bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours
Condition: Tumors
MeSH terms: Hypertension
Intervention: AZD2171
Intervention description: 30 mg & 45 mg oral tablet
Intervention MeSH terms: Cediranib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Solid Tumours; phase II; Hypertension; RECENTIN

Summary:

      The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be
      well tolerated without significant drug withdrawal when accompanied by a suitable
      hypertension management strategy or dose reduction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological confirmation of advanced solid tumour, which is refractory
             to standard therapies or for which no standard therapy exists and for which there is a
             rationale for the therapeutic use of a vascular endothelial growth factor receptor
             (VEGFR) tyrosine kinase inhibitor.

        Exclusion Criteria:

          -  Prior treatment with a VEGF inhibitor

          -  Poorly controlled hypertension
Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Telaprevir and Sofosbuvir
Intervention description: All subjects will have time to read and discuss IRB approved consent form prior to any study procedures. Following proper consenting, subjects will undergo physical exam including ECG and bloodwork prior to baseline visit. Subjects will return for research visits (vitals, collection of AEs, bloodwork, drug accountability) on Day 3, Weeks 1, 2, 3, 4, 6, 8, 10 and 12 of treatment and 4, 12, and 24 weeks after end of treatment. PK samples will be collected at week 2 and week 10.
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV Genotype 1; Hepatitis C Virus Genotype 1; HCV; TVR

Summary:

      This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with
      genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in
      combination with sofosbuvir (SOF) for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide informed consent

          -  BMI (Body Mass Index) ≥ 18 kg/m2

          -  HCV RNA quantifiable at screening and >1,000 IU/ml

          -  HCV treatment Naïve

          -  HCV genotype 1

          -  7. Confirmation of chronic HCV infection documented by either: A positive anti-HCV
             antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months
             prior to the Baseline/Day 1 visit, or A liver biopsy performed prior to the
             Baseline/Day 1 visit with evidence of chronic HCV infection

        Exclusion Criteria:

          -  Current or prior history of any of the following:

        Clinically-significant illness Cirrhosis 2. Screening ECG with clinically significant
        abnormalities

          1. ALT > 10 x the upper limit of normal (ULN)

          2. AST > 10 x ULN

          3. Direct bilirubin > 1.5 x ULN

          4. Platelets < 150,000/μL

          5. HbA1c > 7.5%

          6. Creatinine clearance (CLcr) < 60 mL /min, as calculated by the Cockcroft-Gault
             equation

          7. Hemoglobin < 11 g/dL for female subjects; < 12 g/dL for male subjects.

          8. Albumin < 3.1 g/dL

          9. INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant
             regimen affecting INR 4. Prior exposure to any approved or experimental HCV-specific
             direct-acting

             5. Pregnant or nursing female or male with pregnant female partner.

             6. Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's
             disease, alfa-1 antitrypsin deficiency, cholangitis).

             7. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines
Condition: Glabellar Lines
Intervention: AGN-151586; Placebo
Intervention description: AGN-151586 solution for injection.; Placebo solution for injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range
      of doses for the treatment of moderate to severe glabellar lines (GL).
    

Eligibility criteria:

        Inclusion Criteria:

        -Female participants willing to minimize the risk of inducing pregnancy for the duration of
        the clinical study and follow-up period (at least 10 weeks after study intervention).

        Exclusion Criteria:

          -  Known immunization or hypersensitivity to any botulinum neurotoxin serotype

          -  Any medical condition that may put the participant at increased risk with exposure to
             AGN-151586, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic
             lateral sclerosis, or any other condition that might interfere with neuromuscular
             function

          -  Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick
             sebaceous skin, or the inability to substantially lessen facial lines even by
             physically spreading them apart, as determined by the investigator

          -  Any brow or eyelid ptosis, as determined by the investigator

          -  Infection or skin disorder at the injection sites

          -  History of facial nerve palsy

          -  Any uncontrolled systemic disease

          -  Anticipated need for treatment with botulinum neurotoxin of any serotype for any
             reason during the study (other than study intervention)

          -  Anticipated need for surgery or overnight hospitalization during the study

          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery)

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,
             Gore-Tex®), and/or autologous fat transplantation

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of Screening
Herbal Mouthrinse for Oral Mucositis Study
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Intervention: Neem Mouthrinse; Placebo Mouthrinse
Intervention description: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.; 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Intervention MeSH terms: Ascorbic Acid; Glycerol
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Oral; Mucositis; Stomatitis; Radiotherapy

Summary:

      This study involves adults receiving radiation therapy for head and neck cancer and will test
      whether or not the study mouthrinse may lessen oral mucositis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Anatomic site: lip (inner aspect), oral cavity, pharynx or larynx; includes tonsils
             and salivary glands (ICD-9: 140-149 or 161).

