TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments
Brief Summary: The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.

300 older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training.


Options:
A: Walking Velocity at Baseline and 3 Months (0 and 3 months)
B: Falls Diary (6-7 Months)
C: Falls rate (6 months post intervention)
D: Percentage of "Off" Time During Waking Hours at End of Study (22 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments
Brief Summary: The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.

300 older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training.


Options:
A: Major Mobility Disability, Defined as Incapacity to Walk 400 Meters (Median 2.7 years/Average 2.6 years)
B: health costs after 18 months (baseline 18 month control); falls after 18 months (daily records, analysis after 18 months); Bone parameters after 6, 12 and 18 months (baseline, 6, 12, 18 month-control)
C: Falls rate (6 months post intervention)
D: number of falls (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments
Brief Summary: The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.

300 older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training.


Options:
A: Off Medication UPDRS Part III, Motor Subscale Score (obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
B: The equilibrium score (ES) and sensory ratio were measured. The verbal reaction time (VRT) was recorded. (6 weeks)
C: Parkinson's Disease Quality of Life Questionnaire (PDQL) (8 months); AMC Linear Disability Score (ALDS) (8 months)
D: Falls rate (6 months post intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)
Brief Summary: The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.


Options:
A: Changes in TcPO2 (30 minutes); Correlation of stimulation TcPO2 parameters with the type of peripheral arterial flow (30 minutes)
B: Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke (From randomization to PACD, an average of 2.5 years)
C: Prevalence of PAD in asymptomatic patients with T1DM assessed by ankle-branchial index. (2 years)
D: Diagnostic Accuracy (1 hour; all tests will be performed on the same day of presentation.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)
Brief Summary: The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.


Options:
A: incidence of contrast-induced nephropathy (within 48 hours after using a contrast agent)
B: Cardiovascular events (five years (median)); Cerebral vascular events (five years (median)); Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment (five years (median))
C: Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke (Randomization through end of study (30-month visit))
D: Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke (From randomization to PACD, an average of 2.5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients.
Brief Summary: SPECIFIC AIMS

* Assess risk factors for nausea and vomiting in c-section patients undergoing regional anesthesia
* Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in the ginger and placebo groups.
* Quantify post-operative analgesia and pruritus in the ginger and placebo groups
* Quantify patient satisfaction of the ginger and placebo groups
* Assess patient expectation of ginger on post-op day three


Options:
A: Intraoperative Nausea and Vomiting (Intraoperatively)
B: Intraoperative blood loss (mL) (20 minutes); Postoperative Hemoglobin (gm/L) (20 minutes)
C: Incidence of Nausea and Vomiting (intraoperative 2-3 hours); Incidence of Nausea and Vomiting (2 hrs postoperative); Incidence of Nausea and Vomiting (24hrs postoperative)
D: Occurrence of Intra-operative and Post-operative Vomiting (During surgery (1 hour) and thru 72 hours after surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony
Brief Summary: Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in women with risk factors for uterine atony decreases the need for additional uterotonic medications, uterine atony and postpartum hemorrhage.

Design: randomized, double-blinded, placebo-controlled trial.


Options:
A: Immediate hemodynamic effects of carbetocin and oxytocin (1 day)
B: Maximal uterine tone (within the first 5 minutes after cord clamping)
C: Need for Additional Uterotonic Medications (24 hours)
D: screening of Cessation of bleeding (screening until 24 hours after placenta disconnection); time duration to stop bleeding in the case of post-cesarean section (24 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony
Brief Summary: Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in women with risk factors for uterine atony decreases the need for additional uterotonic medications, uterine atony and postpartum hemorrhage.

Design: randomized, double-blinded, placebo-controlled trial.


Options:
A: Immediate hemodynamic effects of carbetocin and oxytocin (1 day)
B: Need for Additional Uterotonic Medications (24 hours)
C: The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. (3 minutes)
D: Incidence of acute postpartum hemorrhage: blood loss ≥ 500 ml within two hours of delivery

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study)
Brief Summary: The United States Food and Drug Administration (FDA) has specific rules which generic drug companies must follow to get a generic copy of a seizure medication approved. Currently, FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and who take just one dose of the generic drug followed by a series of blood tests. Some people with epilepsy and their physicians have complained about side effects or loss of seizure control when taking generic drugs, but no one knows if these complaints are truly because of problems with the generic drugs.

This research is to determine whether several different generic versions and the brand version of the medication lamotrigine perform in a similar way when given to people with epilepsy.

The study drug Lamictal® (lamotrigine) and both of the generic forms of lamotrigine to be tested are approved by the FDA for the treatment of seizures.


Options:
A: Bioequivalence for generic 1 compared to generic 2 (18 months)
B: Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase (Baseline through end of Double-Blind Treatment Phase (up to Week 19))
C: Bioequivalence for generic 1 compared to generic 2 (18 months)
D: Changes in seizure frequency (12 weeks of stimulation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Carbohydrate Containing Diets on Lipid Metabolism & Fatty Acid Oxidation in Healthy Young Men - a Randomized, Double-Blinded Study.
Brief Summary: The objective of this study is to investigate the impact of sugar sweetened beverages on the fat metabolism of healthy young men. It is well known that consumption of beverages sweetened with fructose is associated with different health risks such as type 2 diabetes. The present study has been designed to dissect differences in the metabolic pathways of fructose and glucose, but also metabolic adaptations during fructose, glucose and sucrose diets. During a period of seven weeks subjects will consume either fructose, glucose or sucrose sweetened beverages or continue their usual drinking habits. During these seven weeks there will be different metabolic investigations using stable isotope tracers. First, the rate of lipolysis and beta-oxidation will be determined. Second, the rates of fatty acid synthesis will be measured. During all examinations there will also be substrate- and energy-utilization measurements by indirect calorimetry, blood analysis and morphometric measurements. Based on the literature main hypotheses are: Fructose enhances de novo lipogenesis postprandially and also in the fasting state significantly more than glucose by enhanced expression of lipogenic enzymes. Fructose decreases beta oxidation via downregulation of oxidative enzymes.


Options:
A: LDL size (baseline and after each of 6 interventions)
B: Weight change (0, 3, 6 months)
C: Lipogenesis (After total 6 weeks dietary intervention)
D: Percent Change in Postprandial Glucose Levels (12 weeks); Percent Change in Fasting Glucose Levels (12 weeks); Percent Change in Body Weight (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blinded Study to Evaluate the Efficacy of Intravenous Dexamethasone for Nausea Prophylaxis Prior to Duramorph and Bupivacaine Spinal Anesthesia for Scheduled Cesarean Section
Brief Summary: Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.


Options:
A: cumulative incidence of nausea and/or vomiting at 24 hours (24 hours)
B: Incidence of Nausea and Vomiting (intraoperative 2-3 hours); Incidence of Nausea and Vomiting (2 hrs postoperative); Incidence of Nausea and Vomiting (24hrs postoperative)
C: Incidence of Post-operative Nausea and/or Vomiting (48 hours)
D: Intraoperative Nausea and Vomiting (Intraoperatively)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacacy of a Mobile Application in the Smoking Cessation Among Young Poeple: Cluster Randomized Trial
Brief Summary: AIM: To assess the efficacy of an intervention based on the specific design and implementation of a mobile application (APP) in order to reduce the prevalence of smoking consumption among young people motivated 18 to 30 years METHODS: Cluster randomised clinical trial. Unit of randomization: Primary Health Care Centers (PHCC). Intention to treat analysis. STUDY POPULATION: Motivated young smokers of 10 or more cigarettes per day aged 18 to 30 years consulting for any reason to PHCC and who provided written informed consent to participate in the trial.

INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation which includes mobile APPs application. Control group: usual care. OUTCOME MEASURES: Abstinence at 12 months confirmed by exhaled air carbon monoxide concentration of less or iqual 10 parts per million in each control.

RESULTS: The application of a smoking cessation intervention with a mobile APPs application will improve the smoking cessation success rate in smokers, besides of their intention or not to give up smoking at baseline.


Options:
A: End-of-intervention Varenicline Adherence (4 Weeks)
B: Smoking abstinence rate (At 12 months); Cost-effectiveness (At 12 months)
C: 30 day point prevalence of abstinence (6 months)
D: Smoking cessation (Change in smoking status from baseline at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacacy of a Mobile Application in the Smoking Cessation Among Young Poeple: Cluster Randomized Trial
Brief Summary: AIM: To assess the efficacy of an intervention based on the specific design and implementation of a mobile application (APP) in order to reduce the prevalence of smoking consumption among young people motivated 18 to 30 years METHODS: Cluster randomised clinical trial. Unit of randomization: Primary Health Care Centers (PHCC). Intention to treat analysis. STUDY POPULATION: Motivated young smokers of 10 or more cigarettes per day aged 18 to 30 years consulting for any reason to PHCC and who provided written informed consent to participate in the trial.

INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation which includes mobile APPs application. Control group: usual care. OUTCOME MEASURES: Abstinence at 12 months confirmed by exhaled air carbon monoxide concentration of less or iqual 10 parts per million in each control.

RESULTS: The application of a smoking cessation intervention with a mobile APPs application will improve the smoking cessation success rate in smokers, besides of their intention or not to give up smoking at baseline.


Options:
A: 30 day point prevalence of abstinence (6 months)
B: Child Urine Cotinine (3 months and 12 months); Cigarettes/Day (3 months and 12 months)
C: verified abstinence 6 months (6 months)
D: Smoking cessation (Change in smoking status from baseline at 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate
Brief Summary: The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.


Options:
A: Change in Infant Movement between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Breathing between Mattress ON and Mattress OFF (control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.); Change in Infant Heart Rate between Mattress ON and Mattress OFF(control) (Single sessions throughout course of hospitalization. Each session may last up to 24 hours.)
B: Heart Rate (up to 2 weeks); Respiratory Rate (up to 2 weeks); O2 sats (up to 2 weeks); Activity level (up to 2 weeks); Sleep category (up to 2 weeks); Feeding (sucking and absorption) category (up to 2 weeks); Neonatal Abstinence Scoring (NAS) (up to 2 weeks)
C: Finnegan Neonatal Abstinence Scoring System (14 days); Duration of Treatment (120 days)
D: Hospital length of stay (Up to hospital discharge, an anticipated average of 4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacological Treatment of Neonatal Abstinence Syndrome: Opiate Versus Non-Opiate
Brief Summary: The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.


Options:
A: Sublingual Buprenorphine safety and tolerability in the neonate (Index hospitalization)
B: Days of Treatment With Opioid Medication (From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months)
C: Finnegan Neonatal Abstinence Scoring System (14 days); Duration of Treatment (120 days)
D: Length of Treatment (Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Dietary Intervention and Later Signs of Beta-Cell Autoimmunity: Potential Mechanisms
Brief Summary: The proposed mechanistic formula feeding study sets out to identify the mechanism(s) by which an extensively hydrolyzed casein formula is able to protect children at risk for type 1 diabetes (T1D) from beta-cell autoimmunity.


Options:
A: Intestinal permeability will be determined at the age of 3, 6, 9 and 12 months with the lactulose/mannitol test Intestinal permeability at the age of 9 months assessed with the lactulose/mannitol test (3, 6, 9 and 12 months)
B: Positivity for two or more diabetes-associated autoantibodies and/or clinical type 1 diabetes (10 years)
C: Number of Participants With Type 1 Diabetes Mellitus (12 and 18 months and annually from 2 years up to 14 years)
D: infants' intake, length of feeding and patterning of feeding of Nutramigen relative to Enfamil (infant-led feeding condition) (0.5-8.5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Dietary Intervention and Later Signs of Beta-Cell Autoimmunity: Potential Mechanisms
Brief Summary: The proposed mechanistic formula feeding study sets out to identify the mechanism(s) by which an extensively hydrolyzed casein formula is able to protect children at risk for type 1 diabetes (T1D) from beta-cell autoimmunity.


Options:
A: Intestinal permeability will be determined at the age of 3, 6, 9 and 12 months with the lactulose/mannitol test Intestinal permeability at the age of 9 months assessed with the lactulose/mannitol test (3, 6, 9 and 12 months)
B: Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator (60 days)
C: Growth (weight) (106 days)
D: Beta-cell autoantibodies (3,6,12,24,36,48,60,72 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Attempt to Optimize the Results of Liver Transplantation With Administration of Probiotics.
Brief Summary: The aim of this study was to evaluate the impact of the administration of probiotics on outcomes of patients qualified for liver transplantation, both in the pre-transplant period and in the early postoperative period.


Options:
A: To maintain normal bowel function and significantly moderate or obviate Immunosuppression Associated Diarrhea following kidney transplantation, utilizing a daily questionnaire, stool cultures and C. Difficile. (5 months)
B: Change in p-cresol plasma concentration (one month)
C: Evaluate the effect of synbiotic on postoperative infection after liver transplantation (15 days)
D: All-cause postoperative mortality (90 days after the date of liver transplantation); Postoperative infection (30 days from the date of liver transplantation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Attempt to Optimize the Results of Liver Transplantation With Administration of Probiotics.
Brief Summary: The aim of this study was to evaluate the impact of the administration of probiotics on outcomes of patients qualified for liver transplantation, both in the pre-transplant period and in the early postoperative period.


Options:
A: Change in hs CRP (baseline and after 16 weeks); Change in TNF alpha (Baseline and at week 16); Change in IL6 (Baseline and at week 16); Change in IL10 (Baseline and at week 16); Change in MCP1 (Baseline and at week 16)
B: Serum levels of p-cresol and indole derivatives (After 4 weeks of intervention)
C: Indoxyl Sulfate concentration (Through study completion, an average of 60 days)
D: All-cause postoperative mortality (90 days after the date of liver transplantation); Postoperative infection (30 days from the date of liver transplantation)

Answer: D