bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Non-metastatic Gastric Adenocarcinoma Undergoing Resection and Chemotherapy
Condition: Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Gastric Adenocarcinoma Undergoing Resection and Chemotherapy
MeSH terms: Adenocarcinoma
Study type: Observational [Patient Registry]

Summary: 
      In this population-based cohort study, data on patients diagnosed with nmGaC in 2004 through
      2016, managed with resection and chemotherapy, followed up until the end of 2016, and
      surviving ≥1 month were retrieved from the US Surveillance, Epidemiology, and End Results-18
      Program. Cumulative mortality functions were calculated. Prognostic factors for
      heart-specific mortality were evaluated using both multivariable-adjusted Fine-Gray
      subdistribution and cause-specific hazard functions.
    


Intervention name(s): Resection and chemotherapy
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Cases of non-metastatic gastric adenocarcinoma (nmGaC) were defined as patients with
        microscopically-confirmed first primary invasive adenocarcinoma of the stomach
        (International Classification of Diseases for Oncology, Third Edition (ICD-O-3) code: C16)
        without distant metastasis. Only those who underwent resection in January 2004 through
        December 2016 were included.
Role of Montelukast in Asthma and Allergic Rhinitis Patients
Condition: Asthma and Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the effect of Montelukast in Asthma and Allergic rhinits patients
    

Detailed description: 
      Montelukast is a potent and selective blocker of the CysLT1 receptor. Accordingly, a recent
      study has shown that Montelukast can improve symptoms of seasonal allergic rhinitis and
      asthma in patients with both diseases. For treatment of asthma, Montelukast is administered
      once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg
      chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form. Asthma and
      allergic rhinitis have been linked clinically for many years as "one airway one diseases".
      Patients with allergic asthma and rhinitis are significantly more likely to experience asthma
      attacks compared to patients with asthma alone. Side effects most commonly reported above
      placebo included headache, otitis media, upper respiratory infection, and pharyngitis
    

Intervention name(s): Montelukast 10mg
Intervention type(s): Drug
Intervention description(s): Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis. Montelukast should be taken once daily in the evening
Other intervention name(s): Aireez
Intervention MeSH terms: Montelukast
Intervention model: Single Group Assignment
Intervention model description: Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MAAP; Asthma; Allergic rhinits
EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity
Condition: Obesity; Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Obesity
Study type: Interventional

Summary: 
      This study is designed to investigate the impact of weight loss achieved with the IGB on NASH
      with early fibrosis in a select cohort of patients with obesity preselected to have a high
      pre-test probability of having NASH with early fibrosis based on magnetic resonance
      elastography (MRE)-Hepatogram. In addition, this study will explore potential non-invasive
      imaging criteria for NASH and early fibrosis using EUS-Elastography.
    


Intervention name(s): Orbera Intragastric Balloon; Endoscopic Ultrasound Guided Core Liver Biopsy
Intervention type(s): Device; Procedure
Intervention description(s): The Orbera Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Non-Alcoholic Steatohepatitis (NASH); NASH with Fibrosis; Intragastric Balloon; Orbera; Orbera Intragastric Balloon
Safety and Efficacy Study of Hydromorphone and Morphine
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a
      standard weight-based dose of IV morphine in adults presenting to the Emergency Department
      (ED) with acute severe pain.
    

Detailed description: 
      There is widespread agreement that pain is under-treated in the Emergency Department (ED).
      The current recommended treatment of acute pain in the ED setting is administration of an
      initial bolus of morphine followed by titration until adequate analgesia is achieved. Several
      studies have shown that even 0.1 mg/kg IV morphine (7-10 mg administered to the average
      70-100 kg patient) inadequately treats many patients' acute pain. In spite of this, it has
      been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of
      morphine as an initial IV dose. In contrast, it has been observed that these same healthcare
      providers were not similarly reluctant to administer a roughly equianalgesic dose of
      hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much
      smaller milligram quantities than morphine, thus providing the illusion of substantially less
      opioid administered to the patient. Having repeatedly observed this phenomenon, it is
      reasonable that if a smaller milligram dose of hydromorphone were shown to provide an
      efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose
      of morphine, it would provide evidence supporting use of hydromorphone as an alternative
      first line opioid in the treatment of acute pain presenting to the ED. As a practical
      corollary to this, it is reasoned further that the increased willingness of healthcare
      providers to use hydromorphone might contribute to reducing one component of the multifaceted
      problem of oligoanalgesia in the ED.
    

Intervention name(s): Morphine; Hydromorphone
Intervention type(s): Drug; Drug
Intervention description(s): 0.1 mg/kg IV morphine; 0.015 mg/kg IV hydromorphone
Other intervention name(s): Dilaudid
Intervention MeSH terms: Morphine; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Acute; Pain; Emergency Department; Morphine; Hydromorphone; Dilaudid; oligoanalgesia
Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
Condition: Candidiasis, Systemic; Candida Meningitis
MeSH terms: Candidiasis; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin
      administered to neonates suffering from systemic candidiasis. This study will also evaluate
      the proportion of success and of failure of the therapy with micafungin among treated
      neonates and will identify a conversion factor to relate plasma levels of micafungin into
      capillary and venous blood measured through blood samples from the heel and from a peripheral
      vein, collected simultaneously. Safety of micafungin in neonates will also be assessed.
    


Intervention name(s): Micafungin
Intervention type(s): Drug
Intervention description(s): Participants will receive micafungin 8 mg/kg per day via intravenous infusion for approximately 1 hour.
Other intervention name(s): Mycamine
Intervention MeSH terms: Micafungin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: candida meningitis; Mycamine; candidiasis, systemic; micafungin
Single-Dose Study of MT203
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, pharmacokinetics and pharmacodynamics of
      single subcutaneous injection of MT203 in healthy adult Japanese and Caucasian male
      participants.
    

Detailed description: 
      The drug being tested in this study is called MT203 (Namilumab), which is a human
      immunoglobulin G1 (IgG1) mAb potently and specifically neutralizing human and macaque
      granulocyte macrophage colony stimulating factor (GM-CSF). This study will consist of Cohorts
      1 to 3 for healthy Japanese participants and Cohort 4 for healthy Caucasian participants.
      Each cohort will be comprised of 8 participants, of whom 6 participants will be randomized to
      receive MT203 and 2 participants will be randomized to receive matched placebo.

      The study population for the study will consist of 24 Japanese and 8 Caucasian healthy
      participants. Participants will be assigned to 4 cohorts which will remain undisclosed to the
      patient and study doctor during the study (unless there is an urgent medical need)::

      Cohort 1:- MT203 80 mg (6 healthy Japanese participants); Matching Placebo (2 healthy
      Japanese participants) Cohort 2:- MT203 150 mg (6 healthy Japanese participants); Matching
      Placebo (2 healthy Japanese participants) Cohort 3:- MT203 300 mg (6 healthy Japanese
      participants); Matching Placebo (2 healthy Japanese participants) Cohort 4:- MT203 150 mg (6
      healthy Caucasian participants); Matching Placebo (2 healthy Caucasian participants).

      Dosing of the Caucasian participants (Cohort 4) may occur in parallel with dosing in Japanese
      participants (Cohorts 1 to 3). Dose escalation will occur in Japanese Cohorts, independent
      from Cohort 4. The dose escalation will only occur following a review of the blinded
      safety/tolerability data up to Day 15 from the previous cohort. All participants will receive
      a single dose on Day 1, admitted from Day -1 to Day 15. Participants will return to the study
      unit for the pharmacokinetic, pharmacodynamic and safety assessment on Days 22, 29, 43, 57,
      71 and 85.

      This trial will be conducted in Japan.Overall time to participate in this trial is 85 days.
    

Intervention name(s): MT203 80 mg or matching Placebo; MT203 150mg or matching Placebo; MT203 300 mg or matching placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MT203 80 mg or matching placebo injection; MT203 150mg or matching placebo injection; MT203 300 mg or matching placebo injection
Other intervention name(s): Namilumab; Placebo; Namilumab; Placebo; Namilumab; Placebo
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized, double-blind, placebo-controlled, single-dose subcutaneous administration study
A Study to Assess the Effect of Race on How a Single Dose of ASP3652 is Taken up, Metabolized and Distributed Through the Bodies of Young, Healthy Male and Female Subjects, and Its Safety and Tolerability
Condition: Pharmacokinetics; Pharmacodynamics; Healthy Subjects; Effect of Race
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates how ASP3652 is taken up, broken down, and distributed through the
      body and excreted in individuals of different races. The study also investigates levels of
      biochemical markers in the bloodstream, and determines how safe the study drug is and how
      well it is tolerated after dosing. A further aim is to look at how the processes of
      metabolism, distribution and excretion of the study drug are possibly altered by the daily
      diet of the volunteers taking part.
    

Detailed description: 
      This is an open label study to assess the pharmacokinetics (PK), pharmacodynamics (PD),
      safety and tolerability of a single dose of ASP3652 in healthy male and female subjects from
      Caucasian, Japanese, Black/African and Chinese origin.

      A total of 64 healthy male and female subjects are included in this study (16 subjects per
      race group). Each race group comprises 8 female subjects and 8 male subjects.

      Screening assessments are performed from Day -22 to Day -2, and subjects are admitted to the
      clinic on Day -1, where they remain until Day 4. On Day 1, the subjects receive a single oral
      dose of ASP3652, and are discharged on Day 4 when all assessments have been performed and if
      there are no medical reasons to stay longer. An end of study visit (ESV) is performed 7-14
      days after discharge.

      For each race group, plasma samples for PK and PD analysis are collected. Vital signs, safety
      electrocardiogram (ECG) measurements, safety laboratory assessments, physical examination,
      adverse events (AEs) and concomitant medications are monitored throughout study.

      In order to identify potential relationships between dietary intake and the PK of a single
      dose of ASP3652, all subjects record their diet for 3 days during the screening period in
      order to assess daily dietary intake (including total daily caloric intake; daily cholesterol
      intake; and total fat, saturated fat, carbohydrate and protein as a percentage of total
      calories).
    

Intervention name(s): ASP3652
Intervention type(s): Drug
Intervention description(s): Oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; ASP3652; Single dose; Dietary intake
A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis; NASH
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single ascending
      doses of ALN-HSD in healthy participants (Part A) and multiple doses of ALN-HSD in patients
      with NASH (Parts B and C).
    


Intervention name(s): ALN-HSD; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ALN-HSD will be administered by subcutaneous (SC) injection.; Normal saline (0.9% NaCl) matching volume of ALN-HSD doses will be administered SC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatobiliary disorders; Non-alcoholic fatty liver disease; NAFLD; Fatty liver; RNAi therapeutic
Neuromodulation to Treat Patients With Heart Failure With Preserved Ejection Fraction
Condition: Heart Failure With Normal Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Heart failure with preserved ejection fraction (HFpEF) is a leading cause of mortality in the
      elderly. Outcomes of patients with HFpEF are poor and so far, no treatment has been shown to
      decrease morbidity or mortality. Recent animal and human studies suggest that a systemic
      proinflammatory state, produced by comorbidities, including aging, plays a central role in
      the development of HFpEF, supporting the notion that attenuating the proinflammatory state is
      an attractive therapeutic target for HFpEF. We have previously shown that low-level
      transcutaneous electrical stimulation of the vagus nerve (tVNS) suppresses inflammation in
      patients with atrial fibrillation. The overall objective of this proposal is to examine the
      effects of tVNS on diastolic dysfunction, exercise capacity and inflammation in patients with
      HFpEF. Our specific aims include: 1. To examine the effect of intermittent (1 hour daily for
      3 months) tVNS on diastolic dysfunction and exercise capacity, relative to sham stimulation,
      in patients with HFpEF and 2. To examine the effect of intermittent (1 hour daily for 3
      months) LLTS on inflammatory cytokines relative to sham stimulation, in patients with HFpEF.
      The proposed proof-of-concept studies will provide the basis for the design of further human
      studies using LLTS among populations with HFpEF. In light of the increasing number of elderly
      patients with HFpEF and the poor success of the currently available treatment options, an
      alternative and novel approach such as tVNS has the potential to impact clinical practice and
      improve health outcomes among a large number of patients. It is anticipated that these
      investigations will contribute to the broader understanding of the role of inflammation in
      the pathogenesis of HFpEF and how its inhibition can be used to provide therapeutic effects.
      Moreover, it is anticipated that a better understanding of how modulation of inflammation
      affects one of the hallmarks of HFpEF, diastolic dysfunction, will lead to the development of
      novel pharmacological and non-pharmacological approaches to treat this disease.
    


Intervention name(s): low level transcutaneous vagus nerve stimulation
Intervention type(s): Device
Intervention description(s): Stimulation of the auricular branch of the vagus nerve
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart failure with preserved ejection fraction; inflammation
AN OBSERVATIONAL STUDY ON CARDIOVASCULAR INVOLVEMENT IN COVID RECOVERED PATIENTS
Condition: Gender Discrimination; Cardiac Event; Complication
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Aim of the study is to evaluate the prevalence and bring awareness ofcardiovascular
      complications in COVID-19 recovered patients. Study is conducted at single site, which is
      Srinivasa Heart Centre, Warangal, Telangana state in India for the duration of 4 months. The
      sample size is calculated 500 patients and the study is cohort, observational study. Patient
      consent has been taken before enrolment.
    

Detailed description: 
      The aim of the study is to evaluate the prevalence and bring awareness of cardiovascular
      complications in COVID-19 recovered patients.

      Objectives of the study:

        1. To study causes and risk factors of cardiac disorders associated with COVID-19

        2. To identify different types of cardiac symptoms patients, present with

        3. To study the impact of co-morbidities on COVID-19 recovered patients

        4. To study treatment patterns and duration of therapy

      Plan to study:

        -  To select the patient based on inclusion and exclusion criteria

        -  To collect the patient information from case sheets and by patient interaction

        -  To identify different types of cardiac disorders related to COVID-19 or its treatment
           regimen

        -  To study the management of COVID-19 complication and related cardiovascular disorders

      Study Sites: Srinivasa Heart Centre, Warangal (T.S) Study Design: Observational cohort study
      Study Duration: 4 months

      Subject Eligibility:

        1. Inclusion Criteria

             -  Patients who are willing to participate

             -  Patients having previous COVID-19 treatment record

             -  Prescriptions reported during the study period

             -  The prescription which is legible and complete

        2. Exclusion Criteria

             -  Patients who are not willing to participate

             -  The patient having no history of COVID-19 and available data

      Source of the data:

        1. Review of patient case sheet, prescription and lab reports

        2. Personal interaction with patients and caregivers

      Sample size: 500 Patients
    

Intervention name(s): Difference in gender, response to disease, diagnostic test values
Intervention type(s): Behavioral
Intervention description(s): Gender difference: Prevalence of disease in male vs female Response to disease: Which group is more prone to cardiac involvement Diagnostic tests: Diagnostic confirmation of disease
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient reporting to the cardiology department during study period
      
Keywords: Cardiovascular involvement; COVID 19 disease; Gender difference