bioihbjkbjnl/mcl2 huggingface dataset:
Study of Dupilumab in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo; Dupilumab
Intervention description: Subcutaneous injection altered between back of arms, abdomen and upper thighs.; Subcutaneous injection altered between back of arms, abdomen and upper thighs.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses
      of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

        The inclusion criteria included, but were not limited to the following:

          1. Male or female, 18 years or older;

          2. Chronic Atopic Dermatitis (AD) for at least 3 years;

          3. History of inadequate response to a stable (>/= 1 month) regimen of topical
             corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before
             the screening visit.

        Exclusion Criteria:

          1. Prior treatment with REGN668;

          2. Presence of certain laboratory abnormalities at the screening visit;

          3. Treatment with an investigational drug within 8 weeks ;

          4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;

          5. Certain treatments and medical procedures, undertaken within a particular time-frame
             prior to the baseline visit, preclude eligibility for participation in the study;

          6. Known history of human immunodeficiency virus (HIV) infection;

          7. History of malignancy within 5 years before the baseline visit, with certain
             exceptions;

          8. Planned surgical procedure during the length of the patient's participation in this
             study;

          9. History of clinical parasite infection;

         10. Any medical or psychiatric condition which in the opinion of the investigator or the
             sponsor's medical monitor, would place the participant at risk, interfere with
             participation in the study, or interfere with the interpretation of study results;

         11. Pregnant or breast-feeding women.
Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Fluocinolone Acetonide; Fluocinolone Acetonide
Intervention description: 0.2 µg/Day in study eye + Sham in fellow eye; 0.5 µg/Day in study eye +Sham in fellow eye
Intervention MeSH terms: Fluocinolone Acetonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: AMD; Age-Related Macular Degeneration; Geographic Atrophy; GA

Summary:

      This study will compare the safety and efficacy of Medidur FA treatment in one eye to the
      sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis bilateral GA secondary to AMD of ≥ 0.5 and ≤ 7 MPS disc areas

          -  Males and non-pregnant females 55 years old or older

        Exclusion Criteria:

          -  GA secondary to any condition other than AMD in either eye

          -  History of or current CNV in either eye or the need for anti-angiogenic therapy

          -  Glaucoma or ocular hypertension (IOP > 21 mmHg OR concurrent therapy at screening with
             IOP-lowering agents) in either eye

          -  Treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to
             enrollment in either eye

          -  Any change in systemic steroid therapy within 3 months of screening

          -  History of vitrectomy in either eye

          -  Any ocular surgery within 12 weeks of screening in either eye
Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo to Ertuglilflozin 1 or 5 mg; Ertugliflozin 1 mg; Ertugliflozin 5 mg; Ertugliflozin 25 mg; HCTZ 12.5mg; Placebo to HCTZ; Placebo to ertuglilflozin 25 mg
Intervention description: Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days; Ertugliflozin tablet 1 mg once daily for 28 days; Ertugliflozin tablet 5 mg once daily for 28 days; Ertugliflozin tablet 25 mg once daily for 28 days; Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days; Placebo to HCTZ 12.5 mg capsule once daily for 28 days; Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
Intervention MeSH terms: Ertugliflozin; Hydrochlorothiazide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 194.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: type 2 diabetes; hypertension; ambulatory blood pressure monitoring

Summary:

      MK-8835-042 (B1521004) is designed to assess the safety and efficacy of an investigational
      drug, ertugliflozin (MK-8835, PF-04971729), in participants with type 2 diabetes and
      hypertension. Participants in the study will receive 1 of 5 treatments for 28 days (either
      placebo, 1 of 3 doses of ertugliflozin [1, 5, or 25 mg], or the approved drug
      hydrochlorothiazide [HCTZ]). The primary hypothesis of the study was that ertugliflozin was
      superior to placebo on the change from baseline in average, 24-hour systolic blood pressure
      (SBP) on Day 28.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with type 2 diabetes and hypertension

          -  Medically stable

          -  On at least 1 (and up to 2) oral diabetes drugs

          -  And up to 2 medicines for blood pressure control

        Exclusion Criteria:

          -  Participants with type 1 diabetes

          -  Heart attack

          -  Stroke

          -  Uncontrolled blood pressure

          -  Significant kidney disease
A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: bevacizumab [Avastin]; fotemustine
Intervention description: 10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity; 75 mg/m2 intravenously on days 1, 8 and 15 followed by, after a 5 weeks interval, 100 mg/m2 on day 1 of a 3-weeks cycle. Until disease progression or unacceptable toxicity
Intervention MeSH terms: Bevacizumab; Fotemustine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, non-comparative study will evaluate the efficacy and safety of Avastin
      (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive
      Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15,
      followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with
      fotemustine serves as a calibration arm and no formal efficacy comparison will be made
      between the two treatment arms. The anticipated time of study treatment is until disease
      progression or unacceptable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 years of age

          -  Diagnosis of recurrent glioblastoma multiforme (Grade IV)

          -  Previous treatment with temozolomide and radiotherapy

          -  First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy
             and chemotherapy)

          -  Adequate hematological, biochemical and organ functions

        Exclusion Criteria:

          -  Previous treatment with Avastin or other anti-angiogenic drugs

          -  Residual relevant toxicity resulting from previous therapy

          -  Radiotherapy within the 3 months prior to the diagnosis of disease progression

          -  Chemotherapy in the previous 4 weeks

          -  Other active or inactive malignancies (except for carcinoma in situ of the cervix, of
             the prostate or basal cell carcinoma)

          -  Clinically significant cardiovascular diseases
HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding
Condition: HIV Infections; Herpes Simplex
MeSH terms: Herpes Simplex
Intervention: valacyclovir; placebo
Intervention description: 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum; oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Intervention MeSH terms: Valacyclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 148.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Disease Transmission, Vertical; valacyclovir; Randomized Controlled Trials; HIV; herpes; Herpesvirus 2, Human; HIV Seronegativity

Summary:

      In this study, we will determine whether treating pregnant and breastfeeding women
      co-infected with human immunodeficiency virus type 1 (HIV-1) and herpes simplex virus type 2
      (HSV-2) with daily valacyclovir will reduce HIV-1 levels in plasma, genital, and breast milk
      and will decrease the risk of mother-to-child HIV-1 transmission (MTCT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 seropositive

          -  HSV-2 seropositive

          -  Plans to deliver in Nairobi

          -  Resides and plans to remain in Nairobi for 12 months postpartum

          -  18 years of age or older

          -  CD4 count>250 cells/μl

        Exclusion Criteria:

          -  indication for highly active antiretroviral therapy (e.g., WHO stage III or IV)

          -  hypersensitivity to valacyclovir or acyclovir
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Combination of GSK573719 and GW642444 in Subjects With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: 500mcg/25mcg once daily; Placebo once daily
Intervention description: GSK573719/GW642444; Inactive, excipients only
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: long-acting beta2-receptor agonist; Safety and tolerability; pharmacodynamics; pharmacokinetics; long-acting muscarinic receptor antagonist; COPD

Summary:

      The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the
      combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed and dated written informed consent prior to study participation

          -  Males or females of non-childbearing potential

          -  40 or more years of age

          -  COPD diagnosis

          -  10 pack-years history or greater of cigarette smoking

          -  Post-bronchodilator FEV1/FVC ratio of 0.70 or less

          -  Post-bronchodilator FEV1 of 80% or less of predicted normal

        Exclusion Criteria:

          -  Current diagnosis of asthma

          -  Other significant respiratory disorders besides COPD, including alpha-1 deficiency

          -  Previous lung resection surgery

          -  Significant abnormalities in chest x-ray presentation

          -  Use of oral steroids, antibiotics or hospitalization for a COPD exacerbation within 3
             motnhs prior screening

          -  Any significant disease that would put subject at risk through study participation

          -  BMI greater than 35

          -  Pacemaker

          -  Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or
             C)

          -  Cancer

          -  Allergy or hypersensitivity to anticholinergics or inhaler excipients

          -  Diseases that would contra-indicate the use of anticholinergics

          -  Use of oral corticosteroids within 6 weeks of screening

          -  Use of long-acting beta-agonists within 48 hours of screening

          -  Use of tiotropium within 14 days of screening

          -  Use of theophyllines or anti-leukotrienes within 48 hours of screening

          -  Use of short-acting bronchodilators within 4 hours of screening

          -  Use of investigational medicines within 30 days of screening

          -  Use of high dose inhaled corticosteroids

          -  Use of long-term oxygen therapy, CPAP or NIPPV

          -  Previous use of GSK573719 or GW642444
Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: 84ug MAP0020; 42ug MAP0020; 21ug MAP0020
Intervention description: 84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol; 42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol; 21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: asthmatic children

Summary:

      This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at
      three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable
      asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation
      aerosol delivery.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female children with a documented diagnosis of mild-to-moderate persistent
             asthma (according to the 2007 NIH [EPR] criteria) for at least 1 year prior to
             screening and medically stable for a minimum of 6 months prior to screening.

          2. Children 4 through 11 years old (up to one day prior to their 12th birthday at
             randomization).

          3. Body weight >=45 lbs, body mass index (BMI) <=30 kg/m2

          4. ICS users had to have been taking an ICS for >=3 months and on a stable dose for >= 1
             month before Visit 1.ICS users had to be stable enough and able to withhold their
             therapeutic ICS for 24 hours prior to study drug administration,

          5. Subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to
             change during the study.

        Key Exclusion Criteria:

          1. Females of child-bearing potential/menarche.

          2. Diagnosis of any other significant chronic illness or abnormality.

          3. Use of corticosteroids
Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)
Condition: Depression
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: MK-8777; Placebo
Intervention description: Orally administered capsules containing either 50 mg or 100 mg MK-8777.; Orally administered matching placebo capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: randomized; placebo controlled; maximum tolerated dose

Summary:

      Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of
      MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female who is non-pregnant, nonlactating, using an acceptable method of birth control,
             or is not of child-bearing potential;

          -  be diagnosed with current major depressive disorder either mild or severe, as
             evidenced by a score of at least 9 but not more than 20 on the Quick Inventory of
             Depression Symptomatology - Clinician Rated (QIDS-C);

          -  be anti-depressant naïve;

          -  be able to refrain from all use of grapefruit containing products from the time of
             admission until the last assessment is performed at discharge;

          -  smokes less than or equal to 10 cigarettes or equivalent daily.

        Exclusion Criteria:

          -  has any current and primary Axis I disorder other than major depressive disorder;

          -  has any history of bipolar I or II disorder, dysthymia, psychotic depression,
             psychotic disorders, posttraumatic stress disorder, borderline personality disorder,
             obsessive compulsive disorder, or eating disorder;

          -  the duration of the current depressive episode is longer than 2 years at screening;

          -  has any history of a significant suicide attempt, or poses a current risk of
             attempting suicide;

          -  is known to be human immunodeficiency virus (HIV) positive, or positive for hepatitis
             B surface antigen or hepatitis A antibodies or hepatitis C total antibodies;

          -  has any clinically significant concurrent endocrine, renal, respiratory,
             cardiovascular, hematological, immunological, cerebrovascular, neurological,
             malignancy, or any other concurrent medical condition, or has any history of diabetes
             mellitus;

          -  donation of blood within 60 days prior to the anticipated first dose of trial
             medication.
Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
Condition: Polio Immunity
MeSH terms: Poliomyelitis
Intervention: IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose
Intervention description: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether a lower dose of inactivated polio vaccine
      (IPV) injected into the skin (intradermal administration) can work equally well or better
      than the standard dose injected into the muscle (intramuscular administration). There are
      more immune cells in the skin than in the muscle, and other vaccines have been shown to
      require a lower dose when administered intradermally. The study is being done in participants
      infected with HIV because HIV-infected people are known to respond less well to vaccines than
      other groups, so it is particularly important to know if IPV might work better in
      HIV-infected people if administered intradermally.

      If it is possible to lower the dose of IPV by intradermal administration, this would make
      inactivated polio vaccine more affordable in the developing countries where it is most needed
    

Eligibility criteria:

        Inclusion Criteria:

          -  documented HIV infection

          -  age of at least 18 years old

          -  HIV viral load <400 on the most recent test

        Exclusion Criteria:

          -  current acute moderate to severe illness (demonstrated by fever over 100.4 Fahrenheit,
             shortness of breath, altered mental status, or by judgment of the primary clinician)

          -  current pregnancy

          -  history of allergic reaction to a polio shot,

          -  history of a life-threatening allergic reaction to neomycin, streptomycin, or
             polymyxin B
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: insulin degludec; insulin degludec; insulin glargine; insulin aspart
Intervention description: Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily; Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily; Treat-to-target dose titration scheme, injection s.c., once daily; Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin, Long-Acting
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of
      this trial is to compare two NN1250 (insulin degludec) formulations with each other and with
      insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetes for at least one year

          -  HbA1c 7-11% (both inclusive)

          -  Treated with insulin for at least six months - any regimen

        Exclusion Criteria:

          -  Any systemic treatment with products which in the Investigator's opinion could
             interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 months
             prior to randomisation

          -  Subject has a clinically significant, active (during the past 12 months) disease of
             the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system
             that, in the opinion of the Investigator, may confound the results of the trial or
             pose additional risk in administering trial product