bioihbjkbjnl/mcl2 huggingface dataset:
Postpartum Management of Gestational Hypertensive Disorders Using Furosemide
Condition: Hypertension, Pregnancy-Induced
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Intervention: furosemide; labetalol
Intervention description: five day course of furosemide 20mg QD; 200mg labetalol BID
Intervention MeSH terms: Labetalol; Furosemide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Masking description: randomized open label
Enrollment: 13.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: pregnancy induced hypertension; preeclampsia; furosemide

Summary:

      -  The main purpose of this study is to learn if incorporating a loop diuretic such as
           furosemide along with labetalol in the routine management of postpartum gestational
           hypertensive disorders could lower the need for additional anti-hypertensive agents to
           control blood pressures, improve blood pressures (as measured by systolic blood
           pressure, diastolic blood pressure and mean arterial blood pressures), shorten hospital
           stays and decrease readmissions for patients with gestational hypertensive disorders.

        -  Based on a study by Veena et al1, there is reason to believe that the addition of
           furosemide to other anti-hypertensives may help decrease the need to add or increase the
           dose of medication to control blood pressures. There may be potential to shorten
           hospital stays and decrease readmissions, as well. Collecting data will be done using a
           prospective, randomized 1:1 controlled study assigning postpartum patients with a
           gestational hypertensive diagnosis to either labetalol alone or labetalol plus
           furosemide.

        -  The study will be performed in the postpartum wing of Miami Valley Hospital Main Campus
           and would use patients who have consented to participate in the study with enrollees
           coming from the OB Staff population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postpartum women delivering at Miami Valley Hospital

          -  Diagnosis of gestational hypertension or preeclampsia

          -  Able to provide written informed consent

        Exclusion Criteria:

          -  Diagnosis of chronic hypertension

          -  Allergy to study medications

          -  Unable to understand English
An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Nivolumab in combination with Ipilimumab
Intervention description: Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1041.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients
      with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or
      non-small cell lung cancer that has come back.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed Stage 4 or recurrent non-small cell lung cancer

          -  Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out
             light housework or office work through to being fully active as you were before
             cancer)

          -  No prior systemic anticancer therapy (including EGFR and ALK inhibitors)

          -  Tissue or Programmed death-ligand 1 (PD-L1) results available

        Cohort 1A Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) score 2 or

          -  Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria
             as listed in the protocol

        Cohort C Inclusion Criteria:

          -  High Tumor Mutation Burden

        Exclusion Criteria:

          -  Untreated brain metastases

          -  An active malignancy that requires concurrent intervention

          -  Active, known or suspected autoimmune disease

          -  Carcinomatous meningitis, which means there is inflammation of the covering of the
             brain, caused by cancer

        Other protocol-defined inclusion/exclusion criteria apply
Changing the Default for Tobacco Treatment
Condition: Tobacco Use Cessation
Intervention: Opt Out Treatment Program; Nicotine Replacement Therapy; Opt In Treatment Program; Nicotine Replacement Therapy
Intervention description: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.; Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.; Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.; Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1000.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tobacco treatment

Summary:

      The purpose of this study is to determine the impact and efficacy of a new approach to
      smoking cessation treatment versus the traditional approach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Speak English or Spanish

          -  Have access to a telephone or mobile phone

          -  Not be currently pregnant or breast feeding

          -  Have no significant co-morbidity that precludes participation

          -  Current daily smoker

          -  Not in treatment for tobacco dependence

          -  Reside in Kansas or Missouri

        Exclusion Criteria:

          -  Admission greater than 3 days
Attenuation of the Side Effect Profile of Regadenoson: Study With Aminophylline in Patients With Severe Kidney Disease Undergoing Myocardial Perfusion Imaging
Condition: Patients With Severe Chronic Kidney Disease Being Evaluated With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Aminophylline; Placebo
Intervention description: 75 mg of intravenous aminophylline; Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
Intervention MeSH terms: Aminophylline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: regadenoson; chronic kidney disease; renal failure; lexiscan; aminophylline; SPECT; Myocardial Perfusion Imaging; pharmacologic stress test; Patients with stage IV or V chronic kidney disease being assessed with nuclear stress testing of the heart using the stress agent regadenoson (Lexiscan ®)

Summary:

      The routine administration of 75 mg of intravenous aminophylline in patients with severe
      chronic kidney disease undergoing a nuclear stress test with regadenoson (Lexiscan®) can
      reduce or eliminate the incidence of diarrhea and other side effects related to regadenoson.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients referred to undergo a clinically-indicated regadenoson-stress
             myocardial perfusion imaging at Rush University Medical Center

          -  Stage IV or V chronic kidney disease (GFR < 30, hemodialysis, and/or peritoneal
             dialysis).

        Exclusion Criteria:

          -  Patient refusal to participate

          -  Known allergic reaction to aminophylline.

          -  Pre-existing headache or acute/subacute GI illness with symptoms of diarrhea,
             abdominal discomfort, nausea or vomiting.

          -  Any contraindication to aminophylline: hypotension, unstable cardiac arrhythmias and
             acute coronary symptoms.

          -  Uncontrolled seizure disorder defined as more than 2 seizure episodes in the past 12
             months or any seizure in the past week.

          -  Pregnant or breast-feeding women.

          -  Patients receiving anti-platelet agent dipyridamole (Persantine® or Aggrenox®).
Prophylactic Pregabalin to Decrease Pain During Medical Abortion
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Pregabalin; Placebo
Intervention description: Pregabalin 300 mg capsule (over encapsulated to maintain blinding); Matching placebo capsule with excipient to match Pregabalin
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Medical abortion has been associated with significant pain. The objective of this trial is to
      determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to
      the standard of care analgesics, will decrease experienced pain. Investigators will perform a
      randomized, double-blinded, placebo-controlled trial. Participant pain levels and side
      effects will be assessed at multiple time points, along with a measure of satisfaction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Requested and consented for pregnancy termination by medical abortion

          -  Willing and able to complete multiple electronic surveys

        Exclusion Criteria:

          -  Previous participation in this trial

          -  Current use of pregabalin or gabapentin

          -  Contraindication to medical abortion with mifepristone and misoprostol

          -  Contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or pregabalin

          -  Unable to understand and sign written informed consents in English
SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Intervention: Sodium Oxybate; placebo (fresh potable water)
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic fatigue syndrome

Summary:

      The investigators wish to investigate whether enhancement of SWS, which is seen after a drug
      called sodium oxybate, reduces the impact of sleep disruption in CFS on daytime function,
      specifically sleepiness and mental performance. This is a safe and well-tolerated drug that
      is licensed for excessive daytime sleepiness (EDS) and cataplexy associated with narcolepsy.

      The investigators will study 12 patients diagnosed with CFS using international diagnostic
      guidelines. The investigators will record overnight sleep with EEG (brainwave) measurement on
      the 1st and 4th nights of a 4 night period during which sodium oxybate and placebo will be
      taken nightly, and the investigators will measure next-day sleepiness, mental performance and
      fatigue, and compare drug and placebo nights.
    

Eligibility criteria:

        Inclusion criteria

          -  Meeting criteria for CFS according to both the revised CDC (Fukuda 5) and Canadian
             diagnostic systems.

          -  Aged 25-65.

          -  Good grasp of the English language.

        Exclusion criteria

          -  Taking any of the following medication: opioids, tramadol, phenytoin, valproate,
             ethosuximide, benzodiazepines, zolpidem, zopiclone, zaleplon, antidepressant except
             <30mg amitriptyline, or any other medications likely to interact with sodium oxybate
             or with sleep in the opinion of the investigators.

          -  Current major psychiatric disorder.

          -  Unusual sleep schedule; (bedtime routines that fall outside 9 p.m. to 10 a.m.; usual
             time in bed > 12 hours).

          -  Pregnancy, lactation or being female and not using reliable contraception.

          -  Relevant abnormal clinical findings at screening visit.

          -  Taken alcohol in the 24 hours before each study visit or drugs of abuse in the week
             before each study visit
Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: hydrocortisone 17-butyrate 0.1% Cream preparation; hydrocortisone 17-butyrate 0.1% Ointment preparation; hydrocortisone 17-butyrate 0.1% Lipocream preparation
Intervention description: Apply medication twice a day to affected areas of atopic dermatitis; Apply medication twice a day to affected areas of atopic dermatitis; Apply medication twice a day to affected areas of atopic dermatitis
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Hydrocortisone-17-butyrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to better understand adherence to Locoid when people
      use it to treat atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 years of age.

          -  Subjects must have diagnosis of mild to moderate atopic dermatitis using IGA criteria.
             (2 or 3 on severity scale)

          -  Subjects must have >5% TBSA and <30% to be enrolled.

          -  Women of child bearing potential will be allowed to participate in the study, and
             these subjects will be required to use at least one form of birth control.

        Exclusion Criteria:

          -  Known allergy or sensitivity to topical Locoid® cream, ointment or lipocream in the
             subject.

          -  Inability to complete all study-related visits.

          -  Introduction of any other prescription medication, topical or systemic, for atopic
             dermatitis while participating in the study.

          -  Requiring >130 gm of cream in a 2 week period.

          -  Having facial or groin involvement of their disease.

