TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Transcervical Foley Balloon Compared to Controlled Release Prostaglandin (Cervidil) for Labor Induction and Cervical Ripening in Term and Near Term Women
Brief Summary: OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction.

HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™).


Options:
A: Time from treatment start to delivery (At delivery)
B: Time Of Start Of Induction Of Labor To Delivery (Hours)
C: Attainment of vaginal delivery within 24 hours. (24 hours)
D: caesarean section rate (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Management of Depression in Primary Health Care: a Controlled Trial on the Effectiveness of Regular, Structured, Patient-centered Visits
Brief Summary: Most people in Sweden with mild to moderate depression are treated in primary care, but follow-up is unstructured, and we know little about whether structured, follow-up would affect the prognosis for depression and working life. The purpose of this study is to determine the effectiveness of regular, structured, patient-centered visits on mild to moderate depression.


Options:
A: N/A
B: Change in Depressive symptoms (3, 6 and 12 months.)
C: Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample. (Baseline and Week 14); Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol. (Baseline and Week 14)
D: Hamilton Depression Rating Scale (HAMD-17) (Baseline, 4, 8, 24, 36, 52 week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Management of Depression in Primary Health Care: a Controlled Trial on the Effectiveness of Regular, Structured, Patient-centered Visits
Brief Summary: Most people in Sweden with mild to moderate depression are treated in primary care, but follow-up is unstructured, and we know little about whether structured, follow-up would affect the prognosis for depression and working life. The purpose of this study is to determine the effectiveness of regular, structured, patient-centered visits on mild to moderate depression.


Options:
A: General practitioners'adherence to treatment recommendations (3-6 months after end of intervention)
B: Change in Depressive symptoms (3, 6 and 12 months.)
C: Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI) (Baseline and Month 12)
D: Child Distress - unrelieved symptoms (20 weeks); Trends of PedsQL Total Scores (20 weeks); Trends of MSAS total scores (20 weeks); Trends of MSAS physical scores (20 weeks); Trends of MSAS psychological scores (20 weeks); Trends of PedsQL Physical Subscale Scores (20 weeks); Trends of PedsQL Emotional Subscale Scores (20 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy (HAART)
Brief Summary: This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes happens when people start HIV treatment. For this study, the following HIV treatment (or HAART) were provided in the form of a single tablet that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common for people who are taking HIV drugs for the first time. The risks seen with this HIV treatment are the same that you would encounter when taking these drugs outside of the study. The lists of risks of this HIV treatment are included in this document because the drugs are provided by the study, not because the drugs are being tested. The purpose of the study is only to look at the impact of high doses of vitamin D and calcium in preventing bone loss. There are no study objectives related to HIV treatment (EFV/FTC/TDF).


Options:
A: Triglycerides (Measured at 24 weeks); Non-HDL-C (Measured at 24 weeks); HDL-C (Measured at 24 weeks); Total Cholesterol (Measured at 24 weeks); Total Cholesterol : HDL-C Ratio (Measured at 24 weeks)
B: The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip (Weeks 0 and 48)
C: To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover. (Baseline, Week 4, Week 12); To measure the safety of 50,000 IU dose of vitamin D3 (Baseline, Week 4, and Week 8)
D: Development of a new or recurrent disease progression event, including all-cause death. (within 24 months after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Brief Summary: The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.


Options:
A: Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event (Randomization to event or last known date if no event (up to approximately 52 months)); Time From Randomization to the First Component Event of MACE (Randomization to event or last known date if no event (up to approximately 52 months))
B: Insulin Resistance (40 weeks)
C: Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL (Following 90 days of treatment)
D: Change From Baseline in Common Carotid Artery Intima-Media Thickness (IMT) (Baseline and Month 36); Change From Baseline in Coronary Artery Calcium Score (Baseline and Month 36)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Community Level Deployment of Rapid Diagnostic Tests for Malaria in Afghanistan: Cluster Randomised Trial
Brief Summary: Malaria is a common, but decreasing, cause of fever in endemic areas. The use of rapid diagnostic tests could improve treatment of malaria at the local community level. Deployment of these tests is, however, a considerable cost. The aim of the study is to evaluate their effect on improving treatment of fever when used by Community Health Workers in Afghanistan. In phase I of the study, the hypothesis is that an RDT diagnosis deployed with standard training and support will improve the accuracy of treatment applied to fever by community health workers when compared to a diagnosis that is based on symptoms alone. In Phase II of the study, the hypothesis is that the accuracy of treatment can be improved by additional training and supportive interventions given to community health workers compared to those who have only had standard training.


Options:
A: Proportion of cases correctly treated (Outcomes measured during consultation - approximately 30-40 minutes)
B: Number of death in children aged 6 to 59 months (12 months)
C: Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups (28 days)
D: Appropriateness of treatment (36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Web-based IHCA for Successful Home Dialysis
Brief Summary: This study involves Chronic Kidney Disease patients that must choose the type of dialysis therapy they ultimately wish to perform. These patients receive education regarding dialysis types from nurses and Nephrologists at a Kidney Function Program. The investigators have developed a web-based Interactive Health Communication Application that could provide more education and support to patients about their dialysis choices. The investigators will compare patients that will receive usual care dialysis education versus patients that will receive additional education through this web-based application. The investigators feel that this tool may increase the proportion of patients who start home dialysis, which offers advantages such as improvement in quality of life and deceased overall healthcare costs, over hospital hemodialysis.


Options:
A: Number of patients that start home-based dialysis. (1 year)
B: Drug adherence (at 6 months after enrollment)
C: Taking Adherence (12 months); Timing Adherence (12 months)
D: Effectiveness of the iChoose Kidney intervention to improve knowledge and shared decision-making between patients and physicians regarding ESRD treatment options. (Up to 19 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Personality and Eating Behaviors in Morbidly Obese Patients
Brief Summary: The aim of this randomized controlled trial is assess the effect of a psychological based treatment model on eating behaviors and motivation for lifestyle changes in morbidly obese patients undergoing bariatric surgery.

Hypothesis: As compared with usual care, Cognitive Behavioral Therapy and Motivational interviewing-based (CBT/MI) intervention program will reduce dysfunctional eating behaviors and increase pre-surgical intrinsic motivation for lifestyle changes.


Options:
A: SCL-90r Depression and anxiety subscales (baseline - 12 months)
B: Change Eating behaviours (This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed); Change Affective symptoms (This co-primary outcome will be assessed, first, one week before the start of the 10 weeks intervention, and second, 1 week after the termination of the 10-weeks intervention. In addition a 1 and 4 year follow-up have been performed)
C: Change from baseline state anxiety via the State Trait Anxiety Scale (STAI) (Ten days)
D: Physiotherapeutic Rehabilitation after THA. (15 days after discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries
Brief Summary: The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (\< 36.5 degrees C) without increasing hyperthermia (\> 37.5 degrees C).


Options:
A: Axillary temperature 36.5-37.5 degrees Celsius (1-4 hours)
B: Mortality within 28 days after birth (within 28 days after birth)
C: Axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later. (Admission to the NICU)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Randomized Trial of Wound Infiltration With Ropivacaine After Breast Cancer Surgery
Brief Summary: Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection


Options:
A: analgesic consumption of level 3 in the two treated groups (24 hours)
B: 30% decrease in VAS score on mobilization on the day of surgery (patients will be followed during all the duration of hospital stay and 2 months after surgery)
C: opiate consumption (hospital discharge/ days 0-7)
D: Evaluation of chronic postsurgical pain. (After 3 and 12 months of surgery.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Double Blind Randomized Trial of Wound Infiltration With Ropivacaine After Breast Cancer Surgery
Brief Summary: Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection


Options:
A: occurrence of chronic pain (3 months)
B: 30% decrease in VAS score on mobilization on the day of surgery (patients will be followed during all the duration of hospital stay and 2 months after surgery)
C: opiate consumption (hospital discharge/ days 0-7)
D: Quality of recovery 40(QoR-40) score (24hours after operation day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy
Brief Summary: The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.


Options:
A: Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring. (6 months)
B: Six Minute Walk Distance 6MWD (Change from baseline in 6MWD at 12 weeks)
C: Changes of health-related physical fitness components (1). (Changes from baseline aerobic capacity at 12 weeks); Changes of health-related physical fitness components (2). (Changes from baseline muscular endurance at 12 weeks); Changes of health-related physical fitness components (3). (Changes from baseline muscular strength at 12 weeks); Changes of health-related physical fitness components (4). (Changes from baseline muscular power at 12 weeks); Changes of health-related physical fitness components (5). (Changes from baseline agility at 12 weeks); Changes of health-related physical fitness components (6). (Changes from baseline flexibility at 12 weeks); Changes of anthropometric parameters (1). (Changes from baseline waist circumference at 12 weeks); Changes of anthropometric parameters (2). (Changes from baseline BMI at 12 weeks); Changes of body composition parameters (1). (Changes from baseline body fat mass at 12 weeks); Changes of body composition parameters (2). (Changes from baseline lean body mass at 12 weeks); Changes of body composition parameters (3). (Changes from baseline percentage body fat at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (1). (Changes from baseline serum levels of DKK1 at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (2). (Changes from baseline serum levels of Sclerostin at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (3). (Changes from baseline serum levels of SFRP1 at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (4). (Changes from baseline serum levels of β-catenin at 12 weeks); Changes of serum levels of Wnt signaling-related molecules (5). (Changes from baseline serum levels of WISP-1 at 12 weeks)
D: Patient rated physical functioning (at 8 weeks and 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy
Brief Summary: The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.


Options:
A: Possible (neuro)physiological determinants of postcancer fatigue (The measurements will be performed at baseline and comparable measurements will be performed 6 months later (after 6 months cognitive behavior therapy or 6 months waiting list condition))
B: Six Minute Walk Distance 6MWD (Change from baseline in 6MWD at 12 weeks)
C: Changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c (At week 16); Improvement of physical fitness, cardiorespiratory fitness, and muscle strength (At week 16); Feasibility of a supervised exercise program for cancer survivors (At week 16); Maintain positive benefits of an exercise intervention (12 weeks post-intervention)
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Understanding Typhoid Disease After Vaccination: a Single Centre, Randomised, Doubleblind, Placebo Controlled Study to Evaluate M01ZH09 in a Healthy Adult Challenge Model, Using Ty21a Vaccine as a Positive Control.
Brief Summary: Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.


Options:
A: Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer (At 28 days after last vaccination as compared to baseline); Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer (At 6 months after last vaccination as compared to baseline); Anti-Vi ELISA Geometric Mean Concentration (GMC) (At 28 days after last vaccination); Anti-Vi ELISA GMC (At 6 months after last vaccination)
B: Diagnosis of typhoid fever (2 weeks after typhoid challenge)
C: Number of Subjects Reporting Any Post Immunization Reactions (During the 7-day period after vaccination); Number of Subjects Reporting Adverse Events (During the 28-day period after vaccination); Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC) (At 28 days after vaccination); Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer (At 28 days after vaccination)
D: Clinically or microbiologically proven typhoid infection (Up to 14 days after typhoid challenge dose administration)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Maternal Metabolic Abnormalities in Pregnancy on Human Milk and Subsequent Infant Metabolic Development
Brief Summary: Childhood obesity is on the rise and is a major risk factor for type 2 diabetes later in life. Recent evidence indicates that abnormalities that increase risk for diabetes may be initiated early in infancy. Since the offspring of women with diabetes have an increased long-term risk for obesity and type 2 diabetes, the impact of maternal metabolic abnormalities on early nutrition and infant metabolic trajectories is of considerable interest. The purpose of the study is to investigate the impact of maternal nutrition and metabolic abnormalities in pregnancy on human milk and subsequently on infant health over the first year of life.


Options:
A: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
B: number of gestational diabetes cases diagnosed with OGTT (24-28th weeks gestation); difference in HOMA values (from first trimester to OGTT)
C: OGTT
D: Infant growth (Growth from birth to anthrometry at 12mo)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Maternal Metabolic Abnormalities in Pregnancy on Human Milk and Subsequent Infant Metabolic Development
Brief Summary: Childhood obesity is on the rise and is a major risk factor for type 2 diabetes later in life. Recent evidence indicates that abnormalities that increase risk for diabetes may be initiated early in infancy. Since the offspring of women with diabetes have an increased long-term risk for obesity and type 2 diabetes, the impact of maternal metabolic abnormalities on early nutrition and infant metabolic trajectories is of considerable interest. The purpose of the study is to investigate the impact of maternal nutrition and metabolic abnormalities in pregnancy on human milk and subsequently on infant health over the first year of life.


Options:
A: Infant growth (Growth from birth to anthrometry at 12mo)
B: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
C: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
D: Prematurity (Women will be interviewed at hospital soon after birth (up to 2 days after delivering))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding
Brief Summary: Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight in young children. In Mexico, breastfeeding extends well into the second half of infancy, but animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo. This study evaluates whether knowledge and practices about dietary diversity and food consistency can be improved using a two-component intervention strategy in semi-urban communities in Mexico. The two components will deliver appropriate complementary feeding messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio messages and interviews. The intervention is evaluated using a cluster randomized design in small semi-urban communities in two states in Mexico with pre- and post-test questionnaires designed to assess changes in feeding behaviors.


Options:
A: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)
B: BMI and aerobic fitness (1 schoolyear)
C: Provision of flesh-food or vitamin A-rich food (Change from baseline to 5 months)
D: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)

Answer: C