bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Intervention: Sevoflurane; Desflurane
Intervention description: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.; The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.
Intervention MeSH terms: Sevoflurane; Desflurane
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      Emergence agitation is a major concern in patients undergoing orthognathic surgery. The
      patients may experience the sense of suffocation during emergence due to nasotracheal
      intubation and orofacial edema. Postoperative pain is also associated with emergence
      agitation. Although there is a lot of studies about emergence agitation in children, there is
      a few in adults, furthermore, no data about comparison of emergence agitation between
      sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to
      compare the incidence and severity of emergence agitation between sevoflurane and desflurane
      anesthesia in adults after orthognathic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists(ASA) physical status classification 1 or 2
             patients

          -  patients scheduled for orthognathic surgery

        Exclusion Criteria:

          -  severe cardiopulmonary disease

          -  psychological disease

          -  patients who cannot understand Korean
Use of Transdermal Clonidine in Trauma Patients
Condition: Delirium
MeSH terms: Delirium
Intervention: Clonidine; Placebo
Intervention description: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours; A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet
Intervention MeSH terms: Clonidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will attempt to learn how to better treat trauma patients with delirium who are on
      a breathing machine. Delirium, also known as acute, temporary brain dysfunction, is a common
      reason why ventilated patients can not be weaned from the breathing machine even though their
      lungs may be healthy enough to breathe without the machine. The study hopes to show that by
      decreasing the patient's delirium it will lead to quicker weaning from the breathing machine
      and possibly a quicker overall recovery as well. Patients enrolled in this study will be
      treated with Clonidine or placebo. Clonidine is a drug that produces significant calming
      effects, decreases anxiety, and reduces pain, but with a lower incidence of delirium than
      other medications used in the ICU for this purpose. Clonidine is not approved by the Federal
      Food and Drug Administration for treatment of delirium, but is commonly used for this
      purpose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ventilated male or female trauma patient 18 years of age or older admitted to the ICU
             >24 hours

          2. Patient must meet minimal medical criteria for potential extubation (meet criteria for
             being placed on spontaneous breathing trials per established MUMC SBT protocol)

          3. Patients must exhibit delirium as assessed by the CAM-ICU assessment tool

          4. Patient must be declared stable from a neurologic, respiratory and cardiovascular
             standpoint to receive clonidine by the attending MD

          5. Consent must be obtained prior to any study procedures

        Exclusion Criteria:

          1. Patient < 18 years old

          2. Bradycardia (HR < 60)

          3. Presence of active pacemaker

          4. Hypotensive (<90/60)or active treatment of hypotension with vasoactive medications

          5. Patient actively being treated with Clonidine or dexmedetomidine

          6. Presence of allergy to Clonidine

          7. Pregnancy
Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Intervention: Nifedipine; Indomethacin
Intervention MeSH terms: Indomethacin; Nifedipine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: pregnancy; preterm labor; tocolysis

Summary:

      Tocolytic agents are used for the treatment of preterm labor. It is unclear whether
      combination treatments of two tocolytic agents are more effective in stopping preterm labor
      compared to one. Therefore, the investigators propose a comparative effective trial of
      nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor
    

Eligibility criteria:

        Inclusion Criteria:

          -  We will include pregnant women between 22 0/7 to 31 6/7 weeks gestation who present
             with regular uterine contractions defined as at least one contraction every 10 minutes
             for 30 minutes with at least one of the following:

          -  cervical change of at least 1 cm or

          -  cervical dilation of 2 cm at the time of initial exam or

          -  positive fetal fibronectin and transvaginal cervical length <2.5 cm

        Exclusion Criteria:

          -  We will exclude pregnant women with any contraindication to tocolysis:

          -  clinical chorioamnionitis (defined as a temperature of >100.4 F and any of the
             following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent
             vaginal discharge)

          -  non reassuring fetal heart tones

          -  suspected placental abruption

          -  preterm premature rupture of membranes

          -  prior tocolytic treatment during the past 48 hours

          -  known adverse effect to indomethacin or nifedipine

          -  already receiving nifedipine for chronic hypertension
Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients
Condition: Shock, Surgical; Shock; Hypotension and Shock; Kidney Transplant; Complications; Intraoperative Hypotension; Postoperative Hypotension
MeSH terms: Hypotension; Shock; Shock, Surgical
Intervention: Angiotensin II
Intervention description: If intraoperative or postoperative hypotension occurs (e.g. SBP < 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.
Intervention MeSH terms: Angiotensin II; Giapreza; Angiotensinogen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The current standard of catecholamine vasopressor management of perioperative hypotension in
      kidney transplant patients carries significant risks and falls short in many ways. Currently,
      there is an absence in the scientific literature and research describing the hemodynamic
      effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang
      II) in perioperative kidney transplant patients. Phase 3 registration trials have
      demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock
      patients compared to traditional vasopressor agents and the novel mechanism of action may
      provide additional protection in renal transplant patients. The pilot study entails giving
      informed and consenting kidney transplant recipients Ang II (Giapreza) as their first
      vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in
      kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic
      effects of Ang II (Giapreza) in the renal transplant population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients > 18 years of age

          -  Receiving deceased donor kidney transplant

          -  Pre-transplant Ejection Fraction (within past 18 months) > 50%

          -  Intraoperative or postoperative distributive shock (according to hospital and study
             protocol) requiring vasopressor support

        Exclusion Criteria:

          -  Pregnant patients (they would be excluded from receiving a transplant)

          -  Prisoners

          -  History of mesenteric ischemia

          -  History of aortic dissection

          -  History of abdominal aortic aneurysm

          -  Allergy to mannitol

          -  Absolute neutrophil count < 1000 cell/mm3 (within past 18 months)

          -  Diagnosis of Raynaud's phenomenon, systemic sclerosis or vasospastic disease
Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)
Condition: Complication of Transplanted Lung
MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
Intervention: Aztreonam Lysine for Inhalation (AZLI); Status Post Lung Transplant
Intervention description: The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI); Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care.
Intervention MeSH terms: Aztreonam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Transplant; Lung Transplant Recipient

Summary:

      This study is a pilot two- center study to determine if aztreonam lysine for inhalation AZLI
      can be safely and self-administered in lung transplant recipients with newly diagnosed
      bronchiolitis obliterans syndrome, grade 1 (BOS) and obtain pilot data regarding its effect
      on lung function in order to appropriately design and power a larger multicenter randomized
      study.

      The hypothesis is that AZLI is a safe and effective treatment for declining lung function in
      lung transplant recipients with early stage BOS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (18 or older at the time of transplant) male or female

          -  Cadaveric first lung transplant recipient, single or bilateral; or multi-organ lung
             transplant recipient.

          -  Current FEV1 66-80% of posttransplant baseline FEV1, and meets all criteria for BOS 1
             as defined by the International Society of Heart and Lung Transplantation.

               -  Onset of BOS 1 within twelve months of screening

        Exclusion Criteria:

          -  Known allergy to aztreonam

          -  Retransplant

          -  Pediatric patients

          -  Live lobar transplant recipients

          -  Inability to provide informed consent.

          -  Patients with advanced BOS (grades 2,3) or established BOS >6 months

          -  Pregnant Women
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab; Methotrexate; Corticosteroid or NSAID; Folate
Intervention description: 1000 mg i.v. on Days 1 and 15; 10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24; ≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24; ≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24
Intervention MeSH terms: Rituximab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the efficacy and safety of MabThera in combination with
      methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one
      or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and
      methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v.
      prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The
      anticipated time on study treatment is 3-12 months, and the target sample size is <100
      individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-80 years of age;

          -  rheumatoid arthritis for >=6 months;

          -  receiving outpatient treatment;

          -  an inadequate response to at least one anti-TNF therapy;

          -  stable methotrexate for >=12 weeks.

        Exclusion Criteria:

          -  other rheumatic autoimmune disease or inflammatory joint disease;

          -  previous treatment with MabThera;

          -  concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy,
             or other biologic agent.
Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Intervention: rosiglitazone; drospirenone/ethinyl estradiol
Intervention description: 4 mg daily for 6 months; 1 tab (3mg/30mcg) daily for 6 months
Intervention MeSH terms: Rosiglitazone; Drospirenone; Ethinyl Estradiol; Drospirenone and ethinyl estradiol combination; Estradiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: Female
Minimum age: 10 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl
      estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory
      markers, vascular markers and bone development in overweight adolescent females with
      polycystic ovary syndrome (PCOS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 10 - 20 years

          -  Pubertal level of Tanner stage III-V and menarchal

          -  BMI percentile for age and sex greater than or equal to 85%ile

        Exclusion Criteria:

          -  Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)

          -  Presence of other diseases, systemic or psychiatric, or chronic medications which
             could interfere with endocrine function

          -  Established diagnosis of diabetes

          -  Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months

          -  Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism
             (PCOS subjects only)

          -  Vitamin D deficiency (<10ng/mL)

          -  Hyperkalemia (K>5.0 meq/L)

          -  Positive pregnancy test (serum)
Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension; Systolic Murmurs
Intervention: Aliskiren; Ramipril; Matching placebo to Aliskiren; Matching placebo to Ramipril
Intervention description: 150 mg Aliskiren as film-coated tablet; Ramipril 5 mg was given in capsule form.; The tablet of matching placebo to aliskiren 150 mg for period I and III. In period II, matching placebo to Aliskiren was given to Ramipril active treatment arm.; The placebo capsule to ramipril 5 mg for period I and III. In period II, matching placebo to Ramipril was given to Aliskiren active treatment arm.
Intervention MeSH terms: Ramipril
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 506.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate systolic hypertension - adults - aliskiren -ramipril

Summary:

      This prospective multicenter, double blind study will evaluate the efficacy and safety of
      aliskiren versus ramipril in patients with moderate systolic essential hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients > 18 years

          -  Male or female patients. Female patients must have been either post-menopausal for one
             year, surgically sterile, or using effective contraceptive methods

          -  Patients with essential hypertension, previously treated with an antihypertensive
             single-drug therapy, either uncontrolled or intolerant.

          -  BP thresholds at visit 1:

               -  For patients previously treated and uncontrolled: 140≤ office SBP<180 mmHg

               -  For patients previously treated, controlled but intolerant: office SBP≥130 mmHg

          -  BP thresholds at visit 2 (for all patients):

               -  160≤office SBP<180 mmHg AND

               -  155≤home SBP<175 mmHg (3-day period of home blood pressure monitoring just before
                  randomization)

        Exclusion Criteria:

          -  Women of child-bearing potential not using any effective methods of contraception

          -  Severe hypertension (office BP ≥ 180/110 mmHg)

          -  Impossibility to stop abruptly previous antihypertensive treatments at visit 1

          -  Patients previously untreated or patients treated with two or three antihypertensive
             medications

          -  History or evidence of a secondary form of hypertension

          -  History of hypersensitivity to ACEi or renin inhibitors

          -  History of heart failure, stroke or coronary heart disease

          -  Serum potassium ≥ 5.2 mmol/l

        Other protocol-defined inclusion/exclusion criteria may apply
A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider
Condition: Smoking Cessation
Intervention: Varenicline; Placebo
Intervention description: Varenicline 1mg twice daily; Matched placebo twice daily
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 498.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to compare the effectiveness and safety of the re-treatment
      of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a
      12 week course of treatment. The study will also assess whether smokers remain abstinent at
      Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of
      treatment).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smokers aged 18 years or above and wanting to stop smoking

          -  Smokers who have smoked an average of at least 10 cigarettes per day over the last 4
             weeks

          -  Smokers who have tried before to stop smoking at least once with varenicline, and who
             took varenicline for at least 2 weeks

          -  The last attempt to stop smoking must be at least 3 months before entering the study

        Exclusion Criteria:

          -  Individuals who have not tolerated varenicline well previously, or who have a current
             or prior medical or psychiatric history that would make entry into the trial
             inadvisable

          -  Individuals who have previously participated in clinical trials of varenicline

          -  Individuals who have been participating in another smoking cessation trial within the
             last 3 months, or other drug trial within the last 30 days