bioihbjkbjnl/mcl2 huggingface dataset:
The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women
Condition: Ketamine; Lactation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Quantification of Ketamine in Breast Milk at 3 hour Intervals up to 30 hours-- obtained from
      lactating women who receive 2 different Intramuscular injections of ketamine on two separate
      days at least 5 days apart.
    

Detailed description: 
      Quantification of Ketamine in Breast Milk at 3 hour Intervals up to 30 hours-- obtained from
      lactating women who receive 2 different Intramuscular injections of ketamine on two separate
      days at least 5 days apart: 0.5mg/kg and 1.0mg kg.

      Women are required to have been breast feeding for at least 3 months and be healthy and on no
      medications. Support is provided for the entire time at the site and for any at home pumping.
      During the period of ketamine's influence, subjects are reclining and with 2 Investigators.
      The initial subject's data will determine the length of time for pumping--most likely 12
      hours as ketamine and the active principle metabolite have half-lives of less than 3 hours.
      Determination of concentration of ketamine in breast milk is being done at the UCSF Clinical
      lab with quantification of metabolites that are inactive as well. This research is of benefit
      by providing lactating women information on potential exposure of infants/children to
      ketamine. It will serve as a guide as KRF conducts research on postpartum depression and for
      women at large using ketamine for psychiatric indications.
    

Intervention name(s): ketamine in lactation
Intervention type(s): Drug
Intervention description(s): 2 dose IM by weight and assessing concentrations of ketamine in expressed milk at intervals
Other intervention name(s): Assessing concentration of ketamine in breast milk at intervals
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Intervention model description: 4 subjects receiving 0.5mg/kg and 1.0mg/kg of ketamine at least 5 days apart with collection of breast milk by pumping at 3 hour intervals
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ketamine; lactation; postpartum depression; breastfeeding; infant exposure
Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain
Condition: Acute Pain; Bunion; Abdominoplasty
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or
      post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out
      of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For
      subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of
      4 subjects will receive placebo.
    


Intervention name(s): Wafermine™ 50 mg; Wafermine™ 75 mg; Placebos; Wafermine™ 25 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered as needed for 12 hours; Administered as needed for 12 hours; Administered as needed for 12 hours; Administered as needed for 12 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      Improving medical compliance and health-related quality of life (HRQoL) among people with
      epilepsy (PWE) has become the focus of various treatment programs and behavioral
      interventions which continue to be challenging to both patients and health care
      professionals.

      In order to design an effective intervention on the management of epilepsy, the drug
      management of epilepsy by community health workers was evaluated.
    


Intervention name(s): Community support group; Printed material Supported
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity
      of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare
      the time course of drug concentrations in the body, safety and tolerability of CP-945,598
      given with or without grapefruit juice in healthy obese/overweight subjects.
    


Intervention name(s): CP-945,598; CP-945,598
Intervention type(s): Drug; Drug
Intervention description(s): Subjects take CP-945,598 alone for 21 days; Subjects take CP-945,598 from Days 1 to 7, then take CP-945,598 and Grapefruit Juice from Days 8 to 21
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Safety,Tolerability,Pharmacodynamics & Pharmacokinetics of JTE-451 in Active Plaque Psoriasis Subjects
Condition: Plaque Psoriasis; Psoriasis; Skin Diseases
MeSH terms: Psoriasis; Skin Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effect of
      JTE-451 administered for 4 weeks in subjects with active plaque psoriasis.
    


Intervention name(s): JTE-451; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active drug tablets containing JTE-451; Placebo tablets identical in appearance to the active drug tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: JTE-451; psoriasis
A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      A 6-week in-patient and out-patient study to test the effectiveness and safety of a new
      medication in the treatment of schizophrenia
    

Detailed description: 
      Study will evaluate the efficacy of a new compound versus placebo in the treatment of
      patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from
      baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from
      the Positive and Negative Syndrome Scale (PANSS).
    

Intervention name(s): Lurasidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg AM dosing once daily; Matching Placebo to 40mg lurasidone tablets
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Latuda; Lurasidone
Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children
Condition: Meningitis; Meningococcemia
MeSH terms: Diphtheria; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study investigated safety profile and the antibody responses to an experimental
      tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have
      received a monovalent meningococcal C conjugate vaccine at least one year previously.

      Primary objective:

      To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C
      in participants receiving Menactra® to the serogroup C antibody response in a control group
      of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28
      days following vaccination.
    


Intervention name(s): Meningococcal Polysaccharide Diphtheria Toxoid Conjugate; Haemophilus Influenzae Type b (Hib) vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Hiberix®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcemia; Neisseria meningitidis
The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer
Condition: Endometrial Receptivity
Study type: Interventional

Summary: 
      This project seeks to demonstrate the clinical value of the personalised diagnosis of the
      endometrial factor in infertility.
    

Detailed description: 
      This project seeks to investigate differences in implantation (IR), pregnancy (PR), ongoing
      pregnancy (OP) rates, miscarriages, deliveries (LB) and obstetrical, delivery and neonatal
      outcomes among women undergoing IVF treatment with own oocytes, at first site appointment (up
      to 3 previous implantation failures in other sites) and blastocyst stage (day 5 or 6).
      Patients are allocated through computer-generated randomization into one of the three groups:
      Fresh embryo transfer (ET), Frozen embryo transfer (FET) or personalized embryo transfer
      (pET) after identification of the personalized window of implantation using the endometrial
      receptivity analysis (ERA) test, all of them following the usual clinical practice in a
      same-cycle embryo transfer.

      A total of 546 infertile women under 38 years old undergoing her first IVF/ICSI cycle with
      elective blastocyst transfer are randomized in this prospective, multicenter, open label and
      controlled trial.
    

Intervention name(s): personalized Embryo Transfer (pET); Frozen Embryo Transfer (FET); Fresh Embryo Transfer (ET)
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Window of implantation; Personalized embryo transfer; Fresh embryo transfer; Delayed embryo transfer; Elective deferred embryo transfer; Endometrial receptivity array; Endometrial receptivity analysis; Endometrial receptivity test; Frozen embryo transfer
Quality of Life in Pediatric Inflammatory Bowel Disease
Condition: Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Measurement of the quality of life (QoL) of children and adolescents with inflammatory bowel
      diseases (IBD) has had little attention, despite the importance of understanding key factors
      affecting QoL, especially for measuring the effects of clinical trials to improve IBD
      outcomes. The main purpose of this pilot study is to examine the impact of clinical severity
      and treatment social factors on the quality of life (QoL) of a diverse population of children
      and adolescents with inflammatory bowel disease (IBD). Secondary purposes include determining
      the effects of sociodemographic factors on QoL and exploring the concordance of views of
      parents and children of QoL. The study aims are to 1) determine the associations of of
      clinical characteristics (condition type, activity/severity, and treatment) with specific
      components of general health-related quality of life and IBD-specific QoL; 2) describe the
      effects of sociodemographic characteristics (SES, age, and gender) on these measures; and 3)
      compare the views of different observers (parent and child with IBD) of the child's QoL. The
      study will apply both general and condition-specific QoL measures among a random sample of
      250 children and adolescents with IBD, ages 5-18 years, in six clinical sites. We will obtain
      measures of QoL from both the child and a parent in each case. The study will obtain
      additional data regarding the subjects' clinical condition (condition type,
      severity/activity, treatment [including surgery], age of onset) and socioeconomic status
      (household structure and income). Main analyses will compare general and specific measures of
      QoL and examine the influence of clinical and sociodemographic variables on QoL, through
      multivariate regression techniques. We will also examine the differences in child and parent
      assessments of QoL. The information from this study will provide a stronger base for future
      studies of treatment and natural history of IBD. It will help to clarify the life domains
      that are affected by IBD and will inform interventions to improve QoL for children with IBD.
    


Time perspective: Retrospective
Keywords: Pediatric IBD; Inflammatory; Bowel
Two Doses of GHB04L1 for Pandemic Influenza Prophylaxis in Healthy Adults
Condition: Influenza, Avian
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates safety, tolerability and immunogenicity of two doses of GHB04L1, a
      liquid formulation of the replication- deficient influenza A/Vietnam/1203/04(H5N1)-like ∆NS1
      virus in healthy adults. Subjects are randomised at a ratio of 2:1 for GHB04L1 (6.8 log10 or
      7.5 log10 TCID50/dose/volunteer) or placebo.
    

Detailed description: 
      GHB04L1 is intended to provide a novel treatment approach for influenza virus H5N1 infection.
      Based on preclinical data from ferrets that demonstrated protection against challenge with
      wild-type virus following treatment with various dose levels of GHB04L1, vaccination with
      GHB04L1 might protect humans from influenza A (H5N1) virus infection.

      Due to the lack of the NS1 protein, the ΔNS1 virus replicates efficiently in
      interferon-deficient cells but has lost its ability to grow in normal hosts and organisms.
      Immunisation with ΔNS1 mutant virus can cause only an abortive replication cycle in the nasal
      mucosa of vaccinated individuals. This allows development of replication-deficient intranasal
      vaccines with genetic stability of the attenuated phenotype and without virus shedding.
    

Intervention name(s): GHB04L1; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Solution; Buffer solution
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Visual Perceptual Learning for the Treatment of Visual Field Defect
Condition: Visual Fields Hemianopsia; Hemianopsia, Homonymous
MeSH terms: Hemianopsia
Study type: Interventional

Summary: 
      This study evaluates the efficacy of visual perceptual learning for the treatment of visual
      field defect caused by brain damage. Half of participants will receive visual perceptual
      training using the Nunap Vision, while the other half will receive sham training using the
      Nunap Vision-C.
    


Intervention name(s): Nunap Vision; Nunap Vision-C
Intervention type(s): Device; Device
Intervention description(s): Participants receive visual perceptual training using the Nunap Vision software; Participants receive sham training using the Nunap Vision-C software
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Visual field defect; visual perceptual learning; Humphrey visual field
Exercise Trial in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated
      with impairment in cognition and physical function. The purpose of this study is to test the
      effects of 12 months of aerobic and resistance exercise training compared to health education
      on cognitive and physical performance in 120 older adults with CKD not requiring dialysis.
      The results of this study will be essential for demonstrating the effectiveness of exercise
      in improving function and ultimately preventing disability in this high-risk population of
      older adults.
    

Detailed description: 
      This is a parallel-group randomized controlled trial comparing 12 months of aerobic and
      resistance exercise training vs. health education (attention control) on neurocognitive and
      physical performance among community-dwelling older adults (age >55) and CKD stage 3b and 4.
      Co-primary outcomes are change in physical performance (including aerobic capacity and
      submaximal walking) and neurocogntive performance (including executive functions).

      Outcome measures will be assessed at baseline and after 6- and 12 months. Exercise training
      will occur thrice weekly at a dedicated research exercise center and will be supervised by
      exercise specialists.
    

Intervention name(s): Aerobic exercise training; Health Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 months of aerobic exercise; 12 months of health education sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Chronic kidney disease; Exercise; Aerobic capacity; Learning and memory; Executive function; Endothelial function
DDI Study With Multiple-dose LX4211 and Single Dose Digoxin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted as a single-center, open-label, 2-period, single-sequence,
      drug-drug interaction study to assess the effects of multiple dose LX4211 (400 mg
      administered as 2 × 200-mg tablets qd × 12 days) on the PK of single-dose digoxin (2 ×
      0.25-mg tablets) in healthy male and female subjects.
    


Intervention name(s): Treatment A digoxin; Treatment B LX4211; Treatment C Digoxin + 400 mg LX4211 administered concomitantly
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5 mg digoxin administered on Day 1 and Day 20; 400 mg LX4211 administered daily on Day 14 through Day 25; 0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Digoxin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis
Condition: Aortic Valve Disease
MeSH terms: Aortic Valve Disease
Study type: Observational

Summary: 
      The overall project aim is to study outcomes following aortic valve replacement with
      surgically implanted bioprostheses or TAVI by retrieving data from the main social security
      carriers in Austria for the years 2010-2020.
    


Intervention name(s): Aortic Valve Replacement
Intervention type(s): Device
Intervention description(s): Aortic Valve Replacement (surgically or TAVI)
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who underwent isolated aortic valve replacement in Austria (surgically
        implanted bioprostheses or TAVI) above 65 years of age with no other concomitant heart
        surgery and no coronary revascularization within 4 months before the index procedure were
        included.
Intubation on a Paediatric Manikin by Emergency Staff: a Comparison of Airtraq and Glidescope
Condition: Difficult Intubation
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      After Local Human Research Ethics Committee approval, emergency medical staff enrolled in
      this study. After watching a video about the intubation using Airtraq, Glidescope or direct
      laryngoscopy, they attempted to intubate a pediatric manikin in three different airway
      models.
    

Detailed description: 
      After Local Human Research Ethics Committee approval, emergency medical staff enrolled in
      this study. After watching a video about the intubation using Airtraq , Glidescope or direct
      laryngoscopy, they attempted to intubate a pediatric manikin in three different airway
      models; normal airway, tongue edema and an entrapped model by face-to-face approach.
      Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades and
      the need for maneuvers of these devices were recorded.
    

Intervention name(s): Airtraq; Glidescope; direct laryngoscopy
Intervention type(s): Device; Device; Device
Intervention description(s): videolaryngoscope for difficult airway; videolaryngoscope for difficult airway; gold standart for intubation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Airtraq; Glidescope; pediatric; face-to-face
Investigation of Safety+Efficacy of Different Doses of RagweedMATAMPL;Assessment of Residual Allergenicity Using Skin Prick Test
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the immunological differences between three
      RagweedMATAMPL treatment arms compared to placebo with respect to immunoglobulin levels.

      In addition, the study will assess the reduced allergenicity of modified Ragweed Pollen
      contained in RagweedMATAMPL compared to unmodified native allergen using skin prick testing.
    


Intervention name(s): RagweedMATAMPL
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergy; Specific Immunotherapy