bioihbjkbjnl/mcl2 huggingface dataset:
Longitudinal Assessment of Children With Severe Asthma and Severe Pre-school Wheeze
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Cross-sectional study to characterize cohorts of children with asthma and healthy controls in
      terms of clinical features, physiological measurements and non-invasive measurement of
      biomarkers and develop phenotype handprints for children with severe asthma
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        -  Severe school aged asthma cohort: persistent symptoms or frequent severe exacerbations
             or persistent airflow limitation

          -  Mild-moderate school aged asthma cohort: controlled or partially controlled asthma
             symtomps

          -  Severe pre school wheeze cohort: persistent symptoms or frequent severe exacerbations

          -  Mild-moderate pre school wheeze cohort: controlled symptoms or partially controlled
      
Keywords: Sputum; Clinical cohorts; Smokers; Asthma; Biopsies; Severe asthma; Collaborative research; Phenotyping; Lipidomics; Transcriptomics; Proteomics; Paediatric cohort; Systems Biology
A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the effect of nipocalimab on the
      pharmacokinetic (PK) of etanercept (Part 1); and to assess the effect of hydroxychloroquine
      (HCQ) on total serum immunoglobin G (IgG) reduction by nipocalimab (Part 2) in healthy
      participants.
    


Intervention name(s): Nipocalimab; Etanercept; Hydroxychloroquine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nipocalimab will be administered as an IV infusion.; Etanercept will be administered subcutaneously.; HCQ will be administered orally.
Other intervention name(s): JNJ-80202135, M281
Intervention MeSH terms: Hydroxychloroquine; Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1 is a single-sequence, 2-period study and Part 2 is a randomized, 2-cohort (Cohort 1 and Cohort 2), parallel study.
Masking: None (Open Label)
Primary purpose: Other
Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare a normal-protein diet containing branched-chain amino
      acids to a low-protein diet in patients with non-terminal cirrhosis (MELD < 25) who have
      developed an episode of hepatic encephalopathy within two months prior to inclusion.
    

Detailed description: 
      Hepatic encephalopathy is a major complication of cirrhosis associated with poor prognosis
      and poor quality of life. Appearance of HE occurs in the setting of precipitating factors
      that increase plasma ammonia. The gastrointestinal tract is the primary source of ammonia,
      which is produced by enterocytes from glutamine and by colonic bacterial catabolism of
      nitrogenous sources, such as ingested proteins. This is the rationale for proposing
      low-protein diet as strategy to reduce ammonia production and as standard diet in patients
      with cirrhosis and hepatic encephalopathy. However, low-protein diet could cause wasting
      muscle and predispose to recurrence of hepatic encephalopathy, since muscle is an important
      site for extrahepatic ammonia removal.

      Branched-chain amino acids have shown beneficial effects on mental state of patients with
      chronic hepatic encephalopathy. The possible mechanism of action may be improvement of
      nutritional status through induction of protein synthesis. However, role of branched-chain
      amino acids in treatment and prevention of acute hepatic encephalopathy is not established.

      Administration of a normal-protein diet containing oral branched-chain amino acids may reduce
      recurrence of hepatic encephalopathy as compared to a low-protein diet.
    

Intervention name(s): Branched-chain amino acids; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 30 grams of oral branched-chain amino acids (leucine: 13.5 grams, isoleucine: 9 grams, valine: 7.5 grams) daily; 30 grams of oral maltodextrin daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Hepatic encephalopathy; Cirrhosis; Proteins of the diet; Branched-chain amino acids
Effects of Empagliflozin on Endogenous Glucose Production in End Stage Renal Disease(ESRD).
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      A study of the effects of empagliflozin, a SGLT-2 inhibitor, on endogenous glucose production
      and plasma glucagon levels in patients with end-stage renal disease (ESRD)
    

Detailed description: 
      The impact of SGLT-2 inhibition on endogenous glucose production and plasma glucagon levels
      will be compared measured in patients with ESRD.The secondary endpoints are the mean
      difference in plasma glucose, insulin, c-peptide, FFA,GH, epinephrine, norepinephrine,
      cortisol and blood pressure during the last hour of the experiment between empagliflozin
      versus placebo administration in patients.
    

Intervention name(s): Empagliflozin; Placebo
Intervention type(s): Combination Product; Drug
Intervention description(s): Sodium-glucose co-transporter 2 (SGLT2), a low-affinity, high-capacity member of an increasingly numerous family of co-transporters, is highly expressed in the proximal renal tubule, and account for the majority of the reabsorption of filtered glucose.; A substance without specific pharmacology principles
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of
      GC3106 after single intramuscular administration in Korean healthy adults.
    

Detailed description: 
      This study is the first in human trial of GC3106 and is designed as an adaptive Phase I/IIa
      to ensure participants protection. Part A is an open-label and single arm study in 9 healthy
      volunteers. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited
      adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days
      after vaccination from the first 9 healthy volunteers. Part B is a randomized (2:1),
      double-blind, active controlled study and a total of 75 volunteers will participate in this
      part. Adverse events assessment will be done according to the 'Toxicity Grading Scale for
      Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'.
    

Intervention name(s): Quadrivalent cell-culture based influenza vaccin; Trivalent influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): GC3106, 0.5ml, intramuscular, a single dosing at Day 1; GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
Other intervention name(s): GC3106; GC Flu Pre-filled Syringe Inj.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza vaccine; Vaccination; cell-culture based influenza vaccine; cell culture derived influenza vaccine; CCIV
Catheterization Laboratory Study: Acute Responses in Diastolic Heart Failure
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure; Heart Failure, Diastolic
Study type: Interventional

Summary: 
      1. Research question: What is the response of the heart's pumping function to changes in
           heart chamber pressures?

        2. Experimental design: Patients undergoing routine cardiac catheterization will be
           studied. A thermodilution pulmonary artery catheter will be inserted through a venous
           sheath and threaded into the pulmonary artery. After several minutes of quiet rest,
           baseline hemodynamics will be obtained, including a determination of cardiac output
           using thermodilution techniques and 30 seconds of pressure recordings from the left
           ventricle and proximal aorta. In addition, a brief echocardiogram will be performed, to
           determine ejection fraction and indices of diastolic filling. Finally, arterial
           tonometry will be obtained in quick succession from the brachial, radial, femoral, and
           carotid arteries. Following the collection of baseline data, a bolus and infusion of
           nesiritide will be started. After 10 minutes of nesiritide infusion, with the drug still
           infusing, a full set of invasive hemodynamics will again be obtained, as well as brief
           echocardiographic and arterial tonometry examinations.
    


Intervention name(s): nesiritide
Intervention type(s): Drug
Intervention description(s): a bolus, then infusion of nesiritide for 10-15 minutes
Intervention MeSH terms: Natriuretic Peptide, Brain
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: arterial stiffness; echocardiography; nesiritide; high heart pressures; cardiac catheterization
Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting Conditions
Condition: To Determine Bioequivalence Under Fasting Conditions
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent
      to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals).
    

Detailed description: 
      To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent
      to 100 mg of doxycycline by Par Pharmaceutical, Inc., USA (test) versus Monodox by Oclassen
      Pharmaceuticals, Inc., USA reference administered as a 1 x 100 mg capsule under fasting
      conditions.
    

Intervention name(s): Doxycycline Monohydrate; Monodox
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, 100 mg, single-dose; Capsules, 100 mg, single-dose
Other intervention name(s): Monodox; Doxycycline Monohydrate
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence; doxycycline monohydrate; fasting
The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors
Condition: Colonoscopy; Bowel Preparation; Predictive Model
Study type: Interventional

Summary: 
      The rate of adequate bowel preparation is one of important quality indicators of colonoscopy.
      Inadequate bowel preparation negatively affects the outcomes of colonoscopy. If patients with
      inadequate bowel preparation were identified before the procedure, enhanced strategy could be
      offered to achieve better bowel cleaning. Currently, there were three predicting models of
      inadequate bowel preparation established based on patient-related factors. So far, none of
      predictive models have been tested in other than their validation cohort populations, and no
      study has attempted to apply a different regimen to patients presenting with risk factors for
      inadequate colon cleanliness. In previous studies, we established a prediction model based on
      procedure-related factors, which has better accuracy and can better predict the quality of
      bowel preparation.

      The aim of this study is to compare the quality of bowel preparation by using a predictive
      model based on procedure-related factors versus the criterion group in unsedation patients
    


Intervention name(s): Polyethylene glycol
Intervention type(s): Drug
Intervention description(s): Before colonoscopy, patient-related and procedure-related parameters were collected by one investigator in each center. In MI group, a procedure-based score, used for predicting inadequate bowel preparation, was calculated for each patients. Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score<3 in IM group and those in the control group underwent colonoscopy directly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: factors; bowel preparation; colonoscopy
Influence of Trigger Threshold on Controlled Twitch Mouth Pressure
Condition: COPD; Healthy
Study type: Interventional

Summary: 
      The inspiratory pressure trigger is essential when assessing the twitch mouth pressure (Tw
      Pmo) for avoiding glottic closure. However, the difference in inspiratory pressure trigger
      threshold may influence the values of Tw Pmo. We sought to determine the trigger threshold
      for healthy subjects and COPD patients.
    


Intervention name(s): twitch by magstim
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Normal; subjects
A Study to Investigate the Efficacy, Safety, and Tolerability of Repeat Doses of Inhaled GSK2269557 in Adults With Persistent, Uncontrolled Asthma
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multi-centre, randomised, double-blind, placebo-controlled (with rescue
      medication), two period crossover study in subjects with persistent uncontrolled asthma,
      currently not treated with an inhaled corticosteroid (ICS) or long acting beta 2 agonist
      (LABA). This study is the first administration of GSK2269557 to asthmatic subjects, and the
      aims of the study are to investigate the efficacy, safety, tolerability, and pharmacokinetics
      of four weeks of treatment with orally inhaled GSK2269557 1000 microgram (mcg) in subjects
      with persistent uncontrolled asthma. In a sub-study, biological mediators will be measured
      from induced sputum and blood.

      Approximately 50 subjects will be randomised into the study (including approximately 16
      subjects in the sputum sub-study). Each subject will complete two treatment periods: subjects
      will be randomised to receive GSK2269557 1000 mcg in one treatment period, and matching
      placebo in the other treatment period. Each treatment will be administered once daily for 28
      days (+/- 2 days) via the DISKUS™ dry powder inhaler (DPI).

      The study will consist of a Screening Visit; a Run-in Period (approximately 2 weeks in
      duration); two 28-day Treatment Periods (each with 4 clinic visits); a 4-week Washout Period
      (between the Treatment Periods); and a Follow-up Visit. The total duration of the study for
      each subject will be approximately 16 weeks. DISKUS is a registered trademark of the
      GlaxoSmithKline group of companies.
    


Intervention name(s): GSK2269557 DPI; Placebo DPI
Intervention type(s): Drug; Drug
Intervention description(s): GSK2269557 will be supplied as a lactose blend in a DISKUS DPI with a unit dose strength of 500 mcg. 2 inhalations will be taken every morning before breakfast.; Placebo will be lactose in a DISKUS DPI. 2 inhalations will be taken every morning before breakfast.
Intervention MeSH terms: Nemiralisib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK2269557; Asthma; Pharmacokinetics; Safety; Adults; DISKUS Dry Powder Inhaler; Efficacy
Pharmacokinetics And Safety Study Of Two CP-690,550 Controlled Release Formulation Following Single Dose In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will explore the drug behavior and safety following single dose of two 20
      milligram CP-690,550 osmotic capsules in 12 healthy volunteers. These will be compared to a
      10 milligram immediate release tablet, using a 3 way crossover design.
    


Intervention name(s): CP-690,550
Intervention type(s): Drug
Intervention description(s): Single doses separated by a minimum of 72 hour washout between treatments
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Relative bioavailability; controlled release; Phase 1; CP-690; 550
A Transdiagnostic Internet Intervention for Parents of Children With Anxiety and Depressive Symptoms
Condition: Emotional Problem; Anxiety; Depression; Psychological Distress
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a transdiagnostic, parent-led,
      Internet-delivered intervention in reducing child and adolescent internalizing problems.
    

Detailed description: 
      Anxiety and depressive symptoms are common in children and adolescents. There is substantial
      research indicating that transdiagnostic Internet interventions are effective for adults and
      children with anxiety and depressive disorders; however, there is limited research on the
      efficacy of such programs aimed at parents of children and adolescents with anxiety and
      depressive symptoms. This study aims to investigate the efficacy of a transdiagnostic
      Internet intervention for parents of children with elevated anxiety and depressive symptoms.
    

Intervention name(s): ParentKIT
Intervention type(s): Behavioral
Intervention description(s): The intervention is structured in 9 modules through which parents learn to identify and manage their children's anxiety and depressive symptoms. The Internet intervention is guided by two psychotherapists under supervision training in Cognitive Behavioral Therapy, trained by the first author on the treatment protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Internet intervention; transdiagnostic; parent-led intervention; internalizing problems; children; Rational emotive and behavioral therapy
Effect of Assisted Reproductive Technology on Cardiac Development in Childhood Assessed by Echocardiography
Condition: Assisted Reproductive Technology
Study type: Observational [Patient Registry]

Summary: 
      Assisted reproductive technology (ART) has extensively allowed pregnancy for infertile
      couples. However, the long-term effect of ART exposure on cardiovascular development and
      potential association with ART procedure and parental factors is confused. The aim is to shed
      more light on the pattern and extent of cardiovascular developmental alteration among ART
      children and its association with potential confounders.
    

Detailed description: 
      A historic cohort study was designed with prospective follow-up of ART children conceived in
      the Clinical Centre of Reproductive Medicine (CCRM) and born in Maternal-Fetal Medicine Unit
      (MFMU) of First Affiliated Hospital of Nanjing Medical University (FAHNMU) from 1 January
      2002 to 31 December 2012.

      The present design is a prospective single-center study in FAHNMU. ART group will be
      recruited by a non-random, consecutive sample on the basis of the unique personal
      identification number assigned to ART children conceived in CCRM and born in MFMU.

      The controls will be recruited by a non-random, consecutive sample on the basis of the
      spontaneous conception population attending the MFMU of FAHNMU during the same period as ART
      group for prenatal screening and subsequent delivery considering their age.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ART group will be ART children conceived in Clinical Centre of Reproductive Medicine and
        born in Maternal-Fetal Medicine Unit (MFMU). The controls will be the spontaneous
        conception children born in the MFMU during the same period as ART group for prenatal
        screening and subsequent delivery.
      
Keywords: reproductive technologies, assisted; echocardiography; cardiology; pediatrics
Prophylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Efforts to decrease the risk of GvHD by depleting T cells from the graft in CML patients have
      been complicated by an increased incidence of leukemia-relapse. Newer protocols using CD34+
      selected hematopoietic cells from matched-sibling donors and subsequent infusion of T cells
      in incremental doses to treat or avoid relapse of disease seem to be more promising. In this
      study, we try to further optimize this approach by the prophylactic infusion of cytotoxic T
      cells activated ex-vivo against leukemia-associated/specific antigens using peptide-pulsed
      dendritic cells.
    

Detailed description: 
      The conditioning protocol contains:

      Total Body Irradiation 8-12 Gy (4-6 x 2 Gy, a 2 x/die) day -9 to-7 Thiotepa 10 mg/kg (2 x 5
      mg/kg) day -5 Fludarabine 200 mg/m2 (5 x 40 mg/m2) day -6 to-2 ATG Fresenius 25 mg/kg (5 x 5
      mg/kg) day -6 to-2 Cyclosporine A 1 mg/kg Day -10 to-3

      on day 0 CD34+ cells after immunomagnetic selection are infused. > 4 x 10e6/kg CD34 cells/kg
      are required.

      On days 28, 56 and 112 after transplantation, cytotoxic T cells generated in-vitro are
      infused in patients who do not have signs of acute GvHD.

      Regular follow-up compromises immune monitoring including Tetramer analyses of
      Peptide-reactive T cells
    

Intervention name(s): Application of activated donor T cells
Intervention type(s): Procedure
Intervention description(s): Ex-vivo generated donor T cells stimulated by antigen presenting cells loaded with peptides derived from leukemia-associated antigens
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adoptive immunotherapy; BCR-ABL reactive T cells; Allogeneic Transplantation