bioihbjkbjnl/mcl2 huggingface dataset:
Maribavir Food-Effect Study in Healthy Adults Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main goals of this study are: 1) To assess the relative bioavailability of a single oral
      dose of 400 mg maribavir commercial (marketed) tablet formulation administered with a
      low-fat/low-calorie meal relative to administration under fasting conditions. 2) To assess
      the relative bioavailability of a single oral dose of 400 mg maribavir commercial (marketed)
      tablet formulation administered with a high-fat/high calorie meal relative to administration
      under fasting conditions.

      A single dose of 400 mg maribavir (commercial [marketed] tablet formulation) will be
      administered orally under 3 different feeding conditions:

        1. Fasting (Treatment A),

        2. Fed following a low-fat/low-calorie meal (Treatment B), and

        3. Fed following a high fat/high-calorie meal (Treatment C).

      There will be a washout period of a minimum of 72 hours between each single dose of
      investigational drug (ID) administration on Day 1 in each treatment cycle of 3 days.

      Pharmacokinetic samples will be collected at pre-dose and up to 36 hours post-dose in each
      treatment period.

      Safety and tolerability will be assessed throughout the study by Treatment Emergent Adverse
      Events (TEAEs), vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations.
    


Intervention name(s): Maribavir
Intervention type(s): Drug
Intervention description(s): Maribavir single 400 mg tablet under three different food conditions (fasted, low fat/low calorie meal, and high fat/high calorie meal) depending upon the treatment sequence allocation on Day 1 of each treatment period.
Other intervention name(s): TAK-620
Intervention MeSH terms: Maribavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Interactions Between Echinacea Purpurea and Etravirine
Condition: HIV
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to characterize drug interactions between one medicinal
      herb: Echinacea purpurea and the protease inhibitor etravirine.
    

Detailed description: 
      Because of its CYP3A4 inducer activity in the liver but its inhibitor effect at the
      intestinal site, concomitant administration of Equinacea purpurea (a medicinal herb
      frequently used by HIV-infected patients) and etravirine (an HIV reverse transcriptase
      inhibitor) might result in clinically relevant pharmacokinetic drug interactions.

      15 HIV-infected patients on stable antiretroviral therapy including etravirine at the dosage
      of 200 mg twice daily during at least 4 weeks will be enrolled. After their inclusion in the
      study, patients will receive Echinacea purpurea root (500 mg every 8 hours) in addition to
      their antiretroviral treatment, from day 1 until two weeks later (day 14). On days 0 and 14,
      blood samples will be drawn immediately before and 1, 2, 4, 6, 8, 10 and 12 hours after the
      administration of an etravirine dose, and etravirine concentrations in plasma will be
      determined by high performance liquid chromatography using a validated method.
    

Intervention name(s): Echinacea purpurea
Intervention type(s): Dietary Supplement
Intervention description(s): Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: etravirine; Echinacea purpurea; interaction
Efficacy and Safety of Budesonide Inhalation Suspension for the Treatment of Chronic Rhinosinusitis With Polyposis.
Condition: Chronic Rhinosinusitis With Polyposis
MeSH terms: Sinusitis; Colorectal Neoplasms; Nasopharyngeal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Topical and systemic steroids constitute the first choice in medical treatment for nasal
      polyps. This study aimed to evaluate the efficacy and safety of a short course of budesonide
      inhalation suspension via transnasal nebulization in the preoperative management of chronic
      rhinosinusitis with nasal polyposis. The second aim was to compare budesonide inhalation
      suspension with budesonide aqueous nasal spray and oral prednisone in nasal polyp treatment.
    


Intervention name(s): budesonide; budesonide; Prednisone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1mg/2ml Pulmicort Respules BIS twice daily; nasal spray 256μg BID; oral prednisone 24mg QD
Intervention MeSH terms: Prednisone; Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Children Follow-up of PCOS Women
Condition: Cardiovascular Health; Metabolic Health; Pulmonary Health
Study type: Observational

Summary: 
      Polycystic ovary syndrome (PCOS) is a complex and frequent disorder with a heterogeneous
      clinical presentation varying throughout life, from birth up to post-menopause. Although
      mostly known for its reproductive consequences, PCOS is associated with metabolic
      abnormalities related to insulin resistance and obesity. Children born from PCOS mothers are
      considered to be at risk for early insulin resistance, leading to development of PCOS and
      metabolic abnormalities in childhood and adolescence. Obesity and insulin resistance are
      considered as states of low- and pro-inflammation associated with endothelial dysfunction. In
      addition, it has been shown that endothelial dysfunction develops from the first decade of
      life in response to genetic and environmental risk factors. Therefore, offspring of women
      with PCOS may be at increased risk for vascular disease later in life. Moreover, some
      evidence suggests that early life respiratory disease also contributes to later life
      cardiovascular consequences. The number of studies on offspring of PCOS mothers is low and a
      systematic follow up of children born form PCOS mothers has not been performed yet. the
      investigators propose a systematic evaluation of cardiometabolic and pulmonary health
      characteristics of children (aged 2,5-8 years) born from mothers diagnosed with PCOS. A
      saliva sample will be performed to determine the biochemical androgenic status of the
      children. Mothers of these children have undergone standardized phenotyping prior to
      conception; the investigators will therefore be able to correlate the metabolic status of the
      mother around the time of conception and the cardiometabolic and pulmonary health of their
      offspring.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cases Children born from mothers who are diagnosed with PCOS at the UMCU will be asked to
        participate. Children who were born before the diagnosed PCOS of their mothers at the UMCU
        will be asked to participate too. All mothers have been diagnosed with PCOS according to
        standardised extensive diagnostic work-up and have given informed consent to be approached
        for future research purposes.

        Controls Children who participated in the WHISTLER study (protocol number 10-194) in . The
        children were born from mothers with a regular cycle prior to conception and who conceived
        naturally. The children were examined at the age of 2.5-4 years or at the age of 6-8 years.
        The data of the WHISTLER 3 and WHISTLER/Cardio study have already been collected.
      
Biospecimen description: 
      saliva, serum, plasma
    
Keywords: PCOS; Children; Cardiovascular; Follow-up
Pharmacokinetic Study of Multi-dose Chloroquine
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      Chloroquine (CQ) remains an alternative cheap, safe and widely available drug. Our previous
      research has shown that double (50 mg/kg) standard dose CQ given in split doses had a 95%
      efficacy and was well tolerated and safe. Still, safety could be an issue when the dose of CQ
      is increased. Severe adverse events are caused by high peak concentrations of CQ. Using split
      doses of CQ avoids high peak concentrations enabling the safe administration of high doses,
      however, pharmacokinetic data are lacking.

      Children included in the study will be given 50 mg/kg as split doses over 3 days or 70 mg/kg
      as split doses over 5 days. Treatment will be observed. Drug concentrations and adverse
      events will be monitored. On day 1, children and their mother/guardian will be requested to
      stay at the health centre between 9 am and 6 pm.

      Fifteen children aged 2-10 years with uncomplicated P. falciparum malaria and fulfilling the
      inclusion criteria will be recruited into each study arm.

      Following the end of treatment, the children will be seen on the morning of day 7, 14, 21 and
      28.

      Any child wishing to withdraw during the treatment phase and any child with reparasitaemia
      during the follow up will be given rescue treatment with arthemeter-lumefantrine or quinine
      according to treatment guidelines in Guinea-Bissau.

      Final analysis will include a description of included children, proportions of adverse events
      and any serious adverse events, drug concentrations and their relation to adverse events, the
      proportion of children withdrawn or lost to follow up, the cumulative PCR corrected and
      uncorrected success and failure rates on day 28 and the proportion of early, late clinical
      and late parasitological treatment failures.
    


Intervention name(s): Chloroquine-base 50 mg; Chloroquine-base 70 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Chloroquine; Chloroquine diphosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plasmodium falciparum; malaria; chloroquine; pharmacokinetic; children
Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction)
      adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus
      Coartem, based on the first malaria attack of each patient.

      Secondary objectives:

      For the first attack:

      To compare the 2 groups of treatment in terms of:

        -  Day 42 efficacy

        -  Parasitological and fever clearance

        -  Clinical and Biological tolerability

        -  Evolution of gametocyte carriage

      For attack 2nd and following:

      To compare the 2 groups of treatment in terms of:

        -  Day 28 and Day 42 clinical and parasitological effectiveness

        -  Clinical and Biological tolerability

        -  Proportion of patients without fever at Day 3

        -  Proportion of patients without parasites at Day 3

        -  Evolution of gametocyte carriage

        -  Compliance

      During the total follow up of the cohort:

      To compare the 2 groups of treatment in terms of:

        -  Treatment incidence density

        -  Impact of repeated treatment on clinical and biological tolerability

        -  Impact on anaemia

        -  Impact on Hackett score.
    


Intervention name(s): Coarsucam; Coartem
Intervention type(s): Drug; Drug
Intervention description(s): Oral route, once daily, dose according to bodyweight range Duration of treatment: 3 days; Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days
Intervention MeSH terms: Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial Evaluating the Safety and Efficacy of the KLOX Biophotonic System in Moderate to Severe Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the KLOX Biophotonic
      System in patients with moderate to severe facial acne vulgaris using a split-face design
      (treated hemiface vs untreated hemiface).
    


Intervention name(s): KLOX Biophotonic System
Intervention type(s): Device
Intervention description(s): KLOX Biophotonic System (KLOX KLGA0105-01 photo-converter gel and KLOX THERA lamp) will be administered twice a week for 6 weeks followed by a 6-week follow up period
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Smoking Topography and Harm Exposure in Menthol Cigarettes
Condition: Cigarette Smoking Toxicity
Study type: Interventional

Summary: 
      This study will examine how menthol affects smoking when menthol smokers switch to
      non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel
      Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given
      Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days
      each. Participants will provide breath and urine samples, track cigarette usage and complete
      smoking topography assessments of smoking behavior.
    

Detailed description: 
      This study will examine how menthol affects smoking behaviors and biomarker level when
      menthol smokers switch to non-menthol cigarettes. Participants will initially smoke their
      preferred brand (control) cigarettes, followed by smoking Camel Crush cigarettes, which have
      the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will
      smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will
      provide breath and urine samples to measure smoke exposures, track cigarette usage to
      establish changes in daily cigarette consumption and complete smoking topography assessments
      of smoking behavior, such as puff volume.
    

Intervention name(s): Menthol to non-menthol
Intervention type(s): Other
Intervention description(s): Switch from smoking menthol to non-menthol cigarettes.
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: menthol cigarettes
Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      The purpose of the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry
      is to study the contemporary natural history of children <16 years of age newly diagnosed
      with inflammatory bowel disease. The project follows these children quarterly from diagnosis
      examining clinical, laboratory, and humanistic outcomes. Genetic and serologic monitoring is
      performed on the study population.
    

Detailed description: 
      Observations of children with IBD often suggest a more severe course than that found in
      adults. Explanations for this are unclear, especially since children are less likely to
      engage in some behaviors (e.g., smoking) that may have a deleterious effect on disease course
      as noted in adults. In many ways children are a better "experimental model" of IBD because
      they don't have as many confounding medical factors as adults. Both Crohn's disease and
      ulcerative colitis are believed to result from a complex interaction of genetic and
      environmental factors (1). Recently, the gene CARD15/NOD2 on chromosome 16 has been
      identified in approximately 25% of Caucasian patients with Crohn's disease and is felt to be
      a significant predisposing factor to the development of fibrostenosing disease (2).
      Additionally, seropositivity for perinuclear antinuclear cytoplasmic factor (pANCA) has been
      demonstrated much more frequently in patients with ulcerative colitis than in those with
      Crohn's disease, while anti-Saccharomyces antibody (ASCA) is more common in the latter
      population (3). The importance of these serological abnormalities is not clear, though some
      data suggest an influence on the development of complications.

      Our hypothesis is that phenotypic, genotypic and serologic characteristics may provide
      prognostic information on response to therapy and course in children with IBD. This type of
      prognostic information is particularly important as newer therapies are developed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children <16 years old with inflammatory bowel disease
      
Biospecimen description: 
      Blood
    
Keywords: pediatric inflammatory bowel disease; multiple site study
Effect of Montelukast on Remodelling Markers in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Airway smooth muscle cell layer thickening and sub epithelial fibrosis, key allergen-induced
      airway remodelling features not modulated by corticosteroids, are reversible by CysLT1
      receptor blockade therapy in animals. No data are available, at the present, about the
      potential effect of LTs receptor antagonists on airway remodelling in asthmatic children.

      In the present study, the investigators aim to assess whether the addition of montelukast to
      ICS in mild asthmatic children to inhibit the release of MMP-9, TIMP-1, MMP-12, MMP-9/TIMP1
      ratio, procollagen type I C-terminal peptide (PICP) and TGF-beta in the airway fluid
      collected by induced sputum in asthmatic children. 30-40 atopic children with mild persistent
      asthma.

      Children with asthma will be recruited and evaluated with a real life open label trial: they
      will be randomised into two groups at first visit (T1): 1) group A: in these patients
      montelukast tablets 5 mg and as needed beta agonist will be administered; 2) group B: in
      these patients beta agonist therapy only.

      All children will be evaluated after 8 weeks (T2). They will be tested for lung function,
      FeNO, metalloproteinase (MMP)-9, MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1),
      procollagen type I C-terminal peptide (PICP) and TGF-beta1 levels in sputum.
    


Intervention name(s): Montelukast; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast, chewing tablets 5mg, once daily, 8 weeks; placebo chewing tablets once daily, plus inhaled short acting beta2 agonist as needed, 8 weeks
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Asthma; Children; Remodelling; Metalloproteinases; Montelukast
A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether CM-AT is safe and effective in treating the
      core symptoms of autism in children with all levels of fecal chymotrypsin.
    

Detailed description: 
      Autism is clearly a significant cause of disability in the pediatric population. Many
      children with Autism exhibit impaired protein digestion which may or may not manifest in
      self-restricted diets. The inability to digest protein affects the availability of essential
      amino acids in the body. CM-AT is designed to enhance protein digestion thereby potentially
      restoring the pool of essential amino acids. Essential amino acids play a critical role in
      the expression of several genes important to neurological function and serve as precursors to
      key neurotransmitters such as serotonin and dopamine. CM-AT is a proprietary enzyme that is
      designed as a granulated powder taken three times daily.
    

Intervention name(s): CM-AT; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days; Single unit dose powder of non-active substance administered 3 times per day for 90 days
Other intervention name(s): placebo powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism
Microperimetry in Macular Edema
Condition: Macular Edema; Uveitis
MeSH terms: Macular Edema; Uveitis; Edema
Study type: Observational

Summary: 
      In uveitic patients with fluorescein angiographically proven macular edema, a fundus related
      microperimetry is performed and results are correlated with foveal thickness as measured with
      optical coherence tomography (OCT).
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with noninfectious uveitis, macular edema
      
Keywords: microperimetry; macular edema; uveitis; Retinal sensitivity as measured with fundus related microperimetry
User Evaluation of the MiniMed 620G and 640G Insulin Pumps
Condition: Type 1 Diabetes; Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This six center international study will include two United Kingdom National Health Service
      centers, two centers in Melbourne, Australia and one center each in Denmark and Spain. The
      objective of the study is to evaluate subject acceptance of the a new insulin pump and
      transmitter together with the accompanying training materials. Descriptive data from
      participant questionnaires and device uploads will be evaluated.

      Pediatric subjects between the ages of 7 - 18 years and adults from the age of 19 years of
      age upwards, who currently use an insulin pump in the management of their type 1 or type 2
      diabetes, will be invited to participate. Each subject will be trained on the study device
      and then use it for approximately six weeks. During this time there will be three in-clinic
      visits and four follow-up phone calls, scheduled at the subjects' convenience. At the end of
      this period, they will revert back to their original insulin pump and complete a
      questionnaire on the study pump training materials, features and usability.
    


Intervention name(s): Medtronic MiniMed 620G or 640G Insulin Pump
Intervention type(s): Device
Intervention description(s): Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)