bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Fluocinonide Cream 0.1%
Intervention description: 0.1% Cream, One Application, Twice Daily, 14 Days
Intervention MeSH terms: Fluocinonide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Open-Label; Topical; Cream; Eczema; Vanos

Summary:

      The purpose of this research study is to better understand how fluocinonide cream 0.1%
      (Vanos®) works when people use it to treat atopic dermatitis for just a few days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with mild to severe atopic dermatitis, 12 years of age or older, that
             agree to participate and provide written consent (and assent if applicable)

          -  Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating
             of 2 - 4 in the Investigator Global Assessment (Appendix B))

          -  Percentage of overall body surface are of involvement (BSA) must be ≥2%

          -  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:

          -  Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may
             influence study outcome, such as systemic corticosteroids

          -  Application or use within 2 weeks of baseline of topical corticosteroid medications or
             topical anti-inflammatory medication, which may influence study outcome

          -  Presence of a concurrent medical condition, which is determined by the investigator to
             potentially interfere with study outcomes or patient assessments

          -  Introduction of any other prescription medication, topical or systemic, for atopic
             dermatitis while participating in the study

          -  Amount of disease involvement that would require >60 gm of cream in a 1 week period

          -  Subjects with known allergy or sensitivity to topical Vanos™ cream or components

          -  Pregnant women and women who are breastfeeding are to be excluded. Women of
             childbearing potential will be allowed to participate in the study, and these subjects
             will be required to use at least one form of birth control.
Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis
Condition: Liver Cirrhosis; Portal Vein Thrombosis
MeSH terms: Liver Cirrhosis; Thrombosis; Venous Thrombosis
Intervention: Nadroparin calcium, warfarin
Intervention description: Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
Intervention MeSH terms: Nadroparin; Warfarin; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Portal vein thrombosis; Nadroparin calcium; Warfarin; Anticoagulation

Summary:

      The study is aimed at evaluating the efficacy and safety of anticoagulant therapy with
      nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 75 years

          -  Liver cirrhosis diagnosis based on clinical, laboratory, and imaging studies, and PVT
             diagnosed by abdominal contrast-enhanced computed tomography, contrast-enhanced MRI,
             or portal angiography

        Exclusion Criteria:

          -  Cavernous transformation of the portal vein

          -  Uncontrolled active bleeding

          -  Platelet count lower than 10*10^9/L

          -  Creatinine more than 170 mmol/L

          -  Ongoing or received antithrombotic/thrombolytic treatment

          -  Primary thrombophilia

          -  Budd-Chiari syndrome

          -  Pregnancy or breast-feeding period

          -  Severe cardiopulmonary diseases

          -  Severe systemic infection or sepsis

          -  Inability to sign informed consent
Compare the Effects of Fluticasone Furoate Nasal Spray vs Placebo in Patients With Nasal Polypoid Disease
Condition: Patients With Nasal Polyps
MeSH terms: Nasal Polyps
Intervention: fluticasone furoate; placebo
Intervention description: nasal steroid spray; nasal steroid vehicle without drug
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nasal polyps; nasal steroid; fluticasone furoate

Summary:

      Fluticasone furoate is being studied to determine whether treatment with a topical nasal
      steroid, in patients with existing nasal polyps , can not only improve symptoms but also
      suppress the recurrence of clinically significant nasal polyp obstruction and prevent
      surgical intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female patients 18-70 years of age, in general good health.

          2. Current evidence of nasal polyps on physical exam. 3) Able to understand the protocol
             and comply with instructions. 4) Have a negative urine pregnancy test in women of
             childbearing potential. 5) Women of childbearing potential must be on an acceptable
             method of birth control or willing to remain abstinent through the duration of the
             study.

        Exclusion Criteria:

          1. Are pregnant and/or breast-feeding.

          2. History of alcohol or drug abuse in the past year.

          3. Signs and symptoms suggestive of fulminant bacterial sinusitis (fever >101 F,
             persistent severe unilateral facial or tooth pain, facial swelling).

          4. Allergies to nasal corticosteroids

          5. .Other chronic significant medical illnesses 6) Maintenance oral prednisone therapy
             for other chronic medical conditions.

             -

             -
Mycophenolate Mofetil and Tacrolimus Versus Tacrolimus for the Treatment of Idiopathic Membranous Glomerulonephritis
Condition: Glomerulonephritis, Membranous
MeSH terms: Glomerulonephritis; Glomerulonephritis, Membranous
Intervention: tacrolimus; tacrolimus and mycophenolate mofetil
Intervention description: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml; tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Intervention MeSH terms: Mycophenolic Acid; Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Glomerulonephritis

Summary:

      Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of
      membranous glomerulonephritis it is likely to improve the initial response to treatment and
      reduce the risk of relapse on stopping therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic membranous glomerulonephritis on renal biopsy

          -  Proteinuria - protein/creatinine ratio (PCR) > 100 units with hypoalbuminaemia or PCR
             > 300 units with normal serum albumin despite 3 months treatment with maximum
             tolerated doses of ace inhibitors and angiotensin 2 antagonists (or shorter if life
             threatening complications of nephrotic syndrome require institution of immediate
             immunosuppression)

          -  Male or female patients aged 18 to 80 years

        Exclusion Criteria:

          -  Hepatitis B hepatitis C or HIV positive

          -  Malignancy (all patients must have a CT chest abdomen and pelvis and other
             investigations if clinically indicated)

          -  Untreated infection

          -  Females who are pregnant, breast feeding, or at risk of pregnancy and not using a
             medically acceptable form of contraception

          -  Any condition judged by the investigator that would cause the study to be detrimental
             to the patient
Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Intravenous Acetaminophen; Placebo (0.9% Normal Saline infusion)
Intervention description: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.; Infusion of 100 ml of 0.9% NS
Intervention MeSH terms: Acetaminophen
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Pain, Postoperative; Ofirmev; Acetaminophen; Analgesics, Non-Narcotic; Arthroscopy

Summary:

      The purpose of this randomized, placebo controlled, single blind study is to determine if
      postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are
      reduced with the administration of IV acetaminophen when compared to a control group.
      Particular focus will be on the postoperative opioid consumption. In addition, we will
      ascertain if the total time the participant is in the PACU differs in those who receive the
      IV acetaminophen versus those who do not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is scheduled for knee arthroscopy with or without chondroplasty.

          -  Scheduled arthroscopy procedure will not include ligament repairs or ligament
             reconstructions and/or bone cutting or fixation procedures.

          -  Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the
             initiation of surgery.

          -  Is willing and able to sign an informed consent.

        Exclusion Criteria:

          -  Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or
             fixation procedures

          -  Has self-reported and/or documented previous hypersensitivity to acetaminophen.

          -  Has self-reported and/or documented history of hepatic disease or impairment.

          -  Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.

          -  Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic
             beverages per day.

          -  Has a medical history of substance dependence (i.e. prescription analgesics or illegal
             drugs such as cocaine, heroin, etc…). May be self-reported or maybe per the judgment
             of the physician PI/Sub-I.
Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria
Condition: Cystinuria
MeSH terms: Cystinuria
Intervention: Tiopronin 1g per day; Tiopronin 2g per day; Tiopronin 3g per day
Intervention description: 500mg PO BID x 7 days; 1g PO BID x 7 days; 1.5g PO BID x 7 days
Intervention MeSH terms: Penicillamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: cystinuria; D-penicillamine (Cuprimine®); tiopronin (Thiola®)

Summary:

      The purpose of this study is to evaluate the effect of escalating doses of cystine biding
      thiol drugs, including tiopronin and d-penicillamine, on the urinary cystine capacity, which
      is a measure of the amount of cystine in the urine, in patients with cystinuria. The overall
      goal will be to help guide therapy and ultimately minimize unnecessary side effects caused by
      larger doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a patient with a confirmed diagnosis of cystinuria.

          -  Be already taking a CBTD (either D-penicillamine (Cuprimine®) or tiopronin (Thiola®)
             as part of your medication regimen.

          -  Be between 18 and 80 years of age

          -  Be enrolled in the Cystinuria Registry.

        Exclusion Criteria:

          -  You are not a patient with cystinuria

          -  You are not already taking a cystine binding thiol drug

          -  You have renal colic (if you are passing a stone)

          -  You are scheduled to undergo a urologic procedure

          -  You are unwilling or unable to provide informed consent in order to be able to
             participate.
Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1%
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene; Adapalene
Intervention description: Gel, 0.3%, 2g, once daily for 30 days; Gel, 0.1%, 2g, once daily for 30 days
Intervention MeSH terms: Adapalene
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Acne vulgaris; Differin; Adapalene

Summary:

      Phase 4 commitment pharmacokinetic study to determine systemic exposure to adapalene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 18 to 35 years of age

          -  Clinical diagnosis of acne vulgaris

          -  Minimum of 20 Inflammatory

          -  Minimum of 20 Non-inflammatory lesions

          -  The subject has a body weight between 45 and 100 kg, and a Body Mass Index (BMI)
             between 18 and 30Kg/m2

        Exclusion Criteria:

          -  More than 1 nodule or any cyst on the face (excluding the nose)

          -  Acne conglobata, acne fulminans, secondary acne or severe acne

          -  Underlying diseases or other dermatological conditions that require the use of
             interfering topical or systemic therapy

          -  Pregnant or nursing or planning a pregnancy

          -  Surgical or medical condition which might interfere with the absorption, distribution,
             metabolism, or excretion of the drug

          -  Known allergies to any of the ingredients of the study medication

          -  History of alcohol or drug abuse or positive test results for any drug abuse

          -  Positive test results for hepatitis B surface antigen (HBs-Ag), hepatitis C virus
             (HCV) or human immunodeficiency virus antibodies (HIV Ab)

          -  Use of prohibited medications prior to the study unless appropriate washout period is
             documented
Effect of Weight and/or Obesity on Caspofungin Drug Concentrations
Condition: Obesity; Fungal Infection
MeSH terms: Mycoses; Obesity
Intervention: Caspofungin
Intervention description: Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)
Intervention MeSH terms: Caspofungin
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
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 caspofungin. Currently,
      the amount of caspofungin a patient receives is the same regardless of the patient's weight.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects, age 18 years of age or older, of all racial and ethnic
             origins. English and/or Spanish speaking volunteers are eligible to participate.

        Exclusion Criteria:

          -  Pregnant or nursing or unwilling to use a reliable contraception method during the
             study. The effects of caspofungin on pregnancy are unknown. In addition, the metabolic
             changes that accompany pregnancy may alter the concentration-time profile of
             caspofungin, so that the pregnancy and post-partum state would be a confounding
             variable.

          -  Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline
             phosphatase>5 times upper limit of normal, total bilirubin>5 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
One Hour Preoperative Gatifloxacin
Condition: Ophthalmic Surgery
Intervention: Zymar
Intervention description: zymar qid
Intervention MeSH terms: Gatifloxacin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Comparison of 1 day versus 1 hour application of topical Zymar.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ophthalmic surgery

        Exclusion Criteria:

          -  taken antibiotics, allergic to fluoroquinolones
Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Intervention description: Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand
      treatment for children with severe Hemophilia A.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, aged 2-16yrs

          -  Severe hemophilia A (<1% FVIII:C [Blood Clotting Factor VIII:C] )

          -  Minimum of at least 50 documented ED (exposure day) prior to enrolment

          -  No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody
             formation

          -  Parents or legal guardians document, sign, and date informed consent

        Exclusion Criteria:

          -  Another bleeding disease that is different from hemophilia A

          -  Known hypersensitivity to the active substance, mouse or hamster protein

          -  Thrombocytopenia (platelet count <100 000/mm3) based on previous medical records
Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Repository corticotropin injection
Intervention description: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis; Joint pain; Repository corticotropin injection

Summary:

      It is hypothesized that repository corticotropin injection in combination with other biologic
      agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of
      rheumatoid arthritis for patients with disease that had inadequately responded to biologics
      previously.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Rheumatoid arthritis of at least 2 years duration

          -  On at least third biologic with a different mechanism of action for at least 12 weeks

          -  Active disease as defined by at least 6 tender and 6 swollen joints

          -  Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at
             least 1.2 times the upper limit of normal

          -  Stable dose of disease modifying anti-rheumatic drug (DMARD) and prednisone for at
             least 4 weeks

        Exclusion Criteria:

          -  Prior treatment with Acthar Gel

          -  History of intolerance or allergy to glucocorticoids

          -  Unstable diabetes

          -  Active infection