bioihbjkbjnl/mcl2 huggingface dataset:
Prematurity Prevalence Among T1D Patients and Its Characteristics Compared With Premature-born Non-diabetic Patients
Condition: Type 1 Diabetes Mellitus
MeSH terms: Premature Birth; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The aims of this study are:

        1. To assess the prevalence of prematurity, especially early prematurity, among T1D
           patients, and compare it to the prematurity prevalence among the non-diabetic general
           population in Israel.

        2. To characterize epidemiological and clinical factors that differ between premature-born
           patients that developed T1D and those that have not, including the nutritional and
           therapeutic properties in NICU.
    

Detailed description: 
      A national cohort study, including linkage of data from 13 pediatric diabetes centers and
      Israeli National Registries, including all patients with T1D born during 1990-2013. Data
      collected includes: ethnicity, gestational age, birth season, age and season at T1DM
      diagnosis, and presence of autoimmunity in family. The prevalence of prematurity among T1D is
      compared to the non-diabetic general population registry of 2000-2013. Additional comparisons
      are between T1D patients born term and preterm, aimed to unveil specific influencing clinical
      and epidemiological factors.

      In the latter part of the study, a multi-centered, paired case-control study is performed.

      Preterm born T1D patients will be paired to matched non-diabetic children at a ratio of 3:1,
      according to medical center, sex, gestational week of birth, season and year of birth. Data
      collected includes: ethnicity, family history of autoimmune diseases, age and type of first
      enteral nutrition, and pharmacological exposures.
    

Intervention name(s): chart review
Intervention type(s): Other
Intervention description(s): data from charts and from registries will be compared
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All T1D patients in Israel, born during 1990-2013 and diagnosed prior to January 2015, time
        of data collection. Inclusion criteria included all patients diagnosed as T1D by a
        pediatric endocrinologist according to the American Diabetes Association criteria, and
        treated for their T1D with insulin. Patients are identified from registries of the 13
        participating centers.
      
Keywords: premature birth; risk factor; type 1 diabetes mellitus; seasonality; prevalence; enteral feeding; immunomodulating medications; early onset
Design and Application of Nasal Stents
Condition: Nasal Septum; Deviation, Congenital
Study type: Interventional

Summary: 
      Comparative study of nasal stents and nasal packing in patients undergoing septoplasty
    

Detailed description: 
      To investigate the safety and effectiveness of nasal stent in clinical application by
      comparing and observing the clinical effect and comfort of nasal stent and merocel sponge
      applied in nasal septoplasty. Methods: patients with nasal septal deviation were selected and
      randomly divided into nasal stent group (experimental group) and merocel sponge group
      (control group) according to the packing method. The hemostasis effect, comfort and
      complications of the two groups were compared during the packing period.
    

Intervention name(s): nasal stents; merocel
Intervention type(s): Device; Device
Intervention description(s): using nasal stents after septoplasty; using merocel after septoplasty
Intervention MeSH terms: Polyvinyl alcohol formaldehyde foam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test
      product to the reference product, using bronchoprovocation (methacholine challenge testing)
      in adult patients with stable mild asthma.
    

Detailed description: 
      This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the
      reference product in terms of FEV1 measured at different time-points, using
      bronchoprovocation (methacholine challenge testing) in adult patients with stable mild
      asthma.
    

Intervention name(s): 90 mcg Reference Product; 180 mcg Reference Product; 90 mcg Test Product; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Drug: 90 mcg Reference Product; Drug: 180 mcg of Reference Product; Drug: 90 mcg of Test Product; Placebo Product
Other intervention name(s): Albuterol; Albuetrol; Albuterol
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to characterize the safety and immunogenicity of pandemic influenza
      (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.
    


Intervention name(s): GSK Biologicals' GSK2340274A (two different formulations); GSK Biologicals' - GSK2340272A
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: H1N1; Influenza; Pandemic; GSK Bio's influenza vaccines GSK2340274A and GSK234072A
Prospective Clinical Study of Retinal Microvascular Alteration After ICL Implantation
Condition: Adolescent; Adult; Human; Male; Female; Follow-up Studies; Prospective Studies; Lens Implantation, Intraocular; Myopia; Phakic Intraocular Lenses; Retinal Vessels; Postoperative Period; Preoperative Period; Tomography, Optical Coherence
MeSH terms: Myopia
Study type: Observational

Summary: 
      To observe the retinal microvascular alteration during 3 months follow-up after Implantable
      Collamer Lens (ICL) operation in moderate and high myopia patients using quantitative optical
      coherence tomography angiography (OCTA) analysis.
    

Detailed description: 
      The study object is moderate and high myopia patients, underwent ICL implantation. OCTA was
      used to image the superficial and deep retinal vascular plexuses before ICL implantation
      surgery and at 3 months follow-up. OCTA images were corrected for magnification,
      skeletonized, separated the large vessels and partitioned. Retinal microvascular density was
      measured by using fractal dimension analysis. The aim of this study was to uncover potential
      retinal vascular network alterations induced by ICL implantation surgery.
    

Intervention name(s): Optical Coherence Tomography Angiography
Intervention type(s): Device
Intervention description(s): AngioVue (Optovue, Fremont, CA, USA) was used to capture the OCTA images before ICL surgery and at 3 months follow-up.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Moderate and high myopia patients, underwent ICL implantation surgery at the Department of
        Ophthalmology, Peking University Third Hospital
Assessment of Novel Respiratory Protective Devices in Healthcare
Condition: Comfort; Tolerability
Study type: Interventional

Summary: 
      This VA-based study will obtain feedback from healthcare workers via validated survey
      instrument on the comfort and tolerability of wearing current models of N95 respirators and
      novel respirator designs currently in development. There will be 4 novel respirators and 1
      commonly used respirator (not locally used) to compare to a locally used respirator, which is
      familiar to participants. Comparisons will be examined between each of the first 5 models
      with the locally used control using Dunnett's t-test.
    

Detailed description: 
      This study aims to compare novel designs to products currently in the marketplace by
      comparing scores on a survey tool which measures comfort and tolerability of respiratory
      protective devices. Study participants will be clinical healthcare workers who have
      experience wearing respiratory protective devices in their workplace. We will enroll up to
      400 participants in the study, made up of physicians, nurses, nursing assistants and other
      healthcare employees who have previously been fit-tested to a N95 respirator. Subjects will
      be screened to determine eligibility and must pass fit-testing on the respirator he/she is
      randomized to. Participants will wear the respirator while performing a series of motions
      that simulate movements made by healthcare workers when performing patient care tasks. There
      will be no contact with patients during participation. Feedback via validated survey tool
      will be collected from all study participants on the comfort and tolerability of the
      respirator worn.
    

Intervention name(s): Study Procedures
Intervention type(s): Other
Intervention description(s): Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.
Condition: Non Variceal Bleed
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
Study type: Interventional

Summary: 
      All patients with non variceal bleed who are admitted under the Department of Hepatology at
      Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide
      informed consent.
    


Intervention name(s): Fresh Frozen Plasma; Platelets Concentrate; Cryo Precitipitate
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Flouro-Gem in Adenocarcinoma of the Pancreas (GEFLUPAN)
Condition: Cancer of Pancreas; Chemotherapy Effect; Metastatic Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, the investigators designed a treatment regimen including the most active
      agents in pancreatic cancer which are gemcitabine and fluorouracil to be tested as a first
      line treatment. This regimen is expected to be less toxic than FOLFIRINOX and aiming at
      better outcomes.
    

Detailed description: 
      Metastatic cancer pancreas has been a challenge for oncologists over the years. It is a
      disease of limited survival and a very poor response to treatment. The median overall
      survival at five years is expected to be between 4-6% only. Adenocarcinoma is the most common
      type of pancreatic cancer. It is the tenth most common adult solid malignancy. Most of the
      new therapeutic modalities has proven to be non-beneficial in this disease including targeted
      and immunotherapy.

      For many years, the first line of treatment for pancreatic cancer was gemcitabine either
      alone or in combinations. Recently, FOLFIRINOX has become the standard of care due to its
      overall survival benefit. However, it is a small benefit on the expense of great toxicity.

      Patients with metastatic cancer pancreas are recruited to receive the test regimen. Baseline
      evaluation will be done either by CT scan or PET/CT. re-evaluation will be repeated after 3
      months of treatment and at end of 6 months
    

Intervention name(s): Gemcitabine fluorouracil
Intervention type(s): Drug
Intervention description(s): chemotherapy protocol given as:
Gemcitabine 1000mg/m2 IV short infusion
Leucovorin 400 mg/m2 IV short infusion
Flourouracil 400 mg/m2 direct IV shot
Flourouracil 2000 mg/m2 contineous infusion over 46 hours
The whole regimen will be repeated bi-weekly
Intervention MeSH terms: Gemcitabine; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreas; cancer; adenocarcinoma; metastatic; gemcitabine; flourouracil; chemotherapy; first line
Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine (rVSVΔG-ZEBOV-GP)
Condition: Hemorrhagic Fever, Ebola
MeSH terms: Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to establish safety, tolerability and immunogenicity of rVSVΔG-ZEBOV-GP
      (BPSC1001), an Ebola Virus Vaccine candidate (recombinant vesicular stomatitis virus (VSV)
      expressing the envelope glycoprotein of Ebola Virus Zaire), investigated at three different
      dose levels in 30 healthy adults in Germany. This study is part of the WHO led VEBCON
      consortium that is aiming to generate harmonized data for the rVSVΔG-ZEBOV-GP (BPSC1001)
      vaccine candidate to allow optimized rapid decisions on dose and safety.
    

Detailed description: 
      This study is being conducted to assess safety and immunogenicity of an experimental ebola
      vaccine.

      An outbreak due to the Ebola Zaire (ZEBOV) strain of unprecedented magnitude and scope and
      with a high mortality continues to spread across West Africa. No vaccine is currently
      licensed.

      The specific opportunity at hand with rVSVΔG-ZEBOV-GP (BPSC1001) is to achieve long-lasting
      protective immunity to ZEBOV on a time scale of weeks in humans upon a single-shot
      vaccination, offering a discrete benefit over prime-boost vaccination protocols. The current
      outbreak represents a global health emergency and the need for access to therapeutic
      intervention and vaccines is paramount.

      The vaccine investigated in this study might provide a critical tool to suppress future
      out-breaks of EVD in areas at risk.

      This study is 1 of 4 clinical trials currently conducted as part of the WHO-led VEBCON
      consortium, aiming to generate harmonized data for the rVSVΔG-ZEBOV-GP (BPSC1001) vaccine
      candidate to allow optimized rapid decisions on dose and safety.
    

Intervention name(s): rVSVΔ-ZEBOV-GP
Intervention type(s): Biological
Intervention description(s): single dose of rVSVΔ-ZEBOV-GP (3x10^6 pfu, 2x10^7 pfu or 3x10^5)
Other intervention name(s): BPSC1001
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ebola virus, vaccination, phase I, healthy volunteers
The Efficacy and Safety of Using the Novel Tyto Device
Condition: Pharyngitis; Respiratory Diseases; Cardiac Diseases; Ear Infection
MeSH terms: Pharyngitis; Respiratory Tract Diseases; Respiration Disorders; Otitis; Heart Diseases
Study type: Interventional

Summary: 
      To investigate the efficacy and safety of using the novel Tyto device for remote physical
      examination by co-investigators as compared to a standard medical physical examination by
      physicians.
    

Detailed description: 
      A single center, prospective, qualitative study. Patients referred to the emergency
      department will be triaged according to The Canadian Triage & Acuity Scale (CTAS).

      Patients presenting with complaints suitable for examination with the Tyto device
      (ear/throat/respiratory/cardiac complaints) and meeting the inclusion criteria will be
      informed and asked for consent. Patients participating in the study will be referred to a
      room dedicated for the purpose.

      A minimum of a hundred volunteer patients will be selected and enrolled for a preliminary
      Pilot Study. Final study design and its extent will be determined accordingly.

      Physical examinations using the Tyto device will be performed by the co-investigators, and
      sent online to the principle investigator for remote analysis.

      The emergency department physician will examine the patient using conventional examination
      instruments (i.e. stethoscope, otoscope).

      The data collected will be recorded on predetermined case report form (CRF), timed, stored
      and analyzed by the principle and co-investigators. The findings of the co-investigators'
      examination will be compared to the conventional examination instruments used by the
      emergency department physician.

      Results will be checked and compared categorically (0-inconclusive; 1-normal; 2-pathological
      findings)
    

Intervention name(s): Tyto Device
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Role of Pentraxin 3 and Cathepsin B Levels in Preeclamptic Pregnancy
Condition: Pre-Eclampsia; Cathepsin B Level; Pentraxin 3 Level
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Observational [Patient Registry]

Summary: 
      In this study, the investigator aim was to compare Cathepsin B and Pentraxin 3 levels
      measured from maternal serum of pregnant women diagnosed with preeclampsia in the second
      trimester, the effects of these levels on maternal/ fetal outcomes and the composite results
      of Cathepsin B and Pentraxin 3 levels alone or together and contribute to the literature in
      this area.
    

Detailed description: 
      This prospective case-control study was conducted between 1 January 2022 and 31 December 2022
      at Bursa Yuksek Ihtisas Training and Research Hospital. The study was conducted with pregnant
      women between ages of 18-45 who were diagnosed with preeclampsia in the second trimester.
      This study was conducted with total 156 pregnant women. participants were grouped according
      to the presence of preeclampsia; Group1: Patients diagnosed with preeclampsia between 20-28
      weeks (study group) (n:78) , Group 2: Healthy pregnant women between 20-28 weeks without a
      diagnosis of preeclampsia ( control group) (n:78) . As soon as preeclampsia is diagnosed and
      before any treatment was started, maternal serum samples were collected in the Cathepsin B
      and Pentraxin 3 kit in amounts suitable for the study. The samples obtained were kept in
      biochemistry laboratory at -80 degrees until the study was conducted. After all samples were
      collected, Cathepsin B and Pentraxin 3 values were measured by ELISA method.
    

Intervention name(s): Cathepsin B and pentraxin 3 levels in preeclampsia with pregnant women
Intervention type(s): Other
Intervention description(s): The effect of cathepsin b and pentraxin 3 levels on maternal/fetal outcomes in pregnant women diagnosed with preeclampsia
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        singleton pregnancy white people socio-cultural differences were not considered
      
Keywords: second trimester; preeclampsia; pentraxin 3; Cathepsin B
Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      -  Evaluate the correlation of ultrasound MASEI index with clinical, functional,
           radiographic and laboratorial variables in patients with ankylosing spondylitis.

        -  Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound
           (synovitis, erosions, power doppler) with same variables.

        -  Evaluate correlation between articular and enthesis ultrasound exam in this study.

        -  Compare patients and healthy individuals data, to calculate the ROC curve to estimate
           predictor value of disease.
    


Sampling method: Non-Probability Sample
Study population: 
        Patients with ankylosing spondylitis healthy subjects
      
Biospecimen description: 
      Blood sample
    
Keywords: ultrasound; MASEI index; clinical and ultrasound correlation; enthesis ultrasound; articular ultrasound; ankylosing spondylitis ultrasound; radiographic and ultrasound correlation
Study of Efficacy and Safety of ABO809 in Healthy Participants
Condition: Cryptosporidium Infection, Cryptosporidiosis
MeSH terms: Infections; Cryptosporidiosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase I controlled human infection model (CHIM) study was to determine if
      oral administration of a good manufacturing practice (GMP) supply of Cryptosporidium parvum
      oocysts (ABO809) to healthy volunteers resulted in a Cryptosporidium infection and diarrheal
      illness. The study measured fecal oocysts (parasitological endpoint) as well as diarrhea and
      associated signs and symptoms (clinical endpoint).
    

Detailed description: 
      This study was funded by the Wellcome Trust. This Phase 1 Cryptosporidium controlled human
      infection model (CHIM) study employed a single-center, open-label design to characterize the
      incidence of infection and associated symptoms following the administration of single doses
      of Cryptosporidium parvum oocysts (CE).

      Healthy volunteers were enrolled in cohorts of approximately 10 participants who received
      ABO809 on the same day (Day 1). The study consisted of three (to a maximum of six) sequential
      cohorts which were dosed one after the other for a total of 30 (to a maximum of approximately
      60) participants. A dose level group received the same ABO809 dose and could be comprised of
      multiple cohorts. The first dose level group started with a cohort of 10 participants who
      received ABO809 at a dose of 1x10^4 oocysts. The study continued to enroll participants in
      the same dose level group if the desired incidences of infection and diarrheal illness were
      observed, up to a total of approximately 30 participants. If the desired incidences of
      infection and diarrheal illness were not observed, a new dose level group, receiving ABO809
      at a dose of 1x10^6 oocysts, could be initiated. If needed to optimize the model,
      intermediate ABO809 doses could be evaluated.
    

Intervention name(s): Cryptosporidium parvum oocysts (ABO809)
Intervention type(s): Biological
Intervention description(s): ABO809 3x10^6 CE/3mL concentrate for oral suspension, single dose at Day 1
Intervention model: Single Group Assignment
Intervention model description: Cryptosporidium controlled human infection model
Masking: None (Open Label)
Primary purpose: Other
Keywords: Controlled Human Infection Model, CHIM, infection, diarrhea, safety, tolerability, healthy volunteers, Phase I, cryptosporidiosis, Cryptosporidium, oral, ABO809