bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Retrograde Autologous Blood Priming on Pulmonary Mechanics in Pediatric Cardiac Surgery
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood
      priming of cardiopulmonary bypass (RAP) has a positive impact on hemodynamics and pulmonary
      mechanics subjected to cardiac surgery.
    

Detailed description: 
      This prospective randomized study analyzed the clinical records of 124 children subjected to
      cardiac surgery for congenital heart diseases with left to right shunt. They comprised 64
      patients with RAP and 60 patients conventional cardiopulmonary bypass priming. The
      preoperative, intraoperative and postoperative data of the studied patients were reported.
    

Intervention name(s): Pediatric cardiac surgery
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were included in the study if they had left to right shunt due to volume or pressure overload
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: retrograde autologous priming pulmonary mechanics
Routine Mini-invasive Electrophysiology Study for Patients Feeling Tachycardia, With a Negative Holter ECG
Condition: Pre-excitation Syndromes; Paroxysmal Tachycardia; Atrial Fibrillation; Atrial Flutter; Wolff-Parkinson-White Syndrome
MeSH terms: Atrial Fibrillation; Tachycardia; Atrial Flutter; Wolff-Parkinson-White Syndrome; Pre-Excitation Syndromes; Tachycardia, Paroxysmal; Syndrome; Accessory Atrioventricular Bundle
Study type: Interventional

Summary: 
      Patients complaining of tachycardia but with a negative Holter ECG, are for a limited time
      period offered a simplified electrophysiological(EP) examination. By a full
      electrophysiological study(EP study)electrodes are introduced for pacing and sensing i all
      four heart chambers. Where as by the mini invasive EP study only one electrode is introduced
      to the right atrium. The simplified procedure represent a smaller risk of complications,
      requires less resources but should yield the same diagnoses in more than 90% of the cases.
      The study is a feasibility study to see if the procedure can discover arrythmias in a fairly
      unselected patient population.
    

Detailed description: 
      Sykehuset Telemark performs every year approximately 800 Holter ECG examinations.
      Approximately 200 of these are on the indications tachycardia, and in about 170 patients the
      examination does not discover any tachycardia Patients who were examined in the period from
      August 1. 2004 to November 1. 2005 with a negative Holter are mailed a letter with
      information of the min invasive electrophysiological examination, and an offer of volunteer
      participation. Patients given their informed consent are then according to waiting list
      called for the mini-invasive EP-study.

      The protocol of the EP stimulation consists of: determination of pacing threshold, pacing
      with 8 asynchronous beats 600ms and an extrasystole with decremental intervals from 550 ms to
      200 ms. The seri is repeated with pacing on 400ms and with two extrasystoles as well as with
      isoprenaline stimulation.
    

Intervention name(s): Mini-invasive electrophysiological study; Atrial pacing
Intervention type(s): Other; Other
Intervention description(s): Transvenous pacing in right heart atrium; Diagnostic pacing in right heart atrium in order to unmask reentry tachycardia
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Electrophysiological study; paroxysmal tachycardia
Bioavailability of Two Sustained-release Theophylline Products in Healthy Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to compare the bioavailability of 350 mg Bronchoretard® - a sustained-release
      theophylline (anhydrous) product with respect to the reference product, Theo Dur® 300 mg
      theophylline anhydrous (sustained-release product) by comparing the rate and extent of
      absorption of theophylline based on both single and multiple-dose profiles.
    


Intervention name(s): anhydrous theophylline, 350 mg; anhydrous theophylline, 300 mg
Intervention type(s): Drug; Drug
Other intervention name(s): Bronchoretard®; Theo-Dur®
Intervention MeSH terms: Theophylline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Metabolic Effects of Prebiotic Supplementation After Roux-en-Y Gastric Bypass Surgery
Condition: Bariatric Surgery
Study type: Interventional

Summary: 
      In this study, it is aimed to evaluate whether the addition of prebiotics to patients'
      post-operative diets increases Roux-en-Y Gastric Bypass surgery effects. Half of the
      participants were randomized prebiotic with conventional yogurt, while the other half were
      randomized only conventional yogurt as a snack
    

