bioihbjkbjnl/mcl2 huggingface dataset:
Coenzyme Q10 in Post-Cardiac Arrest Cerebral Resuscitation
Condition: Cardiac Arrest; Sudden Cardiac Arrest
MeSH terms: Heart Arrest; Death, Sudden, Cardiac
Intervention: Coenzyme Q10; Placebo
Intervention description: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.; Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo.
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac Arrest; Post Cardiac Arrest; CoQ10; Ubiquinone; Post Arrest

Summary:

      Specific Aim #1: To determine if levels of CoQ10 are low post-cardiac arrest (CA). We will
      perform a prospective trial with the primary endpoint of describing the prevalence of low
      serum CoQ10 levels.

      Specific Aim #2: To determine if CoQ10 levels in post-CA patients can be increased with the
      administration of exogenous CoQ10.. We will perform a randomized control trial (RCT) of
      post-CA patients with the secondary endpoint of comparing CoQ10 levels among those randomized
      to CoQ10 supplementation vs placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients (age > 18 years)

          2. Comatose after CA with subsequent return of spontaneous circulation

        Exclusion Criteria:

          1. Comatose status prior to CA

          2. CoQ10 therapy within one month prior to CA

          3. Pregnancy
Efficacy of Enteral Iron Supplementation in Critical Illness
Condition: Anemic, Critically Ill Patients
MeSH terms: Critical Illness
Intervention: Ferrous Sulfate; Placebo Oral Tablet
Intervention description: Iron group; Placebo group
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iron; critical illness; anemia; infection

Summary:

      The purpose of this study is to investigate the efficacy of enteral iron supplementation for
      improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in
      patients who are hospitalized in the intensive care unit. This study will also address any
      relationship between enteral iron supplementation and risk of infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Anemia (Hemoglobin < 13.0 g/dL)

          -  ≤ 72 hours from hospital admission

          -  Current tolerance of enteral medications

          -  Expected ICU LOS > 5 days

        Exclusion Criteria:

          -  Active bleeding

          -  Chronic inflammatory disease

          -  End-stage renal disease

          -  Hematologic disorders

          -  Macrocytic anemia

          -  Current use of erythropoietin

          -  Pregnancy

          -  Prohibition of RBC transfusions

          -  Moribund state in which death is imminent

          -  Enrollment in another clinical trial
Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
Condition: Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Intervention: Momelotinib
Intervention description: Momelotinib tablets administered orally once daily
Intervention MeSH terms: N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary Myelofibrosis; Post Polycythemia Vera Myelofibrosis; Post Essential Thrombocythemia Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia; blood disorders

Summary:

      This open-label study is to determine the long-term safety and tolerability of momelotinib in
      previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia
      vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF),
      polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved
      stable disease or better with momelotinib treatment while enrolled in a previous clinical
      trial.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently enrolled in study CCL09101E, or YM387-II-02, or successfully completed 24
             weeks of study GS-US-352-1672

          -  Able to comprehend and willing to sign informed consent form

        Key Exclusion Criteria:

          -  Known hypersensitivity to momelotinib, its metabolites, or formulation excipients

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration
Condition: Wet Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: BI 144807
Intervention description: twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The present trial will use an open label design to investigate the effect of BI 144807 on
      central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD
      patients. A further objective is to collect data on adverse events, vital signs, ECG and
      clinical laboratory parameters of BI 144807 in the same patient group.
    

Eligibility criteria:

        Inclusion criteria:

        Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization
        secondary to age-related macular degeneration

        Exclusion criteria:

        Additional eye disease that could compromizse best corrected visual acuity, such as
        uncontrolled glaucoma
Cheno Effect on Transit in Health and IBS-C
Condition: Constipation-predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Sodium chenodeoxycholate (NaCDC); Placebo
Intervention description: 500 or 1000 milligrams NaCDC per day each for a period of 4 days; Placebo capsules with identical appearance to the study drug were prepared by the Mayo Clinic research pharmacy.
Intervention MeSH terms: Chenodeoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: chenodeoxycholate, IBS, transit, colon, constipation

Summary:

      The study hypothesis is that the naturally occurring bile acid, chenodeoxycholic acid,
      induces acceleration of colonic transit in health and in patients with
      constipation-predominant Irritable Bowel Syndrome (IBS-C).
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy volunteers:

          -  Age (yr) 18-65

          -  Gender (F:M)3.5 :1

          -  Bowel Disease Questionnaire (BDQ) - IBS symptoms negative by Rome III criteria

          -  Hospital Anxiety/Depression score <8

        IBS patients:

          -  Age (yr) 18-65

          -  Gender (F:M) 5 :1

          -  BDQ - IBS symptoms: positive by Rome III criteria

          -  Hospital Anxiety/Depression score: No restrictions

        Exclusion Criteria:

          -  Abdominal surgery (except appendectomy or cholecystectomy)

          -  GI medications during the 48h prior to transit measurement

          -  Aspartate/Alanine transaminases >2 X Upper Limit of Normal (ULN)

          -  Other Medications except stable doses of estrogen, thyroid, low dose antidepressants
             of the dopaminergic or serotonergic class
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Mirikizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: IL-23; dermatology

Summary:

      The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in
      participants with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of
             chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the
             following criteria:

               -  plaque psoriasis involving ≥10% body surface area (BSA) and absolute PASI score
                  ≥12 in affected skin at screening and baseline

               -  sPGA score of ≥3 at screening and baseline

          -  Candidate for biologic treatment for psoriasis.

        Exclusion Criteria:

          -  Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,
             endocrine, hematological, neurological, or neuropsychiatric disorders or any other
             serious and/or unstable illness that, in the opinion of the investigator, could
             constitute a risk when taking investigational product or could interfere with the
             interpretation of data.

          -  Breastfeeding or nursing (lactating) women.

          -  Have had serious, opportunistic, or chronic/recurring infection within 6 months prior
             to screening.

          -  Have received live vaccine(s) (included attenuated live vaccines) within 1 month of
             screening or intend to during the study.

          -  Have any other skin conditions (excluding psoriasis) that would affect interpretation
             of the results.

          -  Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days
             prior to baseline.

          -  Have received topical psoriasis treatment within 14 days prior to baseline.

          -  Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17
             targeting biologics within 8 weeks prior to baseline.

          -  Have previous exposure to any biologic therapy targeting IL-23 (including
             ustekinumab), either licensed or investigational (previous briakinumab use is
             permitted).
Clomiphene Citrate for Treatment of Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Clomiphene Citrate
Intervention description: Clomiphene citrate, 50 mg, orally for three months
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Acromegaly; SERM; Clomiphene

Summary:

      To assess the impact of clomiphene citrate on serum insulin like growth factor 1 and
      testosterone levels in male acromegalic patients not controlled by surgery, radiotherapy
      and/or medical treatments (somatostatin analogues, dopamine agonists and/or growth hormone
      receptor antagonist)
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with active acromegaly on regular use of a stable dose of Octreotide-LAR
             and/or cabergoline for at least one year,

          -  Insulin like growth factor 1 above the reference range during the last year of
             follow-up and

          -  testosterone levels within or below the third inferior tertile of normality.

        Exclusion Criteria:

          -  radiotherapy in the last 10 years, previous venous embolism (including family
             members),

          -  previous prostatic cancer or symptomatic benign hypertrophy,

          -  triglyceride levels above 400 mg/dL,

          -  renal failure defined by estimative of renal filtration below 30 ml/min,

          -  liver disease defined by hepatic enzymes 3 times above normal limit,

          -  active oncologic disease in the last 10 years and previous cardiac or cerebrovascular
             disease.
Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Intervention: Plasma; Balanced crystalloids
Intervention description: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.; Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      There is a knowledge gap regarding the optimal initial fluid to achieve effective
      resuscitation and improved outcomes in septic shock. The purpose of this study is to compare
      initial resuscitation with plasma to initial resuscitation with balanced crystalloids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients meeting the following criteria will be enrolled: Have a Sepsis Screening
             Score (SSS) ≥ 4 with a suspected source of infection (Table 1); and Written informed
             consent obtained

          -  Patients meeting any of the following criteria will be randomized: Hypotension with
             MAP < 65 mmHg; Lactic acid > 4 mmol/L; Altered mental status; and Decreased urine
             output of < 0.5 mL/kg in the past hour.

        Exclusion Criteria:

          -  Pregnancy

          -  Prisoners

          -  Traumatic brain injury

          -  Evidence of ongoing hemorrhage, history of congenital bleeding disorders, therapeutic
             anticoagulation

          -  History of myocardial infarction or congestive heart failure

          -  History of acute cerebral vascular event

          -  Major burns (>20% total body surface area)

          -  History of adverse reactions to blood product transfusion

          -  Contraindications to blood transfusions (eg. Jehovah's Witness)

          -  Contraindications to central venous line and arterial line placement

          -  On intermittent hemodialysis

          -  Do-Not-Resuscitate or Comfort Care status

          -  Participation in another interventional study

          -  Pending transfer to another unit within the hospital that is not STICU or SIMU
Effect of Intralymphatic Immunotherapy
Condition: Allergy; Immune Tolerance; Injection Site Discomfort
Intervention: Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.; alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.; 0.1 ml Isoton saline
Intervention description: 4; 3 injection into a lymphnode; 4 injection into a lymphnode
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Allergic Rhinitis; Allergen immunotherapy

Summary:

      The investigators want to investigate whether specific immunotherapy can be delivered
      directly into a lymph node. The investigators think that a direct introduction of allergen to
      the antigen presenting cells in the lymph node a give a strong immune response and that this
      can change the number of injections needed in allergen immunotherapy. The investigators do
      measurements of clinical effect and a variety of paraclinical test to see if the
      investigators can find af biomarker of successful specific immune therapy of grass allergy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for
             grass, age between 18 and 40 years.

        Exclusion Criteria:

          -  Uncontrolled asthma.

          -  Severe asthma with post bronchodilator test forced expiratory volume at 1 second less
             than 70% of expected.

          -  Severe co morbidity. Allergy to Fenol or Aluminium hydroxid.

          -  Any autoimmune diseases. Treatment with beta blocking medicine.

          -  Any heart diseases.

          -  Severe arterial hypertension. Kidney failure.

          -  Known malignancy. Known pregnancy.
Low Dose Aprepitant for Patients Receiving Carboplatin
Condition: Chemotherapy-induced Nausea and Vomiting
MeSH terms: Nausea; Vomiting
Intervention: Aprepitant 125 mg; Fosaprepitant 115 MG; Dexamethasone; Ondansetron 16 MG
Intervention description: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting; Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting; Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy; Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
Intervention MeSH terms: Dexamethasone; Ondansetron; Aprepitant; Fosaprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive 125mg of oral aprepitant or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: emesis; aprepitant; carboplatin; chemotherapy-induced nausea and vomiting

Summary:

      This study evaluates a simple one day prophylaxis of nausea and vomiting for patients who are
      getting carboplatin based chemotherapy. In addition to standard oral Dexamethasone and oral
      Ondansetron, participants will be given a third neurokinin 1 (NK1) antagonist agent, either a
      single dose of oral Aprepitant or intravenous (IV) Fosaprepitant (they have been shown to be
      equally effective) to improve prevention of nausea and vomiting. No medications need to be
      taken beyond day 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No prior chemotherapy

          -  Confirmed malignancy, scheduled to receive carboplatin monotherapy, or carboplatin in
             combination with agents of minimal, low, or moderate emetic potential

          -  Laboratory parameters adequate for chemotherapy

        Exclusion Criteria:

          -  Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3
             or 4

          -  Presence of nausea and vomiting or use of major antiemetic agents during the 24 hours
             before chemotherapy administration

          -  Patients receiving radiotherapy within 5 days prior to the carboplatin

          -  Pregnancy or lactation

          -  Known allergy to any of the 3 antiemetics
fMRI Study Examining Effects of D-cycloserine in Specific Phobia
Condition: Phobias
MeSH terms: Phobic Disorders
Intervention: D-cycloserine; Placebo
Intervention description: D-cycloserine; Placebo
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The research team hopes to use brain imaging and mental testing to learn more about specific
      phobias and the treatment of phobia. When given directly prior to therapy sessions,
      D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify
      reasons why D-cycloserine has this effect by measuring brain activity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Right-handed

          -  Adults between 18 and 55 years of age

          -  Subjects in the phobic group will additionally meet diagnostic (DSM-IV) criteria for
             spider phobia.

          -  Individuals of both genders and all races will be included

        Exclusion Criteria:

          -  Women who are breastfeeding or pregnant

          -  Individuals with medical conditions unsuitable for MR scanning

          -  Individuals reporting a history of epilepsy or seizures

          -  Individuals reporting an allergy to cycloserine

          -  Individuals diagnosed with asthma or who report previous anaphylactic reaction to
             insect stings/bites, medication, food, or other material and/or event

          -  Individuals reporting present or past diagnosis of a developmental disorder,
             neurological disorder, or head injury *Individuals found to have Axis I
             psychopathology as defined by the DSM-IV (other than spider phobia)

          -  Individuals currently taking any psychotropic medication