bioihbjkbjnl/mcl2 huggingface dataset:
Risk Factor Analysis for Coronary Atherosclerosis Measured by MDCT
Condition: Atherosclerosis; Metabolic Syndrome
MeSH terms: Atherosclerosis; Metabolic Syndrome
Study type: Observational

Summary: 
      Coronary MDCT (multi-detector computed tomography) has been useful screening imaging modality
      for the coronary artery disease. Recently, novel adipokines and hepatokines as well as
      various inflammatory markers have been known as direct regulators of atherosclerosis.
      Therefore, the investigators examine the correlation of various metabolic risk factors
      including adipokines and hepatokines with coronary atherosclerosis measured by coronary MDCT
      in apparently healthy people.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Apparently healthy people who underwent medical routine check up in Korea Helath Promotion
        Center.
Gender, Pain, and Placebo Analgesia
Condition: Experimental Pain
Study type: Interventional

Summary: 
      The response to standard pain stimuli in males and females is investigated, together with the
      effect of informing participants about the effect of a painkiller. Physiological response to
      pain is recorded.
    

Detailed description: 
      The social context in which pain is reported has been found to modulate pain. Specifically,
      male participants reporting pain to female observers report significantly lower pain levels
      compared to male participants reporting to male observers. Female participants seem less
      affected by social context. This is a methodological problem in the study of pain and has
      consequences in the development of new drugs, and for pain research in general.

      The present study has two aims: To investigate whether social context affects also the
      placebo response to pain, i.e. the reduced pain often observed after administration of a an
      inert substance the participants believes to be a painkiller. It is hypothesized that placebo
      analgesia will be larger in males reporting pain to females. Secondly, heart rate variability
      and skin conductance, measures of parasympathetic and sympathetic activity, will be recorded,
      to investigate if social context affects not only pain report, but also pain response.
    

Intervention name(s): Information (behavior)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Experimental pain; Placebo analgesia; Heart rate variability; Skin conductance
Body Composition Monitor(BCM) Guided Fluid Management in Maintenance Hemodialysis (MHD) Patients
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      It is hypothesized that bioimpedance spectroscope guided fluid management will help patient
      reach euvolemic status, and increase long term survival.

      Background: Bioimpedance analysis (BIA) was helpful in identifying hypervolemia.
      Observational data using BIA methods showed that hypervolemic patients on maintenance
      hemodialysis (MHD) suffered from high mortality risk. But it is not clear if BIA guided fluid
      management can improve MHD patients' survival. The objectives of the BOCOMO study are to
      evaluate the outcome of BIA guided fluid management comparing with standard care.

      Design: This is a multicenter, prospective, randomized, controlled trial. Setting and
      Participants: More than 1300 participants from 16 clinical sites will be included in the
      study. The enrollment period will last 6 months, and minimum length of follow-up will not
      less than 36 months. MHD patients aged more than 18 years but less than 80 years who had been
      on MHD for at least 3 months and considered suitable candidates will be invited to
      participate in the study. Participants will be randomized to BIA arm or control arm using 1:1
      ratio. A portable whole body bioimpedance spectroscopy device (BCM-Fresenius Medical Care D
      GmbH) will be used for BIA measurement at baseline for both arm, and every 2 months in BCM
      arm.

      Predictors: BCM guided fluid management and fluid management using standard care.

      Outcome and measurements: The primary intent-to-treat analysis compares composite endpoint
      between BCM arm and control arm. The secondary intent-to-treat analysis compares left
      ventricular thickness, blood pressure, medication, and incidence and length of
      hospitalization between BCM arm and control arm. Death, acute myocardial infarction, stroke,
      peripheral arterial disease will be used as composite endpoint.
    


Intervention name(s): body bioimpedance spectroscopy device; Device
Intervention type(s): Device; Device
Intervention description(s): Name of the device is BCM from Fresenius Medical Care D GmbH; participants in control arm will not receive BCM measurement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: end stage renal disease; maintenance hemodialysis; dry weight; bioimpedance spectroscopy analysis; body composition monitor; Fresenius BCM; Ultrafiltration
ADDIA Chronobiological Study
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      The present single center clinical chronobiological study on 24 subjects (12 patients with
      mild to moderate form of Alzheimer's disease and 12 Healthy subjects) aims at characterizing
      the ADDIA biomarkers: a) blood cell-based biomarkers measured by flow cytometry using
      proprietary probes specific of two targeted biomarkers, beta-Amyloid (Aβ) peptide and a
      kinase, and b) circulating biomarkers in peripheral body fluids. The biomarkers will be
      analyzed on samples taken at different time points of the day, including under fasting and
      non-fasting conditions and at two periods: day 1 and day 14.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  12 patients with mild to moderate form of Alzheimer's disease 55 to 85 years-old.

          -  12 healthy volunteers (HV), 55 to 85 years-old.

          -  Total expected completed subjects: 24.

          -  Stratification by gender: 6 males and 6 females, age-matched healthy subjects and 6
             males and 6 females, age-matched Alzheimer patients.

          -  Mean age similar in both groups
      
Biospecimen description: 
      Blood
    
Keywords: Blood cell biomarkers, peripheral circulating biomarkers
A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)
Condition: Measles
MeSH terms: Measles
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the safety of a measles, mumps, and rubella study
      vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA
      (recombinant human albumin).
    

Detailed description: 
      The duration of treatment is 6 weeks.
    

Intervention name(s): V205C, measles, mumps, and rubella virus vaccine live; Comparator: Measles, Mumps, and Rubella Virus Vaccine Live
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Prevention of Measles
Is Chronic Abdominal Pain in Pediatric Patients Due to Small Intestinal Bacterial Overgrowth?
Condition: Chronic Abdominal Pain; Small Intestinal Bacterial Overgrowth
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in
      adults, it is one of the functional bowel disorders without a clear framework of
      understanding or an effective treatment. However, new research suggests that small intestinal
      bacterial overgrowth (SIBO) may be the unifying pathophysiology that explains the variety of
      symptoms experienced by patients with IBS. As CAP in children is believed to be a precursor
      to IBS in adults, we hypothesize that children with this disorder have a significantly
      greater prevalence of small intestinal bacterial overgrowth (SIBO) than normal, healthy
      children, and that eradication of bacterial overgrowth with antibiotics will reduce symptoms
      of chronic abdominal pain in children with this condition. To prove this, we will first aim
      to determine the prevalence of SIBO in both healthy children and those with CAP. We will do
      this by performing a lactulose breath hydrogen test, the gold standard for the noninvasive
      measurement of SIBO, on 40 healthy controls and 80 subjects with CAP. We will then assess
      whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain
      in children with this condition. To do this we will randomize, in a double-blinded fashion,
      the 80 CAP patients to receive a 10-day course of either the antibiotic Rifaximin or a
      placebo. After completion of the treatment we will evaluate all these patients for
      eradication of bacterial overgrowth by repeating a lactulose breath hydrogen test. We will
      also assess for symptom improvement by re-administering questionnaires.
    


Intervention name(s): Lactulose Breath Test; xifaxan; placebo; Lactulose Breath Test
Intervention type(s): Procedure; Drug; Drug; Procedure
Intervention description(s): Healthy controls will receive one lactulose breath test to assess for SIBO; xifaxan 550mg TID x10days; placebo TID x 10days; Children with CAP will receive one lactulose breath test to assess for SIBO and one after receiving either Rifaximin or Placebo
Intervention MeSH terms: Rifaximin; Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.
Condition: Mechanical Ventilation
Study type: Interventional

Summary: 
      Muscle weakness and dysfunction are common problems in patients hospitalized in the intensive
      care unit. Respiratory muscle weakness during mechanical ventilation was recognized a state
      of muscular fatigue. The terminology 'ventilator-induced diaphragmatic dysfunction' (VIDD)
      originally was introduced to describe these effects of mechanical ventilation and respiratory
      muscle unloading on the diaphragm.

      Ultrasonography is becoming increasingly popular management of ICU patients. It is a simple,
      non-invasive and safe imaging technique that can be used for the assessment of distinctive
      diaphragmatic characteristics.

      Parameters such as amplitude and velocity of contraction, which can be assessed using M-mode
      ultrasound. In addition, static and dynamic (thickening fraction during inspiration)
      diaphragmatic thickness can also be measured by ultrasonography.
    

Detailed description: 
      The aim of this study is to evaluate the effect of different modes of mechanical ventilation
      on diaphragmatic thickness using ultrasonography and the relation between time of mechanical
      ventilation and the percentage of change of diaphragmatic thickness in head trauma patients
      subjected for mechanical ventilation (>2 days) intensive care unit.

      Modes of ventilation will be used in the study are:

        -  Pressure controlled mandatory ventilation mode (P-CMV).

        -  Pressure synchronized intermittent mandatory ventilation mode (P-SIMV).

        -  Pressure support (PS) mode.
    

Intervention name(s): Pressure controlled mandatory ventilation mode (P-CMV); Pressure synchronized intermittent mandatory ventilation; Pressure support mode (PS)
Intervention type(s): Other; Other; Other
Intervention description(s): Pressure controlled mandatory ventilation mode (P-CMV); Pressure synchronized intermittent mandatory ventilation; Pressure support mode (PS)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      to compare between the use of single dose of paracetamol and pethidine hydrochloride
      intravenously in management of labour pains
    

Detailed description: 
      investigators conducted a randomized clinical study included including 96 primiparous women
      admitted to Obstetrics and Gynecology Department, Menoufia University Hospitals, starting the
      study from May 2019 to March 2020 to assess the use of paracetamol intravenously versus
      Pethidine HCL intravenously in management of intrapartum pain. After obtaining approval from
      the local ethics committee, women who agreed to participate gave their signed informed
      consent after explanation of the trial benefits and hazards
    

Intervention name(s): paracetamol-pethidine
Intervention type(s): Drug
Intervention description(s): 100 ml containing 1000 mg paracetamol -50 mg pethidine HCL
Intervention MeSH terms: Acetaminophen; Meperidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cases were divided into 2 groups:
Group I (paracetamol group): Included 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%].
Group 2 (pethidine group): Included 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%]. Randomization was done by a computer-generated randomization system. Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.
Masking: Single (Participant)
Primary purpose: Treatment
Study to Evalutate Long-term Immunity of Hantavax in High Risk Population of HFRS
Condition: Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was aimed evaluate long-term immunity response by neutralizing antibody test of
      adults in high risk population of HFRS .
    

Detailed description: 
      This clinical trial was designed as a multicenter, non-comparable, open-label clinical
      trial.This trial was conducted written informed consent form by voluntary agreement, negative
      result of hantaanvirus antubidy by neutralizaing antibody test, test drug was administrated
      0, 1, 13 months according to drug label.

      For antibody test, Sampling was conducted pre-dose(T0), 1 month after vaccination(T1), 1 year
      after vaccination(before booster vaccination, T2) and 1 month after vaccination(T3). Also, 1
      month after vaccination (T3) after completion of booster vaccination for antibody retension
      duration observed for subjects with antibody to conduct a three-year follow-up survey was
      conducted, and the antibody test every year.In conclusion, sampling was conducted 12
      months(T4), 24 months(T5), 36months(T6) after the booster vaccionation.

      However, follow-up survey was terminated when the antibody titer was determined as a negative
      by neutralizing antibody test and fluorescent antibody technique.
    

Intervention name(s): Hantavax injection
Intervention type(s): Drug
Intervention description(s): Intramuscular or hypodermic injection of 0.5ml per time twice at interval of 1 month for adults. For more immune, inoculate muscle or subcutaneous once mor 12 months after the completion of the initial immune
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Nasal High Frequency Oscillation Ventilation(NHFOV) for Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome; Preterm Infant
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Premature Birth; Syndrome
Study type: Interventional

Summary: 
      In very preterm infants with severe respiratory distress syndrome(RDS), invasive
      ventilation(IV) , besides nasal continuous positive airway pressure (NCPAP) and
      early/selective pulmonary surfactant administration, is one key cornerstone to reduce
      neonatal mortality. However, IV is related to increased risks of bronchopulmonary dysplasia
      (BPD) and abnormal developmental outcomes in the survival.Weaning from IV is therefore a key
      procedure to reducing these risks above, and if extubation does not success, repeated
      intubation and/or prolonged duration of IV will result in increased medical burden and
      intubation-associated complications and death. How to minimize the need for endotracheal
      ventilation and subsequent complications constitutes a challenge for neonatologists.
    

Detailed description: 
      Early weaning from invasive ventilation and avoiding re-intubation remains a focus. Nowadays,
      early use of noninvasive respiratory support strategies has been suggested to be the most
      effective pathway to reduce those risks. NCPAP is a widely used way of noninvasive
      ventilation strategies in preterm infants. However, there is only 60% success rate in
      avoiding intubation. Supplying with the combined advantages of HFOV and NCPAP with high CO2
      removal, no need for synchronisation, less volume/barotraumas, non-invasion and increased
      functional residual capacity, nasal high frequency oscillation ventilation (NHFOV) is
      considered as a strengthened version of NCPAP. Thus, NHFOV may be more effective as
      post-extubation respiratory support to avoid re-intubation and subsequent
      complications/sequelae comparing with NCPAP in preterm infants. To date, NHFOV was used
      increasingly in neonatal intensive care unit (NICU) around the world due to its convenient
      operation and no consideration of synchronisation, and several small studies have reported
      the beneficial effects of NHFOV in preterm infants. However, there were rare randomized
      controlled studies compared NHFOV with NCPAP as post-extubation respiratory support
      strategies in preterm infants.

      The purpose of the present study was to compare NHFOV with NCPAP as post-extubation
      respiratory support on the need for endotracheal ventilation and subsequent complications in
      preterm infants.
    

Intervention name(s): NHFOV; NCPAP
Intervention type(s): Device; Device
Intervention description(s): NHFOV is used as the noninvasive mode after extubation; NCPAP is used as the noninvasive mode after extubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: preterm infant; respiratory distress syndrome; nasal high frequence oscillation ventilation
Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
Condition: HIV Infections; H1N1 Influenza Virus
MeSH terms: Influenza, Human; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Children and people infected with HIV are particularly susceptible to influenza infections.
      This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus
      in children and youth infected with HIV.
    

Detailed description: 
      The new H1N1 influenza virus seen in 2009 has been designated a pandemic by the World Health
      Organization, due to the sustained community outbreaks seen in the United States and Mexico.
      Based on preliminary data, it appears children and young adults were particularly at risk of
      the H1N1 virus. People infected with HIV were also more susceptible to severe influenza
      infections than those who are uninfected. Children with HIV infection, then, have a
      compounded risk of H1N1 infection. Higher doses of influenza vaccines are associated with the
      development of higher levels of serum antibodies, which are needed to resist infection.
      Higher vaccine doses can be used to improve vaccine effectiveness in at-risk populations.
      This study tested the safety and immune response of HIV infected children and youth to a high
      dose of a vaccine for the new H1N1 influenza virus.

      Participation in this study lasted 7 months and had two steps. The first step involved
      receiving the first dose of H1N1 virus vaccine, and the second step, occurring 21 days later,
      involved receiving the second dose of vaccine. Each dose of vaccine was delivered via two
      intramuscular shots (four total injections). After receiving each dose of the vaccine,
      participants were given a diary to record any symptoms or reactions. Participants were
      stratified into three groups by age, including 4 to 9 years, 9 to 18 years, and 18 to 25
      years.

      Participants completed five scheduled visits, taking place at screening, study entry, Days 21
      and 31, and after 7 months. Measurements taken on these visits included a medical history,
      physical and neurological exams, a blood draw, and, when applicable, a pregnancy test. In
      addition to these visits, participants received up to three additional phone calls or visits
      occurring 2 and 10 days after the first dose of vaccine and 2 days after the second dose of
      vaccine to check for reactions to the vaccine.
    

Intervention name(s): Influenza A (H1N1) 2009 monovalent vaccine
Intervention type(s): Biological
Intervention description(s): Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza A Virus, H1N1 Subtype; Vaccine; Children; Adolescents; HIV-Infected; Perinatal HIV Infection; Treatment experienced
Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Condition: Breast Cancer Female; Diagnoses Disease
Study type: Observational

Summary: 
      This study proposed to construct an ultrasound-based diagnostic model for Differentiating
      Malignant Breast Lesion From Benign Lesion. This study contains both retrospective and
      prospective part, which are designed for model construction and independent validation,
      respectively.This study aims to construct an easy-to-use ultrasound-based model, prove the
      efficacy of the model for identifying malignant breast lesion from benign lesion, and finally
      promote the application of this diagnostic model in more clinics.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        females with breast lesion who need to receive breast ultrasound to make differential
        diagnosis of benign and malignant lesion
      
Biospecimen description: 
      Breast biopsy pathology