bioihbjkbjnl/mcl2 huggingface dataset:
Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Intervention: Lapatinib
Intervention MeSH terms: Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lapatinib; advanced; metastatic breast cancer; GW572016; ErbB2

Summary:

      This phase II study will evaluate and compare the efficacy and tolerability of two dose
      schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with
      advanced or metastatic breast cancer.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with
             T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent
             surgery.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

          -  Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)

          -  Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)

          -  Adequate renal, hepatic and cardiac function

        Exclusion criteria:

          -  Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other
             than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab)
             will be allowed provided it was stopped at least 12 months before study entry.

          -  Patients with active brain metastases

          -  Patients with bilateral breast cancer, bone metastases as the only disease site or
             metastases to more than 30% of the hepatic parenchyma.
Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: AVACEN Thermal Exchange System
Intervention description: Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Fibromyalgia; Pain; Non-Invasive; Arthritis; Rheumatoid Disease

Summary:

      Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved
      Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and
      psychological assessment. This non-invasive device is able to rapidly raise the core body
      temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating
      element. The change in body temperature may change the sympathetic nervous system's activity
      and thereby reduce Fibromyalgia pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fibromyalgia diagnosis

          -  Over the age of 18

          -  Understands English

          -  Not pregnant/planning to become pregnant

          -  Average pain of 4 or greater over the last week (10 point scale)

          -  Fibromyalgia pain lasting longer than 6 months

        Exclusion Criteria:

          -  Pregnant/Planning to become pregnant

          -  Major unstable psychiatric illness

          -  Major, uncontrolled systemic illness for which you may be hospitalized in the next 6
             months
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 5 mg ASB17061; Placebo; 10 mg ASB17061; 20 mg ASB17061
Intervention description: Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days.; Oral administration of placebo taken once daily for 28 consecutive days.; Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days.; Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 370.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; eczema

Summary:

      The purpose of this research study is to gather scientific information about the
      effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult
      subjects with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects ages 18 to 65 years

          -  A diagnosis of atopic dermatitis (AD)

          -  An Investigator's Global Assessment (IGA) score of 2 or higher and AD affecting at
             least 5% of total Body Surface Area (BSA)

          -  Other than active AD, in good health with no medical condition that may jeopardize the
             safety of the subject or impact the validity of the study results

          -  Subjects must be practicing acceptable birth control methods

        Exclusion Criteria:

          -  Taking systemic immunosuppressive therapy within 3 months prior to screening or
             systemic (cortico) steroid therapy within 4 weeks prior to screening

          -  Use of phototherapy or tanning beds within 6 weeks of screening

          -  Presence of a clinically significant disorder involving gastrointestinal, renal,
             hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic,
             psychiatric, or cardiovascular disease or any other condition, which will jeopardize
             the safety of the subject or impact the validity of the study results

          -  Female subjects who are pregnant or breastfeeding
A Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Pertuzumab; Trastuzumab
Intervention description: Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.; Participants will receive trastuzumab at a dose of 6 milligrams per kilogram (mg/kg) of body weight once weekly via IV infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Intervention MeSH terms: Trastuzumab; Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will examine the safety and efficacy of pertuzumab in combination with high-dose
      trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease
      progression in the brain following radiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed HER2-positive MBC

          -  Progression of or new brain metastases after completion of whole-brain radiotherapy or
             stereotactic radiosurgery

          -  Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days
             prior to enrollment

          -  Stable systemic disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  LVEF at least 50%

          -  Adequate hematologic, renal, and hepatic function

          -  Life expectancy more than 12 weeks

        Exclusion Criteria:

          -  Progression of systemic disease at Screening

          -  Leptomeningeal disease

          -  History of intolerance or hypersensitivity to study drug

          -  Use of certain investigational therapies within 21 days prior to enrollment

          -  Current anthracycline use

          -  Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use

          -  Active infection

          -  Pregnant or lactating women

          -  Significant history or risk of cardiac disease

          -  Symptomatic intrinsic lung disease or lung involvement

          -  History of other malignancy within the last 5 years
Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
Condition: Otomycosis
MeSH terms: Otomycosis
Intervention: 7-Day Miconazole Oil (Miconazole 2%); 14-Day Miconazole Oil (Miconazole 2%); 14-Day Placebo - Oil Vehicle
Intervention description: 7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole); 14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole); 14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
Intervention MeSH terms: Miconazole; Clotrimazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Subjects, investigators, and study staff will not be masked as to the treatment duration assigned to each subject (7 versus 14 days). For subjects receiving the 14-day treatment with study drug, the contents of the study drug (active versus placebo) will be masked to the subject, investigator, and study staff.
Enrollment: 65.0
Sex: All
Minimum age: 25 Months
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the efficacy and safety of active treatment
      (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole
      oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with
      fungal infection (otomycosis) of the external ear.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Uncomplicated otomycosis of the external ear only, age more than 2 year

        Exclusion Criteria:

          -  Pregnancy

          -  Other dermatoses or conditions of the ear that may interfere with the evaluation of
             otomycosis, including concomitant otic infections (including bacterial infection) that
             require antimicrobial treatment, disease that has spread beyond the external ear(s),
             or pre-existing skin atrophy of the affected ear(s)

          -  Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated

          -  Previous surgery affecting the ear(s) that will be treated, except for prior
             tympanostomy tube(s) that had been removed and had completely healed

          -  Previous use of medicated treatments for otomycosis or participation in another
             investigational study within 28 days of study entry

          -  Previous use of any systemic antifungal therapy, warfarin, and immunosuppressive or
             immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3
             months of study entry

          -  Recurrent otomycosis that had been unresponsive to previous antifungal treatment

          -  Known hypersensitivity to any of the components in the test formulation
Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients
Condition: Ocular Inflammation
MeSH terms: Cataract; Inflammation
Intervention: IBI-10090
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: cataract; inflammation

Summary:

      This study will test the efficacy and safety of IBI-10090 in the treatment of ocular
      inflammation after cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients 40 years of age scheduled for unilateral cataract surgery
             (phacoemulsification or extracapsular extraction) with posterior chamber intraocular
             lens implantation.

        Exclusion Criteria:

          -  Patients who have used any ocular, topical, or oral corticosteroids within 7 days
             prior to Day 0.

          -  Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to
             screening.

          -  Patients with any signs of intraocular inflammation in either eye at screening.

          -  Patients who have received any prior intravitreal injections in the study eye.
Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine
Intervention description: Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this clinical study is to assess overall safety and tolerability as
      measured by discontinuation rate due to adverse events in doses up to 120 mg/day in relation
      to global clinical studies in adult subjects who meet Diagnostic and Statistical Manual of
      Mental Disorders, Fourth Edition (DSM-IV™) criteria for Attention-Deficit/Hyperactivity
      Disorder (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. at least 18 years of age

          2. meet Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) diagnostic criteria
             for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during
             childhood

          3. have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate
             symptoms) or greater

        Exclusion Criteria:

          1. Patients who meet DSM-IV diagnostic criteria for current major depression and also
             patients who have total score of more than 12 on the 17-item Hamilton Depression
             Rating Scale (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or
             past history of major depression and have received any anti-depression drug therapy
             within 6 months of Visit 1.

          2. Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and
             also require anti-anxiety drug therapy except for those taking benzodiazepines
             analogues for anxiety which need to be limited.

          3. Patients who have any history of bipolar disorder (DSM-IV) , any history of
             schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from
             the study.

          4. Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.
Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
Condition: Lichen Planopilaris; Frontal Fibrosing Alopecia
MeSH terms: Alopecia; Alopecia Areata; Lichen Planus
Intervention: Low-Dose Naltrexone
Intervention description: Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12 months to monitor their progress.
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Oral naltrexone was initially FDA approved to treat opioid use disorder and alcohol
      dependence at doses from 50-100mg/day. At lower doses of 1-5mg/day, naltrexone has been used
      off-label with success in treatment of several dermatologic conditions including the scarring
      hair loss disease lichen planopilaris. A recent case series of four patients with lichen
      planopilaris and a subtype, frontal fibrosing alopecia, treated with oral low-dose naltrexone
      at 3mg daily showed reduction of itch, clinical evidence of inflammation of the scalp, and of
      disease progression. There were no reported adverse events.

      Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg
      to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued
      on their other medications for these conditions. The study would be open-label, so all
      participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12
      months to monitor their progress.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 18 or greater

          -  clinically or histologically confirmed diagnosis of lichen planopilaris or frontal
             fibrosing alopecia

        Exclusion Criteria:

          -  known allergy or hypersensitivity to naltrexone

          -  patients with concurrent use of opioids

          -  active depression, schizophrenia, and bipolar disorder
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: QGE031; Omalizumab; Placebo
Intervention description: QGE031 was supplied as 120 mg liquid in vial per 1 mL; Omalizumab was supplied as 150 mg lyophilisate in vial; Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Intervention MeSH terms: Omalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 471.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: asthma; asthma control; allergy; atopic; IgE; double-blind; placebo; omalizumab

Summary:

      This study assessed the effect on asthma control of different dose levels and regimens of
      QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2
      agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab.
      Information from this study was planned to support the design of future studies.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A diagnosis of allergic asthma , uncontrolled on current medication.

          -  History of at least 1 asthma exacerbation during the last 1 year

          -  Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted
             normal value; reversibility following administration of bronchodilator must also be
             demonstrated (historical positive reversibility or bronchoprovocation result can be
             used).

        Key Exclusion Criteria:

          -  Baseline IgE levels or body weight outside the omalizumab dosing table.

          -  Use of tobacco products within the previous 6 months (Social occasional smokers may be
             included).

          -  Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.
Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: MEDI8968; Saline
Intervention description: SC injection at baseline, Week 4 and Week 8; SC injection at baseline, Week 4 and Week 8
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to gain initial evidence for the safety, tolerability and
      efficacy of MEDI8968 for the treatment of subjects with moderate to severe hidradenitis
      suppurativa
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hidradenitis suppurativa (HS) (moderate to severe)

          -  Diagnosis of HS for at least 1 year

          -  At least 5 active inflammatory lesions in at least 2 locations

          -  On a stable dose of antibiotics and/or analgesics for at least 4 weeks (if already
             taking these medications)

          -  Average pain score of 3-9.

        Exclusion Criteria:

          -  History of cyclic neutropenia

          -  Laboratory assessment abnormalities

          -  Underlying disorder considered unsuitable for inclusion

          -  Other skin diseases that may interfere with HS assessment

          -  Pregnancy or planning for pregnancy