bioihbjkbjnl/mcl2 huggingface dataset:
N-of-1 Trials In Children With Hypertension
Condition: Pediatric Hypertension
MeSH terms: Hypertension
Intervention: NICHE method; Usual care; Amlodipine; Lisinopril; Hydrochlorothiazide; Losartan
Intervention description: Based on underlying comorbidities at enrollment, patients will be assigned to either an unrestricted protocol (amlodipine versus lisinopril) or a restricted protocol (losartan versus lisinopril). Two drugs are tested in randomized order. Failure to achieve BP control at maximum doses of the first two drugs will result in augmentation with a diuretic (hydrochlorothiazide). BP control is assessed with 24 hour ambulatory monitoring at the end of each 2 week treatment period. Side effect tolerability is assessed with a questionnaire.; Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.; Calcium-channel blocker; antihypertensive; Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive; Thiazide diuretic; antihypertensive; Angiotensin II receptor blocker (ARB); antihypertensive
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide; Lisinopril
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 10 Years
Maximum age: 22 Years
Healthy volunteers: No

Summary:

      The single patient (n-of-1) randomized trial is an underused approach to resolving
      therapeutic uncertainty by using a patient's own data to inform an individualized treatment
      plan. The proposed research is designed to assess whether the n-of-1 trial approach improves
      blood pressure control compared to usual care. This trial aims to advance learning about not
      only the treatment of pediatric hypertension but also the use of a neglected type of
      randomized trial to optimize the care of each patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  treating physician determines that pharmacologic therapy is indicated for treatment of
             hypertension

          -  ambulatory hypertension has been confirmed (off meds) within 12 months of enrollment

        Exclusion Criteria:

          -  age < 10 years

          -  resistant hypertension (requiring ≥ 3 drug therapy)

          -  absolute contraindication or allergy to any of the tested drugs.
A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Intervention: HAVpur Junior; Havrix 720 Junior
Intervention description: ≥12 International Units (IU) hepatitis A antigen coupled to virosomes, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus)
Vaccination schedule: single doses at 0 and 6 months; ≥720 ELISA Units (EU) hepatitis A antigen adsorbed to aluminium hydroxide, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus)
Vaccination schedule: single doses at 0 and 6 months
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 18 Months
Maximum age: 47 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis A; Vaccination; Immunity

Summary:

      This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides
      protection that is non-inferior to the protection afforded by vaccination with Havrix 720
      Junior.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female between (and including) 18 months to 47 months of age.

          -  Written informed consent obtained from the parent/legal guardian of the subject.

          -  Free of obvious health problems as established by medical history and/or clinical
             examination before entering the study

        Exclusion Criteria:

          -  Seropositive for anti-HAV antibodies (>=10 mIU/ml).

          -  Use of any investigational or non-registered drug or vaccine within 30 days preceding
             the first dose of study vaccine, or planned use during the study period and safety
             follow-up.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose (for
             corticosteroids, such as prednisone, or equivalent, >=0.5 mg/kg/day.

          -  Inhaled and local steroids are allowed.)

          -  Planned administration/ administration of a measles containing vaccine within 4 weeks
             prior to and after the first or booster dose of study vaccine.

          -  Previous vaccination against hepatitis A.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at the time of enrolment
A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]; ribavirin
Intervention description: 180micrograms sc weekly for 12-48 weeks; 800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)
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: 6661.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the safety and tolerability of ribavirin in combination
      with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or
      1000-1200mg po daily, according to HCV genotype and body weight (< and >75kg)in combination
      with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months,
      and the target sample size is >500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  serological evidence of chronic hepatitis C;

          -  detectable serum HCV-RNA;

          -  liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

        Exclusion Criteria:

          -  history or other evidence of a medical condition associated with chronic liver disease
             other than HCV;

          -  co-infection with active hepatitis A or B;

          -  hepatocellular carcinoma;

          -  patients with severe cardiovascular disease whose condition may worsen due to acute
             anemia.
The Efficacy of Intravenous Acetaminophen During Perioperative Neurosurgery Period
Condition: Craniotomy; Brain Surgery
Intervention: Acetaminophen; Placebo
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: craniotomy; brain surgery; acetaminophen; Tylenol

Summary:

      This is a prospective randomized double blinded trial study involving 128 patients undergoing
      any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed
      envelope technique. The anesthesiologist and nurses who will be administering the placebo or
      intravenous acetaminophen will be blinded to the group in which patients are assigned.

      The following general perioperative data will be recorded: patient information/preoperative
      data, procedural information, postoperative information, and overall satisfaction of pain
      management at 24 hours after surgery.

      Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require
      no opioids in the first 24 hour postoperative period. With the use of intravenous
      acetaminophen, it is hypothesized that the number of patients that do not require opioids in
      the first 24 hours after surgery will double.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject are able to provide informed consent prior to participation in the study

          -  Subjects must be scheduled to undergo elective open craniotomy procedure of > 2 hour
             duration

          -  Subjects must be >18 years old but less than 90 years old

          -  Subjects must have an American Society of Anesthesiologists (ASA) class I-IV

          -  Subjects must have the ability to communicate meaningfully with the investigator staff
             and read/understand the study procedures and the use of pain scales

        Exclusion Criteria:

          -  Subjects used opioids or tramadol daily for >7 days before study medication
             administration

          -  Subjects had been treated with any of the following within 14 days of surgery:
             chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's
             wort, or valerian

          -  Subjects who have a chronic pain condition, significant medical disease or laboratory
             abnormality that in the investigator's judgment could compromise the subject's welfare

          -  Subjects with known hypersensitivity to opioids, acetaminophen or the inactive
             ingredients

          -  Subjects with known or suspected history of alcohol or drug abuse or dependence in the
             previous 2 years prior to the proposed surgery
Intravenous Dexmedetomidine for Cesarean Section
Condition: Breast Feeding; Analgesia Obstetrical; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Normal Saline; Dexmedetomidine 0.03ug/kg/h; Dexmedetomidine 0.05ug/kg/h; Dexmedetomidine 0.08ug/kg/h
Intervention description: Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.; Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.; Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.; Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
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: 120.0
Sex: Female
Minimum age: 24 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dexmedetomidine; Butorphanol tartrate; Analgesia; Breastfeeding; Relative infant dose

Summary:

      Nervous, anxiety, fear and other psychological reactions always appears in parturients during
      cesarean section. This study intends to investigate the effectiveness and safety of
      dexmedetomidine combined with butorphanol tartrate for postoperative analgesia and
      breastfeeding after caesarean section.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Parturients who had successfully breastfed a prior infant and planned to breastfeed
             after this delivery were screened for eligibility.

          2. Parturients undergoing elective caesarean delivery under epidural anaesthesia

          3. ASA I and II parturients aged 18-45 years, with singleton gestation.

          4. Parturients with verbal and written mandarin

          5. Parturients who want to use PCA intravenous analgesia and can use the pump correctly

          6. written informed consent.

        Exclusion Criteria

          1. Multiple gestation.

          2. A history of allergy to dexmedetomidine or other study drugs

          3. Cardiovascular disease (basic HR<50bpm or SBP<100mmHg)

          4. Opioid drugs abuse.

          5. BMI more than 35 kg/m2

          6. Conditions that preclude spinal anesthesia.

          7. Preeclampsia or epilepsy.

          8. A history of neuromuscular disease.

          9. Epidural anaesthesia was unsuccessful.

         10. The parturients, whose surgery ended after 11 a.m.
Depression, Epinephrine, and Platelet Function
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Escitalopram; Desipramine
Intervention description: 10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention; 25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
Intervention MeSH terms: Desipramine; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: platelet function; childhood abuse; depression; antidepressants; immune function; stress response

Summary:

      Men and women who have suffered sexual and/or physical abuse before the age of 12 are at
      increased risk for anxiety and mood disorders, other serious psychiatric disorders, and
      likely medical illnesses. What is not known is whether adult survivors of childhood adversity
      experience heightened negative emotions and increased physical responses due to altered
      norepinephrine or serotonin systems in their brains and bodies. The investigators expect to
      see that survivors of childhood adversity experience heightened negative emotions and
      increased physical responses to stress.
    

Eligibility criteria:

        Inclusion Criteria:

        -

        Exclusion Criteria:

          -  Individuals who are suicidal, psychotic, or with bipolar depression

          -  alcohol or substance abuse or

          -  regularly use medications which alter mood or blood vessel function (zolpidem or
             zalpelon, aspirin, nonsteroidal antiinflammatory drugs, sympatholytics, theophylline,
             central acting agonists, beta-blockers, coumadin, nitrates, triazolobenzodiazapines,
             or use steroids (testosterone-patch or pill form), use tryptophan or monoamine oxidase
             inhibitors (MAOIs),

          -  have narrow-angle glaucoma, liver disease,

          -  severe allergies (especially to antidepressants similar to escitalopram or
             desipramine)

          -  seizures, or a serious medical disorder (e.g. hypothyroidism) that is unstable or is
             untreated.

          -  Depressed patients with a prior history of severe adverse events associated with SSRIs
             or TCAs will not be accepted into the study.
Estrogen Diastolic Heart Failure
Condition: Menopause
MeSH terms: Heart Failure
Intervention: Estradiol/Norethindrone acetate; Placebo
Intervention description: Estradiol/Norethindrone acetate 1mg/0.5 mg; inactive ingredient
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: Female
Minimum age: 45 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Peri-menopausal women will be randomized to hormone replacement therapy or placebo for 12
      weeks to determine if markers of systolic and diastolic function change by echocardiography
      as well as laboratory markers of heart failure, including b-type natriuretic peptide (BNP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  28 healthy recently postmenopausal women with last menstrual bleeding 12 months at
             study entry. Women with last menstrual bleeding within 12 months at study entry are
             those who are peri-menopausal and for whom the drug is FDA approved.

        Exclusion Criteria:

          -  History of hysterectomy, oophorectomy or both

          -  History of heart disease including cardiac transplantation, heart failure, bypass
             surgery or percutaneous intervention, and valve disease defined as moderate or severe
             valve regurgitation or stenosis

          -  History of bone disease including non-traumatic vertebral fractures on radiography

          -  Uncontrolled chronic disease (including uncontrolled diabetes defined as a hemoglobin
             A1C >8, uncontrolled hypertension defined as a systolic blood pressure >160 mmHg,
             awaiting organ transplant)

          -  Previous or current cancer, excluding basal cell carcinoma

          -  Previous or current thromboembolic disease

          -  Previous intolerance of Hormone replacement therapy (HRT) or Oral contraception (OC)

          -  Current or previous use of HRT within the past 3 months

          -  Current or recent (<12 months) substance abuse, including tobacco use

          -  No drug interactions with HRT

          -  No racial or ethnic groups will be excluded
Fingolimod Effect on Cytokine and Chemokine Levels
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod 0.5 mg
Intervention description: 66 relapsing remitting MS (RRMS) patients were recruited. Patients who met all inclusion and none of the exclusion criteria were treated by Fingolimod 0.5 mg.
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: A 6-month, multicenter, prospective, interventional, single arm, open label study investigating the effects of fingolimod administered according to local label recommendations on Cytokine and Chemokine Levels in Relapsing Remitting Multiple Sclerosis Patients
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fingolimod,cytokine,chemokine,RRMS

Summary:

      The main purpose of this study was to measure the serum levels of cytokines and chemokines
      that are known to increase during multiple sclerosis relapses.

      Cytokines are a broad and loose category of small proteins that are important in cell
      signaling.

      The second purpose of the study was to test the cytokine/chemokine changes measured in the
      3rd and 6th months on the efficacy parameters.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Written informed consent must be obtained before the beginning of te study

          2. Nonresponder RRMS patients

          3. Last relapse of the patient should be at least 2 months before study entry.

          4. Last interferon or glatiramer acetate dose of the patient should be at least 1 month
             before study entry.

        Key Exclusion Criteria:

          1. Patients with secondary progressive MS.

          2. Patients with known contraindications for fingolimod treatment.

          3. Other coexistent autoimmune diseases

          4. Pregnant or nursing (lactating) women
Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: zonisamide; carbamazepine
Intervention description: Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.; Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
Intervention MeSH terms: Carbamazepine; Zonisamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of zonisamide with
      carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Epilepsy patients over 15 years old.

          2. Occurrence of seizure should be more than one time within recent 3 months and more
             than two times within recent 6 months.

          3. Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.

          4. Female who can be in the month of pregnancy should agree to prevent conception.

          5. Patients who agree with Informed Consent Form.

        Exclusion criteria:

          1. Patients who have Myoclonic seizures and/or Absence seizures.

          2. Patients who have progressive central nervous system (CNS) disorder.

          3. Patients who have serious systemic disorder.

          4. Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum
             glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen
             (BUN)/Creatinine levels.

          5. Patients who have renal stones.

          6. Medical history of medicinal poisoning and/or alcoholism.

          7. Patients who have long-term medication history (more than 6 months) of zonisamide
             and/or carbamazepine.
Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
Condition: Uveitis
MeSH terms: Uveitis
Intervention: 0.59 mg Fluocinolone Acetonide implant
Intervention description: 0.59 mg Fluocinolone Acetonide implant
Intervention MeSH terms: Fluocinolone Acetonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Healthy volunteers: No
Keywords: uveitis; Cystoid Macular Edema (CME); fluocinolone acetonide; non-infectious uveitis affecting the posterior segment

Summary:

      The purpose of this study is to collect data on patients with severe uveitis that have
      required re-implantation of the sustained-release fluocinolone drug delivery device due to
      depletion of study drug in their previous implanted device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-infectious intermediate, posterior or panuveitis

          -  Previous placement of fluocinolone acetonide implant with initial uveitis quiescence
             and subsequent recurrence of inflammation once implant depleted of drug

        Exclusion Criteria:

          -  Infectious uveitis