bioihbjkbjnl/mcl2 huggingface dataset:
Construction and Evaluation of Airway Leakage Risk Model of Patients With Endotracheal Tube
Condition: Mechanical Ventilation
Study type: Observational

Summary: 
      There are two cases in which the cross-sectional area of the tracheal catheter balloon does
      not match the cross-sectional area of the patient's airway. If the area of the tracheal
      catheter balloon is smaller than the cross-sectional area of the patient's airway, the
      pressure in the balloon reaches 30 cmH2O, and the airway cannot be completely sealed; This
      will increase the risk of VAP. If the area of the tracheal catheter balloon is significantly
      larger than the cross-sectional area of the patient's airway, and the pressure in the balloon
      reaches 30 cmH2O, the airway cannot be effectively sealed; The formation of wrinkles around
      the airbag also increases the risk of VAP in patients. Therefore, the purpose of this study
      is to build a risk model of airway leakage of patients' endotracheal tubes, which provides an
      accurate and objective assessment tool for medical staff, so that medical staff can select
      the endotracheal tubes purposefully and with emphasis from the beginning of the patients'
      endotracheal tubes, and reduce the airway leakage or airway mucosal damage of the
      endotracheal tubes.
    

Detailed description: 
      Admission number, department, name, gender, height, and weight are obtained through the
      hospital's electronic medical record management system。 Tidal volume (set Tidal volume),
      airway peak pressure (real-time data on the ventilator screen), data collection is
      synchronized with the minimum cuff pressure measurement when the airway is closed.
    

Intervention name(s): Construction and evaluation of airway leakage risk model of patients with endotracheal tube
Intervention type(s): Other
Intervention description(s): Conduct statistical analysis on general information, respiratory data, tracheal catheter data, and cross-sectional area of the patient's airway to clarify the current status of airway leakage and related influencing factors.
Based on multivariate logistic regression, a line chart prediction model for predicting the risk of airway leakage in patients with tracheal catheters is constructed. The clinical efficacy of the prediction model is evaluated by using the area under the ROC curve, the Calibration scatter plot, and the DCA decision line, respectively, to assess its discrimination, calibration, and clinical practicality.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators selected mechanical ventilation patients admitted to the Extracardiac and
        Respiratory Care Units of Nantong University Affiliated Hospital from September 2021 to
        September 2022 who underwent cardiac, pulmonary, esophageal surgery, and other procedures
        as the research subjects.
Efficacy Study of Hydroxychloroquine to Treat High-risk Coronary Artery Disease.
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate whether treated with hydroxychloroquine could
      improve therapeutic effect for patients with high-risk coronary artery disease.
    

Detailed description: 
      This double blind, placebo, randomized controlled trial is going to assess if
      hydroxychloroquine could improve the high sensitivity C-reaction protein, blood lipid, blood
      glucose and blood pressure, also whether hydroxychloroquine could affect the secretion of
      inflammatory cytokines and the M1/M2 phenotype polarization of macrophages in patients with
      high-risk coronary artery disease.
    

Intervention name(s): Hydroxychloroquine Sulfate Tablets; Placebo Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Subjects are treated with oral hydroxychloroquine sulfate tablets 200mg twice daily for 20 weeks. All the interventions are built on the guideline-based secondary prevention of coronary heart disease medications.; Subjects are treated with oral placebo tablets 200mg twice daily for 20 weeks. All the interventions are built on the guideline-based secondary prevention of coronary heart disease medications.
Other intervention name(s): Plaquenil; placebo
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; Hydroxychloroquine
Investigation of Cycloserine as a Smoking Cessation Treatment
Condition: Nicotine Addiction
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Psychosocial treatments for drug abuse benefit some patients (Rawson et al 2004), but there
      is an urgent need for new treatment approaches that can improve treatment outcomes. One new
      approach involves facilitation of extinction of conditioned responses through the use of
      d-cycloserine, a partial agonist at the NMDA glycine site. This approach has proved useful
      for the treatment of several anxiety disorders. For example, treatment with d-cycloserine
      enhanced the efficacy of behavioral treatments for acrophobia (Ressler et al 2004) and social
      phobia (Hofmann et al 2006) by enhancing extinction of conditioned fear responses. This
      suggests that d-cycloserine has potential to enhance the efficacy of behavioral treatments
      for drug dependence by enhancing extinction of conditioned responses to drug cues. In this
      Phase I Cutting-Edge Basic Research Awards (CEBRA) application we propose a proof-of-concept
      study to examine effects of treatment with d-cycloserine for facilitating extinction of
      craving provoked by exposure to cigarette smoking cues. The benefits of this treatment
      approach together with cognitive behavioral treatment for reducing cigarette smoking will
      then be determined. Smoking cues will be presented using an established virtual reality
      simulator(Bordnick et al 2004; Bordnick et al 2005a)
    

Detailed description: 
      See brief summary
    

Intervention name(s): Cycloserine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of cycloserine medication (50 mg administered prior to each exposure treatment) on Day 1, 4, 7, and 10 of the study; Oral administration of matching placebo pill on Days 1, 4, 7, and 10
Other intervention name(s): d-cycloserine; Seromycin; Sugar pill
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Cycloserine; Nicotine; Smoking
Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate
      bromide) for the treatment of COPD patients.
    

Detailed description: 
      A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover
      Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI
      (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease
    

Intervention name(s): CHF 5259; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.; Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
Other intervention name(s): glycopyrrolate bromide
Intervention MeSH terms: Glycopyrrolate; Bromides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary disease; COPD
Carpel Tunnel Syndrome and Physical Therapy Modalities
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpel tunnel syndrome (CTS) is very common complain during pregnancy with high percentage to
      continue postnatal. Conservative treatment is more recommended in these cases. There are many
      physical therapy modalities proposed to treat CTS without knowing which modality is better
      than the other. So the aim of this study to compare the effect of two modalities in treating
      CTS in postnatal females.
    

Detailed description: 
      Carpal tunnel syndrome (CTS) is one of the most common peripheral nerve entrapment disorders
      in the upper limb. CTS is common during pregnancy especially in the third trimester as well,
      a significant percentage of females postnatal may still have some complaints up to at least 3
      years postnatal.

      Purpose: To compare the effect of pulsed magnetic field (PEMF) versus ultrasound (US) in
      treating patients with CTS. Forty postnatal female patients with idiopathic CTS were assigned
      randomly into two equal groups. One group received PEMF with nerve and tendon gliding
      exercises for the wrist 3 times for week for 4 weeks. The other group received US plus the
      same exercises. Pain level, sensory and motor distal latencies of the median nerve (MSDL and
      MMDL), sensory and motor conduction velocities of the median nerve (MSCV and MMCV),
      functional status scale and hand grip strength were assessed pre and post treatment
    

Intervention name(s): pulsed electromagnetic field; Therapeutic ultrasound
Intervention type(s): Device; Device
Intervention description(s): it is a magnetic device for magneto-therapy, it has an appliance, motorized bed, and applicable large solenoids which can be moved in 4 different positions according to the treatment area, and the additional small solenoid for hand treatment with 30 cm diameter; Ultrasound is applied using a transducer or applicator that is in direct contact with the patient's skin. Gel is a medium which is used on all surfaces of the head to reduce friction and assist transmission of the ultrasonic waves
Other intervention name(s): (PEMF); US
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: median nerve; wrist joint; carpal tunnel
Systemic Glutathione Level in Normal Tension Glaucoma
Condition: Normal Tension Glaucoma
MeSH terms: Glaucoma; Low Tension Glaucoma
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether systemic glutathione level is decreased in
      patients with normal tension glaucoma.
    

Detailed description: 
      Normal tension glaucoma is one of the most common cause of primary open angle glaucoma in
      Korea. Even though, we still do not know what the cause is. Only IOP-lowering drugs are the
      currently available therapeutic method. Glutathione is one of the mostly high concentrated
      intracellular antioxidants. We find apoptosis of neuronal cell in the mouse retina by
      systemic depletion of glutathione using buthionine sulfoximine. Glutathione is also known to
      be reduced in primary open angle glaucoma with high IOP. So we are planning to evaluate
      systemic glutathione level in normal tension glaucoma.

