bioihbjkbjnl/mcl2 huggingface dataset:
Position of Children During Urine Collection: Evaluation Study
Condition: Urinary Infection
MeSH terms: Urinary Tract Infections
Study type: Interventional

Summary: 
      Urinary tract infection (UTI) is a frequently suspected cause of fever in young children,
      justifying urine cultures. Sampling procedures are decisive for the reliability of UTI
      diagnosis. Even though official guidelines recommend clean catch method, catheterization or
      suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate
      of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators
      have noticed that the rate of contaminated urine cultures was lower when children were kept
      in an upright position at the time of urine collection. The upright position could explain
      this decrease, perineum being less in contact with urine. These results are borderline
      significant, the investigators would like to confirm them with a specific study.
    


Intervention name(s): upright position
Intervention type(s): Other
Other intervention name(s): the impact of an upright position on the number of contaminated urine cultures during urine bag collection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Paediatrics; Urinary tract infection; Urine collection
Glidescope Videolaryngoscope and Macintosh Laryngoscope in Children
Condition: Anesthesiology; Pediatrics
Study type: Interventional

Summary: 
      The main objective of this study was to evaluate the intubation time of Glidescope compared
      with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular
      changes during intubation.
    

Detailed description: 
      This was a prospective randomized clinical study to be performed in pediatric patients older
      than 1 years who are undergoing surgical procedures requiring endotracheal intubation. Time
      to endotracheal intubation was compared between patients intubated using a GlideScope® video
      laryngoscope, and those intubated by standard direct laryngoscopy. The main objective of this
      study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope
      in pediatric patients, ease of intubation, and cardiovascular changes during intubation.
    

Intervention name(s): Endotracheal intubation
Intervention type(s): Device
Other intervention name(s): Glidescope video laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
A Study to Assess Safety and Pharmacokinetics of Telaprevir in Patients With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the pharmacokinetic (what the body does to
      the drug) parameters of telaprevir are altered in patients with moderate hepatic impairment,
      compared to the pharmacokinetic parameters in patients with normal liver function, and
      measure the relative unbound plasma concentrations of telaprevir.
    

Detailed description: 
      This is a Phase I, open-label (all people know the identity of the intervention) study to
      investigate the single dose and steady state pharmacokinetics of telaprevir in patients with
      moderate hepatic impairment, and measure the relative unbound plasma concentrations of
      telaprevir. In addition, a small group of patients with severe hepatic impairment will be
      included to further characterize the pharmacokinetics of telaprevir as a function of liver
      disease. In this study 24 patients will be enrolled. Based upon physical examination and
      laboratory assessments, patients will be scored and classified into hepatic function groups
      on the basis of the Child-Pugh classification (Classification is based on Child-Pugh score
      which is used to assess prognosis of chronic hepatic disease). A Child-Pugh score of 7 to 9
      is considered Child-Pugh category B (CPB) and indicative of moderate liver function
      impairment; a Child-Pugh score of 10 or greater is considered Child Pugh category C (CPC),
      indicative of severe liver impairment. Hepatic function groups will consists of Group 1: 10
      patients with moderate hepatic impairment (CPB 7 to 9]); Group 2: 10 healthy control patients
      with normal hepatic function. Each healthy control patient is matched to a patient in Group 1
      with respect to sex, age (+5 years or -5 years) and body mass index (BMI) (+15% or -15%);
      Group 3: 4 patients with severe hepatic impairment (CPC [limited to Child Pugh score 10 to
      12]). Safety and tolerability evaluations including adverse events, clinical laboratory
      tests, 12-lead electrocardiogram, vital signs and physical examination will be recorded
      throughout the study period.
    

Intervention name(s): telaprevir
Intervention type(s): Drug
Intervention description(s): Type=exact number, unit=mg, number=375, form=tablet, route=oral. Multiple doses of 2 oral tablets of telaprevir will be administered every 8 hours on Days 1 to 5 and a single dose of 2 oral tablets of telaprevir will be administered in the morning on Day 6.
Other intervention name(s): VX-950
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic impairment; Hepatitis C; Telaprevir; VX-950; Pharmacokinetics; Safety; Unbound plasma concentrations; Child-Pugh score
The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease
Condition: Heart Disease; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      A growing body of evidence links Chlamydia pneumoniae to the progression of coronary heart
      disease. The purpose of this study is to determine the positive and negative effect of 14
      days treatment with clarithromycin 500 mg daily in patients already suffering from stable
      coronary heart disease. The participants will be followed for at least two years after the
      treatment.

      Abbott Laboratories supplied Clarithromycin and placebo tablets.
    

Detailed description: 
      Basic science suggests a fundamental role for inflammation in mediating all stages of
      coronary heart disease (CHD), and a large number of clinical studies have reported an
      association between markers of inflammation and CHD. Consequently, infectious agents have
      been proposed as promoters of atherosclerosis and/or acute coronary syndrome (ACS). Many
      studies have suggested a relation between Chlamydia pneumoniae (C. pneumoniae) infection and
      CHD, and C. pneumoniae has been demonstrated in atherosclerotic tissue.

      Macrolide antibiotics are effective in eradication of C. pneumoniae from atherosclerotic
      plaques. Two small trials showed significant beneficial effects of macrolides on
      cardiovascular morbidity in patients with ACS. To corroborate and extend these findings, we
      undertook a randomised, placebo-controlled trial with clarithromycin in patients with stable
      CHD in order to test the hypothesis that intervention with a macrolide would reduce
      cardiovascular risk with regard to mortality and morbidity.
    

Intervention name(s): clarithromycin
Intervention type(s): Drug
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary heart disease; Clarithromycin; Macrolides; Cardiovascular mortality; Chlamydia pneumoniae
A Study of STAR-0215 in Healthy Adult Participants
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single
      ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics,
      and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of
      STAR-0215 in healthy adult participants.
    


Intervention name(s): STAR-0215 (SC); Placebo (SC); STAR-0215 (IV); Placebo (IV)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): STAR-0215 will be administered as an SC bolus injection.; Placebo will be administered as an SC bolus injection.; STAR-0215 will be administered as an IV bolus injection.; Placebo will be administered as an IV bolus injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HAE; Angioedema
Berberine and Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Berberine
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in female
      reproductive-age. Recently, increasing evidence has shown that natural plant-based products
      may play a role in PCOS management. Previous study in PCOS preclinical model and in humans
      demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of
      metabolic, inflammatory and hormonal disorders. However, to date there is no clinical study
      that considers globally all the activities carried out by berberine in PCOS clinical
      features. Given this background, aim of this study was to evaluate in normal-overweight PCOS
      women with normal menses the berberine effectiveness on: insulin resistance by Homeostasis
      Model Assessment (HOMA); inflammation by C-Reactive Protein (CRP), TNF-alpha; lipid
      metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by
      Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); body composition
      by dual-energy X-ray absorptiometry. All these parameters were collected at baseline and 60
      days after supplementation with a new bioavailable and safe berberine formulation. Finally,
      adverse effects were assessed by liver and kidney functions. To evaluate statistically
      significant pre- post-supplementation changes, fitted a linear mixed model for each
      investigated endpoint was performed.
    


Intervention name(s): Berberine
Intervention type(s): Dietary Supplement
Intervention description(s): 2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: berberine; Polycystic Ovary Syndrome
hCT-MSCs for Children With Autism Spectrum Disorder (ASD)
Condition: Autism; Autism Spectrum Disorder; ASD
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1 study is to determine the safety of one, two, and three
      intravenous infusions of human umbilical cord tissue-derived mesenchymal stromal cells
      (hCT-MSC), administered every two months, in children with autism spectrum disorder (ASD).
    

Detailed description: 
      This study is a phase I, prospective, open-label trial designed to assess the safety of one,
      two, and three intravenous doses of hCT-MSC in young children with ASD. Children ages two to
      11 years with ASD will be eligible to participate. All participants will receive intravenous
      infusion(s) of CTCs. The first cohort of three patients will receive a single dose. If there
      are no safety concerns, the second cohort of three patients will receive two doses, given two
      months apart. The third cohort will consist of six patients, each of whom will receive three
      hCT-MSC infusions with a two-month interval between doses. All participants will have an
      initial clinical evaluation to verify the diagnosis of ASD and confirm protocol eligibility.
      The main endpoint is safety, for which acute infusion reactions and incidence of infections
      will be assessed. ASD-specific outcome measures, described below, will be assessed at
      baseline and six months from baseline and results will be described.
    

Intervention name(s): hCT-MSC infusion
Intervention type(s): Biological
Intervention description(s): hCT-MSCs are a product of allogeneic cells manufactured from digested umbilical cord tissue that is expanded in culture, cryopreserved and banked.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Immunogenicity of a Plant-made H7 Virus-like Particle (VLP) Influenza Vaccine in Adults.
Condition: Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; RNA Virus Infections; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging,
      placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2
      intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy
      adults, 18-60 years of age.
    

Detailed description: 
      This study will consist of a dose-ranging in one hundred (100) subjects who will be
      randomized in parallel to a 1:1:1:1:1 ratio in five (5) groups of 20 subjects to receive one
      intramuscular injection at Days 0 and 21 of either a low, medium or high dose of H7 VLP
      vaccine mixed with Alhydrogel® 0.4% (0.5 mg Aluminum per dose) or a high dose of H7 VLP alone
      or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride
      (NaCl) + 0.01% Tween 80). Twenty-one (21) days after each immunization, key safety and
      immunogenicity data will be collected and analysed. All subjects will be followed for safety
      until Day 228.
    

Intervention name(s): Low dose of H7 VLP vaccine + Alhydrogel; Med dose of H7 VLP vaccine + Alhydrogel; High dose of H7 VLP vaccine + Alhydrogel; High dose of H7 VLP vaccine; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Low dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart; Med dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart; High dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart; High dose of H7 VLP vaccine, 2 doses given 21 days apart; Placebo, 2 doses given 21 days apart
Intervention MeSH terms: Aluminum Hydroxide; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza, Human; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Aluminum Hydroxide; Adjuvants, Immunologic; Immunogenic Factors; Physiological Effects of Drugs; Virus Diseases; Orthomyxoviridae Infections; Infection
Endoscopic Procedures of Children in the Normalization Process of Covid-19 Pandemic
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      Endoscopic methods are frequently used in the diagnosis of gastrointestinal system
      pathologies in children.
    

Detailed description: 
      Endoscopic methods are frequently used in the diagnosis of gastrointestinal system
      pathologies in children. In the investigators' center, which is a pandemic hospital, only
      emergency endoscopic procedures were performed during the pandemic period, while emergency
      and elective endoscopic procedures are performed in accordance with the recommendations of
      the Ministry of Health during the normalization process. Staff and patients in endoscopy
      units are at risk for COVID-19 infection by inhalation of airborne droplets, conjunctival
      contact, and potential fecal-oral contamination. In order to reduce the risk of
      contamination, according to the recommendations of the European Gastrointestinal Endoscopy
      Association (ESGE); proper cleaning of endoscopic devices, non-reuse of disposable devices,
      cleaning the endoscopy hall with a disinfectant solution, use of gowns FFP2 / 3 masks and
      jewelry during the procedure, handwashing with soap and hand disinfection is recommended
      before and after each procedure. In addition, it is recommended that patients who have
      undergone endoscopic procedures should be followed up or communicated on days 7 and 14 in
      terms of the development of COVID-19 infection.

      It is recommended that patients should be questioned in terms of COVID-19 infection before
      endoscopy, but rapid antigen testing and serology are not routinely recommended. Molecular
      diagnosis (PCR, amplification) tests are recommended for patients at risk for COVID-19
      infection.
    

Intervention name(s): Endoscopic procedure
Intervention type(s): Procedure
Intervention description(s): Esophagogastroscopy and colonoscopy
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 1 to 18 years who underwent emergency or elective endoscopic procedures will
        be included in the study. Demographic characteristics of the patients, indication of the
        procedure, date, place of operation, procedure performed and endoscopic diagnosis will be
        noted. Before and on the 7th and 14th days after the procedure, patients will be contacted
        and the symptoms and clinical findings in terms of COVID-19 infection will be questioned
        and noted. The results of complete blood count, CRP, coagulation profile, COVID-19 PCR,
        chest radiography and thorax computed tomography will be recorded if it was performed on
        the patient.
      
Keywords: endoscopy; colonoscopy; children; Covid -19 pandemic
A Study to Assess Safety and Efficacy of a Novel Treatment, Keratinocyte Growth Factor (KGF), in Asthmatic Patients
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will look at the permeability, or 'leakiness' of the airway epithelium (the inner
      lining of the lung) in asthmatic patients. Increased leakiness of this lining has been shown
      in asthmatic patients by other studies, not only in the lung but also possibly in the gut,
      perhaps reflecting a widespread defect. This leakiness may underline the interaction between
      the environment and a person's genetic make up, and may contribute to why some people get
      asthma, and how severe it is. Increased leakiness may allow increased exposure to inhaled
      allergic substances, helping to perpetuate the inflammation in the lungs that is a hallmark
      of asthma.

      Specifically, this study will attempt to modify and reduce this permeability through the use
      of a substance called 'keratinocyte growth factor', or 'kgf'. KGF is a naturally occuring
      human protein, which is involved in stimulating the growth of cells lining the layers of the
      skin and gut, helping to repair damage and maintain their structure. It has been manufactured
      in a laboratory as the commercial compound 'Palifermin', which has already been used in
      humans to reduce damage to the lining of the mouth after chemotherapy. The study will see if
      Palifermin can similarly improve the lining of the lung in asthma patients and improve their
      symptoms. To date no treatments have been used in this area in asthma, and if successful the
      study will open up a whole new area of therapy
    


Intervention name(s): Keratinocyte Growth factor; Saline placebo
Intervention type(s): Drug; Drug
Intervention description(s): KGF will be administered intravenously in a 'collapsed dose' regime of 180ug/kg on day 0 and day 11; Normal (0.9%) saline will be used as a placebo.
Other intervention name(s): Palifermin, rhKGF, Kepivance
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moderate asthmatic, uncontrolled
Comparison of RPL554 With Placebo and Salbutamol in Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The number of people with of asthma and allergy is still increasing and a large number of
      patients still do not have their asthma well controlled. There is therefore a need for new
      asthma treatments that work well and have less side effects. The study compares a new
      experimental drug RPL554 with a marketed asthma drug (salbutamol) and placebo.
    

Detailed description: 
      A seven way crossover study to investigate the pharmacodynamics, pharmacokinetics, safety and
      tolerability of inhaled RPL554 compared to salbutamol and placebo in patients with mild to
      moderate chronic asthma.

      Salbutamol is a marketed beta-2 agonist typically used to treat bronchospasm (due to any
      cause, allergen asthma or exercise-induced), as well as chronic obstructive pulmonary disease
      but has associated dose-related systemic side effects.

      RPL554 is a dual PDE3 and PDE4 inhibitor that has bronchodilatory and anti-inflammatory
      actions and also the potential to stimulate increases in mucociliary clearance via its proven
      ability to activate CFTR. Four different doses of RPL554 will be compared with placebo and a
      two doses of salbutamol as benchmarks for bronchodilation and systemic side effects.
    

Intervention name(s): RPL554; Salbutamol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A dual PDE3 and PDE4 inhibitor; a beta-2 receptor agonist; RPL554 placebo containing no active ingredients
Other intervention name(s): VMX554; VRP554
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment