bioihbjkbjnl/mcl2 huggingface dataset:
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
Condition: Renal Insufficiency; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Renal Insufficiency
Study type: Interventional

Summary: 
      The study is a prospective, non-randomized early feasibility study intended to evaluate the
      safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist
      Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing
      cardiac surgery.
    

Detailed description: 
      The BIPASS-AKI study is intended to evaluate participants who are at an increased risk of
      developing cardiac surgery-associated acute kidney injury (CSA-AKI), and, subsequently,
      overall poor outcomes. Patients to be considered for participation include those undergoing
      elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft,
      valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a
      pre-operative eGFR between 15-60 mL/min. Participants meeting inclusion and exclusion
      criteria will be enrolled into a treatment arm (single-arm study) following the completion of
      informed consent. Participants will receive implantation of the JuxtaFlow Catheters following
      completion of the their cardiac surgery while remaining under anesthesia. Treatment with the
      JuxtaFlow System will be initiated upon the participant's arrival into the intensive care
      unit and continue for up to 24 hours post-operatively. Preoperative, intra-operative, and
      post-operative data will be collected on participants to include 15- and 30-day follow-up
      periods.
    

Intervention name(s): JuxtaFlow System
Intervention type(s): Device
Intervention description(s): Mild, controlled negative pressure introduced into the renal pelvis via JuxtaFlow catheters
Intervention model: Single Group Assignment
Intervention model description: BIPASS-AKI is a single-arm, unblinded interventional study designed to assess the safety of the JuxtaFlow System.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI); Renal Compromise; Kidney Disease; Cardiopulmonary Bypass; Renal Assist Device (RAD); Cardiac Surgery
Purdue Study for the Benefits of Breakfast in the Classroom
Condition: Breakfast
Study type: Interventional

Summary: 
      This study is a 24-week crossover design study in adolescents enrolled in the 6-8th grade
      within the Center School District in the Kansas City, MO. This school will begin their
      'Breakfast in the Classroom' program during the fall 2018 school year. Baseline data will be
      collected to include anthropometric measures, participant characteristics, and past eating
      habits. For the first 8 weeks, the students will be provided with breakfast meals containing
      the USDA nutrition requirements. These meals are typically higher in carbohydrates and lower
      in protein. For the second 8 weeks, the students will be provided with higher-protein
      breakfast meals. These meals also contain the USDA nutrition requirements but include
      high-quality protein-rich foods. For the remaining 8 weeks, the students will be provided
      both types of meals and will be permitted to choose which they prefer to consume each day. At
      the end of each 8-week period, eating habits, appetite, mood, cognitive performance, and
      anthropometrics will be completed along with measurements of breakfast waste.
    


Intervention name(s): Breakfast in the Classroom
Intervention type(s): Other
Intervention description(s): For all breakfasts, the students will use the 'grab and go' approach from hallway kiosks. The students will take the breakfasts back to their respective classroom and consume them there.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
RCT on Adjuvant TACE After Hepatectomy for HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection
      in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver
      and thus improve survival. The aim of this study is to compare the survival of patients
      undergoing liver resection plus post-operative TACE versus liver resection alone.
    

Detailed description: 
      Liver resection is the mainstay of curative treatment for hepatocellular carcinoma (HCC).
      However, recurrence is common after surgery and most occurs in the liver. Transarterial
      chemoembolisation (TACE) is an effective palliative treatment for HCC. It involves the
      infusion of chemotherapeutic agent admixed with iodised oil followed by embolisation of the
      hepatic arterial flow using small particles. This procedures allows application of smaller
      dose of chemotherapy concentrated to the liver and thus is well tolerated with minimal side
      effects. We conduct a randomised controlled trial evaluating the efficacy of using TACE after
      hepatectomy in HCC patients.
    

