bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
Condition: Nosocomial Pneumonia (NP); Ventilator-associated Pneumonia (VAP)
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to
      Meropenem for treating hospitalized adults with nosocomial pneumonia including
      ventilator-associated pneumonia
    

Detailed description: 
      A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative
      Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus
      Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia
      in Hospitalized Adults
    

Intervention name(s): ceftazidim-avibactam (CAZ-AVI, experimental product); meropenem (active comparator)
Intervention type(s): Drug; Drug
Intervention description(s): 2000mg ceftazidime plus 500mg avibactam; 1000mg of Meropenem
Intervention MeSH terms: Meropenem; Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ceftazidime,; Meropenem,; Anti-Bacterial Agents,; Anti-Infective Agents,; Therapeutic Uses,; Pharmacologic Actions,; Physiological Effects of Drugs
Uterine Niche After Cesarean Section
Condition: Uterine Scar From Previous Cesarean Delivery (Diagnosis)
Study type: Interventional

Summary: 
      In the past decade several articles have described a defect that can be seen on ultrasound at
      the site of cesarean delivery scar, known as a 'niche' .An incompletely healed scar is a
      long-term complication of cesarean delivery and is associated with symptoms such as
      postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia and subfertility. This
      study aimes to evaluate the prevalence of niche in a large cohort study after long term
      follow up since operation, and characterize the risk factors for its development and for
      symptoms to appear.
    

Detailed description: 
      As the rate of cesarean deliveries continues to increase, concern regarding the association
      between delivery by cesarean section and long-term maternal morbidity has been growing . In
      the past decade several articles have described a defect that can be seen on ultrasound at
      the site of the cesarean delivery scar, known as a 'niche' .A 'niche' describes the presence
      of a hypoechoic area within the myometrium of the lower uterine segment, reflecting a
      discontinuation of the myometrium at the site of a previous cesarean delivery . An
      incompletely healed scar is a long-term complication of cesarean delivery and is associated
      with symptoms such as postmenstual spotting, dysmenorrhoea, chronic pelvic pain dyspareunia
      and subfertility.

      The reported prevalence of a niche in non-pregnant women varies depending on the criteria
      used to define a niche, the time of evaluation since operation, method of detection, and
      study population. Osser et al. used the definition 'any visible defect' , Bij de Vaate et al.
      used 'any indentation of at least 1 mm and van der Voet used a cut-off level of 2 mm,
      however, consensus on the exact cut-off levels is lacking. As approximate evaluation to the
      operation, the prevalence reported is higher, as early scanning may facilitate the
      recognition of the location of the caesarean delivery scar in the uterine wall due to
      incomplete scar healing, with no definition of the most appropriate time since operation.
      Commonly used methods to evaluate the presence of a niche are trans vaginal ultrasound,
      sonohysterography and hysteroscopy with detection rate of approximately ~50% of women with
      previous cesarean section in all methods with no definition of the gold standard.

      The aim of this study in to evaluate the prevalence of niche in a large cohort study after
      long term follow up since operation and characterize the risk factors for its development and
      for symptoms to appear.
    

Intervention name(s): Ultrasound
Intervention type(s): Device
Intervention description(s): Vaginal ultrasound examination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cesarean section, niche, uterine scar defect
Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
Condition: Chronic Lung Disease
MeSH terms: Lung Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of
      ureaplasma urealyticum and prevention of chronic lung disease in premature infants with
      birthweight < 1250 g and have ureaplasma urealyticum colonization.
    


Intervention name(s): Clarithromycin; Dextrose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Chronic lung disease; Clarithromycin; Ureaplasma urealyticum
Efficacy of a Gluten-free Diet in Difficult to Manage Nephrotic Syndrome: Utility of Plasma Zonulin Levels as a Predictive Biomarker
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Observational

Summary: 
      Elevated plasma zonulin levels, which are supportive of a diagnosis of CD (celiac disease) in
      children with gastrointestinal symptoms, may indicate patients with difficult-to-manage NS
      who will benefit from initiation of a GFD (gluten free diet). This pilot study will determine
      whether high plasma zonulin levels can be used as a screening tool to identify patients with
      NS (nephrotic syndrome) who are likely to demonstrate a beneficial response to a GFD. It will
      provide important information about the feasibility of testing the efficacy of a GFD for this
      condition and assist in the design and sample size calculation for a definitive trial to test
      the beneficial effect of this dietary intervention. Although NS is a rare condition in
      childhood, it is a chronic disease that can lead to short- and long-term disability
      especially in those with difficult-to-manage disease. There is an urgent need to develop safe
      and effective new therapies in this subgroup. This project may indicate the utility of a
      common dietary modification, a GFD, to treat these patients. The growing medical use of and
      greater access to gluten-free food items underscore the feasibility and timeliness of this
      approach.
    


Intervention name(s): Implementation of a gluten-free diet
Intervention type(s): Other
Intervention description(s): Patients will be placed on gluten free diet for 9-12 months.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children age 9 months to 18 years of age with steroid sensitive Nephrotic Syndrome
Effects of Fiber on Satiety
Condition: Obesity
Study type: Interventional

Summary: 
      The effects of a dietary fiber on hunger and food intake will be tested in men and women.
      Participants will receive fiber as part of a breakfast meal on two occasions. On another
      occasion, participants will receive the same breakfast, without added fiber. Their feelings
      of hunger and fullness will be measured over the day. They will be offered lunch, dinner and
      an evening snack and how much they eat will be recorded. It is expected that the fiber
      supplement will enhance their feelings of satiety and reduce the amount they eat over the
      day.
    


Intervention name(s): Dietary Fiber
Intervention type(s): Other
Intervention description(s): Fiber added to breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: food intake, satiety, fiber
Outdoor Allergen Exposure, Sensitivity, and Acute Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      To examine the role of outdoor pollen grains and fungal spores in the exacerbation of asthma
      and to produce forecasting models to predict days of high concentration.
    

Detailed description: 
      Asthma is a growing problem, and outdoor allergens play a role in exacerbation of many cases.
      A clearer understanding of this role and its magnitude, and a means of controlling the
      effects of outdoor allergen exposures is needed. We propose Poisson time-series and
      conditional panel studies to test these hypotheses: 1) The incidence of acute asthma attacks,
      as measured by urgent care inhalation treatments and hospitalizations for asthma, has a
      dose-dependent relationship with exposure to specific outdoor allergens; 2) Specific
      sensitization to outdoor allergens is a risk factor for having an acute attack; and 3)
      Exposure conditions that lead to acute asthma attacks can be forecast, creating an
      opportunity to reduce asthma morbidity and mortality ny targeting pretreatment and/or
      exposure controls.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: Asthma; Allergens
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed
      conditions.
    


Intervention name(s): Cefdinir 300 mg Capsule (Sandoz, Austria); Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cefdinir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic
A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation
Condition: Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir
      (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic
      hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to
      assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C
      virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV
      genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior
      treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir
      [PRS]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescent participants 12 to <18 years of age with chronic hepatitis C (CHC) being treated
        with glecaprevir/pibrentasvir (GLE/PIB) in clinical practice in Russian Federation.
      
Keywords: Hepatitis C Virus (HCV); Chronic Hepatitis C (C); Maviret
Subclavian Versus Inferior Vena Cava Collapsibility Indices.
Condition: Hemodynamic Instability
Study type: Interventional

Summary: 
      Traditional methods for intravascular volume status assessment include physical examination,
      raised leg test, central venous pressure (CVP) and pulmonary artery catheters occlusion
      pressure (PAWP). Central venous pressure and pulmonary artery occlusion pressure are invasive
      and associated with significant complications. More recently, a number of less invasive
      techniques have been introduced, but they lack standardization and reliability.
      Ultrasonically, inferior vena cava collapsibility can detect hypovolemia non-invasively.
    

Detailed description: 
      The aim of this study is that measurement of subclavian vein collapsibility index(SCV-CI)
      could be potential adjunct to IVC-CI where the IVC visualization is impaired or not possible
      .

      -Finding a non-invasive reliable accurate method for evaluation of intravascular volume and
      response to volume resuscitation.
    

Intervention name(s): inferior vena cava collapsibility; subclavian vein collapsibility; central venous pressure
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): inferior vena cava diameters is obtained in the supine position with a convex probe .The probe is placed in the subxiphoid region or the right anterior midaxillary plane.The sagittal section of IVC is imaged. M-mode probe is used to identify the measurement of minimum and maximum venous dimensions over the respiratory cycle using the 3.5-5 MHz phased array probe. To standardize the measurements, measuring of the IVC diameter is performed at 2 cm caudal of the junction point of the right atrium and IVC. The difference between the maximum (D max) and minimum (D min)diameters of the target vein is normalized according to the standard formula to yield the collapsibility index (CI).; Right SCV diameters is checked in the supine position using a high frequency linear array probe (6-13 MHz) and M-mode. To standardize the measurements, the probe is placed beneath the proximal part of the middle part of the clavicle perpendicular to long-axis of the SCV to obtain the best cross-sectional view of the vien. After the target vein is localized , the dynamic diameter change is recorded using M-mode to identify and measure the minimum and maximum venous diameters.To calculate SCV collapsibility index, the standard formula is used.; ultrasound guided 7.5-F central venous catheter is introduced via right internal jugular vein under local analgesia with 2% lidocaine for measuring the CVP.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Diagnosing Natriuretic Peptide Deficiency
Condition: Healthy; Lean
Study type: Interventional
Phase: Phase 1

Summary: 
      In this pilot study, the investigators will determine the response of the natriuretic peptide
      (NP) hormone system after a dose of intravenous dexamethasone (a steroid medication). The
      goal of the proposed project is to generate preliminary data that will be used to develop
      power calculations, inform cutoff ranges, and inform the timing of the NP response for larger
      subsequent studies.

      Aim: To determine the range of distribution and time course of natriuretic peptide (NP)
      responses to a single dose of dexamethasone IV 4 mg in healthy lean individuals.

      Hypothesis: Determination of the NP responses (the range and time course of changes in NP
      levels) to dexamethasone in 10 healthy individuals will inform the time course and frequency
      of blood sampling in a definitive prospective study, as well as enable investigators to
      perform a sample size calculation for a definitive prospective study.
    

Detailed description: 
      see above
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): A single dose of dexamethasone IV 4 mg will be administered.
Other intervention name(s): Dexamethasone IV
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Impact of a Combination of Bifidobacterium Longum 35624® and 1714™ Strains in Adults With Irritable Bowel Syndrome
Condition: IBS - Irritable Bowel Syndrome; Depression, Anxiety
MeSH terms: Irritable Bowel Syndrome; Syndrome; Depression
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aimed to assess the impact of consumption of COMBO, a combination product of two
      Bifidobacterium longum strains, on stress, mood and bowel symptoms in adults with Irritable
      Bowel Syndrome (IBS).
    

Detailed description: 
      This is an open label study designed to assess the impact on stress, mood and bowel symptoms
      & safety of COMBO, a combination of Bifidobacterium longum 35624® and Bifidobacterium longum
      1714™ strains, when consumed once daily for 8 weeks, in adults with Irritable Bowel Syndrome
      (IBS). Volunteers will be screened according to the selection criteria in order to identify
      up to 40 female subjects, with recurrent abdominal pain/discomfort and mild to moderate
      stress/mood status. The study will involve 6 visits over an 18 to 20-week period [Screening
      period (Visit 1: week-2), Intervention period (Visit 2: week 0, Visit 3: week 4, Visit 4:
      week 8), and Follow-up/ Washout period (Visit 5: week 12, Visit 6: week 16)]. Participants
      will fill in daily and weekly eDiary from 1st visit onwards. Questionnaires will be
      administered from visit 2 to visit 6. Research blood and saliva will also be collected at
      these time points. Stool sample will be collected at Visit 2, 4, 5, 6.
    

Intervention name(s): Probiotic capsule
Intervention type(s): Dietary Supplement
Intervention description(s): Each probiotic capsule contains 5 x 10^8 CFU B. longum 35624® and 5 x 10^8 CFU B. longum 1714™ with corn starch and magnesium stearate.
The probiotic capsule will be supplied by PrecisionBiotics Ltd.
Intervention model: Single Group Assignment
Intervention model description: Open label study, with intervention period followed by follow-up (wash out) period.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Combination of probiotics; Bifidobacterium longum 35624®; Bifidobacterium longum 1714™; depression; anxiety; bowel symptoms; Irritable Bowel Syndrome (IBS); Sleep quality; Cognition; Safety
Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea in Patients Requiring Anterior Lamellar Keratoplasty
Condition: Leukoma
MeSH terms: Corneal Diseases
Study type: Interventional

Summary: 
      In this study safety and effectiveness of bioengineered cornea comprising of interpenetrating
      networks of recombinant human type III collagen and synthetic phospholipid -
      phosphorylcholine - will be tested in patients with corneal scars (leukomas) after infection,
      trauma or keratoconus. Control group will consist of patients with the same condition who
      will undergo corneal transplantation - current standard of care.
    

Detailed description: 
      Recently developed and passed extensive pre-clinical testing
      collagen-phosphorylcholine(RHCIII-MPC) corneal substitute will be implanted in patient's
      corneas with corneal scar (leukoma) developed after infection, trauma or keratoconus using
      anterior lamellar keratoplasty technique, i.e. once patient's diseased anterior part of
      cornea is removed, either manually or with assistance of femtosecond laser, it will be
      substituted with proposed transparent implant. Control patients with same condition will be
      grafted with human donor cornea using the same surgical technique.

      The investigators will test the safety and the effectiveness of developed biosynthetic
      corneas. Overall 20 patients are planned to recruit. They will be randomized in two groups -
      10 patients will undergo RHCIII-MPC cornea implantation, another 10 will be impanted with
      human donor cornea. The patients will be follow-uped for 12 months.
    

Intervention name(s): RHCIII-MPC cornea; Donor cornea
Intervention type(s): Device; Device
Intervention description(s): Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to 350 um of corneal thickness and then a lamellar dissection will be created. Trephine diameter will be 7.5 mm. Alternatively a femtosecond laser may be used to create the dissection. A RHCIII-MPC cornea 350 um thick and equal or 0.25 mm larger diameter is placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens will be removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.; Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to 350 um of corneal thickness and then a lamellar dissection will be created. Trephine diameter will be 7.5 mm. Alternatively a femtosecond laser may be used to create the dissection. A human donor cornea graft 350 um thick and 0.25 mm larger diameter is placed and sutured. The sutures will be removed in 3-6 months or as determined by physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RHCIII-MPC Biosynthetic Cornea
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: keratoplasty; bioengineered cornea; donor cornea