TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Interlaminar Epidural Injections in Lumbar Disc Herniation, and Discogenic Pain
Brief Summary: 1. To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
2. To evaluate and compare the adverse event profile in all patients.


Options:
A: Radicular Pain Visual Analogue Scale (VAS) Score change from baseline (Baseline, 4 weeks, 8 weeks, 12 weeks post injection)
B: Numerical Rating Leg Pain Score (1 month)
C: To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids. (Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.)
D: To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment (1,3,6,12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Periodontal Therapy on Endothelial Function
Brief Summary: The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease


Options:
A: Changes in C reactive protein (Baseline, 3, 6 and 12 months); Changes in flow-mediated dilation (Baseline, 1, 3 and 6 months)
B: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
C: The difference in dilation measured by brachial artery blood flow (6 months)
D: Brachial Artery Flow-mediated Dilation (Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety of Vitamin D Supplementation in the Elderly
Brief Summary: This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance.


Options:
A: AUC for increment in serum 25(OH)D (12 weeks)
B: Number of Participants Who Develop Hypercalcemia (6 months)
C: fractures (4 years)
D: change of 25-hydroxvitamin D (after 4 and 8 weeks of supplementation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.
Brief Summary: Demonstrate that the use of benchmarking improves quality of patient care, in particular the control of diabetes, lipids and blood pressure, by determining the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c 14,18, LDL-cholesterol16,18 and Systolic Blood Pressure17,18 versus control group (non-benchmarking group) after 12 months of follow-up.


Options:
A: Hemoglobin A1c (1 year after date of discharge)
B: The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l), (18 months)
C: HbA1c, LDL-cholesterol, Systolic Blood Pressure (Visit 1; Visit 2 (after approximately 4 months after visit 1); Visit 3 (after approximately 8 months after visit 1); Visit 4 (after approximately 12 months after visit 1))
D: Mortality (From diabetes diagnosis until median14 year after study start); Diabetic retinopathy (at 6 year and 14 year after study start); Urinary albumin concentration (at 6 year and 14 year after study start); Myocardial infarction (From diabetes diagnosis until median14 year after study start); Stroke (From diabetes diagnosis until median14 year after study start)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.
Brief Summary: Demonstrate that the use of benchmarking improves quality of patient care, in particular the control of diabetes, lipids and blood pressure, by determining the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c 14,18, LDL-cholesterol16,18 and Systolic Blood Pressure17,18 versus control group (non-benchmarking group) after 12 months of follow-up.


Options:
A: The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care. (30 months)
B: doctor-confirmed dilated eye examination (3 and 6 months)
C: HbA1c, LDL-cholesterol, Systolic Blood Pressure (Visit 1; Visit 2 (after approximately 4 months after visit 1); Visit 3 (after approximately 8 months after visit 1); Visit 4 (after approximately 12 months after visit 1))
D: Pt. 1 Dilated Fundus Exam (DFE) (6-month follow-up assessment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan: A Community-based Randomized Control Trial
Brief Summary: The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care.


Options:
A: Incidence of Neonatal Omphalitis (By the end of the styudy); Rate of Neonatal Mortality (By the end of the Study)
B: Neonatal death or severe sepsis (7 days)
C: N/A
D: neonatal mortality; umbilical cord infection

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan: A Community-based Randomized Control Trial
Brief Summary: The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care.


Options:
A: Incidence of Neonatal Omphalitis (By the end of the styudy); Rate of Neonatal Mortality (By the end of the Study)
B: neonatal mortality (3 Month intervals); omphalitis among live born infants. (3 Month intervals)
C: Rates of culture-confirmed or clinical neonatal sepsis, < 3 days of life; Rate of vertical transmission of colonization with group B streptococcus (GBS)
D: Neonatal death or severe sepsis (7 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: School Nurse-Delivered Smoking Cessation Intervention
Brief Summary: The purpose of this study is to conduct a randomized controlled school-based trial to evaluate the effectiveness of a four-session school nurse-delivered smoking cessation intervention in increasing abstinence rates among high school students who smoke.


Options:
A: Abstinence from smoking in the past 30 days at 6 months and 1 year
B: Abstinence from cigarette smoking in the past 30 days at 3 months and 1 year. (3 months and 1 year post baseline)
C: Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F).
D: The change in smoking prevalence between baseline and 24 months of follow-up between the two groups measured via questionnaires. (24 months post intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Calfactant Therapy for Direct Acute Respiratory Distress Syndrome & Direct Acute Lung Injury in Adults and Children
Brief Summary: This study will determine if administration of an suspension of calfactant, a lung surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome within 48 hours of requiring mechanical ventilation can decrease the mortality in patients with lethal disease and shorten the course of respiratory failure in patients with sub-lethal disease.


Options:
A: Mortality rates (measured at time of hospital discharge or 60 days after study entry)
B: Ventilator-free Days During Days 1-28 (Measured at Day 28)
C: Mortality Rate (90 days)
D: Number of Ventilator Free Days (VFD) (Determined 28 days after a subject entered the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sentinel Surveillance of Acute Malnutrition in the Region of Maradi, Niger, Children Under 5: Impact of a Preventive Intervention
Brief Summary: Malnutrition is a critical public health problem in developing countries. Malnutrition may be linked to more than one half of the deaths in children under 5 years old. In July 2001, after an intervention related to a measles epidemic, Medecins sans Frontieres-France opened a nutritional program in Maradi, in the South of Niger. The introduction of ready to use therapeutic foods (RUTF), in particular Plumpy'Nut (Nutriset, France) allowed for the treatment of the majority of children at their homes using ambulatory treatment. Children with complicated cases were cared for in an inpatient center. With ambulatory treatment the number of children cared for in the MSF program reached close to 70000 in 2006.

This study aimed to assess the effect of a 3-month distribution of RUTF in the context of a preventative supplementary feeding program. The primary hypotheses were that short-term RUTF supplementation at the village-level would prevent declines in weight-for-height and reduce the incidence of wasting in children 6 to 60 mo of age over a period of 8 mo. Because RUTF may have additional health effects, the intervention effect on height-for-age, stunting, mortality and morbidity from malaria, diarrhea, and respiratory infection were also examined.


Options:
A: Number of Participants With Nutritional Recovery (12 weeks or upon completion of recovery); Number of Patients With Absence of Bilateral Pedal Pitting Edema (12 weeks or recovery)
B: weight-for-height in children 6 to 60 mo of age (8 months)
C: Recovery Under the Integrated Program and the Standard Protocol (12 weeks)
D: Weight gain during the 12-month follow-up (in grams)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Sentinel Surveillance of Acute Malnutrition in the Region of Maradi, Niger, Children Under 5: Impact of a Preventive Intervention
Brief Summary: Malnutrition is a critical public health problem in developing countries. Malnutrition may be linked to more than one half of the deaths in children under 5 years old. In July 2001, after an intervention related to a measles epidemic, Medecins sans Frontieres-France opened a nutritional program in Maradi, in the South of Niger. The introduction of ready to use therapeutic foods (RUTF), in particular Plumpy'Nut (Nutriset, France) allowed for the treatment of the majority of children at their homes using ambulatory treatment. Children with complicated cases were cared for in an inpatient center. With ambulatory treatment the number of children cared for in the MSF program reached close to 70000 in 2006.

This study aimed to assess the effect of a 3-month distribution of RUTF in the context of a preventative supplementary feeding program. The primary hypotheses were that short-term RUTF supplementation at the village-level would prevent declines in weight-for-height and reduce the incidence of wasting in children 6 to 60 mo of age over a period of 8 mo. Because RUTF may have additional health effects, the intervention effect on height-for-age, stunting, mortality and morbidity from malaria, diarrhea, and respiratory infection were also examined.


Options:
A: Incidence of severe acute malnutrition (15 months)
B: Birth weight (Within 48 hours (or back calculated from later measurements).); Birth length (Within 48 hours (or back calculated from later measurements)); Child linear growth status at 24 months (24 months)
C: Acceptability of at least one Ready -to-Use Complementary Food supplement (7 days)
D: weight-for-height in children 6 to 60 mo of age (8 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sentinel Surveillance of Acute Malnutrition in the Region of Maradi, Niger, Children Under 5: Impact of a Preventive Intervention
Brief Summary: Malnutrition is a critical public health problem in developing countries. Malnutrition may be linked to more than one half of the deaths in children under 5 years old. In July 2001, after an intervention related to a measles epidemic, Medecins sans Frontieres-France opened a nutritional program in Maradi, in the South of Niger. The introduction of ready to use therapeutic foods (RUTF), in particular Plumpy'Nut (Nutriset, France) allowed for the treatment of the majority of children at their homes using ambulatory treatment. Children with complicated cases were cared for in an inpatient center. With ambulatory treatment the number of children cared for in the MSF program reached close to 70000 in 2006.

This study aimed to assess the effect of a 3-month distribution of RUTF in the context of a preventative supplementary feeding program. The primary hypotheses were that short-term RUTF supplementation at the village-level would prevent declines in weight-for-height and reduce the incidence of wasting in children 6 to 60 mo of age over a period of 8 mo. Because RUTF may have additional health effects, the intervention effect on height-for-age, stunting, mortality and morbidity from malaria, diarrhea, and respiratory infection were also examined.


Options:
A: Change in Length for Age (Once per month for 6 months, then once after 12 months.)
B: weight-for-height in children 6 to 60 mo of age (8 months)
C: Cumulative wasting incidence, hemoglobin concentration (monthly)
D: Weight gain during the 12-week follow-up (in grams)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: BAG-RECALL Study: BIS or Anesthesia Gas to Reduce Explicit Recall
Brief Summary: The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of patients remembering being awake during surgery. The BIS monitor may be able to measure how asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be compared with using the concentration of anesthetic gas to guide anesthesia.


Options:
A: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
B: Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery (Four days)
C: Rate of non-response to empiric antimicrobial treatment (5 days)
D: Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) (30 days postoperatively)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: BAG-RECALL Study: BIS or Anesthesia Gas to Reduce Explicit Recall
Brief Summary: The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of patients remembering being awake during surgery. The BIS monitor may be able to measure how asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be compared with using the concentration of anesthetic gas to guide anesthesia.


Options:
A: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)
B: Time to extubation since the interruption in the administration of anaesthetics. (30 minutes-3 hours)
C: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
D: The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. (Outcome of awareness is assessed 30-days after the operation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: BAG-RECALL Study: BIS or Anesthesia Gas to Reduce Explicit Recall
Brief Summary: The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of patients remembering being awake during surgery. The BIS monitor may be able to measure how asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be compared with using the concentration of anesthetic gas to guide anesthesia.


Options:
A: Number of Participants With Delirium (5 days)
B: BIS side difference (intra- and postoperative (day 1))
C: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)
D: 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.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: BAG-RECALL Study: BIS or Anesthesia Gas to Reduce Explicit Recall
Brief Summary: The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of patients remembering being awake during surgery. The BIS monitor may be able to measure how asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be compared with using the concentration of anesthetic gas to guide anesthesia.


Options:
A: evaluation of intra-operative awareness in all the patients investigated (within 4 days after the general anesthesia)
B: Bispectral index (BIS) monitoring in abdominal surgery patients (six months)
C: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)
D: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: BAG-RECALL Study: BIS or Anesthesia Gas to Reduce Explicit Recall
Brief Summary: The overall purpose of this study is to see if a Bispectral Index (BIS) monitor, a Food and Drug Administration (FDA) approved brain monitoring device, will help to reduce the risk of patients remembering being awake during surgery. The BIS monitor may be able to measure how asleep a patient is during surgery. Using the BIS monitor to guide anesthesia will be compared with using the concentration of anesthetic gas to guide anesthesia.


Options:
A: The Primary Endpoint is a Composite of Death and Cardiovascular Events (Clinical and Silent MI, Cardiac Failure, Cardiac Arrest, Pulmonary Embolism, and Stroke) Measured at 30 Days After Surgery. (30 days post op)
B: Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil. (during anesthesia)
C: The incidence of explicit recall of events during the surgical and anesthetic periods. (30 days)
D: The incidence of explicit recall of events during the surgical and anesthetic periods. (Three years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
Brief Summary: The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS


Options:
A: Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) (baseline and 3 months); Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) (baseline and 3 months)
B: Change in Testosterone After 6 Months of Treatment (baseline and 6 months)
C: serum C-reactive protein (CRP) levels (6 months)
D: Changes in fasting insulin and area under the curve for insulin (2 hours) (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Harnessing Health IT for Self-Management Support and Medication Activation in a Medicaid Health Plan
Brief Summary: To measure the effects of a Medical health plan-directed automated telephone self-management support system (ATSM) on patient outcomes among ethnically diverse health plan enrollees with diabetes.


Options:
A: Rate of all-cause hospital readmission or death during the 6-month follow-up period. (6 months)
B: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
C: Smoking Abstinence (12 weeks); Smoking Abstinence (2 weeks)
D: Changes in the Physical Component Summary of the SF-12 Health Survey (Baseline and 6 months); Changes in the Mental Component Summary of the SF-12 Health Survey (Baseline and 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Contingency Management for Smoking in Substance Abusers
Brief Summary: Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate abuse or dependence will meet with research staff on two days for quit preparation sessions (2 per day). These sessions include testing a breath sample for evidence of smoking twice each day (separated by at least 5 hours), counseling based on Public Health Service (PHS) guidelines for quitting smoking during the second session each day, and setting a quit date. After these sessions, participants will be randomly assigned to one of two 4-week conditions: (a) standard care or (b) standard care plus prize CM for smoking abstinence with the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL). Nicotine withdrawal and related measures will be assessed throughout the intervention. Follow-up data will be collected through 6-months post-quit date.


Options:
A: Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score (from treatment entry until 6 weeks post-partum)
B: verified abstinence 6 months (6 months)
C: Cigarette smoking abstinence. (Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.)
D: Abstinence from smoking (Measured 6 months after births at follow-up assessment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Famotidine Compared With Esomeprazole in the Prevention of Ulcer Complications in Patients With Acute Coronary Syndrome or Myocardial Infarction
Brief Summary: Aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and effective treatment for unstable cardiac patients. However, the major complication was gastrointestinal bleeding (GIB) due to peptic ulcer. In the prevention of GIB, anti-ulcer drug either H2-receptor antagonist (H2RA) and proton pump inhibitor (PPI) were commonly prescribed. There has been no prospective controlled study to compare the efficacy of these two classes of anti-ulcer drugs.


Options:
A: Mortality (90 days)
B: The primary objective of the study is to assess gastric acid suppression by esomeprazole iv in critically ill subjects
C: Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function (immediately after heart surgery in patients with LVSD)
D: ulcer complication (bleeding/perforation/obstruction) (up to 12 months)

Answer: D