Intervention name(s): Transarterial chemoembolisation using cisplatin-lipiodol mixture
Intervention type(s): Procedure
Intervention description(s): Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery
Intervention MeSH terms: Ethiodized Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; Randomised controlled trial; Transarterial chemoembolisation
Effects of Fixed Meals With Special Formulated Rice on Blood Glucose Levels of Healthy Volunteers.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study is to compare Diabetec® Fibre Grains (FIbre Grains) in a mixed meal
      setting with Jasmine rice. This is to see whether partial replacement of white rice with
      Fibre Grains can reduce postprandial blood glucose control.
    

Detailed description: 
      Lifestyle modification, in particular adopting an appropriate dietary pattern, is generally
      accepted as the cornerstone for the treatment of people with type 2 diabetes. Consumption of
      low GI food has shown to improve glycemic control, lipid profile and reduce systemic
      inflammation. However, there are few dietary intervention studies attempting to change the GI
      of food by changing the staple carbohydrates. In this study, formulated rice with special
      fibre enrichment, Fibre Grains, was used to replace rice as the staple carbohydrates in one's
      diet. This fibre enriched rice has been previously tested to have a lower GI than normal rice
      while still able to preserve all the sensory characteristics of normal rice. With rice being
      a staple to Asians, this specially formulated fibre enriched rice offers a lower GI
      alternative to the conventional rice without affecting the people dietary preference.
    

Intervention name(s): Fibre Grain; Jasmine white rice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Healthy subjects will be provided with 30% Fibre Grain in a mixed meal. After consumption of the meal, the glucose and insulin response will be compared.; Healthy subjects will be provided with Jasmine white rice in a mixed meal. After consumption of the meal, the glucose and insulin response will be compared.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a within-subject cross-over trial design to assess the glycemic response of fibre enriched rice consumer by human subjects as compared to normal non-enriched rice in a mixed meal setting.
Masking: Single (Participant)
Primary purpose: Prevention
The Effect of Probiotic Intervention on Intestinal Permeability
Condition: Intestinal Permeability
Study type: Interventional

Summary: 
      This trial is a single-site, randomised, double blind, placebo-controlled, two-armed
      parallel-group trial in healthy adult volunteers. The trial will investigate the effect of
      oral supplementation of a probiotic strain on the ability to attenuate exercise-induced
      deterioration of intestinal barrier function and gastrointestinal symptoms.
    

Detailed description: 
      The trial includes a run-in period of two weeks duration followed by a six weeks intervention
      period.

      After having given their written informed consent, subjects will complete screening
      procedures to evaluate their eligibility for the trial and complete a run-in period of
      minimum two weeks duration to washout possible pre-trial probiotics. At the screening visit
      (visit 1), subjects will also perform a VO2max test on a running treadmill to determine their
      individual VO2max.

      After baseline assessments at visit 2 and 3, the subjects will be randomly assigned to one of
      the two treatment groups (active or placebo product) in a ratio of 1:1. The two arms will be
      stratified for gender.

      The subjects will consume 1-2 capsules once daily, together with breakfast, for six weeks
      starting at Day 1, the day after Visit 3. During the entire run-in and intervention period
      the subjects will be asked not to consume any other probiotic products. During the entire
      trial subjects should maintain their habitual life style in relation to physical activity
      level, diet and sleep habits.

      At Visit 2, 3, 4 and 5, the small intestinal permeability will be evaluated by the L:R ratio
      measured in urine obtained 5 hours after oral ingestion of a lactulose and rhamnose solution.
      The permeability test will be performed in combination with a 1 hour treadmill running
      challenge when performed at Visit 3 and Visit 5. The treadmill run will be performed at a
      velocity corresponding to 80% of the subjects individually measured VO2max.

      Faecal, urine and blood samples will be collected at Visit 2, 3, 4 and 5 for evaluation of
      the secondary objectives. The faecal samples collected will be: First bowel movement
      post-permeability test at Visit 2, first bowel movement post-exercise test at Visit 3, first
      bowel movement post-permeability test at Visit 4 and the first bowel movement post-exercise
      at Visit 5.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6 weeks daily oral intake of a probiotic strain.; 6 weeks daily oral intake of placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Dimensional Validation of the Hallux Valgus Orthosis
Condition: Hallux Valgus
MeSH terms: Hallux Valgus; Bunion
Study type: Interventional

Summary: 
      The goal of this project is to optimize the design of the orthosis by establishing the key
      volumetric characteristics of the custom iterations in order to subsequently transpose them
      to a standard model and establish the increment proportions of the different sizes. The final
      product should reduce the pain by repositioning the phalanges of the first toe with the first
      metatarsal in its axis.
    


Intervention name(s): Hallux Valgus orthosis
Intervention type(s): Device
Intervention description(s): Custom designed orthosis and manufactured by 3D printing.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of single ascending doses of ABP-671 administered orally in healthy
      volunteers.
    

Detailed description: 
      Primary Objectives:

      • To assess the safety and tolerability of single ascending oral doses of ABP-671 in Healthy
      Volunteers (HVs).

      Secondary Objectives:

      • To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of single
      ascending oral doses of ABP-671 in HVs.
    

Intervention name(s): ABP-671; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Drug: ABP-671, single oral dose; Other: Placebo, single oral dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gout; hyperuricemia
Unilateral GPi vs Unilateral STN DBS in the Same Patient With PD
Condition: Parkinson Disease; Deep Brain Stimulation; Globus Pallidus Interna; Subthalamic Nucleus
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two main targets in the
      deep brain stimulation (DBS) treatment for Parkinson's disease (PD). Large randomized
      controlled trials, in which patients of comparable clinical and demographics were randomized
      to either GPi DBS or STN DBS, have demonstrated equal effects of both targets in motor
      symptom improvement, the superiority of STN DBS in the medication reduction and the potential
      advantage of GPi DBS for cognitive, psychiatric and axial aspects. Unfortunately, in such a
      highly heterogeneous disease of PD, many of these randomized controlled trials didn't include
      sufficient subjects and thereby yielded inconsistent results. Moreover, most studies are
      investigating the difference between GPi and STN in different patients.

      In order to address the problem, an intra-patient comparison will be made by investigating
      the acute turning-on effects of unilateral STN stimulation versus unilateral GPi stimulation
      on axial symptoms, cognition and also cardinal symptoms within each individual patient who
      received the treatment of combined unilateral STN and contralateral GPi DBS. Axial symptoms
      including gait, balance and posture, motor symptoms and cognition are comprehensively
      assessed under two treatment conditions.
    


Intervention name(s): DBS
Intervention type(s): Procedure
Intervention description(s): Unilateral DBS for treatment of patients with PD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
PROFILE - Evaluation of QoL and PRO Outcomes in Patients Taking Fingolimod
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Observational

Summary: 
      Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting
      multiple sclerosis patients. Patients will complete questionnaires at baseline, 3, 6 and 12
      months.
    

Detailed description: 
      Multi centre, prospective, non interventional study in 200-240 UK relapsing remitting
      multiple sclerosis patients assessing the change in QoL and PRO outcome measures from
      baseline to 12 months after starting fingolimod. Patients will complete 4 questionnaires at
      baseline (prior to first fingolimod dose), then repeat them at 3, 6 and 12 month intervals
      via post.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with relapsing remitting multiple sclerosis starting treatment with fingolimod
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is
      effective in treating asthma when used 'as needed' in patients with milder asthma. The
      efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as
      needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline
      Turbuhaler® 'as needed'.
    

