TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations
Brief Summary: The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.


Options:
A: unmet need (past 6 months); abstinent from alcohol and opioid use, past 30 days (past 30 days); negative consequences related to substance use (past 3 months); Functioning (past 4 weeks); Engagement (30 days of initiation); initiation (Within 14 days of index visit); heavy alcohol use (6 months)
B: Proportion of participants with a PrEP prescription at baseline who initiate PrEP (6 months post enrollment); Proportion of participants with a PrEP prescription at baseline who attend at least one follow-up visit and have at least one documented PrEP prescription refill during each 3-month interval (6 months post enrollment); Percentage of participants with a PrEP prescription at baseline who adhere to their PrEP regimen (6 months post enrollment)
C: Amount of calcium supplement ingested (8 weeks after ANC consultation, during which recruitment into the study occurred)
D: Framingham cardiovascular disease risk (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations
Brief Summary: The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.


Options:
A: Amount of calcium supplement ingested (8 weeks after ANC consultation, during which recruitment into the study occurred)
B: Serum 25-hydroxyvitamin D in pregnant women and cord blood (Change from 1st through 2nd trimester and at delivery)
C: 25-Hydroxyvitamin D Concentration (7 months)
D: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)
Brief Summary: This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).


Options:
A: Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA (180 days)
B: Number of Participants With 0 or 1 on Modified Rankin Scale (90 days); Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration (48-hours)
C: Adjudicated Recurrent Stroke (From randomisation until full follow up period, approximately 43 months.); First Major Bleed (Adjudicated) (Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)
D: New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death (every 4 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)
Brief Summary: This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).


Options:
A: Adherence to medication; self-reported current use of antiplatelet, statin and combination (≥ 2) blood pressure lowering therapy (End of trial follow-up); Change in blood pressure (End of trial follow-up); Change in LDL cholesterol (End of trial follow-up)
B: Any stroke at 90 days; Stroke severity
C: Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke (Within 30 days following the onset of acute atherothrombotic stroke)
D: Adjudicated Recurrent Stroke (From randomisation until full follow up period, approximately 43 months.); First Major Bleed (Adjudicated) (Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Brief Summary: The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.


Options:
A: Knowledge about Living Kidney Donation (3 weeks)
B: Systolic Blood Pressure (SBP) (one year)
C: Number of Adverse Events Reported During the Study. (Thru the Month 24 Visit); Change in C-peptide (Baseline to the Month 6 Visit)
D: The difference of rate of estimated glomerular filtration rate (eGFR) decline (30 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)
Brief Summary: This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.


Options:
A: Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias (90 days)
B: Modified MACTAR scale (6 months)
C: Step Length During Gait (Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks); Walking Speed During Gait (Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks)
D: Unified Parkinson's Disease Rating Scale (UPDRS) Part III (30 minutes post-dose at week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Reaching High Risk Post-partum Women for Nutritional Assessment and Counseling Via a Telephone-based Coaching Program
Brief Summary: The purpose of the STAR-MAMA intervention is to develop a patient-tailored telephone-base counseling intervention for young Latino women who are at high risk of diabetes. The intervention will focus at the end of pregnancy and the 9 months post-partum period to improve education and behavioral counseling on nutrition and other related health topics .

The following hypotheses will be formally tested:

Compared with controls at 9 months post-partum:

1. Women in the STAR-Moms program will have improved self-reported behavioral outcomes for minutes of physical activity, lower fat diet, and breast-feeding duration (in weeks);
2. Women in the STAR-Moms program will have improved diabetes prevention knowledge;
3. Women in the STAR-Moms program will have increased diabetes-relevant screening rates.

Women in the STAR-MAMA will have lost more weight than women in the control group.


Options:
A: HbA1c (30 Weeks)
B: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)
C: Change in Body mass index (BMI) (Baseline, 6 and 9 month follow-up.)
D: Behavior change (6 month -12 months post-partum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis
Brief Summary: Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique utilized to diagnose and treat pathologic conditions involving the ducts draining the liver and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and occurs in approximately 11% of children undergoing the procedure. By definition it leads to prolongation of hospital stay or delays in care and rarely can result in long-term morbidity or even death. Recent adult trials have demonstrated prevention of PEP with administration of rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed in children thus no "gold standard" or even commonly accepted method of preventing PEP in the pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages over rectally administered NSAIDs in the pediatric population in that it would allow for more consistent weight based dosing and would have more predictable absorption compared to suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical Center Dallas over a two-year period. The primary outcome measurement will be development of PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease rates of post-ERCP pancreatitis in pediatric patients.


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: additional administration of analgesics (during stay time in PACU (postanesthesia care unit) average of over 30 minutes up to 1 hour)
C: Post-ERCP Pancreatitis (2 weeks)
D: 11-point Visual Analog Scale for Pain (1-2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cost Effectiveness and Effectiveness of the Addition of Different Weekly Frequency of Modified Pilates Method Exercises to a Minimal Intervention in the Treatment of Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
Brief Summary: Low back pain is a major cause of disability and absenteeism and the supervised exercise is a recommended treatment by the guidelines and has been cost-effective. Currently, the Pilates method has shown to be effective in improving pain and disability in patients with chronic low back pain (CLBP). However, there is still no evidence about the ideal number of sessions for the treatment and the interval between sessions to achieve better efficacy of this method for these patients. Thus, the aim of this study is to investigate the effectiveness of the Pilates method with different weekly frequency of sessions in the treatment of patients with nonspecific CLBP. Investigators will assess 296 patients of both genders, with nonspecific CLBP lasting more than three months and aged between 18 and 80 years. Participants will be randomly divided into four groups (n = 74 patients per group): Control Group will receive an educational booklet and no additional exercise, Pilates 1 Group will receive a program of exercises based on Pilates method once a week for six weeks, Pilates 2 Group will receive the same program of exercises twice a week for six weeks and Pilates 3 Group will receive the same program of exercises three times a week for six weeks. The outcomes overall disability (Roland Morris Disability questionnaire), specific disability (Patient-Specific Functional scale), kinesiophobia (Tampa scale for kinesiophobia), pain intensity (Pain Numerical Rating scale) and global perceived effect (Global Perceived Effect scale) will be assessed by a blinded assessor before, six weeks, six and 12 months after randomization. Investigators expect that the largest number of weekly sessions of Pilates method may influence the results in all analyzes (short, medium and long term), since there is a relationship between frequency of exercises and effect size of the treatment.


Options:
A: Pain Intensity (5 weeks after randomization); Disability (Five weeks after randomization)
B: The Roland Morris Disability Questionnaire (RDQ) Score (12 months)
C: Pain intensity (Six weeks after randomization); Disability (Six weeks after randomization)
D: Low back pain, referred pain and disability (Baseline, 2, 6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) Study
Brief Summary: This study aims to determine whether, compared with usual anesthetic care, an electroencephalography-guided anesthesia protocol is effective at preventing postoperative delirium and its downstream effects, and improving postoperative patient reported health-related quality of life.


Options:
A: POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia (Both groups will complete the MMSE at 1, 6, and 24 hours after the end of anesthesia or to disharge up to 7 days.)
B: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
C: BIS side difference (intra- and postoperative (day 1))
D: Number of Participants With Delirium (5 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tools to Improve Parental Recognition of Developmental Deficits in Children
Brief Summary: In this study, we aim to improve child nutrition by increasing parents' awareness of their children's physical growth. We use a cluster-randomized trial design to evaluate two interventions that provide parents with regular information on their children's physical development and growth: 1) distribution of full-sized growth charts for measurement of child height within households; and 2) organization of community-based meetings, during which children's height and weight are measured by trained project staff.


Options:
A: Changes in body weight after 3 months of intervention in children (3 months); Changes in weight-for-age z score after 3 months of intervention in children (3 months); Changes in height-for-age z score after 3 months of intervention in children (3 months); Changes in weight-for-height z score after 3 months of intervention in children (3 months); Changes in dietary intake after 3 months of intervention in children (3 months); Changes in diet quality after 3 months of intervention in children (3 months)
B: Change from baseline in prevalence of child wasting (baseline, and then at each study visit (every 6 months over 36 months))
C: Height-for-age z-score (At the end of one year); Child development outcomes (At the end of one year)
D: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) (6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions
Brief Summary: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years


Options:
A: Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria (Baseline until disease progression or death up to approximately 3.75 years)
B: Progression Free Survival (PFS) (Up to 2 years 10 months)
C: Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) (Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021))
D: Primary Analysis: Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 30 (Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]).); Final Analysis: PFS Based on Investigator Assessment - Kaplan Meier Landmark Estimates at Month 48 (Month 48 (Median follow-up time was 44.6 months at the time of the final analysis [data cutoff date: 17 October 2019]).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving the Decision Making Process About Location of Care With the Frail Elderly and Their Caregivers
Brief Summary: One of the toughest decisions faced by the frail elderly in Canada is whether to stay at home or move to a care facility. It is certainly difficult to make this decision alone, but can be even harder if someone else makes it for you. Shared decision making is when, instead of making decisions for the patient, healthcare professionals share information about what the evidence says, and they talk about what's important with the patient, and then make the decision together. In the case of the frail elderly in home care services, there are many health care professionals involved, e.g. the doctor, nurse and social worker. In this case decisions should be shared by all the professionals involved with the elderly person along with his or her caregivers. Unfortunately, in this context, shared decision making rarely occurs.

We have designed a training program that teaches interprofessional teams how to share decisions with their frail elderly patients, and tested it in one Quebec City and one Edmonton home care team. This project tests the training program on a broader scale with 16 home care teams attached to community health centres across the province of Quebec, and will compare the results with what happens when no one has completed the training (usual care). Home care is a rapidly growing sector and this study will lay the foundations for a national strategy to ensure that no one has to make this difficult decision alone.


Options:
A: Health Related Quality of Life according to EuroQoL (5 questions, 3 levels) (12 months)
B: Evaluation of effects (T1: Initial evaluation; T2: after three months; T3: one year after T1)
C: The assumed role in the decision making process, and the preferred and chosen options. (3 to 6 months)
D: SF-36 Physical Health Summary Scale (Baseline, 6, 18, and 32 months); SF-36 Mental Health Summary Scale (Baseline, 6, 18, and 32 months); Health Services Utilization (Baseline, 8, 20, and 32 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Delivery of Integrated Family Planning/HIV Testing and Counseling Services in Uganda
Brief Summary: The purpose of this study is to evaluate the feasibility and acceptability of adding HIV testing and counseling (HTC) services to the family planning (FP) services provided by community health workers in Uganda.


Options:
A: Sequence-verified HIV-transmission from index to partner participant (March 2009)
B: Composite score of essential aspects of family planning/HTC service provision calculated from VHTs' responses to survey questions (10 days)
C: HIV sero-incidence (24 months post-baseline)
D: Unintended pregnancies (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tools for Teen Moms: Reducing Infant Obesity Risk
Brief Summary: The purpose of this social media group randomized trial (GRT) is to test the feasibility of our Baby Dayr for Teen Moms intervention to increase maternal responsiveness to infant cues and implement healthy feeding practices through development of a healthy feeding style.

Aim 1: Evaluate the feasibility and acceptability of the Baby Dayr intervention administered to the target population as it relates to their acceptance and satisfaction with the content, format, delivery, and use of social media.

Aim 2: Explore efficacy of the Baby Dayr intervention administered to adolescent mothers of infants 4 months of age or less as assessed by maternal responsiveness, feeding style, and feeding practices evaluated at the completion of the intervention using self-report methods.


Options:
A: Change in Fruit and Vegetable Consumption at School Lunch (assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May).); Change in Student Activity Level (assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September))
B: Changes in weight (3, 6, and 12 months after the beginning of the assigned intervention program)
C: Change in Infant Growth (Baby is less than 2 months; baby is 3 months; baby is 6 months)
D: Overweight (one school year)

Answer: C