bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered
      intravenously in participants experiencing an acute attack of migraine.
    

Detailed description: 
      This will be a parallel group, double-blind, randomized, placebo-controlled study assessing
      the efficacy of eptinezumab for acute migraine, defined as an active intercurrent migraine
      occurring in those participants who are candidates for preventive therapy. Participants will
      be randomized to receive a single dose of eptinezumab or placebo in a 1:1 ratio. The total
      study duration will be approximately 4 to 12 weeks, including up to an 8-week screening
      period and 4-week of safety follow-up, with clinic visits occurring on Screening, Day 0
      (dosing day), and Week 4.
    

Intervention name(s): Eptinezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injection for IV administration; Injection for IV administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in otherwise healthy Japanese and non-Japanese participants with elevated low
      density lipoprotein cholesterol (LDL-C). Following single doses of LY3015014, the safety and
      tolerability of the drug, how the body handles the drug, and the drug's effect on the body
      will be evaluated. Participants will remain in the study for approximately up to 6 months.
    


Intervention name(s): LY3015014 IV; Placebo IV; LY3015014 SC; Placebo SC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered IV over 30-90 minutes; Administered IV only over 30-90 minutes; Administered SC; Administered SC
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Post-Marketing Clinical Study of Postoperative Adjuvant Therapy With Imatinib Mesylate in Patients With Gastrointestinal Stromal Tumors (GIST)
Condition: Gastrointestinal Stromal Tumors
MeSH terms: Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, post-marketing, clinical study evaluating the safety and efficacy of
      postoperative adjuvant therapy with Imatinib Mesylate in high-risk patients after curative
      resection of newly diagnosed GIST.Patients will be evaluated for relapse -free survival as
      measured by the confirmation of tumor recurrence and survival for 3 years after surgery for
      their primary tumors.
    


Intervention name(s): Imatinib Mesylate
Intervention type(s): Drug
Other intervention name(s): Gleevec/Glivec; STI571
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GIST; Imatinib; Postoperative Adjuvant
Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be an open label study using daily does of up to 126mg/day of Concerta in the
      treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD.
      Specific hypotheses are as follows:

      Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC
      Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine +
      phosphocreatine (Glu/Cr) than matched HCS.

      Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC
      Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.
    

Detailed description: 
      The primary objective of this study is to use 1H MRS to assess Glutamate (Glu), myo-Inositol
      (Ino), and creatine + phosphocreatine (Cr) levels in brain regions of interest in 20 children
      with ADHD between the ages of 12-17 years old, before and after a six-week open treatment
      trial with OROS methylphenidate. For comparison, 1H MRS will also be obtained from 20
      controls matched by age and gender. We also will scan 20 children with ADHD between the ages
      of 12-17 years old that are currently enrolled in the protocol entitled "Prevention of
      Cigarette Smoking in ADHD Youth with Concerta" (2003-P-001313) and on a stable dose of
      Concerta. These 20 children will be scanned once while on medication and once while off
      medication
    

Intervention name(s): OROS methylphenidate; No intervention
Intervention type(s): Drug; Other
Intervention description(s): Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks.; No intervention
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: HMRS Scanning; ADHD; Child; Adolescent; HMRS Scans
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock
Condition: Shock, Septic
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to
      investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of
      MOTREM versus placebo in adult patients with septic shock.
    


Intervention name(s): MOTREM; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Formulated LR12 peptide; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, Double-blind, Two-Stage, Placebo Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sepsis; LR12; TREM1; TREM-1
Validation of Romanian Version of Radner Reading Charts
Condition: Visual Acuity
Study type: Observational

Summary: 
      Interventional, parallel groups, single center trial with a prospective design
    

Detailed description: 
      The "Radner Reading Charts" have been developed on the basis of the concept of "sentence
      optotypes" for the standardized examination of reading acuity and reading speed. Print sizes
      are logarithmically scaled (LogRAD) to permit statistical analysis, and the results obtained
      can be compared to other logarithmically scaled vision systems (e.g., LogMAR). To guarantee
      accurate, reproducible and standardized measurements of reading acuity and reading speed at
      every viewing distance, "sentence optotypes" have been created to minimize the variations
      between the test items and to keep the geometric proportions as constant as possible at all
      distances. Through interdisciplinary cooperation, a series of test sentences were developed
      that are highly comparable in terms of the number of words (14 words), as well as the word
      length, number of syllables, position of words, lexical difficulty and syntactical
      complexity. The most similar sentences were statistically selected for the Radner Reading
      Charts.
    

Intervention name(s): Radner test
Intervention type(s): Diagnostic Test
Intervention description(s): The A5 reading booklet is held by the subject
The subject is instructed to read sentence by sentence, by turning consecutively the pages of the booklet (on the first side is the number of sentence and the backward side contains the sentence)
The subject is instructed to read the sentences aloud as quickly and accurately as possible to the end, and to not correct reading errors.
One assessor is writing the reading time and records any reading errors on the scoring sheet while the second assessor is audio recording the operation
Stop criterion: reading time longer than 20 seconds or severe errors.
Other intervention name(s): Validation of the Romanian version-Radner Reading Charts
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Healthy patients
      
Keywords: Reading speed
Comparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this study is to compare single groin puncture and bilateral groin puncture
      during AF ablation procedure. The investigators will compare 1) the degree of patients'
      discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and
      4) 1-year clinical recurrence rate of AF.
    


Intervention name(s): single trans-septal puncture; conventional bilateral groin puncture
Intervention type(s): Procedure; Procedure
Intervention description(s): The investigators will compare bilateral groin puncture AF ablation and single groin puncture AF ablation with 1:2 randomization.; Bilateral groin puncture AF ablation is control procedure exactly same to routine AF ablation with double trans-septal puncture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of New Tablet Formulations and Suspension Formulation Compared to Current (1B) Formulation of BILR 355 BS in Healthy Male Volunteer Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To investigate the relative bioavailability (BA) of improved tablet formulation
           candidates to determine which formulation will be developed for use in late Phase II and
           Phase III clinical trials

        2. To investigate the relative BA of the pediatric suspension, compared to the current 1B
           formulation

        3. To investigate the bioequivalence (BE) of BILR 355 BS in two tablet strengths; three
           25mg tablets vs. one 75 mg tablet, current 1B formulation
    


Intervention name(s): BILR 355 BS /1B, current low dose formulation; BILR 355 BS /1B, current high dose formulation; BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation; BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation; BILR 355 BS - Suspension low dose; BILR 355 BS - Suspension high dose; Ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficiency of Dry Needling and Cold Spray-stretching Treatments
Condition: Myofascial Pain Syndromes; Myofascial Trigger Point Pain
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      A prospective randomized single-blind study included 60 patients aged 18-65 years who have
      MPS with active triger points in the upper trapezius muscle. Patients were randomized into
      two treatment groups as dry needling (DN) and cold spray-stretching. Both treatment groups
      received 1 treatment per week and totally 3 sessions. Evaluation parameters were pain level
      assessed by visual analog scale (VAS) and algometer, neck range of motion angles, functional
      level assessed by neck disability index (NDI). The effects of the treatments on active
      trigger points were evaluated by sEMG and US histogram. All parameters were evaluated at the
      beginning of the treatment and after 3 sessions of treatment. Algometer and sEMG were
      performed also before and after the 1st and 3rd sessions.
    

Detailed description: 
      OBJECTIVE: To compare the efficacy of dry needling and cold spray stretching treatments using
      surface electromyography (sEMG) and ultrasound (US) in the treatment of patients with
      myofascial pain syndrome (MPS) with active trigger point (TrP) in the upper trapezius muscle.

      MATERIAL AND METHODS: A prospective randomized single-blind study included 60 patients aged
      18-65 years who have MPS with ATP in the upper trapezius muscle. Patients were randomized
      into two treatment groups as dry needling (DN) and cold spray-stretching. Both treatment
      groups received 1 treatment per week and totally 3 sessions. Evaluation parameters were pain
      level assessed by visual analog scale (VAS) and algometer, neck range of motion angles,
      functional level assessed by neck disability index (NDI). The effects of the treatments on
      aTP were evaluated by sEMG and US histogram. All parameters were evaluated at the beginning
      of the treatment and after 3 sessions of treatment. Algometer and sEMG were performed also
      before and after the 1st and 3rd sessions.
    

Intervention name(s): dry needling; cold spray and stretching
Intervention type(s): Other; Other
Intervention description(s): The needle inserted in the trigger point and stimulation was performed by manipulating it up and down several times. The needle was kept in the trigger point for 1-3 minutes and removed after the muscle spasm regressed; The cooler spray (in its content; 0.06% menthol, 2.06% isopropyl alcohol, 2% isopropyl alcohol) was sprayed to the surface at an angle of 30° from a distance of approximately 30-50 cm, while passive stretching was applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cold spray; dry neddling; histogram; trigger point
Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Many people with spinal cord injury are no longer able to walk and must use wheelchairs for
      mobility. These individuals experience greater rates of depression and lower quality of life.
      Many of these individuals express a strong desire to walk again, and report many psychosocial
      benefits to being eye to eye with peers in social interactions. Additionally, wheelchairs
      allow only limited community access, creating an additional obstacle to seeking out
      meaningful social roles in the community. Currently, there is new technology called robotic
      exoskeletons that would allow people with spinal cord injury to walk. These robotic
      exoskeletons also allow for curb, ramp, and stair negotiation, which are critical to
      community access. Current research has examined training with robotic exoskeletons indoors
      over level surfaces in clinical settings. This study will examine the potential for everyday
      use, including ramps, stairs, curbs and indoor and outdoor use.
    


Intervention name(s): ReWalk Rehabilitation 2.0
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury; exoskeleton; ambulation; walking; robotics
Effects of Immulina on Immune Measures
Condition: Effects of Immulina on Natural Killer Cells
Study type: Interventional

Summary: 
      This small, randomized, double blind, placebo controlled pilot study is aimed at determining
      the effects of oral Immulina dietary supplementation on specific immune biomarkers in the
      blood.
    

Detailed description: 
      This small, randomized, double blind, placebo controlled pilot study is aimed at determining
      the effects of four weeks of daily Immulina dietary supplementation (800 mg/day) versus four
      weeks of daily placebo on natural killer (NK) cell numbers and/or natural killer (NK) cell
      activity in human peripheral blood mononuclear cells collected from human research
      participants who meet the trial's inclusion/exclusion criteria.
    

Intervention name(s): Immulina Dietary Supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Immulina Dietary Supplementation is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiating properties.
Other intervention name(s): Immulina; Spirulina
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Immulina; Natural Killer Cells (NK); Dietary supplementation
ALT-801 DDI Study in Healthy Volunteers
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, drug-drug interaction (DDI) study of ALT-801 under steady
      state conditions on concomitantly administered medications in healthy subjects. The study
      will evaluate the effect of ALT-801 on the pharmacokinetics (PK) of metformin, warfarin,
      atorvastatin, digoxin, and the combined oral contraceptive (OC)
      ethinylestradiol/levonorgestrel. The study will be conducted in 3 parts, as described below.
      Each part will have 2 periods in a fixed sequence, where the first period is without ALT-801
      administration and the second is with ALT-801 at steady state.
    


Intervention name(s): ALT-801; Metformin; Atorvastatin; Warfarin; Digoxin; Ethinylestradiol and Levonorgestrel
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Injected subcutaneously (SC); Taken by mouth (PO); Taken by mouth (PO); Taken by mouth (PO); Taken by mouth (PO); Taken by mouth (PO)
Intervention MeSH terms: Metformin; Digoxin; Warfarin; Atorvastatin; Levonorgestrel; Ethinyl Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: NASH
Tenofovir Disoproxil Fumarate (TDF) in HIV-1 Patients Who Have Never Taken Anti-HIV Drugs
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of this study is to look at the effectiveness of tenofovir disoproxil fumarate
      (TDF) in HIV-infected patients who have never taken anti-HIV drugs.
    

Detailed description: 
      Patients receive TDF.
    

Intervention name(s): Tenofovir disoproxil fumarate
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; Adenine; Anti-HIV Agents; Viral Load; Organophosphorus Compounds
DNA Analysis From Isolated Cardiomyocytes in the Molecular Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia
Condition: Arrhythmogenic Right Ventricular Dysplasia; Arrhythmogenic Right Ventricular Cardiomyopathy
MeSH terms: Cardiomyopathies; Arrhythmogenic Right Ventricular Dysplasia
Study type: Interventional

Summary: 
      The main objective of this study is to assess if it is possible, at the end of endocardial
      voltage mapping, to accurately collect intact cardiomyocytes and to isolate high quality DNA
      allowing molecular testing of selected genes involved in arrhythmogenic right ventricular
      cardiomyopathy/dysplasia.
    

Detailed description: 
      Arrhythmogenic right ventricular cardiomyopathy/dysplasia is associated with mutations in
      genes encoding proteins from desmosomes and is characterized by a large expression
      variability. The classical molecular diagnosis from blood cells fails to identify mutations
      in around 30% of patients. Probes used for endocardial voltage mapping allow to collect some
      cardiomyocytes which could be used for DNA analysis.

      The aim of this project is to investigate if cardiomyocytes can efficiently be collected
      during endocardial voltage mapping in patients with arrhythmogenic right ventricular
      cardiomyopathy/dysplasia. Thirty patients suffering from arrhythmogenic right ventricular
      cardiomyopathy/dysplasia cardiac and needing endocardial voltage mapping for disease
      diagnosis and/or prognosis assessment will be included. The main outcome will be the
      percentage of patients in whom mapping will allow to collect intact cardiomyocytes from which
      high quality DNA extraction will be achieved. Other outcomes include the identification of
      new mutational mechanisms as somatic mosaicism in selected genes (PKP2, DSCG2 DSP) and the
      feasibility of epigenetic analysis of these genes.
    

Intervention name(s): Cardiomyocytes collection
Intervention type(s): Diagnostic Test
Intervention description(s): collect intact cardiomyocytes from which high quality DNA extraction will be achieved
Intervention model: Single Group Assignment
Intervention model description: Exploratory, monocentric and prospective study
Masking: None (Open Label)
Primary purpose: Diagnostic
Insertion of Different Supraglottic Airway Devices on Manikin
Condition: Ventilation; Airway Management; Education
Study type: Interventional

Summary: 
      When tracheal intubation and face mask ventilation fail, and the insertion of supraglottic
      airway devices (SHA) can provide ventilation, protecting the patient from hypoxemia.
      Supraglottic airway devices have become an important part of difficult airway algorithms. The
      European Resuscitation Council Guidelines recommend supraglottic airway devices for airway
      management by non-specialized healthcare providers. Education through simulators contributes
      to the development of students without direct contact with patients. In this study, it was
      aimed to compare the success of placement of four different supraglottic airway devices on
      the manikin of term 5 students who participate to the Anesthesiology and Reanimation
      internship.
    


Intervention name(s): Proseal Laryngeal Mask; Classic Laryngeal Mask; I-gel; Suprema Laryngeal Mask
Intervention type(s): Device; Device; Device; Device
Intervention description(s): insertion of Proseal Laryngeal Mask; insertion of Classic Laryngeal Mask; insertion of I-gel; insertion of Suprema Laryngeal Mask
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Airway management; Supraglottic airway devices; Manikin study; education
Pulse Oximeter Test
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      Assessment of Spry Health's Loop oximetry accuracy in profound hypoxia
    


Intervention name(s): Spry Loop oximeter
Intervention type(s): Device
Intervention description(s): Oximetry was performed on the subjects and accuracy was determined based on comparison with blood gas analysis.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        11 healthy adults