bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, 2-way crossover, single-dose study that is being performed to
      establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers:
      manufacturer of the Phase 2/3 drug product and manufacturer of the Phase 3 and commercial
      drug product. This bioequivalence study will confirm (1) the drug product manufactured from
      these two manufacturers are therapeutically equivalent and (2) the efficacy and safety data
      obtained in clinical studies using TNX-102 SL from these two manufacturers are comparable.
    

Detailed description: 
      This will be a single centre, bioequivalence, open-label, randomized, single-dose, 2-period,
      2 sequence, crossover study under fasting conditions.

      Potential subjects will be screened by medical and psychiatric history, and laboratory and
      physical examinations 2 to 30 days prior to drug administration. All eligible subjects will
      be admitted to the study unit on Day -1, the day prior to dose administration. Baseline
      values will be considered the last value obtained before dosing for each assessment. On Day
      1, the morning after admission, after all pre-dose assessments have been completed and
      subjects who remain eligible have agreed to continue, subjects will be randomly assigned to
      study medication and will receive the assigned test drug. Subjects will be required to fast
      for at least 10 hours prior to dosing until at least 4 hours post-dose.

      For each period, subjects will be confined to the study site from at least 10 hours before
      dosing until after the 24-hour post-dose blood draw. Subjects will come back for all
      subsequent blood draws. Subjects will be reassessed for eligibility prior to each dosing
      period.
    

Intervention name(s): Treatment A; Treatment B
Intervention type(s): Drug; Drug
Intervention description(s): 1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved.; 1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.
Other intervention name(s): cyclobenzaprine HCl; cyclobenzaprine HCl
Intervention MeSH terms: Amitriptyline; Cyclobenzaprine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Multiple Ascending Dose Study To Assess Safety, Tolerability And Pharmacokinetics Of PF-05212377 (SAM-760)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple ascending dose study to assess the safety, tolerability and
      pharmacokinetics of PF-05212377 (SAM-760) administered orally once a day for 14 days to
      healthy young adults and healthy elderly subjects. The study will be conducted under
      double-blind conditions (neither the investigator nor the subject will know if he/she has
      received PF-05212377 or a placebo). The Sponsor will know if the subject has received active
      treatment or a placebo.
    


Intervention name(s): PF-05212377 (SAM-760); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg; Oral capsule, once daily for 14 days
Other intervention name(s): SAM-760
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51
      non-diabetic obese participants with a body mass index (BMI) ≥ 35 kg/m^2. The participants
      will be observed among 3 separate cohorts and participate in the study for up to
      approximately 27 weeks, including a screening period (including a run-in), treatment period,
      and safety follow-up.
    

Detailed description: 
      This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51
      non-diabetic obese participants with a BMI ≥ 35 kg/m2. Participants will be blinded, but
      investigators/site staff and sponsor will be unblinded for Cohort 1. In Cohorts 2 and 3
      participants, investigators, and contract research organization personnel are blinded to
      investigational product and sponsor is unblinded. The participants will participate in the
      study for up to approximately 27 weeks, including a screening period (including a run-in),
      treatment period, and safety follow-up.

      Participants will be randomized 4:1 to MEDI0382 (n=12) or placebo (n=3) for Cohort 1 and
      randomized 2:1 to MEDI0382 (n=12) or placebo (n=6) for Cohorts 2 and 3. In Cohort 1
      participants randomized to MEDI0382 or placebo will be dosed daily with a weekly titration
      schedule until the highest clinically tolerated dose (CTD) is established. In Cohort 2
      participants randomized to MEDI0382 or placebo will be dosed daily with a 2 week titration
      schedule up to the highest CTD is established in Cohort 1. In Cohort 3 participants
      randomized to MEDI0382 or placebo will be dosed daily with a 4 week participants schedule up
      to the highest CTD established in Cohort 1. Once the highest CTD is identified, participants
      will continue on the highest CTD for an additional 2 weeks of treatment for Cohort 1 and 3
      and additional 4 weeks treatment for Cohort 2. All participants will return 28 days post last
      dose for a safety follow-up visit.
    

Intervention name(s): MEDI0382; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MEDI0382 will be administered subcutaneously daily according to the MEDI0382 cohorts.; Placebo will be administered subcutaneously daily according to the Placebo cohorts.
Other intervention name(s): Cotadutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obesity; MEDI0382; Overweight
Effects of Low Versus High Frequency Percutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients.
Condition: Neck Pain; Chronic Pain; Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Chronic Pain; Neck Pain
Study type: Interventional

Summary: 
      Comparison between high and low frequency percutaneous electrical nerve stimulation as
      treatment of myofascial chronic neck pain. The main hypothesis is that low frequency
      treatment will have more hypoalgesic effects than high frequency, and low frequency effects
      will last longer.
    


Intervention name(s): Low frequency; High frequency
Intervention type(s): Procedure; Procedure
Intervention description(s): A dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a low frequency TENS is applied, at 2 Hz frequency and 120 microseconds of pulse width.; A dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a high frequency TENS is applied, at 12o Hz frequency and 200 microseconds of pulse width.
Other intervention name(s): Low frequency group; High frequency group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized control trial.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Percutaneous electrical nerve stimulation; Myofascial trigger point
Threshold Suspend in Pediatrics at Home
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study objective is to demonstrate that home use of Threshold Suspend (TS) is not
      associated with glycemic deterioration in pediatric patients with type 1 diabetes, as
      measured by change in A1C.
    

Detailed description: 
      This study is a longitudinal, multi-center trial that aims to observe the Threshold Suspend
      (TS) feature with a sensor-augmented insulin pump in patients 7-15 years with Type 1
      diabetes. The study will measure the change in A1C from baseline over a period of one year
      while subjects are wearing the study pump.
    

Intervention name(s): 530G Insulin pump
Intervention type(s): Device
Intervention description(s): Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Intervention model description: single group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Pediatric; Threshold Suspend; Sensor augmented pump
Efficacy of Nebulized Hypertonic Saline in the Treatment of Acute Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of hypertonic saline vs. normal saline
      in the treatment of infants hospitalized for bronchiolitis, regarding length of hospital
      stay, oxygen requirements and clinical outcome.
    

Detailed description: 
      Despite bronchiolitis is a very frequent disease among infants, there are still controversies
      regarding its treatment. Hypertonic saline has been proposed as useful treatment in these
      children, bur information is still controversial.

      The aim is to asses that using Nebulized Hypertonic Saline with bronchodilators (albuterol)
      may reduce the days of hospitalization and improve clinical outcomes in patients with acute
      bronchiolitis, compared with using Normal Saline with albuterol.
    

Intervention name(s): Hypertonic saline; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days; 3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
Other intervention name(s): ClNa 3% (sodium chloride 3%); ClNa 0.9% (sodium chloride 0.9%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertonic; Saline; Bronchiolitis; Efficacy
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab
      every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from
      baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable
      to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A)
      reductase inhibitors).
    


Intervention name(s): Evolocumab; Placebo to Evolocumab; Ezetimibe; Placebo to Ezetimibe
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Subcutaneous injection; Subcutaneous injection; Tablet for oral administration; Tablet for oral administration
Other intervention name(s): AMG 145; Repatha; Zetia
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Transcriptome Assessment After Cardiac Arrest
Condition: Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the blood transcriptome of patients
      resuscitated after out-of-hospital could be an early predictor of the neurological outcome.
    

Detailed description: 
      Assessing the prognosis of the patients resuscitated after out-of-hospital cardiac arrest
      (OHCA) is still highly challenging. Beyond usual neurological markers, experimental and
      clinical studies have also shown that blood levels of several cytokines or miRNA could be
      significantly different after cardiac arrest in subjects prematurely died as compared to
      survivors with a good neurological recovery. Here the investigators propose to investigate a
      screening approach assessing simultaneously multiple targets of the post-cardiac arrest
      syndrome through analysis of the whole transcriptome of patients after OHCA. For this
      purpose, the investigators will collect blood samples from 60 patients after admission at
      hospital and then 1 and 3 days later. The Pittsburgh Cerebral Performance Category of each
      patient will be evaluated for each patient at day 60 after cardiac arrest. At the end of the
      collection period, the blood samples will be prepared for whole genome analysis and RNA
      sequencing. The primary analysis of the investigators will be the comparison of the
      transcriptome at day 0 after cardiac arrest in patients reaching Cerebral Performance
      Category (CPC) 1 at day 60 as compared to all other patients.
    

Intervention name(s): blood sampling
Intervention type(s): Biological
Intervention description(s): Sampling of 15 ml of blood during a blood test at Day 0, Day 1 and Day 3
Other intervention name(s): Blood sampling at Day 0, Day 1 and Day 3
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Transcriptome; messenger ribonucleic acid (mRNA); sequencing; biomarker; cardiac arrest; prognostication; successful resuscitation
Novel Organic Kale Products for Prevention of Obesity/Type 2 Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Investigating the health beneficial effects of freeze-dried Brassica oleracea var. acephala
      with a high content of fibers, protein, vitamin, minerals, and secondary metabolites on
      patients with type 2 diabetes.
    


Intervention name(s): Intervention; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Freeze-dried Brassica oleracea var. acephala; Placebo product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting
Condition: Coronary Artery Disease; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      The primary objective of this pilot study is to identify and quantify inflammatory and
      genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history
      of chronic obstructive pulmonary disease (COPD) undergoing elective coronary
      revascularization (CABG) to determine the risk of developing post operative respiratory
      failure. To achieve this objective, this proposal outlines the following specific aims:

      Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in
      patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at
      the time of intubation immediately prior to surgery and again upon skin closure immediately
      after the surgical procedure.

      Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with
      post-operative pulmonary complications defined as prolonged mechanical ventilation (> 24
      hours), pneumonia, and/or tracheostomy.

