bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery
Condition: Nasal Polyps
MeSH terms: Nasal Polyps
Intervention: Remifentanil; Tramadol; Metoprolol
Intervention description: Remifentanil infusion will be started with a bolus dose of 0.5 µg/kg before the induction, and will be continued throughout the surgery at a dose of 0.25-0.5 µg/kg/min. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.; 1 mg/kg tramadol will be added to 100 ml of isotonic fluid, and will be administered intravenously in exactly 30 minutes via a perfusor. The infusion will be started just before the induction.; 0.1 mg/kg of metoprolol will be administered intravenously within 5 minutes following the administration of neuromuscular blocking agent.
Intervention MeSH terms: Metoprolol; Remifentanil; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug: remifentanil; Drug: tramadol; Drug: metoprolol; Functional endoscopic sinus surgery; Controlled hypotension

Summary:

      Functional endoscopic sinus surgery (FESS) is indicated in diseases such as chronic sinusitis
      refractory to medical treatment, nasal polyposis, mass lesions in the nasal cavity. The
      purpose of this study is to determine whether tramadol and metoprolol are as effective as
      remifentanil in providing controlled hypotension during FESS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of rhinosinusitis

          -  indication for functional endoscopic sinus surgery

        Exclusion Criteria:

          -  American Society of Anesthesiologists risk score > 2

          -  undertreated hypertension

          -  Haemoglobin A1c test level > 7.5

          -  pregnancy

          -  concurrent surgery

          -  history of drug abuse

          -  history of or new diagnosis of allergy to any of the study drugs

          -  history of post-operative nausea and vomiting
Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Intervention: Dexamethasone; Placebo
Intervention description: 8mg IV dexamethesone given; Subjects randomized to placebo receive 50cc normal saline
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: Female
Minimum age: 18 Years
Maximum age: 46 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cesarean section; nausea; vomiting; dexamethasone; postoperative nausea and vomiting; antiemetics

Summary:

      Patients who present for scheduled (non-emergent) cesarean section will be given either
      intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal
      anesthetic. The investigators will then compare the incidence of nausea and vomiting and the
      use of rescue anti-nausea medications in both groups. Our hypothesis is that patients
      receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section
      will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours
      following surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18-46 presenting for scheduled primary or repeat cesarean sections and have
             consented to study

        Exclusion Criteria:

          -  allergy to dexamethasone or morphine

          -  history of gastrointestinal disease

          -  history of severe nausea during pregnancy (hyperemesis gravidarum)

          -  use of anti-emetic in the past 24 hours

          -  history of gestational diabetes or diabetes mellitus

          -  history of hypertension prior to or during pregnancy

          -  presence of non-viable fetus
Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation
Condition: Intubation Complication
Intervention: Etomidate; Ketamine
Intervention description: Etomidate will be administered as the sedative for RSI on even days; Ketamine will be administered as the sedative for RSI on odd days
Intervention MeSH terms: Ketamine; Etomidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 428.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rapid Sequence Intubation; Hemodynamics; Etomidate; Ketamine

Summary:

      The purpose of this study is to compare the hemodynamic effects of ketamine v etomidate
      during rapid sequence intubation (RSI) in the pre-hospital and emergency department setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persons greater than 18yrs requiring rapid sequence intubation for any reason.

        Exclusion Criteria:

          -  Pregnant patients

          -  Children under the age of 18

          -  Patients with a known hypersensitivity to etomidate or ketamine
Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: Dotarem; Gadovist
Intervention description: DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus; Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus
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: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MRA-Contrast agent comparison in peripheral disease

Summary:

      This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography
      (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal
      or lower limb arterial diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged ≥ 18 years.

          -  Patient with infrarenal aorta or chronic lower limb ischemia with various clinical
             signs of gravity (stages II-IV according to the classification of Leriche and
             Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb
             arteriopathy.

          -  Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital
             Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of
             at least 24 hours between the 2 examinations.

        Exclusion Criteria:

          -  Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels
             between the time of MRA and X-ray Angiography will be performed.

          -  Patient who had a major cardiovascular event within 30 days prior to the inclusion.

          -  Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or
             stent.
Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis
Condition: Iron Deficiency Anemia Treatment; Chronic Kidney Disease(CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferumoxytol; Iron Sucrose
Intervention description: IV Ferumoxytol; IV Iron Sucrose
Intervention MeSH terms: Ferrosoferric Oxide; Ferric Oxide, Saccharated
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia (IDA); chronic kidney disease (CKD); hemodialysis; magnetic resonance imaging (MRI); ferumoxytol; Feraheme

Summary:

      The objectives of this study are to compare the efficacy and safety of repeat doses of
      intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with
      hemodialysis-dependent CKD.
    

Eligibility criteria:

        Key Inclusion Criteria include:

          1. Males and females ≥18 years of age

          2. Diagnosis of CKD

          3. Subjects on dialysis must have been on dialysis for at least 3 months prior to
             screening

          4. Female subjects of childbearing potential who are sexually active must be on an
             effective method of birth control for at least 1 month prior to screening and agree to
             remain on birth control until completion of participation in the study

        Key Exclusion Criteria include:

          1. History of allergy to either oral or IV iron

          2. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3
             months postpartum, or have a positive serum or urine pregnancy test

          3. Parenteral iron therapy within 30 days prior to screening or red blood cell
             (RBC)/whole blood transfusion within 14 days prior to screening or planned during the
             study
Head to Head Study of Anti-VEGF Treatment.
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: ranibizumab; Conbercept
Intervention MeSH terms: Ranibizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Healthy volunteers: No
Keywords: Age-related macular degeneration,; ranibizumab,; conbercept,; plasma VEGF; PK

Summary:

      An exploratory single site, open label, randomized, controlled study evaluated plasma
      vascular endothelial growth factor levels after intravitreal injection of ranibizumab
      (Lucentis) and conbercept (Langmu) for neovascular age-related macular degeneration
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent must be obtained before any assessment is performed.

          2. Male or female patient ≥ 50 years of age.

          3. Subfoveal CNV secondary to nAMD.

          4. BCVA score must be between 73 and 24 letters as measured by ETDRS chart

        Exclusion Criteria:

        For both eyes

          1. Any active periocular or ocular infection or inflammation

          2. Uncontrolled glaucoma

          3. Neovascularization of the iris or neovascular glaucoma. For study eye

          4. Choroidal neovascularization of any other cause than wet AMD

          5. Ocular disorders present that may confound interpretation of study results,

          6. Previous treatment with verteporfin PDT (Visudyne®), external-beam radiation therapy,
             focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary
             thermotherapy.

          7. Structural damage within 0.5 disc diameter of the center of the macula

          8. Atrophy or fibrosis involving the center of the fovea.

          9. Inability of obtaining required lab report. Ocular medical history

         10. History of intravitreal injection with any anti-VEGF drugs within 3 months. Exclusion
             criteria for systemic medical conditions and treatment

         11. Any type of systemic disease or its treatment

         12. Any patients diagnosed with tumor.

         13. Stroke or myocardial infarction less than 3 months.

         14. Known hypersensitivity to indocyanine green, fluorescein, or any component of the
             investigational drug formulation.

         15. Use of any systemic anti-VEGF drugs within 6 months. Exclusion criteria for patient

         16. Patients who have participated in other investigational drug study within 60 days.

         17. Pregnant or nursing (lactating) women.

         18. Inability to comply with study or follow-up procedures.
Counseling for Primary Care Office-based Buprenorphine
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Manual-guided Physician Management (PM); Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)
Intervention description: Manual-guided Physician Management (PM) PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services.; CBT is provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Buprenorphine adherence.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Buprenorphine; Buprenorphine/naloxone; Counseling; Primary care

Summary:

      The major goal is to determine whether adding cognitive behavioral therapy to physician
      management will increase the efficacy of buprenorphine/naloxone treatment in an office-based
      primary care setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  opioid dependence

        Exclusion Criteria:

          -  current dependence on alcohol, cocaine, benzodiazepines or sedatives

          -  current suicide or homicide risk

          -  current psychotic disorder or untreated major depression

          -  inability to read or understand English

          -  life-threatening or unstable medical problems
Nicotine Gum Recovery After Colorectal Surgery
Condition: Post-operative Ileus
MeSH terms: Ileus
Intervention: Nicotine gum; Regular chewing gum
Intervention description: Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first; Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: ILEUS

Summary:

      The purpose of this study is to evaluate whether the use of nicotine gum in the postoperative
      period influences surgical outcome in patients undergoing colorectal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to freely give written informed consent to participate in the study and have
             signed the Informed Consent Form;

          -  Due to undergo small and/or large partial bowel resection via laparotomy or
             laparoscopy;

        Exclusion Criteria:

          -  Prior intestinal surgery

          -  Mentally incompetent or unable or unwilling to provide informed consent or comply with
             study procedures

          -  American Society of Anesthesiologists (ASA) Class IV or V;

          -  History of abdominal carcinomatosis;

          -  History of radiation enteritis;

          -  Children < 18 or adults > 85 years of age

          -  Pregnant women

          -  Current cigarette, cigar smokers and chewers of tobacco. ex smokers who quit less than
             3 months ago.

          -  Patients requiring postoperative ventilation, pressor requirement or ICU stay

          -  Patients with prior cardiovascular disorders
Pharmacokinetics of Amlodipine Besylate at Delivery and During Lactation
Condition: Chronic Hypertension in Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Intervention: Amlodipine besylate
Intervention description: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.
Intervention MeSH terms: Amlodipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Amlodipine besylate; Breast milk; Pharmacokinetics; Chronic hypertension; Pregnancy

Summary:

      This is a phase IV prospective trial to collect and analyze information about the maternal
      pharmacokinetics of amlodipine besylate at the time of delivery and during postpartum
      lactation. The study will also evaluate amlodipine concentrations in the infants of
      breastfeeding mothers who are taking amlodipine besylate for treatment chronic hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older;

          -  Pregnant female

          -  Already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy;

          -  Hospitalized following routine term vaginal delivery or uncomplicated cesarean
             delivery

          -  Breastfeeding or breast and bottle-feeding their infant

        Exclusion Criteria:

          -  Known kidney disease

          -  Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage

          -  Administration of greater than 5 mg of amlodipine in 24 hour period
PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial
Condition: Portopulmonary Hypertension
MeSH terms: Hypertension
Intervention: Macitentan; Placebo
Intervention description: Macitentan film-coated tablet 10 mg once daily.; Matching placebo tablet once daily.
Intervention MeSH terms: Macitentan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      24-week study to evaluate the efficacy and safety of macitentan for the treatment of
      portopulmonary hypertension.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Male or female of at least 18 years of age

          -  Confirmed diagnosis of portopulmonary hypertension

        Main Exclusion Criteria:

          -  Severe hepatic impairment

          -  Severe obstructive or restrictive lung disease

          -  Pulmonary veno-occlusive disease

          -  Systolic blood pressure (SBP) < 90 mmHg at Screening

          -  ALT/AST >= 3 x ULN

          -  Bilirubin >= 3 mg/dL at Screening

          -  Any known factor or disease that might interfere with treatment compliance, study
             conduct, or interpretation of results
LIPT - Liraglutide in Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Cardiovascular Disease
MeSH terms: Polycystic Ovary Syndrome; Cardiovascular Diseases; Syndrome
Intervention: Liraglutide for 26 weeks; placebo
Intervention description: GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks; Placebo s.c. daily for 26 weeks
Intervention MeSH terms: Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated
      with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.

      The study investigates the effect af intervention with GLP-1-analog on risk markers of
      cardiovascular disease in women with PCOS.

      70 women will be included in af RCT.

      Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a
      beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PCOS

          -  >18 years

          -  premenopausal

          -  BMI >25 og 25 and thereunder + insulin resistent

        Exclusion Criteria (including):

          -  actualt or intended pregnancy

          -  inadeqvat contraception

          -  hormonal contraception within 6 weeks

          -  metfoomin, GLP-1-analog or DPP IV inhibitor within 3 months

          -  medications affectiv hemostatic mechanisme

          -  diabetes or other severe comorbidity

          -  familar MEN

          -  ...
Pilot Study of Edaravone to Treat Acute Myocardial Infarction
Condition: Myocardial Infarction; Reperfusion Injury
MeSH terms: Myocardial Infarction; Reperfusion Injury; Infarction
Intervention: edaravone
Intervention description: intravenous administration of 30mg Edaravone just before reperfusion therapy
Intervention MeSH terms: Edaravone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Healthy volunteers: No
Keywords: Edaravone; Randomized Control Trial; ST-Elevation Myocardial Infarction; Coronary Angioplasty

Summary:

      Early reperfusion therapy has improved the clinical outcomes of patients with acute
      myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion
      injuries. There is now increasing evidence that reactive oxygen species cause reperfusion
      injury. This study was designed to examine the effects of edaravone, a novel free radical
      scavenger, in patients with AMI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Initial AMI patients admitted to the investigators' institution within 6 hours of
             symptom onset and treated primary percutaneous coronary intervention.

        Exclusion Criteria:

          -  Renal insufficiency defined as serum creatinine > 1.2 mg/dl and altered hepatic
             function defined as serum asparate aminotransferase > 50 IU/L, alanine
             aminotransferase > 50 IU/L and total bilirubin > 1.2 mg/dl.
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: denosumab; teriparatide; Zoledronic acid
Intervention description: denosumab subcutaneous injection; teriparatide daily subcutaneous injection; zoledronic acid infusion
Intervention MeSH terms: Zoledronic Acid; Denosumab; Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of the study is to assess the effect of an antiresorptive medication in combination
      with standard dose or alternate dose teriparatide. The study extension will evaluate the
      effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women aged 45+

          -  postmenopausal

          -  osteoporotic with high risk of fracture

        Exclusion Criteria:

          -  no significant previous use of bone health modifying treatments