bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study in Adolescent and Adult Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be
      able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in
      a double-blinded manner.
    


Intervention name(s): Placebo; Primatene Mist; Epinephrine inhalation
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0 mcg/inhalation, 2 inhalations QID; 220 mcg/inhalation, 2 inhalations QID; 125 mcg/inhalation, 2 inhalations QID
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Bronchial Asthma; Shortness of breath
Prospective Multicentric Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diode Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.
Condition: Chronic Venous Insufficiency C2 or Higher
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open
      crossectomy and stripping. The two most performed techniques for endovenous ablation are the
      endovenous laser ablation and the radiofrequency ablation. According to the trial of
      Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in
      more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in
      observational studies. The aim of this study is to compare radiofrequency ablation with the
      VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new
      fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point
      necroses of the vessel wall and on consequence results in lesser side effects from wall
      perforations such as pain, haematoma,…
    


Intervention name(s): Tulip fiber; VNUS closure fast
Intervention type(s): Device; Device
Intervention description(s): Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.; Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: venous insufficiency
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 in Japanese Healthy Participants With Single and Multiple Ascending Dose Administration
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      AZD9977 is an oral, selective mineralocorticoid receptor (MR) modulator. AZD9977 is a partial
      antagonist and partial agonist in reporter gene assays and has a different interaction
      pattern with the MR compared to eplerenone. This study will assess the safety, tolerability
      and pharmacokinetics (PK) of AZD9977, following oral administration of single and multiple
      ascending dose of AZD9977.
    

Detailed description: 
      This will be a Phase I, randomized, single-blind, placebo-controlled, single and multiple
      ascending dose sequential-group design study. The study will be conducted in healthy Japanese
      participants and performed at a single study center. Fourth-five healthy Japanese
      participants are planned to be included in the study and up to 5 additional participants may
      be enrolled into the study if replacement participants are needed.

      Three cohorts consisting of 9 participants each will participate in the study. Depending on
      the findings, up to 2 additional cohorts may be added if the Safety Review Committee (SRC)
      considers it necessary to repeat a dose level or if additional dose steps are required.

      Within each cohort, 6 participants will be randomized to receive AZD9977 and 3 participants
      randomized to receive placebo.

      Each participant will receive AZD9977 at the selected dose level or placebo on Day 1 and from
      Day 3 to 9, with single dose on Day 1 and Day 9 and twice a day (BID) dosing on Day 3 to Day
      8. No dose will be given on Day 2.

      The study will comprise of:

        -  A Screening Period of maximum 28 days;

        -  A Treatment Period during which participants will be resident at the Clinical Unit from
           the day before Investigational Medicinal Product (IMP) administration (Day -1) until at
           least 48 hours after IMP administration; discharged on Day 11, and

        -  A Follow-up Visit within 5 to 7 days after the last IMP dose. Each participant will be
           involved in the study for approximately 6 weeks.
    

Intervention name(s): AZD9977; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Randomized participants will receive oral dose of AZD9977.; Randomized participants will receive oral dose of matching placebo.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Multiple ascending dose, placebo-controlled, single blind sequential group design
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mineralocorticoid receptor; Heart failure with preserved ejection fraction; Safety; Pharmacokinetics; Single Ascending Dose; Multiple Ascending Dose
Non-Invasive Quantitative Imaging of Human Local Arterial Wall Elasticity Using Supersonic Shear Imaging
Condition: Healthy Volunteers; Vascular Ehlers Danlos Syndrome
MeSH terms: Ehlers-Danlos Syndrome; Ehlers-Danlos Syndrome, Type IV
Study type: Interventional

Summary: 
      Arterial stiffness is associated with increased risk of cardiovascular events and death.

      Most of existing technique need dedicated device for arterial stiffness evaluation and
      indirect calculation of intra arterial pressure. Supersonic Shear Imaging (SSI) is a novel
      non-invasive technique based on remote palpation of biological tissues that can image with
      very high temporal resolution (up to 10,000 images/s) and quantify the local viscoelastic
      properties of tissues. The investigators goal was to apply this SSI technique for arterial
      stiffness evaluation and local pulse wave velocity (PWV) calculation.

      As a first step, the primary goal of this study is to establish normal values of local pulse
      wave velocity and arterial stiffness (carotid and femoral) by SSI on hundred healthy
      volunteers.
    

Detailed description: 
      Provide a more extensive description, if desired. Avoid duplication of information to be
      recorded elsewhere, such as eligibility criteria or outcome measures.
    

Intervention name(s): SSI and SphygmoCor® evaluations
Intervention type(s): Other
Intervention description(s): SSI evaluation need Aixplorer vascular ultrasound machine (available in our department) with 8 MHz linear array probe applied on the carotid and femoral artery.
SphygmoCor® evaluation used pressure captors on carotid and femoral sites to record the intra-arterial pressure wave time delay after QRS wave. After distance calculation between the two sites, Aortic PWV can be derived.
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: Arterial stiffness; Pulse wave velocity; Ultrafastecho; Supersonic shear imaging
Association Between Microvascular Resistance and Outcomes in Patients With Obstructive Hypertrophic Cardiomyopathy
Condition: Microvascular Dysfunction; Hypertrophic Obstructive Cardiomyopathy; Microcirculation Resistance
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Observational

Summary: 
      About 60% of patients with hypertrophic cardiomyopathy have microvascular dysfunction.
      Microvascular dysfunction is directly related to prognosis in hypertrophic cardiomyopathy.
      This new measurement method is microcirculation resistance (MR) based on quantitative flow
      ratio (QFR), which does not need a pressure guide wire on the basis of angiography. The QFR
      system is used to evaluate the blood vessels distal pressure and blood flow, and their ratio
      is microcirculation resistance (MR). The quantitative blood flow fraction measurement system
      was analyzed by interventional laboratory platform image analysis software (AngioPlus 2.0).
      This study is a single-center retrospective cohort study. Participants were selected from
      patients who were diagnosed with hypertrophic obstructive cardiomyopathy in Fuwai Hospital
      from January 2020 to November 2021. The risk factor is whether there is microcirculation
      resistance disorder. The outcome was the major adverse cardiovascular events related to HCM
      (including all-cause death, heart transplantation, left ventricular pacemaker, and heart
      failure readmission) that were followed up one year after angiography. Aim To further clarify
      whether there is a certain correlation between microvascular resistance and adverse
      cardiovascular prognosis.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        From January 2017 to November 2021, patients with hypertrophic obstructive cardiomyopathy
        underwent coronary angiography in Fuwai Hospital.
Early Application of CPAP in Hematologic
Condition: Hematologic Disease
MeSH terms: Hematologic Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the use of CPAP in the prevention of acute
      respiratory failure in neutropenic ( or hematologic malignancy ) patients .CPAP applied
      preventively in hematological patients with high risk of ARF may reduce:need for intubations
      and mechanical ventilation, incidence of pneumonia and sepsis,mortality,length of ICU and
      hospital stay
    

Detailed description: 
      Immunocompromised patients with a hematological malignancy that requiring admission in
      intensive care unit (ICU) and subsequently mechanical ventilation for respiratory failure was
      estimated between 20- 50 per cent of all admitted in hospital.

      The survival rate of this patients that requiring mechanical ventilation is very poor.

      In many cases the immunodepression with a great improvement in severe complication as
      infections , pneumonia, sepsis , is the consequence of our therapy ( chemotherapy , bone
      marrow transplantation and stem cell transplantation ) .

      Pneumonia is very common cause of mechanical ventilation in about 45-74 per cent of the all
      patient with acute respiratory failure (ARF) .

      The trial was designed to enroll 40 patients in two groups to demonstrate reduction from 50%
      to 10 % of the need of mechanical ventilation , with a type I risk of error of 5% and a power
      of 80 %.

      Patients were randomized to be treated for four days Venturi mask at a FiO2 of 0.4 (control)
      or with oxygen at a FiO2 of 0.4 plus a CPAP of 10 cm H2O (CPAP). At the end of the 4-days
      period, patients passed a screening test breathing ambient air. Patients returned to the
      assigned treatment if SaO2 less than 95% a.a or respiratory rate more than 25 bpm.CPAP was
      generated using a flow generator with an adjustable inspiratory oxygen fraction set to
      deliver a flow of up to 140 liters per minute (Whisperflow, Caradyne, Ireland) and a
      spring-loaded expiratory pressure valve (Vital Signs Inc, Totoma NJ) and applied using a
      latex-free polyvinyl chloride transparent helmet (CaStar, Starmed, Italy) (15); all centers
      measured the inspiratory oxygen fraction using an oxygen analyzer (Oxicheck, Caradyne,
      Ireland) through the Venturi mask or the helmet.
    

Intervention name(s): Continuous positive airway pressure
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPAP; Hematologic; Neutropenic; ARF
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with
      relapsing multiple sclerosis.
    

Detailed description: 
      The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301,
      and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to
      receive study drug until the end of the trial or until the Sponsor discontinues the
      development program.
    

Intervention name(s): RPC1063
Intervention type(s): Drug
Other intervention name(s): Ozanimod
Intervention MeSH terms: Ozanimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MS; RMS; Multiple Sclerosis; Relapsing Multiple Sclerosis
A Novel Bio-marker of Zinc Status
Condition: Zinc Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Zinc deficiency is a widespread public health problem in developing countries. The true
      prevalence of this condition remains uncertain because of lack of a specific, sensitive and
      reliable biomarker for assessment of human zinc status. The most widely used indicator for
      measuring zinc status is serum zinc level, which, however, is homeostatically regulated and
      influenced by stress and infection. To explore the possibility of using mRNA levels of zinc
      responsive genes as an indicator of zinc status, Cao and Cousins suggested metallothionein
      (MT) mRNA level in monocytes and peripheral blood mononuclear cells as an indicator of recent
      zinc uptake. However, the usefulness of MT mRNA is also limited because its level is
      influenced by other metals, such as copper, cadmium and cobalt and it is also affected by
      stress. Several authors have proposed that expression of zinc transporter genes might be
      useful markers of Zn status. Evidence shows reduction in dietary zinc content produces a
      marked increase in intestinal absorption and decrease in intestinal zinc losses. As zinc
      homeostasis is regulated in the intestine, study of the zinc transporters in this organ may
      provide indication of recent zinc uptake. Recently, a few studies have begun to investigate
      the applicability of using white blood cell zinc transporter expression as an indicator of
      zinc status and found that some of the transporters are zinc responsive. The primary
      objective of this study is to explore whether the expression of zinc responsive genes, such
      as zinc transporters in human intestinal mucosal cells, can be used as indicators of zinc
      status. The specific aims are to compare gene expression in: a) intestinal mucosal cells
      obtained by duodenal biopsy, b) sloughed intestinal mucosal cells isolated from feces, and c)
      peripheral blood mononuclear cells (PBMC) in fasting individuals who are receiving their
      usual diet + placebo or their usual diet + supplemental zinc (20 mg/d for 7 days). Gene
      expression values from intestinal mucosal cells (biopsy) will be compared between the placebo
      and zinc supplemented groups. Similar comparison will be done in the cells isolated from
      stool and PBMCs. This study will also provide an opportunity to compare the relative
      responsiveness of gene expression and serum zinc concentration following supplementation and
      to explore the kinetics of any changes in serum zinc concentration. Thus, blood samples will
      be obtained for measuring serum zinc concentration on two occasions prior to the
      interventions and at specified intervals during and after the intervention.
    


Intervention name(s): Zinc
Intervention type(s): Biological
Keywords: To identify a new bio-marker for zinc status
Comparison of the Pharmacokinetic Properties of Two Tablet Formulations of Macitentan in Healthy Adults
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study conducted in healthy adults to investigate if a new macitentan tablet leads to the
      same fate of macitentan in the body (time of onset, time of presence, amount in the blood) as
      the marketed macitentan tablet.
    

Detailed description: 
      The purpose of this study is to establish biocomparison of 2 types of tablets containing
      macitentan: a pediatric dispersible tablet and the adult film-coated tablet. A single oral
      dose of each tablet will be given to healthy subjects on 2 different periods separated by a
      washout phase of 10 to 14 days.

      Biocomparison will be based on the comparison of the pharmacokinetic parameters of macitentan
      with the two types of tablets using specific statistical methods. The pharmacokinetic
      parameters will be considered equivalent if specific criteria defined in the study protocol
      are met.
    

Intervention name(s): Treatment A (adult formulation); Treatment B (pediatric formulation)
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration of one film-coated tablet containing 10 mg of macitentan as active substance and lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate type A, polysorbate as inactive ingredients.The film coat contains titanium dioxide, talc, xanthan gum, polyvinyl alcohol, and soy lecithin.; Single oral administration of two dispersible tablets, each containing 5 mg of macitentan as active ingredient and Mannitol delta polymorphic crystals, mannitol, isomalt, isomalt agglomerated, croscarmellose sodium, and magnesium stearate as inactive ingredients.
Other intervention name(s): Opsumit
Intervention MeSH terms: Macitentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: macitentan; biocomparison; safety
Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled
      design, and it is expected that about 105 cases will be enrolled in about 10 sites.
    

Detailed description: 
      The study is divided into two stages, the first stage (1-16 weeks) is the main study; the
      second stage (17-32 weeks) is the extended study. This study set up 3 groups:Jaktinib
      Hydrochloride Tablets 75mg Bid group, 100mg Bid group and a placebo control group. The
      subjects were randomly enrolled in the group 1:1:1.
    

Intervention name(s): Jaktinib Hydrochloride Tablets; Jaktinib Hydrochloride Tablets; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Morning: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets; Evening: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets.; Morning: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets; Evening: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets.; Morning: 1*75mg simulated tablet, 2*50mg simulated tablets; Evening: 1*75mg simulated tablet, 2*50mg simulated tablets.
Other intervention name(s): Jaktinib; Jaktinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase I Study of Sulfatinib(HMPL-012) in Patients With Advanced Solid Tumors
Condition: Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Sulfatinib (HMPL-012) is a novel oral small molecule that selectively inhibits vascular
      endothelial growth factor receptors (VEGFR) 1, 2, and 3 and inhibits FGFR kinase activity has
      demonstrated potent inhibitory effects on multiple human tumor xenografts. This
      first-in-human study is conducted to assess the maximum tolerated dose (MTD) and recommended
      dose for phase II ,to evaluate the pharmacokinetics , safety and preliminary anti-tumor
      activity of HMPL-012 at single doses and multiple doses .
    

Detailed description: 
      This will be an open-label, phase I study. This study will evaluate the safety and
      pharmacokinetics of HMPL-012 after a single administration followed by a 28-Day continuous
      course of therapy; evaluate the safety and preliminary efficacy in an open-label
      administration of at the MTD. All subjects of this study will be permitted to continue
      therapy with only safety monitoring and monthly assessments for progression, if the product
      is well tolerated and the subject has stable disease or better
    

Intervention name(s): Sulfatinib
Intervention type(s): Drug
Intervention description(s): Sulfatinib is a capsule in the form of25, 50mg , 100mg; oral, once a day
Other intervention name(s): HMPL-012
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tumor
Radiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male Subjects
Condition: HCV
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study to assess the routes of elimination of a single oral dose of [14C]
      PF-00868554 and to characterize the metabolic profile following single dose administration.
    


Intervention name(s): [14C]-PF-00868554
Intervention type(s): Drug
Intervention description(s): solution, single dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science