bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Weight and/or Obesity on Anidulafungin Drug Concentrations
Condition: Obesity; Mycoses
MeSH terms: Mycoses; Obesity
Intervention: Anidulafungin
Intervention description: Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)
Intervention MeSH terms: Anidulafungin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Echinocandin; Obesity; Pharmacokinetics; Pharmacodynamics; Fungal infection

Summary:

      This study will find how weight affects the dosing of a drug called anidulafungin. Currently,
      the amount of anidulafungin a patient receives is the same regardless of the patient's
      weight. BMI groups were for enrollment purposes only and not used for ordinal data analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects, age > 18 years old, of all racial and ethnic origins.

          -  Non-English-speaking Spanish speakers will be included in the study.

          -  The investigators are recruiting six normal or underweight (BMI < 25 kg/m2), six
             overweight or obese (BMI 25-40 kg/m2), and six extremely obese (BMI > 40 kg/m2) for
             this study. This index is calculated using the volunteer's height and weight (Formula:
             weight (lb) / [height (in)]2 x 703). Half of each group will be male; the other half
             will be female.

        Exclusion Criteria:

          -  Pregnant or nursing or unwilling to use a reliable contraception method during the
             study. The effects of anidulafungin on pregnancy are unknown. In addition, the
             metabolic changes that accompany pregnancy may alter the concentration-time profile of
             anidulafungin, so that the pregnancy and postpartum state would be a confounding
             variable.

          -  Abnormal liver function tests: transaminases > 3 times upper limit of normal, Alkaline
             phosphatase > 3 times upper limit of normal, total bilirubin > 3 times upper limit of
             normal.

          -  History of allergies to echinocandins.

          -  Echinocandins are contraindicated for any reason.

          -  Volunteers unwilling to comply with study procedures.

          -  Suspected or documented systemic fungal infection.

          -  Concomitant use of rifamycins, tacrolimus, or cyclosporine.

          -  Current participation or previous participation within 28 days of enrollment in
             another research study that involves the use of medication, contrast, or any other
             compound that may alter blood count and/or blood chemistry (liver function, kidney
             function or electrolyte balance) (Unless waved by PI).

          -  Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study
             enrollment (Unless waved by PI).

          -  Creatinine Clearance < 70 ml/min as estimated by the Cockcroft-Gault equation.
A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients
Condition: Thrombocythemia, Hemorrhagic
MeSH terms: Thrombocytosis; Thrombocythemia, Essential
Intervention: Anagrelide; Hydroxyurea
Intervention description: Anagrelide hydrochloride 0.5mg capsules;initial dose administered will be 1.0mg/day administered as 0.5mg bid. The dose will be titrated such that the total daily dose is incremented by no more than 0.5mg per week as required depending on platelet reduction versus adverse event profile.; Hydroxyurea is 500mg hydroxycarbamide capsules; initial dose is 1000mg/day, administered in two divided doses (500mg/dose). Dose titrated to effect to achieve a response.
Intervention MeSH terms: Hydroxyurea; Anagrelide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to
      be produced. Platelets are small cells carried around in the blood, which help form blood
      clots. When patients have too many platelets, there is a risk of blood clots forming
      unnecessarily and excessive bleeding. The aim of this study is to gain additional information
      on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as
      hydroxycarbamide).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of essential thrombocythaemia - high risk profile

          -  Previously untreated with a cytoreductive agent

          -  Females of childbearing potential must have a negative urine pregnancy test prior to
             entering the study and must agree to use effective birth control for the duration of
             the study

        Exclusion Criteria:

          -  Diagnosis of any other myeloproliferative disorder

          -  Any known cause for a secondary thrombocytosis

          -  Anti-coagulant and anti-aggregant therapies

          -  Known or suspected heart disease

          -  Left Ventricular Ejection Fraction < 55%
Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline
Condition: Acne
Intervention: Minocycline
Intervention description: Oral extended release minocycline
Intervention MeSH terms: Minocycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 14 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the skin and plasma concentrations of
      minocycline in subjects undergoing treatment of acne vulgaris with oral extended release
      minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Otherwise healthy male and female subjects 14 to 40 years of age

          -  Moderate to severe inflammatory facial acne vulgaris (EGSA score of 3-5)

          -  Subjects not using oral or topical antibiotic products for at least 30 days prior to
             study entry and willing to refrain from use of oral and topical antibiotics for the
             duration of study participation

          -  Subjects not currently using and willing to refrain from use of other topical acne
             products for the duration of study participation

        Exclusion Criteria:

          -  Mild, non-inflammatory or nodular acne vulgaris

          -  Have current or previous skin cancer

          -  Have a history of skin disease or presence of skin condition the PI believes would
             interfere with the study

          -  Females who report that they are pregnant, planning a pregnancy during the study
             period or breastfeeding

          -  Have conditions or factors that the PI believes may affect the response of the skin or
             the interpretation of the results

          -  Participation in any clinical study within the previous 30 days or plan concurrent
             participation in other studies
Adrenocorticotropic Hormone in Membranous Nephropathy
Condition: Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Intervention: ACTHar
Intervention description: for 6 months
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Membranous nephropathy; adrenocorticotropic hormone; ACTH; proteinuria; glomerulonephritis

Summary:

      The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH,
      Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous
      nephropathy. Acthar is a hormone that stimulates steroid production from small glands above
      the kidneys. It has direct protective effects on the kidney and is currently approved by the
      FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of
      action are not entirely understood and will be studied in the present trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 70 years

          -  Free of immunosuppression for at least 3 months

          -  Capability of understanding the purpose of the study

          -  Written informed consent

        Exclusion Criteria:

          -  Epidermal growth factor receptor (eGFR) < 30ml/min/1.73m2

          -  Kidney Transplant

          -  Secondary MN (defined on the basis of clinical criteria)

          -  Type 1 or Type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus
             is not an exclusion)

          -  History of previous use of Acthar for treatment of nephrotic syndrome

          -  Prior sensitivity to Acthar or other porcine protein products

          -  Contraindication to Acthar per Prescribing Information

          -  Planned treatment with live or live attenuated vaccines once enrolled in the study

          -  More than three previous treatment regiments

          -  Participation to other clinical trials over the previous 12 months

          -  History of cancer, except carcinoma in situ and treated basal and squamous cell
             carcinomas

          -  Pregnancy

          -  Lactation

          -  Current substance abuse

          -  Any clinically relevant condition that might affect study participation and/or study
             results
Ultrasound-guided Injection for DeQuervain's
Condition: DeQuervain's Tenosynovitis
MeSH terms: Tenosynovitis
Intervention: Betamethasone; Ultrasound
Intervention description: Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound
Intervention MeSH terms: Betamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: wrist; tendonitis; dequervain's; tenosynovitis

Summary:

      The investigators aim to perform a prospective study to evaluate the effectiveness of blind
      corticosteroid injections to US-guided injections for the treatment of de Quervain's disease.
      The results of the study will be used to validate current injection protocols or support the
      incorporation of ultrasonography to treat the disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pain with palpation at 1st dorsal compartment at wrist and positive Finkelstein's Test

        Exclusion Criteria:

          -  Patients with evidence of osteoarthritis or degeneration of the wrist.
Chronotherapy in Inflammatory Bowel Disease
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: Evening Group; Morning Group
Intervention description: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.; Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to one of two groups: Evening Time or Morning Time. Participants are used as their own control. The evening time group will take their medication in the evening and the morning time group will take the medication in the morning.
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aims to determine if there is any difference in the efficacy of Inflammatory Bowel
      Disease (IBD) medication and disease outcomes when taken in the morning or in the evening.
      The IBD medications being observed are azathioprine and 6-mercaptopurine. The study team
      believes that there may be a benefit to taking the medication at a certain time of day. To
      test this theory the study asks participants who are already taking either azathioprine or
      6-mercaptopurine for IBD to take the medication consistently at either the morning or in the
      evening based on when they currently take their medication. Participation is up to 10 weeks
      +/- 3 days. There will be 2 study visits where the participant will be asked to fill in
      questionnaires related to their IBD symptoms, their sleep habits, sleep quality, and general
      health information followed by a blood draw.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Above the ages of 18

          -  Diagnosis of Crohn's Disease or Ulcerative Colitis

          -  Currently taking azathioprine or 6-mercaptopurine

          -  Willing to sign study consent form

        Exclusion Criteria:

          -  Vulnerable population (pregnant, prisoner, non-English speaking or cognitively
             impaired)

          -  Breastfeeding subject

          -  Have a history of complications related to immunomodulatory therapy

          -  Participating in other research studies involving research interventions

          -  Treated with dual corticosteroid and immunomodulatory therapy
Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Bupivacaine Block; Placebo
Intervention description: Bupivacaine local anesthesia block prior to start of FESS procedure.; placebo is identical in appearance in comparison to active drug.
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The aim of the study is to quantify postoperative pain after functional endoscopic sinus
      surgery (FESS) and investigate whether preemptive analgesia may positively impact
      intraoperative anesthetic management, decrease patient postoperative pain and discomfort, and
      improve patient functional outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The study subjects will be 18-70 year old.

          2. The subjects will be American Society of Anesthesiology physical status I and II
             patients.

          3. Patients with chronic rhinosinusitis, presenting for bilateral functional endoscopic
             sinus surgery.

          4. The subjects should understand informed consent and study instructions, AND 5. The
             subjects should not participate in any other research protocols.

        Exclusion Criteria:

          1. Patients with pre-existing chronic facial pain not related to chronic rhinosinusitis.

          2. Patients with pre-existing chronic pain of different etiology.

          3. Patients taking prescription pain medications.

          4. Patients taking antidepressant medications.

          5. Patients taking over-the-counter pain medications within 48 hours of scheduled
             surgery.

          6. Patients in whom oral opioid-containing analgesics would be contraindicated
             postoperatively.

          7. Patients with a known or suspected genetic susceptibility to malignant hyperthermia,
             or known sensitivity to Desflurane or other halogenated agents.

          8. Patients with the history of arrhythmias or significant coronary artery disease.

          9. Patients with psychological disorders.

         10. Patients who are unable to understand the questionnaires or the visual analogue scale
             (VAS) pain scores.

         11. Patients with the history of substance or alcohol abuse.

         12. Patients with compromised renal and liver function.

         13. Patients with abnormal coagulation status or platelet count less than 100,000.

         14. Pregnant patients.

         15. Patients with an allergy to Bupivacaine, Lidocaine or Epinephrine.

         16. Other patients that may be excluded by the investigator, based on medical history and
             physical examination
Brilinta DaYu Study
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Ticagrelor
Intervention description: 90mg/tablet, 1 tablet bid
Intervention MeSH terms: Ticagrelor
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2004.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the
      incidence of major cardiovascular events of ticagrelor in Chinese patients with acute
      coronary syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Female or male aged at least 18 years 2.Index event of non-ST or ST segment
             elevation ACS 3.A patient who is considered as ethnic Chinese

        Exclusion Criteria:

          -  1. With coagulation disorder 2.Index event is an acute complication of PCI 3.Patient
             has planned for an urgent coronary artery bypass graft (CABG) within 7days from the
             enrolment 4.Oral anticoagulation therapy within 30 days prior to enrolment or cannot
             be stopped 5.Increased risk of bradycardic events 6. Concomitant oral or intravenous
             therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with
             narrow therapeutic indices, or strong CYP3A inducers 7.Increased risk of bradycardic
             events (eg, no pacemaker and known sick sinus syndrome, second degree A-V block, third
             degree A-V block or previous documented syncope suspected to be due to bradycardia
             unless treated with a pacemaker). 8.Known clinically important thrombocytopenia
             9.Known clinically important anaemia
Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Intervention: Amantadine Hydrochloride
Intervention description: 6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
Intervention MeSH terms: Amantadine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: cerebral palsy; amantadine; cognitive function; gross motor skills; fine motor skills; mood

Summary:

      Cerebral palsy (CP) is a common childhood-onset disability associated with motor and
      cognitive impairments, however most research is focused on motor outcomes. The aim of this
      study is to determine the effects of Amantadine, a dopaminergic agonist, on cognitive
      function in adolescents and adults with CP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Cerebral Palsy

        Exclusion Criteria:

          -  Currently pregnant

          -  Unstable seizure condition

          -  Currently taking methadone

          -  Currently taking other dopamine agonists

          -  Currently taking anti-psychotic medication

          -  Previously taken amantadine

          -  Diagnosed with Chronic Kidney Disease (CKD)
Alternative in Beta Blocker Intolerance: The ABBI Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Nebivolol
Intervention description: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Intervention MeSH terms: Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Intolerance; Beta blocker

Summary:

      In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in
      cardiovascular patients who are not able to tolerate conventional beta blockers. A side
      effect profile will be tracked and compared with previous beta blocker use.

      The investigators hypothesize that Bystolic will be tolerated by many patients who are
      intolerant of conventional blockers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 21

          -  Male or female who is post-menopausal or not pregnant and using an approved
             contraceptive regimen

          -  Previous beta blocker use and intolerant of beta blocker

        Exclusion Criteria:

          -  Systolic blood pressure < 100 mmHg unless another blood pressure medication is stopped
             at the time of study entry

          -  Hospitalized for heart failure within the past 4 weeks

          -  Bradycardia with a heart rate < 60

          -  Heart block greater than first degree

          -  History of sick sinus syndrome (unless a permanent pacemaker is in place)

          -  History of severe hepatic or renal dysfunction; serum Creatinine > 2.0 or Amylase > 3x
             normal

          -  Use of CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)

          -  Ingestion of investigational drug within the past 30 days