive health knowledge and by teaching skills to promote sexual behaviour change, and comprises community mobilisation, skills-based education in primary schools, and youth friendly health services. The evaluation includes a detailed process evaluation, and evaluation of the impact in a cohort of approx. 10,000 adolescents who will be followed for 3 years.


Options:
A: Cohort I: 12 month experience of intimate partner violence; Cohort II: Condom use with last non-spousal partner; Cohort III: Condom use with last non-spousal partner; Cohort III: HIV incidence
B: HIV-1 seroincidence; HSV2 seroprevalence
C: HIV incidence
D: HIV sero-incidence (24 months post-baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies for the Prevention of HIV Infection and the Enhancement of Reproductive Health Among Adolescents in Rural Tanzania: MEMA Kwa Vijana Trial
Brief Summary: The MEMA kwa Vijana Project is a community randomised trial which aims to assess the impact of a targeted intervention on adolescent sexual and reproductive health in Mwanza Region, Tanzania. The intervention aims to reduce HIV, STD and unwanted pregnancy amongst adolescents by improving reproductive health knowledge and by teaching skills to promote sexual behaviour change, and comprises community mobilisation, skills-based education in primary schools, and youth friendly health services. The evaluation includes a detailed process evaluation, and evaluation of the impact in a cohort of approx. 10,000 adolescents who will be followed for 3 years.


Options:
A: HIV-1 seroincidence; HSV2 seroprevalence
B: contraceptive continuation (6 months)
C: HIV sero-incidence (24 months post-baseline)
D: Measurement of contraceptive adherence (12 months); Measurement of dual method use (12 months); Measurement of pregnancy rates and sexually transmitted diseases (STDs) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies for the Prevention of HIV Infection and the Enhancement of Reproductive Health Among Adolescents in Rural Tanzania: MEMA Kwa Vijana Trial
Brief Summary: The MEMA kwa Vijana Project is a community randomised trial which aims to assess the impact of a targeted intervention on adolescent sexual and reproductive health in Mwanza Region, Tanzania. The intervention aims to reduce HIV, STD and unwanted pregnancy amongst adolescents by improving reproductive health knowledge and by teaching skills to promote sexual behaviour change, and comprises community mobilisation, skills-based education in primary schools, and youth friendly health services. The evaluation includes a detailed process evaluation, and evaluation of the impact in a cohort of approx. 10,000 adolescents who will be followed for 3 years.


Options:
A: Time to Service Disengagement (12 months)
B: Number of self-reported falls: Falls surveillance report (10 minutes)
C: a weight loss of 7% in at least 19% of the subjects (one year); reduced body weight of at least 5.6 kg in at least 25% of the subjects (one year); an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects (one year); a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects (one year); a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects (one year)
D: HIV-1 seroincidence; HSV2 seroprevalence

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies for the Prevention of HIV Infection and the Enhancement of Reproductive Health Among Adolescents in Rural Tanzania: MEMA Kwa Vijana Trial
Brief Summary: The MEMA kwa Vijana Project is a community randomised trial which aims to assess the impact of a targeted intervention on adolescent sexual and reproductive health in Mwanza Region, Tanzania. The intervention aims to reduce HIV, STD and unwanted pregnancy amongst adolescents by improving reproductive health knowledge and by teaching skills to promote sexual behaviour change, and comprises community mobilisation, skills-based education in primary schools, and youth friendly health services. The evaluation includes a detailed process evaluation, and evaluation of the impact in a cohort of approx. 10,000 adolescents who will be followed for 3 years.


Options:
A: Contraceptive use at time of last sexual intercourse (18 months)
B: HIV-1 seroincidence; HSV2 seroprevalence
C: rates of STIs (Baseline, 6 and 12 months); computer-assisted survey results (baseline, 1 week, 3, 6, & 12 months); - score on self-report of frequency of risky sexual and substance use behaviors (baseline, 1 week, 3, 6, & 12 months)
D: HIV sero-incidence (24 months post-baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial: Changing Behavior in Post-Angioplasty Patients
Brief Summary: The long-term objective of this study is to determine whether a positive affect and self-affirmation condition added to an empirically demonstrated approach for motivating behavior change is more effective than a standard approach in reducing risk factor behavior among a high-risk group of patients with coronary artery disease. Thus, the goal of the project is to refine and improve strategies for long-term maintenance of physical activity among patients post-angioplasty or stent.


Options:
A: nicotinic weaning (1year); weight loss at least 5% (1 year); waist reduction at least 4% (1 year); physical activity at least 30 minute per day (3h per week) (1 year)
B: Within patient change in the Paffenbarger Exercise and Physical Activity Index (basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout)
C: Medicare program expenditures (Eight years)
D: The reduction of systolic blood pressure in the nurse administered intervention will be 5 mm hg lower than those patients randomized to an education control group over 12 months of follow-up (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Combined Aerobic and Resistance Exercise in Breast Cancer Survivors. The CARE Trial.
Brief Summary: Endurance exercise such as walking has been shown to help breast cancer survivors maintain their energy and quality of life while they are receiving chemotherapy, but there have not been any studies on weight training. In this study, the researchers want to determine if a combined program of endurance and weight training exercises is better than a standard amount of endurance exercise or even a higher amount of endurance exercise in breast cancer survivors receiving chemotherapy. The study will be an experimental design in which the researchers have breast cancer survivors participate in one of the three different exercise programs. The researchers' main interest is in patient rated physical functioning and quality of life, which they will measure before and after the exercise programs by asking participants how they feel on various rating scales. The researchers will also measure their aerobic fitness on a treadmill and how strong they are by having them lift weights.


Options:
A: Patient rated physical functioning (at 8 weeks and 24 weeks)
B: Exercise Tolerance (Exercise tolerance 3 weeks after hospital discharge); Exercise Tolerance (Exercise tolerance 3 months after surgery)
C: Change from baseline in numbers of goal behaviors at 3 months (Baseline (pre-treatment) and after 12 weeks of intervention (post-treatment))
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of the Safety and Effectiveness of CONCERTA® (Methylphenidate Hydrochloride), up to 72 mg Daily, in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents..


Options:
A: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)
B: Change in ADHD and ODD symptoms (Every week for six weeks); Change in attention, motor activity and executive functioning (The neuropsychological tests are administered once on each type of medication during the six week trial); Change in side-effects (Once every week through the six week trial)
C: ADHD Severity (baseline and 20 weeks); Substance Use (20 weeks)
D: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of the Safety and Effectiveness of CONCERTA® (Methylphenidate Hydrochloride), up to 72 mg Daily, in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents..


Options:
A: Systolic Blood Pressure (Baseline and 6 months); Diastolic Blood Pressure (Baseline and 6 months); Pulse Rate (Baseline and 6 months); Electrocardiogram Results (QTcF Interval) (Baseline and 6 months); Post Sleep Questionnaire (PSQ) Quality of Sleep (6 months); Weight (Baseline and 6 months); Dermal Reactions (6 months)
B: Cigarette Smoking (24 months)
C: The change from survey day 1 to first visit in Clinical Global Impression score (3 weeks)
D: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of the Safety and Effectiveness of CONCERTA® (Methylphenidate Hydrochloride), up to 72 mg Daily, in Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of CONCERTA® (methylphenidate hydrochloride, a central nervous system (CNS) stimulant) versus placebo for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents..


Options:
A: Total score on the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale, evaluated by the investigator at the end of the Double-Blind Phase.
B: Attention Deficit / Hyperactivity Disorder Total Sum Score of All 18 ADHD Symptom Items (end of first week, end of second week, end of third week, end of fourth week. Total of 4 weeks.)
C: Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9). (12-hours from 8:00 am to 8:00 pm)
D: Change from Baseline in Clinician-administered ADHD-5-Rating Scale (Baseline week 2, weeks 3-6)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Therapeutic Workplace Maintenance Study
Brief Summary: This application is a competing continuation of a grant in which we developed and pilot tested a computerized Therapeutic Workplace designed to train and employ adults as data entry operators. A randomized trial is planned over 5 years to investigate the Therapeutic Workplace business as a maintenance intervention to sustain long-term abstinence and employment. Welfare recipients in methadone treatment, actively using cocaine, and at risk for contracting or spreading HIV infection will participate in an initial Therapeutic Workplace training phase. Participants who become abstinent and skilled will be randomly assigned to an Abstinence \& Employment, or an Employment Only group. Participants in the Abstinence \& Employment group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary. Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work. This study will provide a rigorous evaluation of the efficacy of the Therapeutic Workplace business as a long-term treatment of cocaine addiction and unemployment; determine the benefits of requiring daily evidence of abstinence to work; and provide information on the extent to which a Therapeutic Workplace business can become self-sustaining. This research could provide firm scientific foundation for the dissemination of Therapeutic Workplace businesses in the long-term treatment of cocaine addiction and unemployment. The main hypothesis being tested is that cocaine abstinence will be reliably maintained during the yearlong intervention evaluation period only in the group exposed to the explicit abstinence maintenance intervention. We expect that cocaine abstinence in the Abstinence and Employment group will be significantly greater than cocaine abstinence in the Employment Only group.


Options:
A: Percentage of Monthly Urine Samples That Are Negative for Cocaine (1 year)
B: Longest Duaration of Achieved Abstinance (12 weeks of treatment); Percentage Samples Submitted Negative for Crack Cocaine Use (12 weeks); Number of Participants Completing 4, 8 and 12 Weeks of Treatment (Number of participant retained in treatment at weeks 4, 8 and 12.); Treatment Attendance (12 weeks)
C: Addiction Severity Index Alcohol Composite (Baseline, end of treatment (month 3), 3-month post-treatment follow-up); Addiction Severity Index Drug Composite (Baseline, end of treatment (3 months), and 3-month post-treatment followup); Brief Addiction Monitor (Baseline, end of treatment (month 3), 3-month post-treatment follow-up)
D: Reduction in Condomless Anal Sex Acts (CAS) over study follow-up (Baseline, 4 month, 8 month, 12 month)

Answer: A