bioihbjkbjnl/mcl2 huggingface dataset:
Immune Responses to the Flu Shot During Pregnancy
Condition: Pregnancy
Study type: Observational

Summary: 
      This study will examine effects of everyday life stress and obesity on immune responses to
      influenza virus vaccine (the flu shot) during pregnancy. Following vaccination, antibody
      levels against influenza (the flu) increase. Higher antibody levels indicate better immune
      protection from influenza. In addition to providing protection from the flu for yourself,
      being vaccinated during pregnancy may protect your baby from the flu during the first six
      months of life during which time infants cannot be vaccinated. Our primary goals are to
      determine whether greater life stress and obesity reduce 1) antibody responses to the flu
      shot in women and 2) antibody levels in the newborn at the time of delivery.
    


Intervention name(s): influenza virus vaccination
Intervention type(s): Biological
Intervention description(s): comparison of immune responses to the flu vaccine in obese and non-obese populations
Other intervention name(s): flu shot; influenza shot; flu vaccine
Intervention MeSH terms: Vaccines
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample, prenatal clinic
      
Biospecimen description: 
      serum whole blood plasma
    
Keywords: pregnant; flu shot; influenza; vaccine
To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients
Condition: COPD; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics
      of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic
      obstructive pulmonary disease.
    

Detailed description: 
      A Phase I, Randomized, DoubleBlind Placebo-Controlled Study to Investigate the Safety,
      Tolerability and Pharmacokinetics of Multiple Ascending Inhaled Doses (MAD) of AZD7624 to
      Healthy Subjects and Patients with COPD
    

Intervention name(s): AZD7624; Placebo to match
Intervention type(s): Drug; Drug
Intervention description(s): Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer; Multiple doses inhaled placebo via a nebulizer
Intervention MeSH terms: AZD7624
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1,; Safety,; Tolerability,; Healthy,; COPD patients
Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena
Condition: Pharyngitis
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      It has been proven that tracheal tube inflated with lidocaine could decrease the
      post-intubation sore throat in nitrous oxide anesthesia. In the study, the investigators
      would like to evaluate the effect of lidocaine inflation in non-nitrous oxide anesthesia and
      compare the effect of tetracaine, the best mucosal local anesthetics with lidocaine.
    

Detailed description: 
      The female patients receiving gynecological surgeries were divided into air, saline and 2%
      lidocaine and 1% tetracaine groups of 25 each using sealed envelope technique. The cuff of
      the endotracheal tube was inflated by the inflation medium (with the help of intracuff
      pressure monitoring device) to occlude the leak around the tube by the Minimal Occlusive
      Volume Technique. This was done by the same anaesthesiologist in all the patients. The cuff
      volume and pressure were then recorded. The primary outcome of the study was to evaluate the
      post-intubation sore throat using the visual analogue scale 6h, 24h and 48h after extubation.
      The secondary outcomes were incidence of complications during emergence of anesthesia and
      after extubation. Intra-cuff pressure monitoring was done with a pressure monitor, which
      consisted of the pressure gauge, three-way stopcock whose one end was attached to the
      pressure monitoring line. Net volume of the inflation medium was noted. Volume of the
      inflation medium, intra cuff pressure, duration from intubation to extubation and volume of
      the inflation medium withdrawn from the cuff was noted. Incidence (Yes/No) of tube
      intolerance, coughing on tube, restlessness, hoarseness, sore throat, breathlessness and
      laryngospasm were analyzed by the anaesthesiologist who did not know which group the patient
      belonged to.
    

Intervention name(s): 2% lidocaine; placebo; 1% tetracaine; N.S
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume; Air injected into the cuff to seal the space between the trachea and the tube at minimal volume; tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume; 0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume
Intervention MeSH terms: Lidocaine; Tetracaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: lidocaine; tetracaine; tracheal intubation; pharyngitis
Cognitive-behavioral Therapy for Insomnia in Adolescent Psychiatry
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The study is a clinical pilot study that examine the preliminary effect of
      cognitive-behavioral therapy for insomnia (CBT-I) in adolescents with comorbid psychiatric
      disorders. Participants (n=25) are recruited from three psychiatric clinics (n=19) and one
      pediatric pain clinic (n=6). After diagnostic assessment, participants that fulfil inclusion
      criteria are offered the CBT-I intervention. Pre-post and 3-months follow-up assessments
      include subjective measures of insomnia symptom severity, sleep parameters (collected through
      sleep-wake diaries), symptoms of depression and anxiety and daytime functioning.
    


Intervention name(s): CBT-I
Intervention type(s): Behavioral
Intervention description(s): The theoretical framework is cognitive-behavioral therapy that includes sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive interventions and relaxation. The intervention has been adapted to adolescents by reducing the amount of psychoeducational information and the interventions related to changing cognitions. It involves six weekly face-to-face individual sessions with a therapist, supported by a participant workbook that contains information, work- sheets, and at-home tasks. Clinical psychologists or graduate clinical psychologists in training delivered the intervention sessions under supervision by the first author. Parents/care-givers were given information about the components, but did not take active part of the intervention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
iPod Games in Hepatic Encephalopathy
Condition: Hepatic Encephalopathy; Cirrhosis
MeSH terms: Hepatic Encephalopathy; Brain Diseases; Fibrosis
Study type: Interventional

Summary: 
      To see if using ipod games can improve mental functioning
    


Intervention name(s): ipod games
Intervention type(s): Behavioral
Intervention description(s): Patients will be given ipod games for 4 weeks and tested in related and unrelated cognitive measures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic encephalopathy; covert hepatic encephalopathy; cirrhosis
Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To investigate effects of SAR440340 (anti-interleukin-33 [IL-33] monoclonal antibody [mAb])
      compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of
      COPD (AECOPD) over up to 52 weeks of treatment.

        -  Moderate exacerbations were recorded by the Investigator and defined as AECOPD that
           require either systemic corticosteroids (such as intramuscular, intravenous or oral)
           and/or antibiotics.

        -  Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring
           hospitalization, emergency medical care visit or resulting in death.

      Secondary Objectives:

      To investigate effects of SAR440340 compared with placebo, on improving respiratory function,
      as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1).

      To evaluate effects of SAR440340 compared with placebo, on post-bronchodilator FEV1.

      To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first
      moderate or severe AECOPD event.

      To evaluate effects of SAR440340 compared with placebo, on safety and tolerability.
    

Detailed description: 
      Study participation for each participant were up to a total of 46 weeks to 76 weeks including
      up to 10 days to 4 weeks of screening, 24-to-52 week treatment period on investigational
      medical product (IMP), and 20 weeks of post IMP treatment period.
    

Intervention name(s): SAR440340; Placebo; Any Inhaled Corticosteroids as prescribed by treating physician as standard of care; Any Long Acting Beta Agonist as prescribed by treating physician as standard of care; Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care; Any short-acting β agonist as prescribed by treating physician as standard of care
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: Solution for injection; Route of administration: SC; Pharmaceutical form: Solution for injection; Route of administration: SC; Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: Inhaled; Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled; Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled; Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: inhaled
Other intervention name(s): Itepekimab; REGN3500
Intervention MeSH terms: Cholinergic Agents; Muscarinic Agonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
BTT-1023 in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with adult-onset rheumatoid arthritis will be enrolled. They will be dosed with
      repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the
      treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to
      treatment groups will occur at random, and the actual treatment will not be revealed to the
      investigator or to the patient during the trial.
    


Intervention name(s): BTT-1023; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intravenous; Intravenous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rheumatoid arthritis; safety
Observation on the Curative Effect of Assisted Reproduction by TCM Multi-channel Interventional Therapy
Condition: Failure After Assisted Reproductive Technology
Study type: Interventional

Summary: 
      Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on
      women with ART Failure; to compare the curative effect of the dual therapy and triple therapy
      on women with ART Failure; to choose the best TCM interventional therapeutic plan.

      Methods: The cases with ART Failure from West China second University Hospital of Sichuan
      University (West China Women's and Children's Hospital of Sichuan University) meeting the
      inclusion criteria were randomly divided into three groups: the dual therapy group, the
      triple therapy group and the control group, compare the natural pregnancy number, the
      condition during the period of secondary IVF-ET and the improvement of the kidney deficiency,
      liver depression and blood stasis syndrome among those three groups.
    

Detailed description: 
      Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on
      women with ART Failure; to compare the curative effect of the dual therapy and triple therapy
      on women with ART Failure; to choose the best TCM interventional therapeutic plan.

      Methods: The cases with ART Failure from West China second University Hospital of Sichuan
      University (West China Women's and Children's Hospital of Sichuan University) meeting the
      inclusion criteria were randomly divided into three groups: the dual therapy group, the
      triple therapy group and the control group, compare the natural pregnancy number, the
      condition during the period of secondary IVF-ET and the improvement of the kidney deficiency,
      liver depression and blood stasis syndrome among those three groups.

      The results will show the effect of TCM multi-channel interventional therapy for patients
      with ART failure
    

Intervention name(s): The dual therapy; The triple therapy
Intervention type(s): Other; Other
Intervention description(s): TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy; TCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TCM multi-channel therapy; ART failure
Safety and Efficacy of DNK333 in Atopic Dermatitis Patients
Condition: Pruritus in Patients With Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis
      suffering from pruritus, who require systemic treatment of the disease.
    


Intervention name(s): DNK333 5 mg; Placebo to 5 mg; DNK333 25 mg; Placebo to 25 mg; DNK333 100 mg; Placebo to 100 mg; Betamethasone 4 mg; DNK333 1mg; Placebo to 1mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg oral; 5 mg placebo oral; 25 mg oral; 25 mg placebo oral; 100 mg oral; 100 mg placebo oral; 4 mg oral; 1 mg oral; 1 mg placebo oral
Intervention MeSH terms: Betamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dermatitis; inflammatory skin disease; itch; eczema
A Study for Schizophrenia Relapse Prediction
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The purpose of this study is to identify if there are self-reported/caregiver reported or
      objective measures that can predict near-term relapse (within 1 month or at another
      identified time point before meeting the criteria for relapse) or early symptomatic changes
      indicative of pre-relapse.
    


Intervention name(s): Oral Antipsychotics (OAP)
Intervention type(s): Drug
Intervention description(s): This is an observational study. Participants enrolled in this study will continue to receive routine treatment of OAPs for example, risperidone (1 to 6 mg OD to BID), olanzapine (5 to 20 mg OD), haloperidol (5 to 20 mg OD to TID) etc, as directed by their treating physician.
Intervention MeSH terms: Antipsychotic Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with clinical diagnosis of schizophrenia receiving an oral antipsychotic (OAP)
        treatment regimen directed by their treating clinician will be observed.
Glucolipotoxicity and Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Elevations of blood glucose and lipid are thought to be deleterious to the insulin secretory
      function of the pancreas. This is known as glucolipotoxicity. However, few studies have
      examined this in detail. This investigation will examine pancreatic insulin secretory
      function in physiological models of glucolipotoxicity such as obese and type 2 diabetic
      individuals. Furthermore, healthy subjects will undergo 24 hour infusion of glucose or
      Intralipid to induce experimental models of glucolipotoxicity. Insulin secretion in response
      to intravenous infusions of glucose, GLP-1, GIP, and arginine and in response to meal
      ingestion, will be examined. the investigators hypothesize that experimental
      glucolipotoxicity will impairs pancreatic insulin secretory function to levels akin to that
      seen in type 2 diabetics.
    


Intervention name(s): Glucotoxicity; Lipotoxicity
Intervention type(s): Procedure; Procedure
Intervention description(s): Glucose will be infused intravenously for a 24 hour period to raise blood glucose concentrations 5 mM above basal.; Intralipid and heparin will be infused intravenously for a 24 hour period to raise blood free fatty acid concentrations to approximately 1 mM.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: diabetes; incretin; beta-cell function; glucolipotoxicity; glucagon-like peptide 1; glucose-dependent insulinotropic polypeptide
Effect of Yellow-Tinted Intraocular Lens on Standard Automated Perimetry (SAP) and Short-wavelength Automated Perimetry (SWAP) in Patients With and Without Glaucoma
Condition: Cataract; Glaucoma
MeSH terms: Glaucoma; Cataract
Study type: Interventional

Summary: 
      To investigate the effect of yellow-tinted IOLs on the Short Wave-length Automated Perimetry
      (SWAP) and Standard Automated Perimetry (SAP) in patients with and without glaucoma.
    

Detailed description: 
      Glaucoma is mostly a disease of old people and is highly accompanied with cataract.Some of
      these patients may need to perform cataract surgery during the course of glaucoma. But in
      glaucoma patients, the effect of cataract surgery and/or type of implanted intraocular lens
      (IOL) on the results of specific visual field tests, like SWAP, is still not well
      studied.From the past decade, various yellow-tinted IOLs with the speculation of protecting
      the retinal photoreceptors and decreasing the incidence of age-related macular degeneration
      have been introduced.These blue-light-filtering IOLs contain a yellow chromophore that
      filters ultra violet (UV) and a larger part of the high-energetic visible blue-light between
      380 and 500 nm. Based on previous studies yellow-tinted IOLs decrease the amount of light
      transmission to the retina which may theoretically affect perimetry results. This might be
      even more important in patients with glaucoma where the sensitivity of test locations has
      decreased per se.

      Since early diagnosis of glaucoma and its progression is highly dependent on visual field
      results, it is important to evaluate the effect of these IOLs on perimetry, particularly on
      SWAP, in which the blue-light-filtering IOLs might interfere with its findings.
    

Intervention name(s): Phacoemulsification with yellow-tinted intraocular lens; Phacoemulsification with yellow-tinted intraocular lens
Intervention type(s): Procedure; Procedure
Intervention description(s): Phacoemulsification is a kind of cataract surgery using ultrasound machine. Yellow-tinted intraocular lens are a sort of lens with the ability to filter blue and ultraviolet spectrum of light (380-500 nanometer); Phacoemulsification is a kind of cataract surgery using ultrasound machine. Yellow-tinted intraocular lens are a sort of lens with the ability to filter blue and ultraviolet spectrum of light.
Other intervention name(s): bluelight filteing intraocular lens; bluelight filteing intraocular lens
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Open angle Glaucoma; Yellow-tinted intraocular lens; Short-wavelength Automated Perimetry (SWAP); Standard Automated Perimetry (SAP); cataract
Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score
      5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics,
      safety and tolerability of nintedanib, in comparison with a control group with normal hepatic
      function following oral administration of nintedanib as single dose.
    


Intervention name(s): Nintedanib; Nintedanib; Nintedanib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Soft gelatine capsule; Soft gelatine capsule; Soft gelatine capsule
Intervention MeSH terms: Nintedanib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment