bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Preterm Body Composition at Discharge on 2 Years Neurological Development (ASQ Evaluation)
Condition: Other Preterm Infants
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Neonatal nutritional management consists in reproducing miming uteri growth kinetic. Since
      the seventies, NICU (Neonatal Intensive Care Unit) strategy consists in a high proteidic
      input (apport) supposed to allow optimal neurodevelopment. However, nutritional practices and
      strategies have significantly evolved during these last years, influenced by Baker
      nutritional imprinting concept (2002). Actually, neonatal high proteidic exposition could
      perturb metabolism and hormonal systems of newborns conducting to a reinforcement of obesity
      and cardio-vascular pathology prevalence in this target population at adulthood. In this
      context many studies emerged since 2000 and try to assess the trade-off between
      neurodevelopment and growth under nutrition conditions. EPIPOD try to focus the link between
      heterogenous proteic input dispensed in our NICU (described by tercil methods on population)
      and fat mass phenotype variations at discharge (described by tercil methods); and its
      consequences on neurodevelopmental growth. Understanding how particular nutritional
      exposition could determine "fatty" phenotype and impact neurodevelopment is clearly our main
      goal.
    


Intervention name(s): Peapod assessment
Intervention type(s): Other
Intervention description(s): EPIPOD consists in a Non-Interventional Research according to French regulations. Actually, Peapod examination at discharge takes part of current clinical practice and patient management in Nantes Neonatal Intensive Care Unit since 2008.
After checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, PEAPOD assessment was leaded in the last week of hospitalization. Consisting in 2 repeated measurement, body composition estimation was completed by clinical and demographic data as neonatal nutrition (Parenteral nutrition pattern at Day 5, 10 and 21, and ASQ/BLR Neurodevelopmental assessment at 2 years old).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants (< 35 weeks gestation)
AposTherapy for Singaporean Patients With Knee Osteoarthritis (OA)
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Osteoarthritis (OA) is the most prevalent form of arthritis in the elderly. It is estimated
      that 7% of men and 11% of women over the age of 65 have KOA. The most significant symptoms of
      the disease are pain and functional disability.

      This study has two aims:

        1. To characterise the gait patterns and clinical parameters of patients with knee
           osteoarthritis (KOA) in Singapore at baseline, prior to treatment.

        2. To investigate the changes in gait patterns and the clinical benefits of treatment with
           a new biomechanical device, AposTherapy, for patients with KOA.
    


Intervention name(s): AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BioEnergetics and Metabolomics in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are
      enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related
      diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal
      health in cystic fibrosis (CF). This project is designed to investigate nutrition-related
      factors, such as diet and body composition, on outcomes in patients with CF. The data
      generated from this study will be used to inform future nutrition intervention studies in
      adults with CF and CFRD.
    

Detailed description: 
      Research methods include blood draws for plasma markers of oxidative stress and metabolomics
      (the measurement of thousands of small chemicals in the blood), magnetic resonance imaging
      (MRI, to assess energy capacity and thigh fat), dual energy X-ray absorptiometry (DEXA, to
      assess total and regional body fat and muscle), and indirect calorimetry (to assess resting
      energy expenditure and whole body fat oxidation). Clinically-relevant data, such as lung
      function, CF genotype, and diabetes status will be obtained from the electronic medical
      record and the CF Registry.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with cystic fibrosis and healthy volunteers from the Atlanta community
      
Biospecimen description: 
      We will collect sputum, urine, and blood.
The Effectiveness of an Exclusive Cold Snare Polypectomy Snare for the Removal of Diminutive Colorectal Polyps
Condition: Diminutive Colorectal Polyp; Cold Snare Polypectomy; Polypectomy Snare; Complete Resection Rate; Postpolypectomy Bleeding
MeSH terms: Polyps
Study type: Interventional

Summary: 
      The use of an exclusive cold polypectomy snare enables a clean cut of diminutive colorectal
      polyps, resulting in an increase in the complete resection rate and a decrease in the adverse
      events.
    


Intervention name(s): exclusive cold polypectomy snare (Exacto cold snare, product number 00711115); Regular polypectomy snare (Snare Master, SD-210U-10)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Rosuvastatin on Function of High Density Lipoprotein Cholesterol in Type 2 Diabetes
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The patients who have achieved LDL-C levels below the currently recommended targets may still
      experience cardiovascular events. To reduce further the risk of coronary heart disease (CHD),
      raising HDL-C and lowering TG may be the secondary therapeutic target. However, increased
      HDL-C levels do not mean increase in functional HDL-C. It also remains controversial whether
      functional HDL is more important than total circulating levels of HDL-C in reducing CHD.

      Actually, the increased concentration of HDL alone might be ineffective indicating that
      qualitative changes in HDL levels in response to drug interventions are required to result in
      clinical benefit.

      The investigators set up a clinical trial investigating effect of (rosuva)statin treatment on
      functional HDL-C levels particularly in Asian populations, who have relatively low HDL-C.
    

Detailed description: 
      1. Study design Study subject Number of Subjects (N = 30)

        2. Study outcome

           Primary outcome - functional HDL-C Secondary outcome - Non-HDL cholesterol

        3. Evaluation of functional aspect of HDL Cholesterol efflux from macrophages LDL-induced
           monocyte chemotactic activity (MCA) Assay Quantitation of gene expression of monocyte
           chemotactic protein-1 (MCP-1)
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): Rosuvastatin 20mg once a daily for 12 weeks
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Dyslipidemia; HDL function; Cholesterol efflux; MCA assay; MCP-1
AF Ablation Based on High Density Voltage Mapping and CFAE
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of additional ablation targeting
      complex fractionated atrial electrogram area within low voltage zone identified by high
      resolution mapping in patients with persistent atrial fibrillation.
    

Detailed description: 
      Fifty patients with persistent atrial fibrillation will be randomized a 1:1 ratio to each
      group. A test group includes those who undergoing ablation targeting low voltage areas which
      contains complex fractionated trial electrogram in addition to pulmonary vein isolation and a
      control group includes who undergoing pulmonary vein isolation only.
    

Intervention name(s): pulmonary vein isolation; Low-Voltage & CFAE guided ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein; In CFAE guided ablation,. Within low voltage zone, CFAE areas defined by shortest SCI and high ICL are identified.-Areas with the shortest SCI and high ICL within low voltage areas should be targeted first, followed by longer SCI regions (up to 120ms). Radiofrequency energy is delivered at target sites for 30-60 sec until the local electrogram is completely eliminated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Rectovestibular Fistula Which Surgical Approaches?
Condition: Vestibular Fistulae
MeSH terms: Fistula
Study type: Observational [Patient Registry]

Summary: 
      This study was a prospective, randomized, comparative study that included female children
      with rectovestibular fistulae who were selected from patients with anorectal malformations
      treated at the pediatric surgical unit, Assiut University Hospital during the period from
      January 2016 to February 2020. The patients were randomly divided into four groups according
      to the procedure performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal
      anorectoplasty, classic anterior sagittal anorectoplasty (ASARP), and modified ASARP.
    

Detailed description: 
      Background: The management of a vestibular fistula is a challenge for pediatric surgeons. The
      investigator compared four different operative techniques in terms of postoperative
      complications, continence, and cosmetic appearance. Patients and methods: This study was a
      prospective, randomized, comparative study that included female children with rectovestibular
      fistulae who were selected from patients with anorectal malformations treated at the
      pediatric surgical unit, Assiut University Hospital during the period from January 2016 to
      February 2020. The patients were randomly divided into four groups according to the procedure
      performed: trans- sphincter anorectoplasty(TSARP), posterior sagittal anorectoplasty, classic
      anterior sagittal anorectoplasty (ASARP), and modified ASARP.
    

Intervention name(s): TSARP; PSARP; Classic ASARP; Modified ASARP
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): We make four different surgical operations for female patients with rectovestibular fistula; Posterior sagittal anorectoplasty; Anterior Sagittal anorectoplasty; External anal sphincter preservation
Other intervention name(s): Transfistula anorectoplasty TFARP; Posterior sagittal anorectoplasty; Anterior Sagittal anorectoplasty; External anal sphincter preservation
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study was a randomized, comparative trial involving female children suffering from
        vestibular fistula taken from among patients with anorectal malformations treated at the
        pediatric surgical unit, Assiut University Hospital from January 2016 to February 2020. The
        patients were randomly separated into four groups according to the procedure performed. The
        different procedures included were TSARP, PSARP, classic ASARP, and modified ASARP.
        Randomization did by copies the names of the techniques on four separate papers and then
        the surgeon was blindly chose one paper for each patient. Four pediatric surgeons had
        experience in ARMs techniques were performed the repair.
      
Keywords: Vestibular anus,; Anal transposition,; Anorectal malformations; Transfistula anorectoplasty
Assessment of Risk in Chronic Airways Disease Evaluation
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Patients with chronic obstructive pulmonary disease (COPD) have an increased risk of
      cardiovascular disease,osteoporosis, muscle wasting and diabetes mellitus. Cardiovascular
      disease is a major cause of death in such patients and it may be related to excess stiffening
      of the walls of major arteries, such as the aorta, and it has been suggested to represent
      premature aging. However, there is little known of the development of these problems, which
      were previously considered to be due to smoking and which is now known not to be the only
      factor. The investigators will study a large group of patients with mild to very severe
      airflow obstruction based on the NICE 2010 classification of severity and a matched
      comparator group free of COPD. This study involves three assessments of the development of
      the complications of COPD over a five year period. The key measure will be the rate of change
      in the aortic wall stiffness, an accepted indicator of the risk of heart disease. Changes in
      wall stiffness will be related to the severity of lung disease; other known cardiovascular
      risk factors, such as high blood pressure, increased blood cholesterol and to cardiovascular
      events including heart attacks and death; and to the presence of other complications, such as
      osteoporosis, muscle wasting and diabetes mellitus. These measures will be analysed in the
      context of changes in bodywide inflammation and metabolic function and the changes in the
      rate of ageing. This increased knowledge of interacting factors in the complications of COPD
      is likely to lead to studies of treatments to avoid their development.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
Condition: Atopic Dermatitis; Eczema; Chronic Pruritus
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in
      the United States in subjects with treatment-resistant pruritus diagnosed with atopic
      dermatitis.
    


Intervention name(s): Tradipitant; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Behavioral Effects of Drugs: Inpatient (35)
Condition: Cocaine Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will determine the influence of methylphenidate (Metadate®) and duloxetine
      (Cymbalta®), alone and in combination, on the reinforcing, subjective and physiological
      effects of cocaine.
    


Intervention name(s): Cocaine; Placebo oral capsule; Methylphenidate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine.; The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.; The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
Other intervention name(s): Metadate®
Intervention MeSH terms: Cocaine; Methylphenidate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
A Study for Participants With Pancreatic Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the Phase 1 portion of this study was to determine the dose of LY2603618 that
      can be safely administered 24 hours after gemcitabine treatment. This dose was then used for
      the Phase 2 portion of the study. The Phase 2 portion of the study evaluated whether
      LY2603618, when administered 24 hours after gemcitabine therapy, was an effective treatment
      for participants with pancreatic cancer.
    

Detailed description: 
      Phase 1 included a dose escalation of LY2603618 doses from 70 milligrams/meter squared
      (mg/m^2) to 250 mg/m^2 divided into 5 cohorts. Each participant was assigned to a single
      cohort with no intra-participant dose escalation. Phase 1 also included an expansion cohort
      where participants received a flat dose of 200 or 230 mg LY2603618. Participants received
      gemcitabine on Days 1, 8, and 15, followed by LY2603618 on Days 2, 9, and 16 of each 28-day
      cycle. The purpose of the Phase 1 portion was to determine the maximum tolerated LY2603618
      dose to be carried into the Phase 2 portion of the study.
    

Intervention name(s): LY2603618; Gemcitabine
Intervention type(s): Drug; Drug
Other intervention name(s): Gemzar; LY188011
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreas; metastatic cancer; advanced cancer; Pancreatic cancer
Medication Development in Alcoholism: Suvorexant Versus Placebo
Condition: Alcohol Use Disorder (AUD)
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary hypotheses under test are that alcohol dependent subjects treated with suvorexant
      will report decreased craving for alcohol following alcohol exposure in the laboratory and
      report significantly less drinking under naturalistic conditions, than those treated with
      placebo. Suvorexant (Belsomra®) received approval by the FDA in 2014 for treatment of
      insomnia. To control for any effect of pre-existing sleep disturbance for which suvorexant
      may be indicated, subjects will be stratified on the basis of a Pittsburgh Sleep Quality
      Index total score of > 5 versus <5. Subjects were also stratified by sex.
    


Intervention name(s): Suvorexant 20 mg; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit; Single-dose administration of placebo given on an inpatient clinical research unit
Other intervention name(s): Belsomra; Sugar pill
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment, Double-Blind, Randomized Stratified at randomization based on sex and Pittsburgh Sleep Quality Index Total Score (PSQI) greater than or equal to 5 versus less than 5.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery
Condition: Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the
      patient, including significant cardiovascular and respiratory complications. Apart from the
      human suffering that is undeniable pain. Schemes oral analgesia with opioids for the
      treatment of DAPO, have shown to be as or more effective than intravenous or epidural
      regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone
      sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20)
      undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone
      metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at
      rest and effort, requirement for rescue intravenous morphine and incidence of side effects to
      the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and
      patient satisfaction.
    


Intervention name(s): Extended-release oxycodone; Extended- release Oxycodone; ketoprofen; dipirone; dexametasone; Morphine IV (rescue)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery
Other intervention name(s): Both groups received ketoprofen; Both groups received dipirone; Both groups received dexametasone; Both groups received Morphine IV (rescue)
Intervention MeSH terms: Ketoprofen; Morphine; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Postoperatory pain; Oxycodone
TAK-438 Bismuth Drug Interaction Study
Condition: Helicobacter Pylori
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with
      bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth,
      clarithromycin, amoxicillin, and lansoprazole.
    

Detailed description: 
      This is a phase 1, double-blind, parallel group study in participants with Helicobacter
      pylori (HP positive) who are, additionally, cytochrome P-450 (CYP)2C19 extensive metabolizers
      (EM) to evaluate the safety, tolerability and pharmacokinetics (PK) of a quadruple therapy
      with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth,
      clarithromycin, amoxicillin, and lansoprazole. The study will enroll 30 participants.

      The treatment phase consists of quadruple therapy twice daily (BID) with tripotassium bismuth
      dicitrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and TAK-438 (20 mg)
      (Group B) or quadruple therapy BID with tripotassium bismuth dicitrate (600 mg),
      clarithromycin (500 mg), amoxicillin (1000 mg),and lansoprazole (30 mg) (Group A) from Days 1
      to 14. Participants will be discharged on Day 15 after final PK blood samples are collected
      and all procedures performed.

      This single-center will be conducted in Korea. Participants will remain confined to the study
      site from check-in (Day -1) through Day 15 and will followed up through call on Day 17 and
      return on Day 42 for a follow-up assessment.
    

Intervention name(s): Clarithromycin; Amoxicillin; Tripotassium bismuth dicitrate; Lansoprazole; TAK-438
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Clarithromycin tablets; Amoxicillin capsules; Tripotassium bismuth dicitrate tablets; Lansoprazole capsules; TAK-438 tablets
Intervention MeSH terms: Amoxicillin; Clarithromycin; Lansoprazole; Dexlansoprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy