bioihbjkbjnl/mcl2 huggingface dataset:
Biomarkers in Tissue Samples From Patients With Hodgkin Lymphoma Enrolled on ECOG-2496 Clinical Trial
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
      It may also help doctors find better ways to treat cancer.

      PURPOSE: This research study is studying biomarkers in tissue samples from patients with
      Hodgkin lymphoma enrolled on ECOG-2496 clinical trial.
    

Detailed description: 
      OBJECTIVES:

        -  To explore the predictive power of a gene expression-based multi-gene predictor in
           classical Hodgkin lymphoma (cHL) with the potential to change clinical practice by
           basing treatment decisions on biological markers.

      OUTLINE: Archived tissue samples are analyzed for gene expression profile using NanoString
      technology. Results are then compared with patients' treatment outcomes, including
      failure-free survival and overall survival.

      PROJECTED ACCRUAL: A total of 306 patients from ECOG-2496 (training cohort) and 87 patients
      treated with ABVD in other trials (validation cohort) will be accrued for this study.
    

Intervention name(s): gene expression analysis; laboratory biomarker analysis
Intervention type(s): Genetic; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients who participated in E2496 and provided samples for research.
      
Keywords: stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma
Health Effects of Indoor Air Filtration in Healthy Chinese Adults
Condition: Blood Pressure
Study type: Interventional

Summary: 
      This study aims to detect serum metabolite changes, as well as other health indicators with
      the intervention of air purifiers on a randomized, crossover, double-blind trial.
    

Detailed description: 
      The investigators conducted a randomized double-blind crossover trial among 60 healthy
      college students in Shanghai, China from November to December, 2015. These students lived in
      dormitories that were randomized into two groups and alternated the use of true or sham air
      purifiers for 9 consecutive days with a 2-week wash-out interval. All participants and
      research staffs were blinded to the group assignment. All participants were required to stay
      in their dormitory with the windows/doors closed for at least 50% of the time on weekdays and
      for 80% on weekends throughout the 9-day intervention period. All interventions started at 7
      a.m. to avoid issues related to diurnal variation. Health endpoints, including blood
      pressure, fractional exhaled nitric oxide were evaluated and biological samples such as
      morning urine, fast blood and buccal cells were collected at baseline and immediately after
      the completion of each intervention period.
    

Intervention name(s): Air Purifiers; Sham Air Purifiers
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment.; The control group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms with the windows/doors closed. All participants and research staffs were blinded to the group assignment.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: PM2.5; air purification; randomized controlled trial; metabolomics; Metabolites; exhaled nitric oxide
Percutaneous Coronary Intervention With the Angiolite Drug-eluting Stent: an Optical Cohenrece Tomography Study
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to perform a first-in-man assessment of feasibility, exploratory
      efficacy and clinical performance of the novel Angiolite drug-eluting stent (iVascular,
      Barcelona, Spain) utilizing intracoronary optical coherence tomography (OCT).
    

Detailed description: 
      This is a prospective registry including patient scheduled for a clinically-indicated
      percutaneous coronary intervention (PCI) of a de novo epicardial lesion with indication for
      drug-eluting stent implantation. Following study enrolment and PCI/stent with the Angiolite
      DES, patients will be scheduled for follow-up surveillance coronary angiography and OCT with
      the C7-XRTM Fourier Domain OCT system with C7 DragonflyTM catheter (St Jude Medical,
      Minneapolis, MN) or with the Terumo LunawayTM OCT system with fastview catheter (Terumo
      Medical Corporation, Tokyo, Japan). An adaptive design component of the study will randomize
      patients to either 3-month or 6-month angio/OCT follow-up. Clinical follow-up will occur at
      30 days, 3 months, 6 months, 12 months and 24 months post PCI.
    

Intervention name(s): Angiolite stent
Intervention type(s): Device
Intervention description(s): Following index PCI, patients will be followed via scheduled clinic and/or phone contact at 1-, 3-, 6-, 12- and 24-month. Patient will be randomized to undergo a scheduled repeat coronary angiogram and OCT evaluation at either at 3- or 6-month post index PCI.
Other intervention name(s): (Angiolite CE Mark reference number: 2014 12 0833 ED)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cut Off for the Diagnosis of Cytomegalovirus (CMV) Disease in Serum-positive Kidney Transplant Recipients
Condition: Cytomegalovirus Disease
MeSH terms: Cytomegalovirus Infections
Study type: Observational

Summary: 
      CMV disease is a challenge to the success of renal transplantation. Recently, the
      investigators analyzed data from 792 renal transplant recipients performed at our hospital
      between 1999 and 2005. After the usual exclusions, 663 patients were analyzed. This
      population showed that the incidence of CMV disease is stable and occurs in approximately
      20-22% of all patients and invasive disease in approximately 5% every year. In seronegative
      patients and those receiving anti-lymphocyte (AL), CMV prophylaxis, done with ganciclovir for
      90 days is our routine and in the majority of transplant centers. In seropositive patients
      without associated risk factors (such as the use of AL) universal prophylaxis is not done.
      Rather, in this group, early diagnosis, by detection of antigenemia or viremia by
      quantitative PCR, is performed in patients who show symptoms compatible with CMV disease. In
      the investigators analysis the incidence of CMV disease in seropositive patients is around
      16%. These patients are usually hospitalized and treated with GCV IV for 14-21 days. This
      leads to an additional costs of admissions, biopsies for the diagnosis of disease invasion,
      etc. Besides these costs, the survival of the grafts in the long run is lower in patients
      with CMV disease than in those without CMV, particularly when associated with acute
      rejection. In recent years, monitoring of viremia (PCR / antigenemia) and preemptive
      treatment when it reaches substantial values, have increasingly been suggested. Patients in
      whom the detection of viremia in progressive values is detected would be treated as
      outpatients before the disease develops. To turn this hypothesis into reality, there is an
      urgent need to define cutoff values for CMV-PCR in the detection of developing CMV disease.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Kidney transplant recipients
      
Keywords: Kidney transplantation; PCR quantitative; cytomegalovirus; antigenemia
A Clinical Study to Access the Pharmacokinetics of HMS5552 in Hepatic Impaired Subjects and Healthy Volunteers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in
      single dose in mild and moderate hepatic impaired subjects and matched healthy adult
      subjects.
    

Detailed description: 
      This is an open-label and paralleled study with single oral dose of HMS5552 given to hepatic
      impaired subjects and matched healthy volunteers.

      The primary objective is to access the pharmacokinetic profiles of HMS5552 in 25 mg dose in
      hepatic impaired subjects and (gender, age and BMI) matched healthy adult subjects.

      The secondary objective is to characterize the safety profiles of HMS5552 in single dose in
      hepatic impaired subjects.

      The subjects include mild hepatic impaired subjects (A group), moderate hepatic impaired
      subjects (B group), and healthy subjects (C Group) matched with hepatic impaired subjects in
      gender, age and BMI. The number of subjects in each group was no less than 8, and no less
      than 3 subjects in each gender.
    

Intervention name(s): HMS5552
Intervention type(s): Drug
Intervention description(s): single dose of HMS5552 25mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Daily Irrigation With Silicone Hydrogel Contact Lens Continuous Wear
Condition: Corneal Epithelial Permeability
Study type: Interventional
Phase: Phase 4

Summary: 
      This study sought to determine whether daily irrigation with sterile saline solution during
      silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface
      integrity and reduce the risk of adverse events.
    

Detailed description: 
      The purpose of this study was to determine whether daily irrigation with sterile saline
      solution during silicone hydrogel (SiH) contact lens 30-day continuous wear (CW) can mitigate
      increases in corneal epithelial permeability (Pdc) and reduce the risk of mechanical, contact
      lens-induced, inflammatory, and overall adverse events. 161 non-contact lens wearers were fit
      with SiH contact lenses and randomized to either a treatment (n = 81) or control (n = 80)
      group for 30-day CW. Subjects in the treatment group irrigated every morning and whenever
      dryness symptoms occurred; subjects in the control group did not.
    

Intervention name(s): Daily irrigation; 30-day SiH CW
Intervention type(s): Drug; Device
Intervention description(s): Daily morning irrigation of the eye with sterile, borate-buffered, saline solution (Unisol 4) and gentle nudging of the lens to promote solution flow beneath the lens; 30-day continuous wear of silicone hydrogel contact lenses
Other intervention name(s): Unisol 4 (Alcon Laboratories, Inc., Fort Worth, TX)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 161 non-contact lens wearers were fit with silicone hydrogel (SiH) contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day continuous wear (CW). Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: continuous contact lens wear; silicone hydrogel contact lenses; irrigation; corneal epithelial permeability; contact lens-related adverse events
A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare how the body takes up and then eliminates the study
      drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule.
      This study will also evaluate whether food has any effect on how the body takes up BCX4161.
    


Intervention name(s): BCX4161
Intervention type(s): Drug
Intervention description(s): Each subject will receive Treatments A, B, and C in an open-label, randomized sequence with a washout period of at least 7 days between each dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BCX4161; BioCryst; hereditary angioedema; relative bioavailability; kallikrein inhibitor
Vitamin D Status Among Infertile Women in Sweden
Condition: Infertility, Female; Vitamin D Deficiency
MeSH terms: Infertility; Infertility, Female; Vitamin D Deficiency
Study type: Observational

Summary: 
      The goal of this prospective cohort study is to learn about the overall and seasonal
      prevalence of vitamin D insufficiency and its determinants in a population of women with
      infertility who will go through in vitro fertilization in Sweden. The main questions it aims
      to answer are:

        -  What is the prevalence of vitamin D insufficiency?

        -  What are the determinants of this insufficiency? Participants will be asked to complete
           a questionnaire validated for dietary assessment of vitamin D intake and sun exposure
           habits and they will leave a blood sample for measurement of 25(OH)D concentration.

      Researchers will compare the in vitro fertilization outcomes between women with vitamin D
      insufficiency and sufficiency to see if there is any difference.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 18-38 who will go through in vitro fertilization during 2020-2021 (one year) for
        infertility at the Department of Obstetrics and Gynecology, Sahlgrenska University Hospital
        in Gothenburg, Sweden.
Climat Impact on Urinary Iodine Concentration
Condition: Iodine Deficiency
Study type: Observational

Summary: 
      Urinary iodine concentration (UIC) is the recommended biomarker of iodine status in
      populations. Yet, the influence of climate on UIC remains unclear. Hot climate may reduce
      urine volume and consequently increase UIC independent of iodine status. This could lead to
      an overestimation of population iodine intake, thus masking iodine deficiency in vulnerable
      groups.

      In this longitudinal observational cohort study in women of reproductive age we will collect
      24h and spot urine samples in the summer and winter season. The influence of high temperature
      climates on UIC, measured and estimated urinary iodine excretion will be estimated.
    


Intervention name(s): Climate
Intervention type(s): Other
Intervention description(s): Hot and temperate climate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women between 18 and 49 years of age
      
Biospecimen description: 
      24h urine samples, spot urine samples, dried blood spots
    
Keywords: Urinary iodine concentration
Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the
      absolute bioavailability of oral ONO-5788. The study will be conducted in two parts: Part 1
      to assess the absolute bioavailability using ONO-5788 and radiolabelled ONO-5788 as
      intravenous and oral forms; part 2 will assess the mass balance of ONO-5788 using orally
      administered radiolabelled ONO-5788
    


Intervention name(s): ONO-5788; [14C]-ONO-5788
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Drug; Investigational Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunoglobulin Gene Rearrangement and Repair in Healthy Donors
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      B-cells ensure humoral immune response against antigens (Ag) thanks to their receptor (BCR).
      V(D)J rearrangement, somatic hypermutation, immunoglobulin (Ig) class switch and locus
      suicide recombination are mutational/recombinational processes targeting Ig loci influencing
      BCR expression. Study of these events is essential for B cell function analysis. Our project
      will provide the normal reference values using high throughput sequencing-based protocols.
    


Intervention name(s): Blood sample
Intervention type(s): Genetic
Intervention description(s): The blood samples will be collected from healthy volunteers : 7 tubes of 7 ml with anti-coagulant Héparine Lithium and 1 tube of 7ml with anti-coagulant EDTA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: B-cells; BCR; VDJ rearrangement; SHM; CSR; LSR; Ig; HTS; normal values
A First-In-Human Study With a Single Ascending Dose of UCB7858 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and tolerability of UCB7858 when given as
      single ascending doses administered by intravenous or subcutaneous infusion in healthy
      subjects.
    


Intervention name(s): UCB7858; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: First in human; subjects
Efficacy and Safety of Tideglusib in Congenital Myotonic Dystrophy
Condition: Congenital Myotonic Dystrophy
MeSH terms: Myotonic Dystrophy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2/3 study of
      patients (aged 6 to 16 years) diagnosed with Congenital Myotonic Dystrophy (Congenital DM1).
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled study of weight adjusted dose 1000
      mg/day tideglusib versus placebo in the treatment of children and adolescents 6-16 years of
      age with Congenital DM1.
    

Intervention name(s): Tideglusib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tideglusib for oral suspension, weight-adjusted at 400mg, 600mg or 1000 mg dose levels, once daily; Matching placebo formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tideglusib; AMO-02-MD-2-003; Congenital Myotonic Dystrophy; Myotonic Dystrophy; Dystrophia Myotonica; Myotonia Atrophica; Myotonia Dystrophica; Myotonic Dystrophy, Congenital; Steinert Disease; Steinert Myotonic Dystrophy; Steinert's Disease
What is the Future of Vulnerable New-borns
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in
      Pontoise Hospital (In the neonatology service) and compare the information with the national
      data of preterm birth.
    

Detailed description: 
      The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in
      Pontoise Hospital (In the neonatology service), it means, newborns who are in these following
      risk categories:

        -  Birth before 33 weeks of amenorrhea

        -  Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the
           3rd for the gestation age

        -  Perinatal anoxic-ischemia

        -  Other children whose birth, perinatal history or the existence of a pathology classified
           them in a category at risk of developmental psychomotor disorders, the co-twin of a
           child of the preceding groups.

        -  A regular follow-up is made in Pontoise hospital till the age of 7 to 8 year sold. It
           tries to screen growth anomalies (neuromotor, sensorial, behavioral, and cognitive or
           growth development) or health status. The data collect allow us to monitor these
           parameters and do a statistical study with them.

      These information may be used to inform the parents about the future of the premature
      children cared at Pontoise. They also may be used to compare these children's future with the
      national data (EPIPAGE 2)
    

Intervention name(s): Data collection
Intervention type(s): Procedure
Intervention description(s): Data collection of growth, neuromotor, sensorial, behavioral, and cognitive development.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm bith children
      
Keywords: Preterm birth; growth; neonatology; Pregnancy; Delivery
WEB French Observatory of the WEB Aneurysm Embolization System
Condition: Brain Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      An observational post-market, open label, multicenter Observatory. The decision to use a WEB
      device to treat the patients has been made before and independently of the decision to
      include the patient in the French Observatory.
    

Detailed description: 
      Subjects will be screened for Observatory eligibility after giving informed consent. The
      embolization procedure will be performed in the digital angiographic suite using standard
      angiographic techniques.

      Initial analysis of Observatory data will be performed at completion of 12 month follow-up
      for the first thirty-five (35) subjects.

      Subjects will be followed per Institution's standard of care.
    

Intervention name(s): WEB Aneurysm Embolization System
Intervention type(s): Device
Intervention description(s): WEB Aneurysm Embolization System
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The decision to use a WEB device to treat the patients has been made before and
        independently of the decision to include the patient in the French Observatory
      
Keywords: Endovascular; Brain Aneurysm
Measurement of Lung Water by Transpulmonary Thermodilution in Lung Transplanted Patients
Condition: Mucoviscidosis; Pulmonary Insufficiency
MeSH terms: Cystic Fibrosis; Respiratory Insufficiency
Study type: Observational

Summary: 
      Repeated measurements of lung water by single transpulmonary thermodilution during the first
      postoperative days following lung transplantation
    


Intervention name(s): Double-lung transplantation
Intervention type(s): Procedure
Intervention description(s): Double-lung transplanted patients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        double-lung transplanted patients