bioihbjkbjnl/mcl2 huggingface dataset:
Role of Prohepcidin in Uremic Patients
Condition: Inflammation; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Inflammation
Study type: Observational

Summary: 
      The investigators aimed to study the effect of prohepcidin levels on hematologic parameters
      and inflammatory markers in non-diabetic uremic patients. The investigators selected three
      groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4
      chronic kidney disease. A control group was formed from healthy volunteers also. Each group
      has been planned to be formed of about 25 patients. Diabetic patients were excluded.
      Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine
      biochemical analysis including hematological ones.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the
        group with stage 4 chronic kidney disease. A control group was formed from healthy
        volunteers also.
      
Keywords: hemodialysis; inflammation; iron; peritoneal dialysis; prohepcidin; uremia
MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
Condition: Mitral Regurgitation
MeSH terms: Mitral Valve Insufficiency
Study type: Observational

Summary: 
      This Study is designed to observe the clinical outcomes of patients requiring mitral repair
      that were treated with the CE certified Cardinal System.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are candidate for mitral valve repair, with our without concomitant
        procedures.
      
Keywords: mitral; valve; annuloplasty; mitral regurgitation
Treatment of Resistant Langerhans Cell Histiocytosis With ENBREL
Condition: Histiocytosis, Langerhans-Cell
MeSH terms: Histiocytosis, Langerhans-Cell; Histiocytosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to learn about the response of Langerhans cell histiocytosis
      (LCH) to Enbrel in patients who have failed to respond to standard therapies. We are also
      looking specifically at what side effects Enbrel has on patients. We expect to enroll 20
      patients on this study and anticipate the subjects active participation to last up to one
      year.
    

Detailed description: 
      After subjects have completed the pretreatment evaluations, they will receive an injection of
      Enbrel - the study drug -(given under the skin) twice weekly. If the subjects disease
      stabilizes or regresses, they may continue to receive treatment for up to 1 year.

      Subjects with disease involvement of risk organs (this means patients have disease in their
      liver, lung, spleen, or bone marrow): will be admitted to the hospital for observation during
      the first week of administration of Enbrel. If after the first two doses there appears to be
      no problems, subjects may be followed as an outpatient with twice weekly evaluation visits
      (similar to those performed before treatment began) until abnormal blood tests have become
      normal. Then the frequency of clinic visits will decrease and be similar to those described
      below for subjects without disease involvement of risk organs.

      Subjects without disease involvement of risk organs will be treated as an outpatient. While
      receiving the treatment, subjects may not receive any other chemotherapy agents. Doctors will
      be monitoring subjects closely for side effects. Most side effects usually disappear after
      the treatment is stopped. In the meantime, however, the doctor may prescribe medication to
      keep these side effects under control.
    

Intervention name(s): Etanercept
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LANGERHANS; HISTIOCYTOSIS
Trial to Collect Safety Data and Sera for Immunogenicity Testing
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from
      healthy children receiving the 2006-2007 formulation of the inactivated, split-virion
      influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA),
      Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).
    


Intervention name(s): Influenza Virus Vaccine (Fluzone®); Influenza Virus Vaccine (Fluzone®)
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL, Intramuscular (infant/children dose); 0.25 mL, Intramuscular (infant/children dose)
Other intervention name(s): Fluzone®; Fluzone®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza Virus Vaccine; Fluzone®
ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma
Condition: Lymphoma, Large-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in
      case of bcl-2 overexpression in non previously treated patients aged 60 years or less with
      low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal
      is to obtain a 15% increase of event-free survival at 2 years.
    


Intervention name(s): doxorubicin; cyclophosphamide; Autologous stem cell transplantation
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Cyclophosphamide; Doxorubicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lymphoma; autologous stem cell transplant; chemotherapy; BCL2
Ides in Highly Sensitized (HS) Patients Awaiting Kidney Transplantation
Condition: Renal Disease
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a single center phase I/II open label, exploratory study assessing safety and
      efficacy of IdeS® (Hansa Medical, Lund, Sweden) given immediately prior to kidney
      transplantation. We hope that IdeS® will help eliminate DSAs in HS patients who are DSA+ and
      flow cytometry (FCMX) crossmatch + at time of transplant. We plan to enroll a total of 20
      patients. Patients will be followed for 6 months post administration of IdeS®.
    

Detailed description: 
      IdeS® is an IgG-degrading enzyme of S.pyogenes that cleaves all four human subclasses of IgG
      with strict specificity. Alloantibodies are a major deterrent to access to and success of
      life-saving organ transplants. We hypothesize that the use of IdeS® pre-transplant in HS
      patients will represent a more robust and complete technique to eliminate DSA from the sera
      of HS patients. A single dose administration of IdeS® in the pre-operative period to HS
      patients with positive DSAs and flow cytometry crossmatches will durably eliminate
      circulating DSAs, allow transplantation to occur without ABMR and, in conjunction with
      standard desensitization therapy, result in a durable suppression of DSA levels thus
      eliminating the risk for ABMR.
    

Intervention name(s): IdeS® (Imlifidase)
Intervention type(s): Drug
Intervention description(s): 0.24mg/kg IdeS
Other intervention name(s): IgG endopeptidase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: End Stage Renal Disease; Kidney Transplant; Desensitization; Highly Sensitized; Antibodies
Validity and Reliability of the Turkish Version of Performance Measure for Activities of Daily Living-8
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Observational [Patient Registry]

Summary: 
      Chronic heart failure (CHF) is characterized by limited exercise performance, which is mainly
      determined by disease-specific factors, such as diminished cardiac output, abnormal
      ventilatory response, and low perfusion in skeletal muscles, which lead to skeletal muscle
      dysfunction.1 Exercise intolerance and symptoms may lead to activity restriction and further
      functional deterioration with the progression of CHF. There is some evidence that
      disease-specific self-report measures more quantify clinically relevant domains than measures
      of general health status and are generally more sensitive to clinical change. aim of the
      study is to investigate the validity and reliability of the PMADL-8 questionnaire in the
      Turkish population.
    

Detailed description: 
      Chronic heart failure (CHF) is characterized by limited exercise performance, which is mainly
      determined by disease-specifi factors, such as diminished cardiac output, abnormal
      ventilatory response, and low perfusion in skeletal muscles, which lead to skeletal muscle
      dysfunction.Exercise intolerance and symptoms may lead to activity restriction and further
      functional deterioration with the progression of CHF.

      There is some evidence that disease-specific self-report measures more quantify clinically
      relevant domains than measures of general health status and are generally more sensitive to
      clinical change. aim of the study is to investigate the validity and reliability of the
      PMADL-8 questionnaire in the Turkish population.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The sample size of the study was determined as at least 40 people, 5 times the number of
        items used in the scale.
      
Keywords: Congestive heart failure; Functional limitation; Questionnaire
Evaluation of the Ulthera® System and Efficacy Correlation to Morphological Differences
Condition: Facial and Neck Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Evaluate if there is a correlation between efficacy results and where the Thermal Coagulation
      Points (TCPs) produced during a treatment with the Ulthera System make contact with
      anatomical layers of the skin and underlying tissues.
    

Detailed description: 
      This is a prospective, single-site, non-randomized study designed to evaluate if there is a
      correlation between efficacy results and where the Thermal Coagulation Points (TCPs),
      produced during treatment with the Ulthera System, make contact with the anatomical layers of
      skin and underlying tissues. The study consists of one Ultherapy treatment administered at
      two depths using DeepSEE transducers on the full-face and neck area. Ultrasound images will
      be captured at the beginning, middle and end of each treatment section during treatment.
    

Intervention name(s): Microfocused ultrasound w/ visualization
Intervention type(s): Device
Other intervention name(s): Ultherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of CVP and IOH on AKI and AKD
Condition: Acute Kidney Injury; Acute Kidney Disease
MeSH terms: Kidney Diseases; Acute Kidney Injury
Study type: Observational

Summary: 
      This study was aimed to explore the effect of intraoperative venous congestion and
      intraoperative hypotension (IOH) on acute adverse kidney events, defined as acute kidney
      injury (AKI) and acute kidney disease (AKD), after cardiac surgery
    

Detailed description: 
      Venous congestion and IOH were primary exposures and quantified as area under the curve (AUC)
      of central venous pressure ≥12, 16 or 20 mmHg or mean arterial pressure ≤55, 65, 75 mmHg. The
      primary outcome was AKI or AKD defined as renal dysfunction persisting > 7 days after
      surgery. Multivariable logistic regression and Cox proportional hazard models were used to
      determine the association between intraoperative venous congestion/hypotension and
      postoperative acute adverse kidney events, respectively, adjusted for relevant confounding
      factors and multiple comparisons.
    

Intervention name(s): Venous congestion; Introperation hypotension
Intervention type(s): Other; Other
Intervention description(s): Venous congestion exposures were quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg; Introperation hypotension exposures were quantified as area under the curve (AUC) of mean arterial pressure ≤55, 65, 75 mmHg
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All adults undergoing cardiac surgery between 2016 and 2020 (data analysed in 2021) using
        electronic health records collected from the Nanjing First Hospital.
      
Keywords: Acute kidney injury; Intraoperative hypotension; Central venous pressure; Acute kidney disease; Cardiopulmonary bypass
Neonatal Gastro-Esophageal Reflux Disease (GERD) Management Trial
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The overall purpose of the investigator's study is to evaluate the causes of and treatment
      for feeding difficulty in infants with Gastro-esophageal Reflux Disease (GERD). New
      treatments can be possible only if the cause is known. Many infants have GERD and feeding
      difficulties, such as sucking and swallowing problems, vomiting, or delayed emptying of the
      stomach. Some of these infants have difficulty in protecting their airway during feeding or
      during reflux, and as a result can breathe fluid into their lungs or hold their breath. Most
      GERD treatments are done based on experience, but there is no scientific proof that these
      methods work for infants. GERD and feeding difficulties can lead to longer hospitalization
      and more stress for the family.

      In this clinical trial, the investigators are developing new methods to help with diagnosis
      as well as defining better treatment strategies in relieving GERD and GERD complications.
    

Detailed description: 
      Gastroesophageal reflux disease (GERD) and its troublesome complications constitute serious
      diagnostic and management challenges to the development of safe feeding and airway protection
      strategies among infants convalescing in the neonatal intensive care units; thus contributing
      to prolonged lengths of stay, recurrent hospitalizations, and death. GERD is frequently
      diagnosed by inadequate criteria, and the relative risks, benefits and indications of GERD
      therapies are unclear. Significant gaps in knowledge exist in understanding the complex
      causal or adaptive aerodigestive protective reflex mechanisms implicated in GERD in infants.
      The long-term goal is to improve digestive health, nutrition, and infant development through
      the design of simplified personalized treatment paradigms by better understanding the
      pathophysiology of aerodigestive reflexes.

      The current objective is to conduct a prospective single center randomized blinded controlled
      trial comparing the short term effects of the investigators innovative feeding strategy
      bundle (study approach) versus standard feeding approach (conventional approach).
    

Intervention name(s): Study Arm - acid suppression plus feeding bundle; Conventional arm - acid suppression only
Intervention type(s): Other; Other
Intervention description(s): Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)
Total fluid volume restriction (120-140 milliliters/kilogram/day)
Feeding duration over 30 minutes
Infant feeds with right side down
Infant is placed on back following feeds; -Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: infant; esophagitis; neonate; GERD
Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing
Condition: Plaque, Dental
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate and compare plaque removal efficacy of four
      dentifrices following a single timed tooth brushing. Prior to each evaluation visit of the
      four-way cross-over study, subjects will abstain from all oral hygiene for 24 hours. At each
      evaluation visit, subjects will be given a pre-brushing plaque evaluation, followed by a
      1-minute supervised brushing and a post-brushing plaque evaluation.
    

Detailed description: 
      This study is a randomized, single-brushing, examiner-blinded, 4-cell cross-over design that
      enrolled approximately 70 subjects to ensure that at least 60 subjects to complete the study.
      This 4-week cross-over study will evaluate plaque removal following a single brushing with
      the assigned dentifrices. Qualified subjects will have sufficient plaque (Lobene-Soparkar
      Modification of Turesky Plaque Index). Subjects will be given a pre-brushing plaque
      evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.
    

Intervention name(s): Dentifrices
Intervention type(s): Drug
Intervention description(s): Dentifrice on plaque
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Sleep Respiratory Disorders Evaluation in Sickle Cell Disease Children
Condition: Sickle Cell Disease; Respiration Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases; Anemia, Sickle Cell
Study type: Observational

Summary: 
      In Sickle cell disease children, sleep respiratory abnormalities are risk factors for
      vaso-occlusive complications, as well as cerebral vasculopathy.

      A 18 months follow-up children with sickle cell disease evaluating sleep respiratory problems
      frequency and etiology, as well as their influence on sickle cell disease complications.
    

Detailed description: 
      -  Inclusion visit with physical examination. A 2.9 ml blood sample will be necessary, if
           not done within the framework of care within 6 months for: CBC (Cell Blood Count),
           reticulocytes counts (1.2 ml of blood), liver enzymes, electrolytes, urea, creatininemia
           (1,2 ml of blood) and fetal hemoglobin (0.5 ml of blood). - A complete standardized
           examination including nasopharynx endoscopy, if not yet done in usual care, to
           identified upper airway obstruction

        -  A standardized pneumology evaluation to identified obstructive lung symptomatology

        -  An ambulatory polysomnography will be performed within days following inclusion, during
           sleep and will allow electroencephalogram recording, oculomotricity, muscles (mentalis
           muscles and tibialis anterior) movements, electrocardiogram and respiratory activity
           recording.

      The steering committee will classify the children in three populations based on their exam
      results:

        -  Group 1: no abnormality in polysomnography

        -  Group 2: obstructive sleep-related disorder

        -  Group 3: isolated sleep hypoxemia for group3, patients will have a new ambulatory
           polysomnography.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The objective of this study is to provide an early curative treatment for homozygous sickle
        cell children in age group of 2 to 6 years based on the anomalies identified in
        polysomnography. The choice of the age of 2 to 6 is linked to the peak risk of onset of
        cerebrovascular occlusive complications in this age
      
Keywords: Sickle Cell Disease; Respiration Disorders; Polysomnography
A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a double-blind, randomized, placebo-controlled dose-escalation study in adults
      recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups.
      Enrollment into a dose group was sequential. Enrollees were stratified based on time from the
      start of TB treatment. The "on-TB-treatment" stratum started TB treatment between 1 and 4
      months (30 to 120 calendar days) prior to Study Day 0. The "post-TB-treatment" stratum
      started TB treatment at least 12 months (360 calendar days) prior to Study Day 0. Subjects
      were randomized to receive a placebo or AERAS-402 vaccine. In Dose Groups 1 and 2, subjects
      were randomized to receive a single injection of AERAS-402 or placebo. Dose Group 3 subjects
      were randomized to receive two injections on study day 0 and study day 42 of AERAS-402 or
      placebo.
    

Detailed description: 
      A total of 72 subjects were randomized into the study. Subjects were stratified, based on
      time from the start of TB treatment, into the 'on-TB-treatment' stratum (TB treatment started
      between 1 and 4 months prior to Study Day 0) or the 'post-TB-treatment' stratum (TB treatment
      started at least 12 months before Study Day 0). In the on-TB-treatment stratum, 36 subjects
      were randomized to receive AERAS-402 or placebo as follows: 1 or 2 doses of placebo (N=5); 1
      dose of AERAS-402 at 3 x 10^8 vp (N=5) or 3 x 10^9 vp (N=10), or 2 doses of AERAS-402 at 3 x
      10^10 vp (N=16). In the post-TB-treatment stratum, 36 subjects were randomized to receive
      AERAS-402 or placebo as follows: 1 or 2 doses of placebo (N=6); 1 dose of AERAS-402 at 3 x
      10^8 vp (N=5) or 3 x 109 vp (N=10), or 2 doses of AERAS-402 at 3 x 10^10 vp (N=15).
    

Intervention name(s): Placebo; AERAS-402 3 x 10^8 vp; AERAS-402 3 x 10^9 vp; AERAS-402 3 x 10^10 vp
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): This is the identical buffer solution in which AERAS-402 is formulated. The placebo (1.0 mL volume) was administered by intramuscular (IM) injection to the deltoid area on Study Day 0 for groups 1 and 2 and Study Day 0 and 42 for group 3.; AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0; AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0; AERAS-402 was administered by intramuscular (IM) injection to the deltoid area on Study Days 0 and 42.
Other intervention name(s): Sterile buffer; AERAS-402; AERAS-402; AERAS-402
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Genotype-related Effects of PUFA
Condition: Healthy
Study type: Interventional

Summary: 
      To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements)
      depending on genotype of relevant factors in lipid metabolism
    

Detailed description: 
      To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements)
      depending on genotype of relevant factors in lipid metabolism.
    

Intervention name(s): Triple Strength Fish Oil
Intervention type(s): Dietary Supplement
Intervention description(s): Triple Strength Fish Oil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: volunteers