bioihbjkbjnl/mcl2 huggingface dataset:
Amphia Premature Infant Pain Study
Condition: Premature Infant; Breast Feeding, Exclusive; Puncture Skin
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Last thirty years, many research was performed concerning pain in the newborn. These
      investigations showed us the negative effects of pain in the neonatal period. Our research
      concerns the choice of analgesics for the premature newborn during a heel lance. Newborns
      with a gestational age of 32-37 weeks are randomly assigned over three groups. They can
      receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or
      sucrose.

      The primary objective of the Amphia Premature Infant Pain study, is to investigate whether
      there is a difference in PIPP-scores in premature newborns who undergo a heel lance,
      receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in
      newborns receiving breast milk compared to sucrose. And the investigators presume that breast
      feeding has the same analgesic effect as giving supplemental breast milk.
    


Intervention name(s): breast feeding; supplemental breast milk; sucrose
Intervention type(s): Other; Other; Other
Intervention description(s): Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.; In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.; In the third group, newborns receive sucrose 1ml 24% two minutes before procedure, followed by non-nutritive sucking. During the procedure the newborn lies in his cot.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heel lance; Premature; Breast milk
Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild
      cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is
      evidence CX516 enhances brain activity by specifically targeting remaining glutamate
      receptors in the affected portions of the brain. This study will test the safety and efficacy
      of CX516 in the symptomatic treatment of participants with mild cognitive impairment.
    


Intervention name(s): CX516; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Mild Cognitive Impairment; Memory Loss; Alzheimer's Disease; Brain Aging; Ampalex®; CX516
The Effect of a Multispecies Probiotic on Hypersensitivity in Irritable Bowel Syndrome (IBS) Patients
Condition: Irritable Bowel Syndrome; Hypersensitivity
MeSH terms: Irritable Bowel Syndrome; Hypersensitivity; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a specifically designed multispecies
      probiotic decreases visceral hypersensitivity in IBS-patient (defined by an increased pain
      tolerance threshold). Moreover, the effect on general symptom scores and inflammatory and
      microbiological parameters will be studied.
    


Intervention name(s): multispecies probiotic (Ecologic 801); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): once daily, 5 gram [10e9 cfu/gram]; once daily, 5 gram [10e9 cfu/gram]
Other intervention name(s): Ecologic 801
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Hypersensitivity; Probiotics; Multispecies
A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab
      is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding :

      Serum Systemic VEGF levels. Retinal Vascularization.
    


Intervention name(s): Intravitreal Bevacizumab
Intervention type(s): Drug
Intervention description(s): Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Study of the Effect of Fructans on Fermentation in the Colon & Transit
Condition: Evidence of Adaptation to Dietary Exposure to Fructans
Study type: Interventional

Summary: 
      Some carbohydrates (complex sugars) which are found in grains, fruit and vegetables, cannot
      be digested by humans. When eaten they pass through the small bowel to the large bowel, or
      colon. Some bacteria that live in the colon are able to digest these carbohydrates, and use
      them as an energy source. This releases energy that humans can absorb, and may have other
      effects on health as well. The process also releases gases such as hydrogen and methane into
      the colon, which will eventually be released as flatulence.

      There is some evidence in animals, and humans, that changing the carbohydrate content of the
      diet may increase the numbers of bacteria in the colon that can use this energy source.
      Recent work has looked at how changes in colon bacteria and carbohydrate in the diet affect
      transit, the speed at which food and stool moves through the stomach and bowels. This
      undergraduate project will use techniques in Magnetic Resonance Imaging developed in
      Nottingham to investigate how a prolonged change in dietary carbohydrate might affect speed
      of transit through the bowel and gas production in the colon, and whether there is any
      evidence of a change in the level of signalling chemicals that may affect bowel function.
    


Intervention name(s): Inulin challenge; oligofructose supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): On two study days one week apart, fasted participants will consume 500ml of water, flavoured with lime juice, containing 40g inulin.; Starting at the end of study day 1, consumption of 5 grams oligofructose coloured with carmine red food dye(<5%), dissolved in a hot drink, twice daily for 6 1/2 days/ 13 doses. The 14th dose of the week is the inulin challenge consumed as part of study day 1.
Other intervention name(s): Orafti HP (Beneo-Orafti, Belgium); Orafti P95 (Beneo-Orafti P95, Belgium)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fructans; inulin; oligofructose; colonic fermentation; microbiota; whoe gut transit
Clinical Study of Arbidol Hydrochloride Tablets in the Treatment of Pneumonia Caused by Novel Coronavirus
Condition: 2019-nCoV
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      In the absence of 2019-ncov specific therapeutic drugs, arbidol is effective against a
      variety of coronaviruses in vitro pharmacodynamics. In order to observe the efficacy and
      safety of arbidol in the treatment of 2019-ncov infected pneumonia, this study is planned.
    

Detailed description: 
      In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of
      pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome
      information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a
      real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. The number of cases
      of infection with 2019-nCoV identified in Wuhan increased markedly over the later part of
      January 2020, with cases identified in multiple other Provinces of China and internationally.
      Mathematical models of the expansion phase of the epidemic suggested that sustained
      person-to-person transmission is occurring, and the R-zero is substantially above 1, the
      level required for a self-sustaining epidemic in human populations.

      There is currently no specific treatment for 2019-ncov-infected pneumonia. Arbidol tablet is
      a non-nucleoside broad-spectrum antiviral drug with immune-enhancing effect. Abidor is
      pharmacodynamic in vitro against a variety of coronaviruses.This is a randomized, open,
      multicenter clinical study of pneumonic subjects diagnosed with 2019-ncov infection. The main
      objective was to compare the viral negative conversion rate in the first week after the
      subjects were randomized to arbidol plus basic treatment.

      In this study, 380 eligible patients with pneumonia diagnosed with 2019-ncov infection were
      randomly assigned to one of two treatment groups at a 1:1 ratio.

      patients will receive one of two treatment regimens: A .Abidor tablets + basic treatment B.
      basic treatment Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days Basic
      treatment :The basic treatment used by the investigator was based on the condition of the
      patient.
    

Intervention name(s): Arbidol; basic treatment
Intervention type(s): Drug; Other
Intervention description(s): Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days; basic treatment
Other intervention name(s): The basic treatment used by the investigator was based on the condition of the patient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia
Condition: Refractive Errors; Esotropia; Amblyopia Strabismic
MeSH terms: Amblyopia; Esotropia; Refractive Errors
Study type: Observational

Summary: 
      To investigate changes in refractive errors and evaluate clinical outcomes of strabismus
      surgery in patients with both amblyopia and partially refractive esotropia (PAET).Amblyopic
      patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative
      esotropia (RAET) were included in the study as a control group. Preoperative and
      postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism,
      stereoacuity and deviations at near and distance were evaluated and statistically compared in
      the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the
      control groups.
    

Detailed description: 
      Purpose: To investigate changes in refractive errors and evaluate clinical outcomes of
      strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).

      Material-Method: Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full
      refractive accommodative esotropia (RAET) were included in the study as a control group.
      Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent
      (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and
      statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared
      between the patient and the control groups.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        study population was composed of amblyopic children with partially refractive ET.
LEVITRA® 20mg Special Drug Use Investigation (Long-term)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      This investigation targets either the patients of 18 years-old or older and under 65
      years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient
      efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg.
      This investigation will be limited to the patients whose tolerability of Levitra 10mg is
      judged to be no problem.
    


Intervention name(s): Vardenafil, (Levitra, BAY38-9456)
Intervention type(s): Drug
Intervention description(s): Patients under daily life treatment receiving Levitra according to local drug information.
Intervention MeSH terms: Vardenafil Dihydrochloride
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Erectile dysfunction,; Phosphodiesterase Inhibitors
The Role of SCUBE-1 in Ischemia-reperfusion Injury
Condition: Gonarthrosis; Diabetes
MeSH terms: Reperfusion Injury; Ischemia
Study type: Observational

Summary: 
      One consequence of tissue damage caused by tourniquet is ischemia-reperfusion injury.
      Short-term ischemia leads to vasodilatation and reactive hyperemia resulting in post-ischemic
      reperfusion microcirculation failure and tissue edema that extends from 30 minutes to 4
      hours.

      SCUBE-1 is a newly defined cell surface molecule. It emerges from many developing cells,
      including endothelium and platelets. Immunohistochemical demonstration of subendothelial
      matrix deposition in atherosclerosis in humans. We did not find any study that showed the
      post-ischemic regression of scube 1, which was shown to be significantly higher in ischemic
      events in the literature.

      in this study is aimed to investigate the location / sensitivity of SCUBE-1 in diabetics and
      nondiabetics after application of regional anesthesia for ischemia-reperfusion injury induced
      by tourniquet application in knee prosthesis attempts in our aimed patients and compare this
      with other total antioxidant status (TAS) and MDA of ischemia-reperfusion parameters
    

Detailed description: 
      After being taken to the operation room, the patient will be divided into two groups as group
      D (diabetic) and group K (control) by standardized anesthesia monitoring with 5-lead
      electrocardiogram (ECG), peripheral oxygen saturation (SpO2) and noninvasive blood pressure
      measurements.

      In both groups, spinal anesthesia will be applied in a lateral decubitus position using a 22
      gauge Quincke spinal needle from the interspinal space as 0.5% heavy marcaine 10-12.5 mg 1
      min. Atropine 0.5 mg and ephedrine 5 mg should be administered if bradycardia develops in
      both groups. The disease tourniquet will be applied after induction, in accordance with the
      literature, to be above 150 mmHg of the systolic blood pressure.
    

Intervention name(s): spinal anesthesia
Intervention type(s): Diagnostic Test
Intervention description(s): before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation SCUBE-1, MDA and TAC will measured from plasma
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the patients who will go to surgery for gonarthrosis disease
      
Keywords: SCUBE-1
Representational Approach to Hippocampal Functions : a fMRI Study
Condition: Memory, Episodic; Form Perception
Study type: Interventional

Summary: 
      Although traditional neuropsychological models associate medial temporal lobe (MTL) regions
      to memory, and the hippocampus to episodic memory, there is growing evidence supporting an
      alternative view. The representational view of the MTL proposes that such regions depends on
      the representations processed rather than the cognitive processes. The aim of this project is
      to characterise the role played by MTL areas, and particularly the hippocampus, in mnemonic
      and non-mnemonic cognition. Hypotheses stemming from the representational view will thus be
      tested, using functional MRI among young healthy participants.
    

Detailed description: 
      Traditional neuropsychological models associate the medial temporal lobe (MTL) with episodic
      memory. Further, the hippocampus would be responsible for recollection, or the rich and
      contextualised retrieval of a memory; whereas the perirhinal cortex (PRC) would process
      familiarity, or the feeling that a stimulus has been encountered before, without remembering
      where or when it happened. However, there is growing evidence questioning this view, and
      supporting an alternative proposal. The representational view of the MTL proposes that such
      regions would not be organised according to cognitive processes, but rather according to the
      representations (or the mnemonic content, represented by a pattern of neuronal spikes. A
      2018-fMRI study demonstrated that the engagement of the hippocampus in recollection depends
      on the presence of a spatial scene in the memory that is retrieved, and not on the
      reconstructive nature of the retrieval. However, this demonstration is incomplete, as the
      only process that was investigated is recollection. The current project aims to extend such
      results to memory processes such as familiarity, and even to non-mnemonic processes such as
      visual discrimination. A fMRI study will thus be conducted, where 30 healthy participants
      will first perform a visual-discrimination task on scenes and objects, before taking a
      recognition task, in which images will either be presented in full or in the form of circular
      cues only. Multivariate-Pattern Analyses (MVPA) will complete traditional fMRI analyses, in
      order to determine whether activity in the MTL can be categorised on the basis of
      representations through a machine-learning classifier.
    

Intervention name(s): MRI-scanner
Intervention type(s): Device
Intervention description(s): Only one group of 30 participants is constituted. All participants will perform perception and memory tasks inside a MRI-scanner. Functional activity (BOLD signal) will be registered, as well as anatomical and behavioural data.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: memory; neuropsychology; hippocampus; perception; neuroimaging
Feasibility Study of the FARAPULSE Endocardial Multi Ablation System in the Treatment of Persistent Atrial Fibrillation
Condition: Persistent Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      PersAFOne:

      Feasibility Study of the FARAPULSE™ Endocardial Ablation System in the Treatment of
      Persistent Atrial Fibrillation
    

Detailed description: 
      This is a prospective, multi-center safety and feasibility study in subjects with persistent
      AF. Subjects will undergo percutaneous PEF ablation for pulmonary vein isolation as well as
      cavotricuspid isthmus interruption and other left atrial ablations at the investigator's
      discretion. Subjects will then be followed at 30 days, 75 ± 15 days, 6 months and 12 months
      for adverse events, recurrence of arrhythmia after a 90 day blanking period and other
      relevant outcome measures.
    

Intervention name(s): Ablation
Intervention type(s): Device
Intervention description(s): Ablation using the FARAPULSE Endocardial Multi Ablation System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Differential Study of Muscle Transcriptome
Condition: ALS; SMA; SBMA
Study type: Interventional

Summary: 
      To isolate biomarkers of ALS in muscle
    

Detailed description: 
      At present, there is no validated biological diagnostic marker for amyotrophic lateral
      sclerosis (ALS). The main objective of the study is to isolate a set of genes that are
      specifically dysregulated in muscle from ALS patients.

      Gene profiling in muscle will be compared between ALS patients and patients with other motor
      neuron diseases (SMA and SBMA)
    

Intervention name(s): Muscle biopsy
Intervention type(s): Procedure
Intervention description(s): open muscular biopsy of the deltoid under local anaesthesia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ALS; Motor neuron diseases; Transcriptome
Effects of Curcumin on Vascular Reactivity
Condition: Healthy Volunteers (Middle-aged Smokers)
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to determine if an oral loading-dose of curcumin can improve
      vascular endothelium reactivity in patients with moderate cardiovascular risk
    

Detailed description: 
      The aim of this study is to determine if an oral loading-dose of curcumin can improve
      vascular endothelium reactivity in patients with moderate cardiovascular risk
    

Intervention name(s): Curcumin
Intervention type(s): Drug
Intervention description(s): The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Polyphenol; Curcumin; Endothelium, vascular; Endothelium-dependant relaxing factor; Smoking; Transcriptome
Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics of a single 900 mg oral dose of BIA 2-093 and a single
      900 mg oral dose of Oxcarbazepine in healthy volunteers and to assess the tolerability of a
      single 900 mg dose of BIA 2-093 and Oxcarbazepine.
    

Detailed description: 
      Single centre, open label, balanced randomised, two-way crossover study in 12 healthy
      volunteers. The study consisted of 2 periods separated by a washout period of 7 days or more.
      On each of the study periods the volunteers received either a single 900 mg oral dose of BIA
      2-093 or a single 900 mg oral dose of Oxcarbazepine.
    

Intervention name(s): BIA 2-093; Oxcarbazepine
Intervention type(s): Drug; Drug
Intervention description(s): Tablets containing BIA 2-093 in doses of 300 and 600 mg; Tablets containing 300 mg and 600 mg of Trileptal®
Other intervention name(s): Eslicarbazepine acetate; Trileptal®
Intervention MeSH terms: Eslicarbazepine acetate; Oxcarbazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eslicarbazepine acetate; Epilepsy; Oxcarbazepine