bioihbjkbjnl/mcl2 huggingface dataset:
Study of Milk Allergy and Tolerance in Children
Condition: Food Hypersensitivity; Milk Hypersensitivity
MeSH terms: Hypersensitivity; Milk Hypersensitivity; Food Hypersensitivity
Intervention: Baked Milk; Non-baked Milk
Intervention description: At baseline, each subject will undergo sequential oral food challenges with the products that contain increasing amounts of milk protein that are baked: Stage 1 (muffin), Stage 2 (pizza), and Stage 3 (rice pudding) doses of baked milk to determine the extent to which they tolerate various baked milk proteins. Based on the outcomes of the baseline oral food challenges, subjects will be assigned to one of the 5 study arms.; Those subjects tolerant to rice pudding will undergo oral food challenge with non-baked milk.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 4 Years
Maximum age: 10 Years
Healthy volunteers: No
Keywords: Food Allergy; Milk Allergy

Summary:

      The purpose of this study is to determine if children who are allergic to milk can increase
      tolerance through frequent dose-escalation every 6 months versus 12 months leading to
      eventual tolerance of less heated milk and ultimately unheated milk.
    

Eligibility criteria:

        Inclusion Criteria:

        One or more of the following inclusion criteria for enrollment in the study have to be met:

          -  Convincing history of an allergic reaction to milk or a positive double blind placebo
             controlled milk challenge (DBPCMC) within the past 2 years and either detectable milk
             immunoglobulin E (IgE) or positive prick skin test to milk OR

          -  Serum milk-IgE of high predictive value >14 kUa/L or prick skin test to milk > 10mm
             wheal within the past 6 months regardless of past clinical history of reactions OR

          -  Convincing history of an allergic reaction to milk or a positive DBPCMC more than 2
             years ago and either a positive serum milk-IgE < 14 kUA/L or positive prick skin test
             to milk < 10 mm wheal within the past 6 months (eligible only for the active arm of
             the study and will undergo a reversed sequence of initial baked-milk challenges)

        Exclusion Criteria:

          -  Inability or unwillingness of a participant to give written informed consent or to
             comply with study protocol
Improving Smoking Cessation Outcomes in Heavy Drinkers - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Alcoholic Intoxication
Intervention: Standard treatment plus brief alcohol intervention; Standard treatment (ST)
Intervention description: Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention; Behavioral smoking cessation counseling and nicotine patch.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: tobacco; alcohol

Summary:

      To test the effectiveness of an smoking cessation treatment for smokers who also drink
      alcohol heavily.
    

Eligibility criteria:

        Inclusion Criteria:

          1. be at least 18 years of age

          2. have smoked cigarettes regularly for at least one year

          3. currently smoke at least 10 cigarettes a day

          4. currently be using no other tobacco products or nicotine replacement therapy

          5. currently drink heavily according to self-report (>14 drinks per week or >5 drinks per
             occasion at least once per month over the last 12 months for men; >7 drinks per week
             or >4 drinks per occasion at least once per month over the past 12 months for women)

        Exclusion Criteria:

          1. meet full DSM-IV criteria for alcohol dependence in the past 12 months

          2. meet criteria for other current psychoactive substance abuse or dependence (excluding
             nicotine dependence and alcohol abuse) in the past 12 months [this would also exclude
             individuals with lifetime substance dependence who continue to have some
             abuse/dependence symptoms in the past 12 months]

          3. meet criteria for current dysthymia, major depression, or manic episode [past month]

          4. are currently psychotic [past 12 months] or suicidal [suicidal ideation or intent in
             the past month]

          5. have an unstable medical condition that would suggest caution in the use of the
             nicotine patch (e.g., unstable angina pectoris, arrhythmia, recent congestive heart
             failure)

          6. are currently pregnant or lactating or intend to become pregnant. We also will exclude
             participants who are not alcohol dependent but who have characteristics that might
             make supervised alcohol detoxification necessary (e.g., morning drinking to avoid
             withdrawal, daily drinking of >12 drinks, recent withdrawal symptoms, history of
             severe withdrawal symptoms such as hallucinations, seizures, or delirium tremens).
Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Secukinumab; Placebo
Intervention description: Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: type 1 diabetes mellitus

Summary:

      This study will assess the safety and efficacy of secukinumab on the preservation of
      pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

        Males and females aged 18-35 years initially (subjects aged 8-17 may be included at a later
        stage, starting with age 12-17 years, followed by age 8-11 years).

        Body weight between 40-120 kg initially (subjects weighing 21-39 kg may be included at a
        later stage).

        Recent onset type 1 diabetes mellitus, diagnosed with 100 days of first dose. Peak
        stimulated C-peptide levels >/= 0.2 pmol/L following mixed meal tolerance test

        Exclusion Criteria:

        Any form of diabetes other than auto-immune type 1 (eg, type 2 diabetes, maturity onset
        diabetes of the young, latent autoimmune diabetes of the adult).

        Diabetic ketoacidosis within 2 weeks of screening. Pregnancy or lactation. Recent (within 2
        weeks of screening), ongoing, chronic or recurrent infectious disease.

        Active infection with hepatitis B or C, Epstein-Barr virus, cytomegalovirus, or HIV.

        Tuberculosis infection. Other protocol-defined inclusion/exclusion criteria may apply
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Condition: Follicular Lymphoma (FL); Non Hodgkin Lymphoma; Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone
Intervention: Zandelisib (ME-401)
Intervention description: Zandelisib (ME-401) 60 mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Treatment with Zandelisib (ME-401) (60 mg) given orally once a day on an intermittent schedule
Masking: None (Open Label)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with
      relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2
      prior lines of systemic therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis as defined in the World Health Organization (WHO)
             classification scheme

               1. Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or

               2. Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL

          -  Subjects that have had progression of disease or had no response to therapy after at
             least 2 prior systemic therapies for FL or MZL

          -  Age ≥ 18

          -  At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter
             by computed tomography (CT) scan as defined by the Lugano Classification

          -  Adequate hematologic, renal and hepatic parameters at screening unless abnormal values
             are due to FL per Investigator assessment

          -  QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds
             (msec);

          -  Left ventricular ejection fraction (LVEF) ≥ 45%

        Exclusion Criteria:

          -  Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma

          -  Known lymphomatous involvement of the central nervous system

          -  Uncontrolled clinically significant illness

          -  Ongoing or history of drug-induced pneumonitis

          -  History of clinically significant cardiovascular abnormalities

          -  History of clinically significant GI conditions

          -  Known history of, or active HIV infection
Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Participants With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: enzastaurin; pemetrexed; carboplatin; bevacizumab; Placebo
Intervention description: 1125 milligram (mg) loading dose then 500 mg, oral, daily until disease progression; 500 milligrams per square meter (mg/m^2), intravenously ( IV), Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles every (q) 21 days x 3 cycles; Area under the curve (AUC) 6, IV, Day 8 cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles; 15 milligrams/kilogram (mg/kg), IV, Day 8 of cycle 1 - 28 days, Day 1 of subsequent cycles q 21 days x 3 cycles; oral, daily
Intervention MeSH terms: Bevacizumab; Carboplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab
      plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival
      time without disease progression in the first-line treatment of participants with advanced
      stage non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  participants or their legal representative must have signed an informed consent
             document for clinical research

          -  have laboratory confirmed diagnosis of advanced, nonsquamous cell non-small cell lung
             cancer (NSCLC) (Stage IIIB or IV disease) which is not curable

          -  have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or
             biological therapy for advanced NSCLC, prior radiation therapy is allowed to less than
             25% of the bone marrow

          -  have measurable disease

          -  have adequate organ function and estimated life expectancy of 12 weeks

        Exclusion Criteria:

          -  have known central nervous system (CNS) disease; major surgery within 28 days; minor
             surgery within 7 days; serious concomitant systemic disorder; serious cardiac
             condition; have a serious, nonhealing wound, ulcer, or bone fracture

          -  have received treatment within the last 30 days with any drug that has not received
             regulatory approval for any indication at the time of study entry

          -  have previously received treatment with enzastaurin, pemetrexed, or bevacizumab

          -  are pregnant or breast-feeding

          -  are unable to swallow tablets
A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
Condition: Allogeneic Hematopoietic Stem Cell Transplantation
MeSH terms: Graft vs Host Disease
Intervention: Vedolizumab
Intervention description: Vedolizumab IV infusion
Intervention MeSH terms: Vedolizumab
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: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the initial activity, tolerability, safety and to
      identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for
      treatment of steroid-refractory acute intestinal GvHD in participants who have undergone
      allo-HSCT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Recipient of 1 allogeneic hematopoietic stem cell transplantation (allo-HSCT) but not
             more than 1 allo-HSCT.

          2. Has primary steroid-refractory graft-versus-host disease (GvHD). Steroid-refractory
             disease is defined as worsening or no improvement in 5 to 7 days of treatment with
             methylprednisolone 2 milligram per kilogram (mg/kg) or equivalent or lack of a CR
             after 14 days of primary treatment with methylprednisolone 2 mg/kg or equivalent. Note
             that participants who develop intestinal GvHD while receiving systemic therapy for
             other GvHD are still eligible after 5 to 7 days, even if the intestinal GvHD has not
             been present for the entire duration. Participants who may have received an increase
             in their steroid dose treatment (example, increased methylprednisolone from 1 mg/kg to
             2 mg/kg) before enrollment will be eligible, provided the participant has met the
             definition of steroid refractory above. Participants who develop toxicity on
             corticosteroids or who are otherwise medically unable to be dosed to this level, will
             also be eligible.

          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.

          4. Evidence of myeloid engraftment defined by absolute neutrophil count greater than or
             equal to (>=) 0.5*109/liter (L) on 3 consecutive days.

        Exclusion Criteria:

          1. Presence of chronic GvHD at Screening (including acute-chronic overlap syndrome).

          2. Relapse of underlying malignant disease after allo-HSCT.

          3. Hyperacute GvHD defined as onset of GvHD within the first 15 days following
             hematopoietic stem cell infusion.

          4. Received systemic agents other than corticosteroids for treatment of acute GvHD. GvHD
             prophylaxis agents (example, calcineurin inhibitors) may be continued.

          5. Life expectancy of <3 weeks.
Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Condition: Homozygous Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Intervention description: Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, single-arm study to assess the reduction of low-density lipoprotein
      cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia
      (HoFH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women ≥18 years of age at the time of the screening visit

          2. Diagnosis of homozygous familial hypercholesterolemia (HoFH)

          3. Willing to consistently maintain usual diet for the duration of the study

        Exclusion Criteria:

          1. Background medical lipid modifying therapy that has not been stable for at least 4
             weeks (6 weeks for fibrates) prior to the screening visit

          2. Having undergone lipid apheresis within 4 weeks prior to the screening visit

          3. Use of another investigational drug or therapy within 30 days or at least 5 half-lives
             (whichever is longer) prior to the screening visit

          4. Previous participation in any clinical trial of REGN1500

        Note: The information listed above is not intended to contain all considerations relevant
        to a patient's potential participation in this clinical trial therefore not all inclusion/
        exclusion criteria are listed.
Extension Study for Patients Who Have Participated in a BMN 701 Study
Condition: Pompe Disease
MeSH terms: Glycogen Storage Disease Type II
Intervention: BMN 701
Intervention description: GILT-tagged recombinant human GAA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      This is a Phase 2 open-label, multiple dose study of BMN 701 administered by IV infusion
      every 2 weeks (qow) to patients with late-onset Pompe disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed a prior BMN 701 clinical development study;

          -  Have provided written informed consent after the nature of the study has been
             explained prior to performance of any study-related procedures. Minors may participate
             as long as they provide written assent after the nature of the study has been
             explained to them and after their parent, or legal guardian has provided written
             informed consent, prior to the performance of any study-related procedures;

          -  Have been diagnosed with late-onset Pompe Disease, based on the entry criteria of a
             prior BMN 701 study;

          -  If sexually active, be willing to use 2 known effective methods of contraception from
             Screening until 4 months after the last dose of study-drug;

          -  If female, and not considered to be of childbearing potential, be at least 2 years
             post-menopausal, or have had tubal ligation at least 1 year prior to screening, or
             have had a total hysterectomy;

          -  If female, and of childbearing potential, have a negative pregnancy test during the
             Screening Period and at the Baseline visit, and be willing to have additional
             pregnancy tests during the study;

          -  Have the ability to comply with the protocol requirements, in the opinion of the
             Investigator.

        Exclusion Criteria:

          -  Have received any experimental or approved therapy for Pompe disease, other than BMN
             701, subsequent to completion of a BMN 701 study and prior to entry into POM-002;

          -  Have received, or are anticipated to receive, any investigational medication, other
             than BMN 701, within 30 days prior to the first dose of study-drug;

          -  Are breastfeeding at screening or planning to become pregnant (self or partner) at any
             time during the study;

          -  Have a medical condition or extenuating circumstance that, in the opinion of the
             Investigator, might compromise the patient's ability to comply with the protocol
             requirements or compromise the patient's well being or safety.
Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Peginterferon alfa-2b; Temozolomide; Recombinant interferon alfa-2b
Intervention description: Given either IV or SQ. Therapeutic drug class: interferon.; Given PO. Therapeutic drug class: antineoplastic agent.; Given IV. Therapeutic drug classes: antineoplastic agent, immunomodulatory agent, interferon
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Cutaneous Melanoma

Summary:

      The main goal of this study is to estimate the tumor response rate of temozolomide
      administered in combination with peginterferon alfa-2b to pediatric patients with
      unresectable Stage III, metastatic, or recurrent cutaneous melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  AJCC stage IIC, III, IV or recurrent cutaneous melanoma

          -  Adequate bone marrow function

          -  Age less than or equal to 21 years of age at diagnosis

          -  Adequate liver and kidney function

        Exclusion Criteria:

          -  Prior Therapy with dacarbazine or temozolomide

          -  Patients who have uncontrolled infection

          -  Patients with autoimmune hepatitis

          -  Patients who have a history of depression or other psychiatric diseases requiring
             hospitalization

          -  Patients taking systemic corticosteroids including oral steroids (i.e. prednisone,
             dexamethasone) or topical steroid creams/ointments. Steroid containing inhalers,
             steroid replacement for adrenal insufficiency and steroid premedication for prevention
             of transfusion or imaging contrast-agent related allergic reaction will be permitted.

          -  Patients with hypersensitivity reaction to non-pegylated interferon α-2b are not
             eligible for study

          -  Patients with diabetes mellitus not adequately controlled with medication

          -  Patients with hypo- or hyperthyroidism not adequately controlled with medication.

          -  Patients with a history of myocardial infarction, severe or unstable angina, or severe
             peripheral vascular disease.