bioihbjkbjnl/mcl2 huggingface dataset:
A Study on the Safety of Tranexamic Acid for the Chronic Subdural Hematoma Population
Condition: Subdural Hematoma
MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
Intervention: Tranexamic Acid
Intervention description: 1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
Intervention MeSH terms: Tranexamic Acid
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: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This is a single center single arm study of 50 patients to 1) determine the safety of
      tranexamic acid in the chronic subdural hematoma population following surgical drainage of
      chronic subdural hematomas and 2) determine if the use of oral tranexamic acid reduces the
      rate of ipsilateral recurrence following drainage of chronic subdural hematomas. This will be
      compared to historical controls. This study intends to be a prerequisite to a large
      nationally funded randomized control trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all patients undergoing intervention for chronic subdural hematoma (cSDH) including
             drainage

          -  cSDH will be defined as hematoma on CT imaging that is predominantly iso- to hypodense
             to brain

          -  18-85 years of age

        Exclusion Criteria:

          -  cSDH not requiring surgical drainage

          -  patients undergoing bedside twist drill craniostomy

          -  medically unstable for surgery

          -  patients requiring long-term anticoagulation (unable to stay off for less than 30
             days)

          -  patients not expected to survive to the completion of followup

          -  patients comatose prior to the initiation of treatment

          -  history of thromboembolic problem including stroke, myocardial infarction, deep vein
             thrombosis and/or pulmonary embolism

          -  pregnant

          -  minor

          -  allergy/sensitivity to tranexamic acid

          -  irreversible coagulopathy

          -  known clotting disorder

          -  bilateral hematomas with both requiring drainage

          -  incarcerated

          -  any patient not judged suitable for the study by the investigators

          -  women who are taking combination hormonal contraception
Efficacy of Losartan in Preventing Progression of COPD
Condition: COPD; Emphysema; Chronic Bronchitis; Smoking
MeSH terms: Bronchitis; Bronchitis, Chronic; Pulmonary Emphysema; Emphysema
Intervention: Losartan; Placebo
Intervention description: Losartan 100 mg daily; Placebo pill daily
Intervention MeSH terms: Losartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; emphysema; angiotensin receptor blocker

Summary:

      Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage
      due to smoking. The goal of this study is to determine whether this drug which is also used
      to treat hypertension can stabilize or improve lung function in people who have from chronic
      obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with COPD who are either active or former smokers

        Exclusion Criteria:

          -  Clinical requirement or history of intolerance of angiotensin receptor blockers,
             serious heart, liver, kidney, neurological disease.
Dynamic Hyperinflation and Tiotropium
Condition: COPD
Intervention: Placebo
Intervention description: Procedure/Surgery - tiotropium 18ug capsule daily for 1 month vs placebo to study the effect of trough and peak effect on bronchodilation and effect of metronome paced hyperventilation induced dynamic hyperinflation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      We will detect dynamic hyperinflation (DH) in 40 COPD (chronic obstructive pulmonary disease)
      patients with moderately severe disease using metronome paced hyperventilation (MPH) with
      inspiratory capacity as the primary end point. Hypothesis: Is tiotropium capable of lung
      volume protecting inspiratory capacity from MPH induced DH vs placebo in a randomized
      crossover double blinded study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderately severe COPD patients age 40-85 yr with post 180ug albuterol FEV 1 between
             60 and 79% predicted and FEV 1/FVC < 70%.

          -  Smoking history > 10 pack yr.

          -  Clinically stable X 6 weeks.

          -  No oxygen usage.

        Exclusion Criteria:

          -  History of asthma

          -  Clinically unstable

          -  Any other significant medical problem precluding full cooperation for study
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]; ribavirin [Copegus]
Intervention description: standard treatment, subcutaneously weekly; standard treatment, orally daily
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1013.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multi-center study will evaluate the viral response in patients with chronic hepatitis
      C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a)
      and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral
      Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients identified as
      slow responders/non-rapid virological responders will be eligible for an additional 24 weeks
      of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody
             test

          -  Documented pre-treatment HCV RNA quantitative result

          -  Compensated liver disease (Child-Pugh Grade A)

          -  Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and
             Copegus (ribavirin)

        Exclusion Criteria:

          -  Decompensated liver disease (Child-Pugh Class B or C cirrhosis)

          -  Co-infection with active hepatitis A and/or hepatitis B

          -  History or evidence of a medical condition associated with liver disease other than
             HCV

          -  Signs and symptoms of hepatocellular carcinoma

          -  History of poorly controlled thyroid disease, elevated TSH or any clinical
             manifestations of thyroid disease

          -  Therapy with antineoplastic treatment </= 6 months prior to study day

          -  Diabetes mellitus in subjects receiving an insulin therapy

          -  Evidence of severe retinopathy

          -  Pregnant or breast-feeding women, and male partners of women who are pregnant
Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Intervention: 7-day quadruple therapy; 10-day sequential therapy; 7-day standard triple therapy
Intervention description: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days; pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days; pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Pantoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 307.0
Sex: All
Minimum age: 20 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Helicobacter pylori infection

Summary:

      To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day
      quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected
      patients were randomly assigned to a 7-day standard triple therapy (pantoprazole,
      clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and
      amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a
      further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and
      metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter
      pylori eradication rates between three groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consecutive H. pylori-infected outpatients, at least 20 years of age, with
             endoscopically proven peptic ulcer diseases or gastritis

        Exclusion Criteria:

          -  previous H. pylori-eradication therapy

          -  ingestion of antibiotics, bismuth, or proton pump inhibitors within the prior 4 weeks

          -  patients with allergic history to the medications used

          -  patients with previous gastric surgery

          -  the coexistence of serious concomitant illness (for example, decompensated liver
             cirrhosis, uremia)

          -  pregnant women
Eovist vs. Dotarem Healthy Volunteer MRI
Condition: Transient Severe Arterial Phase Motion
Intervention: gadoxetate disodium; gadoterate dimeglumine; Saline
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate changes in volunteer breath-holding capacity in
      response to gadoxetate disodium (Eovist) administration, compared with saline, and gadoterate
      dimeglumine (Dotarem). Healthy volunteers will be recruited from three study sites. These
      subjects will be given three, blinded, randomized injections while undergoing an MRI of their
      liver and holding their breath. During the scan, the subjects' oxygen saturation and heart
      rate will be closely monitored. Following the scan, the subjects will complete a
      questionnaire regarding the breath hold.
    

Eligibility criteria:

        Inclusion Criteria:

        - normal renal function (serum eGFR >60)

        Exclusion Criteria:

          -  renal impairment

          -  allergy to gadolinium-based contrast

          -  metallic implanted devices

          -  claustrophobia

          -  pregnant and lactating females
A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy
Condition: Colonoscopy
Intervention: Miralax (PEG 3350); Amitiza (Lubiprostone); Dulcolax (Bisacodyl); Golytely (polyethylene glycol)
Intervention description: Miralax 255gm bottle; Amitiza 24mcg gelcap; Bisacodyl 5mg tab x2; Golytely 1 gallon
Intervention MeSH terms: Bisacodyl; Polyethylene glycol 3350; Lubiprostone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Efficacy of bowel cleansing; Patient tolerability; Amitiza; Dulcolax; Miralax; Colonoscopy preparation; Bowel preparation; Screening colonoscopy

Summary:

      Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to
      colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel
      cleansing regimen in adults and to determine the benefit of adding a pretreatment medication
      to this bowel preparation. The tolerability of Miralax will hopefully improve patient
      satisfaction with colonoscopy and decrease their reluctance to be screened because of the
      uncomfortable taste and side effects of bowel preparation regimens.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients referred to our clinic for average or increased risk screening for
             colorectal cancer

        Exclusion Criteria:

          -  elevated serum creatinine (Men >1.4mg/dL, Women >1.3mg/dL)

          -  previous diagnosis of congestive heart failure

          -  history of bowel obstruction

          -  history of solid organ transplant

          -  current pregnancy

          -  lactating mother

          -  participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza),
             or bisacodyl (Dulcolax)
Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: tiotropium inhalation; salmeterol xinafoate; fluticasone propionate; placebo matched for fluticasone propionate
Intervention MeSH terms: Fluticasone; Xhance; Tiotropium Bromide; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2488.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This is a randomised study to be conducted in patients with severe to very severe Chronic
      Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients
      to be continuously treated with an inhaled corticosteroid on top of two potent long-acting
      bronchodilators. The study also aims to identify the type of patients who are likely to
      benefit from inhaled corticosteroid maintenance therapy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Male or female aged 40 years or more

          2. Severe to very severe chronic obstructive pulmonary disease (COPD)

          3. Current or ex-smoker with smoking history of at least 10 pack years

          4. At least one documented exacerbation of COPD in previous year

        Exclusion criteria:

          1. Significant diseases other than COPD; significant alcohol or drug abuse

          2. Current clinical diagnosis of asthma requiring steroid treatment

          3. History of thoracotomy with pulmonary resection

          4. Regular use of daytime oxygen

          5. Recent history (within 3 months) of myocardial infarction

          6. Recent (within 6 weeks) respiratory infection or COPD exacerbation

          7. Recent (within 6 weeks) treatment with systemic corticosteroids at doses in excess of
             5milligram / day

          8. Recent (within 3 months) unstable or life-threatening cardiac arrhythmia requiring
             intervention

          9. Recent (within 1 year) hospitalisation for cardiac failure

         10. Malignancy requiring chemotherapy or radiotherapy

         11. Clinical diagnosis of bronchiectasis

         12. Pregnant or nursing women

         13. Known hypersensitivity to study drugs

         14. Current or recent (within 30 days) participation in another clinical study

         15. Current participation in or recent completion (within 4 weeks) of a pulmonary
             rehabilitation program
Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Condition: Acute Bacterial Skin and Skin Structure Infections
MeSH terms: Infections; Communicable Diseases; Skin Diseases, Bacterial
Intervention: Usual Care; Dalbavancin
Intervention description: Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.; Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
Intervention MeSH terms: Dalbavancin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Critical Pathways; Health Facilities; Clinical Protocols; Patient Satisfaction; Absenteeism; Anti-Bacterial Agents; Quality of Life; Economics, Medical; Health Resources; Health resource utilization; Acute bacterial skin and skin structure infection (ABSSSI)

Summary:

      This study will evaluate a new critical pathway (use of guideline-based patient
      identification criteria and for those who meet these criteria, use of dalbavancin) for the
      treatment of ABSSSI compared to usual care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presents to the Emergency Department (ED) and meets the clinical definition for Acute
             Bacterial Skin and Skin Structure Infections (ABSSSI)

          -  Known or suspected gram-positive infection.

        Exclusion Criteria:

          -  Known or suspected gram-negative infections, anaerobic infections, or fungemia

          -  Known or suspected infections that are severe, life threatening or are not included in
             the ABSSSI Food and Drug Administration (FDA) guidance

          -  Injection drug users with a fever

          -  Severe neurological disorder leading to immobility or confined to a wheelchair

          -  Bilateral Lower extremity involvement of the suspected infection.
Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever
Condition: Fever
MeSH terms: Fever
Intervention: Acetaminophen; Ibuprofen
Intervention description: Given for fever control 15mg/kg; Given for fever control 10 mg/kg
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 6 Months
Maximum age: 7 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: fever treatment; children

Summary:

      Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen
      (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter
      use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to
      determine whether giving both medications together is better than giving one medication alone
      for the treatment of fever.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 6 months - 7 years of age at time of the fever.

          -  Initial temperature of 38.0C (100.4F) or more.

          -  Ability to cooperate with serial temporal artery temperature measurements.

          -  Ability to take medications by mouth.

          -  Willingness of the child's guardian/sponsor to give informed consent

        Exclusion Criteria:

          -  Patients who have received acetaminophen within 6 hours of presentation, or ibuprofen,
             aspirin, or other non-steroidal anti-inflammatory medications within 8 hours of
             presentation.

          -  Patients >=3 years of age that have received narcotics in the previous 24 hours.

          -  Children with weight >60 kg. Treatment of children with weights >60 kg will result in
             greater than recommended adult doses of the medications.

          -  History of adverse reaction to any study medication ingredient.

          -  History of diabetes mellitis, renal dysfunction, hepatic dysfunction, or
             thrombocytopenia.

          -  Presence of moderate or severe dehydration.

          -  Inclusion in the trial on 3 previous occasions

          -  Medical judgment that the severity of the underlying illness prohibits inclusion.
Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children
Condition: Moderate, Deep Sedation
Intervention: Ketamine IV 1mg/kg; Ketamine IV 1.5mg/kg; Ketamine IV 2mg/kg
Intervention description: Intervention: Ketamine IV 1mg/kg; Intervention: Ketamine IV 1.5 mg/kg; Intervention: Ketamine IV 2 mg/kg
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 182.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Procedural sedation; ketamine; children

Summary:

      There is a wide variation of published IV ketamine dosing regimens used for procedural
      sedation in children in the Emergency Department (ED). The purpose of the study was to
      compare the efficacy, duration of sedation and adverse events between the three commonly
      administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional
      administration method of 30-60 second infusion for ED sedation in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 3 -18 years of age

          -  Belonging to American Society of Anesthesiologists (ASA) classification 1 or 2

          -  Receiving IV ketamine for procedural sedation for orthopedic procedures,

          -  Incision and Drainage of skin abscess and laceration repair

        Exclusion Criteria:

          -  Contraindications to use of Ketamine

          -  Parents or legal guardian not available or declined to provide informed consent

          -  Child declined to provide assent,

          -  Patients that received intramuscular ketamine,

          -  Patient that received benzodiazepines in addition to ketamine

          -  Children weighing >100 kilogram

          -  Children with developmental disabilities.