bioihbjkbjnl/mcl2 huggingface dataset:
Detection of Salivary Insulin Following Meals
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      In addition to its role as the major regulator of glucose uptake into peripheral tissues, the
      hormone insulin is also a primary regulator of fat storage and fat burning of the body.
      Mechanistic animal studies have shown that high insulin may be the initial trigger for weight
      gain and be the proximal cause of obesity. There is currently no quick or non-invasive way of
      measuring insulin as research and clinical techniques require collection of a blood sample
      followed by a complicated and costly biochemical assay. The investigators will test the
      hypothesis that insulin levels can be accurately measured in saliva in humans following meals
      that elicit high and low blood insulin responses. Findings will help determine if insulin can
      be use as a valid fluid to track insulin changes in humans.
    

Detailed description: 
      Lean and obese healthy participants will consume both a high carbohydrate meal and a low
      carbohydrate meal designed to elicit different insulin responses on two separate occasions.
      Blood samples and saliva samples will be collected for 2 hours following each meal and
      insulin will be measured in both plasma and saliva. The relationship between plasma and
      saliva insulin following the two meals will be assessed.
    

Intervention name(s): High-carbohydrate meal; Low-carbohydrate meal
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will consume a high-carbohydrate low fat meal. The macronutrients content will be 55% carbohydrate, 25% protein and 20% fat providing 400-500 kcal. Between interventions there will be at least a 48-hours washout, where participants are encouraged to return to their baseline dietary habits.; Participants will consume a low-carbohydrate high fat meal. The macronutrients content will be 10% carbohydrate, 25% protein and 65% fat and will provide 400-500 kcal (matched to the high carbohydrate meal). Between interventions there will be at least a 48-hours washout, where participants are encouraged to return to their baseline dietary habits.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery
Condition: Post Operative Pain; Midline Sternotomy Incision
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management
      post cardiac surgery
    

Detailed description: 
      A well formulated analgesic protocol is fundamental to fast tracking post cardiac surgery.
      Traditional analgesic methods have their own set of drawbacks unique to cardiac surgery.
      Opioids have well established side effects like nausea, vomiting, respiratory depression,
      urinary retention. Regional anesthetic techniques in anti coagulated patients may result in
      potentially catastrophic neurological, bleeding and thromboembolic sequelae. Non steroidal
      Anti Inflammatory Drugs (NSAIDs) have been associated with increased cerebrovascular events,
      renal dysfunction, sternal wound infections. These make alternative therapies, including non
      pharmacological modalities, attractive options for optimal analgesic therapy during the post
      operative period.

      Alternative methods like topical application of COX -2 inhibitors, intravenous magnesium,
      Transcutaneous Electrical Nerve Stimulation (TENS) have been tried with varied results in
      cardiac surgery. A somatotopic relationship has been described between the auricle and the
      other anatomical regions of the body. When specific points are accurately identified along
      the meridians of the ear and stimulated electrically, analgesic effects are known to occur.
      Percutaneous Electrical Nerve Stimulation (PENS) of the auricle and its efficacy in
      management of post midline sternotomy pain has not been evaluated previously. Primary Relief
      v 2.0 is a device which provides continuous PENS aimed at non pharmacological post operative
      pain management.
    

Intervention name(s): Primary Relief v 2.0
Intervention type(s): Device
Intervention description(s): To prove the effectiveness of Post Operative Pain Solution using Primary relief v 2.0 by Percutaneous Electrical Nerve Stimulation in the auricle.
Other intervention name(s): Neurostimulator
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Cardiac surgery pain reduction; Post operative pain; PENS; Neurostimulation
Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Study Design

             -  Randomized, Double-blind, Placebo-controlled, escalating single-dose design.

             -  Five ascending dose cohorts.

             -  In each cohort, subjects will be randomized to receive a single dose of HM10460A or
                placebo (negative control)

        -  Objectives

             -  The primary objective of the study is to assess the safety and tolerability of
                single escalating subcutaneous doses of HM10460A in healthy adult Korean Subjects
    

Detailed description: 
      The secondary objectives of the study are as follows:

        -  to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.

        -  to assess the relationship between the serum concentration of HM10460A and absolute
           neutrophil count (ANC).

        -  to assess the relationship between the serum concentration of HM10460A and CD34+ cell
           counts in the blood.

        -  to assess the immunogenicity (HM10460A, native G-CSF antibody,neutralizing antibodies)
           of a single subcutaneous dose of HM10460A.
    

Intervention name(s): HM10460A 5μg/kg; HM10460A 15μg/kg; HM10460A 45μg/kg; HM10460A 135μg/kg; HM10460A 350μg/kg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneously administrate at 0 hour on Day 1; Subcutaneously administrate at 0 hour on Day 1; Subcutaneously administrate at 0 hour on Day 1; Subcutaneously administrate at 0 hour on Day 1; Subcutaneously administrate at 0 hour on Day 1; Subcutaneously administrate at 0 hour on Day 1
Intervention MeSH terms: Immunoglobulin Fc Fragments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Candidate Malaria Vaccines in Senegalese Adults
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      Malaria transmission is falling in some parts of Africa as bed nets and anti-malarials become
      more widely available. However, transmission still persists and it appears that additional
      control measures are required. The leading malaria vaccine candidate in development is RTS,S
      which has efficacy against clinical malaria measured at 30-50% in the field. This partial
      protection might be enhanced by combination with other components. The other vaccination
      approach that has produced repeatable efficacy in humans is the use of viral vectors to
      induce T cell responses. Previous attempts with this vaccine approach have been effective in
      challenge studies in Oxford, but ineffective in the field, probably because of reduced
      immunogenicity with previous vector platforms.

      Recently, studies in Oxford, Kenya and the Gambia have shown higher levels of immunogenicity
      by using a chimpanzee adenovirus (ChAd63) followed by an attenuated vaccinia virus (modified
      vaccinia Ankara) to deliver the pre-erythrocytic antigen, multiple epitope string with
      thrombospondin- related adhesion protein (ME-TRAP).

      The increase in immunogenicity has lead to sterile protection in 3 out of 14 volunteers and
      partial protection in 5 out of 14 volunteers in challenge studies.

      The investigators propose a Phase 2b study of 120 healthy adult men in Senegal. The
      investigators will assess the efficacy and further evaluate the immunogenicity and safety
      profile of the vaccine regimen. The investigators also intend to assess the correlates of
      efficacy and natural immunity.
    


Intervention name(s): ChAd63 ME-TRAP and MVA ME-TRAP; Rabies vaccine
Intervention type(s): Biological; Biological
Intervention description(s): ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 2 x 10^8 pfu heterologous prime-boost immunisation; 2 x 2.5IU Verorab
Other intervention name(s): Verorab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Effect of Food on Pharmacokinetics of Obeticholic Acid (OCA)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomized, balanced, single center, single dose, trial to assess the
      pharmacokinetic (PK) profile of OCA, glyco-OCA and tauro-OCA on an empty stomach (fasted
      condition) and following a high fat, high calorie meal (fed condition) in a 2-period,
      2-sequence, crossover manner.
    


Intervention name(s): OCA 10 mg; OCA 25 mg
Intervention type(s): Drug; Drug
Intervention description(s): OCA 10 mg tablet oral; OCA 25 mg tablet oral
Other intervention name(s): 6α-ethyl chenodeoxycholic acid;(6-ECDCA), INT-747; 6α-ethyl chenodeoxycholic acid;(6-ECDCA), INT-747
Intervention MeSH terms: Chenodeoxycholic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because
      we plan to have only single capsules administered in the later phase clinical trials but we
      have not had a 100mg strength before. As this is a new previously untested strength we need
      to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess
      the effect of high fat food on the PK of the 100mg capsule. The study is planned to consist
      of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There
      will be a week wash out between each dose. In the three dosing periods subjects will either
      received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or
      100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14
      days after the final dose. It is expected that the total duration of the study should be
      approximately eight weeks.
    


Intervention name(s): GSK598809 new formulation; GSK598809 old formulation
Intervention type(s): Drug; Drug
Intervention description(s): GSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.; GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer; relative bioavailability.
The Optimization of Mycoplasm Pneumonia Antibiotic Therapy
Condition: Mycoplasma Pneumonia
MeSH terms: Pneumonia; Pleuropneumonia; Mycoplasma Infections; Pneumonia, Mycoplasma
Study type: Interventional

Summary: 
      Mycoplasma pneumoniae, an important pathogen of community acquired pneumonia,are becoming
      more and more resistant to macrolide. The study aim is to optimize anti-infection therapy.
    

Detailed description: 
      Mycoplasma pneumoniae was one of important atypical pathogens of community acquired
      pneumonia. As lack of cell wall, β-lactam medicines were invalid, however, macrolides,
      tetracyclines and quinolones were effective. But from 2001, many countries reported
      macrolide- resistant Mycoplasma pneumoniae. Typically, erythromycin was first-line antibiotic
      medicine. With the resistance increasing, Mycoplasm pneumonia treatment will become more and
      more difficult. Thus, optimization of Mycoplasm pneumonia antibiotic therapy is very
      important.
    

Intervention name(s): Moxifloxacin; Cephalosporins and azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): 0.4 Qd for 7days; cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days
Intervention MeSH terms: Moxifloxacin; Azithromycin; Cephalosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: macrolide- resistant Mycoplasma pneumoniae,; Mycoplasm pneumonia antibiotic therapy
Driving Pressure Guided VT in ARDS Patients
Condition: ARDS
Study type: Interventional

Summary: 
      A prospective physiologic study, in participants with COVID-19 related or non-COVID-19
      related acute respiratory distress syndrome (ARDS) requiring mechanical ventilation less than
      48 hours. The investigators assessed the effect of different tidal volume guided by different
      levels of driving pressure on ventilation inhomogeneity and ventilation/perfusion mismatch by
      electrical impedance tomography (EIT) in supine and/or prone position.
    

Detailed description: 
      Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the
      participant's chest at the fifth or sixth intercostal space and connected it to an EIT
      monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany).

      Data were collected in the enrolled day (Day 1),Day 3 and Day 7 including demographic and
      anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters
      including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen
      in inspired air (FiO2).

      Volume control mode without spontaneous breathing, PEEP will be set according to best
      respiratory compliance method, and tidal volume (VT) will be set to reach three levels of
      driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT
      was maintained 10 minutes in supine and/or prone position. In the last minutes of each
      phase，the participants received instructions of end expiratory occlusion lasting at least 10
      seconds and, 1 seconds after the start, a bolus of 10 mL of 10% NaCl solution was injected
      via the central venous catheter. Clinical data and outcome will be collected.
    

Intervention name(s): driving pressure guided tidal volume
Intervention type(s): Device
Intervention description(s): Volume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ARDS; ventilation and perfusion matching; ventilation inhomogeneity
Effect of Red Furu Consumption on Serum Vitamin B12 and Homocysteine Concentration In Healthy Young Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the present study is to investigate the effect of red furu (Chinese fermented
      soybean product) consumption on serum vitamin B12, Homocysteine concentration and other
      cardio-metabolic risk factors in healthy young volunteers.
    

Detailed description: 
      The study will apply the parallel study method and participants will be randomized into two
      groups. In the randomized controlled clinical trial, twenty-three healthy young volunteers
      (11 females and 12 males, aged 19-39 years) were recruited from Zhejiang University, China.
      They were randomly assigned to two groups of either red furu (n=11, 5 females and 6 males) or
      tofu (n=12, 6 females and 6 males). Volunteers consumed a provided meal, either 50 g of red
      furu or tofu with two slices of bread for 1 day breakfast meal. Volunteers also recorded
      their normal dietary intake during the 3 days trial period using provided self-report food
      diary. Fasting blood sample was drawn at 0h, 24h and 72h. Serum VB12, Hcy and other
      cardio-metabolic risk factors were measured by standard methods.

      Test Meals:

      Red Furu Group: 50 g of red furu with 2 slices of bread. Tofu Group: 50 g of plain tofu eaten
      with 2 slices of bread. Volunteers will refrain from consumption of fermented products 1 week
      prior to the study. Thereafter subject feed on control diet and intervention diet for 1 day.
      Volunteers' normal diets and test meals will be recorded on a self-administered
      questionnaire, followed by testing serum vitamin B12, Homocysteine and other biochemical
      parameters.

      5-10 mL blood will be collected per session. Blood will be collected: 3 times
      (0h-24h-72h).Participants will be asked to fast for 10-12 hours prior to the blood draw.
    

Intervention name(s): Red Furu; Tofu
Intervention type(s): Other; Other
Intervention description(s): 50 g red furu was consumed with 2 slices of plain bread for one-day
50 g Fresh tofu was consumed with 2 slices of plain bread for one-day; 50 g Fresh tofu was consumed with 2 slices of plain bread for one-day
50 g red furu was consumed with 2 slices of plain bread for one-day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will apply the parallel method and volunteers will be randomized into two groups.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Red furu; Metabolism; Randomized
Phase I, Open Label Dose Ranging Safety Study of GLS-5300 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute
      respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe
      pulmonary infection in 2012. Infection with MERS CoV has been diagnosed in more than 1600
      individuals with a mortality rate between 35% and 40%. GLS-5300 is a DNA plasmid vaccine that
      expresses the MERS CoV spike (S) glycoprotein. This study will evaluate the safety of
      GLS-5300 at one of three dose levels following a three-injection vaccination regimen followed
      by electroporation. The study will also assess immune responses over a 1 year period with
      respect to the generation of antibody and cellular responses.
    

Detailed description: 
      GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein.
      Following administration of the vaccine, a specialized medical device, CELLECTRA®, will
      deliver brief electrical pulses in a process known as electroporation (EP), to help move DNA
      into cells more efficiently.
    

Intervention name(s): GLS-5300
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MERS CoV; MERS-CoV; Middle East Respiratory Syndrome; MERS; DNA Vaccine
Laser Therapy in Nipples Injured During Breastfeeding
Condition: Nipple Trauma
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of low-level laser in pain relief and tissue repair in
      mothers with nipple trauma during breastfeeding, compared to a control group.
    

Detailed description: 
      The selection was made through the search of women hospitalized in Accommodation beds with
      nipple trauma, lifting of stipulated criteria, and inclusion of women in the study upon
      acceptance and signing of the consent form. To collect the data, a group was formed with
      people trained as evaluators, responsible for election, randomization, filling of First
      Assessment and Subsequent Assessment forms, recording of photo images and pain evaluation
      before and after treatment with laser; and applicators, responsible for laser handling and
      irradiation. Data collection followed the following order: filling of the first instrument,
      breast image capture, suckling observation, identification of pain during the child's breast
      sucking, laser irradiation and re-identification of pain during the child's breast sucking
      after laser treatment. The collection of data of this form occurred continuously every twelve
      hours until repair of the nipple trauma or patient discharge. A minimum of two and a maximum
      of six assessments were carried out, from the inclusion of the patient in the study (taken as
      zero hour) to 60 hours postpartum. Irradiation, in turn, was performed every 24 hours during
      the same period, including one to three irradiations per patient in each of the breasts.
    

Intervention name(s): low-level laser on nipples
Intervention type(s): Radiation
Intervention description(s): The LASER HAND WL device, manufactured by MM Optics.
Other intervention name(s): LASER HAND WL InGaAIP semicondutor; registered by ANVISA/MS No. 80051420009; wavelength 660 nn; Optical power 40mW; visible red spectrum range; with emission of continuous light (CW)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nipple/injure; breastfeeding; pain; laser
Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo
Condition: Third Molar Extraction
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of this study is to demonstrate the superiority of local analgesia with
      ropivacaine versus placebo on postoperative pain during the first 24 hours following
      bilateral surgery of all four third molars under general anesthesia.
    

Detailed description: 
      The secondary objectives of this study are to compare regional anesthesia by ropivacaine
      versus placebo for the bilateral resection of all four third molars under general anesthesia,
      in terms of:

      A. intraoperative use of propofol and remifentanil B. postoperative pain (EVN) at different
      time points C. in-hospital analgesic consumption D. time to first rescue analgesic request E.
      time spent in the post interventional treatment room F. length of hospital stay G. side
      effects H. analgesic consumption at home I. analgesic consumption (total) J. patient
      satisfaction K. Chronic pain after surgery
    

Intervention name(s): Placebo injection; Ropivacaine injection
Intervention type(s): Drug; Drug
Intervention description(s): Injection of saline solution into the vestibular capsule of each tooth to be extracted.; Ropivacaine is injected into the vestibular capsule of each tooth to be extracted.
Other intervention name(s): Standard intervention; Saline solution; Experimental intervention.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Third molar extraction; local anesthesia; ropivacaine