      Aim #3. To inform the development and implementation of a large pivotal trial which may
      impact clinical decision-making during the initial pre-operative outpatient assessment of
      COPD patients undergoing CABG.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients from Cardiothoracic surgery service
      
Biospecimen description: 
      BAL fluid, Serum
    
Keywords: coronary artery bypass grafting; coronary artery disease; chronic obstructive pulmonary disease
Evaluation of McGrath® MAC Video Laryngoscope
Condition: Intubation; Difficult
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether the McGrath® MAC video laryngoscope is equal
      or superior when compared to the Glidescope® Ranger and the Macintosh laryngoscope for novice
      users in a simulated airway manikin.
    

Detailed description: 
      Investigators compared two portable video laryngoscopes (the GlidesScope® Ranger (Verathon
      Inc, Bothell, WA, USA) and the McGrath® MAC (Aircraft Medical Ltd, Edinburgh, UK)) and a
      German type Macintosh metal blade with a fiberoptic light. A blade size of 4 was used on all
      devices. All intubations using video laryngoscopes were performed according to the
      manufacturers' instructions. A specialised rigid stylet (the GlideRite®) was used with the
      Glidescope® and a flexible plastic stylet bent with a hockey stick curvature, was used with
      the McGrath® MAC and the Macintosh laryngoscope. A size 7.5 endotracheal tube (Mallinckrodt™
      Hi-Lo Oral/Nasal Tracheal Tube Cuffed Murphy Eye, Covidien, Ireland) was used with all the
      laryngoscopes.

      All participants were randomly divided into 3 device groups. Each group was allowed to
      attempt to perform endotracheal intubation five more times using the Laerdal® Airway
      Management Trainer (Laerdal Medical Korea Ltd., Seoul, Korea) with the normal airway setting.
      After completing the normal airway session, the participants performed another five attempts
      with the neck immobilisation setting using a neck collar.

      The sequence in which the three devices were used was randomly assigned, and all participants
      performed the same sequence at intervals of five weeks during the study.
    

Intervention name(s): the McGrath® MAC video laryngoscope; the GlidesScope® Ranger video laryngoscope; the Macintosh laryngoscope
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Intubation; Laryngoscopes
Evaluation of a Home-based NMES Therapy for Knee Osteoarthritis Pain
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Evaluation of knee pain and functional mobility of knee osteoarthritis patients with a
      home-based neuromuscular electrical stimulation (NMES) therapy
    


Intervention name(s): CyMedica e-vive NMES
Intervention type(s): Device
Intervention description(s): Neuromuscular Electrical Stimulation (NMES) therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee OA; arthritis; knee pain
Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of
      the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects with
      Moderate to Severe Ulcerative Colitis.
    

Detailed description: 
      This is a Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a
      Study to evaluate the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in
      Subjects with Moderate to Severe Ulcerative Colitis.
    

Intervention name(s): AMT-101 (oral); Placebo (oral); Humira (adalimumab)
Intervention type(s): Drug; Other; Combination Product
Intervention description(s): AMT 101 is orally administered biological therapeutic taken once daily; Orally administered placebo comparator taken once daily; Humira comparator is administered subcutaneously, on Humira frequency schedule.
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Diseases
Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      OBJECTIVES: I. Determine the toxicity of total-body irradiation, anti-thymocyte globulin, and
      cyclophosphamide followed by syngeneic or autologous peripheral blood stem cell (PBSC)
      transplantation in patients with multiple sclerosis.

      II. Determine the disease response of patients treated with this regimen. III. Determine the
      safety and efficacy of filgrastim (G-CSF) for PBSC mobilization in this patient population.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral prednisone on days 0-10.
      Beginning on day 1, patients undergoing autologous peripheral blood stem cell (PBSC)
      transplantation receive filgrastim (G-CSF) subcutaneously daily until leukapheresis is
      completed. Leukapheresis begins on approximately day 4 and continues until adequate CD34+
      PBSC are collected.

      PBSC are collected from syngeneic donors in a similar manner. Patients undergo total-body
      irradiation twice daily on days -5 and -4. Patients receive cyclophosphamide IV on days -3
      and -2 and anti-thymocyte globulin IV on days -5, -3, -1, 1, 3, and 5. Patients undergo
      autologous or syngeneic PBSC transplantation on day 0. Following PBSC transplantation,
      patients receive oral prednisone on days 7-30 and G-CSF IV daily beginning on day 0 and
      continuing until blood counts recover.

      Patients are followed at 30, 80, and 90 days, monthly for 6 months, and then at 1 and 2
      years.
    

Intervention name(s): anti-thymocyte globulin; cyclophosphamide; filgrastim; prednisone; peripheral blood stem cell transplantation; irradiation
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Prednisone; Cyclophosphamide; Antilymphocyte Serum
Primary purpose: Treatment
Keywords: multiple sclerosis; neurologic and psychiatric disorders; rare disease