Detailed description: 
      Following bariatric surgery, positive alterations are observed in gut microbiota, intestinal
      peptides, and inflammatory cytokines. Previous studies demonstrate that prebiotic use alone
      in a tolerable dose (which is 10 g/day) among obese, overweight, or diabetic individuals
      accelerated the weight loss by reducing hunger and food intake. Furthermore, it could also
      contribute to the improvement of glucose homeostasis by increase postprandial PYY and GLP-1
      levels. Prebiotics feeds healthy intestinal bacteria and enhances their positive effects. The
      present positive effects appear with SCFAs that stimulates PYY and GLP-1 release and produced
      by fermentation of prebiotics by bacteria. From this point forth, it was hypothesized that
      post-operative pre-probiotic usage may enhance the effects of Roux-en-Y Gastric Bypass
      (RYGB). In addition, administration of pre-probiotics following RYGB may be considered as a
      simple and cheap treatment support, especially for protecting patients with poor medicine
      compliance against nutritional deficiencies, as well as for diabetic patients whose glucose
      regulations deteriorate in the long term, and for those who regain weight.

      With the result that the effects of prebiotic supplementation on metabolic results of RYGB
      surgery in this prospective, randomized, controlled study with a duration of 24 weeks were
      tested.
    

Intervention name(s): Prebiotic; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Prebiotic (Inulin+Oligofructose) consumed as 10 g/d in yogurt (200 g/d); The only yogurt consumed as 200 g/d without prebiotic.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Bariatric surgery; Prebiotics; gut microbiota; GLP-1; PYY
A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.
Condition: Prevention of the Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult
      population potentially at risk for meningococcal disease (e.g. lab workers).
    


Intervention name(s): rMenB+OMV NZ
Intervention type(s): Biological
Intervention description(s): Recombinant MenB with Outer Member Vesicle (OMV) from the New Zealand strain
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal disease,; Adults
Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)
Condition: Healthy; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to validate a new reference marker for evaluation of renal
      function (glomerular filtration rate).
    

Detailed description: 
      Chronic kidney disease (CKD) is a worldwide public health problem with an increasing
      incidence and prevalence, poor outcomes (kidney failure, complications of decreased kidney
      function and cardiovascular disease), and high cost. Some of the adverse outcomes can be
      prevented or delayed by early detection and treatment. However, CKD is frequently
      underdiagnosed and undertreated. The glomerular filtration rate (GFR) is considered as the
      best index of renal function. The clinical action plan promoted by International Guidelines
      groups refers to GFR values. Despite recent improvements, prediction equations developed in
      order to estimate GFR elicit a huge lack of accuracy when considering the individual patient,
      especially in case of early CKD. Rigorous assessment of GFR requires the measurement of
      urinary or plasma clearance of an ideal exogenous filtration marker which is either
      non-radioactive (inulin, iothalamate, or iohexol) or radioactive ( 51Cr-EDTA or 99mTc DTPA.
      Measuring clearance with the use of exogenous markers is difficult to perform in clinical
      practice because it is expensive and cumbersome and needs specialised laboratories and thus,
      is underused. There is an unmet need for the development of a new non-radioactive GFR tracer
      that could combine both the analytical accuracy of radioactive tracers and the simplicity of
      its measurement. Such a tracer should improve clinical care and follow-up of patients.
    

Intervention name(s): AcSDKP-NH2 inuline; AcSDKP-NH2 Cr-EDTA
Intervention type(s): Drug; Drug
Intervention description(s): Once intravenous administration of 100 µg or less; Once intravenous administration of 100 µg or less
Intervention MeSH terms: Mechlorethamine; Goralatide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Chronic kidney disease; GFR; Inulin; 51Cr-EDTA; ASDKP-NH2; Healthy male 18-35 yrs old, non smokers, non allergic; Or Male/female 18-80 yrs old with chronic Kidney disease
DSC-MRI With Ferumoxytol and DCE-MRI With Gadolinium in Imaging Vascular Properties in Younger Patients With Brain Tumors
Condition: Childhood Brain Neoplasm; Recurrent Childhood Brain Neoplasm
MeSH terms: Neoplasms; Brain Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This clinical trial studies dynamic susceptibility-weighted contrast enhanced magnetic
      resonance imaging (DSC-MRI) after administration of ferumoxytol and dynamic contrast-enhanced
      MRI (DCE-MRI) after administration of a gadolinium-based contrast agent (GBCA) in viewing the
      vessels of the brain in younger patients with brain tumors. Ferumoxytol is an experimental
      form of very small iron particles that are taken by the blood stream to cells adjacent and
      inside the tumor. These iron particles may make it easier to see the areas of the brain that
      are affected by tumor. Ferumoxytol may work better than standard GBCA in viewing the vessels
      of the brain and brain tumor on MRI. Using ferumoxytol and GBCA in the same MRI session may
      provide more information about tumor blood supply and the extent of the tumor.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To describe the vascular properties of pediatric brain tumors using ferumoxytol for
      DSC-MRI and GBCA for DCE-MRI in pediatric brain tumor (proven or presumptive) patients in a
      single MRI session.

      II. To describe evolving imaging characteristics of tumor vasculature using DSC-MRI with
      ferumoxytol and DCE-MRI with GBCA in pediatric brain tumor patients.

      SECONDARY OBJECTIVES:

      I. Compare and evaluate magnetic resonance angiogram (MRA) with ferumoxytol between different
      time points.

      II. To describe number and size of tumors imaged. III. To assess histology and electron
      microscopy (EM) on tissue samples. IV. To demonstrate differences in patients with prior
      therapy versus (vs.) no prior therapy (radiation and/or chemotherapy).

      OUTLINE:

      Patients receive ferumoxytol and gadolinium intravenously (IV) and then undergo DSC-MRI and
      DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24
      hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3
      weeks apart over up to 2 years.

      After completion of study treatment, patients are followed up at approximately 4-6 weeks.
    

Intervention name(s): Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Ferumoxytol Non-Stoichiometric Magnetite; Gadolinium
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): Undergo DCE-MRI; Undergo DSC-MRI; Given IV; Given IV
Other intervention name(s): DCE MRI; DCE-MRI; DYNAMIC CONTRAST ENHANCED MRI; Dynamic Susceptibility Contrast-Enhanced MRI; Feraheme; Ferumoxytol; Gd
Intervention MeSH terms: Ferrosoferric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Lactic Acidosis During and After Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures; Acidosis; Acidosis, Lactic
Study type: Observational

Summary: 
      This project looks at the time course of lactic acid rise (if any) after seizures. Salivary
      and capillary lactic acid are tested. This type of measurement may be useful in signalling
      the occurrence or recent history of a seizure.
    

Detailed description: 
      Lactic acid is released from cells during seizures and elevates lactic acid levels in blood
      and saliva. The time course of this rise is unknown. If lactic acid rises within a few
      minutes of a seizure, than it might be feasible to develop lactic acid sensors to provide
      notification of a recent seizure. This could lead to better safety monitoring for people with
      epilepsy. This study was designed to utilize a commercially available lactic acid sensor
      (investigators have no connection with the sensor manufacturer and purchased the device at
      list price) to measure salivary lactic acid levels after a seizure during inpatient video-EEG
      epilepsy monitoring.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Age range will be 18-75, men and women, all ethnic backgrounds to be eligible. Eligible
        population will be determined by who gets admitted to the epilepsy monitoring unit with a
        history of generalized tonic-clonic seizures.
      
Keywords: epilepsy; lactic acid; saliva; postictal
Utilization of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Healing
Condition: Cornea Injury
MeSH terms: Corneal Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson
      syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal
      surgery and others, it is important that short time treatment with minimal side effect should
      be considered. This study is a prospective clinical trial to use Amniotic Membrane Extract
      Eye Drop (AMEED) as a natural substance for acceleration of corneal healing
    

Detailed description: 
      The cornea is the specific anterior part of eye that is essential for normal vision. The
      corneal surface is comprised of a unique type of non-keratinized epithelial cell. Corneal
      epithelium contains transient amplifying cells and post mitotic cells. The limbal stem cells
      (LSC) are located between limbal cornea and conjunctiva which are main source of corneal
      epithelium healing in eye injuries. For some corneal disease such as chemical and thermal
      injuries, Corneal Dystrophies and corneal surgery, treatment in short time is important.

      AM can modulate corneal epithelium healing by promoting re-epithelialization and migration of
      limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. This
      biological substrate maintain epithelial progenitor cells within the limbal stem cell niche
      and facilitate ocular surface epithelial renewal. It is well accepted that amniotic membrane
      Transplantation (AMT) as a temporary patch normally dissolves within 2 weeks. Consequent
      reapplication of membrane is difficult for the patient.

      Other studies have been reported that processed AM as a liquid has comparable effect to AMT
      in treatment of corneal epithelial healing.

      This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED)
      as a natural substance for acceleration of corneal healing.
    

Intervention name(s): Amniotic Membrane Extract Eye Drop
Intervention type(s): Biological
Intervention description(s): Amniotic Membrane Extract use as eye drop for patients with corneal injury.
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cornea epithelium healing Amniotic Membrane Eye Drop
Community Health Workers and Diabetes Education
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of a diabetes education program delivered to
      CHW in improving the metabolic control of patients with type 2 DM.

      The study is a randomized controlled trial conducted in a primary care unit. Eight CHW,
      providing care for 118 patients, are randomized in two groups to receive a one-month diabetes
      education program (intervention group, patients n= 62) or an education course in other health
      issues (control group, patients n= 56).
    

Detailed description: 
      Background: In Brazil, community health workers (CHW) are members of the community hired by
      the government to provide education and care for patients for a broad range of health issues,
      including diabetes mellitus (DM). However, few CHW are trained for diabetes education and
      little is known about the effectiveness of their interventions. The aim of this study is to
      evaluate the effect of a diabetes education program delivered to CHW in improving the
      metabolic control of patients with type 2 DM.

      Materials and methods: the study is a randomized controlled trial conducted in a primary care
      unit. Eight CHW, providing care for 118 patients, are randomized in two groups to receive a
      one-month diabetes education program (intervention group, patients n= 62) or an education
      course in other health issues (control group, patients n= 56). Each CHW is responsible for
      transmitting the acquired knowledge to patients from their respective working areas. The
      primary outcome is change in HbA1C three months after intervention.
    

Intervention name(s): diabetes education; education in other areas
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Diabetes education program includes: 4 theoretical sessions, 60 minutes long, taught once a week for 4 weeks, developed in the form of group classes, and given by one of the authors. The educational program content comprises (1) definition of diabetes, and identification of modifiable risk factors for type 2 diabetes, (2) non-pharmacological treatment, with emphasis on diet and exercise, (3) pharmacological therapy, including mechanism of action and side effects of anti-diabetic medications provided by the Brazilian public health system and (4) an overview of chronic diabetes complications.; Four theoretical sessions related to education in other health areas, not related to diabetes, administered during 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: diabetes education; community health workers; diabetes control
A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of CMX157 and the amount
      of CMX157 that reaches the blood stream, the manner in which the body processes CMX157 and
      the time that it takes to eliminate CMX157 following one oral dose when given to healthy
      volunteers.
    


Intervention name(s): CMX157; Placebo; Viread
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One single oral dose of CMX157 will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the CMX157 dose.; One single oral dose of placebo will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the placebo dose.; One single oral dose of 300mg Viread.
Intervention MeSH terms: Hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy adult volunteers; Pharmacokinetics
Effect of Pressure Regulation on Optic Nerve Sheath Diameter
Condition: Optic Nerve Sheath Diameter
Study type: Interventional

Summary: 
      Intracranial pressure is known to increase during robot-assisted laparoscopic radical
      prostatectomy (RALRP) due to steep trendelenberg position. Measurement of optic nerve sheath
      diameter (ONSD) is a indirect method which can assess the degree of intracranial pressure.

      This study is designed to measure the ONSD during RALRP under regulation of arterial
      pressure.
    

Detailed description: 
      During last decades, RALRP has been advocated due to the advantages of short hospital stay,
      reduced blood loss during surgery, less postoperative pain and complication. During RALRP,
      steep trendelenberg postion and pneumoperitoneum are required essentially, and this is for
      the acquisition of adequite surgical field. However, such position and pneumoperitoneum can
      result in harmful hemodynamic change. Previous study demonstrated that patients of RALRP
      showed 12.5% increase of ONSD.

      The relationship of ONSD and increase of intracranial pressure has been proved previously
      through many studies. Recent meta analysis showed that ONSD measurement for the monitor of
      ICP demonstrated that sensitivity 0.9, specificity 0.85 and ROC cuve 0.983.

      In addition, increase of ONSD during RALRP can be affected by the degree of arterial pressure
      and end tidal CO2 increase.

      This study is designed to see the effect of arterial pressure regulation on the increase of
      ONSD
    

Intervention name(s): RALRP under lower mean BP; RALRP under lower mean BP
Intervention type(s): Other; Other
Intervention description(s): RALRP under regulation of lower mean BP; RALRP under regulation of highly normal mean BP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arterial pressure regulation