bioihbjkbjnl/mcl2 huggingface dataset:
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this first human dose trial is to investigate
      the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body)
      and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287
      (insulin 287) in a GIPET® I tablet formulation in healthy subjects.
    


Intervention name(s): insulin 287; insulin glargine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.; Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.; Oral placebo adminstered corresponding to insulin 287 treatment
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-naïve Adult Male Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy
      of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male participants
      diagnosed with Fabry disease.
    

Detailed description: 
      The total duration of study per participant was 7 to 8 months for participants who entered a
      planned extension study and approximately 13 to 14 months for participants who did not enter
      a planned extension study. A 2-year extension study was planned for eligible participants.
    

Intervention name(s): GZ/SAR402671
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Capsule; Route of administration: Oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Venglustat
The Effect of Different Masks Used by Pregnant Women on Vital Signs and Non Stress Test During The COVID-19
Condition: Covid-19; Pregnant; Fetus; Mask
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This study was conducted to examine the effects of different masks used by pregnant women on
      vital signs and non stress test (NST) during the COVID-19. This study was conducted as a
      single-blind randomized controlled trial. Healthy pregnant women aged 19 years and older, who
      were followed up on an outpatient basis, and who were in the 37-40th week of pregnancy, were
      included in the study. The study consisted of a single surgical mask group (n=30), double
      surgical mask group (n=30), and N95 mask group (n=31). Masks were given to the resting
      pregnant women 30 minutes before the NST, and they were provided to wear masks. After 30
      minutes, the vital signs of the pregnant women were measured just before and after the NST,
      and the images of the NST traces were taken.
    


Intervention name(s): Single surgical mask group, Double surgical mask group, N95 mask group
Intervention type(s): Behavioral
Intervention description(s): Masks were given to the resting pregnant women 30 minutes before the NST, and they were provided to wear masks. After 30 minutes, the vital signs of the pregnant women were measured just before and after the NST, and the images of the NST traces were taken.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single surgical mask group (n=30) Double surgical mask group (n=30) N95 mask group (n=31)
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Management and Thermal Comfort of Premature Infants Under 32 Weeks
Condition: Thermoregulation
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Sleep propensity was assessed in terms of the duration of a spontaneous episode of
      wakefulness (W). Skin temperatures at six body sites (the abdomen, pectoral region, eye,
      hand, thigh and foot) were measured (using infrared thermography) during nocturnal
      polysomnography in 29 9-day-old preterm neonates (postmenstrual age: 209 9 days). Te
      investigators then determined whether the duration of the W episode depended upon the local
      skin temperatures measured at the start, during and end of the episode.
    

Detailed description: 
      Although sleep is of paramount importance for preterm neonates, care of the latter in a
      neonatal intensive care unit does not favour sleep. Given that several studies in adults have
      described a 'vegetative preparedness to sleep' (in which distal skin vasodilation before
      lights-out promotes rapid sleep onset), the investigators looked at whether or not this
      process operates in preterm neonates. Sleep propensity was assessed in terms of the duration
      of a spontaneous episode of wakefulness (W). Skin temperatures at six body sites (the
      abdomen, pectoral region, eye, hand, thigh and foot) were measured (using infrared
      thermography) during nocturnal polysomnography in 29 9-day-old preterm neonates
      (postmenstrual age: 209 9 days).
    

Intervention name(s): mesure of skin temperature
Intervention type(s): Other
Intervention description(s): The infants are placed in a closed incubator to study the variability of the heart and respiratory frequencies according to the regulation of the incubator and to quantify the time spent outside. Data will be collected during the first 10 days of life of the preterm infant. Skin temperatures at six body sites (the abdomen, pectoral region, eye, hand, thigh and foot) were measured (using infrared thermography) during nocturnal polysomnography in 29 9-day-old preterm neonates (postmenstrual age:
209 9 days). The investigators then determined whether the duration of the W episode depended upon the local skin temperatures measured at the start, during and end of the episode.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Premature infants less than 32 weeks of amenorrhea admitted to birth in the Neonatal
        Medicine Unit will be included after obtaining written parental consent. Data will be
        collected during the first 10 days of life of the preterm infant.
      
Keywords: infant; thermoregulation; wakefulness episode
Cardiometabolic Effects of Sweet Cherry Juice
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      This study aims to determine the effects of consuming sweet cherry juice on cardiovascular
      function, glucose regulation, and lipid status in overweight human subjects. The
      investigators hypothesize that sweet cherry juice consumption will improve metabolic and
      physiological status in overweight persons compared to a placebo.
    

Detailed description: 
      The investigators will conduct a randomized, cross-over study lasting 14 weeks and including
      1 week for screening/enrollment, 1 week baseline assessment, and two intervention periods of
      6 weeks each for the cherry juice and placebo interventions. Two test visits, 3 to 7 days
      apart, will occur before the start of intervention (baseline, or week 0) and then at weeks 6
      and 12. Participants will be randomized to consume either the cherry juice or placebo
      beverage first, and will cross over to the alternate intervention immediately following the
      end of the first 6 weeks. Test Visit 1 will include measures of blood pressure, vascular
      tone, liver fat and stiffness, post-prandial metabolic response to the study beverage,
      cardiovascular activity and function, and nervous system control of cardiovascular activity
      and tone. Acute effects of study beverages will be measured, as will the chronic effects of
      study beverage consumption after 6 weeks. At Test Visit 2, participants will take a standard
      75 gram oral glucose tolerance test (OGTT). Participants will be equipped with physiological
      monitoring devices, which will monitor cardiovascular activity and function and nervous
      system control of cardiovascular activity and tone, and continuously measure blood pressure.
      A series of cognitive function tasks will be administered, and a mental stress test will be
      conducted. The Test Visit 1 and 2 will be repeated at week 6 and week 12 following each
      intervention with cherry juice or the placebo beverage.
    

Intervention name(s): Cherry juice; Placebo beverage
Intervention type(s): Other; Other
Intervention description(s): FruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit.; Cherry flavored placebo beverage prepared from commercially available cherry syrup with food coloring and thickener to match the color and viscosity of the cherry concentrate.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: cherries; inflammatory disease; chronic stress
Endometrial Priming for Embryo Transfer
Condition: Sterility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this trial is compare two different endometrial priming protocols

        -  women that receive oral estrogens

        -  women that receive transdermal estrogens
    


Intervention name(s): Oral strogen; Transdermal strogen
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg of estradiol every day beginning the second day of the cycle until day 7. 4 mg of estradiol every day beginning 8th day of the cycle until day 10. 6 mg of estradiol every day beginning 11th day of the cycle until day 16.; One patch of 75 mcg of estradiol hemimydrate every 48 h from 2 to day 6. Two patches of 75 mcg of estradiol hemimydrate every 48 h from 6 to day 12. Three patches of 75 mcg of estradiol hemimydrate every 48 h from 12 to day 16.
Intervention MeSH terms: Saw palmetto extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral estrogens; transdermal estrogens; endometrial priming
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending
      doses of BCX7353 in healthy subjects, and single and multiple doses of BCX7353 in healthy
      Japanese subjects. Pharmacokinetics is an analysis of how the body handles the study drug
      BCX7353 and pharmacodynamics is an analysis of the activity the study drug BCX7353 may have
      in the body.
    

Detailed description: 
      Up to 6 ascending, single dose cohorts are planned to be dosed in a sequential manner in Part
      1 of the study. Eight subjects will be treated with a single dose of study drug per dose
      cohort (6 subjects per cohort will receive BCX7353 and 2 subjects per cohort will receive
      matching placebo). Escalation to the next higher dose level will occur only after completion
      of a review of clinical safety and pharmacokinetics by the Sponsor and PI.

      Up to 4 ascending, multiple dose cohorts will be enrolled in a sequential manner in Part 2 of
      the study. Twelve subjects will be treated with study drug per dose cohort (10 subjects will
      receive BCX7353 and 2 subjects will receive placebo per cohort). The planned doses, dosing
      regimens, and duration of dosing (7 or 14 days) for each of the Part 2 cohorts will be
      determined based upon safety and pharmacokinetic data collected during the study. Escalation
      to the next higher dose level in Part 2 will occur only after completion of a review of
      clinical safety and pharmacokinetics by the Sponsor and clinical site study physician.

      In Part 3 of the study, the safety, tolerability, PK, and PD of single and multiple doses of
      oral BCX7353 versus placebo in healthy subjects of Japanese origin will be evaluated. In the
      single dose cohort, 16 Japanese subjects will be randomized into a single cohort to receive
      either placebo or 1 of 2 active doses of BCX7353. In the multiple dose cohort, twelve
      subjects will be treated with study drug (10 subjects will receive BCX7353 and 2 subjects
      will receive placebo per cohort). The planned doses (single and multiple dose cohort), and
      dosing regimen and duration of dosing (7 or 14 days; multple dose cohort) for Part 3 will be
      determined based upon safety and pharmacokinetic data collected during Parts 1 and 2 of the
      study.
    

Intervention name(s): BCX7353; Placebo to match BCX7353
Intervention type(s): Drug; Drug
Intervention MeSH terms: Berotralstat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: kallikrein inhibitor; oral prophylaxis; BioCryst; first-in-human; hereditary angioedema
IAI for Persistent DME After Treatment With Bevacizumab And Ranibizumab
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial.
      Study eyes will receive 5 required initial monthly Intravitreal Aflibercept (IAI) doses of 2
      mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be
      enrolled.
    

Detailed description: 
      This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial.
      Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for
      a total of 52 weeks; only one study eye from each patient will be enrolled.

      Starting at week 24, patients may be eligible to receive additional 2mg IAI (2q4) treatment
      if both of the following criteria is met and the investigator feels additional treatment
      would be beneficial:

        -  Loss of >5 letters from baseline or best previously recorded best corrected visual
           acuity (BCVA)

        -  Presence of new or recurrent intraretinal fluid or subretinal fluid as assessed by SD
           OCT

      Starting at week 24, rescue therapy with macular laser photocoagulation may be administered
      if any the following criteria are met

        -  Loss of > 15 letters from baseline or best previously recorded BCVA and loss of acuity
           felt to be secondary to Diabetic Macular Edema (DME) and not from other cause (i.e.,
           cataract, epiretinal membrane, vitreous hemorrhage, etc) and investigator feels patient
           would benefit from rescue therapy

        -  Increase in SD OCT CSF > 100 um from baseline or best previously recorded SD OCT CSF and
           investigator feels patient would benefit from rescue therapy.

      Every 4 week visit will include ETDRS BCVA, IOP measurement, Slit lamp biomicroscopy,
      Indirect ophthalmoscopy, Heidelberg Spectralis SD-OCT and evaluation for systemic and ocular
      adverse events. Fundus Photography and Wide field Optos fluorescein angiography will be
      performed at baseline and at week 20and week 52.

      STUDY DURATION: Approximately 52 weeks to the end of the study. Primary endpoint will be
      evaluated at week 52.
    

Intervention name(s): Alflibercept
Intervention type(s): Drug
Intervention description(s): Intravitreal Injection
Other intervention name(s): Eylea
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Ultrasound-guided Bilateral ESP Block and Wound Infiltration for Spinal Surgical Analgesia
Condition: Pain, Postoperative; Spinal Disease; Anesthesia, Local; Anesthesia, Regional
MeSH terms: Spinal Diseases; Pain, Postoperative
Study type: Observational

Summary: 
      The aim of our study is to determine the superior procedure in analgesia management by
      comparing the traditional wound infiltration technique with the ultrasound-guided bilateral
      erector spina plan block technique in spinal surgery patients.
    

Detailed description: 
      Patients in ASA I-II-III risk group aged 18-80 who will undergo spinal surgery by Trakya
      University Faculty of Medicine, Brain and Nerve Surgery will be included. In this study,
      patient data will be collected in the form of file scanning. Intra-operative; hemodynamic
      data of patients; heart rate, blood pressure values, anesthetic and other drugs applied,
      surgery and anesthesia durations will be written from the anesthesia document after the
      operation is over. In the study, the application preferred by the anesthesiologist for the
      patient will not be intervened. The patients will be divided into three groups; wound
      infiltration technique was applied, ultrasound-guided bilateral erector spina plan block
      technique was applied and both techniques were applied together. After the operation; pain
      values will be calculated by VAS at the 1st, 2nd, 4th, 6th, 12th and 24th hours of the
      patients. The patient's length of stay, satisfaction (excellent, good, moderate, poor) and
      methods used for analgesia will be recorded. With the results collected in our study, it will
      be determined which procedure is superior in pain management for spine surgery.
    

Intervention name(s): Visual Analog Score; patient satisfaction
Intervention type(s): Other; Other
Intervention description(s): The VAS is a widely used tool in research and clinical practice, and its reliability and validity in pain assessment has been clearly demonstrated. It consists of a 100 mm line. 0 cm no pain, 10 cm is associated with 'worst possible pain'. The patient is asked to mark the line to 'score' the pain. VAS values of 1cm - 3cm weak, 4cm - 6cm moderate, and >7cm are the indicators of "severe pain".; The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.
Other intervention name(s): VAS
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in ASA I-II-III risk group aged 18-80 who will undergo spinal surgery by Trakya
        University Faculty of Medicine, Brain and Nerve Surgery will be included. 75 patients
        meeting these conditions will be included in the study.
      
Keywords: ultrasound-guided bilateral erector spina plane block; wound infiltration analgesia; spinal surgery
Accuracy of Owlet Smart Sock Sensor 3rd Generation With Profound Hypoxia
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen
      desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia
      has been attained. The blood sample is analyzed for oxygen saturation with a gold standard
      bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents
      for pulse oximeter testing.
    


Intervention name(s): Owlet Smart Sock Sensor 3rd Generation
Intervention type(s): Diagnostic Test
Intervention description(s): Pulse Oximetry
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in this study should be healthy, between 18 and 50 years of age and willing to
        participate in breathing studies with or without blood samples in San Francisco.
      
Keywords: Verification of SpO2 accuracy; Induced hypoxia; Owlet Smart Sock; Pulse oximeter
Application of Cervical Elastography in Obstetrics
Condition: Cervical Elastography
Study type: Observational

Summary: 
      The purpose of this study is to develop cervical elastography nomograms using Samsung's novel
      technology "E-cervix" and determine its ability to predict preterm birth.

      During each sonogram in which cervical lengths are measured, 5 additional cervical indices
      will be collected using Samsung's E-cervix technology. Each index will then be separated
      based on characteristics to create a nomogram for singletons, twins, and those with
      interventions already in place (i.e. cerclage and/or progesterone) at the time of their
      E-cervix assessment.
    


Intervention name(s): Samsung's E-cervix technology
Intervention type(s): Device
Intervention description(s): While patients are having their routine cervical ultrasound assessments which requires a 5 minute time period, we will use the built-in software to obtain additional E-cervix measurements to evaluate the consistency of the cervical os. This will be done within the standard 5 minute period which is typically done to observe for dynamic changes. The measurements will be obtained with the same sonogram machine, using updated software.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who present for early screening or level II ultrasound, aged 18 to 50 years
Multiple Ascending Oral Dose Phase I Study With Px-102
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102
      in healthy subjects after 7 days multiple oral dosing.
    

Detailed description: 
      The study is a single-centre, double-blind, randomized, placebo-controlled, parallel group
      phase I study with healthy male subjects receiving ascending multiple oral oral doses of
      Px-102 to assess the safety and tolerability, pharmacokinetics and pharmacodynamics.
    

Intervention name(s): Px-102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Px-102 drinking solution, 0.5 mg/kg, 1.0 mg/kg and 1.5 mg/kg; Drinking solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment