bioihbjkbjnl/mcl2 huggingface dataset:
Nebulized 3% Hypertonic Saline Solution Treatment of Bronchiolitis in Infants
Condition: Bronchiolitis; Wheezing
MeSH terms: Bronchiolitis; Respiratory Sounds
Intervention: 0.9% Sodium Chloride; 3% Sodium Chloride
Intervention description: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.; Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 2 Months
Maximum age: 24 Months
Healthy volunteers: No
Keywords: bronchiolitis; hypertonic; saline; salbutamol

Summary:

      - Determine the efficacy of nebulized salbutamol/hypertonic saline combination in moderate to
      severe bronchiolitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All pediatric patients aged 2 months to 24 months of age, both genders attending the
             pediatric emergency service.

          -  With first episode of wheezing associated with respiratory distress and a history of
             upper respiratory tract infection.

          -  You have the evaluation of respiratory difficulty with Scale Hospital Sant Joan de Deu
             (HSJD) from 6 to 16 at entry points (moderate and severe degree).

        Exclusion Criteria:

          -  Subjects with a history of previous wheezing, asthma, or who have received
             bronchodilator treatment before the present illness.

          -  Subjects with chronic lung disease, with heart disease, with congenital or acquired
             anatomic abnormalities of the airway.
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
Condition: Spinal Fusion Acquired; Spinal Stenosis; Lesions of Lumbosacral Intervertebral Disc; Spinal Diseases
MeSH terms: Spinal Stenosis; Spinal Diseases
Intervention: Dexmedetomidine; 0.9% Saline
Intervention description: Patients will be given 0.7 mcg/kg/hr of dexmedetomidine over the first hour of surgery, followed by continuous infusion of 0.5 mcg/kg/hr of dexmedetomidine for the next 2 hours of surgery. Dexmedetomidine dose will be reduced to 0.2 mcg/kg/hr for the duration of the procedure and continued at that rate for four hours postoperatively. Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.; Patients in the placebo arm will receive an equal per-kg IV volume of 0.9% Sodium Chloride over the same periods. Drug administration will be controlled for both arms of the study using a continuous infusion pump.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Lumbar Fusion; Inflammation; Dexmedetomidine; Length of Hospital Stay; General Anesthesia; Anti-inflammatory; GPCR; Cytokine; Immune Response

Summary:

      Major lumbar spine surgery causes inflammation, soreness and swelling that can delay
      discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory
      effects. This study will evaluate whether DEX can help get patients out of the hospital
      faster after major spine surgery by reducing the inflammation associated with the procedure
      itself. A separate part of the study will evaluate the blood levels of some specific
      indicators of inflammation called cytokines. Measuring cytokines before and after surgery
      will aid in determining if DEX has altered the inflammatory response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) Classification I - III

          -  Scheduled for Open Posterior Lumbar Fusion over 3+ (bony) levels

        Exclusion Criteria:

          -  Allergy to dexmedetomidine

          -  Cardiac disease with reduced ejection fraction < 30%

          -  History of cirrhosis, active hepatitis or attenuated hepatic function

          -  Chronic use of steroids, COX-2 inhibitors, alpha-2 agonists, or statins

          -  Current anticoagulant therapy

          -  Patients requiring motor evoked potential (MEP) monitoring

          -  Positive pregnancy test
Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart
Intervention description: Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin)
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe.

      This is a clinical trial investigating the effectiveness and the safety of using biphasic
      insulin aspart 30 both for initiation and intensification of insulin treatment in type 2
      diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 Diabetes Mellitus for more than 12 months

          -  HbA1c: 7.5 - 11.0%

          -  An antidiabetic regimen that has been stable for at least 3 months prior to screening

          -  An antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (OADs)
             or 1 OAD plus evening or bedtime basal insulin

          -  OADs dosed at 50% or more of the maximum recommended dose

        Exclusion Criteria:

          -  Use of any insulin preparations other than NPH or glargine within the past 6 months

          -  Use of more than 60 units of insulin per day

          -  Morning time insulin administration

          -  Use of more than one insulin dose daily
Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
Condition: Fatty Liver
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Glucophage (Metformin); Placebo
Intervention description: metformin XR 2000 mg daily for 12 months; placebo 2000 mg daily for 12 months
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: nonalcoholic fatty liver disease

Summary:

      The purpose of this study is to find out if Metformin is safe and useful in the treatment of
      NAFLD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  biopsy-proven NAFLD, determined within 12 months of study initiation

        Exclusion Criteria:

