bioihbjkbjnl/mcl2 huggingface dataset:
Metabolomics of Intraoperative Saline and Balanced Crystalloid Infusion
Condition: Metabolomics
Study type: Interventional

Summary: 
      Different crystalloids, namely 0.9% saline and balanced crystalloid may result in different
      metabolomic profile among surgical patients. This study aims to investigate the serum and
      urine profiles between patients undergoing major spine surgery using 0.9% saline and balanced
      crystalloid.
    

Detailed description: 
      Intravenous fluid is mandatory for acute and critically ill patients as well as for surgical
      patients. Two crystalloid iv. solutions namely 0.9% saline and balanced crystalloid are the
      most commonly administrated. However, early literature suggests that 0.9% saline is
      associated with hyperchloremic acidosis, which affects cellular metabolism and may result in
      worse prognosis among acute or critically ill patients. However, recent literature in 2018,
      including a meta-analysis and a large randomized controlled trial published in the New
      England Journal of Medicine revealed neutral or merely slight different clinical outcomes
      between 0.9% saline and balanced crystalloids. Therefore, the metabolic differences between
      these two fluids may only exist in specific metabolic pathway which may be easily masked by
      the complex pathophysiological changes in acute and critically ill patients. These metabolic
      alteration may be only identified by precise research t the technology such as liquid
      chromatography mass spectrometry, which provides more comprehensive metabolomics profiles. By
      comparison, surgical patients undergoing major spine surgery receive a relatively large
      amount of intravenous infusion during surgery, and there is not complicated with complex
      pathophysiological alteration of cormorbid diseases. Accordingly, this study aim to identify
      the metabolomic differences between 0.9% saline and balanced crystalloid among patients
      undergoing major spine surgery by using the liquid chromatography mass spectrometry
      technique.
    

Intervention name(s): Saline; Balanced crystalloid
Intervention type(s): Drug; Drug
Intervention description(s): Intraoperative fluid therapy is administrated by using 0.9% saline; Intraoperative fluid therapy is administrated by using balanced crystalloid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparison between two intraoperative iv. fluids
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolomics; Fluid therapy
A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the efficacy and safety of XP21279/Carbidopa in
      comparison to Sinemet as well as evaluate the pharmacokinetics (PK) of levodopa after
      administration of XP21279/Carbidopa and Sinemet and to explore exposure-response
      relationships in a subset of subjects.
    


Intervention name(s): XP21279 and carbidopa (experimental); Sinemet (comparator); Placebo for XP21279 and carbidopa; Placebo for Sinemet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa; Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.; Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa; Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet
Intervention MeSH terms: Carbidopa; Carbidopa, levodopa drug combination; Levodopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Candesartan in Alcoholic Liver Fibrosis
Condition: Alcoholic Liver Disease
MeSH terms: Liver Diseases; Liver Cirrhosis; Liver Diseases, Alcoholic; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background:

      Alcohol is one of principal causes of hepatic fibrosis. Although the most effective treatment
      for alcoholic hepatic fibrosis is abstinence of alcohol consumption, additive treatment to
      reduce the accumulation of scar tissue can accelerate the improvement of hepatic fibrosis in
      alcoholic liver disease. The renin-angiotensin system can be an attractive antifibrotic
      target in liver. Several lines of evidence indicate that overproduction of angiotensin II(ANG
      II) in chronic liver injury stimulates the activation of hepatic stellate cells(HSCs)
      attributed to fibrogenesis. Additionally, the antifibrotic effect of ANG II blocking agent
      has been shown in various animal models and hepatitis C patients. Hence, drugs that inhibit
      the renin-angiotensin system have promise in ameliorating hepatic fibrosis in chronic liver
      injury. However, no study has been conducted in patients with alcoholic liver disease to
      evaluate the effect ANG II type I receptor blocking agent on hepatic fibrosis.

      Aim:

      This study aimed to investigate the safety and the efficacy of chronic administration of
      candesartan to hepatic fibrosis patients with alcoholic liver disease.

      Methods

      1) Patients with liver fibrosis(F2) were randomized to receive either the angiotensin
      receptor blocker(ARB), candesartan(8 mg/day) with ursodeoxycholic acid(UDCA)(600 mg/day)(n =
      42), or UDCA alone(n = 43) as control for 6 months. 2)All enrolled patients underwent liver
      biopsies twice for measurement of fibrosis score, area of fibrosis and alpha-smooth muscle
      actin(SMA) positive and hydroxyproline. 3) Transforming growth factor-beta1(TGF-beta1),
      collagen-1, angiotensin II type I receptor(AT1-R), tissue inhibitor of
      metalloproteinase-1(TIMP-1), Rac1 and p22phox which represent oxidant stress were also
      measured by real-time RT-PCR before and after 6 months of therapy.
    


Intervention name(s): candesartan for hepatic fibrosis
Intervention type(s): Drug
Intervention description(s): Candesartan group(42 patients): oral candesartan at a daily dose of 8 mgin addition to ursodeoxycholic acid (UDCA, 600 mg/day) for 6 months.
UDCA group(43 patients): oral ursodeoxycholic acid (UDCA, 600 mg/day) only for 6 months
Other intervention name(s): atacand for hepatic fibrosis
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hepatic fibrosis; angiotensin II blocking agents; alcoholic liver disease
Sevoflurane in COVID-19 ARDS (SevCov)
Condition: ARDS, Human; Coronavirus
MeSH terms: COVID-19; Respiratory Distress Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to study the effect of initial temporary sevoflurane sedation on
      mortality and persistent organ dysfunction (POD) in survivors at day 28 after ICU admission
      in the population of patients suffering from COVID-19 ARDS.
    

Detailed description: 
      The corona virus disease 19 (COVID-19) pandemic, caused by the severe acute respiratory
      syndrome corona virus 2 (SARS-CoV-2), is spreading rapidly across Europe. While data from
      European centers are still missing, several publications from Chinese centers are available.
      Respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of
      mortality, and may be caused or exacerbated by a 'cytokine storm syndrome'.

      Recent trials from our group demonstrated that the volatile anesthetic sevoflurane
      administered during ventilation of patients has anti-inflammatory properties. Moreover, in in
      vivo studies volatile anesthetics reduce the severity of ARDS compared to intravenous
      sedation, which has been confirmed in a clinical pilot trial. Attenuating ARDS and thereby
      improving oxygenation strongly decreases morbidity and mortality of patients.
    

Intervention name(s): Sevoflurane; Intravenous drug
Intervention type(s): Drug; Drug
Intervention description(s): Sedation with sevoflurane (etSevo 0.5-1.5 Vol %) for 48 hours in patients with COVID-19 ARDS; Intravenous sedation in control group will be continued as initiated at the ICU e.g. propofol, fentanyl, midazolam, dexmedetomidine
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a randomized, controlled multi-center trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID-19; ARDS
Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
Condition: Atrophy
MeSH terms: Lipodystrophy
Study type: Interventional

Summary: 
      The study is being undertaken to establish the effectiveness and safety of Macrolane volume
      restoration factor 30 (VRF30) when used for treatment of HIV-infected subjects with buttocks
      lipoatrophy.
    


Intervention name(s): Macrolane VRF 30
Intervention type(s): Device
Intervention description(s): One administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lipoatrophy; Buttock treatment
Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy and safety of everolimus- and
      biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.

      The null hypothesis to be rejected is that there is no significant difference with regard to
      lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR
      at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting
      bioresorbable vascular scaffold stents.
    


Intervention name(s): Implantation of everolimus-eluting bioresorbable vascular scaffold stent; Implantation of everolimus-eluting stents; Implantation of biolimus-eluting stents
Intervention type(s): Device; Device; Device
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: percutaneous coronary intervention; bioresorbable vascular scaffold stents; everolimus; biolimus
A Validation Study of a New System for Measuring the End Expiratory Lung Volume During Mechanical Ventilation
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      In this study the investigators aim to evaluate a new system dedicated to estimate the end
      expiratory lung volume, by measuring the VO2-VCO2, during mechanical ventilation compared to
      the helium dilution technique and the computed tomography (CT) scan.
    

