bioihbjkbjnl/mcl2 huggingface dataset:
A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi®
Condition: Psoriatic Arthritis
MeSH terms: Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical
      study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity
      between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single
      subcutaneous administration in healthy Chinese male subjects.
    

Detailed description: 
      This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical
      study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity
      between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single
      subcutaneous administration in healthy Chinese male subjects.

      The study planes to enroll 375 healthy male subjects who will be randomly assigned to the
      BAT2506 Injection group, Simponi® (EU-licensed) or Simponi® (US-licensed) groups in a 1:1:1
      ratio to receive a single subcutaneous injection of 50 mg BAT2506 Injection or Simponi®
      (EU-licensed or US-licensed).
    

Intervention name(s): BAT2506 injection; Simponi® (EU commercially available product); Simponi® (US commercially available product)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg, subcutaneous administration; 50 mg, subcutaneous administration; 50 mg, subcutaneous administration
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Remimazolam Tosilate for Sedation in the ICU
Condition: Sedation in the ICU
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for
      Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety
      of Remimazolam Tosilate for Injection for sedation in the ICU.
    


Intervention name(s): Remimazolam Tosilate; Remimazolam Tosilate
Intervention type(s): Drug; Drug
Intervention description(s): Loading dose: 0.08mg/kg IV of Remimazolam Tosilate, Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1mg/kg/h; Loading dose: 0.08mg/kg, Drug: Propofol Injection Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.2mg/kg/h IV of Propofol Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Multicenter, Randomized, Single Blind, Dose Finding, Phase II Clinical Trial to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Examine APL-130277 in Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy, tolerability and safety of
      single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD)
    


Intervention name(s): APL-130277
Intervention type(s): Drug
Intervention description(s): Apomorphine Hydrochloride, Sublingual Thin Film
Other intervention name(s): Apomorphine Hydrochloride, Sublingual Thin Film
Intervention MeSH terms: Apomorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease
Safety of RG2077 in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body's immune system
      attacks and destroys the cells that cover and protect nerves. This study will test the safety
      of a new drug called RG2077 that is designed to treat MS. The study will not determine
      whether RG2077 is effective in treating MS, only whether it is safe to use in patients with
      MS.

      Study hypothesis: RG2077 will arrest MS if administered early in the course of MS and
      decrease accumulation of lesions on MRI.
    

Detailed description: 
      Effective treatment of autoimmune disorders is likely to arise not from improved
      immunosuppression, but from improved understanding of the normal mechanisms that generate and
      maintain self-tolerance. RG2077 may block a T cell costimulation pathway central to the
      pathophysiology of MS. A total of 20 patients with MS will be enrolled in this study. Each
      patient participates in the study for 4 months.

      The dose-escalation portion of this study evaluated the safety of a single infusion of RG2077
      (CTLA4-IgG4m) in 16 patients with MS and is now complete. Patients who participated in the
      single infusion portion of the study were assigned to one of four groups. Each group received
      a different dose of RG2077. The second portion of the study will evaluate the safety of 4
      doses of RG2077 in 4 additional patients. In the multiple infusion portion of the study, all
      patients will receive the same dose of RG2077. Patients will be monitored for possible side
      effects of RG2077.
    

Intervention name(s): RG2077 (CTLA4-IgG4m)
Intervention type(s): Drug
Intervention description(s): RG2077
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ataxia; MRI; MS; CTLA4-IgG4m; Costimulatory Signals; Autoimmune Disorders
Effect of Initial Empirical PEEP Setting on the Esophageal Pressure-guided PEEP Titration in ARDS
Condition: ARDS, Human; PEEP, Occult; Esophageal and Pleural Pressure
MeSH terms: Respiratory Distress Syndrome; Positive-Pressure Respiration, Intrinsic
Study type: Observational [Patient Registry]

Summary: 
      Esophageal manometry was used as surrogate of pleural pressure to titrate positive
      end-expiratory pressure (PEEP) in ARDS patients. However, Absolute values of esophageal
      pressure (Pes) could be affected by the PEEP setting. In moderate to severe ARDS patients,
      the end-expiratory Pes changed differently with PEEP adjustment. and the esophageal
      phenotypes could be divided into type I and type II. with Type I （ΔPes≥30%ΔPEEP）and Type
      II（ΔPes<30%ΔPEEP）.
    


Intervention name(s): PEEP adjustment
Intervention type(s): Other
Intervention description(s): adjusting PEEP about 3-5cmH2O (increase or decrease)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients all the moderate to severe ARDS with P/F<200 no contraindication to
        esophageal catheter
A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.
Condition: Anemia
MeSH terms: Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This single arm study will determine the effects of complete anemia correction in anemic
      patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon.
      Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be
      treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to
      reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart
      function and quality of life will be measured before and after anemia correction. The
      anticipated time on study treatment is 3-12 months, and the target sample size is 100
      individuals.
    


Intervention name(s): epoetin beta [NeoRecormon]
Intervention type(s): Drug
Intervention description(s): At a dose to achieve and maintain an Hb level of 120-135g/L
Intervention MeSH terms: Epoetin Alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on COPD Corticosteroid-induced Hyperglycemia on Clinical Outcome in Patients With COPD
Condition: COPD
MeSH terms: Hyperglycemia
Study type: Observational

Summary: 
      Hyperglycemia is a common complication of corticosteroid (cortisone) therapy. It is estimated
      that more than a third of patients with chronic pulmonary disease (COPD) exacerbation (16).
      Despite its frequency, the impact of corticosteroid-induced diabetes on clinical outcome and
      mortality is not known. A computerized search of biomedical journal literature from MEDLINE,
      PubMed, and Ovid from 1966 to 2006 provided very little information on the prevalence and
      outcome of corticosteroid-induced diabetes in patients with COPD. Therefore, the present
      study aims to evaluate the impact of corticosteroid-induced diabetes on clinical outcome in
      patients with COPD exacerbation. We will perform a retrospective chart review of all patients
      admitted to the hospital with COPD exacerbation from 1/01/05 to 06/30/06 at Grady Memorial
      Hospital. Medical records of all patients with COPD exacerbation treated with corticosteroids
      will be analyzed. Data on demographics, laboratory values, mortality rate, rate of
      hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.
    

Detailed description: 
      Hypotheses:

      We hypothesize that COPD patients with corticosteroid-induced hyperglycemia experience higher
      morbidity (infections, ventilator associated pneumonia, length of stay, acute renal failure)
      and mortality compared to COPD patients with normal glucose levels.

      Specific Aim:

      To determine the impact of corticosteroid-induced hyperglycemia on clinical outcome (length
      of stay, disposition, APACHE score, need for ventilatory support and ICU admission,
      mortality) in patients with COPD exacerbation.
    

Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients admitted with COPD exacerbation at Atlanta Medical Center and Grady Memorial
        Hospital
      
Keywords: COPD; Diabetes; Respiratory Disorders
Cognitive Orientation to Daily Occupational Performance and Conductive Education Approaches on Down Syndrome
Condition: Down Syndrome, Trisomy 21
MeSH terms: Down Syndrome; Syndrome; Trisomy
Study type: Interventional

Summary: 
      This study will be conducted to investigate and compare the effects of Cognitive Orientation
      to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills,
      activity, and participation limitations in children with DS. Children with DS aged 7-18 years
      will be included. Both CO-OP and CE interventions will last 12 weeks and be conducted for 2
      sessions per week in the cross-over randomized study. Following 12-week wash-out period,
      interventions will be changed for each group.
    

Detailed description: 
      Down syndrome (DS) is a chromosomal anomaly characterized by the presence of an extra copy of
      genetic material on the 21st chromosome. Sensory, motor, cognitive and perceptual impairments
      can be seen in children with DS. These impairments probably affect the development and
      learning of their various fundamental and complex actions. Those children experience
      decreased motor proficiency, reduced social participation and lower life quality.

      Fine motor skills are important for children's everyday functioning such as dressing,
      feeding, bathing, holding objects, cutting etc. In addition, fine motor skills are related to
      cognitive, social and academic abilities in children.

      This study will be conducted to investigate and compare the effects of Cognitive Orientation
      to Daily Occupational Performance (CO-OP) and Conductive Education (CE) on fine motor skills,
      activity, and participation limitations in children with DS. Children with DS aged 7-18 years
      will be included.

      Random allocation software will be used to assign CO-OP or CE to participants. Both CO-OP and
      CE interventions will last 12 weeks and be conducted for 2 sessions per week. Both
      intervention will be applied as groups including 3-4 children. Following 12-week wash-out
      period, interventions will be changed for each group. Two meetings before and during the
      study will be done in order to inform parents about the interventions and their effects.
      Another investigator who is blind about the groups will conduct the assessments before and
      after both first and second treatment durations so 4 assessments will be done in total. At
      the end of whole treatment schedule, a satisfaction form will be asked from the parents for
      feedback about both interventions.
    

Intervention name(s): CO-OP; Conductive Education
Intervention type(s): Other; Other
Intervention description(s): Interventions (from top to down) related to the development of fine-motor skills; Interventions (from down to top) related to the development of fine-motor skills
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Influence of Light Exposure on Exercise Performance Dependent on Chronotype.
Condition: Endurance Performance; Reaction Time; Muscle Strength
Study type: Interventional

Summary: 
      The purpose of this study is to determine if an exposure to light in the evening has a
      positive influence on physical performance regarding endurance, strength and reaction time.
    


Intervention name(s): exposure to normal light; exposure to bright light; exposure to blue-enriched light
Intervention type(s): Other; Other; Other
Intervention description(s): exposure for 60 minutes in duration; exposure to bright light for 60 minutes of duration; exposure to blue-enriched light for 60 minutes of duration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: circadian rhythm; light exposure; exercise capacity; endurance; strength; reaction
Budesonide 9 mg Capsules in Active UC
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9
      mg budesonide in patients with active ulcerative colitis
    


Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention MeSH terms: Budesonide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Insulin in the Blood After Inhalation of a Dry Powder Insulin Formulation (Called Technosphere®/Insulin) in Non-diabetic Patients With & Without Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Trial will include 40 subjects and consists of 3 visits: Screening, Treatment and Follow up.
      A euglycemic clamp procedure and Technosphere®/Insulin (T/I) administration will occur at
      Visit 2 for both COPD and non COPD subjects.
    

Detailed description: 
      Trial objectives are to evaluate the impact of a defined lung disease (COPD) on
      pharmacokinetic parameters of insulin and fumaryl diketopiperazine (FDKP) after inhalation of
      Technosphere®/Insulin (T/I), the investigational medicinal product. 40 non diabetic subjects,
      20 COPD and 20 age/gender/BMI-matched non COPD subjects will participate in 3 visits: Visit 1
      (screening), Visit 2 (subjects will undergo a euglycemic clamp procedure and be dosed with
      T/I) and Visit 3 (follow up visit).
    

Intervention name(s): Technosphere®/Insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Technosphere® Insulin Inhalation Powder
SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

        -  To assess the sexual function improvement from baseline to the end of treatment (Week 24
           or premature withdrawal (PW)) with XATRAL 10mg OD.

      Secondary Objective:

        -  To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and
           sexual disorders,

        -  To compare the improvement in sexual function, urinary symptoms and Quality of Life
           among the different regions,

        -  To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of
           the International Index of Erectile Function),

        -  To assess the onset of action of XATRAL 10mg OD,

        -  To assess the peak flow rate improvement (Qmax),

        -  To assess the safety and the tolerability of XATRAL 10mg OD.
    


Intervention name(s): Alfuzosin
Intervention type(s): Drug
Intervention description(s): Alfuzosin 10mg Once Daily for 24 weeks
Intervention MeSH terms: Alfuzosin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Danish Osteoporosis Prevention Study
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: Use of hormone replacement therapy (HRT) decreases the incidence of fractures in
      early postmenopausal women.

      The project was initiated in 1990, and the inclusion ended in 1993. A total of 2,016 early
      postmenopausal women were divided into two groups: The first group accepted randomisation to
      HRT or not, and the second group was allowed to choose HRT or not.

      The study was not blinded. Main measurements were fracture risk over 20 years, changes in
      bone mineral density over 20 years, and side effects, mainly breast cancer.
    

Detailed description: 
      Aim: To study the ability of hormone replacement early after menopause on risk of fractures
      and changes in bone mineral density, and side effects.

      The project was designed as a comprehensive cohort trial. One group accepted randomisation,
      and was randomised to hormone replacement therapy (HRT) or not (no placebo used).

      502 were randomised to HRT, and 504 were randomised to no HRT) One group was allowed to
      choose HRT or not. A total of 221 chose HRT, and 789 chose no HRT.

      First line HRT was oral sequential oestradiol/norethisterone in women with intact uterus and
      oral continuous oestradiol in hysterectomised women.

      The study was initiated in 1990, and inclusion ended in 1993.
    

Intervention name(s): Hormone replacement therapy
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fracture; Osteoporosis; Bone mineral density; Hormone replacement therapy; Estrogen; Breast cancer
Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The investigators wish to examine whether a novel 'nanoparticle' of iron oxide, administered
      intravenously allows an area of heart muscle damage after heart attack to be visualised using
      a magnetic resonance scanner.
    

Detailed description: 
      Using ferumoxtran (Feraheme) as a USPIO contrast agent for magnetic resonance imaging at 3
      Tesla, we aim to conduct the first clinical study to examine the utility of this novel
      contrast agent to image myocardial inflammation after myocardial infarction.

      We will test the following hypotheses in patients who have suffered recent acute myocardial
      infarction.

        1. Intravenous injection of ferumoxytol accumulates at the site of myocardial infarction
           and this can be visualised by magnetic resonance imaging.

        2. The spatial extent of the MRI signal change evoked by ferumoxytol in the myocardium is
           proportional to the volume of infarcted myocardium (as assessed by a gadolinium
           late-enhancement study).

        3. Myocardial MRI signal change evoked by ferumoxytol is positively correlated with blood
           markers of systemic inflammation.
    

Intervention name(s): Ferumoxytol
Intervention type(s): Other
Intervention description(s): One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)
Other intervention name(s): Feraheme; Advanced Magnetics, Inc., Cambridge, MA
Intervention MeSH terms: Ferrosoferric Oxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Myocardial infarction; Magnetic resonance; Nanoparticle; Iron; Inflammation