          -  Pregnant women and women who are breast feeding are to be excluded. Women of child
             bearing potential will be allowed to participate in the study, and these subjects will
             be required to use at least one form of birth control.
Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism
Condition: Subclinical Hypothyroidism
MeSH terms: Hypothyroidism
Intervention: Levothyroxine; Placebo
Intervention description: Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.; Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigators propose the following hypothesis: discontinuation of levothyroxine (LT4)
      for veterans with subclinical hypothyroidism (SCH) will be feasible, acceptable, and safe and
      will not negatively affect their Quality of Life (QoL). The investigators aim to evaluate the
      feasibility of LT4 discontinuation among veterans with SCH and determine the changes in QoL
      measures, lipids, and adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Veterans

          -  diagnosis of SCH

        Exclusion Criteria:

          -  thyroid-stimulating hormone (TSH) > 10 milli-international units per liter (mlU/L) (at
             any point)

          -  Levothyroxine (LT4) dose more than 75 mcg daily

          -  use of antithyroid medications, amiodarone, tyrosine kinase inhibitors or lithium

          -  history of thyroidectomy or radioactive iodine therapy

          -  LT4 suppressive therapy for thyroid cancer, goiter, or inflammation

          -  pregnancy or plans for pregnancy in the next 6 months

          -  an unstable medical condition that would jeopardize safety or interfere with study
             participation

          -  severe hypothyroidism-related symptoms

          -  strong family history of hypothyroidism

          -  severe dyslipidemia

          -  hospitalization for major illness within the previous 4 weeks

          -  acute coronary artery syndrome, acute myocarditis, or pancarditis with the previous 12
             months

          -  grade IV New York Heart Association heart failure

          -  receiving services from hospice

          -  lack of decision-making capacity

          -  terminal medical condition for which life expectancy would be less than 6 months

          -  not willing to stop LT4

          -  self-reported non-adherence to LT4 therapy

          -  abnormal TSH at time of screening for participation (assessed during Baseline Visit)
Acetaminophen and Ibuprofen With and Without Magnesium and Primary Migraine in Childhood
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Magnesium 400Mg; Ibuprofen 10 mg/kg; acetaminophen 15 mg/kg
Intervention description: magnesium 400 mg + conventional treatment; ibuprofen 10 mg/kg oral single dose; Acetaminophen 15 mg/kg oral single dose
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 160.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Aim: The purpose of this study was to evaluate both the effects of ibuprofen and/or
      acetaminophen for the acute treatment of primary migraine in children in or out prophylactic
      treatment with magnesium.

      Methods: The study had been approved by the Researchers Ethics Committee of the
      "Pugliese-Ciaccio" Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36) and the
      children ranging from the ages of 5 to 18 years with at least four attack/month of primary
      migraine were enrolled. A Visual Analogical Scale was used to evaluate pain intensity at the
      moment of admission to the study (start of the study) and every month up to 18 months later
      (end of the study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with migraine without aura (MoA) diagnosed according to the criteria for
             pediatric age of the International Classification of Headache Disorders (IHS-2)

          -  aged from 5 to 18 years

          -  at least four attacks /month

        Exclusion Criteria:

          -  mental retardation (IQ <70)

          -  genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome)

          -  hypothyroidism

          -  psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD),

          -  neuromuscular disorders,

          -  epilepsy,

          -  obesity (BMI>95 percentiles),

          -  liver or renal diseases,

          -  gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn;

          -  hypersensitivity to medication studies.
Evaluating the Effectiveness of Escitalopram to Prevent Depression in Head and Neck Cancer Patients Receiving Treatment
Condition: Depression
MeSH terms: Head and Neck Neoplasms; Depression; Depressive Disorder
Intervention: Escitalopram; Placebo
Intervention description: Participants take 10 mg for 1 week and then 20 mg for 15 weeks.; Placebo distribution matches the active medication.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Antidepressant; Major depression; Prevention; Head and neck cancer

Summary:

      This study will evaluate the effectiveness of escitalopram to prevent depression in head and
      neck cancer patients receiving treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newly diagnosed or recurrent epidermoid cancer of the head and neck

          -  Requires more than minimal therapy for treatment

          -  Able to read and write in English

          -  Willing to use an effective form of birth control throughout the study

        Exclusion Criteria:

          -  Meets MINI criteria for major depression, schizophrenia, or bipolar illness or scores
             24 or less

          -  Suicidal or psychotic

          -  Current allergy or hypersensitivity to citalopram or other SSRIs

          -  Treated with monoamine oxidase inhibitors 14 days prior to study entry

          -  Use of antidepressants within 1 week of study entry

          -  Pregnant or breastfeeding

          -  History of an adequate cancer operation, radiation, or chemotherapy within 6 months of
             study entry

          -  Diagnosed with melanoma or lymphoma cancer of the head and neck

          -  Currently participating in another research study involving a therapeutic intervention