bioihbjkbjnl/mcl2 huggingface dataset:
Plasma Citrulline Concentration in Tropical Enteropathy
Condition: Malabsorption Syndromes; Granulomatous Enteritis; Enteritis; HIV Enteropathy; Ileal Diseases
MeSH terms: HIV Enteropathy; Intestinal Diseases; Malabsorption Syndromes; Enteritis; Sprue, Tropical; Crohn Disease; Ileal Diseases
Study type: Observational

Summary: 
      Citrulline is an amino acid produced in the intestine and in the liver, but the liver does
      not contribute significantly to circulating citrulline concentrations. The intestine is thus
      the only organ that normally releases significant amounts of citrulline into the blood
      stream. The investigators have designed a study looking at the value of measuring plasma
      citrulline concentration in patients with tropical enteropathy of mixed HIV status. The focus
      will be on the ability of the intestine to sustain the individual concerned from a
      nutritional standpoint. The investigators hypothesise that plasma citrulline concentration is
      a marker of small bowel absorptive integrity and an appropriate surrogate for HIV related
      enteropathy.
    

Detailed description: 
      Preliminary studies reported that plasma citrulline concentrations may be a reliable
      biochemical marker for intestinal dysfunction and absorptive enterocyte mass. The
      relationship between citrulline concentration and intestinal function has been supported in
      other studies including those examining rejection in small bowel allografts. Concentrations
      of citrulline are dramatically reduced in cases of mucosal damage (e.g. moderate graft
      rejection or viral enteritis)and strongly correlate (inversely) with severity on biopsy.
      Plasma citrulline concentration is lower also in patients with villous atrophy
      (24±13µmol/L)than in healthy subjects (40±10µmol/L)and patients with anorexia nervosa
      (39±9µmol/L).Experimental studies have been carried out also in assessing the value of
      citrulline as a marker for severity of small bowel epithelial damage from radiation and viral
      infections. The plasma citrulline was shown to be a simple, non invasive and sensitive essay
      to monitor and quantify radiation and/or chemotherapy induced small bowel damage in mice and
      humans. Otherwise, the literature on citrulline as a potential marker of intestinal and
      nutritional integrity is young and consistent data for specific conditions as for HIV
      enteropathy are missing.We hypothesise that plasma citrulline concentration is a marker of
      small bowel absorptive integrity and an appropriate surrogate for HIV related enteropathy.
    

Sampling method: Non-Probability Sample
Study population: 
        Tropical enteropathy with mixed HIV status
      
Keywords: citrulline; malabsorption; Villous atrophy; enteropathy
Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      The is study will examine whether variation in clinical bleeding frequency and severity among
      boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in
      laboratory measurements of platelet activity.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Boys with severe Hemophilia A, Factor VIII coagulant activity less than or equal to 1%
Dose Finding Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)(174007/P05805/MK-8777-003)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 multicenter, randomized, double-blind trial of MK-8777 (Org 26576, SCH
      900777) in adult subjects with Attention-Deficit/Hyperactivity Disorder (ADHD). MK-8777 or
      placebo will be administered in a crossover fashion for two 3-week treatment periods. The two
      3-week treatment periods will be separated by a 2-week placebo washout period.

      The primary objective is to compare the efficacy of various doses of MK-8777 to that of
      placebo in the treatment of ADHD symptoms in adults.
    


Intervention name(s): MK-8777; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: randomized; double blind; placebo controlled
DCI COVID-19 Surveillance Project
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This is a prospective longitudinal census study conducted at a single center (DCI Inc., Henry
      Avenue, Philadelphia). The purpose of this study is to gain information about COVID-19
      infection and antibody response in an in-center dialysis population. The investigators
      hypothesize that screening and surveillance for COVID-19 positive test (viral infection) and
      antibodies response to infection (potential immunity) in a dialysis center population within
      a high-prevalence region can provide foundational information to guide approaches toward
      prevention of COVID-19 related illness in a susceptible population. Participants will be
      given a questionnaire initially and monthly over the study period to find out whether they
      have had COVID-19 infection, hospitalization, or symptoms. A nasopharyngeal swab test for
      COVID-19 infection and a blood sample for COVID-19 antibody will be collected monthly for the
      study period.
    


Intervention name(s): SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection
Intervention type(s): Diagnostic Test
Intervention description(s): COVID-19 infection and antibody testing
Other intervention name(s): Beckman Coulter Access SARS-CoV-2 IgG Antibody Test
Intervention MeSH terms: Immunoglobulin G
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Portion Size and To-go Container on Dinner Intake
Condition: Obesity; Eating Behavior
Study type: Interventional

Summary: 
      This study investigated whether the provision of a to-go container influenced the portion
      size effect at a meal. Following a screening visit, women came to the lab once a week for 4
      weeks to eat a meal of multiple foods. At each visit, the portion size of the meal was varied
      in a counterbalanced order. Prior to their first meal, women were randomly assigned to one of
      two groups: a group that would have their leftovers packaged to go (to-go group) and a group
      that did not have leftovers packaged (control group). Women were instructed to eat ad libitum
      at the meals. They also answered questions about hunger and fullness as well as food
      characteristics before and after each meal. Following the final meal, subjects completed a
      series of questionnaires assessing subject characteristics as well as food characteristics.
      It was hypothesized that the effect of portion size on intake would be attenuated in subjects
      who received a to-go container with the meal. In addition, we aimed to identify any subject
      characteristics that moderated or exacerbated the portion size effect. It was also of
      interest to determine whether the portion size effect on individual foods were influenced by
      food characteristics such as perceived value.
    


Intervention name(s): To-Go container; Control
Intervention type(s): Behavioral; Other
Intervention description(s): Subjects were provided a to-go container in which leftover foods would be packaged; Subjects were not provided a to-go container with the meal
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The two factors were meal portion size and provision of a to-go container. The portion size factor was within-subjects (crossover). All subjects received each of the 4 portions served (the order in which portions were served was counterbalanced). The container factor was between-subjects. Subjects were randomly assigned to 1 of 2 groups: one group had uneaten food packaged to take home, the other group (control) did not.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: portion size; food intake; energy intake; food choice
Effects of Nintendo Wii Balance Board in Children With Cerebral Palsy
Condition: Balance Problem; Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      I wan to check the effects of Nintendo Wii balance board therapy in children with CP.
    

Detailed description: 
      Evaluate the effects of Nintendo Wii balance board therapy in combination with conventional
      physical therapy.
    

Intervention name(s): Nintendo Wii balance board
Intervention type(s): Other
Intervention description(s): Experimental group was given Nintendo Wii balance board therapy in combination with conventional physical therapy for 16 sessions/8 weeks
Control group was conventional physical therapy which include stretching of the hamstrings, quadriceps and calf muscles. strengthening of the lower limb. Balance exercises include walk in parallel bar
Other intervention name(s): Conventional physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Effects of Nintendo Wii balance board in combination with conventional physical therapy in children with CP
Masking: Single (Investigator)
Primary purpose: Treatment
A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum
      toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor
      overactivity in participants who successfully completed Study 191622-120 (NCT01852045).
    


Intervention name(s): OnabotulinumtoxinA
Intervention type(s): Biological
Intervention description(s): OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
Other intervention name(s): BOTOX®; botulinum toxin Type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
Condition: Antibiotic-Associated Diarrhea; Clostridium Difficile-Associated Diarrhea
MeSH terms: Clostridium Infections; Cross Infection; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the
      prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated
      Diarrhea (CDAD) in hospitalized patients exposed to nosocomial infection.
    


Intervention name(s): BIO-K+ CL-1285®; Placebo
Intervention type(s): Other; Other
Intervention description(s): A mixture of Lactobacillus acidophilus and Lactobacillus casei, contains over 50 billion living bacteria per administered dose.; Placebo is devoid of microorganisms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Probiotic; Antibiotic-Associated Diarrhea (AAD) Prevention; Clostridium Difficile-Associated Diarrhea (CDAD)Prevention
Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Citalopram on Motivation
Condition: Normal Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the current study is to examine the role of serotonin on the cognitive parameters
      of motivation. They are embedded in a conceptual framework of motivation that merges
      decision-making and reinforcement learning theories. Every action is conceived as path from
      one state to another. The different states are associated to different values (positive for
      rewards and negative for punishments), and the different actions to different costs (risk,
      effort and delay). The tasks are designed such that the sensitivity to the state and action
      parameters can be inferred by fitting computational models.The primary objective is to
      characterize the effect of Citalopram 30mg on reward sensitivity, assessed in an incentive
      force task, in which participants are asked to squeeze a hand grip to win monetary rewards.
      Secondary objectives are to characterize the effect of Citalopram 30mg on other cognitive
      parameters of motivation (assessed with a motivational battery that includes rating, choice
      and learning tasks).
    


Intervention name(s): Citalopram 30mg
Intervention type(s): Drug
Intervention MeSH terms: Citalopram
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
E-Bike Versus Classic Bike Intervention Trial
Condition: Physical Activity; Obesity
Study type: Interventional

Summary: 
      The effects of active commuting with an e-bike, as compared with a "classic" bike, on
      cardiorespiratory fitness and vascular health are largely unknown. To assess whether active
      commuting with an e-bike or a classic bike increases peak oxygen consumption (VO2peak) in
      untrained and overweight individuals.
    

Detailed description: 
      Riding an electrically assisted bicycle (e-bike) is thought to be suitable to increase
      physical activity in daily life, to promote health, and to increase cardiorespiratory fitness
      in normal-weight individuals. The positive effect of commuting to work by a normal bike on
      cardiorespiratory fitness has been shown to be an important predictor of cardiovascular
      mortality in previous studies. We thought to improve maximal oxygen uptake by commuting to
      work by e-bike vs. classic bike. Besides cardiorespiratory fitness we assessed arterial
      stiffness as brachial-ankle pulse wave velocity as an independent predictor of cardiovascular
      events and all-cause mortality.
    

Intervention name(s): Commuting to work
Intervention type(s): Behavioral
Intervention description(s): Commuting by an electric assisted bike to work for a period of 4 weeks at least 3 times per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of an association with one
      anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent
      isolated in the treatment of osteomuscular pain in adults.
    

Detailed description: 
      -  Double-blind, randomized, multicenter

        -  Maximal experiment duration: 9 days

        -  02 or 03 visits and a phone contact

        -  Evaluate the efficacy of an association with one anti-inflammatory and one muscle
           relaxant agent compared to the one muscle relaxant agent isolated in the treatment of
           osteomuscular pain in adults.

        -  Adverse events evaluation
    

Intervention name(s): ketoprofen and cyclobenzaprine association; Cyclobenzaprine
Intervention type(s): Drug; Drug
Intervention description(s): The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.; The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h.
Other intervention name(s): EMS association; Miosan®
Intervention MeSH terms: Ketoprofen; Amitriptyline; Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Condition: Renal Insufficiency; Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in
      participants with varying levels of renal function or impairment.
    


Intervention name(s): INCB054707
Intervention type(s): Drug
Intervention description(s): INCB054707 75 mg will be administered orally on Day 1.
Other intervention name(s): Povorcitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal impairment; hemodialysis; Kidney failure; end-stage renal disease
Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)
Condition: Kidney Diseases; Nephrotic Syndrome; Tacrolimus
MeSH terms: Kidney Diseases; Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Exploring the efficacy and safety of Tacrolimus on refractory nephrotic syndrome ; Acquiring
      the experience of Tacrolimus on the treatment of refractory nephrotic syndrome in Chinese
      patients.
    


Intervention name(s): tacrolimus (FK506)
Intervention type(s): Drug
Intervention description(s): Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractory Nephrotic syndrome; Tacrolimus
Liver and Fat Regulation in Overweight Adolescent Girls
Condition: Hepatic Steatosis; Polycystic Ovarian Syndrome; Obesity
MeSH terms: Polycystic Ovary Syndrome; Fatty Liver; Overweight
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Women with polycystic ovarian syndrome (PCOS) have increased rates of hepatic steatosis
      compared to weight similar women with regular menses. It is unclear if this is related to
      high testosterone or insulin resistance. The investigators will assess hepatic glucose
      release, rates of lipolysis and hepatic de novo lipogenesis in the fasted and postprandial
      state to determine if alterations in the processes contribute to hepatic steatosis.
      Participants will be overweight, sedentary girls with or without PCOS. Those with PCOS will
      either be medication naive, or must be taking metformin or combined oral contraceptives
      (COCPs) for a period of at least 6 months prior to study procedures.
    

Detailed description: 
      Hepatic glucose release will be assessed with a stable isotope glycerol tracer, lipolysis
      with a glycerol tracer, and hepatic de novo lipogenesis with an acetate tracer. Data will be
      collected fasting and after a glucose challenge. The degree of hepatic steatosis and
      abdominal fat partitioning will be assessed with Magnetic Resonance Imaging (MRI), and total
      body composition with Dual-energy X-ray absorptiometry (DEXA).
    

Intervention name(s): Byetta 5Mcg Pen Injection
Intervention type(s): Drug
Intervention description(s): 10 participants will receive 2 doses of Byetta, one at 7 PM the night prior to metabolic study and the second 30 min before ingestion of glucola
Other intervention name(s): Exenatide
Intervention MeSH terms: Exenatide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of the Low Glucose Suspend (LGS) feature
      in reducing hypoglycemia with the MiniMed Paradigm® X54 System with hypoglycemic induction
      from exercise.

      The study will consist of a total of 50 subjects, age 16 through 60 years with Type 1
      Diabetes Mellitus.
    

Detailed description: 
      50 subjects with previously diagnosed Type 1 Diabetes Mellitus will be studied. The subject
      population includes the following subsets: 4 pediatric subjects aged 16 -17 years, 4 young
      adult subjects age 18-21 years, and 42 adult subjects age 22-60 years at time of enrollment.
      Results for all subjects will be analyzed.
    

Intervention name(s): The MiniMed Paradigm® X54 System
Intervention type(s): Device
Intervention description(s): The MiniMed Paradigm® X54 System: A insulin pump equipped with a number of features to actively manage the user's glucose levels. One example is the "Low Glucose Suspend (LGS)" feature. The LGS feature is only available when the pump is used with the subcutaneous glucose sensor for continuous glucose monitoring. To use this feature, the user will be required to select a sensor low suspend limit, or threshold, at which the LGS feature will be triggered. When this feature is selected, if the sensor glucose reading reaches the level that is equal to or less than the programmed threshold, the user receives an alert and the pump suspends.
Other intervention name(s): MiniMed Paradigm® X54 Pump (X54 Pump)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ASPIRE (Automation to Simulate Pancreatic Insulin Response); X54; Medtronic Diabetes; Diabetes Mellitus; Type 1
Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
Condition: Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Appendicitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Research hypothesis:

      Does delayed primary wound closure after appendectomy in adults with complicated appendicitis
      reduce postoperative superficial surgical site infection compare to primary wound closure.

      Study design:

      This study is a multicenter randomized controlled trial of delay versus primary wound closure
      in complicated appendicitis.

      Setting:

      Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira
      Hospital, and Pathumthani Hospital

      Participants:

      Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as
      gangrenous or ruptured appendicitis.

      Outcome:

      Superficial surgical site infection

      Period of study:

      August 2012 - August 2014
    


Intervention name(s): Primary wound closure
Intervention type(s): Procedure
Intervention description(s): A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: complicated appendicitis; wound closure; infection