TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Effects of a Probiotic Formulation in Hemodialysis Patients
Brief Summary: Previous studies found that lactic acid bacteria could inhibit the activity of the performance of aristolochic acids (AAs) and improve apoptosis of proximal tubular epithelial cells (NRK-52E) and renal fibrosis on rats. The aim of this study is to assessment a novel health food of lactic acid bacteria for preventing renal dysfunction and replacing or assisting conventional drug treatment. This study in 300 hemodialysis patients with dialysis quality assessment index (KT/V, urea reduction ratio (URR), albumin, prealbumin, Hb, CRP...) screened for more than three months, and the stability of the situation in dialysis patients. They will be divided into two groups in order to conduct ergonomic assessments. One group maintains their original diet and medicine. The other group will take the novel lactic acid bacteria and placebo (1x1011 cfu/3±0.2 g/bag) in every morning and evening after their meals. The effect of 0, 6, 12, 18, 24 weeks of the novel lactic acid bacteria will be assessed after starvation for 4 weeks. Group C was the control group did not give any test samples, but continued to observe. The overall goal of the aforementioned study is to develop a novel food product of lactic acid bacteria which can improve dialysis quality for hemodialysis patients. The investigators hope that this novel product can get a patent and be commercialized.


Options:
A: inflammatory adipokine- Progranulin (PGRN) (8 week); cytokine receptor -soluble tumor necrosis factor receptor 1 (sTNFR1), (8 week); serum levels of Neutrophil gelatinase-associated lipocalin (NGAL) (8 week); cystatin C (Cys- C) (8 week)
B: Change from Baseline Triglyceride/HDL cholesterol ratio at 3 months, 6 months and 3 months after the trial (baseline,3 months, 6 months and 3 months after the trial)
C: 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)
D: Changes in plasma p-cresol concentration (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Fructose Restriction on Liver Steatosis
Brief Summary: Nonalcoholic fatty liver disease (NAFLD) is an emerging health problem as it can lead to end stage liver failure and cardiovascular complications. Diet play an important role in the development of NAFLD. Many studies have addressed the effects of added fructose on NAFLD. To date, little attention has been paid to the effects of a diet devoid of fructose. Therefore, the investigators aim to study the effects of fructose restriction on hepatic fat accumulation and vascular function using a double-blind randomized placebo-controlled design.


Options:
A: percent liver fat as determined by nMR spectroscopy (6 months)
B: Change in hepatic lipid assessed via magnetic resonance imaging (MRI and magnetic resonance spectroscopy (MRS). (8 weeks after baseline)
C: The effect of aerobic exercise on: Intrahepatic fat content (3 years)
D: Change in intrahepatic triglyceride content (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Trimodal Prehabilitation Strategy on Perioperative Functional Capability and Prognosis of Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer：a Randomized Controlled Trail
Brief Summary: The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. This is a prospective randomized controlled trail, designed to explore if the patients who take thoracoscopic lobectomy for lung cancer will benefit from family trimodal prehabilitation strategy. Trimodal prehabilitation includes exercise, nutrition supplement and physiology management preoperatively. It starts from the day that patients decide to take the surgery until the day before surgery, lasting 2\~3 week in our hospital. And we follow-up patients until 8 weeks after surgery to investigate if trimodal prehabilitation strategy can improve the postoperative functional recovery，reduce complications and improve prognosis.


Options:
A: Six Minute Walk Test (6MWT) (up to 8 weeks after surgery)
B: 6 Minute Walk Test (baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks)
C: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) (1 year after the date of primary surgery for colorectal cancer)
D: 6-minute-walking-distance (6MWD) (4 weeks postoperatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Trimodal Prehabilitation Strategy on Perioperative Functional Capability and Prognosis of Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer：a Randomized Controlled Trail
Brief Summary: The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. This is a prospective randomized controlled trail, designed to explore if the patients who take thoracoscopic lobectomy for lung cancer will benefit from family trimodal prehabilitation strategy. Trimodal prehabilitation includes exercise, nutrition supplement and physiology management preoperatively. It starts from the day that patients decide to take the surgery until the day before surgery, lasting 2\~3 week in our hospital. And we follow-up patients until 8 weeks after surgery to investigate if trimodal prehabilitation strategy can improve the postoperative functional recovery，reduce complications and improve prognosis.


Options:
A: six minute walk test (baseline, preop, 4 weeks, 8weeks postop)
B: 6 minute walk test (6MWT) (up to 8 weeks after surgery)
C: Post operative complications (30 days after surgery)
D: 6-minute-walking-distance (6MWD) (4 weeks postoperatively)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of Trimodal Prehabilitation Strategy on Perioperative Functional Capability and Prognosis of Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer：a Randomized Controlled Trail
Brief Summary: The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. This is a prospective randomized controlled trail, designed to explore if the patients who take thoracoscopic lobectomy for lung cancer will benefit from family trimodal prehabilitation strategy. Trimodal prehabilitation includes exercise, nutrition supplement and physiology management preoperatively. It starts from the day that patients decide to take the surgery until the day before surgery, lasting 2\~3 week in our hospital. And we follow-up patients until 8 weeks after surgery to investigate if trimodal prehabilitation strategy can improve the postoperative functional recovery，reduce complications and improve prognosis.


Options:
A: Exercise Tolerance (Exercise tolerance 3 weeks after hospital discharge); Exercise Tolerance (Exercise tolerance 3 months after surgery)
B: Six minute walking test (up to 12 months postoperatively)
C: 6-minute-walking-distance (6MWD) (4 weeks postoperatively)
D: A composite endpoint of respiratory or cardiac or other post-operative complications requiring therapy (30 days after surgery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sit-to-stand Test Use in Children and Adolescents With Cystic Fibrosis : Correlations With 6-Minute Walking Test, Quadriceps and Respiratory Muscle Strength and Health Related Quality of Life
Brief Summary: Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of CF patients regular assessment.

Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to assess physical capacities. However, simple field tests are emerging. These tests are easier to perform especially in a population of CF children and adolescents.

The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates with maximal oxygen consumption during CPET.

The investigators hypothesized that this test also correlates with 6-Minute Walking distance (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and health-related quality of life.


Options:
A: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
B: weight of sputum that was expectorated (12 months)
C: Change in forced expiratory volume in 1 second (FEV1) (%predicted) (Baseline to 3 months and Baseline to 6 months); Change in peak oxygen uptake (% predicted) (Baseline to 3 months and Baseline to 6 months); Change in number of steps per day (Baseline to 3 months and Baseline to 6 months)
D: Correlation between number of repetitions (STS Test) and 6-Minute Walking Distance (This outcome will be measured after both tests realization up to 15 minutes.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylactic Use of Tranexamic Acid for Preventing Postpartum Hemorrhage: A Randomized, Double-blinded, Placebo-controlled Pilot Trial
Brief Summary: Postpartum hemorrhage (PPH) occurs in up to one in ten deliveries worldwide and is the leading cause of maternal morbidity and mortality. In developing countries 30% of women develop PPH because access to a number of treatments is not readily available. Interestingly, the rate of PPH and consequently of maternal morbidity has increased significantly even in developed nations, such as Canada, over the past decades. This rate is also increasing amongst parturients in Ontario. Unfortunately, few effective preventative treatments exist.

Antifibrinolytic drugs are routinely used to reduce bleeding and the requirement for blood transfusions in a wide range of hemorrhagic conditions. The most commonly used antifibrinolytic drug is tranexamic acid (TXA). TXA is safe, affordable, with very few side effects. The World Health Organization recommended that TXA be used to reduce blood loss in several conditions, including in patients with established PPH refractory to conventional therapy.However, little is known about the prophylactic use of TXA to prevent PPH.


Options:
A: Pharmacokinetic (24 hours after randomisation)
B: 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)
C: Number of patients receiving study intervention (At time of delivery)
D: Number of Participants With Postpartum Hemorrhage (PPH) (Up to day 2 postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment - A Randomized Controlled Trial About Stability and Patients' Perceptions
Brief Summary: The purpose of this trial is to evaluate and compare stability after orthodontic treatment with an Essix retainer and a bonded cuspid-to-cuspid retainer (CTC), respectively in the mandibular arch and longitudinally follow these patients over time up to 5 years. The patients' perceptions of the two methods are also evaluated with questionnaires during the follow-up period.

A further aim of this study is to analyze the relationship between diagnosis, treatment outcome, treatment time, age at start of treatment and stability with an Essix retainer in the maxilla.

The null hypotheses are:

* that there is no difference in retention capacity between Essix retainer and cuspid-to-cuspid retainer
* that there is no difference in patients' perception between Essix retainer and cuspid-to-cuspid retainer
* that there is no difference in retention capacity for Essix retainer in the maxilla concerning diagnosis before treatment, treatment outcomes, treatment time and age at start of treatment


Options:
A: Changes in Tooth Position (Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1))
B: Survival times via recording to the patients' re-visit (one year)
C: Measuring periodontal status through clinical examination (approximately 20 months); measuring PDL width in periapical radiographs (approximately 20 months)
D: Compliance of retainer wear (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Retrievable Inferior Vena Cava Filter for Primary Pulmonary Embolism Prophylaxis in At-Risk Trauma Patients: RIPT Feasibility Trial
Brief Summary: The risk of venous thromboembolism (VTE) is very high in trauma patients, secondary to tissue injury, venous status from immobilization, and thrombophilia. As such, early initiation of VTE prophylaxis is essential in this population. The competing risks of life threatening hemorrhage and VTE need to be considered very carefully. Potential approaches to VTE prophylaxis include pharmacologic means, and mechanical devices. For patients unable to receive pharmacologic VTE prophylaxis, retrievable inferior vena cava filters (rIVCFs) may be placed until low molecular weight heparin (LMWH) can be initiated, as per guidelines such as Eastern Association for the Surgery of Trauma

The investigators propose a feasibility study to determine whether or not our center can insert rIVCFs in at-risk trauma patients expeditiously enough to cause a meaningful reduction in the time they are left unprotected to PE.


Options:
A: Resolution of hypoxia (Post-procedure and 3 months); Survival from acute PE (Post-procedure and 3 months); Stabilization of hemodynamics (Post-procedure and 3 months)
B: PE thrombus load reduction (CT obstruction index) from baseline to the termination of lysis (48 hours)
C: Time left unprotected to venous thromboembolism (two weeks post trauma)
D: Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy (Baseline, within 48 +/- 6 hours of initiation of therapy); Number of Participants With Major Bleeding (From start of study drug infusion up to 72 hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients With Resistant Hypertension and Chronic Kidney Disease
Brief Summary: The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).


Options:
A: Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. (Baseline and Day 28)
B: Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group (Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.)
C: Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). (22 Days; Maintenance Phase Days 8 - 29, inclusive.)
D: Number of Participants Remaining on Spironolactone at Week 12 (At week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients With Resistant Hypertension and Chronic Kidney Disease
Brief Summary: The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).


Options:
A: Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First (Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.)
B: Number of Participants Remaining on Spironolactone at Week 12 (At week 12)
C: Proteinuria reduction (bi-monthly)
D: Change of serum potassium (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Assessment of a New Protocol for Indirect Pulp Capping Procedures
Brief Summary: The aim of the study is to assess clinically, radiographically and microbiologically a new protocol for indirect pulp capping procedures compared to the conventional protocol in painful teeth. It was postulated that there is no difference between both protocols in terms clinical, radiographical and microbial outcome measure after one year of follow up in painful teeth.


Options:
A: Failure Rate of the Three Treatment Arms Judged Clinically (2 years)
B: cold pulp test (signalling the nerve of the pulp of the tooth by cold application) (One year follow up)
C: Primary outcome is whether the treatment can be made with a maintained sensible pulp and without root infection following a 1-year control. (1year control data for all treatments primo 2008)
D: Number of lesions that evidence progression by a higher ICDAS code. The score will be expressed as percentage of progression among all the treated lesions. (24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Supplementation of Vitamin B12 in Pregnancy and Postpartum on Growth and Cognitive Functioning in Early Childhood: A Randomized, Placebo Controlled Trial
Brief Summary: Scientific basis: Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of vitamin B12 is animal-source foods and poor gut function may decrease absorption. Vitamin B12 is crucial for normal cell division and differentiation, and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation to pregnant women on neurodevelopment and growth of their children. We also aim to measure the impact of B12 supplementation on several other outcomes.

Study design: Individually randomized double-blind placebo controlled trial in pregnant South Asian women at risk of poor vitamin B12 status. Participants will be randomized in a 1:1 ratio.

Study participants and site: 800 pregnant women from early pregnancy. Women will be enrolled as early as possible, but no later than in week 15 of pregnancy.

Intervention: Daily administration of 50 µg of vitamin B12 from early pregnancy until 6 months after birth.

Comparator: Placebo, identical to the vitamin B12 supplements.

Outcomes: Primary: (i) neurodevelopment in children measured at 6 and 12 months of age (ii) growth in children measured by weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children at 24 months (ii) gestational age at birth, (iii) fetal and infant growth measured by weight and length at birth, after 1 month and then at 3, 6, 9, and 24 months, (iv) hemoglobin concentration in children and mothers.

Relevance for programs and public health: The results from this study can suggest new dietary guidelines for South Asian women that again can lead to improved pregnancy outcomes and neurodevelopment and cognitive functioning in South Asian children.


Options:
A: Length (12 months of age); Neurodevelopment (measured 6 and 12 months of age)
B: Change in concentrations of biomarkers of vitamin B12 in mother-child pairs (Baseline and 6 months postpartum); Vaccine specific immunity in infants (6 months); Cognitive, Language and Motor Composite Score (12 months); Nuroinflammatory cytokines (12 months)
C: Fetal loss, low birth weight and pre-term birth. (Delivery)
D: Changes in Maternal Serum B12 Concentration From 1st to 3rd Trimester (from 1st to 3rd trimester)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Maternal Docosa-Hexaenoic Acid (DHA) Supplementation and Offspring Neurodevelopment in India (DHANI-2)
Brief Summary: DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from \<20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by the addition of repeated biochemical measures from mother-child dyads.


Options:
A: Plasma elongated n-3 PUFA levels (12 weeks)
B: Infant neurodevelopment as measured by his/her Development quotient scores (DQS) at 12 months of age (12 months (± 4 weeks))
C: Birth size (1 year)
D: amount of fat mass in the offspring (at birth, 6 weeks, 4 months, 1 year postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: CrescNet - Computer-guided, Population-based Surveillance System for Growth Disorders
Brief Summary: CrescNet is a network of primary care physicians and pediatricians (n=219) and endocrinological treatment centers (n=33), established in Leipzig in 1998, whose aim is to improve the early detection of growth disorders. Secondary to this clinical aim, epidemiological analyses, for example on secular trends of growth data of children, are performed.


Options:
A: growth disorders (18 years); obesity (18 years)
B: Body Mass Index (kg/m2) (2 years after treatment initiation)
C: Overall mortality (10 years)
D: Primary Safety Endpoint (12 months); Primary Efficacy Endpoint (12 months); Co-Primary Efficacy Endpoint (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Renal and Vascular Endstage Disease Intervention Trial
Brief Summary: The Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT) was designed to determine whether intervention with the angiotensin-converting enzyme (ACE) inhibitor fosinopril and/or the hydroxymethylglutaryl coenzyme A reductase inhibitor pravastatin reduced cardiovascular and renal events in nonhypertensive, nonhypercholesterolemic subjects with microalbuminuria.


Options:
A: Combined incidence of all-cause mortality, MACE and/or end-stage renal disease (4 years)
B: serum LDL-C (at week 12); ALT value
C: Total Cholesterol (-2, 0, 4, 6 weeks); LDL Cholesterol (-2, 0, 4, 6 weeks); HDL Cholesterol (-2, 0, 4, 6 weeks); Triglycerides (-2, 0, 4, 6 weeks); C-reactive protein (-2, 0, 4, 6 weeks)
D: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks (12 weeks minus baseline)

Answer: A