bioihbjkbjnl/mcl2 huggingface dataset:
Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic
      control while treated with combination of premixed insulin analogue formulations twice daily
      and metformin will be randomly assigned to follow one of two insulin treatment strategies
      used in combination with metformin administration. The aim of the trial is to try to achieve
      optimal metabolic control and explore full therapeutic potential of the strategies, patients
      in both arms will follow progressive insulin dose titration algorithms for 16 weeks.
    


Intervention name(s): Insulin Biphasic Aspart 30/70; insulin lispro LM; insulin lispro MM; insulin lispro LM
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks; Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels.; Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks; Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
Other intervention name(s): Low Mix; Humalog; Mid Mix; Humalog; Low Mix; Humalog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; type 2
Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin
Condition: Nosocomial Neonatal Sepsis
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to
      vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial
      sepsis probably caused by Coagulase-negative staphylococcus.

      The investigators hypothesized that newborn infants with the presumptive diagnosis of
      nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome
      not inferior to that of those treated with vancomycin.
    


Intervention name(s): Cefazolin; Vancomycin; Amikacin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Vancomycin; Cefazolin; Amikacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coagulase negative staphylococcus; nosocomial neonatal sepsis; cefazolin; vancomycin; newborn
Atorvastatin in Perioperative Vascular Surgery - Pilot Study
Condition: Vascular Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG
      coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular
      outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in
      comparative standard doses in the perioperative period of major vascular surgery.

      Abdominal aortic aneurysm , Carotid endarterectomy , Revascularization of lower limbs
    


Intervention name(s): Atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Atorvastatin 80 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60; Atorvastatin 20 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ATORVASTATIN; VASCULAR SURGERY; CARDIOVASCULAR OUTCOMES
A Study of LY2216684 and Warfarin in Healthy Subjects
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how warfarin might affect LY2216684 and how giving
      LY2216684 might affect warfarin in the body. Information about any side effects that may
      occur will also be collected.
    


Intervention name(s): Warfarin; LY2216684
Intervention type(s): Drug; Drug
Intervention description(s): 10-mg warfarin oral dose; 18-mg LY2216684 oral dose
Intervention MeSH terms: Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine
      the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus
      SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior
      systemic chemotherapy for recurrent or metastatic disease.
    

Detailed description: 
      Patients will be randomized in a 2:1:1 ratio to MEDI4736 + tremelimumab combination therapy,
      MEDI4736 monotherapy, or SoC. Patients in all arms will continue therapy until progression.
      Tumor assessments will be performed on computed tomography scans or magnetic resonance
      imaging scans, preferably with intravenous (IV) contrast. Efficacy for all patients will be
      assessed by objective tumor assessments every 6 weeks for the first 24 weeks, then every 8
      weeks thereafter until treatment discontinuation due to progression or toxicity. All patients
      will be followed every 3 months for survival after progression is confirmed.
    

Intervention name(s): MEDI4736; Tremelimumab; MEDI4736+Tremelimumab; Cetuximab; 5-fluorouracil (5FU); Cisplatin; Carboplatin
Intervention type(s): Biological; Biological; Biological; Biological; Drug; Drug; Drug
Intervention description(s): Anti-PD-L1 antibody; Anti-CTLA-4 Antibody; Monoclonal Antibody; Chemotherapy Agent; Chemotherapy agent; Chemotherapy Agent
Intervention MeSH terms: Carboplatin; Fluorouracil; Cetuximab; Durvalumab; Tremelimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: programmed cell death ligand 1 (PD-L1), MEDI4736, Cytotoxic T-lymphocyte-associated antigen 4 {CTLA-4}, PFS, SCCHN
Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is conducted to evaluate and compare the relative bioavailability for
      Rosuvastatin in two different products containing 10 mg film coated tablet after single oral
      administration.
    

Detailed description: 
      A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study of the two
      different products containing 10 mg film coated tablet after oral administration to 38
      healthy adult volunteers under fasting conditions. Blood samples were collected at different
      time intervals and stored at -70⁰C freezer. Plasma concentrations of Rosuvastatin were
      analyzed and determined using a validated LC-MS-MS method then pharmacokinetics and
      statistical analysis were performed.
    

Intervention name(s): Rosuvastatin 10 mg
Intervention type(s): Drug
Intervention description(s): Film Coated Tablets products containing 10 mg Rosuvastatin
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Randomized, Single-Dose, Two-Way Crossover, Open-Label, Bioequivalence Study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Rosuvastatin; Bioequivalence; Randomized; Cross-Over
Healthy Volunteer Pilot Study Using 3 Types of Modified Release Formulations of Firategrast to Investigate How Quickly Absorption From the Digestive System Takes Place.
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate how 3 new types of drug formulations are absorbed by the body.
      This study is termed 'open-label', which means volunteers will be aware of which treatment
      they are receiving. The study involves all volunteers receiving all 3 different formulations,
      as a single dose, and there is no placebo (dummy-drug; no active ingredient) in this study.
      Volunteers will also receive a single dose of a formulation used in previous trials
      (reference formulation), so as a proper comparison with the new formulations can be made. One
      of the new formulations will also be administered along with food, to assess if the drug
      performs or is absorbed differently.
    

Detailed description: 
      The present study will investigate the tolerability and pharmacokinetics of single oral doses
      of firategrast administered as the existing immediate release tablet formulation and as three
      modified release tablet formulations designed to release drug over differing relase rates.
      The range of release rates is expected to give preliminary information on the performance of
      a matrix modified release formulation for use in future efficacy studies.

      Subjects will receive each formulation in the fasted state in a randomised 4-part single dose
      crossover fashion. Based on the review of pharmacokinetic data from at least the first two
      study sessions, subjects may also receive a fifth dose of firategrast, administered after a
      high fat meal. The formulation administered with food will be chosen based upon
      pharmacokinetic data from previous dose sessions. Doses administered will be different with
      respect to gender; the doses are expected to result in similar exposures across the genders.
    

Intervention name(s): A; B; C; D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose treatment IR formulation; Low Extended release single dose; Medium extended release formulation; High extended release rate single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteers; firategrast; Pharmacokinetics; modified release
Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Condition: Milk Allergy; Anaphylaxis
MeSH terms: Hypersensitivity; Milk Hypersensitivity; Anaphylaxis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to study the number of Participants with Adverse Events as a
      Measure of Safety and Tolerability.
    

Detailed description: 
      Eligibility criteria:

      Age 6 - 16 yrs

        -  IgE-mediated milk allergy

        -  and milk provocation within 3 months prior to or an documented accidental milk contact
           with clear immediate symptoms

      Outcome measures:

        -  number of patients with successful desensitization (195 - 200 ml milk per day)

        -  number of patients with adverse events
    

Intervention name(s): milk
Intervention type(s): Dietary Supplement
Intervention description(s): milk for milk allergic children (1:25 dilution, whole milk)
Other intervention name(s): milk allergy; desensitization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: milk allergy; desensitization; anaphylaxis; school-age
Danhong Injection in the Treatment of Unstable Angina Pectoris
Condition: Unstable Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Unstable
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy and safety of Danhong injection in the
      treatment of unstable angina pectoris.
    


Intervention name(s): Danhong injection; Standard medical care; Placebo
Intervention type(s): Drug; Other; Drug
Intervention description(s): A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower; Standard medical care is in accordance with China Guideline for the diagnosis and treatment of unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) (2007) issued by Chinese Society of Cardiology of Chinese Medical Association; 0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Unstable Angina Pectoris; Randomized Controlled Trial; Traditional Chinese Medicine
A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of VX-548
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability and food effect of a
      new tablet formulation of VX-548 in healthy adult participants.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): VX-548
Intervention type(s): Drug
Intervention description(s): Tablet for oral administration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Perioperative Depression and Postoperative Arrhythmia in Elective Coronary Bypass Graft Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Arrhythmias, Cardiac; Depression
Study type: Observational

Summary: 
      Postoperative arrhythmias (heart irregularities) are one of the most common complications
      after cardiac surgery and are associated with increased morbidity and mortality. Preoperative
      depression may be an important co-factor in the generation of postoperative arrhythmias due
      to sympathetic hyperactivity evident in patients with depression.

      Objectives: To determine the effect of preoperative depression on postoperative arrhythmia in
      patients undergoing elective coronary artery bypass graft (CABG) surgery.

      Prospective observational study, 120 patients undergoing elective CABG surgery ECG will be
      preformed preoperatively on all patients. All patients will be assessed for signs of
      depression using the Prime MD Patient Health Questionnaire (Prime MD PHQ) one week before
      surgery and 6 weeks postoperatively.Based on the Prime MD PHQ results, patients will be
      divided into two groups: those with or without signs of depression. Heart rate and rhythm
      monitoring with Holter will be performed for 3 days postoperatively in order to compare the
      incidence of postoperative arrhythmias between groups.

      The primary outcome is the number of patients with and without depression suffering from
      ventricular and/or supraventricular arrhythmias. Secondary outcomes include all cause
      mortality, non-fatal myocardial infarction, cardiac arrest, and congestive heart failure.

      CABG surgery is the most common operative procedure in North America and arrhythmias are one
      of the most common postoperative complication. It is estimated that about a third of these
      cardiac patients suffer from preoperative depression and therefore may be exposed to a higher
      risk of perioperative morbidity and mortality. If an association between preoperative
      depression and postoperative arrhythmia is found, treatment modalities may be indicated to
      reduce the prevalence of perioperative arrhythmia in patients with preoperative depression
      undergoing cardiac surgery.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing elective CABG surgery
      
Keywords: Arrhythmia; Depression; Coronary Artery Disease
Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Despite the physiologic and clinical effects provided by coupling nebulization with
      noninvasive ventilation in asthma exacerbation, there are few and controversial studies
      reported in the literature.
    

Detailed description: 
      Reduced work of breathing, increased oxygenation and increased in expiratory peak flow (EPF)
      and forced expiratory volume in the first second (FEV1) are benefits of noninvasive
      ventilation (NV) in the treatment of asthma. Despite these clinical improvements attributed
      to NV during asthma exacerbations and the well-established effects of nebulization, there are
      few studies in the literature coupling both therapeutic resources.

      In addition to this, no studies on scintigraphic analysis of radioaerosol deposition coupled
      with NV in asthmatics have published. A previous study was published by our group, but
      involved healthy subjects.
    

Intervention name(s): NV; NEB group
Intervention type(s): Device; Other
Intervention description(s): Noninvasive ventilation coupled with nebulization(Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm); Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm
Other intervention name(s): Interventional Group; Control group
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; status asthmatics
A Study in Healthy Men to Compare 2 Different Formulations of Alteplase
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish the bioequivalence of alteplase derived from two different manufacturing
      processes.
    


Intervention name(s): Alteplase (from modified manufacturing process); Alteplase (from current manufacturing process); Heparin-Natrium-5000-ratiopharm (unfractionated heparin)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alteplase, TPA-05; Alteplase, TPA-02; Heparin-Natrium-5000-ratiopharm (unfractionated heparin)
Intervention MeSH terms: Heparin; Calcium heparin; Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part A: Open label Part B: Adaptive two-stage group-sequential design
Masking: None (Open Label)
Primary purpose: Treatment
Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis
Condition: Post Dialysis Arterio-Venous Fistula Puncture Sites
MeSH terms: Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      The study aimed to evaluate the Effectiveness of Applying Moziak Device Compared to Standard
      Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis
    

Detailed description: 
      application of new device to find a Solution for Nursing Challenge for caring patient Post
      Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis
    

Intervention name(s): Moziak Device
Intervention type(s): Device
Intervention description(s): Applying Moziak Device Compared to Standard Manual Compression
Other intervention name(s): Standard Manual Compression
Intervention model: Single Group Assignment
Intervention model description: A Mixed Methods Sequential Explanatory Study
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety Study of CTX-100 Inhalation Solution (Formerly ETX-100)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety of administering repeated doses of CTX-100
      (formerly ETX-100) to subjects with smoking-related chronic obstructive pulmonary disease.
    

Detailed description: 
      The study primarily aims to establish safety and evaluate biochemical activity of CTX-100
      (formerly ETX-100) with respect to elastin breakdown, but will also concurrently gather data
      that may point to efficacy. The preliminary efficacy results will be used to assist in the
      design of subsequent phase 2b clinical studies of longer duration to examine both efficacy
      and safety of CTX-100 as a therapy for chronic obstructive pulmonary disease.
    

Intervention name(s): CTX-100 (formerly ETX-100) (hyaluronic acid)
Intervention type(s): Drug
Intervention description(s): 3 mL of either 0.01%, 0.03% CTX-100 (formerly ETX-100), or placebo will be dispensed into the PARI LC STAR nebulizer and inhaled using the PARI Ultra II compressors.
Number of cycles: if the study drug (0.01% CTX-100 Inhalation Solution or placebo) bid is well tolerated in the first cohort, the second cohort of subjects will begin dosing with 0.03% CTX-100 Inhalation Solution or placebo in the same manner as the first cohort.
Other intervention name(s): CTX-100; ETX-100; Hyaluronic acid
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease (COPD)