          -  > 20 grams of alcohol/day

          -  impaired oral glucose tolerance test

          -  known diagnosis of diabetes mellitus

          -  hepatitis C infection

          -  cirrhosis
Fibrinolysis Before Cardiopulmonary Bypass?
Condition: Pathologic Fibrinolysis
Intervention: Epsilonaminocaproic acid; Placebo
Intervention description: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.; Placebo administered in same volume as in experimental arm.
Intervention MeSH terms: Aminocaproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac surgery; cardiopulmonary bypass; fibrinolysis; thromboelastography; D-Dimers; antifibrinolytic agents

Summary:

      It is common practice to use antifibrinolytic agents before and during cardiopulmonary
      bypass. They are not without side effects. The investigators want to show that there is no
      proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary
      bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult patients, undergoing first time sternotomy for Coronary artery bypass
             grafting/Aortic valve replacement/aortic surgery

        Exclusion Criteria:

          -  Resternotomy, renal insufficiency, deep hypothermia, age < 18 yrs
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
Condition: Distal Femur Fractures
MeSH terms: Fractures, Bone; Femoral Fractures; Femoral Fractures, Distal
Intervention: DLS 5.0 (Dynamic locking screws); SLS (Standard locking screw)
Intervention description: Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0; Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 5.0
Sex: All
Minimum age: 21 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Femoral fracture; Periprosthetic fracture; Fracture fixation, internal; Distal femur fractures; Dynamic Locking Screw; WOMAC

Summary:

      The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used
      to stabilize the shaft component of distal femur fractures in comparison to standard locking
      screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC
      score) due to increased and more symmetrical callus formation and fewer non-unions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21 years and older

          -  Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur
             fractures above a total knee arthroplasty

          -  Ability to walk independently prior to injury

          -  Eligible for treatment with ORIF of the distal femur with a large fragment locking
             plate (LISS, LCP)

          -  Willing and able to comply with post-operative protocol and return for follow-up.

          -  Ability to understand the content of the patient information / informed consent form
             and participate in the clinical investigation

          -  Signed informed consent

        Exclusion Criteria:

          -  Additional ipsi- or contralateral lower extremity fracture

          -  Any kind of implant at the ipsilateral proximal femur

          -  Pre-existing malunion or nonunion of the ipsilateral lower extremity

          -  Segmental bone defect requiring bone grafting

          -  More than 4 weeks between injury and surgery

          -  Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis)

          -  Polytrauma

          -  Active malignancy

          -  Any not medically managed severe systemic disease

          -  Recent history of substance abuse (ie, recreational drugs, alcohol) that would
             preclude reliable assessment

          -  Pregnancy or women planning to conceive within the study period

          -  Prisoner

          -  Participation in any other medical device or medicinal product study within the
             previous month that could influence the results of the present study
Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction
Condition: Oocyte Retrieval; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Fentanyl; Acetaminophen; Oxycodone
Intervention description: 0.5, 1 mcg/kg; Single + Oxycodone; With Acetaminophen
Intervention MeSH terms: Acetaminophen; Fentanyl; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Assessment of immediate and delayed postoperative pain
Masking: None (Open Label)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: assisted reproduction; postoperative pain; opioid

Summary:

      The central objective of this study will be to evaluate the relationship between estrogen
      levels and the pain following oocyte retrieval in women undergoing in vitro fertilization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) I to III health status (moderate systemic
             disease),

          -  Age between 18 and 50 yrs

          -  Undergoing oocyte retrieval with intravenous general anesthesia.

        Exclusion Criteria:

          -  Refuse or withdraw their consent

          -  Fail to adequately respond to IVF stimulations medications, and thus are not eligible
             for oocyte retrieval.
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: HX575 recombinant human erythropoietin alfa
Intervention description: HX575 epoetin alfa i.v. will be administered according to the SmPC
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1695.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CKD subjects with or without dialysis treatment

Summary:

      Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of
      relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney
      Disease (CKD) subjects receiving HX575 epoetin alfa i.v.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CKD subjects with or without dialysis treatment

          -  Age over 18 years

          -  Subjects requiring i.v. ESA treatment

          -  Subjects likely to remain on i.v. ESA treatment for 6 months

          -  Provision of informed consent -

        Exclusion Criteria:

          -  Systemic immunosuppressive medication or any other drugs known to adversely affect the
             hemoglobin level

          -  Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant
             erythropoietin product

          -  History of PRCA or aplastic anemia

          -  History of anti-erythropoietin antibodies

          -  Uncontrolled hypertension

          -  Pregnant woman or nursing mother

          -  Women of childbearing potential do not agree to maintain effective birth control
             during the study treatment period.
Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery
Condition: Cystoid Macular Edema
MeSH terms: Cataract; Macular Edema; Edema
Intervention: Standard Care; nepafenac
Intervention description: topical antibiotic for 10 days plus topical corticosteroids for 1 month; liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid
Intervention MeSH terms: Nepafenac
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: cystoid macular edema; cataract; nonsteroidal antiinflammatory drugs; optical coherence tomography

