TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of a Multimodal Rehabilitation Programme (MRP) for Adolescents With Chronic Musculoskeletal Pain (12-21 Years) Compared to Care as Usual (CAU); a Randomized Clinical Trial (2B Active)
Brief Summary: The purpose of this study is to evaluate whether a multimodal rehabilitation program effectively reduces functional disability in adolescents with chronic musculoskeletal pain, compared to care as usual.


Options:
A: PATIENT-RATED LOW BACK PAIN (3 and 12 months)
B: Change in Functional Disability (Baseline, 8 weeks, 16 weeks, 10 months, 12 months)
C: Feasibility and retention (8 weeks)
D: Change in Level of Adherence in Subjects (Objective Measure) (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky (Baseline, 3 months, 6 months); Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement (Baseline, 3 months, 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Empagliflozin (10mg, 25mg) Administered Orally, Once Daily Over 24 Weeks in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus
Brief Summary: This trial is designed to investigate the efficacy and safety of empagliflozin compared with placebo in hypertensive black/African Americans with type 2 Diabetes Mellitus. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and BP lowering effects of empagliflozin in hypertensive African American patients with type 2 Diabetes Mellitus could provide clinically highly relevant, new information for the use of empagliflozin.

Essential hypertension is four times more common in African Americans than in Caucasians.

One of the risk factors for hypertension is sodium sensitivity and approximately one third of the essential hypertensive population is responsive to sodium intake. There is a higher association of hypertension with sodium sensitivity in African American patients with type 2 Diabetes Mellitus.

The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in HbA1c, a well accepted measurement of chronic glycaemic control and the key secondary endpoints of decreases in systolic BP (SBP) and diastolic BP (DBP) at 12 and 24 weeks.


Options:
A: The First 3-point Major Adverse Cardiovascular Events (3P-MACE) (From randomization until individual day of trial completion, up to 432 weeks)
B: Change in low-density lipoprotein cholesterol (52-weeks); Change in glycated hemoglobin (52-weeks)
C: Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks (baseline and 24 weeks)
D: Change in Left ventricular function from visit 1 to week 24, measured by Ecco (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Additional Therapeutic Effects of Virtual Reality System in Children With Developmental Delays
Brief Summary: The purpose of this study is to investigate the effects of virtual reality system on children with developmental delays.


Options:
A: health of children (Pediatric Quality of Life Inventory) (changes from baseline at one and two months.)
B: Upper extremity functional status (30 minutes)
C: Gross Motor Function Measure, Sitting Section (2 months)
D: Gross Motor Function Measure-66 (GMFM) (Basline and Post Intervention); 600 Yard Walk-Run Test (Baseline and Post Intervention); 30 Second Walk Test (Basline and Post Intervention); Knee Flexor and Knee Extensor Torque (Basline and Post Intervention); Pediatric Quality of Life Inventory (PedsQL) (Basline and Post Intervention); Pediatric Outcomes Data Collection Instrument (PODCI) (Basline and Post Intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Levosimendan Pretreatment in Patients With Low Ejection Fraction (40 % or Less) Undergoing CABG: a Randomised, Double Blind, Multicenter Trial
Brief Summary: The investigators want to test the hypothesis that an infusion of levosimendan started prior to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients with poor LV function (EF 40% or less).


Options:
A: Number of Dual Efficacy Endpoint Events (30 days); Number of Quad Efficacy Endpoint Events (30 days)
B: Length of ICU stay (two weeks)
C: Mortality (30-days)
D: Confirmed low cardiac output syndrome (within the 28 days after ICU admission)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D Supplementation: Impact on Severe Pneumonia Among Under-five Children
Brief Summary: Background:

* Burden: Pneumonia is the leading cause of morbidity and mortality in under-five children, particularly in developing countries.
* Knowledge gap: Although many studies have reported an association between vitamin D deficiency and pneumonia, there is lack in information on its therapeutic impact, i.e. the impact of vitamin D supplementation in the management of childhood pneumonia.
* Relevance: Vitamin D plays an important role in modulating the innate immune response against infections. We, therefore, propose to conduct this study to assess the impact of vitamin D supplementation, in addition to standard antibiotic and supportive therapy, on the outcome of severe childhood pneumonia.

Hypothesis: The investigators hypothesise that in the management of hospitalized severe pneumonia in under-five children, vitamin D3 supplementation, as an adjunct to the standard antibiotic and other supportive therapy, will hasten recover from severe pneumonia and may thereby shorten duration of severe pneumonia and also reduce the risk of new episode of pneumonia.

Objectives: The objective of the investigators study is to assess the clinical benefit of oral supplementation of vitamin D3, in addition to standard antibiotic and other supportive therapy, to hospitalised, under-five children with severe pneumonia.