      Blood samples will be obtained by venipuncture to the antecubital vein of normal tension
      glaucoma patients and age-matched normal controls. Five milliliters of blood will be
      collected in EDTA-treated tubes (to prevent oxidation). Thirty microliters of blood will be
      then transferred into centrifuge tubes, and will be added 33.3 microliter of 5-sulfosalicylic
      acid (SSA), 100mg/mL within 10 minutes from the blood collection.Each sample will be then
      diluted with 936.7 microliter sodium phosphate buffer (pH 7.5), and the content of each tube
      will be mixed rapidly in a centrifuge at 13,000 rpm for 5 minutes. A portion of supernatant
      (150 microliter) will be then collected into clean centrifuge tubes and immediately cooled at
      -70°C. To each well of a 96-well plate, 150 microliter of daily buffer (3 mg NADPH into 10 mL
      sodium phosphate buffer), 50microliter of DTNB solution, and 25 microliter of standards or
      samples will be added in quadruplicate, and the plate will be incubated at 37 °C for 3
      minutes.Finally, 25 microliter GSSGR will be added to the previous mixture, and the plate
      will be read at 410 nm using a 96-well plate reader(UV spectrophotometer).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients of tertiary referred center
      
Biospecimen description: 
      serum
    
Keywords: Normal tension glaucoma; Glutathione; Antioxidant
Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Peritoneal Infection
Condition: Peritoneal Infection
MeSH terms: Infections; Communicable Diseases; Peritonitis
Study type: Interventional

Summary: 
      Peritoneal infection is still a frequent complication in peritoneal dialysis patients . In
      France, It contributes to the technique failure, responsible for about 20% of cases of
      transfer in hemodialysis. The risk of direct mortality is estimated at 1 to 6% according to
      studies. Peritoneal infection is involved in the dysfunction of the peritoneal membrane.

      Based on the recommendations of the International Society for Peritoneal Dialysis, the
      intraperitoneal route is preferentially recommended. For many antibiotics, pharmacokinetics
      (intravenous and intraperitoneal) was studied and protocols for IP administration were
      validated.

      Daptomycin, is a cyclic lipopeptide natural, active only on Gram-positive bacteria. It is
      presented as an alternative to vancomycin in infections resistant pathogens. The stability of
      daptomycin in peritoneal dialysis fluids (PDF) has been tested, and antimicrobial activity as
      well.

      Seven patients were treated with daptomycin intraperitoneally successfully. But no study has
      reported pharmacokinetics of daptomycin via the IP route. We propose a pharmacokinetic study
      of daptomycin administered intraperitoneally in 12 patients on CAPD and with Gram-positive
      peritoneal infection.
    

Detailed description: 
      Methodology:

      Prospective, open-label, non-randomized pharmacokinetic study. Daptomycin will be given IP in
      the CAPD fluid (200mg in 2L Nutrineal) once daily, in a 6 hours-dwell time. The process of
      dialysis is done four times per day : three during the day (6,6,and 4 h) and one time at
      night (8h). Duration of treatment depends on bacteria identified (14 or 21 days).

      Analyses will be performed on data from all patients meeting the criteria for inclusion and
      exclusion.

      For each patient, plasma, dialysate and urine kinetics will be studied.

      For each parameter, mean and standard deviation are calculated.

      Number of centers & patients:

      One center, twelve patients.

      Sample size justification:

      This is an observational pharmacokinetic study of consecutive PD patients presenting to Caen
      University Hospital with peritoneal infection and who meet inclusion criterias over one year.

      Population: CAPD patients with a Gram positive peritoneal infection
    

Intervention name(s): intraperitoneal daptomycin
Intervention type(s): Drug
Intervention description(s): intraperitoneal daptomycin administartion and study of daptomycin kinetics
Intervention MeSH terms: Daptomycin
Intervention model: Single Group Assignment
Intervention model description: dose-finding study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intraperitoneal; peritoneal dialysis; daptomycin; pharmacokinetics; peritonitis
Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      safety, efficacy and acceptability of Flavocoxid
    

Detailed description: 
      Safety, Efficacy and acceptability of Flavocoxid (Limbrel) compared with Naproxen in Subjects
      with Osteoarthritis of the Knee. A Pilot Study
    

Intervention name(s): flavocoxid; Naproxen
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): flavonoid mixture; non-steroidal anti-inflammatory drug
Other intervention name(s): Limbrel; naprosyn
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a
      positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer
    


Intervention name(s): ZD4054; Moxifloxacin; ZD4054 Placebo; Moxifloxacin placebo; ZD4054 Placebo; ZD4054; ZD4054
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ZD4054 10mg Tablet; 400 mg capsule; 3 tablets; 1 capsule; 2 tablets; 30mg tablet; 10mg tablet
Other intervention name(s): Zibotentan; AVELOX
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: ZD4054; Healthy Volunteers; QT interval
Study Evaluating Mylotarg (Gemtuzumab Ozogamicin) in Usual Care
Condition: Acute Myeloid Leukemia
Study type: Observational

Summary: 
      This study is designed to assess the safety of Mylotarg therapy in routine practice.
    


Intervention name(s): Mylotarg
Intervention type(s): Drug
Intervention MeSH terms: Gemtuzumab
Observational model: Defined Population
Time perspective: Prospective
Keywords: Leukemia
Capturing Parkinson's Disease Medication Side Effects During Daily Activities
Condition: Parkinson's Disease; Dyskinesia
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Observational

Summary: 
      The purpose of the study is to test whether body-worn wireless motion sensors can measure
      dyskinesias (involuntary movements caused by medications) in individuals with Parkinson
      disease (PD) independent of voluntary activity being performed and other PD motor symptoms
      (e.g. tremor).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Idiopathic PD demonstrating levodopa-induced dyskinesias
      
Keywords: levodopa; tremor; bradykinesia; motion sensors
Absence of Steroid in Renal Transplantation and Digital Fibrosis Observation
Condition: Renal Transplant
MeSH terms: Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of this study is to demonstrate that the absence of post-transplantation
      corticosteroids does not induce a larger increase of renal graft fibrosis (by numerical
      reading) on biopsy at one year post-transplantation than immunosuppressive treatment strategy
      that includes standard oral corticosteroids.The secondary objectives of the study consist to
      compare on various parameters (fibrosis progression, renal function, dialysis, ratio of
      proteinuria/creatinuria, acute rejection, donor-specific antibody, graft survival, clinical
      and biological tolerance) therapy with no corticosteroids post-transplantation in comparison
      to standard immunosuppressive treatment strategies including oral corticosteroids. Secondary
      objectives of the study consist also to compare the two techniques for assessing fibrosis by
      numerical reading and by centralized blinded reading of the treatment group (by 2 anatomical
      pathologists).
    


Intervention name(s): Absence of corticotherapy post-transplantation; Corticotherapy post-transplantation
Intervention type(s): Other; Drug
Intervention description(s): No study treatment; Prednisone or prednisolone orally for at least one year post-transplantation with the following minimal doses :
D1 to D14 : 20 mg/day,
D15 to M1 : 15 mg/day,
M1 to M3 : 10 mg/day,
M3 to M12 : 5 mg/day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Corticotherapy; Fibrosis; Numerical reading; 18-70 years; first renal transplant was lost due to rejection; first or second renal transplant
Imipenem Versus Cefepime in Spontaneous Bacterial Peritonitis and to Evaluate the Risk Factors for Treatment Failure
Condition: Spontaneous Bacterial Peritonitis
MeSH terms: Peritonitis
Study type: Interventional

Summary: 
      1. All consecutive patients with Cirrhosis and ascites admitted to ILBS (Institute of Liver
           & Biliary Sciences) will be evaluated for the presence of SBP (Spontaneous Bacterial
           Peritonitis) by ascitic fluid examination at admission.

        2. SBP (Spontaneous Bacterial Peritonitis) will be diagnosed in the presence of absolute
           neutrophil count (ANC >250/mm3) with/without positive ascitic fluid culture and Patients
           with SBP (Spontaneous Bacterial Peritonitis) included in the study will be randomized to
           receive cefepime or imipenem.

        3. However, other SBP (Spontaneous Bacterial Peritonitis) patients not included for
           randomization will be given empirical therapy with 3rd generation cephalosporin
           (ceftriaxone).
    

Detailed description: 
      Baseline evaluation:

      Baseline clinical, laboratory and disease severity parameters will be evaluated for each
      study patient.

        1. Etiology of cirrhosis.

        2. Severity of liver disease. CTP (Child-Turcotte-Pugh) score MELD (Model for End-stage
           Liver Disease) score MELD (Model for End-stage Liver Disease)-Na score IMSAA score

        3. Decompensations/complications of CLD (Chronic Liver Disease) UGI bleed, Hepatic
           encephalopathy, AKI (Acute Kidney Injury) etc.

        4. Laboratory investigations:

      Serum electrolytes Liver function tests Kidney function tests Pro calcitonin USG/CT abdomen
      Complete blood counts Coagulation parameters Ascitic fluid analysis- TLC, DLC, Protein,
      sugar, culture, SAAG. Chest X ray PA view HBsAg and Anti-HCV and other etiological workup as
      available.
    

Intervention name(s): cefepime + Albumin; Imipenem + Albumin
Intervention type(s): Drug; Drug
Intervention description(s): cefepime + Albumin will be given for 2 days; Imipenem + Albumin will be given for 2 days.
Intervention MeSH terms: Imipenem; Cefepime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment