TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a PDA-Based Dietary Adherence Intervention on Interdialytic Weight Gain and Blood Pressure in Hemodialysis Patients
Brief Summary: With this study the investigators will test, in a randomised clinical trial (RCT), the efficacy of a behavioral dietary adherence enhancement intervention paired with PDA-based dietary self-monitoring for controlling sodium intake. Seventy hemodialysis patients will be recruited from units in Pittsburgh, Pennsylvania. Participants will be randomized to a 4-month PDA-based dietary counseling intervention or to a 4-month attention control. Potential participants will be stratified by whether or not they have diabetes. Data on primary and secondary outcomes will be obtained at baseline and four months. Primary dependent variables are:

1. adherence to dietary sodium targets as assessed from 3-day food recalls,
2. average monthly interdialytic weight gain, and
3. average pulse pressure. Secondary dependent variables are:
4. adherence to dietary targets for calories, protein, carbohydrates, fats, saturated fats, potassium, and phosphorus, as assessed from 3-day food recalls, (5) serum potassium and phosphorus levels determined on a monthly basis, and (6) nutritional status as determined from serum albumin. Laboratory data, interdialytic weight gain, and blood pressure data will be obtained per dialysis center routine and abstracted from the medical record. Three-day food recalls will be obtained at baseline, 4 and 8 months and analyzed using the Nutrient Data System.


Options:
A: Number of Adverse Events Reported During the Study. (Thru the Month 24 Visit); Change in C-peptide (Baseline to the Month 6 Visit)
B: Use of sun protection (6 weeks)
C: Systolic Blood Pressure (SBP) (one year)
D: adherence to dietary sodium targets as assessed from 3-day food recalls (baseline and 4 months); average daily interdialytic weight gain (IDWG) (IDWG gathered with each dialysis treatment); average pulse pressure from pre-dialysis blood pressures (with each dialysis treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
Brief Summary: Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant.


Options:
A: Any toxic effect reported during MSCs infusion or in the subsequent 10 days by clinical monitoring (During MSCs infusion or in the subsequent 10 days); Feasibility as the possibility of producing adequate lots of patient dedicated MSCs for any patients presenting with steroid resistant GVHD (three years)
B: Determine the safety/efficacy of expanded in-vitro allogenic mesenchymal stem cell infusion in patients developing a GVHD refractory to the usual therapeutic measures after undergoing an allogeneic hematopoietic stem cell transplant.; Efficacy will be evaluated in terms of GVHD response.; Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC.
C: Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs) (One month post-catheterization)
D: Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation (One month post-catheterization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
Brief Summary: Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patients with opioid dependence.


Options:
A: Time to Relapse (Intent to Treat Population) (Weeks 3-24); Time to Relapse (Per Protocol Population) (Weeks 3-24)
B: Analgesia (6 months)
C: Illicit Opioid Use (18 weeks)
D: The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids (weeks 1-16)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients With Opioid Dependence
Brief Summary: Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patients with opioid dependence.


Options:
A: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
B: Time to resumption of heroin use; Time to relapse; Maximum consecutive weeks of opiate abstinence; Reduction of HIV risks
C: The cumulative distribution function (CDF) of the percent of urine samples negative for illicit opioids (weeks 1-16)
D: Opiate abstinence

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Yoga Vs. Stretching on Chronic Back Pain
Brief Summary: This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.It will also for physical, psychological and physiological factors associated with improvement in back pain.


Options:
A: Patient-rated pain (0-11 box scale) (short term = 12 weeks; long term = 52 weeks)
B: Change from Self-reported lumbar pain intensity at 3 weeks. (At the start of the study, before the fifth treatment session (third week)); Change from Self-reported lumbar pain intensity at 5 weeks. (After the last treatment session (fifth week).); Change from Disability at 3 weeks. (At the start of the study, before the fifth treatment session (third week)); Change from Disability at 5 weeks. (After the last treatment session (fifth week).)
C: Number of Days on Sick Leave (12 MONTHS)
D: Back-related function (6 months); Pain (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Yoga Vs. Stretching on Chronic Back Pain
Brief Summary: This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.It will also for physical, psychological and physiological factors associated with improvement in back pain.


Options:
A: Change from Baseline in Average Pain intensity in previous week (12 wks); Change from Baseline in Modified Roland Morris questionnaire for Back pain specific disability (12 wks)
B: N/A
C: Back-related function (6 months); Pain (6 months)
D: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Yoga Vs. Stretching on Chronic Back Pain
Brief Summary: This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.It will also for physical, psychological and physiological factors associated with improvement in back pain.


Options:
A: Change from baseline in low back pain (Baseline, 6 weeks, 12 weeks, 24 weeks); Change from baseline in back-related function (Baseline, 6 weeks, 12 weeks, 24 weeks)
B: Pain Interference (assessed at baseline, 12 weeks, and 6 months; baseline and 12 weeks reported)
C: Back-related function (6 months); Pain (6 months)
D: Average pain intensity (up to 12 weeks); Modified Roland Morris Disability Questionnaire for back pain-specific disability (up to 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Integrated Treatment to Persons With Mental Disorders and Co-occurring Substance Use Disorders
Brief Summary: The purpose of this study is to determine whether Integrated Treatment is effective in the treatment of anxiety and/or depression with co-occurring substance use disorders.


Options:
A: Percent Medication Adherence at 3-month Follow-up Assessment (3-month assessment); Percent Medication Adherence at 12-month Follow-up Assessment (12-month follow-up assessment)
B: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
C: The Symptom Check List 90 (SCL90-r), The Alcohol Use Disorder Identification Test (AUDIT), The Drug Use Disorder Identification Test (DUDIT). (Change during 6 and 12 months follow-up)
D: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's
Brief Summary: The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamline safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy.Traditional NSAID's are associated with significant morbidity and mortality from gastrointestinal toxicity. Cyclooxygenase 2 (Cox-2)selective agents are associated with reduced upper gastrointestinal toxicity.Traditional NSAID's and Cox-2 inhibitors may also be associated with cardiovascular and renal disorders. Data from both randomised and observational studies suggest that celecoxib has similar or reduced cardiovascular toxicity when compared to traditional NSAID's. However, the overall safety balance of a strategy of celecoxib therapy versus a strategy of NSAID therapy is unknown. The European Medicines Evaluation Agency (EMEA) has requested that studies of the cardiovascular safety of celecoxib be carried out within the indicated population of Europe. This study addresses these issues by comparing the cardiovascular safety of celecoxib therapy with traditional NSAID therapy in the setting of the EU healthcare system.

As of May 2013, 7300 patients had been randomised, and had accrued an average 4.2 years of follow up by the end of May 2014.


Options:
A: Proportion of enrolled patients who attend for their assigned screening test (Immediate)
B: All-cause, Pregnancy-related Mortality (Deaths during pregnancy through 12 weeks postpartum)
C: compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis. (4 years)
D: Receipt of mammography screening (six month post intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Overactive Bladder Innovative Therapy Trial
Brief Summary: The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).


Options:
A: Changes in 24-hour micturition frequency (Bladder diaries completed at recruitment and 6 weeks, 12 weeks and 6 months.)
B: The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis. (13 weeks)
C: Frequency of Voids at 12 Weeks (Baseline to 12 weeks)
D: Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline (36 months total)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters
Brief Summary: Since many of the patients in an intensive care unit suffer from disorders of hemostasis, bleeding is a main concern applying central venous catheters. Even if there are some data indicating elevated international normalized ratio may not increase the risk of bleeding no clear cut-off has been defined so far. An INR \> 1.5 is generally considered to increase the risk of bleeding. Furthermore, many authors consider platelets below 50 x 109 /l as a contra-indication to CVC cannulation, since there are some data this may increase the risk of bleeding. Therefore platelet transfusion before venous puncture is suggested. In our clinical experience INR \> 1.5 and platelets \< 50 x 109 /l do not correlate with increased risk of bleeding. The aim of this study is to demonstrate, that coagulopathy, defined by INR and platelet count, is not decisive for bleeding.


Options:
A: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
B: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))
C: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
D: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters
Brief Summary: Since many of the patients in an intensive care unit suffer from disorders of hemostasis, bleeding is a main concern applying central venous catheters. Even if there are some data indicating elevated international normalized ratio may not increase the risk of bleeding no clear cut-off has been defined so far. An INR \> 1.5 is generally considered to increase the risk of bleeding. Furthermore, many authors consider platelets below 50 x 109 /l as a contra-indication to CVC cannulation, since there are some data this may increase the risk of bleeding. Therefore platelet transfusion before venous puncture is suggested. In our clinical experience INR \> 1.5 and platelets \< 50 x 109 /l do not correlate with increased risk of bleeding. The aim of this study is to demonstrate, that coagulopathy, defined by INR and platelet count, is not decisive for bleeding.


Options:
A: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))
B: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
C: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.
D: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters
Brief Summary: Since many of the patients in an intensive care unit suffer from disorders of hemostasis, bleeding is a main concern applying central venous catheters. Even if there are some data indicating elevated international normalized ratio may not increase the risk of bleeding no clear cut-off has been defined so far. An INR \> 1.5 is generally considered to increase the risk of bleeding. Furthermore, many authors consider platelets below 50 x 109 /l as a contra-indication to CVC cannulation, since there are some data this may increase the risk of bleeding. Therefore platelet transfusion before venous puncture is suggested. In our clinical experience INR \> 1.5 and platelets \< 50 x 109 /l do not correlate with increased risk of bleeding. The aim of this study is to demonstrate, that coagulopathy, defined by INR and platelet count, is not decisive for bleeding.


Options:
A: Volume of transfused plasma during surgery (5 years)
B: 24-hour Mortality (First 24 hours after ED admission); 30-day Mortality (First 30 days after ED admission); Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE) (From time of ED admission, for up to 72 hours)
C: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
D: Procedure-related relevant bleeding, occurring within 24 hours after the procedure. (24 hours after the procedure)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Thrombocytes and International Normalized Ratio Are no Predictors for Bleeding in Application of Central Veneous Catheters
Brief Summary: Since many of the patients in an intensive care unit suffer from disorders of hemostasis, bleeding is a main concern applying central venous catheters. Even if there are some data indicating elevated international normalized ratio may not increase the risk of bleeding no clear cut-off has been defined so far. An INR \> 1.5 is generally considered to increase the risk of bleeding. Furthermore, many authors consider platelets below 50 x 109 /l as a contra-indication to CVC cannulation, since there are some data this may increase the risk of bleeding. Therefore platelet transfusion before venous puncture is suggested. In our clinical experience INR \> 1.5 and platelets \< 50 x 109 /l do not correlate with increased risk of bleeding. The aim of this study is to demonstrate, that coagulopathy, defined by INR and platelet count, is not decisive for bleeding.


Options:
A: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy) (2010)
B: At Least One Day With Grade 2 or Higher Bleeding (From randomization until the subject ends the study (10 days after most recent platelet transfusion, 30 days after first platelet transfusion on study, or hospital discharge, whichever occurs first))
C: Bleeding within 24 hours after cvc application; other complications within the first 24 hours
D: Daily hemostatic assessments will be conducted to determine presence of WHO Grade 2 bleeding or greater.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Family-Supported Smoking Cessation for Chronically Ill Veterans
Brief Summary: The overarching aim of the study is to evaluate in a randomized trial the impact of a family-supported intervention compared to a standard veteran-focused telephone counseling control group to promote smoking cessation among cancer and heart disease patients.


Options:
A: Smoking abstinence (one year)
B: The Impact of a Family-supported Intervention on Rates of Abstinence From Cigarettes Compared to a Standard Intervention (5 months)
C: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations
D: "Quality of care process" (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)
Brief Summary: Adolescent idiopathic scoliosis (AIS) is a structural curve of the spine with no clear underlying cause. Bracing is currently the standard of care for preventing curve progression and treating AIS. However, the effectiveness of bracing remains unclear. The purpose of this study is to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS.


Options:
A: Cobb's angle (10 week)
B: Skeletal Maturity With a Cobb Angle of <50 Degrees (Successful Outcome) (Skeletal maturity and the Cobb angle were measured at baseline and at each 6-month follow-up. Subjects were followed until they reached criteria for either success or failure. The average duration of follow-up was 23.67 months.)
C: Change in Cobb angle (From baseline to 6 months)
D: Change from baseline Forced Vital Capacity (FVC) at 8 weeks (Eight weeks); Change from baseline Forced Expiratory volume in 1 second (FEV1)at 8 weeks (Eight weeks); Change from baseline Peripheral Muscle strength at 8 weeks (Eight weeks); Change from baseline Balance at 8 weeks (Eight weeks); Change from baseline distance covered in Six- Minute Walk Test at 8 weeks (Eight weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of progress in new treatment for diabetes and anti hypertensive drugs. Additional treatments are thus needed to arrest the progression of diabetic nephropathy. Although there is insufficient evidence to suggest that a low-protein diet improves renal dysfunction, it is recommended as a mainstay of nutritional management. We here assessed the role of low protein diet in renal function as well as albuminuria in type 2 diabetic patients with nephropathy for a median of 5 years.


Options:
A: annual change of GFR; annual change of Ccr; annual change of 1/Cr; incidence rate of the doubling of sCr; time to the doubling of sCr
B: changes in glomerular filtration rate (1 year)
C: Time to renal death, defined as the first event between start of renal replacement therapy or patient death (Months)
D: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)

Answer: A