bioihbjkbjnl/mcl2 huggingface dataset:
Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure
Condition: Acute Decompensated Heart Failure; Cytokine Storm; Inflammatory Response; Heart Failure
MeSH terms: Heart Failure; Cytokine Release Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute
      decompensated heart failure.

      Trial Design

        -  An open-label, randomized, prospective trial of patients hospitalized due to acute
           decompensation of heart failure with reduced ejection fraction.

        -  Patients will be enrolled within 24 hours from hospital admission.

        -  Randomization and intervention will begin within 24 hours of enrollment (and at least 24
           hours after admission).

        -  Patients will be randomized in a 1:1 ratio either to receive guideline directed medical
           therapy (GDMT) or GDMT plus Copaxone.

        -  Patients assigned to intervention group will receive daily SC Copaxone 20 mg for 14
           days.

        -  Patients will be assessed during 4 time points(screening/randomization, visit 3 day,
           visit 14 day, visit 30 day) as elaborated in article "monitoring".

        -  Changes in inflammatory cytokines will be compared between control and intervention
           group throughout 3 time points.

        -  The trial will be approved by the institutional view board and conducted in accordance
           with the principles or Good Clinical Practice guidelines and the Declaration of
           Helsinki.
    


Intervention name(s): Copaxone; guideline directed medical therapy (GDMT)
Intervention type(s): Drug; Drug
Intervention description(s): Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days; GDMT for heart failure according to the AHA guidelines.
Other intervention name(s): Glatiramer Acetate
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor
      BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period
      in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524
      or placebo will be given on top of evidence-based standard of care for diabetic kidney
      disease. Primary objective is the analysis of first signs of efficacy as determined by
      favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis
      of safety and tolerability as evidenced by the incidence and severity of adverse events. 64
      valid patients have to complete treatment with verum and 32 valid patients have to complete
      treatment with placebo.
    


Intervention name(s): Fulacimstat (BAY1142524); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg BAY1142524 are given twice daily over a treatment period of 6 months; Matching placebo tablets are given twice daily over a treatment period of 6 months
Intervention MeSH terms: Fulacimstat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type II diabetes; diabetic kidney disease
Study of Oxycyte in Severe Closed Head Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that
      die with severe head injuries. Laboratory studies in animals and clinical trials have shown
      that increasing oxygen in the brain results in better brain oxygen consumption, less cell
      death, and better functional outcome. This study will test the hypothesis that Oxycyte is an
      effective way to increase brain oxygen levels in severe head injury.
    

Detailed description: 
      Decreased brain oxygen in severe brain injuries appears to be implicated in poor functional
      outcome and death. Animal and clinical studies have shown that increasing brain oxygen in
      such patients improves functional outcome, and Oxycyte has been shown to be an effective
      means of delivering oxygen to tissues, including the brain. This study is an eight patient
      proof of concept study to test the effects of oxygen delivery with Oxycyte in patients with a
      severe traumatic head injury with a Glasgow Coma Scale (GCS) score of 3 to 9.

      Subjects diagnosed with a severe head injury (GCS 3-9) who receive a brain oxygen monitor and
      microdialysis catheter, will undergo baseline monitoring for 4 hours. In the first 4 subjects
      the Fi02 on the ventilator will be increased to 50% for a 4 hour stabilization period and
      this will be followed by a single intravenous infusion of 3ml/kg of Oxycyte. The Fi02 will
      remain at 50% for 24 hours.

      In the second 4 subjects the Fi02 on the ventilator will be increased to 100% for a 4 hour
      stabilization period and this will be followed by a single intravenous infusion of 3ml/kg of
      Oxycyte. The Fi02 will remain at 100% for 24 hours.

      Subjects will be enrolled, treated, and then monitored by LICOX 02 monitor before and after
      infusion of PFC, and then for at least 48 hours following the discontinuation of Oxycyte.
    

Intervention name(s): perfluorocarbon emulsion (Oxycyte) infusion
Intervention type(s): Drug
Intervention description(s): one time dose of 3mL/kg over 15 minutes
Other intervention name(s): Oxycyte
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxycyte; perfluorocarbon oxygen carrier; brain oxygen tension
Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software
Condition: Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to determine if providing some care to diabetic patients
      remotely, using Accuchek 360 yields at least the same clinical results for their diabetes
      care, according to existing guidelines, as providing all care to patients in person.
    

Detailed description: 
      This will be a non-inferiority study between two groups: a control group, which will receive
      5 routine office visits in one year; and a study group which will receive 3 routine office
      visits in the same time, and have two visits conducted by computer interaction, using the
      Accuchek 360 software. All will be capable of independent care of their diabetes. All
      patients will be 19-65 years of age. The end-points will include similar changes in
      hemoglobin A1c, systolic and diastolic blood pressure, body mass index, lipid fractions, and
      similar levels of patient satisfaction with care.

      There will be 50 patients in each group, matched for age and sex distribution, educational
      level, computer literacy, and type of diabetes.
    

Intervention name(s): Accu-Chek 360 software; Normal care
Intervention type(s): Other; Other
Intervention description(s): Study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accu-Chek 360 software.; Control group will receive 5 routine office visits in one year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Liver Impairment in Comparison With Matched Healthy Control Subjects
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical trial to investigate the pharmacokinetics, safety and tolerability of CHF6001
      after single administrations in participants with mild, moderate and severe liver impairment
      with matched healthy adult volunteers
    


Intervention name(s): CHF6001
Intervention type(s): Drug
Intervention description(s): CHF6001 will be administered using the NEXThaler® DPI device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures
Condition: Vertebral Compression Fracture; Myeloma; Bone Metastases; Malignant Bone Tumour; Lymphoma; Plasmocytoma
MeSH terms: Plasmacytoma; Bone Neoplasms; Fractures, Bone; Spinal Fractures; Fractures, Compression
Study type: Observational

Summary: 
      Background : Vertebral fracture is the most common complication of osteoporosis.
      Vertebroplasty is a widespread treatment modality for osteoporotic vertebral fractures,
      providing consolidation, rapid pain relief and preventing secondary vertebral collapse.
      Performing a biopsy at the same time as the operation does not lengthen the procedure or
      increase the risk of complications. The question therefore arises as to whether it is
      cost-effective diagnostically: are non-osteoporotic vertebral lesions detected when biopsies
      are taken? Methods: The investigators carried out a single-centre retrospective study at Nice
      University Hospital.

      From January 2016 to March 2022, 1729 biopsies were performed during 1439 vertebroplasty
      procedures on 1120 patients.

      The pre-operative laboratory work-up included a blood count, a C-reactive protein assay and a
      coagulation test.

      The imaging work-up systematically included MRI, unless contraindicated, in which case CT
      alone was performed.

      Vertebroplasty was performed in an interventional CT suite under dual CT and fluoroscopic
      guidance. The systematic biopsy sample was then sent to the anatomopathology department for
      analysis.

      Findings :

      The samples detected cancer in 35 patients, including 5 (0.44%) for whom the pre-operative
      work-up had not raised any suspicion.

      All the incidental findings were haemopathies, including 4 myelomas and one lymphoma.

      Conclusion :

      These results highlight the good performance of MRI in distinguishing osteoporotic vertebral
      fractures from solid tumour metastases.

      However, an exhaustive pre-operative work-up does not seem to be able to formally rule out an
      underlying malignant lesion.

      The investigators therefore recommend that biopsies be taken systematically when performing
      vertebroplasty.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who underwent a vertebroplasty with bone biopsy during the study period in the
        osteoarticular interventional radiology department of the Pasteur 2 hospital of the CHU of
        Nice
COVID-19 SARS-CoV-2 Screening Protocol
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      The aim of this screening protocol is to assess volunteers for their potential eligibility to
      participate in a dose finding human experimental infection study in healthy subjects using a
      GMP-produced SARS-CoV-2 wild type strain
    

Detailed description: 
      Recruitment will be done through a number of channels:

        -  Approved advertising, including social medial

        -  hVIVO volunteer database

        -  Referral

        -  Organic search, i.e. where the volunteer has learned of this study by doing a Google
           search or through friends or family rather than due to any advertising Following
           Research Ethics Committee approval of the full study, screened subjects who confirm
           their willingness to participate in the SARS-CoV-2 human infection challenge
           characterization study will be invited to consider the study-specific PIS-ICF and enter
           the final study consenting process.

      The number of subjects who are to be recruited will depend on specific sample-size
      requirements for the SARS-CoV-2 human infection characterization study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers aged 18-30
      
Biospecimen description: 
      Samples of tissue, cells and fluids will be stored according to Imperial College London and
      hVIVO SOPs as appropriate. Samples will be pseudoanonymised with participant identification
      numbers only and the anonymisation key kept in a separate locked location accessible only to
      the hVIVO clinical study team. Samples may be used for further assays or in other ethically
      approved studies. Samples and data may be shared with UK and international collaborators in
      studies that have been approved by local ethics committees and subject to a valid Materials
      Transfer Agreement. At the end of the study any remaining samples will be either destroyed,
      transferred to the sponsor or subject to consent, transfer to and maintained under hVIVOs HTA
      licenses.
    
Keywords: COVID19; Coronavirus; Coronavirus disease 19; SARS-COV-2; Healthy volunteer; human challenge
Eon™ FR Clinical Study Protocol 1064
Condition: Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      This study evaluates the treatment of subjects with the eon™ FR 1064 nm device in a single
      session to thermally induce apoptosis in adipose tissue.
    

Detailed description: 
      This study evaluates the treatment of subjects between 18-60 with the eon™ FR 1064 nm device
      in a single session to thermally induce apoptosis in adipose tissue in the abdomen.
    

Intervention name(s): eon™ FR 1064 nm device
Intervention type(s): Device
Intervention description(s): The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adipose tissue, abdominal
Effect of Prevalence of BMI on Efficacy of Herbal Medicines in Girls' Sexual Precocity
Condition: Precocious Puberty
MeSH terms: Puberty, Precocious
Study type: Observational

Summary: 
      Effect of Prevalence of Overweight and Obesity(Body Mass Index (BMI)) on Efficacy of herbal
      medicines(ZiYinXieHuo) in girls sexual Precocity
    

Detailed description: 
      Herbal medicines(ZiYinXieHuo) might have implications for the effects of treatment. in sexual
      Precocity among the higher BMI girls. Thus the investigator use cohort studies to confirm
      this hypothesis. Selected children were from the precocious puberty clinic of the affiliated
      Pediatrics Hospital of Fudan University. Calculated according to the sample size (sample 6),
      the total number of cases was 192. All cases met the selected criteria. The subjects were
      divided into three groups according to the cut-off point of BMI of height and weight of
      Chinese children and adolescents (girls age in 2-18). Compared with children of the same age
      and sex, overweight group includes those BMI in the range of P85-P95, obese group includes
      those BMI greater than (or equal to) P95, and the girls whose BMI in the range of P5-P85 are
      assigned to the normal group. Chinese herbs for ZiYinXieHuo were used to treat girls with
      precocious puberty, only given by hospital preparation, drug dose: 30ml/once, 3 times a day.
      A course of treatment lasts for three months. In this study, two courses of treatment (6
      months） were observed. The subjects would received three examinations: before taking the drug
      (baseline), the third month (metaphase) and the sixth month (end point).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Selected children were from the precocious puberty clinic of the affiliated Pediatrics
        Hospital of Fudan University.
      
Keywords: Puberty
A Clinical Study of Iobitridol in Patients Undergoing Multislice Computed Tomography (CT) Abdominal Angiography
Condition: Diagnostic Imaging
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a clinical study of iobitridol in patients undergoing multislice CT (MSCT) abdominal
      angiography.
    


Intervention name(s): Iobitridol
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: MSCT indications
Effectiveness of the Iconic Therapy for Borderline Personality Disorder Symptoms
Condition: Personality Disorder, Borderline
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      Borderline personality disorder (BPD) is the most prevalent personality disorder in young
      community population whose most severe complication is suicide. Pharmacotherapy should not be
      used as the primary treatment for BPD as the benefits are unclear. Psychotherapy is the main
      treatment for people with BPD and the current recommendation is adapting available
      comprehensive treatments to develop easier and briefer therapies that are also effective.
      Iconic Therapy is an innovative option whose good clinical results should be validated on a
      clinical trial.
    

Detailed description: 
      Borderline Personality Disorder (BPD) in the early adulthood is an increasing diagnosis among
      general population. First symptoms detection and early intervention might help prevent its
      aggravation and further BPD diagnosis. Iconic Therapy is an innovative manual-driven
      psychotherapy to specifically and intensively treat BPD symptoms. Preliminary clinical
      results are good. The aim of the present study is to assess the effectiveness of the Iconic
      Therapy in comparison to a support structured therapy in an ecological setting (Spanish
      public specialized mental health care). The study is planned as a randomized controlled
      prospective trial that will randomize 60 young people (15 to 25 years old) with suicidal
      ideation/self-injuring behaviour and borderline personality traits. Participants will be
      randomly assigned to one of the two groups: Iconic Therapy or support structured therapy on a
      1:1 basis. Both the Iconic Therapy and the support therapy programs consist of 10-12 weekly
      sessions delivered by two trained psychologists for about 8-12 outpatients on group format.
      The primary outcome measure is the change of symptoms severity assessed by the Borderline
      Personality Disorder List (BSL-23). Secondary outcomes include suicidal ideation and
      behavior, non-suicidal self-injures maladjustment to the daily life and economic evaluation
      for health care. Assessments will be performed at baseline after the intervention 6 and 12
      months of follow-up. It is hypothesized that those attending the Iconic Therapy group will
      show a permanently reduction of the severity of symptoms as compared with those attending the
      structured support group. Data will be analyzed using generalized estimating equations (GEE)
      models.
    

Intervention name(s): Emotional regulation
Intervention type(s): Behavioral
Intervention description(s): Educate people with difficulty in regulating their emotions and help them acquire skills to do so
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Terapia Iconica; BPD; adolescence; suicide
The Influence of Lutein Supplements on Age-related Macular Degeneration
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      Rationale: Age-related macular degeneration is the most common cause of blindness in the
      industrialized world. Macular pigment is hypothesized to protect against the vision loss in
      this disease.

      Objective: 1. To study if the macular pigment optical density can be raised by lutein
      supplementation. 2. To study if lutein supplementation can stop or slow down the decrease in
      visual functions.

      Study design: Randomized, double blind, placebo controlled intervention study.

      Study population: Eighty patients with early signs of age-related macular degeneration
      Intervention: The intervention group (40 subjects) receives 10 mg lutein per day, while the
      control group (40 subjects) gets a placebo.
    


Intervention name(s): Lutein; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lutein supplement, 10 mg daily; Placebo
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: macular pigment; lutein; age-related macular degeneration; AMD
Efficacy and Safety of Deoxycholic Acid Injections for Removal of Adipose Tissue in the "Bra Strap Fat" Region
Condition: Brassiere Strap Fat (BSF); Bra Strap Fat (BSF)
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the safety and efficacy of deoxycholic acid injections to dissolve
      adipose tissue in the anterior and posterior aspect of the axilla or the so called "brassiere
      strap fat" (BSF). Adult females aged 18-65 dissatisfied with their moderate or severe BSF
      will receive deoxycholic acid (dose strength: 2 mg/cm2) via subcutaneous injections into
      posterior and/or anterior axillary roll adiposity .
    

Detailed description: 
      The efficacy and safety of deoxycholic acid injections to dissolve adipose tissue in the
      submental area have been extensively evaluated. Deoxycholic acid injections have also been
      used successfully off-label to dissolve adipose tissues in other body areas. Our clinical
      experience in addition to a few case reports have shown the effectiveness and safety of
      deoxycholic acid injections to dissolve the adipose tissue in the anterior and posterior
      aspect of the axilla or the so called "brassiere strap fat" (BSF).

      This is a single-center, prospective, single-arm, single-blind trial study.

      This study is expected to benefit the existing literature by potentially adding a new
      non-invasive injectable treatment to a condition of excessive adipose tissue in the anterior
      and posterior aspect of the axilla that until now could only be treated with invasive
      surgery.
    

Intervention name(s): Deoxycholic Acid
Intervention type(s): Drug
Intervention description(s): The active ingredient in KYBELLA® is synthetic deoxycholic acid. Deoxycholic acid is a naturally occurring molecule in the body that aids in the breakdown and absorption of dietary fat.
Other intervention name(s): Kybella
Intervention MeSH terms: Deoxycholic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment