bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-0941; Glimepiride; Metformin
Intervention description: MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.; Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.; The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], the participant should remain on the same metformin dose throughout the study.
Intervention MeSH terms: Metformin; Glimepiride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants
      taking metformin for type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus

          -  Between the ages of 18 and 70

        Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or ketoacidosis.

          -  Patient is on a weight loss program and is not in the maintenance phase or is taking
             weight loss medication.

          -  Patient has had surgery within 30 days of starting the study or has planned major
             surgery during the study
A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Nemolizumab
Intervention description: Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
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: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Nemolizumab; Atopic dermatitis

Summary:

      The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in
      adolescent participants with AD.
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Male or female participants ≥ 12 to < 17 years of age

          -  Chronic AD that has been documented for at least 2 years

          -  Eczema Area and Severity Index (EASI) score ≥ 16

          -  Investigator's Global Assessment (IGA) score ≥ 3

          -  AD involvement ≥ 10% of Body Surface Area (BSA)

          -  Documented recent history of inadequate response to topical medications

          -  Women of childbearing potential must agree to be strictly abstinent or to use an
             effective and approved method of contraception throughout the study and for 12 weeks
             after the last study drug injection.

        Key Exclusion Criteria

          -  Body weight < 30 kilogram (kg)

          -  Cutaneous infection within 1 week or any infection requiring treatment with oral or
             parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week

          -  History of hypersensitivity (including anaphylaxis) to an immunoglobulin product
             (plasma-derived or recombinant, example., monoclonal antibody)

          -  Any medical or psychological condition, or any clinically relevant laboratory
             abnormalities that may have put the subject at significant risk according to the
             investigator's judgment
A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: MEDI-545; MEDI-545; MEDI-545; MEDI-545; MEDI-545; MEDI-545 600
Intervention description: Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.; Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses; Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.; Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.
Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.; Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses; Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.
Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
Intervention MeSH terms: Sifalimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 20 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus; Japanese; phase 2; safety; tolerability; MEDI-545; Autoimmune Disease; Immune System Diseases

Summary:

      The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese
      adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1
      cohort of SC doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have previously met ≥4 of the 11 revised ACR criteria

          -  Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at
             screening

          -  Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG
             index at screening, or have a SELENA-SLEDAI score ≥6

        Exclusion Criteria:

          -  Have received prednisone >20 mg/day (or an equivalent dose of another oral
             corticosteroid) within 14 days before Visit 2 (Day 1)

          -  Have received the following medications within 28 days before Visit 2 (Day 1):

               -  Systemic cyclophosphamide at any dose

               -  Cyclosporine at any dose

               -  Tacrolimus at any dose

               -  Thalidomide at any dose

               -  Mycophenolate mofetil >2 g/day

               -  Methotrexate >15 mg/week

               -  Azathioprine >2 mg/kg/day

          -  Women who have a positive pregnancy test (serum hCG) at Visit 1
Study of Exchange of Travoprost Intraocular Implant
Condition: Open Angle Glaucoma
MeSH terms: Glaucoma, Open-Angle
Intervention: Travoprost
Intervention description: Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
Intervention MeSH terms: Travoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study objective is to evaluate the safety of the operative and surgical exchange
      procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular
      hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able and willing to attend scheduled follow-up exams for the duration of the study

          -  Able and willing to provide written informed consent on the IRB (institutional review
             board)/IEC (institutional ethics committee)-approved Informed Consent form

          -  Best spectacle corrected visual acuity of 20/80 or better in each eye.

          -  Previously qualified for GC-009 clinical trial using the Travoprost Intraocular
             Implant with the travoprost intraocular implant (G2TR) that is present in the study
             eye.

