bioihbjkbjnl/mcl2 huggingface dataset:
Fundus Autofluorescence After Vitrectomy for Epiretinal Membrane
Condition: Epiretinal Membrane
MeSH terms: Epiretinal Membrane
Study type: Observational

Summary: 
      Fundus autofluorescence (FAF) at the macula originates from hyperfluorescence from retinal
      pigment epithelium (RPE) and blockage of hyperfluorescence by macular pigment. Investigators
      evaluate whether presence of FAF may correlate to the postoperative visual outcome for
      epiretinal membrane.
    

Detailed description: 
      92 eyes with epiretinal membrane were performed vitreous surgery, epiretinal membrane removal
      and internal limiting membrane (ILM) peeling. Presence of hyperfluorescence in FAF at the
      macular area and best-corrected visual acuity (BCVA) was evaluated preoperatively and at
      postoperative 1, 3, and 6 months with ultra-wide angle imaging.
    

Intervention name(s): Vitrectomy with internal limiting membrane removal
Intervention type(s): Procedure
Intervention description(s): Vitrectomy with removal of epiretinal membrane and internal limiting membrane
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients with epiretinal membrane who underwent vitrectomy with epiretinal membrane and
        internal limiting membrane removal
      
Keywords: Epiretinal membrane
Data Collection of Arterial Line Waveform and BP Values
Condition: Blood Pressure Measurement
Study type: Observational

Summary: 
      Collect continuous systolic and diastolic blood pressure values and waveforms as recorded by
      an arterial line catheter and by non-invasive blood pressure (NIBP) and to collect
      Photoplethysmogram Pulse Oximetry (PPG) waveform in order to optimize the Sensifree
      algorithm.
    

Detailed description: 
      Sensifree is developing a continuous non-invasive blood pressure measurement system, that
      uses a fingertip PPG sensor as a signal source. The system provides systolic, diastolic and
      mean arterial pressure values, for use in hospitals and other clinical settings. The PPG
      waveform is analyzed by a proprietary software algorithm, calculating BP values.

      The current best method to obtain similar information is by using an Arterial line catheter
      which will serve as a reference device. In this study, the sponsor aims to prospectively
      collect continuous radial arterial line & PPG waveforms, as well as NIBP data over the period
      of the surgery in order to test and refine the algorithm.
    

Intervention name(s): Arterial catheterization kit; GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor; NIBP Cuff (GE Healthcare)
Intervention type(s): Device; Device; Device
Intervention description(s): Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform and blood pressure values.; PPG fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform; A blood pressure cuff is used to measure blood pressure. The cuff has an inflatable rubber bladder that is typically fastened around the arm. A pressure meter indicates the cuff's pressure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for elective surgery involving placement of radial artery A-line for BP
        monitoring
An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This study is conducted in the United States of America (USA). The aim of the study is to
      assess longitudinal variation of immune biomarkers in subjects at risk for development of
      type 1 diabetes (T1D).
    


Intervention name(s): No treatment given
Intervention type(s): Other
Intervention description(s): The participants will not receive any treatment.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects who are at risk for developing T1D either by genetic testing or due to family
        history and identified with one or more islet autoantibodies).
      
Biospecimen description: 
      Blood sampling for biomarkers. A portion of each sample collected will be tested for five
      different islet autoantibodies (presence and precise titers). The remaining portion of each
      sample will be coded and then assessed for autoantibody isotypes, phenotyping of peripheral
      blood mononuclear cells (PBMC), and profiling of cytokines, and pharmacogenetic markers.
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series
      in Healthy Infants
    


Intervention name(s): 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Condition: Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Developmental Disabilities; Child Development Disorders, Pervasive; Asperger Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of memantine in
      pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive
      Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for
      participation in a follow-up randomized withdrawal study.
    

Detailed description: 
      This 50-week multicenter and multinational clinical study is comprised of a 2-week screening
      period, a 6-week open-label dose-titration period followed by a variable duration maintenance
      period (up to 42 weeks).

      Patients with at least 12 weeks of investigational product exposure who meet the protocol
      specified responder criterion at two consecutive visits separated by at least two weeks are
      eligible to transition to a randomized withdrawal study. A responder is defined as a patient
      who demonstrates at least a 10 point improvement (reduction in score) in the Social
      Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score.

      Weight based dose limits were selected in this study to ensure that exposure in terms of area
      under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a
      10-fold lower exposure than observed at the No observed adverse effect level (NOAEL) of 15
      mg/kg/day in juvenile rats.

      The weight-based dose limits in this study were as follows:

        -  Group A: ≥ 60 kg; maximum 15 mg/day

        -  Group B: 40-59 kg; maximum 9 mg/day

        -  Group C: 20-39 kg; maximum 6 mg/day

        -  Group D: < 20 kg; maximum 3 mg/day
    

Intervention name(s): Memantine Hydrochloride (HCl)
Intervention type(s): Drug
Intervention description(s): Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS); Memantine; Pediatric Disorder
Brachial Plexus Block in Post-Op Pain Control After Distal Upper Extremity Fracture: A Prospective Randomized Study
Condition: Pain
Study type: Interventional

Summary: 
      Despite the plethora of literature suggesting that regional blockade provides adequate
      andimproved postoperative pain control, function and improved intraoperative and
      postoperative safety in proximal upper extremity surgery, little is known of its benefits for
      the treatment of forearm and distal radius fractures . The purpose of this randomized,
      prospective, study is to determine if brachial plexus blockade with general anesthesia is
      superior to general anesthesia alone in immediate and long-term pain control in patients
      undergoing operative fixation of distal upper extremity fractures.
    

Detailed description: 
      The purpose of this study is to compare two (2) different types of anesthesia treatments that
      are used during surgery for broken arms for post-surgery pain relief. One group will receive
      general anesthesia (state of total unconsciousness) the other group will get sedation
      (medicine injected into patient's vein that helps patient fall asleep), and a nerve block
      (injection of anesthetic drug into the nerves going to patient's arm in order to make
      patient's arm numb).

      Both forms of anesthesia are used for a variety of surgeries to the arm including shoulder
      and elbow surgeries. Currently it is thought that there are advantages and disadvantages to
      both types. The advantage of not using the nerve block in addition to general anesthesia
      (current standard or care) is that it decreases the potential risk for bleeding, infection
      and nerve injury. Alternatively, the advantage of using the nerve block with sedation
      (research-related procedure) is that it can potentially offer better post-operative pain
      control. This study will examine whether there is added benefit with the addition of nerve
      block for anesthesia for decreasing pain after surgical treatment of lower arm fractures.
    

Intervention name(s): Brachial Plexus Nerve Block
Intervention type(s): Procedure
Intervention description(s): The brachial plexus will be visualized under ultrasound and a 22 gauge, 3.5 inch needle will be used. 20 cc of bupivicaine will be injected around the brachial plexus after confirming negative aspiration every 5 cc
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain
Study to Evaluate the Potential for Interaction Between OC000459 and CYP 450 3A4
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open label, sequential study of midazolam (dose 5 mg orally) followed by
      midazolam (5 mg orally) given after dosing with OC000459 100 mg twice daily for 6.5 days.
      Twenty subjects will be included to ensure at least 16 subjects with analysable PK data. PK
      sampling for midazolam and 4-hydroxymidazolam plasma concentrations will continue for up to
      and including 24 hours after dosing with midazolam on both occasions.
    


Intervention name(s): OC000459
Intervention type(s): Drug
Intervention description(s): OC000459 100mg tablet, twice daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open-label phase I trial to investigate the effects of moderate to
      severe hepatic impairment on the pharmacokinetics of prucalopride in comparison with healthy
      volunteers. Furthermore the short-term safety and tolerability of a single dose of
      prucalopride will be assessed.
    

Detailed description: 
      In this phase I trial two groups of 6 to 8 hepatically impaired subjects will be evaluated.
      The first group are the moderate hepatic impairment (Grade B) subjects and the second group
      the severe hepatic impairment (grade C) subjects. Subjects for both groups will be recruited
      and treated in parallel. After all subjects with hepatic impairment completed the treatment a
      third group with matching healthy volunteers will be recruited. Eight healthy subjects will
      be selected matching for age, gender and weight (BMI based).

      The subjects will receive a single dose of 2 mg prucalopride in the morning after overnight
      fasting followed by the consumption of a standard breakfast after 2 hours.

      Pharmacokinetic evaluation of blood samples will be done immediately before and at a specific
      timepoint up to 120h post-dosing. Urine samples will be taken to determine prucalopride.

      Adverse events, including serious adverse events, will be reported from signing the Informed
      Consent until the last visit. Safety blood samples and a urine sample for urinalysis will be
      taken.
    

Intervention name(s): prucalopride; prucalopride; prucalopride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral dose of 2 mg prucalopride; single oral dose of 2 mg prucalopride; single dose of 2 mg prucalopride
Intervention MeSH terms: Prucalopride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Two groups of 8 hepatically impaired subjects, one group of 8 matched healthy subjects
The CLEVER Study - Coreg And Left Ventricular Mass Regression
Condition: Hypertrophy, Left Ventricular
MeSH terms: Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare the effects of COREG MR (carvedilol modified release
      formulation) to atenolol on indices of left ventricular dimensions when added to standardized
      angiotensin converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone.
      Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The
      primary endpoint will be the change in left ventricular mass index (LVMI) characterized by
      magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints
      include the change in LV (left ventricular) mass, LV wall thickness, diastolic left
      ventricular filling parameters, and left ventricular ejection fraction by echocardiographic
      methods at Treatment Month 12. Composite outcomes and individual event data will also be
      evaluated by treatment group.
    

Detailed description: 
      A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Modified
      Release Formulation (COREG MR) and Atenolol in Combination with and Compared to an
      Angiotensin Converting Enzyme Inhibitor (Lisinopril) on Left Ventricular Mass Regression in
      Hypertensive Patients with Left Ventricular Hypertrophy (LVH).
    

Intervention name(s): carvedilol MR; atenolol; lisinopril
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Study drug; Comparator; Comparator
Other intervention name(s): Carvedilol controlled release or modified release; carvedilol MR; atenolol
Intervention MeSH terms: Atenolol; Carvedilol; Lisinopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: left ventricular hypertrophy (LVH); echocardiogram; left ventricular mass regression; cardiac MRI; left ventricular mass index (LVMI)hypertension
Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare safety and the oxidative stress potential of two
      doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single
      dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA)
      in female subjects.
    

Detailed description: 
      This was a Phase 2a, open-label, multicenter, randomized study that compared the safety and
      oxidative stress potential of FCM vs. IV iron sucrose or IV iron dextran in female subjects
      with IDA. Subjects with a diagnosis of IDA who required iron supplementation met all
      inclusion and no exclusion criteria, and had given informed consent were randomized. The
      duration of the study for each subject was a maximum of 6 weeks.

      Eligible subjects were randomized in a 1:1 ratio to FCM (Group A) or IV iron sucrose or IV
      iron dextran (Group B).

      Group A subjects received a single undiluted dose of iron as FCM by a slow IV injection on
      Day 0. Cohort I received 500 mg and Cohort II received 750 mg. Group B subjects received a
      single dose of iron as IV iron sucrose or as IC iron dextran on Day 0. Cohort I receive 500
      mg iron sucrose and Cohort II received 750 mg iron dextran. Iron dextran administration was
      preceded by a 25 mg test dose 1 hour prior to infusion.

      All subjects had laboratory assessments at Baseline, 2 hours post-infusion, 24 hours
      post-infusion, Day 7 (drawn at the same time of day [within 4 hours] as the 24-hour visit),
      and Day 30 (drawn at the same time of day [within 4 hours] as the the 24-hour visit). On Days
      7 and 30, the safety evalutation for all subjects included treatment-emergent adverse event
      reporting, concomitant medication review, physical examination including vital signs, and
      laboratory assessments. Any subject who withdrew from the study received a follow-up phone
      call 30 days after they received study drug.
    

Intervention name(s): Ferric Carboxymaltose (FCM); Iron Sucrose / Iron Dextran
Intervention type(s): Drug; Drug
Intervention description(s): One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II); One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
Other intervention name(s): Injectafer; Venofer, Dexferrum
Intervention MeSH terms: Dextrans; Ferric Oxide, Saccharated; Iron-Dextran Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate
      and dienogest in healthy female subjects.
    


Intervention name(s): EV/DNG (Qlaira, BAY86-5027)
Intervention type(s): Drug
Intervention description(s): Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Efficacy; Safety; oral contraception; estradiol valerate; dienogest
Biosynthesis of PGD2 in Vivo
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The investigator would like to see if aspirin could block niacin-induced flushing by
      analyzing blood and urine after taking aspirin.

      Phase I: Subjects were assigned to either placebo or aspirin groups. They were given 5 days
      of 81 mg aspirin or placebo. On day 5, they were given a single dose of niacin (600 mg)
      administered 30 minutes after the last dose of aspirin or placebo. The same subjects came
      back for cross-over study and were assigned to a different group. There was a 2-week washout
      period between each treatment. Urine was collected sequentially for analysis

      Phase II: The same study subjects come back for an open label one week study. They were given
      5 days of taking 81 mg Aspirin, taken once daily, followed by a single dose of 600 mg Niacin
      on day 6. Urine was collected sequentially for analysis
    

Detailed description: 
      The purpose of this study is to look at the roles of various blood cells and their
      contributions of different prostaglandins. The intention is that by better understanding
      these prostaglandins and various metabolites, it will provide insights into their roles in
      the cardiovascular system.

      Prostaglandins and metabolites are naturally occurring substances found in the blood and
      urine which can act as markers which can be quantified and studied as we will be doing in
      this study. Flushing response to niacin will also be assessed by laser doppler measuring
      blood flow of the facial skin.

      Untransformed and transformed data will be subjected to exploratory analysis of variance
      appropriated for a three factor design with one two period crossover factor and two
      non-repeated factors. Additionally, volunteer's test(s) for paired observations will
      characterize the magnitude of the niacin effect on the response variables within selected
      time points.
    

Intervention name(s): Aspirin; Placebo; Niacin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Aspirin 81 mg; Niacin 600 mg
Intervention MeSH terms: Aspirin; Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science