bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability and Pharmacokinetic Study of LTI-03 in Healthy Adult Subjects
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study will investigate the initial safety, tolerability, and PK profile of
      inhaled LTI-03 in healthy volunteers. In order to minimize exposure, the study will first
      test single ascending doses (SAD) of LTI-03 followed by multiple ascending dose (MAD)
      cohorts.

      Findings from this study will direct the clinical development of LTI-03 for the treatment of
      IPF

      The study subject population will include normal healthy male and female volunteers between
      18 and 55 years of age (inclusive).

      Consistent with other trials involving inhaled medication, subjects must have normal
      pulmonary function at Screening and will be excluded if they have a history of active or
      recurring allergies, asthma, chronic obstructive pulmonary disease (COPD), chronic sinus
      drainage, chronic or acute cough or other respiratory condition deemed exclusionary by the
      Investigator. History of liver dysfunction or elevated bilirubin, alanine aminotransferase
      (ALT) or aspartate aminotransferase (AST) values at Screening will also be grounds for
      exclusion.
    


Intervention name(s): Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LTI-03, a Caveolin-1 scaffold protein-derived 7-amino acid peptide to be administered as a dry powder by inhalation through a dry powder inhaler.; Matching placebo is micronized lactose powder administered by inhalation through a dry powder inhaler.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The first part of the study will follow a Single Ascending Dose design. Subjects receive a single dose of double-blind study medication (investigational medicinal product LTI-03 or placebo) on Day 1.
For each dose level cohort, two eligible sentinel subjects will be randomized in a 1:1 ratio to receive active:placebo study medication.
If no tolerability issues are observed by the Investigator within 48 hours post-dose, dosing will commence for the remaining six subjects in the cohort, who will be randomized in a 5:1 ratio to receive active:placebo study medication.
The second part of the study will follow a Multiple Ascending Dose design. Subjects receive double-blind study medication (LTI-03 or placebo) once-daily from Day 1 to Day 14.
For each dose level cohort, eight eligible subjects will be randomized in a 6:2 ratio to receive active:placebo study medication.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Inflammatory Biomarkers for the Diagnosis of oPRES
Condition: Posterior Reversible Encephalopathy Syndrome; Inflammatory Biomarkers; Neutrophil-lymphocyte Ratio
MeSH terms: Brain Diseases; Posterior Leukoencephalopathy Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to explore the inflammatory biomarkers for the diagnosis of
      obstetric posterior reversible encephalopathy syndrome.
    

Detailed description: 
      The investigators retrospectively collected data (General information, clinical data,
      biochemical indicators, imaging features, and pregnancy outcome) from pregnant woman
      diagnosed with PRES to explore the inflammatory biomarkers for the diagnosis of oPRES during
      2012 to 2021.Then, the investigators grouped all the patients into PRES group (PE or E with
      PRES) and NOT-PRES group (PE or E without PRES) according to the diagnostic criteria of PRES.
      Then, the investigators analysed the inflammatory biomarkers, such as neutrophil-lymphocyte
      ratio (NLR), platelet-lymphocyte ratio (PLR), monocyte-lymphocyte ratio (MLR), and so on of
      two groups, and compared the difference of tow groups.
    

Intervention name(s): Whether the PE or E patient combined with PRES
Intervention type(s): Other
Intervention description(s): According to the Diagnostic criteria of PRES, all the patients grouped into two groups.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant Women diagnosed with PE or E.
A Comparison of Supraglottic Airway Devices
Condition: Airway Management
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aimed to compare the advantages and disadvantages of LMA Supreme, LMA Classic and
      LMA Fastrach regarding ease of insertion, repositioning, insertion time, effects on
      hemodynamic parameters, provision of adequate and safe airway, and oropharyngeal and systemic
      complications.
    

Detailed description: 
      As a result of studies regarding the provision of an airway which is less invasive than
      intubation but safer than mask to maintain patency of airway after anesthesia induction in
      brief surgical interventions, supraglottic airway devices have been introduced into practice.
      They are inserted to glottic entry via the oral route and can be used in emergent conditions
      where tracheal intubation and mask anesthesia are challenging.

      Classic LMA was first introduced by Archie Brain, MD in 1988, and consists of a mask with a
      surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a
      30° angle with a mask.

      Fastrach LMA ( LMA Fastrach: LMA North America. Inc. San Diego. CA) was first introduced in
      1997 and has similar features to the LMA Classic, but it is designed to provide upper airway
      during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that
      allows one-handed insertion, removal or adjustment.

      Supreme LMA, first introduced in April, 2007, is a novel, sterile, single use, new generation
      supraglottic airway device which provides more rapid and higher volume gas passage through
      airway and can be inserted in a rapid and safe manner because of the advanced cuff and airway
      tube. The integrated gastric canal facilitates gastric aspiration.

      Supraglottic airway devices seem to have advantages over each other in different aspects due
      to their distinct features. In literature, there are studies comparing various LMA types for
      different features. However, to best of our knowledge, there is no study comparing these 3
      types of LMA regarding these parameter. This is the main point of difference of our study.
    

Intervention name(s): LMA CLASSIC; LMA FASTRACH; LMA SUPREME
Intervention type(s): Device; Device; Device
Intervention description(s): Classic LMA consists of a mask with a surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a 30° angle with a mask.; Fastrach LMA has similar features to the LMA Classic, but it is designed to provide upper airway during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that allows one-handed insertion, removal or adjustment.; Supreme LMA is a novel, sterile, single use, new generation supraglottic airway device which provides more rapid and higher volume gas passage through airway and can be inserted in a rapid and safe manner.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Laryngeal Masks
Osteopathic Manipulation Therapy in the Treatment of Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Study type: Observational

Summary: 
      As a safe and noninvasive method of treatment, the intent of the study is to show that
      Osteopathic manipulation therapy is a beneficial treatment for the aggravating bladder
      symptoms seen in all patients with interstitial cystitis.
    

Detailed description: 
      The management of interstitial cystitis is predominantly based on the reduction of the
      symptoms of frequency, urgency, and pain.In addition to Osteopathic manipulation Other
      conservative treatments frequently include dietary modification, pharmaceuticals, bladder
      training, neuromodulation, and stress reduction. The goal of Osteopathic manipulation is to
      relax the pelvic muscles used by the bladder and improve the flow of blood and lymph fluid to
      this region, which may result in easing pain and discomfort associated with cystitis.Some
      physicians have found that Osteopathic Manipulation works for some people as an alternative
      to surgery. A secondary objective will be to determine if the increased attention and power
      of touch are as effective as OMT in treating patients with interstitial cystitis based on the
      results of using attention control treatment in some patients.Thus, this is a pilot study
      comparing OMT to an attention control arm and standard of care arm of treatment.We will
      review palpatory visceromatic reflex changes as documented by tissue texture changes,
      asymmetry, restriction of motion and tenderness pre and post treatment.Physical examination
      including detailed musculoskeletal examination of the lumbosacral region will be performed
      pre and post and then compared the results.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A sample of 60 patients that have a confirmed diagnosis of Interstitial Cystitis as
        patients of Urological Surgical Associates and Charleston Area Medical Center (CAMC) based
        on current diagnostic recommendations. The patients will be selected based on their
        clinical history of interstitial cystitis.
      
Keywords: Osteopathic Manipulation
Task-oriented Circuit Class Training in Multiple Sclerosis Subjects
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Aims of the study:

      This is a single blind randomized-controlled trial to test the feasibility and the effects of
      a task oriented training on locomotor function, mobility and balance in multiple sclerosis
      subjects with moderate gait impairments (EDSS 4 - 5,5). The control group will not be treated
      with a specific physical therapy (usual care).

      Subjects and methods:

      60 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic
      (Azienda Ospedaliero-Universitaria di Ferrara).

      Informed consent will be obtained. Participants will be randomized to (TOCT) task-oriented
      training (experimental group) or usual care (control group) through a randomization
      stratification approach, according to a block randomization of 6.

      The experimental group will receive 10 task-oriented training sessions over 2 weeks (5
      sessions/week=intensive training). Three subjects with a supervisor physiotherapist will take
      part at the TOCT.

      Feasibility outcome will be measured with a specific questionnaire. Treatment efficacy
      outcome measures will be clinical test for gait speed (10m walking test), walking endurance
      (six minute walking test), balance (Dynamic Gait Index) and mobility (Time Up and Go Test); a
      structured interview for the performance(Lower Extremity Mal); self-assessment questionnaire
      for motor fatigue (Fatigue Severity Scale FSS), multiple sclerosis physical and psychological
      impact (multiple sclerosis impact scale MSIS-29), walking ability (multiple sclerosis walking
      scale MSWS-12).

      Outcome measures will be assessed the week before the treatment (T0), after the treatment
      (T1) and at 3 months follow-up (T2) to evaluate treatments retention, by a clinician blinded
      to the treatment.
    


Intervention name(s): Task-oriented circuit class training; usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5 sessions/week over 2 weeks (10 sessions) 120 minutes/each; no specific rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; gait rehabilitation
A Study of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to characterize the inflammatory response to lipopolysaccharide
      (LPS; molecules that contains fats and carbohydrates) in the presence of a targeted immune
      pathway modulator.
    


Intervention name(s): Adalimumab; Lipopolysaccharide (LPS)
Intervention type(s): Drug; Drug
Intervention description(s): Adalimumab will be administered subcutaneously.; LPS will be administered intravenously.
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess how blood clotting and thinning time is effected when
      a single dose of warfarin is given alone and when a single dose of warfarin is given with
      mipomersen; to assess the blood levels of a single dose of warfarin, a single dose of
      mipomersen, and a single dose of warfarin when given with mipomersen; and to assess the
      safety of mipomersen when given with or without warfarin.
    

Detailed description: 
      This will be a Phase 1, open-label, single-sequence, 2-period, crossover study to determine
      the effect of multiple doses of mipomersen (200 mg SC given every other day for a total of 4
      doses) on the PD and PK of warfarin and to evaluate the PK of mipomersen when administered
      alone and in combination with warfarin. Subjects will be admitted to the clinic on Day -1
      until discharge from the clinic on Day 18 and return for outpatient visits on Days 19, 20,
      and 78. All subjects will receive a single 25-mg oral dose of warfarin given alone on Day 1
      (designated the reference treatment). All subjects will then receive 200-mg SC doses of
      mipomersen given every other day on Days 8, 10, 12, and 14 (total of 800 mg mipomersen) with
      a single 25-mg oral dose of warfarin also given on Day 14 (combination designated the test
      treatment).
    

Intervention name(s): warfarin sodium; mipomersen sodium; warfarin sodium
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg of warfarin oral (single dose); 200 mg of mipomersen subcutaneous (SC) (4 doses) plus a single 25 mg of warfarin oral administered with the final mipomersen SC dose
Other intervention name(s): Coumadin®; Coumadin®
Intervention MeSH terms: Warfarin; Mipomersen
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ISIS301012; antisense; ApoB (Apolipoprotein B); LDL (low density lipoprotein); mipomersen
A Trial Comparing Two Pertussis-containing Vaccines in Pregnancy and Vaccine Responses in UK Mothers and Their Infants
Condition: Responses to Infant Immunisations
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 4

Summary: 
      Due to an unexpectedly high number of infant deaths from whooping cough in 2012, the
      Department of Health acted to protect newborns between birth and completion of primary
      immunisations, the period with greatest risk of disease.