Methods: This would be a randomised, double blind, controlled clinical trial (RCT). Children of either sex, aged 3-59 months, attending the Dhaka Hospital of icddr,b, with clinically diagnosed severe pneumonia will comprise the study population. Eligible children will be allotted a sequential study number, which will have been previously assigned to vitamin D or placebo in accordance with the randomisation. The study staff and mothers/ caregivers of the children will be blinded as to whether vitamin D3 or placebo has been added to their child's diet. Infants aged 3-5 months will receive breast milk and/or infant formula, and those 6 months or older will receive "Milk Suji" as a complementary food. Vitamin D3 supplementation will be given on five consecutive days, from the day of enrolment in addition to standard antibiotic and other supportive therapy.

Outcome measures/variables:

Primary outcome measure will be time to resolution of severe pneumonia.

Secondary outcome measures will be duration of hospitalization, fever, tachypnoea, chest in drawing, hypoxia, lethargy and inability to feed during hospital stay and as well as new episode of pneumonia after discharge.


Options:
A: Change in serum level of 25hydroxycholecalciferol (25(OH)D) (At baseline and 7 days after vitamin D3 (Cholecalciferol) injection)
B: incidence of pneumonia (18 months)
C: Time taken for recovery from severe pneumonia (12 months)
D: Serum calcium (at each dose change)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Wellness Action Plan to Address the Childhood Obesity Epidemic
Brief Summary: The objective of this study was to determine the effectiveness of a novel Wellness Action Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing follow-through with plans and 3) aiding parents in identifying their child's weight category.


Options:
A: Daily physical activity > 60 minutes (4 years)
B: Improvement of maximal oxygen uptake
C: Overweight (one school year)
D: Diet plan recall directly after visit (On day of primary visit); Activity plan recall directly after visit (On day of primary visit, directly after seeing physician)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Growth Hormone Co-treatment With the Microflare Stimulation Protocol in IVF/ICSI, Can it be a New Hope for Poor Responders?
Brief Summary: The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI cycles in poor responders


Options:
A: Live birth rate (Up to 9 months)
B: Numbers of oocytes retrieved and number of fertilized oocytes (2 years)
C: Live birth rate (12 months)
D: Clinical pregnancy rates (15 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Importance of Mean Arterial Pressure During Cardiopulmonary Bypass to Prevent Cerebral Complications After Cardiac Surgery - a Randomised Clinical Trial.
Brief Summary: STUDY HYPOTHESIS

In cardiac surgery the volume of perioperative cerebral infarctions can be reduced by increasing mean arterial pressure (MAP) during the cardiopulmonary bypass procedure.

BRIEF STUDY SUMMARY

Heart surgery using cardiopulmonary bypass (CPB) can be complicated by injury to the brain. Previous studies using brain scans have reported small stroke-like lesions in up to 51% of patients after cardiac surgery. However, only 1-6 % of patients have permanent symptoms of severe brain damage.

The majority of brain lesions seem to be caused by particulate matter (emboli) that wedge in blood vessels of the brain thereby compromising flow. In addition, insufficient blood flow to areas of the brain supplied by narrowed, calcified vessels may contribute. MAP during CPB usually stabilizes below the lower limit of cerebral autoregulation, which is accepted since sufficient total blood flow is guaranteed during CPB.

The aim of the PPCI trial is to investigate if increased MAP during CPB can prevent or reduce the extent of brain injury after cardiac surgery. A beneficial effect could result from reduced embolic injury through increased blood flow in collateral vessels and/or by increased blood flow in calcified arteries.

180 patients scheduled for cardiac surgery will be randomly allocated to increased MAP (70-80 mm Hg) or 'usual practice' (typically 45-50 mm Hg) during CPB, whereas CPB blood flow is intended equal and fixed in the two groups. Patients are examined before and 3-6 days after surgery with magnetic resonance imaging (MRI) brain scans, mental tests and by blood borne markers of brain injury.

If higher MAP during CPB is beneficial, a change of practice can easily be implemented in the clinical routine.


Options:
A: Total Number of Days in Hospital (Within 60 days of randomization)
B: N/A
C: Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction (up to 10 days post procedure)
D: Total volume of new ischemic cerebral lesions (6 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The improvement in inspiratory muscle function might result in beneficial changes in breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing pattern during an incremental cycle exercise.


Options:
A: Measurement of the MIP
B: ventilator dependent status
C: Dyspnea measure (21 - 4 days / +7 jours)
D: Change in breathing pattern during an incremental cycle exercise test (Baseline and 8 weeks follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Control Trial of Bone Loading Exercises Versus Risedronate on Bone Health in Post-Menopausal Women
Brief Summary: The purpose of this study is to identify the best way to prevent bone loss in the first years after menopause. The HOPS study will compare bone loss at 12 months in women: 1) who take calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication "risedronate"; or 3) who take calcium and vitamin D plus participate in bone-loading exercises. Our central hypothesis is that improvements in bone health will be greater in women randomized to bone-loading exercises with calcium and vitamin D compared to women who take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.


Options:
A: Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group. (Baseline, 6, and 12 months)
B: Urinary markers of bone resorption; measured at the end of each treatment phase (Every 50 days)
C: Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months (Baseline and 12 months); Mean percent change from baseline in hip trochanter BMD at 24 months (Baseline and 24 months)
D: Proportion of Participants With New Vertebral Fractures (Baseline through 24 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease
Brief Summary: The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).


Options:
A: Ocular Surface Disease Questionnnaire Results; Lissamine green staining; Fluorescein Staining; Schirmer testing
B: Changes of inflammatory cytokines in the tears of moderate and severe MGD (1 second before using topical loteprednol etabonate, after 1 month, and after 2 months of using topical loteprednol etabonate)
C: Conjunctival hyperemia (5 minutes)
D: Bulbar Conjunctival Hyperemia (Visit 6 (Day 29)); Ocular Discomfort (Visit 6 (Day 29))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers
Brief Summary: Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and neck) and negatively impacts survival and other outcomes, but many patients have difficulty quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far have had limited success. This is a pilot randomized controlled trial designed to determine if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates for cancer patients who smoke.


Options:
A: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
B: Smoking cessation (8 weeks)
C: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
D: 7 Day Point Prevalence Abstinence From All Forms of Tobacco (4 weeks after beginning study)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Exercise Training in a Weight-loss Lifestyle Intervention on Clinical Control and Psychosocial Morbidity in Obese Asthmatics: a Randomized and Controlled Trial
Brief Summary: Obese asthmatics have more severe symptoms, reduced lung function, poorer quality of life and a reduced response to inhaled corticosteroid medication compared to non-obese asthmatics. In addition, the impact of a weight-loss program on clinical control and psychological outcomes has been poorly demonstrated and the effect of exercise training remain unknown. The investigators aim to investigate the effect of exercise training in a weight-loss program on asthma clinical control (primary outcome), health factors related to quality of life and psychosocial symptoms (secondary outcomes) in obese patients with moderate-to-severe persistent asthma. Physical activity, inflammatory profiles and sleep disorders will also be evaluated. The investigators' hypothesis is that exercise as part of a weight-loss program is more effective to lose weight and improve asthma control, quality of life and psychosocial symptoms in obese asthmatics.


Options:
A: Clinical Control (Before and after 3 months of intervention)
B: Asthma control Questionnaire (Juniper) (Within 1 week of completion of the intervention (i.e., after 12 weeks))
C: Asthma Control Questionnaire (Baseline, 6- and 12-months)
D: psychosocial morbidity and airway inflammation (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Making Ramadhan Fasting a Safer Experience With Technology Study
Brief Summary: Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of illness, disability, and death in Malaysia with an increasing prevalence. Despite the best effort, only 1 in 3 patients ever meet their HbA1c goal. In most patients with type 2 diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will generally consume large quantities of fried and sugary foods when they break their fast or during the night. Given the importance and public health significance of poor diabetes management and its associated risk especially during Ramadan, the investigators aim to test the intervention of using remote monitoring within community provider practice for patients with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer which can directly feedback the patients glycaemic levels to the physicians will reduce and even eliminate the occurrence of hypoglycaemia whilst ensuring that patients remain euglycaemic throughout the whole Ramadan month.


Options:
A: The primary endpoint is the A1c level or the change in A1c level. (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: Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 (Baseline, Month 12)
D: Number of patients with hypoglycaemia in usual care versus telemedicine during Ramadan (Week 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Making Ramadhan Fasting a Safer Experience With Technology Study
Brief Summary: Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of illness, disability, and death in Malaysia with an increasing prevalence. Despite the best effort, only 1 in 3 patients ever meet their HbA1c goal. In most patients with type 2 diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will generally consume large quantities of fried and sugary foods when they break their fast or during the night. Given the importance and public health significance of poor diabetes management and its associated risk especially during Ramadan, the investigators aim to test the intervention of using remote monitoring within community provider practice for patients with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer which can directly feedback the patients glycaemic levels to the physicians will reduce and even eliminate the occurrence of hypoglycaemia whilst ensuring that patients remain euglycaemic throughout the whole Ramadan month.


Options:
A: Proportion of Participants With at Least One Symptomatic Hypoglycemic Event (30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10))
B: Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority (1 month)
C: Number of patients with hypoglycaemia in usual care versus telemedicine during Ramadan (Week 4)
D: Postprandial glucose (mg/dl) (180 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Keeping Weight Off: Brain Changes Associated With Healthy Behaviors
Brief Summary: The goal of this project is to characterize changes in emotion regulation pathways associated with healthy behaviors in people who have recently lost weight and are seeking to maintain weight loss over a 1-year period.


Options:
A: Progression of albuminuria (1,2,3,4 and 5 year)
B: change in severity of depressive symptoms (change from baseline in severity of depressive symptoms at 3 months, 6 months, and 12 months)
C: Functional connectivity on fMRI (8 weeks)
D: The Dutch Eating Behavior Questionnaire (Baseline in experimental and control groups.); The Dutch Eating Behavior Questionnaire (Post-treatment 8 weeks from baseline in experimental and control groups); The Dutch Eating Behavior Questionnaire (twelve-months follow-up in experimental and control groups)

Answer: C