Detailed description: 
      A 52-week, double-blind, randomised, multi-centre, parallel-group, Phase III study in
      patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort®
      (budesonide/formoterol) Turbuhaler® 160/4.5 μg 'as needed' compared with terbutaline
      Turbuhaler® 0.4 mg 'as needed' and with Pulmicort® (budesonide) Turbuhaler® 200 μg twice
      daily plus terbutaline Turbuhaler® 0.4 mg 'as needed'
    

Intervention name(s): budesonide/formoterol 'as needed' + budesonide placebo bid; terbutaline 'as needed' + placebo budesonide bid; budesonide bid + terbutaline 'as needed'
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment; Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment; Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
Intervention MeSH terms: Budesonide; Terbutaline; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers
Condition: Peptic Ulcer
MeSH terms: Peptic Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug interaction
      and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers
    

Detailed description: 
      A phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and
      Irsogladine maleate in healthy adult volunteers. Subjects judged to be appropriate to this
      study by screening before 28days of first administration. Subjects administrate Lafutidine
      bid during period I. After wash-out period, administrate Irsogladine maleate qd during Period
      II. After than, coadministration Lafutidine bid and Irsogladine maleate qd.
    

Intervention name(s): Lafutidine; Irsogladine maleate
Intervention type(s): Drug; Drug
Intervention description(s): Lafutidine 10mg, 1 tablet, bid; Irsogladine maleate 2mg, 2 tablet, qd
Other intervention name(s): STOGAR; STOWON
Intervention MeSH terms: Irsogladine; Lafutidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Improving Perception of Speech in Noise in Children With Communication Disorders
Condition: Speech Perception
MeSH terms: Communication Disorders
Study type: Interventional

Summary: 
      Smarty Ears has developed a prototype of an innovative therapeutic training system to improve
      speech perception in noise by training children on interrupted noise (which has silent
      intervals that allow for fragments of the target to be heard). The study will attempt to
      validate the technology and gather initial design feedback from clinicians and caregivers and
      from children with ASD and HL.
    

Detailed description: 
      Recent evidence indicates that listening in interrupted noise can provide perceptual
      benefits, such as remapping the auditory environment and learning to use acoustic cues. The
      developed technology, uses adaptive listening training that automatically increases noise
      level difficulty as performance improves, and includes age appropriate rewards to maintain
      interest. The mobile app includes an initial and final screening, a training system that
      administers training via the child's own mobile device, and detailed performance dashboard.
      The study will attempt to validate the technology by gathering feedback from clinicians and
      caregivers and from children with ASD and HL.
    

Intervention name(s): Audiovisual speech training in noise for children
Intervention type(s): Other
Intervention description(s): Children will participate in listening training in the form of an iPad app
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The model is ABA design, that is participants get an initial, pre-treatment noise assessment, then get individualized training, then get a post-noise assessment. This is designed to look for change from baseline after training.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ASD; speech in noise; Hearing Loss; speech-to-noise ratio
Diclofenac Potassium Alone Versus Diclofenac Potassium With Hyoscine-N-butyl Bromide (HBB in Endoscopy
Condition: Pain
Study type: Interventional

Summary: 
      Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that
      has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be
      effective in treating a variety of acute and chronic pain and inflammatory conditions.
    

Detailed description: 
      Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that
      has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be
      effective in treating a variety of acute and chronic pain and inflammatory conditions.

      . As with all NSAIDs, diclofenac exerts its action via inhibition of prostaglandin synthesis
      by inhibiting cyclooxygenase-1 (COX-1)
    

Intervention name(s): Diclofenac + HBB with hysteroscopy; Diclofenav + placebo
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Giving Diclofenac + HBB with hysteroscopy; Giving Diclofenac + placebo with hysteroscopy
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients
Condition: Healthy
Study type: Interventional

Summary: 
      This pilot study is aimed at assessing the acute effect of several combinations of lipids
      differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1
      secretion in healthy subjects.
    

Detailed description: 
      In this study, the investigators aim to investigate the effect of various lipid types on
      GLP-2 and GLP-1 secretion. This will allow to determine the importance of lipids in
      nutritional solutions. Moreover, this will allow us to assess whether existing clinical
      formulas can be improved in order to stimulate GLP-2 and accelerate intestinal recovery.
    

Intervention name(s): meal intake; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Intake of meals characterized by lipid composition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy