bioihbjkbjnl/mcl2 huggingface dataset:
Impact of the Therapeutic Education on the Quality of Life of the Child Suffering of Food Allergy IgE-mediated
Condition: IgE Mediated Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether therapeutic education can improve the
      quality of life of the child from 8 to 12 years old suffering of food allergy.

      This study also show us if therapeutic education has an effect on the quality of life of
      child's family.
    

Detailed description: 
      Food allergy affects 5 - 6% of children. The major risk is anaphylaxis by ingestion of the
      forbidden allergen. The child and his family have to learn to deal with this risk.
      Therapeutic education can help the children to take care of their allergy.

      Food allergy limits the child socialisation, leads to anxiety/fear, and impairs
      health-related quality of life. In the day of today, there is no cure treatment. Also,
      improve the quality of life is one of the goals of the food allergy management.

      The impact of therapeutic education on quality of life has never been studied. We intend to
      study the impact of therapeutic education on the quality of life of children from 8 to 12
      years old with IgE mediated food allergy.

      Our hypothesis is the quality of life can be improved by therapeutic education.
    

Intervention name(s): Therapeutic education group
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Food allergy; Children and families; Therapeutic education; Quality of life
Vitamin D, Insulin Resistance, and Cardiovascular Disease
Condition: Vitamin D Deficiency; Insulin Resistance; Type 2 Diabetes Mellitus; Cardiovascular Disease; Hypertension
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Vitamin D Deficiency
Study type: Interventional

Summary: 
      In recent years, vitamin D has been shown not only to be important for bone and calcium
      metabolism but also for homeostasis of critical tissues involved in vascular disease in
      patients with diabetes. Epidemiological studies indicated the high prevalence of vitamin D
      deficiency among Type 2 DM patients and suggest an increased risk of cardiovascular disease
      and hypertension with low vitamin D levels. The objective of this proposal is to evaluate the
      effects of vitamin D replacement on blood pressure control and vascular disease in vitamin D
      deficient hypertensive patients with diabetes
    

Detailed description: 
      This is a double blinded, placebo controlled trial. Patients who meet the inclusion criteria
      will be randomized to placebo or 25(OH)D3, 4,000 IU/d orally for 16 weeks. Enrolled patients
      will be tested for 24h-blood pressure, brachial arterial blood flow, vascular inflammatory
      markers and macrophage inflammatory response to modified-lipoproteins at baseline, middle and
      at the end of the study.
    

Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily; Placebo pill orally daily Calcium carbonate 500 mg twice daily
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D; Insulin Resistance; Type 2 Diabetes Mellitus; Cardiovascular Disease
Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first-in-human study is to determine the safety and tolerability profile
      of CD388 Injection, as compared to saline placebo, when administered as a single dose to
      healthy adult subjects by injection either in the muscle or under the skin.
    

Detailed description: 
      A Phase 1, single-center, prospective, randomized, double-blind, single-dose and repeat
      single-dose, dose-escalation study to determine the safety, tolerability, and
      pharmacokinetics of CD388 Injection, as compared to saline placebo, when dosed either by
      intramuscular (IM) or subcutaneous (SQ) administration to healthy adult subjects.
    

Intervention name(s): CD388 Injection; Saline placebo
Intervention type(s): Combination Product; Drug
Intervention description(s): CD388 liquid for injection; Sterile normal saline for injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to look for ways to improve breast cancer treatment by giving
      breast cancer drugs through the skin of the breast.

      The drug used in this study is a diclofenac epolamine patch and is a nonsteroid
      anti-inflammatory pain reliever. The drug amount that gathers in the breast, after
      application of a patch to the skin of the breast, will be measured and compared to the amount
      that is found in the breast when the patch is applied to the skin of the belly.
    

Detailed description: 
      This is a randomized study where participants in group 1 will apply the diclofenac epolamine
      patch to the breast and participants in group 2 will apply the same drug to her abdomen.
      Participants are instructed to apply a new patch every 12 hours for 3 days. Total
      participation in this study will be for three days, ending on the day of surgery. On the day
      of surgery, participants will have blood drawn to measure the level of diclofenac epolamine
      in the body, and the final patch will be removed.
    

Intervention name(s): Diclofenac epolamine patch
Intervention type(s): Drug
Intervention description(s): Patch (10cm X 14cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner [B].
Other intervention name(s): Flecto Patch
Intervention MeSH terms: Diclofenac; Diclofenac hydroxyethylpyrrolidine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Women undergoing total mastectomy; Breast cancer prevention
Allogeneic Stem Cell Transplantation in Chronic Myeloid Leukemia Failing TKIs Therapy
Condition: Leukemia; Myelogenous; Chronic; BCR-ABL Positive
MeSH terms: Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients newly diagnosed with chronic phase chronic myeloid leukemia undergo treatment with
      TK inhibitors (TKI). A possible cause of TK failure is represented by the insufficient
      recovery of normal Ph- hematopoiesis during TKI treatment, with consequent severe cytopenias
      that limit TKI adequate administration. Although rare, this event happens in a proportion of
      4-5% of CML patients. Our hypothesis is to circumvent this peculiar condition by providing a
      normal hematopoiesis from a HLA-matched donor (Human Leukocyte Antigen). The transplant
      procedure is therefore intended in providing a sustained hematopoiesis that will allow an
      early treatment with an adequate dosing of TKI. The transplant procedure planned in our study
      is built on all available evidences to provide the lowest incidence of acute and chronic GvHD
      (Graft-versus-host disease). Therefore, a bone marrow will be the preferential source and a
      GvHD prophylaxis based on Anti-thrombocyte globulin (ATG) and Cyclosporine/Methotrexate will
      be used according to standard current experience in the field of family and unrelated donors.
      The pre-transplant TKI will be continued until aplasia will develop, in order to decrease the
      tumor load as much as possible.The use of TKIs shortly after transplant carries the risk of
      inhibiting the newly transplanted hematopoietic cells, as Kit, an important kinase in normal
      bone marrow cells, is frequently blocked by Abl inhibitors. The use of bosutinib as
      post-transplant therapy is justified by the lack of Kit inhibition that distinguishes
      bosutinib from all other TKIs, and which could allow a minimal inhibitory activity against
      the transplanted normal bone marrow.
    


Intervention name(s): Bosutinib; Bone Marrow Transplant; Bone Marrow cells
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): Subjects will receive 400mg of bosutinib once daily from day +30 after transplant, by mouth with food, preferably in the morning. Bosutinib will also be administered from day at least -45 to day -15 to assess the sensitivity of patient CML to this TKI.; Samples of the unrelated stem cell graft shall be characterised with respect to the number of CD34 positive cells per kg body weight of the recipient.
The number of transplanted CD34 positive cells per kg body weight (BW) of the recipient shall be recorded in the Case Report Form (CRF). If the transplant was cryopreserved the number of viable CD34 positive cells has to be determined after thawing and documented.
The goal is to transplant > 3 x 106 CD34+ cells/kg BW recipient from bone marrow or > 3 x 108 nucleated cells/kg BW recipient from bone marrow
Other intervention name(s): Bosulif; SKI-606
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Given the potential age-related differences in safety, tolerability, pharmacokinetics, and
      differences in sleep architecture in young children versus adolescent versus adult, studies
      to identify the appropriate drug and dosage for children of all ages are essential in
      addressing this health problem that impacts the child and their family. The objective of this
      study is to evaluate the safety, pharmacokinetics and preliminary efficacy of eplivanserin.

      Primary objective: to assess the safety and tolerability after administration of single
      ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various
      origins.

      To assess the pharmacokinetics of eplivanserin (and active metabolite: SR141342) after
      administration of single ascending oral doses of eplivanserin to children aged 6-17 years
      with insomnia of various origins.

      Secondary objective: to assess the effect of single ascending oral doses of eplivanserin on
      global sleep parameters and sleep architecture measured via polysomnography recordings in
      children aged 6-17 years old with insomnia of various origins.
    


Intervention name(s): Eplivanserin (SR46349)
Intervention type(s): Drug
Intervention description(s): Oral administration
Intervention MeSH terms: SR 46349B
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: insomnia pediatric safety
Logistic Regression and Elastic Net Regularization for the Diagnosis of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      This study will utilize ultrasound image texture variables to construct an elastic net
      regularized, logistic regression model to differentiate between healthy and Fibromyalgia
      patients. The collected ultrasound data will be from participants who are healthy, and from
      participants who have Fibromyalgia. The predicted performance accuracy of the diagnostic
      model will be validated and this will confirm or deny the hypothesis that differentiation
      between the two cohorts is possible.
    

Detailed description: 
      Fibromyalgia (FM) diagnosis remains a challenge for clinicians due to a lack of objective
      diagnostic tools. One proposed solution is the use of quantitative ultrasound (US)
      techniques, such as image texture analysis, which has demonstrated discriminatory
      capabilities with other chronic pain conditions. The investigators propose the use of US
      image texture variables to construct an elastic net regularized, logistic regression model,
      for differentiating between the trapezius muscle in the healthy and FM patients. 162
      Ultrasound videos of the right and left trapezius muscle were acquired from healthy
      participants and participants with FM. The videos will then be put through a mutli-step
      processing pipe including converting them into skeletal muscle regions of interest (ROI). The
      ROI's will be then filtered by an algorithm utilizing the complex wavelet structural
      similarity index (CW-SSIM), which removes ROI's that are too similar to one another.
      Eighty-eight texture variables will be extracted from the ROI's, which will be used in nested
      cross-validation to construct a logistic regression model with and without elastic net
      regularization. The generalized performance accuracy of both models will be estimated and
      confirmed with a final validation on a holdout test set. Depending on the predicted,
      generalized performance accuracy it will be validated or not by the final, holdout test set
      (confirming the model construction is accurate). These models should then confirm or deny the
      hypothesis that a regularized logistic regression model built on ultrasound texture features
      can accurately differentiate between healthy trapezius muscle and that of patients with FM.
    

Intervention name(s): Ultrasound Imaging
Intervention type(s): Diagnostic Test
Intervention description(s): B-mode ultrasound pictures of the upper Trapezius were collected from both left and right sides.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with Fibromyalgia and healthy age-matched controls.
      
Keywords: Fibromyalgia; Ultrasound; Regularization; Logistic Regression; Imaging
A Study of a New Candidate Vaccine Against Hepatitis C Virus (HCV)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine
      against Hepatitis C virus (HCV). The vaccine is based on the sequential delivery, by
      intramuscular route, of two different adenoviral vectors, of human and chimpanzee origin
      respectively, bearing the same genetic information for HCV antigens (NS region).

      The two recombinant vectors, called Ad6NSmut and AdCh3NSmut, are weakened and unable to
      multiply within the body; they are designed to induce an immune response against HCV
      proteins. Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial,
      promising results have been obtained in non-human studies.

      The HCV001 study is designed to explore different prime-boost regimes concerning dose, order
      and interval of administration of Ad6NSmut and AdCh3NSmut.
    


Intervention name(s): Ad6NSmut; AdCh3NSmut; Ad6NSmut; AdCh3NSmut; Ad6NSmut; AdCh3NSmut; AdCh3NSmut; Ad6NSmut; AdCh3NSmut; Ad6NSmut; AdCh3NSmut; Ad6NSmut; Ad6NSmut; AdCh3NSmut; AdCh3NSmut; Ad6NSmut; AdCh3NSmut; Ad6NSmut
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 2 doses Ad6NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.; 2 doses Ad6NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.; 2 doses Ad6NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.; 2 doses AdCh3NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.; 2 doses AdCh3NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.; 2 doses AdCh3NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.; 1 dose Ad6NSmut 2.5 x 10^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 8.; 1 dose AdCh3NSmut 2.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 8.; 1 dose AdCh3NSmut 7.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10^10vp at week 8.
Intervention MeSH terms: Cloricromen
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis C virus; HCV; Adenovirus; Vaccine
Endobiotics for Phenotyping of Human Cytochrome P450 Enzymes
Condition: Healthy
Study type: Interventional

Summary: 
      CYP2D6 metabolizes ~25% of all marketed drugs. There is an important variability in the
      activity of this enzyme among individuals. The cause of this variability might be
      environmental, genetic, ethnical or even related to a disease. The administration of a CYP2D6
      probe drug (e.g. dextromethorphan) is a good way to characterize CYP2D6 phenotype.
      Nonetheless, it is relatively invasive and the vulnerable population (e.g. pregnant women)
      cannot be phenotyped in this manner. Therefore, finding an endogenous substance which is
      metabolized by CYP2D6 could replace usual phenotyping procedure using a probe drug. This
      study evaluates the impact of a CYP2D6 inhibitor and of genetic polymorphism on the
      metabolome of healthy volunteers in order to identify new CYP2D6 biomarkers. To this end,
      untargeted metabolomics analysis using LC-HRMS will be performed on plasma and urine samples
      This single-centre open-label clinical trial will include 40 healthy subjects (men and women)
      between 18 and 65 years. Eligible participants will be assigned to a study group according to
      their CYP2D6 genotypes: poor metabolizers (PMs) and extensive/ultrarapid metabolizers
      (EMs-UMs). Two sessions will take place for each subjects.

      Session 1: CYP2D6 phenotyping (dextromethorphan 5 mg, single dose) Session 2: idem session 1
      with prior uptake of a CYP2D6 inhibitor (paroxetine 10 or 20 mg, one dose a day for 7 days).

      In both sessions, urine will be collected up to 24 hours and capillary/venous blood will be
      sampled before phenotyping for metabolomics analyses. Urine will also be collected for 4
      hours after dextromethorphan intake in order to phenotype the CYP2D6 enzyme.
    


Intervention name(s): Dextromethorphan 5 MG; Paroxetine 10Mg Tablet; Paroxetine 20Mg Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dextromethorphan 5 mg po; Paroxetine 10 mg po; Paroxetine 20 mg po
Intervention MeSH terms: Dextromethorphan; Paroxetine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)
Condition: Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, Undifferentiated
MeSH terms: Schizophrenia; Schizophrenia, Paranoid; Schizophrenia, Disorganized
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate whether asenapine, which is approved by the United States
      Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is
      generally safe and well tolerated in adolescents with schizophrenia. This is an extension of
      base study P05896 (NCT01190254), which means participants must have completed participation
      in the 8-week base study in order to qualify for this extension study P05897. Participants in
      this extension study will receive open-label asenapine for 26 weeks. Throughout the study,
      observations will be made on each participant at various times to assess the long-term
      safety, tolerability and efficacy of the study treatment.
    


Intervention name(s): asenapine
Intervention type(s): Drug
Intervention description(s): asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID
Other intervention name(s): Saphris®, SCH 900274, Org 5222
Intervention MeSH terms: Asenapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fetal Thymus Involution as a Predictor of Adverse Neonatal Outcomes
Condition: Women Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)
MeSH terms: Premature Birth; Obstetric Labor, Premature; Fetal Membranes, Premature Rupture; Rupture
Study type: Observational

Summary: 
      The thymus gland is a specialized organ in the chest that plays a central role in the
      adaptive immune system throughout development until puberty. In response to stress, the fetal
      thymus gland may shrink, or involute. The investigators propose a prospective cohort study
      that will enroll pregnant women admitted to labor and delivery for the management of preterm
      labor and/or preterm premature rupture of membranes from 28-36 weeks gestation. Based on
      sonographic thymus measurements, the investigators will develop a clinical prediction tool to
      identify babies who are at increased risk for adverse neonatal outcomes. A reliable
      non-invasive predictor of adverse neonatal outcome using thymic ultrasound measurements has
      the potential to affect clinical management, improve outcomes for premature babies, and
      direct further research efforts.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant patients with singleton pregnancies admitted to labor and delivery at the Hospital
        of the University of Pennsylvania between 28-36 weeks gestation for the management of
        spontaneous preterm labor (defined as uterine contractions and documented cervical change)
        and/or preterm premature rupture of membranes.
      
Keywords: PPROM; Pregnant; Preterm; Premature, labor