bioihbjkbjnl/mcl2 huggingface dataset:
Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy
Condition: Cutaneous Atrophy Due to Corticosteroids
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether spironolactone could significantly reduce
      cutaneous atrophy due to corticosteroids.
    

Detailed description: 
      skin cutaneous atrophy due to corticosteroids limits the long-term use of highly potent
      topical glucocorticoids which are the treatment of choice for many inflammatory skin
      diseases. This atrophy results in fragile skin, delay of healing, purpura, irreversible
      striae, telangiectasia and secondary infections. Up to now, no treatments can prevent
      efficiently skin atrophy.

      The mineralocorticoid receptor, belonging to the superfamily of nuclear receptors, is
      expressed in human epidermis but its actual function is unknown. Experimental results in
      animals obtained in INSERM unit U772 by Dr N FARMAN suggest that spironolactone which is a
      mineralocorticoid receptor antagonist 1- might limit epidermal atrophy and 2- might promote
      healing.

      Study description We propose to test clinically these hypotheses for the first time on
      humans, at the CIC in BICHAT's hospital on healthy volunteers: 1- by applying on the skin a
      highly potent cutaneous corticosteroids in association or not with spironolactone, 2- by
      applying or not spironolactone on wounds after 3-mm punch biopsies.
    

Intervention name(s): Clobetasol + Spironolactone; Clobetasol + Placebo; Placebo + Spironolactone; Placebo + Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One application 6 days a week during 4 weeks; One application 6 days a week during 4 weeks; One application 6 days a week during 7 weeks; One application 6 days a week during 7 weeks
Intervention MeSH terms: Clobetasol; Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: aldosterone; clobetasol; atrophy; skin; epidermis; wound healing; mineral corticoid receptor; spironolactone
Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop
      the growth of tumor cells, either by killing the cells or stopping them from dividing.
      Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping
      chemotherapy drugs near the tumor.

      PURPOSE: This clinical trial is studying how well chemoembolization using doxorubicin works
      in treating patients with liver cancer that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads
           mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular
           carcinoma.

      OUTLINE: This is a pilot study.

      Patients undergo catheterization of the hepatic artery followed by chemoembolization
      comprising an infusion of GelSpheres™ beads mixed with doxorubicin hydrochloride into the
      target hepatic artery. Patients may receive up to 3 chemoembolization treatments.

      After completion of study treatment, patients are followed at 1 month, every 2 months for 1
      year, and then every 3 months during year 2.

      PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
    

Intervention name(s): Drug-eluting beads loaded with doxorubicin hydrochloride
Intervention type(s): Device
Intervention description(s): Doxorubicin eluting beads
Other intervention name(s): Gelspheres; LC Beads
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer
Monitoring of the Ischemic Stroke Patient Through the Use of New Serum Biomarkers and MRI Imaging
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      Aim of this study will be the evaluation (by ELISA quantification and quantitative RT-PCR) of
      circulating biomarkers of damage and regeneration in patients affected by ischemic stroke.
      The biomarker levels will be measured from the acute event (48h) and in subsequent 4 times (7
      days, 30 days, 90 days, 180 days) following hospitalization, up to 6 months after the acute
      event. These data will then be correlated for all five times with the clinical scales
      normally used for patient evaluation and will also be associated with MRI-DTI measurements
      performed in the post-acute (30 days) and post-discharge (180 days) phase.
    

Detailed description: 
      In current clinical practice, outcome's assessment after stroke and patients' monitoring
      during rehabilitation rely on scores in clinical scales and instrumental evaluations
      (electrophysiological evaluations and MRI imaging). This approach follows current guidelines
      but has some limitations:

        -  subjectivity of the patient's clinical evaluation and instrumental data's interpretation

        -  poor prognostic value of clinical scales;

        -  poor prognostic value of instrumental measurements;

        -  difficulty in standardizing and automating clinical/instrumental assessments;

        -  difficulty in evaluating medical services on a large scale due to the lack of discrete
           values of treatment efficacy.

      The identification and validation of reliable and accessible biomarkers associated with
      patients' functional recovery could improve their care but still remains a clinical
      challenge.

      Aim of this study will be to measure the levels of circulating biomarkers of brain damage and
      regeneration in patients affected by ischemic stroke, and to evaluate their prognostic
      relevance over a 6-month follow-up. Biomarkers' levels will be measured by ELISA and
      quantitative RT-PCR from the acute event (within 24h from symptoms onset) and in subsequent 4
      time-points (7 days, 30 days, 90 days, 180 days post-stroke). Obtained data will be
      correlated with clinical scales used for patient evaluation and will be associated with
      MRI-DTI measurements performed in the post-acute (30 days) and post-discharge (180 days)
      phase.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with minor/moderate/severe stroke
      
Keywords: stroke; biomarkers
Population Pharmacokinetics of Anti-infectious Drugs in Children
Condition: Pediatrics; Ceftazidime; Ciprofloxacin; Voriconazole
Study type: Interventional

Summary: 
      The Pharm A project is a French national collaborative project aiming to determine the
      population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric
      patients aged one month to five years.
    

Detailed description: 
      The licensing process was introduced in order to ensure that medicines are safe, effective
      and of high quality. However, over 50% of children admitted to hospital in France and Europe
      will receive an unlicensed or off-label medicine. This occurs for most drugs in children less
      than 6 years of age. They represent a particularly vulnerable subgroup of the paediatric
      population.

      There are major practical and ethical issues in relation to studying medicines in paediatric
      patients aged 5 years or less.

        -  They represent only a small part of the population as compared to older children and
           adults, and the variation of specific types of diseases in this young subpopulation is
           higher than in the paediatric counterpart. There are major differences in drug
           disposition in the different age groups.

        -  There is a need for suitable methodological approaches for clinical trials

        -  There are major ethical issues It is essential, therefore, to recruit children from
           various regions in France in order to obtain a critical sample size of sufficient
           magnitude and to conduct scientific sound studies. This will be achieved by performing
           Pharm A, a population pharmacokinetic study of three different anti infectious agents
           (ceftazidime, ciprofloxacin, voriconazole) and identify covariates including
           pharmacogenetic biomarkers that explain pharmacokinetic variability.

      After parental informed consent, sampling strategy will be randomized depending on the drug
      and the age group (2 samples in patients below 2 years and 3 samples in patients from 2 to 5
      years).
    

Intervention name(s): Ceftazidime; Ciprofloxacin; Voriconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Bloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment.; Bloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment.; Bloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment.
Intervention MeSH terms: Ciprofloxacin; Ceftazidime; Voriconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic; Population; Children; Ceftazidime; Ciprofloxacin; Voriconazole; Pediatric
Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention in NSTEMI
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear.

      Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and
      others even showed a benefit of a selective invasive approach only in case of recurrence of
      symptoms or a positive stress test.

      The optimal timing of intervention is still matter of debate as a result of a randomized
      clinical trial.
    

Detailed description: 
      In this randomized, controlled, open-label clinical trial we compare a very early cardiac
      catheterization (< 2,5 hours after randomization) similar to ST-elevation myocardial
      infarction treatment, versus an early invasive approach (within 2-48 hours after
      randomization) versus a selective invasive approach in patients with non-ST-elevation
      myocardial infarction.

      All patients are treated with heparin, ASA, Clopidogrel loading dose (600 mg) with subsequent
      75 mg/d and tirofiban for 24 hours.
    

Intervention name(s): Timing of percutaneous coronary intervention
Intervention type(s): Procedure
Intervention description(s): Immediate, early or selective invasive angiography
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSTEMI; infarction; treatment; percutaneous coronary intervention; non-ST-elevation myocardial infarction
Effect of Neutrophil Lymphocyte-platelet Lymphocyte Ratio on Complications in Pediatric Patients
Condition: Anesthesia; Complication
Study type: Observational

Summary: 
      The aim of this study was to investigate the relationship between NLR, PLR and postoperative
      complications in children undergoing adenotonsillectomy and adenoidectomy.
    

Detailed description: 
      Between the dates of February 1, 2018 and June 30, 2018, patients between 2-10 years of age,
      ASA I-II, elective adenotonsillectomy and adenoidectomy under general anesthesia were planned
      to be included in the study. The number of neutrophils, lymphocytes and platelets will be
      taken from the hospital registry system taken preoperatively and the NLR and PLR ratios will
      be calculated.

      All patients in the operating room will be started with routine monitoring and anesthesia.
      Hemodynamic data during surgery will be recorded. The entrance to the operating room (T1), 5
      minutes after the start of anesthesia (T5), 15 minutes (T15), 30 minutes (T30) and 45 minutes
      (T45) will be recorded in the follow-up form of the anesthesia. The fasting period of the
      patients and the drugs and fluids applied during surgery will be recorded from the anesthesia
      form. At the end of the operation, the patients who were taken to the recovery room at the
      end of the surgery will be evaluated with 1 point, 15 minutes, 30 minutes, 1 hour and 4 hours
      and 6 hours vomiting using the 4 point nausea scale.

      Introduction to recovery room using Modified Eastern Ontario Children's Hospital Pain Scale
      (mCHEOPS), postoperative pain at 15 min, 30 min, 1 hr and 4 hr. Analgesic requirement will be
      recorded. Bronchospasm, agitation, etc. will be recorded by evaluating whether there are
      complications.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        2-10 years
Corheart 6 LVAS LTFU
Condition: End-stage Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular
      Assist System (Corheart 6 LVAS) when used for the treatment of advanced refractory heart
      failure.
    


Intervention name(s): Corheart 6 Left Ventricular Assist System
Intervention type(s): Device
Intervention description(s): Implantation of left ventricular assist device for hemodynamic support
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of CVL-231 Following Single Oral Administration of Modified- and Immediate-release Formulations in Fasted and Fed Healthy Participants
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A 2-part, crossover design, open-label treatment trial with 4 periods, 4 sequences (Part A)
      to evaluate MR formulations of CVL-231 and a 2 periods, 2 sequences (Part B) to understand
      effect of food on CVL-231 exposures from an MR formulation.
    

Detailed description: 
      CVL-231 is a muscarinic acetylcholine receptor (mAChR) activator that selectively binds to
      the M4 muscarinic receptor subtype (M4 mAChR) and is being developed for treatment of
      psychosis in schizophrenia. Part A of this 2-part trial will investigate the PK of CVL-231 in
      healthy participants following a single oral dose of CVL-231 as 3 modified-release (MR)
      formulations with different release rates and an immediate-release (IR) formulation under
      fasted conditions. Upon selection of an MR formulation with appropriate PK characteristics,
      the effect of food on the PK of CVL-231 and its metabolite following single oral doses of the
      selected MR formulation may be evaluated in Part B.
    

Intervention name(s): 10 mg CVL-231 as IR formulation; 30 mg CVL-231 as slow-release MR formulation; 30 mg CVL-231 as medium release MR formulation; 30 mg CVL-231 as fast release MR formulation; 30 mg CVL-231 Target Release, Fasted; 30 mg CVL-231 Target Release, Fed
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets; Capsules; Capsules; Capsules; Capsules; Capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part A is an open-label, randomized, 4-period, 4-sequence, crossover design to investigate the PK, relative bioavailability, safety, and tolerability of single doses of CVL-231 IR/MR formulations in healthy participants. The following treatments, administered under fasted conditions are: 1) 10mg CVL-231 as IR formulation, 2) 30mg CVL-231 as slow release MR formulation, 3) 30mg CVL-231 as medium release MR formulation, 4) 30mg CVL-231 as fast release MR formulation.
Part B is an open-label, randomized, 2-period, 2-sequence, crossover design to investigate the effect of food on CVL-231 PK following a single dose of the CVL-231 MR formulation in healthy participants. After completion of Part A, a target release formulation (MR formulation with acceptable PK characteristics) may be selected and effect of food on CVL-231 PK from the target release formulation may be evaluated. Based on Part A data, if a target release formulation cannot be selected, Part B of the trial may be canceled.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Healthy Volunteer; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders
Cold Challenge With C21 in RP
Condition: Raynaud Phenomenon; Systemic Sclerosis
MeSH terms: Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, double-blind, placebo-controlled, cross-over phase 2 trial
      investigating the effect of C21 on cold-induced vasoconstriction in subjects with Raynaud's
      phenomenon secondary to systemic sclerosis. The purpose of the trial is to achieve a
      vasodilatory effect in subjects with Raynaud's phenomenon by stimulation of the AT2R
      (angiotensin II type 2 receptor) with C21.
    


Intervention name(s): C21; C21; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): C21 as first treatment; C21 as second treatment; Placebo as second treatment; Placebo as first treatment
Intervention MeSH terms: Compound 21
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomised, double-blind, placebo-controlled cold challenge study. A cross-over design is applied to control for inter-individual variability in response to cold challenge.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Systemic sclerosis; Raynaud's phenomenon; Vasoconstriction
Healthy Buddies Manitoba
Condition: Healthy Children; Elementary School Age; Rural and Urban; First Nations
Study type: Interventional

Summary: 
      School-based interventions are generally ineffective for preventing weight gain in children.
      In 2007, a group from the University of British Columbia, developed a program called Healthy
      Buddies, that relied on peer mentors to help young children adopt healthy living behaviours.
      Pilot studies revealed that the program effectively prevented weight gain in children. This
      trial had never been tested on a large scale using a more scientifically sound study design.
      We developed a large school-based randomized trial to overcome that limitation and test the
      hypothesis that that a school-based peer-led healthy living program would reduce adiposity
      and increase physical activity among children 6-12yrs old.
    


Intervention name(s): Healthy Buddies Curriculum
Intervention type(s): Other
Intervention description(s): Each week, intermediate students will receive a 45-minute healthy-living lesson plan from their classroom teacher. Later that week, intermediate students will serve as peer mentors ("Buddies"), teaching a 30-minute lesson to their younger students. The Physical activity (i.e."Go Move!") component of the lesson plans includes 30-minutes of structured aerobic fitness sessions, called fitness loops, with the student pairs twice weekly. The dietary ("Go Fuel!") component includes lessons about distinguishing nutritious and from unhealthy (nutrient poor-energy rich) foods and beverages. The body image ("Go Feel Good!") component, the students are taught to value classmates based on individual traits rather than peer influence.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Determine the Effect of Multiple Oral Doses and Regimens of KD025 in Healthy Male and Post-menopausal Female Subjects
Condition: Immune System Disorder (Healthy Volunteer)
MeSH terms: Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of
      multiple oral doses and regimens of KD025 in healthy male and post-menopausal female
      participants.
    

Detailed description: 
      Up to approximately 37 days including safety follow up period of 30 days after participant is
      treated with the last dose of study drug.
    

Intervention name(s): Belumosudil mesylate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: capsule; Route of administration: oral; Pharmaceutical form: capsule; Route of administration: oral
Other intervention name(s): KD025; SAR445761
Intervention MeSH terms: Belumosudil
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of Educational Intervention in Mothers for Prevention of Caries in Their Children
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of an educational intervention on
      mothers knowledge, attitudes and practices for preventing childhood caries.
    

Detailed description: 
      Health education is being used as a key preventive tool in the prevention of chronic diseases
      such as heart disease, cancer, obesity, mental illness, neurological disturbances as well as
      dental diseases.

      Amongst the dental diseases, dental caries is a high prevalence chronic childhood disease
      having long term growth and developmental implications . A number of educational programs
      have been utilized to decrease its prevalence especially in disadvantaged communities.

      Dental caries is a complex interplay of a number of risk factors such as demographic
      (socioeconomic status, race, etc.) behavioral, dietary and cultural factors. Among the
      dietary intake, the most significant risk factor has been a high frequency intake of sugary
      foods and drinks.Patterns of sugar intake are established early in life and sugar intake
      increases in the first two years of life.

      Early feeding practices and lack of oral hygiene maintenance have been identified as risk
      factors for caries in subsequent years. Maternal education can prove to be protective against
      dental caries by way of child's dietary practices.

      Research has also indicated a reduction in prevalence of caries in children whose parents
      were previously participants of an oral health educational program.

      Educating mothers about oral hygiene and feeding practices before the child transitions from
      exclusive milk diet to a variety of foods in an important time to exert a positive influence
      on dietary intake of child and overall oral health.
    

Intervention name(s): oral health education; reminder phone call
Intervention type(s): Behavioral; Behavioral
Intervention description(s): oral health education in the form of a pictorial pamphlet.; a reminder phone call on oral health instructions would be given to mothers after every one month over a period of three months.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention