bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
Condition: Choroidal Neovascularization; Wet Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Wet Macular Degeneration; Neovascularization, Pathologic
Intervention: ICON-1; aflibercept
Intervention description: ICON-1 0.6 mg by intravitreal injection; aflibercept 2 mg by intravitreal injection
Intervention MeSH terms: Aflibercept; Immunoconjugates
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effects of repeated intravitreal
      injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with
      aflibercept in patients with wet macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females of any race, ≥50 years of age

          -  Active primary CNV secondary to AMD in the study eye

        Exclusion Criteria:

          -  Any prior treatment of CNV or advanced AMD in the study eye, except for dietary
             supplements or vitamins

          -  Any intraocular or ocular surface surgery (including cataract surgery and laser
             procedures) in the study eye within 3 months

          -  Vitrectomy in the study eye
A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ruxolitinib phosphate cream; Dovonex® calcipotriene 0.005%; Diprolene® AF betamethasone dipropionate 0.05% cream.; Placebo cream; Ruxolitinib phosphate cream; Ruxolitinib phosphate cream
Intervention description: Ruxolitinib phosphate cream 0.5%; Cream applied once or twice daily for up to 56 days.; Cream applied once or twice daily for up to 56 days; Cream applied once or twice daily for 56 days; Ruxolitinib phosphate cream 1.0%; Ruxolitinib phosphate cream 1.5%
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study is comprised of two parts. The first portion of this study will be a double-blind,
      Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to
      paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part
      2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA
      approved products in patients with active but stable plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) of 17 to 40 kg/m2

          -  Subjects must have two comparable psoriatic lesions measuring between 9 and 100 cm2
             and these target lesions must be similar in size to each other, and separated by at
             least 15 cm.

        Exclusion Criteria:

          -  Subjects with lesions solely involving the palms of the hands or soles of the feet or
             intertriginous areas, the scalp or the face.

          -  Subjects with pustular psoriasis or erythroderma.

          -  Subjects currently on other topical agents or UVB therapy within 2 weeks of the first
             dose of study medication.

          -  Subjects receiving PUVA within 4 weeks of the first dose of study medication.

          -  Subjects receiving systemic retinoids, etanercept, adalimumab or efalizumab or oral
             immunosuppressives within 3 months prior to the first dose of study medication.

          -  Subjects receiving any other biological therapy (infliximab, alefacept, abatacept,
             etc) within 3 months of the first dose of study medication.
Minocycline Hydrochloride in Reducing Chemotherapy-Induced Peripheral Neuropathy and Acute Pain in Patients With Breast Cancer Undergoing Treatment With Paclitaxel
Condition: Acute Pain; Breast Carcinoma; Peripheral Neuropathy
MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases; Acute Pain
Intervention: Minocycline Hydrochloride; Placebo; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given PO; Given PO; Ancillary studies; Ancillary studies
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized pilot trial studies how well minocycline hydrochloride works in reducing
      chemotherapy-induced peripheral neuropathy and acute pain in patients with breast cancer
      undergoing treatment with paclitaxel. Drugs used in chemotherapy, such as paclitaxel, may
      cause damage to nerves that result in aches, pains, and tingling or numbness of fingers and
      toes. Minocycline hydrochloride may help lessen nerve damage from paclitaxel and improve the
      quality of life in breast cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to complete questionnaires by themselves or with assistance

          -  Planned paclitaxel at a dose of 80 mg/m2 IV given, in the adjuvant breast cancer
             (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks
             without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody
             and/or small molecule treatment is allowed, except for PARP inhibitors)

          -  Life expectancy > 6 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for
             women of childbearing potential only (determined per clinician discretion)

        Exclusion Criteria:

          -  Any of the following:

               -  Pregnant women

               -  Nursing women

               -  Men or women of childbearing potential who are unwilling to employ adequate
                  contraception

          -  Previous diagnosis of diabetic neuropathy or peripheral neuropathy from any cause

          -  History of allergic or other adverse reactions to minocycline

          -  Prior exposure to neurotoxic chemotherapy

          -  Diagnosis of fibromyalgia

          -  Current or planned use of methoxyflurane, oral contraceptives, isotretinoin,
             penicillin, or ergot alkaloids

          -  History of allergic or other adverse reactions to tetracycline
Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
Condition: Hyperphosphataemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: PT20; Placebo
Intervention description: Modified ferric oxide adipate tablets; Placebo tablets matched to each PT20 dose arm
Intervention MeSH terms: Iron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Dialysis Dependent Chronic Kidney Disease

Summary:

      The main purpose of this study is to see whether PT20 can help people with a high level of
      phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for
      kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 18 90 years

          -  Subject must have a stable dialysis prescription for at least 28 days prior to start
             of Screening.

          -  Subject must have the most recent serum phosphate measurement, taken during the 28
             days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.

        Exclusion Criteria:

          -  Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days
             prior to the start of Screening (Visit 1) is < 18 mg/dL.

          -  Subject has, in the opinion of the investigator, severe chronic lung disease and/or
             carbon dioxide retention.
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: elezanumab; placebo
Intervention description: solution for infusion; solution for infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Progressive multiple sclerosis; Elezanumab; ABT-555

Summary:

      The purpose of this study is to evaluate the safety and efficacy of elezanumab in
      participants with progressive Multiple Sclerosis (PMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing
             secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24
             months.

          -  Evidence of physical disability according to Expanded Disability Status Scale (EDSS)
             or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.

        Exclusion Criteria:

          -  Treatment with any of the following within the 6 months prior to Screening:
             natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil;
             intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral,
             or intrathecal corticosteroids for the purposes of disease modification.

          -  Treatment with the following within 1 year prior to Screening: cyclophosphamide or
             alemtuzumab.
Early Insulin and Development of ARDS
Condition: Respiratory Distress Syndrome, Adult; Sepsis; Hyperglycemia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Hyperglycemia; Syndrome
Intervention: Insulin
Intervention description: Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) for up to 48 hours after ICU admission.
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Respiratory Distress Syndrome; Acute Lung Injury

Summary:

      Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) is a severe lung condition
      that causes respiratory failure. Symptoms usually develop within 24 to 48 hours of an
      original injury or illness, and people with ALI/ARDS typically require care in the intensive
      care unit (ICU). Little is known about how to prevent the onset of ALI/ARDS. The purpose of
      this study is to examine if early infusions of insulin, known as intensive insulin therapy
      (IIT), can help prevent ALI/ARDS in hospitalized patients with high levels of blood sugars
      and severe infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with severe sepsis, which is defined as sepsis AND one or more signs of
             organ dysfunction or hypotension

          -  Hyperglycemia (i.e., glucose level greater than 130 mg/dL on one or more tests)

        Exclusion Criteria:

          -  Diabetic ketoacidosis

          -  Severe chronic liver disease with Child-Pugh score greater than 10 (Class C)

          -  Documented episodes of blood or plasma glucose less than 60 mg/dL within 24 hours of
             study entry

          -  Lack of any available IV access for insulin infusion

          -  Pregnant

          -  Known advanced directives against intubation or aggressive ICU care

          -  Inability to be enrolled into the study in the 12 hours following admission to the ED
Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population.
Condition: Obesity; Prediabetic State
MeSH terms: Prediabetic State
Intervention: Melatonin; Placebo
Intervention description: 2mg controlled release melatonin tablet; placebo tablet identical to circadin
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to
      extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly
      controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether
      sleep extension and nightly melatonin supplementation in the community is a feasible
      intervention with a beneficial effect on the following chronic kidney disease (CKD) risk
      factors: systemic and renal specific renin-aldosterone-angiotensin system (RAAS) activation
      (systemic plasma renin activity, plasma angiotensin II levels, 24-hour urine aldosterone
      excretion, and renal plasma flow response to captopril); nocturnal blood pressure measured by
      24-hour ambulatory blood pressure monitor; central blood pressure measured by pulse wave
      analysis; and glucose metabolism measured by Minimal Model assessment of insulin resistance
      and β-cell response to a mixed meal protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) ≥ 30 kg/m2

          -  Hemoglobin A1c (HbA1c) 6.7-6.4%

          -  Self reported sleep < 7 hours per night

        Exclusion Criteria:

          -  Inability to extend sleep by one hour each night

          -  Current or prior history of diabetes OR random serum glucose ≥200mg/dL

          -  Pregnancy

          -  Preexisting lung disease requiring oxygen

          -  Preexisting cardiovascular disease

          -  Active or uncontrolled psychotic disorder

          -  Active or uncontrolled bipolar illness

          -  Active malignancy with in the prior 5 years

          -  Use of hypoglycemic medication

          -  estimated glomerular filtration rate (eGFR) <60ml/min/1.73m2

          -  Use of antihypertensive medications

          -  Hepatic impairment

          -  Job requiring rotating overnight shifts

          -  Bariatric surgery within prior 12 months

          -  Use of hypnotic medications

          -  Hematocrit <34% (women), <36% (men)
Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain
Condition: Melanoma and Brain Metastases
MeSH terms: Melanoma; Neoplasm Metastasis; Brain Neoplasms
Intervention: Dabrafenib; Trametinib
Intervention description: Dabrafenib will be provided as 50 mg and 75 mg capsules; Trametinib will be provided as 0.5 mg and 2.0 mg tablets
Intervention MeSH terms: Trametinib; Dabrafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: BRAF V600K mutation; Metastatic Melanoma; BRAF V600R mutation; BRAF V600D mutation; BRAF V600E mutation; Brain metastases BRAF inhibitor; Intracranial

Summary:

      This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and
      Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma
      that has metastasized to the brain. This study will evaluate the safety and efficacy of 4
      cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain,
      symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without
      prior local (brain) therapy, and range of ECOG scores from 0-2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ECOG Performance Status range of 0-2

          -  Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R.

          -  May be systemic naïve or received up to two previous systemic treatment regimens for
             metastatic melanoma.

          -  Must be able to undergo MRI and have at least one measurable intracranial lesion for
             which specific criteria have to be met.

        Exclusion Criteria:

          -  Prior treatment with any BRAF inhibitor or any mitogen-activated protein/extracellular
             signal-regulated kinase inhibitor.

          -  Anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without
             delayed toxicity within treatment specific timeframe.

          -  Treatment with stereotactic radiosurgery or treatment with whole-brain radiation
             within treatment specific timeframe.

          -  Any presence of leptomeningeal disease or any parenchymal brain metastasis

          -  History of another malignancy, some exceptions may apply.

          -  A history or evidence of cardiovascular risk- specific criteria have to be met

          -  A history or current evidence/risk of retinal vein occlusion or retinal pigment
             epithelial detachment - specific criteria have to be met.
A Long-Term Study of Rovalpituzumab Tesirine
Condition: Cancer
Intervention: rovalpituzumab tesirine; rovalpituzumab tesirine
Intervention description: Optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles; Rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing). Subjects will receive rovalpituzumab tesirine on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.
Intervention MeSH terms: Rovalpituzumab tesirine; Immunoconjugates
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rovalpituzumab tesirine; rollover study; cancer

Summary:

      The purpose of this long-term, extension study is to provide ongoing safety and efficacy
      follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed
      the primary analysis and that is closing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab
             tesirine in a parent study.

          -  Additional eligibility criterion for Arm A: subjects who discontinued the study drug
             in the parent study have completed the treatment emergent adverse event reporting
             window.

        For subjects who elect optional retreatment in Arm A, must meet additional criteria before
        receiving rovalpituzumab tesirine retreatment including:

          -  Tolerated their initial 2 doses of rovalpituzumab tesirine.

          -  Achieved clinical benefit as defined by stable disease or better, and is determined
             that the subject would potentially benefit from additional treatment.

          -  Experienced radiographic disease progression at least 12 weeks after the second dose
             of rovalpituzumab tesirine.

          -  Received no other systemic anti-cancer therapy after rovalpituzumab tesirine
             treatment.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Adequate hematologic, kidney, and liver function, per protocol.

          -  In subjects with central nervous system (CNS) metastases, documentation of stable or
             improved status as described in the protocol.

        Exclusion Criteria:

          -  Subjects not previously enrolled in a rovalpituzumab tesirine study.
A Long-Term Treatment Study of ACH-0144471 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: ACH-0144471
Intervention description: ACH-0144471 will be administered to all participants enrolled in the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH; Paroxysmal; Hemoglobinuria; ACH-0144471; ALXN2040; Danicopan

Summary:

      The purpose of this study is to evaluate the long-term safety and efficacy of ACH-0144471 in
      participants with paroxysmal nocturnal hemoglobinuria (PNH) who have demonstrated clinical
      benefit from ACH-0144471 in Study ACH471-100. This study is designed to include up to 12
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study designed to include up to 12 participants who completed treatment in Study
             ACH471-100 and demonstrated clinical benefit from ACH-0144471 with no significant
             safety or tolerability concerns.

          -  Negative pregnancy test for females prior to dosing and throughout the study.

        Exclusion Criteria:

          -  Have developed any clinically relevant co-morbidities while participating in Study
             ACH471-100 that would make the participant inappropriate for the continuation of
             treatment with ACH-0144471, in the opinion of the Investigator.

          -  Have developed any clinically significant laboratory abnormalities while participating
             in Study ACH471-100 that, in the opinion of the Investigator, would make the
             participant inappropriate for the study or put the participant at undue risk.

          -  Females who are pregnant, nursing, or planning to become pregnant during the study or
             within 90 days of study drug administration or participants with a female partner who
             is pregnant, nursing, or planning to become pregnant during the study or within 90
             days of study drug administration.