TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease: A Multi-centred, Randomised, Controlled Trial
Brief Summary: The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.


Options:
A: Mean weight gain (3 years); Mean weight gain (5 years)
B: Composite measure of Growth (1 year)
C: Infant weight gain (Between ages 14 weeks (+/- 1 week) and 12 months (+/- 2 weeks))
D: Growth velocity of formula regimen 1 and 2 versus WHO growth curve (0-6 months); Growth velocity (g/day) of formula regimen 1 and 2 versus a human milk (HM)-fed comparator group (0-6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study
Brief Summary: The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints include insertion of CVSs, peripheral venous catheters, catheter patency and a number of possible complications.


Options:
A: successful placement of a venous catheter on the first attempt (within the hour after insertion of peripheral venous catheter)
B: The occurence of catheter related venous thrombosis (Upon clinical suspiscion during the one the patient i enrolled in the study)
C: Patient's experience of pain during the procedure (up to 5 minutes.); Patient's experience with the method used to obtain venous access (1/2) (up to 5 minutes.); Patient's experience with the method used to obtain venous access (2/2) (up to 10 minutes.)
D: Reducing the use of CVC and PVC (through study completion, an average of 7 month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Clinical Efficacy of Midline Catheters for Intravenous Therapy: a Randomized, Controlled Study
Brief Summary: The study will evaluate the clinical efficacy of midline catheters compared to conventional treatment in patients with an expected intravenous therapy duration of more than 5 days. Patients will be randomized in a 1:1 ratio. The study will include 120 patient. Endpoints include insertion of CVSs, peripheral venous catheters, catheter patency and a number of possible complications.


Options:
A: Reduction in number of minor surgical procedures that may be required to deliver fluids into the blood of critically ill patients by using the ultrasound guided technique (1 Day)
B: Initial success rate (immediatetely after first attempt, average attempt takes 15 minutes)
C: Reducing the use of CVC and PVC (through study completion, an average of 7 month)
D: First pass success (1 day); Number of attempts (1 day); Overall success (1 day); Time to completion (1 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Repeat Dose, Open Label, Two Period, Randomized, Cross Over Study to Compare the Effect of Daprodustat to Recombinant, Human Erythropoietin (rhEPO) on Oral Iron Absorption in Adult Participants With Anemia Associated With Chronic Kidney Disease Who Are Not on Dialysis
Brief Summary: Daprodustat administration has the potential, by virtue of increasing hypoxia-inducible factor (HIF) levels, to increase oral iron absorption and incorporation into hemoglobin (Hgb). Therefore, the purpose of this study is to compare the effect of daprodustat to rhEPO (i.e., epoetin alfa or darbepoetin alfa) on non-heme oral iron absorption using stable isotopic iron (57Fe and 58Fe) by measuring incorporation of iron in erythrocytes. This study will be a randomized, repeat dose, open label, two period cross-over study in adult, male and female participants with anemia associated with chronic kidney disease who are not on dialysis currently treated with stable doses less than or equal to (\<=) 50 percent (%) change in 4-weekly dose) for at least 8 weeks prior to and including the screening period, of rhEPO (i.e., epoetin alfa or darbepoetin alfa). Sufficient participants will be enrolled such that at least 12 participants comprise the Evaluable Population. The study will compare the fractional iron absorption between treatment arms (daprodustat and rhEPO \[i.e., epoetin alfa or darbepoetin alfa\]) and will evaluate the difference is equal/not equal to zero.


Options:
A: Absolute Change From Baseline in Hemoglobin (Hgb) to End of Treatment (Week 6) (Baseline, Week 6)
B: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants (Weeks 40 to 52)
C: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period: Non-inferiority Analysis (Up to 3.9 person-years for CV follow-up time period); Mean Change From Baseline in Hemoglobin (Hgb) Levels During Evaluation Period (Week 28 to Week 52) (Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52))
D: Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO (Up to Day 57)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Virtual Reality Attention Training in Stroke Patients
Brief Summary: Hemispatial neglect is a post-stroke condition in which patients fail to detect stimuli presented on the side of space opposite to the damaged brain hemisphere (contralesional space). To date, there is no established effective treatment for this condition. A virtual reality (VR) behavioral training for the attention deficits characteristic of patients with hemispatial neglect was developed. Patients are stimulated in the visual and auditory modality to orient towards the contralesional side and are rewarded for detecting targets on this side in this training. In the current study the researchers aim to answer two main questions: 1) how feasible is a VR game-based intervention in stroke patients? and 2) what is the efficacy of the virtual reality game-based intervention in reducing the attention deficits characteristic of hemispatial neglect? To answer these questions a randomized partially double-blind placebo-controlled crossover study will be conducted. Two within-subject conditions will be compared: in the active condition patients will play a VR game in which multisensory stimulation is progressively presented in the neglected region (the location where previously presented targets were missed by the patient) and in the placebo condition patients will play a VR game in which the stimulation is presented in the center of of the VR environment. Neglect symptoms will be measured on a two-daily basis to establish the trend of symptom recovery through time. The hypothesis states that symptoms will recover more quickly when patients receive the active version of the VR intervention compared to the placebo version of the VR intervention.


Options:
A: Change in excitability of fronto-parietal connectivity (Participants will be assessed at baseline and 30 minutes later)
B: Change in the Posner reaction times (The primary outcome variable is measured at 8 timepoints: First timepoint = Baseline (pre-intervention), Timepoints 2 until 6 = during intervention, Timepoint 7 = immediately after intervention, Timepoint 8 = 1 week after intervention.)
C: Behavioral Inattention test (Day 0)
D: Kessler Foundation Neglect Assessment Process (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity Intervention for Loneliness (PAIL) in Community-dwelling Older Adults: a Feasibility Study
Brief Summary: The purpose of this study will be to examine the feasibility of a Physical Activity Intervention for Loneliness (PAIL) in community-dwelling older adults. The research is a feasibility study designed as a two-arm randomised controlled trial (RCT) with a wait-list control group (intervention will be offered at 12 weeks to control group).


Options:
A: Aerobic fitness (before and after the 10 week intervention)
B: Arterial stiffness (12 weeks); Blood pressure (BP) (12 weeks); Muscle strength (12 weeks); Body composition (12 weeks); Height (12 weeks); Heart rate (HR) (12 weeks); Body mass index (BMI) (12 weeks)
C: Attendance (12 months); Recruitment rate (12 months); Retention rate (12 months); The appropriateness and practicality of the designed intervention in the proposed settings (12 months); The acceptability of the intervention by participants and willingness to participate (12 months); The assessment rate of questionnaires (12 months); The appropriateness of statistical methods of data analysis (12 months); Likely required sample size for the future pilot trial (12 months); The effect size will be calculated for loneliness (12 months); The effect size will be calculated for social support (12 months); The effect size will be calculated for social networks (12 months); The effect size will be calculated for depression (12 months); The effect size will be calculated for anxiety (12 months); The effect size will be calculated for self-efficacy for exercise (12 months); The effect size will be calculated for satisfaction with level of social contacts (12 months); The effect size will be calculated for expected outcomes and barriers for exercise (12 months)
D: 24 hour blood pressure (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults
Brief Summary: Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily. Several studies in rodents report that TRF reduces body weight, improves blood sugar control, and reduces the risk of cardiovascular disease-even when food intake is matched to the control group or no weight loss occurs. Preliminary evidence suggests that TRF may also increase weight loss, fat loss, and reduce the risk of diabetes and cardiovascular disease in humans. This study will test whether TRF enhances fat loss and increases weight loss in adults with obesity, relative to conventional dieting alone. In addition, this study will determine whether TRF reduces risk factors for type 2 diabetes and cardiovascular disease and will measure the feasibility and acceptability of TRF.

In conjunction with the parent study described above, four ancillary studies will be conducted:

1. Effect of weight loss on nitrogen metabolism and bacteria in the mouth. The primary endpoints for this ancillary study are plasma and salivary nitrate and nitrite, and the secondary endpoints are salivary nitrate reductase activity and salivary bacterial abundance.
2. Effect of weight loss on several biomarkers related to kidney stones. The primary endpoint for this ancillary study is urinary oxalate, and the secondary endpoints are urinary citrate, chloride, sodium, potassium, calcium, phosphorus, uric acid, and creatinine.
3. Effect of meal timing on blood pressure regulation and kidney function. The primary endpoints of this ancillary study include urinary aldosterone excretion, sodium, potassium, and endothelin, whereas the secondary endpoints include nitric oxide and albumin. Additional exploratory endpoints include renal injury markers (KIM-1, nephrin, and urine albumin-to-creatinine ratio), measures of reactive oxidative stress (e.g., hydrogen peroxide and TBARs), and urinary exosomes. Urine will be analyzed in 12-hour bins to determine how meal timing affects differentially affects these endpoints during the daytime and nighttime. The effects of weight loss on these endpoints may also be considered.
4. Validation of a meal timing questionnaire to assess the distribution of food intake throughout the day.


Options:
A: Fat loss and lean mass retention (14 weeks); Weight loss (14 weeks); Absolute changes in body composition (14 weeks)
B: Change in Glucose Tolerance (Before and after 5 weeks on each feeding schedule)
C: Change From Baseline in Fasting Body Weight (Week 0, Week 56); Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. (At Week 56); Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (At 56 weeks); Proportion of Subjects With Onset of Type 2 Diabetes (At 160 weeks)
D: Change in Total Body Weight (in kg) at 3 months compared to baseline (Baseline to 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: BOLD: A Trial of Blood Pressure Lowering in Dialysis
Brief Summary: Blood pressure may be one of the most important modifiable risk factors for cardiovascular disease in patients with end-stage-renal-disease undergoing maintenance hemodialysis. Although a systolic blood pressure \<140 mmHg treatment target has been recommended, there remains uncertainty on which blood pressure should be targeted, more specifically that measured in the dialysis unit or at home. Observational studies have reported a paradoxical U-shaped associated with dialysis unit (pre-dialysis) systolic blood pressure and cardiovascular events and death (where blood pressure below 140 mmHg is actually linked with poor outcomes). Conversely, the same studies have reported a linear association between higher home systolic blood pressure and worse clinical outcomes, where blood pressure below 140 mmHg is associated with better outcomes. This pilot clinical trial aims to address this important question.


Options:
A: Feasibility - Screen:Enrollment Ratio (Screening); Adherence to Assigned Treatment Arm (4 months); Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] (Assessed every 2 weeks over 4 months); Mean Duration (in Minutes) of Recovery From Dialysis Treatments (Assessed every 2 weeks; Data averaged over 16 weeks)
B: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first); Time to All-cause Mortality or End Stage Renal Disease (ESRD) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first)
C: Proportion of participants screened as eligible who enroll (34 months); Proportion of participants who enrolled who completed the 8 week-trial (34 months); Tolerability of Meditation Intervention on a 10-point Likert scale (8 weeks)
D: Insomnia Severity Index (ISI) Short-term (Week 7); Insomnia Severity Index (ISI) Long-term (Week 25)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intravenous Infusion of Magnesium Sulphate on Arterial Oxygenation and Pulmonary Mechanics in Patients With Chronic Obstructive Pulmonary Diseases Undergoing Cancer Larynx Surgery. A Randomized Controlled Trial
Brief Summary: Chronic Obstructive Pulmonary Disease \[COPD\] is a major cause of chronic morbidity and mortality worldwide. COPD is characterized by persistent progressive airflow limitation that adversely affects the ventilation/perfusion (V/Q) matching and mechanics of the respiratory muscles and leads to hypoventilation and reduced gas transfer. COPD was identified as a significant comorbidity associated with increased incidences of postoperative pulmonary complications and prolonged hospital stay. MgSO4 either intravenous or inhalational has been shown to promote bronchodilation and to improve lung function in asthmatic patients. MgSO4 either intravenous or inhalational has been shown to promote bronchodilation and to improve lung function in asthmatic patients. Administration of MgSO4 in patients with stable COPD was associated with reduced lung hyperinflation and improvement of respiratory muscle strength. This randomized control trial is designed to assess the effect of intravenous MgSO4 infusion on oxygenation and pulmonary mechanics and incidence of postoperative pulmonary complications and length of hospital stay in patients with COPD undergoing cancer larynx surgery.


Options:
A: Measurements of forced vital capacity (FVC), forced expiratory volume (FEV1), functional residual capacity (FRC),maximal respiratory pressures,maximal oxygen consumption and maximal work load. (Immediatly after the end of IV infusion)
B: Identifying new patient subtypes and endpoints for COPD (3 years)
C: All cause mortality at 3 years
D: lung oxygenation (over a period of 6-8 hours, from the time of induction of general anesthesia until time of patients discharge from the PACU.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Long-term Home-based Exercise Training Program Using Minimal Equipment vs. Usual Care in COPD Patients: a Multicenter Randomized Controlled Trial
Brief Summary: The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who have completed a pulmonary rehabilitation.


Options:
A: Dyspnea (Change from baseline to 12 months)
B: Prevalence of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) (baseline); Incidence and worsening of risk factors to develop comorbidities (vascular dysfunction, osteoporosis, muscle wasting and metabolic syndrome) (3 years)
C: Exercise behavior (3 & 6 Months)
D: Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo (Baseline, day 22, baseline day 36, day 57); Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level (Baseline, day 22, baseline day 36, day 57)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.
Brief Summary: When patients suffer from chronic pain after multiple back surgeries, this is denominated as the 'failed back surgery syndrome'. A possible treatment for these patients is spinal cord stimulation. This is an invasive treatment where no other treatment options (medication, minimal invasive treaments) can offer progress to the patients' health status. In spinal cord stimulation, an electrode will be placed at the spinal cord under local anaesthesia whereas via a battery a painless electrical stimulation will arise. Clinical research have demonstrated that a new way of spinal cord stimulation can improve back and leg pain significantly. This will lead to a better quality of life for the patients and a decreased use of medications. In Ziekenhuis Oost-Limburg, different manners of spinal cord stimulation will be compared to each other.


Options:
A: The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
B: Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods (12 months)
C: Evaluation of pain (28 days)
D: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.
Brief Summary: When patients suffer from chronic pain after multiple back surgeries, this is denominated as the 'failed back surgery syndrome'. A possible treatment for these patients is spinal cord stimulation. This is an invasive treatment where no other treatment options (medication, minimal invasive treaments) can offer progress to the patients' health status. In spinal cord stimulation, an electrode will be placed at the spinal cord under local anaesthesia whereas via a battery a painless electrical stimulation will arise. Clinical research have demonstrated that a new way of spinal cord stimulation can improve back and leg pain significantly. This will lead to a better quality of life for the patients and a decreased use of medications. In Ziekenhuis Oost-Limburg, different manners of spinal cord stimulation will be compared to each other.


Options:
A: Changes in pain (6 months)
B: Evaluation of pain (28 days)
C: Oxford Shoulder Score (6 months post randomisation)
D: Percent pain relief obtained during the one-month follow-up compared to baseline; The magnitude of change in other indexes of function, such as MPI, during the one-month follow-up period

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.
Brief Summary: When patients suffer from chronic pain after multiple back surgeries, this is denominated as the 'failed back surgery syndrome'. A possible treatment for these patients is spinal cord stimulation. This is an invasive treatment where no other treatment options (medication, minimal invasive treaments) can offer progress to the patients' health status. In spinal cord stimulation, an electrode will be placed at the spinal cord under local anaesthesia whereas via a battery a painless electrical stimulation will arise. Clinical research have demonstrated that a new way of spinal cord stimulation can improve back and leg pain significantly. This will lead to a better quality of life for the patients and a decreased use of medications. In Ziekenhuis Oost-Limburg, different manners of spinal cord stimulation will be compared to each other.


Options:
A: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
B: The difference of Visual-analogue scale (VAS) between the experimental group and the control group (13 weeks)
C: Evaluation of pain (28 days)
D: Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. (6 months)

Answer: C