Detailed description: 
      In this study we aimed to evaluate a new system dedicated to estimate the end expiratory lung
      volume, by measuring the VO2-VCO2, during mechanical ventilation compared to the Helium
      dilution technique and the CT scan. We will compare the data considering the CT scan data as
      the gold standard.
    

Intervention name(s): Helium dilution technique, lung CT scan
Intervention type(s): Procedure
Intervention description(s): Helium dilution technique and lung CT scan
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ALI/ARDS patients
      
Keywords: Acute respiratory failure
Brain Network Activation Analysis in Epilepsy
Condition: Epilepsy; Epilepsy, Temporal Lobe
MeSH terms: Epilepsy; Epilepsy, Temporal Lobe
Study type: Observational

Summary: 
      This is a prospective study investigating the utility of Brain Network Activation (BNA)
      analysis in patients with epilepsy.
    

Detailed description: 
      BNA technology is based on a network model to depict functional connectivity. The descriptive
      network model approach provides insights regarding inter-connectivity of brain networks and
      can describe the temporal-spatial brain activation patterns applied to various types of
      data-sets including EEG, MEG and fMRI.

      In this study it is proposed that synchronization in brain activity may be disrupted in
      patients who experience frequent seizures and may correspond to functional impairments (e.g.,
      memory, processing speed). As such, BNA analysis may provide additional data that complement
      current functional assessments, inform clinical assessment and management of epilepsy, and
      identify subgroups of patients that might be at risk for poor treatment outcomes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from the long-term EEG monitoring floor and outpatient EEG
        laboratory. Controls will be recruited in response to advertisements. All participants will
        be given the BNA Auditory Go/NoGo task. Patient identity will be coded with a master record
        kept on a password protected computer in the laboratory. Deidentified data will be sent to
        ElMindA for scoring of the BNA test. Patient data from electronic medical records will be
        extracted along with patient MRI data processed.
Effects of Constructive Debriefing on Procedural Skills and Satisfaction of Nursing Students in Low Fidelity Context. A Randomized Controlled Trial.
Condition: Procedural Skill. Learning
Study type: Interventional

Summary: 
      Purposes: This study was set out to measure the effectiveness of constructive debriefing on
      procedural skills and satisfaction of nursing students in the low-fidelity context in
      comparison to traditional debriefing.

      Method: The randomized controlled (Parallel double blinded) trial design was used.

      Participant: Out of 51 approached, 34 students were selected from the list of participants by
      a data collector using simple random sampling technique. Following, block randomization was
      applied using Microsoft Excel to create two equivalent (n=17) groups i.e. experimental and
      non-experimental.

      Setting: The study was conducted in private college of nursing Islamabad Pakistan
      Intervention: The experimental group received constructive debriefing and non-experimental
      group received the traditional debriefing. The data were collected using suctioning, sterile
      dressing skills checklist, and debriefing reflection subscale of Satisfaction with Simulation
      Experience Scale.
    


Intervention name(s): constructive debriefing
Intervention type(s): Other
Intervention description(s): Constructive debriefing was applied to an interventional group Traditional debriefing was applied on noninterventional group
Other intervention name(s): traditional debrieifng
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Debriefing, Procedural skills, Satisfaction, Reflection, Critical thinking
PREGNANT Short Cervix Trial
Condition: Preterm Delivery; Short Cervix; Short Uterine Cervical Length
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to evaluate the usefulness of progesterone vaginal gel
      in decreasing the preterm birth rate in a population of pregnant women with short cervical
      length and at high risk for preterm birth.
    

Detailed description: 
      A Short uterine cervical length in the mid-trimester is the most powerful predictor of
      preterm birth.
    

Intervention name(s): progesterone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8% vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation; vaginal gel, 1.125 Grams once daily, beginning at 19 0/7 to 23 6/7 weeks gestation through 36 6/7 weeks gestation
Other intervention name(s): Prochieve 8%
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preterm; Cervix
Remission of ICD by Switching Dopamine Agonist to Levodopa/Carbidopa
Condition: Impulse Control Disorder
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved
      and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist
      to levodopa/carbidopa in patients with Parkinson's disease who have been treated with
      dopaminergic medications.
    

Detailed description: 
      -  PRIMARY OBJECTIVE To evaluate the improvement of mMIDI(modified version of Minnesota
           Impulsive Disorders Interview,Korean version) score from the baseline to 12 weeks or
           LOCF(Last Observation Carried Forward)

        -  SECONDARY OBJECTIVE i) To evaluate the improvement of neuropsychiatric profiles from the
           baseline to 12 weeks or LOCF ii) To evaluate the improvement of UPDRS(Unified
           Parkinson's Disease Rating Scale)Score from the baseline to 12 weeks or LOCF
    

Intervention name(s): Levodopa/Carbidopa(200mg/50mg); Dopaminergic Agonists
Intervention type(s): Drug; Drug
Intervention description(s): Treated for at least 6 months after diagnosis of Parkinson's Disease.
Intervention MeSH terms: Dopamine; Levodopa; Carbidopa; Dopamine Agonists
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Penicillin Skin Testing in Patients With History of Allergic Reactions to Betalactams
Condition: Penicillin Allergy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This study aims to compare the readings of skin testing results in patients with suspected
      penicillin allergy between in-house penicillin test preparation and commercial available
      penicillin testing kit.
    

Detailed description: 
      The results of skin test with immediate reading will be compared between alkali-treated
      penicillin G and DAP reagents from Diater
    

Intervention name(s): Immediate skin test
Intervention type(s): Procedure
Intervention description(s): Intradermal test with immediate reading
Other intervention name(s): Intradermal test with reading at 15 minutes after injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Penicillin; Beta-Lactams; Allergy; Hypersensitivity
LILRB4 STAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Condition: Relapsed/Refractory Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, single-arm, open-label phase I clinical study to determine the
      safety and efficacy of LILRB4 STAR-T cells in relapsed/refractory acute myeloid leukemia
      subjects.
    

Detailed description: 
      This study will recruit LILRB4 positive AML subjects,and Subjects will receive cytoreductive
      chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion
      of LILRB4 STAR-T cells. LILRB4 STAR-T cells will be intravenously infused with a escalated
      dose of 1E6、3E6、1E7 cells/kg.The purpose of current study is to evaluate the clinical safety
      and tolerability of LILRB4 STAR-T cells therapy in patients with refractory and relapsed
      AML.Safety and efficacy of LILRB4 STAR-T cells therapy will be monitored.The primary endpoint
      of the study is to observe DLT, AE, SAE, CRS and ICANS. Secondary objectives are to observe
      the efficacy of LILRB4 STAR-T cells, including RFS, EFS and OS, and PK.
    

Intervention name(s): LILRB4 STAR-T
Intervention type(s): Biological
Intervention description(s): Subjects with relapsed/refractory acute myeloid leukemia will be enrolled in the study, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of STAR-T cells. STAR-T cells will be intravenously infused with a escalated dose of 1E6#3E6#1E7 cells/kg。
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TPTNS for Treating Patients With Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional

Summary: 
      Background: Transcutaneous posterior tibial nerve stimulation is an effective therapy for
      controlling urinary incontinence. Premature ejaculation (PE) and urinary incontinence are
      anatomically and physio-pathologically similar. Based on this, the use of this therapy is
      considered to be viable for the control of PE.

      Objective: To evaluate the efficacy of transcutaneous posterior tibial nerve
      electrostimulation for the ejaculatory reflex.

      Patients and Methods: Phase II clinical trial. Patients with a diagnosis of premature
      ejaculation who are treated at the Colombia Boston Medical Group clinic will be included. The
      participants will receive 3 transcutaneous posterior tibial nerve stimulation therapies per
      week for 12 weeks. The IELT and the PEDT scale will be evaluated on week 6, at the end of
      treatment and three months after completing the protocol.
    


Intervention name(s): Transcutaneous Posterior Tibial Nerve Stimulation
Intervention type(s): Other
Intervention description(s): Three (3) sessions per week for twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual. In each session, it is normal to have plantar flexion of the foot and flexion of the first toe, and after the session and particularly during the first sessions there is the possibility of muscle pain, which should be tolerable.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment