bioihbjkbjnl/mcl2 huggingface dataset:
In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
Condition: Hemostasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate
      and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass
      to develop effective and safe strategies for managing coagulopathies in neonates.
    

Detailed description: 
      This study is a prospective, randomized control trial comparing two different sources of
      fibrinogen on clot kinetics (degradation time, structure, strength and polymerization) in
      post-CPB coagulopathy in neonates undergoing cardiac surgery. The two sources of fibrinogen
      include the blood product, cryoprecipitate, and a blood product alternative, fibrinogen
      concentrate. Cryoprecipitate is an allogenic blood product that requires cross-matching and
      thawing prior to administration and is associated with immunologic reactions and possible
      pathogen transmission. Fibrinogen concentrate, a blood product alternative, is a purified
      form of fibrinogen, which undergoes a pasteurization process to minimize the risk of
      immunologic and allergic reactions. The primary aim of this study is compare the in vivo
      effect of post-CPB administration of FC, a blood product alternative, to cryoprecipitate on
      neonatal clot properties and clinical outcomes.
    

Intervention name(s): Fibrinogen Concentrate (FC); Cryoprecipitate
Intervention type(s): Drug; Drug
Intervention description(s): The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.; Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 345mg/dL
Other intervention name(s): RiaSTAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fibrinogen Concentrate; FC; Cryoprecipitate; Transfusion; in vivo; Open-heart surgery; Cardiopulmonary Bypass; Fibrin Network Structure
Variation of Glucose Values at Early Stages of Diabetes - Continuous Glucose Monitoring
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study aims at improving the prediction of type 2 diabetes among high-risk individuals by
      examining glucose excursion patterns in subjects with impaired glucose tolerance. In
      addition, this study will show whether the currently used diagnostic test could be replaced
      by an easier and less expensive method.
    

Detailed description: 
      Type 2 diabetes is a chronic disease of glucose metabolism leading to various disabling
      conditions. The onset of type 2 diabetes is a gradual shift from normal to abnormal, giving
      rarely noticeable symptoms at its early stages or even in later stages when damage has
      already been caused. Due to the gradual onset, the diagnosis is often delayed, and as much as
      half of the asymptomatic patients remain undetected. The diagnostic criteria for diabetes are
      based on artificial boundaries reflecting the risk of complications related to diabetes. The
      golden standard of diagnosis of diabetes is a 2 hours oral glucose tolerance test, which is
      both time consuming and costly. This study aims at improving the prediction of type 2
      diabetes among high-risk individuals by examining glucose excursion patterns in subjects with
      impaired glucose tolerance. In addition, this study will show whether the currently used
      diagnostic test could be replaced by an easier and less expensive method.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with impaired glucose tolerance (2h plasma glucose during oral glucose
        tolerance test >7.8-11.1 mmol/l, n=50) or with type 2 diabetes (fasting plasma glucose >
        7.0 mmol/l and/or 2h plasma glucose > 11.1 mmol/l on two occasions, or both criteria
        fulfilled in the same oral glucose tolerance test while not pregnant, n=50) with short
        duration (<3 years); 40 from Padova University Hospital, 60 from the Botnia Study or the
        PPP-Botnia Study in Finland. The Botnia Study and the PPP-Botnia Study are population based
        studies investigating type 2 diabetes in western Finland.
      
Biospecimen description: 
      serum, plasma, urine
    
Keywords: type 2 diabetes; continuous glucose monitoring
Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery
Condition: Spine Surgery
Study type: Interventional

Summary: 
      Protein intake in spinal fusion surgery can prevent paraspinal muscle atrophy by maintaining
      muscle mass, regeneration, and growth. Also, by reducing the amount of pseudarthrosis, pain
      and disability can have a positive effect on recovery.

      The high prevalence of this type of surgery, the instability and degeneration of adjacent
      surfaces of fused sections, lumbar muscle atrophy, increased muscle tissue fat, and negative
      impact on patient recovery, also with regard to the fact that research has so far aimed to
      determine The effect of protein supplementation on para-spinal muscles has not been studied
      in patients undergoing posterior lumbar spine fusion surgery, therefore clinical trials are
      necessary. In this trial patients undergoing elective posterior spine fusion surgery are
      divided into two groups of intervention or control.
    

Detailed description: 
      A randomized, double blind, controlled trial will be conducted in patients undergoing
      elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion
      and exclusion criteria and explanation of the risks and benefits of the study, written
      consent form will be completed. The participants are 80 eligible posterior spine fusion
      surgery patients, aged ≥ 18 years. Intervention patients will be received 36 grams of protein
      supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and
      control patients will be received maltodextrin along with diet containing 1.2 g/kg/day of
      protein 30 days after surgery. Patients will be evaluated for occurrence of paraspinal
      muscles after 3 months surgery
    

Intervention name(s): Three sachet of protein supplement to be mixed in with water used daily
Intervention type(s): Drug
Intervention description(s): Three sachet of protein supplement to be mixed in with water used daily
Other intervention name(s): Pure-protein®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Protein supplement; Spine Surgery; Paraspinal Muscles
Effect of Various Sealers on Healing of Teeth With Apical Periodontitis
Condition: Apical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      This study will compare the effect of three different sealers on healing of teeth with apical
      periodontitis after primary root canal treatment.
    

Detailed description: 
      Various sealers with different chemical composition and properties are available but it is
      yet not clear if one sealer is superior to other in terms of healing of apical periodontitis.

      Three different groups of sealers will be used- a zinc oxide based sealer, an epoxy resin
      based sealer and a bioactive silicone based sealer. Mature mandibular permanent molar with
      the diagnosis of apical periodontitis (as confirmed clinically & by periapical radiograph)
      will be chosen for the study. Primary non surgical root canal treatment will be performed.
      The sealer will be randomly selected just before obturation of root canals. The patient will
      be allotted to one of the three groups.

        -  Group I: Zinc oxide eugenol sealer group. The material will be mixed according to
           manufacturer instructions and applied to canals using a lentulospiral and the obturation
           will be performed.

        -  Group II: Epoxy resin based sealer group. The material will be mixed according to the
           manufacturer's instructions and obturation will be done.

        -  Group III: Bioactive silicone based sealer: The material will be used according to the
           manufacturer's instruction and obturation will be performed
    

Intervention name(s): Zinc oxide based sealer; Epoxy resin based sealer; Bioactive silicone based sealer
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): After root canal treatment obturation will be done using zinc oxide eugenol based sealer.; After root canal treatment obturation will be done using epoxy resin based sealer.
Other intervention name(s): After root canal treatment obturation will be done using bioactive silicone based sealer.
Intervention MeSH terms: Zinc Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Benzonatate Dose Tolerance Study
Condition: Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, third party blind, placebo controlled, dose escalation
      study of benzonatate following single dose administration. The primary oobjective is to
      assess the safety and tolerability of increasing oral doses of benzonatate following single
      dose administration in healthy male and female subjects.
    


Intervention name(s): Placebo; Benzonatate - 400 mg; Benzonatate - 600 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo - single dose at start of each treatment period; Benzonatate - 400 mg single dose; Benzonatate - 600 mg single dose
Intervention MeSH terms: Benzonatate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Effect of Sitagliptin and an ACE Inhibitor on Blood Pressure in Metabolic Syndrome
Condition: Metabolic Syndrome; Hypertension
MeSH terms: Hypertension; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will measure the effect of the anti-diabetic agent sitagliptin on blood pressure
      in individuals with the metabolic syndrome. We will also measure the effect of sitagliptin on
      blood pressure in people already taking a blood pressure medication called an ACE inhibitor.
    

Detailed description: 
      The prevalence of metabolic syndrome and Type 2 diabetes mellitus (T2DM) has reached epidemic
      proportions in developed countries and is closely associated with hypertension. As new oral
      hypoglycemic agents become available for clinical use, practitioners wishing to treat both
      hyperglycemia and hypertension will use varieties of combinations of medications. In this
      setting, understanding interactions and additive effects of these medications becomes
      essential. Sitagliptin, a selective dipeptidyl peptidase-IV (DPP-4) inhibitor, improves
      glycemic control in patients with T2DM by decreasing the degradation of the incretin
      hormones. The incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent
      insulinotropic peptide (GIP) augment nutrient mediated insulin release. To date there have
      been two reports of a blood pressure lowering effect of the DPP-4 inhibitor vildagliptin, but
      no mechanism for this effect has been proposed.

      Specific Aim 1: To test the hypothesis that the DPP-4 inhibitor sitagliptin lowers blood
      pressure compared to placebo therapy in subjects with the metabolic syndrome.

      Specific Aim 2: To test the hypothesis that the DPP-4 inhibitor sitagliptin potentiates the
      blood pressure response to acute ACE-inhibition.
    

Intervention name(s): Placebo; Enalapril 5mg; Enalapril 10mg; Sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Enalapril 0mg after 5 days of placebo versus after 5 days sitagliptin 100mg/d; Enalapril 5 mg after 5 days placebo versus after 5 days sitagliptin 100mg/d; Enalapril 10mg after 5 days placebo versus after 5 days sitagliptin 100 mg/d; Sitagliptin 100mg/day for 5 days crossed over to placebo daily for 5 days prior to arms.
Intervention MeSH terms: Sitagliptin Phosphate; Enalapril; Enalaprilat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Metabolic syndrome; Hypertension; Sitagliptin; Enalapril
Short-term Working Memory and Executive Training
Condition: Psychotic Disorders
MeSH terms: Psychotic Disorders
Study type: Interventional

Summary: 
      Cognitive remediation (CR) therapies refer to a number of recent developments to use
      behavioural strategies to improve neurocognitive abilities and improve everyday functioning
      in mental disorders such as schizophrenia, bipolar disorder, and depression. In this study,
      we aim to examine whether we can observe CR effects on measures of neuroplasticity,
      cognition, and functioning when using a rigorous control comparison group. We hypothesize
      that the active group will exhibit improvements in executive functioning composite scores,
      improved EEG theta-gamma frequency modulation, and increased EEG alpha power compared to the
      placebo group.
    


Intervention name(s): Executive Function Training; Placebo
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Placebo version of executive function training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Neurological Disorders; Neuroscience; Neuropsychology; EEG; Cognitive remediation; Cognitive Response
Cipro® XR in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this clinical trial was to determine the time to improvement of the
      signs and symptoms (eg, dysuria, frequency, urgency, gross hematuria, suprapubic pain,
      hesitancy, low back pain) of acute, uncomplicated, symptomatic, lower UTIs in women treated
      with Cipro XR 500 mg once daily for 3 days.
    


Intervention name(s): Cipro XR (Ciprofloxacin, BAYQ3939)
Intervention type(s): Drug
Intervention description(s): 3 tablets of Cipro XR 500 mg and were instructed to take 1 tablet per day for 3 days.
Intervention MeSH terms: Ciprofloxacin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cipro; Urinary Tract Infection
Sugammadex Versus Neostigmine in Pediatric Less Than Two Years Undergoing Cardiac Catheterization
Condition: Cardiac Catheterization
Study type: Interventional

Summary: 
      This study hypothesizes that Sugammadex may has more appropriate recovery profile than
      neostigmine in pediatric cardiac patients undergoing cardiac catheterization. In pediatric
      cardiac patients, clear and rapid recovery (fast-tracking) is required to maintain
      hemodynamic within the normal physiological values which may be saved by sugammadex
    

Detailed description: 
      There are numerous advantages of early tracheal extubation otherwise known as fast-tracking
      following anesthesia for congenital heart disease (CHD)

      Early tracheal extubation not only eliminates the potential morbidity related to an
      endotracheal tube and mechanical ventilation such as atelectasis, accumulation of secretions,
      nosocomial infections, and the potential for airway trauma, it also limits the need for
      sedation and the antecedent adverse effects including respiratory and hemodynamic depression,
      tolerance, withdrawal, and delirium. Most importantly, the shift from positive pressure to
      spontaneous ventilation augments cardiovascular function and improves preload. Reversal of
      neuromuscular blockade is a fundamental aspect of emergence from general anesthesia.
      Historically, the only option to actively reverse blockade will be to administer
      anticholinesterase inhibitors, which are unable to reverse deep neuromuscular blockade. They
      are also associated with a variety of cholinergic side effects, including bradycardia,
      nausea, and increased secretions, which require concomitant administration of an
      anticholinergic agent, with its own adverse effects. Sugammadex is a newer, selective
      relaxant binding agent
    

Intervention name(s): Reversal Neostigmine; Reversal Sugammadex
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 0.02 mg/ kg atropine and 0.04 mg/ kg neostigmine following observing the second response on stimulating the ulnar nerve on the TOF watch; Interventional Arm Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch
Other intervention name(s): PROSTIGMIN®; BRIDION®
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies
Condition: Indolent or Intermediate Grade B-cell Malignancy
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the feasibility of a 60 minute rapid infusion
      rituximab protocol in the institution's outpatient infusion center.
    


Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypersensitivity Reactions; B-cell malignancies
Agreement and Accuracy of Different Devices Corneal Measurements
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Observational

Summary: 
      To compare repeatability, reproducibility and agreement of both, AS- OCT and Scheimpflug
      imaging, for the measurement of corneal curvature and corneal thickness in patients with
      keratoconus.
    


Intervention name(s): Pentacam® (Oculus, Inc., Wetzlar, Germany); Casia II (Tomey Germany, Nürnberg); Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)
Intervention type(s): Device; Device; Device
Intervention description(s): Scheimpflug imaging; Anterior segment optical coherence tomography; Anterior segment optical coherence tomography
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        50 patients with keratoconus will be recruited in the outpatient department of the
        Department of Ophthalmology.
Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to determine if single doses of PUL-042 inhalation solution are safe in
      healthy subjects.
    

Detailed description: 
      The study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of
      single ascending doses of PUL-042 inhalation solutions in healthy subjects.

      Subjects will be enter a screening period of up to 14 days to determine eligibility. Subjects
      will be admitted to the Phase 1 unit the day prior to dosing and remain in the unit until 24
      hours post-dose. Subjects will be seen in the clinic at 3 and 7 days post-dose

      A modified 3+3 design will be used to determine the maximum tolerated dose (MTD) based on the
      occurrence of dose-limiting toxicities (DLTs) defined by Common Terminology Criteria for
      Adverse Events (CTCAE) v4. Additional specific DLTs will be defined as: 1) Hypoxia, defined
      as a non-artifactual drop in pulse oximetry to < 90% on room air, 2) A decrease in forced
      expiratory volume in one second (FEV1) of 12% or greater compared to the last observation
      prior to dosing, 3) Any evidence of bronchospasm or wheezing requiring medical intervention.
      Doses will be doubled until the maximum tolerated dose (MTD- defined as the largest dose with
      0/6 or 1/6 DLTs) is reached.
    

Intervention name(s): PUL-042 Inhalation Solution
Intervention type(s): Drug
Intervention MeSH terms: Pam2CSK4 acetate and ODN M362 combination
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Single ascending dose; Safety and tolerability in healthy subjects
Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim is to investigate the best treatment regime of PEG-Intron A and lamivudine
      combination in terms of viral clearance in chronic hepatitis B patients.
    

Detailed description: 
      Chronic hepatitis B is a major cause of mortality and morbidity in Hong Kong and most
      Southeast Asian countries. The efficacy interferon-alfa (IFN-alfa) or lamivudine monotherapy
      is far from satisfactory with approximately 20% sustained viral response. Extended use of
      lamivudine is associated with the emergence of drug resistance mutants. As interferon is an
      immune modulator and lamivudine directly suppresses viral replication, it is therefore
      logical to combine the 2 drugs for more efficient viral clearance.

      Previous studies on IFN-alfa and lamivudine combination treatment of chronic hepatitis B
      showed marginal benefit over lamivudine monotherapy. In these studies, lamivudine was either
      started 8 weeks prior to IFN-alfa or simultaneous with IFN-alfa. Recently, we have performed
      a study comparing the efficacy of polyethylene glycol-interferon alfa-2b (PEG-Intron A) and
      lamivudine versus lamivudine monotherapy for 1 year in the treatment of chronic hepatitis B.
      In our protocol, PEG-Intron A is started 8 weeks before the commencement of lamivudine, and
      PEG-Intron A is given for 32 weeks while lamivudine is given for a total of 52 weeks. Our
      published results suggested PEG-Intron A and lamivudine combination treatment is far superior
      to lamivudine monotherapy (end of treatment virological response 92% vs 20%, p=0.0015). We
      are not certain whether the benefit of PEG-Intron A and lamivudine combination in our study
      is due to our staggered regime, the superiority of PEG-Intron A over IFN-alfa, or both. The
      aim of this study is to investigate the best treatment regime of PEG-Intron A and lamivudine
      combination in terms of viral clearance.
    

Intervention name(s): Pegylated Interferon; Lamivudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Lamivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B; Pegylated Interferon; Lamivudine