bioihbjkbjnl/mcl2 huggingface dataset:
Drug Interaction Study Between Linezolid and Clarithromycin in Tuberculosis Patients
Condition: Multidrug-resistant Tuberculosis; Extensively Drug-resistant Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant; Extensively Drug-Resistant Tuberculosis
Intervention: Addition of different doses of clarithromycin.
Intervention description: At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks.
Intervention MeSH terms: Clarithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pharmacokinetic; drug-interaction; linezolid; clarithromycin; Mycobacterium tuberculosis

Summary:

      Future patients might benefit from a combination of linezolid (LIN) and clarithromycin (CLA)
      in the treatment of Multidrug-resistant and Extensively Drug-resistant Tuberculosis
      (MDR/XDR-TB) due to possible synergistic activity as shown in in vitro experiments in
      different Mycobacteria strains. The investigators observed increased LIN serum levels in
      three cases after combining LIN and CLA of which the investigators described one in a case
      report (Bolhuis et al). The investigators suggest to conduct a prospective pharmacokinetic
      study in MDR- and XDR-TB patients to quantify the above described interaction between LIN and
      CLA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years old

          -  Signed informed consent

          -  Diagnosis of MDR/XDR-TB confirmed with standard microbiological criteria
             (culture-based, molecular or both)

          -  Treatment with linezolid 300mg twice daily per os.

        Exclusion Criteria:

          -  Hypersensitivity to: linezolid, clarithromycin, erythromycin, or any macrolide
             antibiotics, or any of the excipients of linezolid or clarithromycin.

          -  Concomitant use with astemizole, cisapride, ergotamine derivatives (dihydroergotamine,
             ergotamine), monoamine oxidase inhibitors (phenelzine, isocarboxazid, selegiline, or
             moclobemide), pimozide, or terfenadine.

          -  Pregnancy or breast-feeding.

          -  Hypokalemia

          -  Concomitant use of other P-gp inhibitors/inducers, e.g. amiodarone, verapamil,
             digoxin, tipranavir/ritonavir, lovastatin, tariquidar, itraconazole, dipyridamol,
             erythromycin, ritonavir, quinidine.
Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Laboratory Tests
Intervention description: Blood draws to determine the level of factor VIII activity before and after dosing at appropriate visits, and blood draws to determine levels of factor VIII inhibitor (antibody to factor VIII).
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Male
Maximum age: 6 Years
Healthy volunteers: No
Keywords: ReFacto AF; factor VIII; inhibitors; antibodies

Summary:

      Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe
      hemophilia A in patients who have not yet received treatment for their hemophilia. Study
      subjects will be males less than 6 years old who have not taken any clotting factor or other
      blood products before the study. The safety and effectiveness of ReFacto AF will be
      determined in this study by tests and procedures done at the doctor's office.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects <6 years of age with severe hemophilia A (FVIII:C <1%) based on clinical
             records, including newborns.

          -  No prior exposure to factor products or any blood products.

        Exclusion Criteria:

          -  Presence of any bleeding disorder in addition to hemophilia A.

          -  Treatment with any investigational agent or device within the past 30 days.

          -  Any condition(s) that compromises the ability to collect study-related observations,
             or that poses a contraindication to study participation (these conditions include, but
             are not limited to, inadequate medical history to assure study eligibility; and
             expectation of poor adherence to study requirements).
Dalteparin Versus Unfractionated Heparin In Patients With Acute Coronary Syndrome
Condition: Angina, Unstable; Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable; Infarction
Intervention: Dalteparin ( Fragmin); Unfractionated heparin
Intervention description: Dalteparin will be administered at a dose of 120 IU/kg (international units per kilogram) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours.; Unfractionated heparin will be given intravenously according to a weight-adjusted nomogram (bolus of 60 U/kg [units per kilogram] and initial infusion of 12 U/kg/h [units per kilogram per hour]).
Intervention MeSH terms: Heparin; Calcium heparin; Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 173.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-ST Elevation Acute Coronary Syndromes coronary interventions

Summary:

      To compare efficacy and safety of dalteparin compared to unfractionated heparin in patients
      of non ST elevation acute coronary syndromes who are planned to undergo coronary
      interventions (angioplasty or bypass surgery)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients more than 18 years

          -  Ischemic pain of more than 10 minutes within 24 hours before enrollment

          -  At least two of the following three risk factors : Age more than 60 years ( or more
             than 50 in case of diabetics), Raised cardiac enzyme levels, abnormal ECG findings

        Exclusion Criteria:

          -  Contraindications to use of anticoagulants

          -  Active bleeding or abnormal coagulation tests

          -  Ischemic stroke within last 6 months or hemorrhagic stroke

          -  Lumbar or spinal puncture within last 48 hours

          -  S creatinine levels more than 2
The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block
Condition: The Duration of Motor Block May Vary Between 12-36 Hrs
Intervention: Bupivacaine; Ropivacaine
Intervention description: Varying doses to determine the duration of analgesia; Varying doses to determine the duration of analgesia
Intervention MeSH terms: Bupivacaine; Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The duration of motor block for infragluteal parabiceps sciatic nerve block following total
      knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic
      given.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients (>18 years of age) who are undergoing elective total knee arthroplasty
             will be included in the study.

        Exclusion Criteria:

          -  Exclusion criteria for the study are patient refusal to be included in the study,
             contraindications to regional anesthesia, history of allergy to amide local
             anesthetics, the presence of a progressive neurological deficit, the presence of
             coagulopathy or infection, or pregnancy
Time of Intravenous Acetaminophen Administration
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Acetaminophen
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 126.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: acetaminophen; timing; arthroplasty

Summary:

      The purpose of the study is to examine the effects of timing of administration of intravenous
      (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative
      pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled
      total hip replacement under general anesthesia will be randomized into one of two arms: 1)
      the pre-closure group will receive the first dose administered upon onset of skin closure, 2)
      the preemptive group will receive the first dose administered within 60 minutes prior to
      incision. Both groups will receive subsequent doses every 6 hours x 24 hours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 30-75 years of age weighing ≥55 kg scheduled for elective total hip
             arthroplasty performed under general anesthesia will be included. As determined by the
             anesthesia team assigned to the case, eligible patients will also be assigned ASA
             physical status of I, II, or III and deemed capable of reporting their perceived pain
             using numeric pain scales and capable of operating a patient controlled anesthesia
             (PCA) device.

        Exclusion Criteria:

          -  Exclusion criteria include known allergy, hypersensitivity, or contraindication to
             acetaminophen, history of alcohol or drug abuse, prisoners, emergency THAs, patients
             with chronic malnutrition or a body mass index (BMI) < 18 kg/m2 and non-English
             speaking patients. Additional exclusion criteria include impaired liver function
             defined as AST and ALT each ≥ twice normal limits and renal dysfunction (creatinine
             >2.0 mg/dl).
Functional Magnetic Resonance Imaging (fMRI) Study of Nasal Strips in Nasal Congestion
Condition: Nasal Congestion
Intervention: Test strip; Placebo strip; Nasal spray
Intervention description: Class I device for the application to the nose to facilitate better air flow through the nose; Placebo strip; Nasal decongestant to be used on a single occasion (one spray per nostril), 20 minutes prior to commencing the third MRI scanning sessions.
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of the study is to evaluate the effect of the nasal strip (relative to the placebo
      strip) on the nasal passages using anatomical MRI scans and to demonstrate the effect of the
      strip on breathing correlated cortical activity, using interoceptive fMRI task and analysis
      techniques derived from physiological data collected during scanning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a self-rating of at least 3 to 8 for nasal congestion on the
             numerical rating scale

          -  Participants with a nasal congestion frequency score of 1, 2, 3 or 4.

        Exclusion Criteria:

          -  Evidence of obstructive nasal polyps, nasal tract structural malformations, visible
             open sores, sunburn, irritation, eczema or chronic skin condition on the face or nose

          -  Use of any medications like nasal decongestant, alpha adrenergic drugs,
             glucocorticoids and any current treatment which in the opinion of the investigator
             will affect nasal congestion

          -  Known or suspected intolerance or hypersensitivity to the study materials.
Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate
Intervention description: Different doses for both arms followed by similar escalation (2.5 mg every 15 d) till max of 25 mg per week or 3 months completed
Intervention MeSH terms: Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis; Active

Summary:

      To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in
      patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2
      weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of efficacy)
      versus the adverse effects.

      Hypothesis: There will be no difference in the adverse effects, but better and faster control
      of disease when starting with a higher methotrexate dose
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria

          -  Between 18 years to 65 year of age

          -  Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1

          -  Not on methotrexate in the last 2 months

          -  Permitted to be on corticosteroids if the dosages stable for at least 1 weeks before
             randomization and if corticosteroid dosage less than 10 mg/day

          -  Permitted to be on other disease modifying anti-rheumatic drug (DMARD) like
             sulfasalazine, leflunomide and hydroxychloroquine, if dosages stable for at least 2
             weeks before randomization

        Exclusion Criteria:

          -  Pregnant/Breastfeeding

          -  Ongoing/Recent treatment with methotrexate (2 months)

