bioihbjkbjnl/mcl2 huggingface dataset:
Pulmonary Embolism in Pregnancy: Biomarkers and Clinical Predictive Models
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Observational

Summary: 
      Objective: To evaluate whether trimester specific d-dimer levels and brain natriuretic
      protein (BNP), along with the modified Wells score (MWS), is a useful risk stratification
      tool to exclude pregnant women at low-risk of pulmonary embolism (PE) from diagnostic imaging
      with radiation exposure.
    

Detailed description: 
      To account for all women meeting the study eligibility criteria, this study utilized a
      combined prospective and retrospective arm. Pregnant women who underwent diagnostic imaging
      to evaluate for suspected PE at our institution were prospectively enrolled from February
      2014 to August 2015. Both d-dimer and BNP serum levels were drawn, and a MWS was assigned.
      All pregnant women diagnosed with a PE that underwent diagnostic imaging and had a d-dimer
      level drawn from January 2009 to June 2014 were retrospectively enrolled. Patient electronic
      records were used to apply the MWS and analyze their risk.
    

Intervention name(s): blood draw
Intervention type(s): Procedure
Intervention description(s): blood draw
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pregnant women who presented to the Emergency Department or Labor and Delivery unit with
        signs and symptoms suspicious for PE
      
Keywords: Pulmonary Embolism; Pregnancy; D-Dimer
Impact of Genetic Polymorphism on Drug-Drug Interactions Involving CYP2D6
Condition: Healthy
Study type: Interventional

Summary: 
      CYP2D6 is characterized by a huge variability in the general population, mainly because of
      genetic polymorphism and drug-drug interactions (DDIs). CYP2D6 genotype is known to have an
      impact on the extent of DDIs. Indeed several studies have pointed out differential DDIs
      extent according to CYP2D6 genotype. The terms phenoconversion and phenotype switch are both
      used to describe the phenomenon by which a given subject changes his phenotype to another due
      external influence such as DDIs. When given a sufficiently strong CYP2D6 inhibitor, the
      phenotype of an individual with no mutant allele (extensive metabolizer, EM) of CYP2D6 can be
      modified to a poor metabolizer (PM) phenotype. This vulnerability is also thought to be
      dependent on CYP2D6 genotype. Various combinations of alleles predict an EM genotype, which
      represents about 60 to 70% of the general population. The aim of the study is to determine
      whether the presence of genetic mutation in CYP2D6 has an impact on DDIs involving the CYP2D6
      enzyme. Our interest focuses on CYP2D6 EM carriers of two fully functional alleles and
      carriers of one non-functional and one functional allele. In order to elucidate this
      question, CYP2D6 activity will be measured on healthy volunteers by administration of single
      low doses of dextromethorphan and tramadol in presence or not of duloxetine and paroxetine,
      two known CYP2D6 inhibitors.
    


Intervention name(s): Dextromethorphan 5 MG; Tramadol 10 mg; Duloxetine 60mg; Paroxetine 20 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Tramadol; Duloxetine Hydrochloride; Dextromethorphan; Paroxetine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Determination of Circulating Placental Biomarkers Levels to Predict the Pregnancy Outcome of First Trimester After IVF.
Condition: Infertility, Female; First Trimester Spontaneous Abortion
MeSH terms: Infertility; Infertility, Female; Abortion, Spontaneous
Study type: Observational

Summary: 
      This study will assess the predictive potential of circulating placental biomarkers for
      spontaneous miscarriage within the following month in an IVF setting. It is hypothesized that
      a robust algorithm including one or more of these biomarkers may allow for the accurate
      same-day distinction between women with a low and high risk of a spontaneous miscarriage.
    

Detailed description: 
      Spontaneous miscarriage is the most common adverse outcome in the first trimester of
      pregnancy. This is a particularly stressful situation for the expecting parents, since their
      need for a final diagnosis is frustrated for a potentially extended period on time which may
      span over several weeks. The emotional impact of this complication can be devastating,
      resulting frequently in depression and anxiety which may last for several months.

      In an attempt to allow for an earlier and more accurate diagnosis of first trimester
      miscarriage, multiple circulating placental biomarkers have been tested over last years.
      However, their potential usefulness in an everyday clinical setting remains unclear.

      The investigators propose a single-center observational prospective cohort study in an in
      vitro fertilization (IVF) setting. All recruited consenting patients will collect blood
      samples on a day of the first pregnancy test (12-14 days after embryo transfer) and at the
      time of the first (at 5 weeks plus 4-5 days of gestational age) and second (at 7 weeks plus
      4-5 days of gestational age) ultrasound scan to determine the circulating placental
      biomarkers concentrations in order to predict the pregnancy outcome (spontaneous miscarriage
      versus evolutive pregnancy) until the first obstetrical ultrasound, performed between 11
      weeks and 13 weeks plus 6 days of gestational age.
    

Intervention name(s): Blood samples collection
Intervention type(s): Other
Intervention description(s): Collection of blood samples from consenting subjects to evaluate circulating biomarkers concentrations.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        120 pregnant subjects, confirmed by blood βhCG test, following vitrified-warmed single
        blastocyst cycles performing IVF/Intracytoplasmic Sperm Injection (ICSI) with autologous
        oocytes without preimplantation genetic testing for aneuploidies (PGT-A).
      
Biospecimen description: 
      Blood samples will be collected to determine the circulating placental biomarkers
      concentrations.
    
Keywords: Placental biomarkers; In vitro fertilization (IVF); Pregnancy outcome; Miscarriage; Early prediction; Intracytoplasmatic sperm injection (ICSI)
A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient,
      early-intervention evaluation of subjects who have migraine with or without aura and who
      discontinued use of short acting triptan(s) within the past year due to non-response or
      intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each
      attack; one attack will be treated with one tablet of the Combination Product (sumatriptan
      succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover
      design). [Study 2 of 2]
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient,
      early-intervention evaluation of subjects who have migraine with or without aura and who
      discontinued use of short acting triptan(s) within the past year due to non-response or
      intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each
      attack; one attack will be treated with one tablet of the Combination Product (sumatriptan
      succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover
      design); however, the order of these treatments will be randomized. A minimum 1-week washout
      period is required between study medication treatment of the first and second migraine
      attacks.

      Each subject will have two visits: (1) a Screening visit at study entry and (2) a Final visit
      4-10 days after the second (or last) attack. A telephone contact will also be required 1-3
      days after the first attack, and then once per month until the Final visit.

      The primary study objective is to assess efficacy as measured by sustained pain-free (SPF)
      relief of Combination Product compared to placebo in treating migraine subjects who have
      previously discontinued treatment with short acting triptans (rizatriptan, sumatriptan,
      almotriptan, zolmitriptan, and eletriptan).
    

Intervention name(s): Placebo; Combination Product (sumatriptan succinate/naproxen sodium)
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo tablet; Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in second layer.
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: migraine with or without aura; naproxen sodium; combination product; sumatriptan succinate; poor response; short acting triptan; migraine, acute
Insulin Sensitivity and Secretion During Pregnancy and Post Partum in Women With Gestational Diabetes.
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational
Study type: Observational

Summary: 
      Aim of the study:

      To define insulin requirement during pregnancy and to identify the rapid changes in insulin
      sensitivity around parturition and the first 6 months post partum. Such knowledge would be
      clinically useful and markedly improve insulin treatment before and after parturition for
      women with type 1 diabetes and serve to identify the best possible timing of testing women
      with gestational diabetes mellitus (GDM) for the development of type 2 diabetes post partum.

      Method:

      Botnia clamp in women before, immediately after delivery and 6 months post partum. The
      investigators will compare 20 women with GDM in late pregnancy, day 15 post partum and 6
      months post partum with 20 normal women investigated at the same time points. In addition the
      investigators will collect feces samples from the mother and baby in order to determine
      microbiota.

      Perspectives:

      Diabetes is a common condition with important implications for pregnancy outcome and
      long-term morbidity for mother and offspring. Accordingly, tailoring the best treatment is
      expected to have beneficial consequences both for the pregnant women and the future
      generation.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All women visiting the outpatient gestational diabetes clinic at Aarhus University Hospital
        will be approached.
      
Biospecimen description: 
      Whole blood approximately 10 mL.
    
Keywords: Insulin sensitivity
Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants
Condition: Necrotizing Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Study type: Interventional

Summary: 
      The primary purpose of this study is to compare two surgical treatments for perforated
      necrotizing enterocolitis in very low birth weight babies.
    

Detailed description: 
      This is a multi-center randomized clinical trial comparing laparotomy vs peritoneal drainage
      for perforated Necrotizing Enterocolitis. The current literature does not allow an objective
      comparison between these two methods. A recent comprehensive meta-analysis of all published
      and much unpublished data regarding the use of these procedures in the treatment of
      perforated NEC revealed that the degree of bias in assignment to treatment precluded an
      adequate determination as to the best treatment. The conclusion that only a randomized
      clinical trial would answer this question has led to this multi-center effort. The relative
      infrequency of the disease at any one neonatal center has necessitated enrollment of patients
      at many centers.

      Comparison: Premature neonates weighing less than 1500 grams at birth who develop perforated
      necrotizing enterocolitis are randomized within two birth weight blocks (<1000 gms and 1000 -
      1499 gms) for treatment with either laparotomy or primary peritoneal drainage. Daily
      postoperative clinical care is kept uniform between the two groups by means of a critical
      care pathway. The primary outcome variable is mortality, i.e. death within 90 days of
      intervention. The main secondary outcome is short bowel syndrome - defined as the need for
      chronic parenteral nutrition greater than 3 months following operation.
    

Intervention name(s): laparotomy; primary peritoneal drainage
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: randomized; controlled; trial; necrotizing; enterocolitis; premature; infants; laparotomy; peritoneal; drainage
Comparing Effectiveness of Merocel and Packing With Tranexamic Acid in the Management of Anterior Epistaxis
Condition: Tranexamic Acid; Epistaxis; Nasal Packing
MeSH terms: Epistaxis
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of this study is evaluate whether superior nasal compression with tranexamic acid to
      simple nasal compression and Merocel packing.

      In this study, patients who presented with non-traumatic anterior epistaxis to emergency
      departments will be included in this study. Three different therapy option are created;
      first, nasal compression with tranexamic acid, second, simple nasal compression without any
      drugs. And third, packing with Merocel.
    


Intervention name(s): Tranexamic Acid; Normal saline; Merocel
Intervention type(s): Drug; Drug; Device
Intervention description(s): 500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.; 5 cc normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.; Merocel packing is applied.
Intervention MeSH terms: Tranexamic Acid; Polyvinyl alcohol formaldehyde foam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
MRI to Detect Breast Tumors in Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: New imaging procedures, such as MRI, may improve the ability to detect breast
      tumors.

      PURPOSE: Diagnostic study to determine the value of MRI in detecting breast tumors in women
      who have had suspicious mammographic or clinical examinations.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the performance of breast magnetic resonance imaging (MRI) in
      conjunction with mammography for the detection and characterization of lesions in women with
      suspicious mammographic or clinical examinations. II. Assess the incremental value of breast
      MRI to determine the local extent of cancer in these patients. III. Assess the value of
      breast MRI to determine the prevalence and characteristics of incidental enhancing lesions in
      the remainder of the breast.

      OUTLINE: This is a multicenter study. Patients undergo a high resolution 3D post contrast
      magnetic resonance imaging (MRI) scan. Patients with enhancing abnormalities undergo a
      dynamic scan no less than 18 hours later. Some patients may require a third scan if a core
      biopsy is to be performed. Patients who are ultimately found to have cancer are assessed for
      extent of cancer including measurement of the index lesion and identification of other
      present foci of cancer in relation to the index lesion. Further histological diagnosis of
      index lesions is determined by MRI-guided needle localization excisional biopsy. Patients
      with benign needle biopsy are followed for 2 years. Patients with benign primary lesions
      receive a follow up MRI scan 1 year after the initial scan. Patients with benign primary
      lesions and incidental enhancing lesions (IEL) are followed at 2 years. Patients with
      negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent
      excisional biopsy are followed yearly for 2 years.

      PROJECTED ACCRUAL: A total of 1500 patients will be accrued for this study over 4.25 years.
    

Intervention name(s): biopsy; magnetic resonance imaging; mammography
Intervention type(s): Procedure; Diagnostic Test; Diagnostic Test
Primary purpose: Diagnostic
Keywords: breast cancer
Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge
Condition: Diabetes Mellitus; Upper Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections; Diabetes Mellitus
Study type: Observational

Summary: 
      Effect of upper respiratory infection (URI) on diabetic subjects with a meal challenge
    


Intervention name(s): Technosphere Insulin
Intervention type(s): Drug
Intervention description(s): Technosphere® Insulin (TI) Inhalation Powder, prandial
Intervention MeSH terms: Insulin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who developed symptoms of URI at any point during the MKC-TI-030 trial and were
        randomized to study treatment of TI
Bioequivalence of Two Different Polymorphs of Dabigatran Etexilate in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence of two polymorphs of dabigatran etexilate, polymorph I and
      polymorph II
    


Intervention name(s): Dabigatran etexilate polymorph II; Dabigatran etexilate polymorph I
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Rationale: For the development of a closed loop system, faster insulin absorption after bolus
      administration could help to reduce the system's delay and thus increase patient safety. It
      has been shown that regular insulin absorption is faster when injecting insulin with a
      sprinkler needle (containing holes in the walls and being sealed at the tip). The current
      study will evaluate the impact of different application volumes on pharmacokinetic and
      pharmacodynamic properties of rapid acting insulin analogue (insulin aspart).

      Objective: To compare the pharmacokinetic response (based on the time to maximum observed
      serum insulin concentration) and pharmacodynamic properties of rapid acting insulin aspart
      after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in
      patients with type 1 diabetes.

      Study design: Monocentric, randomised, controlled, two-arm cross-over intervention study.

      Population: Twelve type 1 diabetic subjects

      Intervention: The investigational treatment is the subcutaneous administration of insulin
      aspart either as one bolus of 18 IU at one injection site or as 9 separately and
      simultaneously applied bolus of 2 IU each at 9 separate injection sites. Serum and plasma
      samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an
      8-hour clamp experiment. Patients will undergo both investigational treatments in a
      randomized order; between the two clamp visits there will be a wash-out period of 5-21 days.

      Main study endpoint: Time to maximum observed serum insulin aspart concentration.
    


Intervention name(s): Insulin aspart; Insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Application of 18 IU insulin aspart as one bolus at one injection site; Application of 18 IU insulin aspart as 9 bolus of 2 IU each at nine injection sites
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insulin aspart; Type 1 diabetes; Glucose clamp; Pharmacodynamics; Pharmacokinetics; Rapid Acting Insulin Analog
Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study
Condition: Wheat Allergy
MeSH terms: Hypersensitivity; Wheat Hypersensitivity
Study type: Interventional

Summary: 
      Nowadays, commercial wheat extract is widely accessible, and is used for skin prick test for
      wheat allergy. However, commercial wheat extracted for skin prick test have less precise test
      result compared to extract from omega-5 gliadin, which is one of the major allergen with
      immediate wheat allergy.
    


Intervention name(s): Commercial extract and in-house wheat extract
Intervention type(s): Other
Intervention description(s): Patients with a history of wheat allergy underwent two skin test extracts, and open challenge with wheat. A blood test for specific IgE was performed in the same time.
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: skin test; open wheat challenge