TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Physsurg - a Controlled Randomized Trial on the Effect of Physical Activity in Relation to Outcome After Surgery
Brief Summary: This study will compare the outcome after surgery between a group of patients that receives instructions for prehabilitation training and one group that received standard treatment.


Options:
A: Oswestry Disability Index (ODI) (Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery)
B: Maintain or improve physical fitness (anaerobic threshold measured by CPET)after treatment with neoadjuvant chemoradiotherapy in colorectal cancer patients. (3 years)
C: 6-minute-walking-distance (6MWD) (4 weeks postoperatively)
D: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Physsurg - a Controlled Randomized Trial on the Effect of Physical Activity in Relation to Outcome After Surgery
Brief Summary: This study will compare the outcome after surgery between a group of patients that receives instructions for prehabilitation training and one group that received standard treatment.


Options:
A: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
B: Change in psychosocial status (from baseline to 24 month)
C: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)
D: Health-related quality of life (Week 10)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dissemination of CVD Risk Factor Treatment Among Diabetic Patients in Safety Net Clinics
Brief Summary: The purpose of the ALL Study is to determine the effectiveness of the dissemination of the ALL intervention from an integrated care setting into Community Health Centers (CHCs) by measuring changes in diabetes mellitus (DM) population prescription rates for the medications, using a pre-post comparison within clinics and a staggered, randomized implementation across clinics.


Options:
A: Hemoglobin A1c (Baseline, 6 months)
B: Rate of LDL cholesterol control (< 100 mg/dL) (12 months); Rate of blood pressure control (< 130/80 mmHg) (12 months); Rate of HbA1c control (<7%) (12 months)
C: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)
D: Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both (Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional and Cognitive Impairment Prevention Through Early Physical Activity for Elderly Hospitalized Patients: a Randomized Clinical Trial
Brief Summary: The current model of care for the hospitalized elderly patients has been conditioned by many factors unrelated to the disease process that caused the hospitalization and usually worsen the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are walking). These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, deconditioning, pressure ulcers and decreased caloric intake, social isolation, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory.


Options:
A: Changes in functional status after the intervention (Barthel Index) (Baseline (Hospital Admiission), 1 and 3 months later); Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test) (Baseline (Hospital Admiission) and 1 and 3 months later)
B: Recover basal functional capacity (During hospital stay, from admission (first evaluation) until hospital discharge (second evaluation, and 3-months postdischarge (last evaluation).)
C: Falls (18 months); Amount of Time Spent Out of Bed as Measured by Wireless Accelerometers (During hospital stay)
D: Glittre test (up to 9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional and Cognitive Impairment Prevention Through Early Physical Activity for Elderly Hospitalized Patients: a Randomized Clinical Trial
Brief Summary: The current model of care for the hospitalized elderly patients has been conditioned by many factors unrelated to the disease process that caused the hospitalization and usually worsen the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are walking). These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, deconditioning, pressure ulcers and decreased caloric intake, social isolation, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory.


Options:
A: Postoperative delirium rate within 7 days after surgery (7 days after surgery)
B: Changes in functional status after the intervention (Barthel Index) (Baseline (Hospital Admiission), 1 and 3 months later); Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test) (Baseline (Hospital Admiission) and 1 and 3 months later)
C: Reduction in the incidence of Post-Operative Delirium (%) (Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first))
D: Delirium (5 days); Subsyndromal delirium (5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Functional and Cognitive Impairment Prevention Through Early Physical Activity for Elderly Hospitalized Patients: a Randomized Clinical Trial
Brief Summary: The current model of care for the hospitalized elderly patients has been conditioned by many factors unrelated to the disease process that caused the hospitalization and usually worsen the outcome of hospitalization circumstances. Many times hospitalized elderly patients spend most of the time in bed (even higher than 83% of bed rest versus 4% of those who stand or are walking). These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, deconditioning, pressure ulcers and decreased caloric intake, social isolation, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory.


Options:
A: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
B: Instrumental and Physical Functionality (Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)); Re-Admission to Hospital (Assessed 3 months and 12 months after the time of hospital discharge (T1, T2).); Institutionalisation (Assessed 12 months after the time of hospital discharge (T2).)
C: Compliance with recommendations for intraoperative temperature management (1 day); Compliance with recommendations for intraoperative blood glucose management (1 day); Assess the usability of the Anesthesiology Control Tower (ACT) for an operating suite (2 years)
D: Changes in functional status after the intervention (Barthel Index) (Baseline (Hospital Admiission), 1 and 3 months later); Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test) (Baseline (Hospital Admiission) and 1 and 3 months later)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: One of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the United States experiencing this condition.

Hypertension is very prevalent in the emergency department (ED), but significantly undertreated. The overall goal of this project is to develop a text messaging intervention to improve hypertension care in the ED. This will first be done by testing the feasibility of identifying hypertensive patients in the ED, and the response rate to text messages.


Options:
A: The change in mean daytime systolic BP from baseline to the last (12-month) visit on 24-hour ambulatory. (1 year)
B: Proportion of people who respond to text messages and are persistently hypertensive (3 weeks)
C: Change in systolic blood pressure (12-months from baseline)
D: Net change in systolic (SBP) and diastolic BP (DBP) from baseline to month 18 between the intervention and control groups among hypertensive study participants. (Baseline and 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ischemic Compression Compared With Dry Needling as a Treatment of Myofascial Trigger Points in the Neck Region in Office Workers.
Brief Summary: A randomized controlled trial will be conducted to examine the effectiveness of DN versus IC on trigger points in the neck and shoulder region for reducing pain and improving functionality (primary outcome measures) and to investigate the effectiveness of DN versus IC for muscle strength, mobility and muscle tone (secondary outcome measures).


Options:
A: Pain intensity (Ninety days)
B: Change in functionality assessment NDI (Neck Disability Index) & SPADI (Shoulder Pain and Disability Index) (at baseline, one week after the end of the treatment sessions, at 3 months); Pain assessment 0-10 (at baseline); Change in Pain assessment (at baseline, one week after the end of the treatment sessions, at 3 months)
C: Pain Assessment (6 weeks); Disability (6 weeks)
D: Neck Pain (Baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Using an Interactive Game to Reduce Fear & Increase Spine Motion in Low Back Pain
Brief Summary: A fundamental clinical problem in individuals with chronic low back pain is the significant alteration in movement patterns that restrict lumbar spine motion. This is particularly true for individuals with fear of re-injury with movement (i.e., kinesiophobia). The primary aims of the current study are to use a whole body video game environment to 1) determine the effects of game play on lumbar spine flexion and expectations of pain and harm and 2) determine the effects of altered movement gain on lumbar spine flexion.


Options:
A: 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).)
B: Roland-Morris Disability Questionnaire (baseline to 12 weeks); Roland-Morris Disability Questionnaire (baseline to 6-months)
C: Pain VAS
D: Lumbar spine flexion changes (baseline (day 1) to post-test (day 5)); Expectation of pain changes (baseline (day 1) to post-test (day 5)); Expectation of harm changes (baseline (day 1) to post-test (day 5))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter Study of Once Daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, Twice Daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Twice Daily Fluticasone Propionate 250 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents Already Adequately Controlled on Twice-daily Inhaled Corticosteroid and Long-acting beta2 Agonist
Brief Summary: This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate \[FP\]/salmeterol 250/50 microgram \[mcg\]twice daily \[BD\]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA.

SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.


Options:
A: Morning Peak Expiratory Flow (AM PEF) (Baseline (run-in) and throughout 12 weeks)
B: Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period (Baseline and Week 24)
C: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
D: Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population (Baseline and Week 24); Change From Baseline in PM FEV1 Using Per Protocol (PP) Population (Baseline and Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter Study of Once Daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, Twice Daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Twice Daily Fluticasone Propionate 250 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents Already Adequately Controlled on Twice-daily Inhaled Corticosteroid and Long-acting beta2 Agonist
Brief Summary: This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate \[FP\]/salmeterol 250/50 microgram \[mcg\]twice daily \[BD\]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA.

SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.


Options:
A: Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population (Baseline and Week 24); Change From Baseline in PM FEV1 Using Per Protocol (PP) Population (Baseline and Week 24)
B: FEV1, (Forced expiratory volume in the 1st second).
C: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
D: Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization) (Up to 27 weeks); Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation (Up to 26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multifactorial Exercise Program to Reduce Falls in People With Parkinson Disease
Brief Summary: The primary objective of this study is to investigate the effects of a theoretically driven, highly challenging exercise program (balance and strengthening exercises) in reducing fall rate, improving balance and reducing fear of falling in persons with Parkinson's disease.

In this pilot, randomized, cross-over study, 32 participants with Parkinson disease will be randomly assigned to either an early start (immediately following enrollment) or late start (3 months after enrollment) multifactorial exercise program which will meet 2 times per week for 1.5 hours over 3 months. The exercise program will consist of balance and strengthening exercises which will be individualized depending on the ability of each participant. Fall rate, balance, walking ability, fear of falling, mood, anxiety, and quality of life will be measured prior to the start, at 3 months and 6 months after enrollment. Subjects will be enrolled for 6-7 months.


Options:
A: No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
B: Falls Diary (6-7 Months)
C: Percentage of "Off" Time During Waking Hours at End of Study (22 weeks)
D: Balance (3 time points)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Automatic Oxygen Administration in Spontaneous Ventilation During the Hypoxemic Acute Respiratory Distress in Infants and Children
Brief Summary: The aim of the study is to assess the use feasibility of the FreeO2 system so as to deliver automatically oxygen in infants and children admitted at hospital for hypoxemic acute respiratory distress.

In healthy volunteers adults, FreeO2 system provided a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. Our hypothesis is that FreeO2 system use is feasible in infants and children with hypoxemic acute respiratory distress. We think FreeO2 will provide a better control of the oxygen saturation, a faster oxygen weaning than classical way (Rotameter). In addition, FreeO2 could reduce the number of intervention by nurses.


Options:
A: Percentage of time spent in the target zone of oxygen saturation in the acute phase of treatment (6 hours or 1 hour after cessation of oxygenation)
B: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)
C: The duration of mechanical ventilation (Through study completion, an average of 2 years)
D: proportion of time spent in extreme saturation ( less than or equal to 80%) (Through study completion, an average of 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery: a Multicenter Randomised Double Blind Placebo Controlled Trial
Brief Summary: The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.


Options:
A: need for additional uterotonics (30 minutes)
B: postpartum bleeding in the third stage of labour (participants will be followed for the duration of hospital stay, an expected average of 48 hours)
C: Need for additional treatment after initial PPH study treatment (all additional interventions recorded following initial uterotonic treatment)
D: Incidence of PPH (24 hours after birth)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery: a Multicenter Randomised Double Blind Placebo Controlled Trial
Brief Summary: The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.


Options:
A: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)
B: Incidence of PPH (24 hours after birth)
C: o compare the estimated blood loss (EBL) during cesarean delivery among the three groups (Intraoperative and within the first 24 hours postoperative.)
D: Pharmacokinetic (24 hours after randomisation)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery: a Multicenter Randomised Double Blind Placebo Controlled Trial
Brief Summary: The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.


Options:
A: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)
B: Blood loss =>500 mls within one hour after enrollment
C: The amount of blood loss in the third and fourth stages (the fourth stage of labor begins with delivery of the placenta and ends 2 hours after delivery) of labor. (2 hours)
D: Incidence of PPH (24 hours after birth)

Answer: D