        Exclusion Criteria:

          -  Glaucoma status as follows:

               -  Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma
                  associated with vascular disorders

          -  Corneal status as follows:

               -  Any active inflammation or edema

          -  Any pathology for which, in the investigator's judgement, the following would be
             either at risk or contraindicated:

          -  Implantation of Travoprost Intraocular Implant

          -  Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up
             visits)

          -  Fellow eye status as follows:

               -  Fellow eye actively enrolled in this trial or any other clinical trial

          -  Subject status as follows:

               -  Pregnant or planning to become pregnant during the course of the study
Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: TAS-102; Bevacizumab
Intervention description: TAS-102 Twice a day by mouth day 1-5 and 8-12; Bevacizumab by intravenous infusion once every 14 days
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Colorectal Cancer; Advanced Colorectal Cancer

Summary:

      Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC
    

Eligibility criteria:

        Inclusion criteria:

          -  Written informed consent

          -  Histologically proven, unresectable, evaluable metastatic colorectal cancer

          -  16 to 20 weeks of first-line therapy with oxaliplatin, and/or irinotecan-based
             flourorpyrimidine-containing chemotherapy plus Bevacizumab

          -  Patients must have stable disease (or better) during the initial induction
             chemotherapy with first-line chemotherapy.

          -  No progressive disease at the time of initiation of maintenance therapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

          -  Adequate organ and marrow function

          -  Women of child-bearing potential and men must agree to avoid pregnancy

          -  Patient must start maintenance therapy at least 14 days after the last administered
             induction chemotherapy but no later than 30 days.

        Exclusion Criteria

          -  Patients whose tumors have progressed on first-line treatment

          -  Patients with active concurrent malignancy, other than superficial, non-invasive
             squamous cell carcinoma of the skin or uterine cervix, within the past three years.

          -  Women who are pregnant or lactating

          -  Unstable heart disease

          -  Uncontrolled active infection requiring antibiotics within one week prior to first
             dose.

          -  Patients with active CNS malignancy.

          -  Persistent protein in the urine

          -  Patients with bowel obstruction or uncontrolled vomiting.

          -  Patients with serious psychiatric or medical conditions that could interfere with
             treatment.
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Condition: HIV-1 Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Islatravir; Placebo
Intervention description: Islatravir 30 mg capsules taken by mouth.; Placebo capsules taken by mouth.
Intervention MeSH terms: Islatravir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly
      doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of
      HIV-1 infection
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is in general good health with acceptable laboratory values at screening

          -  Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before
             randomization

          -  Has low risk of HIV infection, within 12 months prior to screening visit or the
             rescreening visit (if applicable)

          -  Use contraceptives consistent with local regulations

          -  Female is not pregnant or breastfeeding, and is not a woman of childbearing potential
             (WOCBP)

          -  A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual
             intercourse as their preferred and usual lifestyle; or has a negative pregnancy test.

        Exclusion Criteria:

          -  Has hypersensitivity or other contraindication to any of the components of the study
             interventions as determined by the investigator

          -  Has an active diagnosis of hepatitis due to any cause

          -  Has a history of malignancy ≤5 years prior to signing informed consent except for
             adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

          -  Is taking or is anticipated to require systemic immunosuppressive therapy, immune
             modulators, or any prohibited therapies from 30 days prior to Day

             1 through the duration of the study.

          -  Is currently participating in or has participated in an interventional clinical study
             with an investigational compound or device within 30 days prior to Day1 through the
             duration of the study.

          -  Has previously been randomized in a study and received islatravir (MK-8591).

          -  Female is expecting to conceive or donate eggs at any time during the study

          -  Has QTc interval (using Fridericia correction) >450 msec (for males) or >460 msec (for
             females) or deemed clinically abnormal by the investigator.
A Study of MK-6913 for the Treatment of Hot Flashes in Postmenopausal Women (6913-004)
Condition: Moderate to Severe Vasomotor Symptoms in Postmenopausal; Women
Intervention: MK-6913; 17-β estradiol; Placebo to MK-6913; Placebo to 17-β estradiol; MK-6913 25 mg
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 99.0
Sex: Female
Minimum age: 35 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of
      moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal
      women. The primary study hypothesis is that one or more doses of MK-6913 will result in a
      significantly greater reduction from baseline, compared to placebo, in the number of moderate
      to very severe hot flashes after 4 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Woman with at least 50 moderate to very severe hot flash episodes per week

          -  Postmenopausal

          -  Between 45 and 60 years of age if naturally menopausal, or between 35 and 60 if she
             underwent a bilateral oophorectomy

          -  Not receiving hormone therapy

          -  Has had both a normal mammogram and a normal Pap test in the past 6 months

          -  Generally healthy

        Exclusion Criteria:

          -  A history of cancer, except for certain skin cancers

          -  Undiagnosed vaginal bleeding or any uterine endometrial disorder

          -  Currently uses tobacco products, or has used them in the last 6 months

          -  Has human immunodeficiency virus (HIV)
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
Condition: Candidiasis; Candidemia
MeSH terms: Infections; Candidiasis; Mycoses; Candidemia
Intervention: voriconazole (Vfend)
Intervention description: Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h
Notes:
If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.
(IV = Intravenous; POS = Powder for oral suspension)
Intervention MeSH terms: Voriconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Open-Label; Pharmacokinetics; Intravenous to oral switch; Safety; Voriconazole; Immunocompromise; Children; High Risk For Systemic Fungal Infection.

Summary:

      In this study we will measure the concentration of the drug called voriconazole which is used
      to fight infections caused by fungus in children who usually are cancer patients and have
      their immune system down. Since we know the dose in adults, and we think we know the matching
      doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that
      goes into the system with what we know works in adults. We give the drug by a needle directly
      into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we
      draw a little bit of blood at certain times to measure the drug in it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female from 2 to <12 years of age.

          -  Require treatment for the prevention of systemic fungal infection.

          -  Expected to develop neutropenia (ANC <500 cells/μL) lasting more than 10 days
             following chemotherapy.

          -  Anticipated to live for more than 3 months.

        Exclusion Criteria:

          -  Evidence of any clinically significant liver or renal function or other abnormalities
             such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.

          -  Documented bacterial or viral infection not responding to appropriate treatment.

          -  Hypersensitivity to or severe intolerance of azole antifungal agents.

          -  Receiving other azoles or drugs that is are prohibited in the voriconazole label or
             associated.
Resveratrol and Exercise to Treat Functional Limitations in Late Life
Condition: Aging
Intervention: Resveratrol; Placebo; Exercise
Intervention description: Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages; Vegetable-based cellulose; Multi-modal exercise regimen, 3 days/week
Intervention MeSH terms: Resveratrol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to evaluate the effects of combining physical exercise
      with a resveratrol supplementation on the physical function of older adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand study procedures and to comply with them for the entire length
             of the study

          -  Willingness to be randomized into either treatment group

          -  Age 65 years and older

          -  Physical limitations evidenced by >290 seconds needed to complete long-distance
             corridor walk test

          -  Sedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed
             by CHAMPS questionnaire

        Exclusion Criteria:

          -  Failure to provide informed consent

          -  Regular consumption of a resveratrol supplement

          -  Current involvement in supervised rehabilitation program

          -  Absolute contraindication(s) to exercise training according to American College of
             Sports Medicine guidelines

          -  Pain classification > Grade 3 on Graded Chronic Pain Scale

          -  Peripheral vascular disease; peripheral neuropathy; retinopathy

          -  Severe cardiac disease, including:

        NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis,
        history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina

          -  Myocardial infarction or stroke within past year

          -  Significant cognitive impairment, including:

        known dementia diagnosis or a Mini-Mental State Examination exam score <24

          -  Progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple
             sclerosis, ALS)

          -  Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active
             inflammatory disease)

          -  Severe pulmonary disease, requiring either steroid pills or injections or the use of
             supplemental oxygen

          -  Hip fracture, hip or knee replacement, or spinal surgery within past 4 mos.

          -  Other significant co-morbid conditions that would impair ability to participate in the
             exercise-based intervention

          -  Simultaneous participation in another intervention trial