          -  Chronic liver disease

          -  Renal failure

          -  Any leucopenia or thrombocytopenia

          -  Breast-feeding

          -  Desirous of pregnancy in the next 6 months

          -  Known Hepatitis B or C positive

          -  Known clinically relevant chronic lung disease: ILD

          -  Tuberculosis or other active infections

          -  Known HIV positive
Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty
Condition: Arthritis of Hip
MeSH terms: Arthritis
Intervention: Fascia iliaca compartment block; Placebo; Bupivacaine
Intervention description: The patient will be brought to the block room within 30 minutes of arriving in recovery. An injection of local anesthetic into the fascia iliaca compartment using ultrasound guidance will be administered. The patient will then be transported back to recovery.; The patient will be brought to the block room within 30 minutes of arriving in recovery. An ultrasound probe will be placed to the skin and a blunt needle will be touched to the patient's skin in the area that a fascia iliaca compartment block would be performed. The patient will then be transported back to recovery.; A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The patients will be randomized to receive fascia iliaca blocks post-operatively or to receive a touch with a blunt needle and a bandaid post-operatively by the regional anesthesia team. Neither the patient nor the investigators will have knowledge of which group the patients belong to until the completion of the data collection.
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Total Hip Arthroplasty; Fascia Iliaca; Nerve Block; Pain Control

Summary:

      The fascia iliaca compartment block (FICB) is a regional block that anesthetizes the femoral,
      obturator, and lateral femoral cutaneous nerves around the hip. The purpose of this study is
      to determine whether FICB can reduce postoperative pain and increase progress with physical
      therapy after total hip arthroplasty (THA). This randomized, double-blind, clinical trial
      will randomize patients to receive either a FICB or placebo after THA. The primary outcomes
      will be pain scores reported by the patient post-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over the age of 18

          -  Scheduled for total hip arthroplasty at Henry Ford Hospital

          -  Epidural anesthesia during surgery

        Exclusion Criteria:

          -  Pregnancy

          -  Known intolerance to local anesthetic or narcotics

          -  Revision hip surgery
"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."
Condition: Pain
Intervention: Lidocaine Cream 4%; Placebo
Intervention description: Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure; inactive placebo without LMX4
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 0 Days
Maximum age: 60 Days
Healthy volunteers: No
Keywords: pain; lumbar puncture; neonates; infants; emergency department; topical anesthesia; LMX4

Summary:

      The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of
      infants undergoing Lumbar Puncture (spinal tap).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Full term (>=37 weeks gestation)

          -  Age 0-60 Days

          -  Undergoing Lumbar Puncture

        Exclusion Criteria:

          -  Unstable

          -  Premature (<37 weeks gestation)

          -  Allergy to study medicine

          -  Parent refusal of consent
Comparative Effectiveness of Intubating Devices in the Morbidly Obese
Condition: Obesity
Intervention: McGrath; GlideScope; Direct Macintosh Laryngoscopy; Video-Mac
Intervention description: Intubation with the McGrath device; Intubation with the GlideScope device; Intubation with Direct Macintosh Laryngoscope; Intubation with the Video-Mac device
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Direct Laryngoscopy; Video-Mac; GlideScope; McGrath; Laryngoscopy; Bariatrics; Glottic view; Airway intubating devices; Tracheal intubation

Summary:

      This prospective, randomized study will compare the effectiveness of 4 different airway
      intubating devices which are most commonly used.

      The four different devices are as follows: McGrath video laryngoscope, GlideScope video
      laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a documented body mass index (BMI) of >35.

          -  Patients scheduled to undergo inpatient surgery procedures under general anesthesia.

          -  Willingness and ability to sign an informed consent document

          -  18 - 80 years of age

          -  American Society of Anesthesiologists (ASA) Class II- III adults of either sex.

        Exclusion Criteria:

          -  Patients who are deemed to be such a significant of an airway risk that they
             necessitate awake fiberoptic intubation

          -  Patients with a history facial abnormalities, oral-pharyngeal cancer or reconstructive
             surgery

          -  Emergency surgeries

          -  Pregnancy

          -  The inability to tolerate 0.2mg of glycopyrrolate based on tachycardia.

          -  Any other conditions or use of any medication which may interfere with the conduct of
             the study.
ASCEND: A Study of Cardiovascular Events iN Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: Aspirin; Omega-3 Ethyl Esters; Placebo Aspirin; Placebo Omega-3 Ethyl Esters
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15480.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Cardiovascular Disease; Aspirin; Omega-3 fatty acids; Primary prevention; Randomized Controlled Trial; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; n-3 fatty acid

Summary:

      The purpose of this study is to determine whether 100mg daily aspirin versus placebo and/or
      supplementation with 1 gram daily omega-3 fatty acids or placebo prevents "serious vascular
      events" (i.e. non-fatal heart attack, non-fatal stroke or transient ischaemic attack, or
      death from vascular causes) in patients with diabetes who are not known to have occlusive
      arterial disease and to assess the effects on serious bleeding or other adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females with type 1 or type 2 diabetes mellitus.

          -  Aged ≥ 40 years.

          -  No previous history of vascular disease.

          -  No clear contra-indication to aspirin.

          -  No other predominant life-threatening medical problem.

        Exclusion Criteria:

          -  Definite history of myocardial infarction, stroke or arterial revascularisation
             procedure.

          -  Currently prescribed aspirin, warfarin or any other blood thinning medication.