bioihbjkbjnl/mcl2 huggingface dataset:
Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients
Condition: NSCLC
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare icotinib with induction and maintenance chemotherapy
      in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR
      mutation.
    

Detailed description: 
      This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based
      first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with
      EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall
      survival, time to progression, and so on.
    

Intervention name(s): Icotinib; Chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Icotinib: 125 mg is administered orally three times per day.; First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
Other intervention name(s): BPI-2009; Conmana; ALIMTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
This Study Tests BI 1467335 in Healthy Japanese and Caucasian Men. The Study Tests How Different Doses of BI 1467335 Are Taken up in the Body and How Well They Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the safety and tolerability of
      BI 1467335 in healthy Japanese male subjects following oral administration of multiple rising
      doses The Caucasian group will receive higher dose only.

      A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI
      1467335 in healthy Japanese and Caucasian male subjects.
    


Intervention name(s): BI 1467335; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Duration - 28 days; Duration - 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vitamin D Supplementation and Regulatory FoxP3+ T Cells in the GUT
Condition: Immune Tolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      In this pilot study the investigators aim to investigate the effects of vitamin D
      supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women
      and men.
    

Detailed description: 
      This is a monocentric, open pilot study, with the aim to evaluate the effect of vitamin d
      supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women
      and men.

      The primary goal is to evaluate the influence of vitamin D supplementation on the regulatory
      FoxP3+ T cells in the gastrointestinal mucosa under controlled conditions within 2 months.

      The secondary study goals are to evaluate the effect of vitamin D supplementation on
      peripheral induced tregs and on other important immune cells in the tissue (NK, NKT cells and
      LPCD) and in the blood (NK, NKT cells, Th17, Th1, Th2 cells) within 2 months.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): weekly dose (based on 70IU KG body weight/day)
Other intervention name(s): Oleovit D3
Intervention MeSH terms: Cholecalciferol; Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vitamin D; regulatory T cells; GUT
Pain Detecting and Analgesic Stimulating Device on Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Purpose of study is to test in a randomized controlled trial (RCT) the effects of the
      Nervomatrix device on various clinical outcomes of patients with low back pain, as well as
      its mechanisms of action.
    

Detailed description: 
      This will be a matched randomized-controlled trial - RCT. Using random numbers from a random
      number generator, pairs of patients will be randomized to either the Nervomatrix stimulation
      (experimental group) or to sham stimulation (controls). Matching of pairs will be done based
      on the baseline data of the primary outcomes - pain and disability, as well as on other
      treatments received.
    

Intervention name(s): Stimulation; Sham
Intervention type(s): Device; Other
Intervention description(s): The Nervomatrix device first measures skin impedance, and then creates a digital pain matrix map of the back. Regions with low resistance are then selected for brief electric stimulation, thus targeting the treatment to specific peak pain regions. Preliminary evidence supports the effectiveness of this device in reducing pain and disability over 6 sessions; The Nervomatrix device first measures skin impedance, and then creates a digital pain matrix map of the back. Regions with low resistance are then selected for brief mechanical pressure.
Other intervention name(s): Nervomatrix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; chronic pain; sensitization; treatment; trigger points
Respiratory Variations in the Diameter of the Inferior Vena Cava With Spontaneous Ventilation
Condition: Collapsibility of the Inferior Vena Cava
Study type: Interventional

Summary: 
      The main objective of this study is to determine a threshold value of diaphragmatic excursion
      (ultrasound measures: expiration versus inspiration)that best predicts a 50% collapsibility
      of the inferior vena cava.
    

Detailed description: 
      Secondary objectives of this study are:

        -  to determine a threshold value of diaphragmatic excursion (ultrasound measures:
           expiration versus inspiration)that best predicts a 40% collapsibility of the inferior
           vena cava (IVC).

        -  to determine a threshold value of diaphragmatic excursion (ultrasound measures:
           expiration versus inspiration)that best predicts a 100% collapsibility of the IVC.

        -  to determine the location of the cutting plane for the TM analysis of collapsibility of
           the IVC.

        -  to evaluate the hemodynamic conditions of normal healthy volunteers.

        -  to detect any abnormality of cardiac function.
    

Intervention name(s): Ultrasounds with controlled breathing
Intervention type(s): Procedure
Intervention description(s): The patient will have cardiac, abdominal and thoracic ultrasounds with controlled and monitored inspiratory effort. This gesture takes about 40 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diaphragmatic excursion; normality
Pregnancy With Morquio Syndrome - What Are Patients' Perspectives and Has ERT Changed Them?
Condition: Morquio Disease; MPS - Mucopolysaccharidosis
MeSH terms: Osteochondrodysplasias; Mucopolysaccharidoses; Mucopolysaccharidosis IV
Study type: Observational

Summary: 
      The present study seeks to interview women with Morquio A and Morquio B syndrome, to explore
      their concerns surrounding pregnancy and the impact of ERT on their perspectives, in
      comparison with the control group of Morquio B subjects for whom no ERT treatment exists.

      Interviews will be conducted by a health psychologist, in-person or over the telephone. Data
      will be analyzed using MAXQDA 12.0 software and Grounded Theory. Differences in thematic
      trends between Morquio A subjects, for whom treatment exists, and a control group of Morquio
      B subjects, for whom there is no treatment, will be compared.
    

Detailed description: 
      The present study seeks to interview women with Morquio A and Morquio B syndrome themselves,
      to explore and discover their perspectives and concerns surrounding pregnancy and having
      biological children, the impact of the advent of ERT for Morquio A on their perspectives and
      concerns in comparison with the control group of Morquio B subjects for whom no ERT treatment
      exists, as well as what each group is being told by the medical community and others in their
      lives in this regard.

      Interviews will be conducted by a health psychologist, either in-person or over the
      telephone. We will interview 1) those women with Morquio syndrome who are known to have been
      pregnant and 2) those women with Morquio syndrome who have not been pregnant and/or chose to
      adopt children. All information will be kept confidential, except as in accordance with
      Georgia law relating to reporting of child or elder abuse, suicidal and/or homicidal intent.

      Data will be analyzed using MAXQDA 12.0 software to develop code which can be used to
      describe and compare the data using Grounded Theory. Differences in thematic trends between
      Morquio A subjects, for whom treatment exists, and a control group of Morquio B subjects, for
      whom there is no treatment, will be compared.
    

Intervention name(s): Interview
Intervention type(s): Other
Intervention description(s): In-person or telephone in-depth interview
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women with Morquio syndrome, at least 15 years of age, English-speaking
      
Keywords: Pregnancy
The Effect of Aerobic Endurance Training in Patients With Drug Addiction
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Physical health does not have a high priority in today's treatment of patients with substance
      use disorder (SUD) patients have a poor physical health not only due to injuries related to
      the substance abuse, but also because of the lifestyle that addiction causes. There are today
      few studies that provide information about SUD patients' physical health. One of the
      project's aims is to document the physical health of SUD patients in treatment, using
      objective measures. After completion of various physical tests, an 8 week period of high
      intensity aerobic training intervention will follow. It will be investigated if the SUD
      patients are able to engage and participate throughout the whole training intervention, to
      what degree the participants improve their physical health and the effect of physical health
      improvement on substance abuse treatment.
    


Intervention name(s): high intensity aerobic training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Oxygen Consumption; mental health
Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes
Condition: Anxiety; Stress
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of
      health and wellness products on feelings of anxiety, stress and other health outcomes
    

Detailed description: 
      This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult
      participants per study arm, age 21 and older and residing in the United States.

      Eligible participants will (1) endorse a desire for less feelings of anxiety and/or stress,
      (2) indicate an interest in taking a health and wellness product to potentially improve their
      anxiety and/or stress, and (3) express acceptance in taking a product and not knowing its
      formulation until the end of the study.

      Participants with known liver or kidney disease, heavy drinkers, and those who are pregnant,
      trying to become pregnant, or breastfeeding will be excluded. Those taking certain
      medications will be excluded.

      Self-reported data will be collected electronically from eligible participants over 5 weeks.
      Participant reports of health indicators will be collected during baseline, throughout the
      active period of study product use, and in a final survey. All study assessments will be
      electronic; there are no in-person visits or assessments for this real-world evidence study.
    

Intervention name(s): Radicle Calm Study Placebo Control 1; Radicle Calm Study Placebo Control 2; Radicle Calm Study Active Product 1.1; Radicle Calm Study Active Product 2.1; Radicle Calm Study Active Product 2.2
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will use their Radicle Calm Placebo Control Product 1 as directed for a period of 4 weeks.; Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks.; Participants will use their Radicle Calm Active Product 1.1 as directed for a period of 4 weeks.; Participants will use their Radicle Calm Active Product 2.1 as directed for a period of 4 weeks.; Participants will use their Radicle Calm Active Product 2.2 as directed for a period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be stratified based on gender at birth then randomized to one of the study arms
Masking: Double (Participant, Investigator)
Primary purpose: Other
Cornea Preservation Time Study
Condition: Cornea Preservation Time; Endothelial Keratoplasty; Transplant Success; Endothelial Cell Density
MeSH terms: Corneal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if the 3-year graft failure rate following
      endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14
      days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or
      fewer days are used.
    

Detailed description: 
      When the donor cornea is removed from the person who died, it is prepared for transplantation
      by an eye bank. The donor cornea is placed into a liquid that helps preserve the cornea until
      it is transplanted. The Food and Drug Administration (FDA) has approved storage of the cornea
      in this liquid for up to 14 days before the transplant. The purpose of this study is to see
      if the length of time the donor cornea is kept in the preservation liquid before the
      transplant affects the likelihood of the transplant being successful. We will follow
      participants for 3 years after transplant to see if there are any differences in transplant
      success or in the number of transplanted endothelial cells (the layer of cells that line the
      undersurface of the cornea) on the corneas that were preserved for 7 days or less compared to
      those preserved between 8 and 14 days. We have no reason to believe that there is any greater
      risk for transplant failure with either preservation time group.
    