Summary:

      Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative
      cystoid macular edema following uncomplicated cataract surgery

      Participants: Patients having cataract surgery at UNC who meet eligibility criteria

      Procedures (methods): Patients will have pre and post-operative vision measured and optical
      coherence tomography (OCT) testing, also cataract density and intraoperative
      phacoemulsification parameters including ultrasound power and ultrasound time will be
      measured. Patients will be randomized into two groups. Group 1 will be treated with standard
      post-operative cataract management. Group 2 will be treated with standard post-operative
      cataract management plus topical nepafenac for one month. Post-operative macular thickness
      will be studied by analyzing the visual acuity and OCT measurements at two months post
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  over age 50

          -  having cataract surgery at UNC

        Exclusion Criteria:

          -  medically controlled diabetes

          -  history of intraocular surgery

          -  abnormal pre-op optical coherence tomography scan

          -  history of ocular inflammation

          -  have age related macular degeneration
Efficacy and Acceptability of Two Lubricant Eye Drops
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Intervention: Lubricant Eye Drops (Optive™); Lubricating Eye Drops (blink® Tears)
Intervention description: 1 drop in both eyes as needed for 7 days'; 1 drop in both eyes as needed for 7 days
Intervention MeSH terms: Ophthalmic Solutions; Lubricant Eye Drops
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Efficacy and acceptability of two new artificial tears following two weeks of treatment in
      patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then
      crossover to the alternate treatment for 7 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female

          -  At least 18 years of age

          -  Current use of artificial tears

        Exclusion Criteria:

          -  Any uncontrolled systemic disease

          -  Pregnancy or planning a pregnancy

          -  Contact lens wear
Anti-hypertensive Medication Dosing Regimen in Effective Blood Pressure Control
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Anti-hypertensive Medication -
Intervention description: Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.
Dosing regimen either in the morning (between 06.00 and 11.00) or in the evening (between 18.00 and 23.00).
Intervention MeSH terms: Antihypertensive Agents; Calcium Channel Blockers; Angiotensin II; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Renin Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hypertension

Summary:

      A randomised crossover trial of anti-hypertensive medication dosing regimen in effective
      blood pressure control.

      To investigate whether there is a difference in 24 hour blood pressure (BP) control when
      antihypertensive medications are taken in the morning compared with the evening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Caucasian patients aged 18-80 years;

          -  History of any grade of hypertension for at least 1 year, including at least 3 months
             of constant antihypertensive medication (consisting of ≥ 1 antihypertensive drugs,
             each administered in one dose daily), with reasonably controlled BP (≤150/90 mmHg and
             ≥ 115/75 mmHg on usual medication) based on previous clinic records, in the last 3
             months.

        Exclusion Criteria:

          -  BP levels > 150/90 mmHg or < 115/75 mmHg in the last 3 months.

          -  Postural hypotension, defined as symptoms resulting from a > 20 mm Hg drop of systolic
             BP or a > 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing
             from the sitting position.

          -  Known Extreme dippers at baseline (fall of mean night time SBP > 20% of mean day time
             SBP)

          -  Individuals with jobs which require night-time shift work.

          -  Pregnant women or those planning to become pregnant.
Intra-articular Local Anesthetic Injection and Hematoma Aspiration
Condition: Tibial Fractures
MeSH terms: Hematoma; Tibial Fractures
Intervention: Aspiration; Bupivacaine
Intervention description: A needle is placed into the knee joint and all of the blood that is in the joint is removed.; An injection of 20cc bupivacaine 0.5% with 1:200,00 epinephrine
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to receive aspiration of the joint alone, receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine, or receive no injection or aspiration therapy
Masking: Single (Participant)
Masking description: This study uses a single blind masking scheme
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Aspiration; Bupivacaine; Epinephrine; Marcaine; Pain; Shin Bone

Summary:

      The primary objective of this study is to determine whether a patient with a tibial plateau
      fracture (non-displaced, displaced, or depression type) will have decreased pain and narcotic
      analgesia requirements following an intra-articular injection of local anesthetic and
      aspiration of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with isolated tibial plateau fractures aged 18 years and older

          -  Patients with tibial plateau fractures and associated soft tissue complaints about the
             knee, not associated with a fracture outside of the tibial plateau

          -  Patients with bilateral tibial plateau fractures and no other noted fractures

        Exclusion Criteria:

          -  Any patient that does not wish to participate in the study or is unable to give
             consent at the initial encounter

          -  Patients under 18 years old

          -  Pregnant patients

          -  Patients who are unable to understand the study procedures

          -  Incarcerated patients

          -  History of allergic reaction to local anesthetics

          -  Emergent conditions requiring operations or airway protection

          -  Polytrauma patients

          -  Patients presenting for care greater than 24 hours following their injury.