      Vaccination of pregnant women with whooping cough vaccine in the third trimester of pregnancy
      was instigated nationally, so that antibodies produced by the Mum would cross the placenta to
      the unborn child, giving them passive protection at the most vulnerable time. This antibody
      transfer has been known for some time but has not been compared between the two whooping
      cough vaccines being used in pregnancy. Any effect the raised antibody might have on infant
      responses to the vaccines given in the first few months of life has also not been measured.
      This is particularly important as the infant immunisations include some of the same
      components as the whooping cough vaccines, which include diphtheria, tetanus and polio.
      Previous studies have shown that high levels of antibody prior to vaccination may affect
      subsequent antibody responses. It is therefore important to assess whether administration of
      the whooping cough vaccine in pregnancy adversely affects the protection afforded by the
      infant vaccines, particularly to those which are similar, namely tetanus and diphtheria as
      well as meningitis C and Hib vaccines which include diptheria and tetanus components in their
      structures. This study will assess immune responses of mothers and their babies (~200 pairs)
      to their vaccinations and will allow the comparison of two whooping cough vaccines being used
      in pregnancy. This will be done by taking small amounts of blood, which is the only way to
      measure antibody levels (the proxy of the immune response), before and after the
      vaccinations. A group of unvaccinated women and their babies (50 pairs) will also be
      recruited to allow comparison of their immune responses.
    


Intervention name(s): Repevax; Boostrix-IPV
Intervention type(s): Drug; Drug
Intervention description(s): vaccine; vaccine
Other intervention name(s): Pertussis containing vaccine; Pertussis containing vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pertussis; maternal vaccination; maternal immunisation; immune response
Four-hour Glycemic Kinetic Response Following 13C-enriched Oatmeal Breakfast Compared to Hot Corn Grits
Condition: Glycemic and Insulinemic Response
Study type: Interventional

Summary: 
      The objectives of this study are to assess the 4 hr postprandial kinetics of total and
      exogenous glucose in response to consumption of oatmeal containing a high percentage of the
      viscous agent β-glucan, in comparison to a β-glucan free corn cereal that is matched by grams
      of available carbohydrate.
    


Intervention name(s): Oatmeal; Corn grits
Intervention type(s): Other; Other
Intervention description(s): Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence; Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of multiple doses of seltorexant compared
      with placebo on respiration during sleep in adult participants with mild to moderate
      obstructive sleep apnea.
    


Intervention name(s): Seltorexant 40 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.; Matching placebo to seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.
Other intervention name(s): JNJ-42847922
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0123-0338 in Healthy Subjects and in Subjects With Type 1 Diabetes Mellitus
Condition: Healthy; Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The purpose is to evaluate safety and tolerability of a
      range of single doses of subcutaneous insulin 338.
    


Intervention name(s): Insulin 338; placebo; Insulin 338; insulin glargine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).; Healthy subjects will receive a single dose of placebo. Injected subcutaneously (under the skin).; Subjects with type 1 DM will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).; Subjects with type 1 DM will receive 0.4 U/kg insulin glargine once daily for 4 days. Injected subcutaneously (under the skin).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetic and Safety Study of LY03004 in Stable Patients With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetics (PK) of LY03004 following
      an escalating single intramuscular injection at 12.5, 25, 37.5, or 50 mg; and to evaluate the
      safety and tolerability and preliminary efficacy of LY03004 following intramuscular
      injection.
    


Intervention name(s): LY03004
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective disorder
Intracranial Pressure Waves Via Lumbar Puncture
Condition: Idiopathic Normal Pressure Hydrocephalus
MeSH terms: Hydrocephalus; Hydrocephalus, Normal Pressure
Study type: Observational

Summary: 
      Patients are subjected to simultaneous intracranial and lumbar puncture pressure
      measurements. This study focus on intracranial pulse amplitude. Hypothesis: Intracranial
      pressure amplitude is reflected by lumbar puncture pressure amplitude.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with idiopathic normal pressure hydrocephalus