          -  Malignant tumor: ICD-O morphology 2 (in situ) or 3 (malignant, invasive or
             infiltrating).

          -  Adult aged 18-89 years.

          -  Patient recommended or planned to undergo radiotherapy to the head and neck regions,
             as part of their cancer treatment regimen.

          -  Radiotherapy to be given in standard doses over a 4 - 7 week period.

        Exclusion Criteria:

          -  Prior radiation treatment for cancer of the oral cavity, head or neck.

          -  Baseline mouth and throat soreness (MTS) extreme score of 4.

          -  Eastern Cooperative Oncology Group (ECOG) performance status >2.

          -  Unable to sign Informed Consent.

          -  Known history of allergy to any of the mouthrinse constituents (aloe, anise, ascorbic
             acid, clove, glycerin, peppermint, poloxamer 407, potassium sorbate, spearmint, thyme,
             water, xylitol).

          -  Inability to use a mouth rinse.

          -  Patient unable to communicate with study personnel in English (either themselves or an
             interpreter).
LEO 29102 Cream in the Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: LEO 29102; Elidel®
Intervention description: comparison of different dosages of drug; comparison
Intervention MeSH terms: Pimecrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with
      vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment
      regimen in mild to moderate atopic dermatitis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of atopic dermatitis defined according to Hanifin and Rajka

          -  IGA assessment scored as mild (2) to moderate (3) atopic dermatitis

          -  Treatment lesions located on the trunk and limbs

          -  Treatment lesions involving 3% to 10% of the total body surface area

          -  Patients of either gender between 18 years and 65 years of age

        Exclusion Criteria:

          -  Systemic treatment with immunosuppressive drugs or corticosteroids within 6 weeks
             prior to randomisation

          -  Topical treatment with immunomodulators (pimecrolimus, tacrolimus) within 2 weeks
             prior to randomisation

          -  Topical treatment with corticosteroids from WHO groups II, III or IV within 1 week
             prior to randomisation

          -  Use of topical or systemic antibiotics within 2 weeks prior to randomisation

          -  PUVA or UVB therapy within 4 weeks prior to randomisation

          -  Clinical infection (viral, fungal or bacterial) on the treatment area

          -  Known or suspected severe renal insufficiency or severe hepatic disorders

          -  Patients with history of an immunocompromised disease (e.g., lymphoma, HIV,
             Wiskott-Aldrich Syndrome)

          -  Patients with concomitant serious disease (e.g., cancer) which might affect the AD
             treatment in this trial

          -  Females who are pregnant or are breast feeding

          -  Females intending to temporarily or permanently stop their hormonal contraceptive
             regime during and up to one month post study termination visit
Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: erlotinib
Intervention description: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: OSI-774, TARCEVA (ERLOTINIB); Lung; recurrent; 10-097; Gefitinib

Summary:

      The purpose of this study is to measure the ability of erlotinib to effectively treat
      recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with
      erlotinib or gefitinib received in the post-surgical or post-radiation setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A history of stage I-IIIB NSCLC

          -  Previously underdone definitive surgery or radiation

          -  Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a
             total of at least 3 months at any time

          -  Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first
             imaging demonstrating recurrence

          -  Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing
             mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented
             in the primary or recurrent tumor

          -  Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to
             evaluate for the presence of the T790M mutation (results do not need to have been
             reported to be eligible)

          -  Measurable disease by RECIST; if received prior irradiation, then must have a target
             lesion outside the irradiated field

          -  Signed informed consent

          -  Age > or = to 21 years old

          -  Persons of reproductive potential must agree to use an adequate method of
             contraception throughout treatment and for at least 4 weeks after study drug is
             stopped

        Exclusion Criteria:

          -  Prior progressive disease while receiving erlotinib or gefitinib therapy

          -  Patients with known pre-existing interstitial lung disease

          -  Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's
             syndrome

          -  AST or ALT greater than five times the upper limit of normal

          -  Pregnant or lactating women

          -  Medically unfit for erlotinib therapy as determined by treating oncologist
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
Condition: Uveitis; Macular Edema; Uveitis, Posterior; Uveitis, Anterior; Panuveitis; Uveitis, Intermediate
MeSH terms: Macular Edema; Uveitis; Panuveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Uveitis, Anterior; Edema
Intervention: 4 mg CLS-TA; 0.8 mg CLS-TA
Intervention description: 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension); 8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: uveitis; macular edema; UME; posterior uveitis; anterior uveitis; panuveitis; intermediate uveitis; noninfectious uveitis; triamcinolone acetonide; suprachoroidal space; injection; microneedle; intravitreal injection; corticosteroid; CME; choroid; retina; microinjection; SCS

Summary:

      The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA,
      in subjects with macular edema following non-infectious uveitis. A single suprachoroidal
      injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema
      following non-infectious uveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of noninfectious uveitis

          -  diagnosis of macular edema associated with noninfectious uveitis

        Exclusion Criteria:

          -  any ocular trauma within the immediate 6 months prior to treatment

          -  any photocoagulation or cryotherapy in the 6 months prior to treatment

          -  any IVT injection of anti-VEGF treatment in the 2 months prior to treatment

          -  any eye diseases other than uveitis and ME that could compromise central visual acuity

          -  any previous suprachoroidal injection of triamcinolone acetonide in the study eye
Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Vonafexor; Placebo
Intervention description: Oral tablets; Oral tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Triple (Participant, Care Provider, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: EYP001 (vonafexor); Liver Diseases; Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; NASH

Summary:

      The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to
      safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with
      NASH
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Suspected diagnosis of NASH, evidenced by elevated alanine aminotransferase (ALT),
             liver stiffness compatible with F2 or F3 fibrosis and Liver Fat Content (LFC) ≥10% as
             measured by MRI

          -  Women of childbearing potential and male patients with female partners must agree to
             use a dual method of contraception

        Exclusion Criteria:

          -  Evidence of worsening liver injury

          -  Previous diagnosis of other forms of non-NASH liver disease

          -  Use of Vitamin E, glitazones, glucagon-like Peptide-1 receptor agonists,
             ursodeoxycholic acid, or obeticholic acid within 90 days prior to screening

          -  History of cirrhosis or liver decompensation

          -  Known history of alcohol abuse or daily heavy alcohol consumption

          -  Pregnant or breastfeeding women

          -  Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus

          -  Patients with contraindications to MRI imaging
Adrenal Function and Use of Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10) in Patients With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: Triamcinolone Acetonide 10 mg/mL (Kenalog-10)
Intervention description: Triamcinolone Acetonide 10 mg/ml (Kenalog-10) intralesional injection
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Screening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to see whether treating alopecia areata with injections of the
      corticosteroid, Triamcinolone acetonide 10mg/cc (Kenalog-10), has an impact on the adrenal
      glands.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has clinical diagnosis of alopecia areata.

          -  Written informed consent and HIPAA authorization have been obtained.

               -  Female subjects of childbearing potential have a negative pregnancy test and
                  agree to use an acceptable method of birth control to prevent pregnancy.

          -  In the opinion of the investigator, subject is a candidate for intralesional therapy
             for alopecia areata.

          -  Subject agrees to comply with protocol requirements and attend all required study
             visits and is considered to be a good study subject.

          -  Subject meets concomitant medication washout requirements.

          -  Subject is >/= 18 years of age.

        Exclusion Criteria:

          -  Subject has alopecia universalis.

          -  Subject has known adrenocortical insufficiency or Cushing's Syndrome.

          -  Subject is pregnant or lactating.

          -  Subject has current controlled or uncontrolled bacterial, viral, fungal, atypical, or
             opportunistic infections.

          -  Subject possesses hypersensitivity to cortrosyn or Triamcinolone Acetonide
             (Kenalog-10) or any component of their formulation.

          -  Subject is currently or has undergone therapy for malignancy within the past five
             years.

          -  Subject has history of substance abuse within the past five years.

          -  Subject has used oral corticosteroids within the past 12 months.

          -  Subject has concurrent use of phenytion rifampin, phenobarbital, mitotane, or other
             formulations of corticosteroid medications.

          -  Subject has any medical condition that, in the judgement of the investigator, would
             jeopardize the subject's safety following exposure to the administered medications.