Intervention name(s): Cornea tissue transplant; Cornea tissue transplant
Intervention type(s): Biological; Biological
Intervention description(s): Cornea tissue preserved 0 to 7 days; Cornea tissue preserved 8 to 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cornea; transplant; preservation; endothelial keratoplasty
Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of multiple
      oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive
      days) in healthy subjects.
    


Intervention name(s): LX4211 400 mg; LX4211 800 mg; LX4211 Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders
Condition: Dermatitis, Atopic; Hay Fever
MeSH terms: Smallpox; Rhinitis, Allergic, Seasonal; Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to gather information on the safety and immunogenicity of an
      investigational smallpox vaccine in populations with atopic disorders.
    


Intervention name(s): IMVAMUNE (MVA-BN)
Intervention type(s): Biological
Intervention description(s): 1x10E08 TCID50, subcutaneous vaccination
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Connection Between Gait Variability Parameters and Balance Performance in Children With Physical Disability
Condition: Brain Injury; Cerebral Palsy
MeSH terms: Brain Injuries; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to explore the connection between gait variability parameters
      and balance performance in children with physical disability
    

Detailed description: 
      Step length and step time variability will be measured with an electronic walkway, strength
      of 4 lower-extremity muscle groups will be tested bilaterally with a hand held dynamometer,
      walking performance as will be assessed by the 2 minute walk test, energy expenditure index
      (EEI) and rating of perceived exertion (OMNI scale).
    

Intervention name(s): walking and balance performance evaluation; muscle strength, walking and balance performance
Intervention type(s): Other; Procedure
Intervention description(s): HHD- muscle strength, Balance performance - TUG, FRT, Walking performance- gaiterite and 2 min walk test
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sun Protection Factor Assay (SPF Assay 19009)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987517
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-034)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-term Effects of COVID-19 in Adolescents
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The overarching objective for this prospective cohort study of COVID-19 in adolescents is to
      study the long-term effects, with particular emphasis on post-infectious chronic fatigue. A
      total of 500 individuals with a SARS-CoV-2 positive test will be enrolled in the acute phase
      of COVID-19 and followed for 6 months. A total of 100 individuals with SARS-CoV-2 negative
      test will be included during the same time period as a control group. Investigations include
      autonomic, pulmonary and cognitive assessement; a questionnaire charting symptoms,
      emotionality, personality, loneliness, life events and demographics; and extensive biobanking
      including genetic markers, viable PBMC, urine, feces and hair. A subgroup of 40 SARS-CoV-2
      positive and 20 SARS-CoV-2 negative individuals will also undergo detailed cardiological
      examination by echocardiography. Primary endpoints are fatigue at 6 months as assessed by the
      Chalder Fatigue Scale and post-COVID-19 syndrome cases at 6 months according to the WHO
      definition
    


Intervention name(s): No active intervention (observational only)
Intervention type(s): Other
Intervention description(s): No active intervention (observational only)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents living in the counties of Oslo and Viken, Norway
Trial of Non Invasive Ventilation for Respiratoy Distress Syndrome
Condition: Prematurity; Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the hypothesis that nasal intermittent positive
      pressure(NIPP), used as a primary mode of ventilation in preterm infants with RDS, will
      decrease the need for conventional endotracheal ventilation when compared to nasal continuous
      positive airway pressure.(NCPAP)
    

Detailed description: 
      Respiratory distress syndrome(RDS) and its sequelae, bronchopulmonary dysplasia(BPD) are
      complications of prematurity.The pathogenesis of BPD is multifactorial and one of the most
      important risk factors is the ventilator-induced lung injury caused by invasive respiratory
      support.

      The two modes of non-invasive ventilation, NIPP and specially NCPAP, have been used
      frequently in the respiratory care of preterm infants in neonatal units.NCPAP is currently a
      common practice for the treatment of RDS . NIPP has been found to be more effective than
      NCPAP in apnea of prematurity and immediately after extubation in preterm infants,decreasing
      the need of endotracheal ventilation.

      Alternative techniques of non-invasive ventilation has been suggested in some studies to
      decrease respiratory morbidities associated with prematurity.This non-invasive approach could
      be used initially as a primary mode of ventilation for infants with RDS in a effort to
      decrease lung injury and BPD.Studies are needed to compare the effectiveness of these
      therapies.
    

Intervention name(s): nasal intermittent positive pressure ventilation
Intervention type(s): Device
Intervention description(s): Nasal intermittent positive airway pressure will be compared are the nasal continuous positive pressure as an initial ventilatory mode in preterm infants with respiratory distress syndrome
Other intervention name(s): NIPPV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non invasive ventilation; mechanical ventilation; pulmonary morbidity; preterm infant; Respiratory distress syndrome; nasal intermittent positive pressure; nasal continuous positive pressure; bronchopulmonary dysplasia