bioihbjkbjnl/mcl2 huggingface dataset:
Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease
Condition: Hypercholesteremia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Intervention: Rosuvastatin; HMG CoA inhibitor
Intervention description: 2.5-20 mg; 3-hydroxy-3-methylglutaryl-coenzyme A
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 214.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate that 76 weeks of treatment with
      rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic
      volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic
      subjects with coronary heart disease (CHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent,

          -  20 to 75 years old,

          -  Plan to undergo coronary angiography (CAG) or Percutaneous coronary intervention (PCI)
             and LDL-C ≥ 140 mg/dL (untreated patients) or LDL-C ≥ 100 mg/dL (treated patients)

        Exclusion Criteria:

          -  Acute myocardial infarction within 72 hours after the onset,

          -  Heart failure of New York Heart Association (NYHA) Class III or above,

          -  Serious arrhythmia,

          -  Being treated with LDL-apheresis

          -  History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.
The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis
Condition: Hypokalemia
MeSH terms: Phlebitis; Hypokalemia
Intervention: potassium chloride replacement; Experimental - 4% Sodium Bicarbonate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 17.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the impact of 4% sodium bicarbonate additive during
      peripheral intravenous potassium chloride replacement therapy for adult patients in a
      Medical/Surgical unit. Using a randomized controlled double blinded experimental study
      design, patients who are 21 years or older are alert, awake, and oriented at the time of
      enrollment and have been ordered peripheral intravenous potassium chloride replacement will
      be recruited from one Medical/Surgical during the first 24-48 hours of their admission.
    

Eligibility criteria:

        Inclusion Criteria:

          -  admitted to the medical/surgical unit within the last 24 to 48 hours

          -  awake, alert, and oriented times three

          -  21 years old and greater

          -  receiving first peripheral intravenous potassium chloride replacement therapy as
             ordered by physician or ARNP as part of care and regardless of research

          -  potassium level of 3.5 mmol/L or less.

        Exclusion Criteria:

          -  patients who have been in the medical/surgical unit more than 48 hours.

          -  altered mental status defined as not being awake, alert, and oriented times three

          -  patients who already received intravenous potassium chloride replacement during the
             current admission and with the current IV access

          -  patients receiving intravenous potassium replacement therapy through a central line

          -  patients that are not ordered potassium replacement by physician or ARNP as part of
             their care while hospitalized.
The Glucosamine-study: The Effect of Glucosamine in Treatment of Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Glucosamine sulphate; Placebo
Intervention description: Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months; Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chronic low back pain

Summary:

      Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and
      degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability.
      Some indications exist for symptomatic and possible cartilage-structurmodifying effect on
      knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar
      spine is most likely to OA processes in knees and hips, hence GS could have comparable
      symptomatic and structural effect on lumbar OA.

      Study hypothesis: No difference in treatment effect exists between oral intake of GS- or
      placebo-capsules for patients' with chronic low back pain measured with Roland Morris
      Disability Questionnaire.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Low back pain for more than 6 months

          -  Patient older than 25 years old

          -  MRI findings comparable with lumbar degenerative/osteoarthritic changes.

        Exclusion Criteria:

          -  Spinal stenosis with neurological deficits

          -  Spinal prolapse with neurological deficits

          -  Rheumatoid arthritis, psoriatic arthritis,

          -  Old lumbar fractures

          -  Chronic pain syndromes (e.g. fibromyalgia)

          -  Psychosocial status not suitable for participation

          -  Pregnancy

          -  Breastfeeding

          -  Allergic to shellfish
Antiplatelet Therapy Effect on Extracellular Vesicles in Acute Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: Ticagrelor; Clopidogrel
Intervention description: Comparison of ticagrelor with another antiplatelet drug (clopidogrel); Comparison of clopidogrel with another antiplatelet drug (ticagrelor)
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: extracellular vesicles; inflammation; thrombosis; antiplatelet drugs

Summary:

      Platelet activation and aggregation leads to myocardial infarction. Platelet P2Y12 receptors
      are essential for platelet activation. Antagonists against the P2Y12 receptor, which are
      established in secondary prevention of myocardial infarction, have unexplained
      anti-inflammatory effects. A novel P2Y12 receptor antagonist ticagrelor reduced
      infection-related mortality compared to clopidogrel, previous standard treatment for patients
      with myocardial infarction. Activated platelets release pro-inflammatory and procoagulant
      platelet extracellular vesicles. The investigators assume that decrease in infection-related
      mortality in patients treated with ticagrelor may be explained by greater inhibition of the
      release of platelet vesicles by ticagrelor, compared to clopidogrel. This study is expected
      to identify an additional mechanism of action of ticagrelor, which might contribute to the
      observed clinical benefits in patients treated with ticagrelor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Informed consent to participate in the study

          -  Percutaneous coronary intervention with stent implantation due to first S T elevation
             myocardial infarction, or first non S T -elevation myocardial infarction

          -  Administration of a loading dose of clopidogrel

        Exclusion Criteria:

          -  Known coagulopathy

          -  Known history of bleeding disorder

          -  Suspicion of intracranial haemorrhage

          -  Need for oral anticoagulation therapy

          -  Administration of glycoprotein (GP) II b - III a antagonists

          -  Cardiogenic shock

          -  Severe chronic renal failure (estimated glomerular filtration rate < 30 mL/min)

          -  Severe liver insufficiency

          -  Chronic dyspnea

          -  Increased risk of bradycardia

          -  Autoimmune disease

          -  Infectious disease

          -  Neoplasms

          -  Pregnancy

          -  Study drug intolerance

          -  Co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors

          -  Participation in any previous study with ticagrelor or clopidogrel
Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis
Condition: Calcinosis Cutis
MeSH terms: Calcinosis Cutis; Calcinosis
Intervention: Sodium Thiosulfate; Saline Solution
Intervention description: A volume of 0.1 ml/cm2 of STS will be injected into each lesion.; A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
Intervention MeSH terms: Sodium thiosulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a parallel two-arm study comparing sodium thiosulfate and saline control.
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Calcinosis cutis; sodium thiosulfate; sodium chloride

Summary:

      The purpose of our research is to compare the effectiveness of 125mg/50ml sodium thiosulfate
      (STS) solution to normal saline (0.9% sodium chloride) when injected intralesionally for the
      treatment of calcinosis cutis. Our specific aim is to assess the response of dystrophic and
      idiopathic calcinosis cutis to the injections of sodium thiosulfate in our patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adult 18 years of age or older

          -  Must have health insurance will be eligible to participate

          -  Must have a current diagnosis of dystrophic or idiopathic calcinosis cutis

          -  Subjects must have at least 2 lesions of at least 2mm in size

        Exclusion Criteria:

          -  Unable to read and speak English

          -  Allergy to any component of the sodium thiosulfate solution

          -  Adults unable to consent

          -  Individuals who are not yet adults (infants, children, teenagers)

          -  Pregnant women

          -  Women who are breastfeeding

          -  Prisoners
Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma
Condition: Normal Tension Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Low Tension Glaucoma; Hypertension
Intervention: Travoprost Ophthalmic Solution 0.004%
Intervention description: benzalkonium chloride (BAC) free
Intervention MeSH terms: Travoprost; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Glaucoma; Ocular hypertension

Summary:

      The purpose of this study is to investigate IOP reduction efficacy of travoprost 0.004%
      ophthalmic solution (TRAVATAN Z®) in subjects with normal tension glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of normal tension glaucoma.

          -  Must sign an Informed Consent form.

          -  IOP within protocol-specified range.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Pregnant and lactating women, or women who intend to become pregnant during the study
             period.

          -  Advanced and serious glaucoma, as specified in protocol.

          -  Complicated chronic or recurrent uveitis, scleritis or corneal herpes.

          -  History of ocular trauma, intraocular surgery or laser surgery for the included eye.

          -  Ocular-infection and severe ocular complication.

          -  Best-corrected visual acuity (BCVA) worse than 0.2 decimal.

          -  Difficulty in conducting applanation tonometry for the included eye as determined by
             the doctor.

          -  Severe or serious hypersensitivity to prostaglandin analogues or any ingredients used
             in the study.

          -  Use of IOP lowering ophthalmic solutions other than TRAVATAN Z® or oral carbonic
             anhydrase inhibitor (Diamox, etc.) during the study period.

          -  Use of any adrenocorticosteroids during the study period.

          -  Use of IOP lowering ophthalmic solution within the past 30 days.

          -  Regarded by doctor as not suitable for study participation.

          -  Other protocol-specified exclusion criteria may apply.
Oral Prednisolone Dosing in Children Hospitalized With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Prednisolone high dose; Prednisolone lower dose
Intervention description: 4 mg/kg/day orally divided every 6 hours (maximum 30 mg per dose); 2 mg/kg/day orally divided q 12 (maximum 30mg/dose) alternating with placebo
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Corticosteroids; Treatment; Pediatric

Summary:

      This study hopes to determine the appropriate oral steroid dose for treating children
      hospitalized with asthma exacerbations. Practice guidelines from different countries
      recommend a wide range of doses, and the doses used in actual practice vary widely. There is
      no data on what is the most appropriate dose of prednisone (or equivalent) in this situation.
      We will be looking at the dose recommended by the National Asthma Education and Prevention
      Program guidelines, which are published by the National Heart, Lung, and Blood Institute, as
      compared with a lower dose which is commonly used in practice. We hypothesize that the lower
      dose will be no worse than the higher dose as determined primarily by duration of
      hospitalization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician-diagnosed asthma with at least two previous visits to ED or primary care
             provider for asthma care

          -  Clinical decision by ED attending physician to admit to Acute Care Unit (ACU) after
             standardized initial ED treatment

        Exclusion Criteria:

          -  Clinical decision to begin continuous intravenous beta-agonist infusion

          -  Clinical decision to begin intravenous methylprednisolone therapy

          -  Clinical decision to admit to the Pediatric Intensive Care Unit

          -  Other concurrent disease such as sickle cell disease, cystic fibrosis, or cardiac
             disease

          -  Any contraindication to corticosteroid administration

          -  Any systemic corticosteroid treatment within two weeks of presenting to the ED

          -  Potential subjects will be excluded if informed consent is not obtained
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
Condition: Pressure Ulcer
MeSH terms: Pressure Ulcer
Intervention: Window
Intervention description: Dressing
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: No skin breakdown; Prevention; protection of the skin

Summary:

      This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable
      subjects at 3 sites with approximately 5-10 subjects/site. Subjects with acute vascular,
      surgical and orthopaedic medical care in the elderly admission, with a high risk to develop
      skin breakdown or subjects with category 1 pressure ulcer can be enrolled in this
      investigation.

      The rational for this study is to evaluate the potential for Window in the prevention of
      pressure ulcers because of its ability to reduce shear and friction forces.
    

Eligibility criteria:

        Inclusion Criteria:

          1. acute vascular, surgical, orthopaedic, medical or care of the elderly admission

          2. aged 18 years or over

          3. have an expected total length of stay of 5 or more days

          4. at high risk of PU development due to one or more of the following

               -  bedfast/chairfast AND completely immobile/very limited mobility

               -  category 1 PU on any pressure area skin site (see appendix G)

          5. give their written, informed consent to participate

          6. expected to be able to comply with follow-up schedule

        Exclusion Criteria:

          1. risk area which doesn't fit the dressing size 6*7cm, 10*12 cm and 15*20cm

          2. subject has category 2-4 pressure ulcer

          3. subject has documented skin disease at time of enrolment, as judged by the
             investigator

          4. known allergy/hypersensitivity to any of the components in the dressing

          5. previous enroled in the present study

          6. subject included in other ongoing clinical investigation at present, as judged by the
             investigator
High Dose IV Lidocaine vs Hydromorphone for Abdominal Pain in the Emergency Department
Condition: Abdominal Pain; Renal Colic
MeSH terms: Emergencies; Abdominal Pain; Renal Colic
Intervention: Lidocaine Iv; HYDROmorphone Injection
Intervention description: 2 mg/kg over 5 minutes; 1 mg over 5 minutes
Intervention MeSH terms: Lidocaine; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: lidocaine; hydromorphone; abdominal pain

Summary:

      Intravenous lidocaine will be given at a dose of 2 mg/kg intravenously to patients in the
      emergency department with a diagnosis of acute abdominal pain. Its efficacy will be compared
      to 1 mg of intravenous hydromorphone, with a primary endpoint of mean improvement of pain at
      90 minutes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be a patient in the emergency department (ED)

          -  Must have acute abdominal pain, defined as abdominal or flank pain of a duration of 7
             days or less

          -  Predicted treatment must include the use of an intravenous opiate

        Exclusion Criteria:

          -  Cardiac conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, PR
             interval <0.12s or > 0.2s)

          -  Known renal (CKD >2) or liver disease (Childs-Pugh B or greater)

          -  Hemodynamically instability, defined by the attending physician

          -  Pregnant or breastfeeding

          -  Have a known allergy to either medication

          -  Used of prescription or illicit opioids within the previous week

          -  Patients with a chronic pain disorder, defined as use of any analgesic medication on
             more days than not during the four weeks preceding the acute episode of pain
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
Condition: Thrombosis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Thrombosis; Acute Coronary Syndrome
Intervention: Prasugrel; Clopidogrel
Intervention description: Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder; Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize
      safety of coronary stenting by reducing heart attacks and repeat interventions while
      simultaneously minimizing adverse bleeding events. This study compares the efficacy of two
      laboratory guided treatment algorithms to personalize antiplatelet medication choice after
      coronary stenting
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients admitted with acute coronary syndrome (unstable angina, non-ST elevation
             myocardial infarction) and referred for coronary angiography.

          -  Current therapy with clopidogrel (at least 300mg loading dose, or 75mg po daily for >5
             days)

          -  Age range 21-75 years.

        Exclusion Criteria:

          -  Unable to give consent

          -  Age younger than 21 years, greater than 75 years

          -  History of stroke

          -  Body weight <60 kg

          -  Acute STEMI,

          -  Thrombocytopenia<100'000,

          -  requirement for chronic warfarin therapy