bioihbjkbjnl/mcl2 huggingface dataset:
Persistence of Oral Tolerance to Peanut
Condition: Eczema; Egg Allergy; Food Allergy; Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity; Egg Hypersensitivity
Intervention: Avoidance of peanut
Intervention description: All participants will be assigned to peanut avoidance as per United Kingdom (UK) public health recommendations and will avoid exposure to peanut protein during the study until the last study visit when they will receive the Oral Food Challenge.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 556.0
Sex: All
Minimum age: 5 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Peanut

Summary:

      ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).

      Peanut Allergy, a recognized public health concern, is a common and potentially
      life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study
      evaluated whether early exposure to peanut promotes tolerance and provides protection from
      developing peanut allergy in children who are allergic to eggs or who have severe eczema.
      ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect
      of twelve months of cessation of peanut consumption in LEAP Study participants who consumed
      peanut and those who avoided peanut over the previous five years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All LEAP Study participants who are evaluable for peanut allergy at year 5 by LEAP
             (ClinicalTrials.gov ID NCT00329784) Study criteria.

          -  Parent or guardian willing to provide informed consent.

        Exclusion Criteria:

          -  Unable or unwilling to comply with study intervention and procedures.

          -  Participation in other food allergy intervention trials.
The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Naltrexone; Placebo, sugar pill
Intervention description: Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day orally for 16 weeks; Placebo -Sugar pill or liquid identical to active drug in appearance and taste given by mouth at bedtime once daily
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: children; pediatric; Crohn's Disease; naltrexone; LDN; IBD; Inflammatory bowel disease

Summary:

      It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing
      endogenous enkephalin levels in subjects with active Crohn's disease. This is especially
      important in children who often are suffering from nutritional deprivation which retards
      their growth.

      The key objectives are to:

        1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using
           the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers,
           weight, and pediatric quality of life survey.

        2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with
           active Crohn's Disease.

        3. Assess the potential mechanism by which naltrexone exerts its action by measuring plasma
           opioid (enkephalin and endorphin levels) and proinflammatory cytokines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects must give written informed consent by parent or guardian

          -  Male or female subjects, > 6 - 17 years

          -  Patients must have endoscopic or radiographic confirmed Crohn's Disease.

          -  Patients must have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least 31.

        Exclusion Criteria:

          -  Adolescent women of childbearing potential and / or sexually active unless surgically
             sterile or using adequate contraception (either IUD, oral or deport contraceptive, or
             barrier plus spermicide), and willing and able to continue contraception for 3 months
             after the completion of the study.

          -  Adolescent women who are pregnant or breastfeeding

          -  Subjects with an ostomy or ileocolic anastomosis from surgery as these operations
             interfere with the PCDAI assessment

          -  Subjects taking tacrolimus, cyclosporin, mycophenolate, or anti-TNF-α therapy must be
             discontinued 4 weeks prior to study initiation.

          -  Patients with abnormal liver function tests

          -  Prednisone greater than 10 mg or > 0.2 mg/kg orally
A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Peritoneal Cancer
Intervention: pemetrexed
Intervention description: 900 mg/m2, intravenous (IV), every 21 days, until disease progression
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: Female
Healthy volunteers: No

Summary:

      The primary purpose of this trial is to estimate the drug effect on tumors in patients with
      ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until
      disease progression or unacceptable toxicity. This medication will be given over 10 minutes
      and may be administered intravenously (IV), through a vein in your arm. Vitamin
      supplementation is a required part of this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed recurrent or persistent disease ovarian epithelial or primary
             peritoneal cancer

          -  Measurable disease

          -  Must have received 1 prior platinum-based (carboplatin, cisplatin, or another
             organoplatinum compound) chemotherapy regimen for primary disease. Patients who had
             not received prior paclitaxel may have received a second regimen that included
             paclitaxel

          -  Treatment-free interval < 6 months after prior platinum-based therapy OR progressed
             during platinum-based therapy

          -  Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol (i.e.,
             any active phase III GOG protocol for the same patient population)

        Exclusion Criteria:

          -  Patients who have had prior therapy with pemetrexed

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
             being present within the last five years. Patients are also excluded if their previous
             cancer treatment contraindicates this protocol therapy.

          -  Patients who have received radiation to more than 25% of marrow
Late Phase 2 Study of OPC-12759 Ophthalmic Suspension
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: placebo; 1% OPC-12759 ophthalmic suspension; 2% OPC-12759 ophthalmic suspension
Intervention description: comparison of different dosages of drug; comparison of different dosages of drug; comparison of different dosages of drug
Intervention MeSH terms: Rebamipide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 308.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Dry Eye Syndromes; OPC-12759

Summary:

      The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye
      patients
    

Eligibility criteria:

        Inclusion Criteria:

          1. Outpatient

          2. Subjective complaint of dry eye that has been present for minimum 20 months

          3. Ocular discomfort severity is moderate to severe

          4. Corneal - conjunctival damage is moderate to severe

          5. Unanesthetized Schirmer's test score of 5mm/5minutes or less

          6. Best corrected visual acuity of 0.2 or better in both eyes

        Exclusion Criteria:

          1. Presence of anterior segment disease or disorder other than that associated with
             keratoconjunctivitis sicca

          2. Ocular hypertension patient or glaucoma patient with ophthalmic solution

          3. Anticipated use of any topically-instilled ocular medications or patients who cannot
             discontinue the use during the study

          4. Anticipated use of contact lens during the study

          5. Patient with punctal plug

          6. Any history of ocular surgery within 12 months

          7. Female patients who are pregnant, possibly pregnant or breast feeding

          8. Known hypersensitivity to any component of the study drug or procedural medications

          9. Receipt of any investigational product within 4 months
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
Condition: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Intervention: catridecacog; catridecacog; placebo
Intervention description: Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute; Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute; Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 479.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to
      investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve
             replacement/repair or planned replacement/repair of a single heart valve

        Exclusion Criteria:

          -  Known intolerance to protamine

          -  Known or suspected allergy to the used antifibrinolytic agent

          -  Refusal to receive blood or blood product

          -  Planned surgery including the aortic arch and/or descending aorta

          -  Planned surgery including any implantable ventricular assist device

          -  Adult congenital heart diseases

          -  Two or more previous cardiac surgery procedures

          -  Any known autoimmune diseases: Collagen vascular disease (Systemic lupus
             erythematosus, Rheumatoid arthritis, Sjögrens syndrome) - Endocrine: hyperthyroidism
             (Graves disease), adrenal insufficiency, Hashimoto's thyroiditis - Neurologic:
             Multiple sclerosis, myasthenia gravis - Skin: pemphigous vulgaris Hematologic:
             Pernicious anaemia, Autoimmune haemolytic anaemia - Vasculitis - Primary or secondary
             antiphospholipid syndrome

          -  Weight above 140 kg
A Study of MK2578 in Patients With Chronic Kidney Disease Who Are Not on Dialysis (2578-002)
Condition: Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: MK2578; MK2578; MK2578; Comparator: darbepoetin alfa
Intervention description: MK2578 1.0 mcg/kg/month; MK2578 2.0 mcg/kg/month; MK2578 3.6 mcg/kg/month; darbepoetin alfa
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Anemia

Summary:

      This study will define an effective starting dose for subcutaneous administration of MK2578
      to correct anemia in erythropoiesis-stimulating agent (ESA)-naive patients with chronic
      kidney disease (CKD) who are not on dialysis while evaluating its safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or is a female who either cannot have children or who agrees to use
             appropriate contraceptive measures

          -  Patient has chronic kidney disease

        Exclusion Criteria:

          -  Patient is morbidly obese

          -  Patient has used another erythropoiesis (red blood cell formation) stimulating agent
             within 12 weeks of screening

          -  Patient will require dialysis during the study or is planning to have a kidney
             transplant within the next 6 months

          -  Patient has had a blood transfusion within 12 weeks of screening

          -  Patient has had major surgery within the past 12 weeks or plans to have surgery

          -  Patient has Human Immunodeficiency Virus (HIV)

          -  Patient has a history of diseases other than CKD known to cause anemia

          -  Patient has severe congestive heart failure

          -  Patient has history of malignant cancer, except certain skin or cervical cancers

          -  Patient has a history of grand mal seizures within the last 6 months

          -  Patient is pregnant or breastfeeding
A Study of RO5185426 in Patients With Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: RO5185426
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 374.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in
      patients who have received prior systemic therapy for metastatic melanoma and who have no
      other satisfactory treatment options.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed metastatic melanoma with documented BRAF V600E mutation,
             determined by the cobas BRAF V600 mutation test

          -  Patients with either measurable or non-measurable disease

          -  Adequate recovery from most recent systemic or local treatment for metastatic melanoma

          -  Adequate organ function

          -  For women of childbearing potential, agreement to the use of two acceptable methods of
             contraception, including one barrier method, during the study and for 6 months after
             discontinuation of RO5185426

          -  For men with female partners of childbearing potential, agreement to use a latex
             condom, and to advise their female partner to use an additional method of
             contraception during the study and for 6 months after discontinuation of RO5185426

          -  Negative serum or urine pregnancy test within 7 days of commencement of treatment in
             premenopausal women. Women who are either surgically sterile or have been
             post-menopausal for at least 1 year are eligible to participate in this study

          -  Agreement not to donate blood or blood products during the study and for at least 6
             months after discontinuation of RO5185426; for male patients, agreement not to donate
             sperm during the study and for at least 6 months after discontinuation of RO5185426

        Exclusion Criteria:

          -  Pregnant or breast-feeding

          -  Concurrent anti-tumor therapy

          -  Uncontrolled medical illness

          -  History of congenital prolonged QT syndrome or patients with a mean QTc interval
             greater than 470 milliseconds at baseline, or ongoing grade 2 or greater cardiac
             arrhythmia
Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
Condition: Healthy
MeSH terms: Dengue
Intervention: TDV; Placebo
Intervention description: TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.; TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 18 Months
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Normal healthy adults and children; Safety and tolerability; Active vaccine; Placebo; Dengue virus vaccine; Immune response

Summary:

      The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine
      (TDV) (previously DENVax) administered subcutaneously in healthy adults and children. In
      addition the antibody response to the four dengue virus serotypes will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good health as determined by medical history, physical examination including height
             and weight

          -  Normal safety laboratory values at screening

          -  Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies
             & Hepatitis B surface antigen

          -  Females negative by urine pregnancy test at screening and immediately prior to
             injection, and were willing to use reliable means of contraception

          -  Weight: Within 1.3 times of the upper limit of local normal age-adjusted body mass
             index (BMI)

        Exclusion Criteria:

          -  For participants ≥12 years, clinically significant electrocardiogram (ECG) findings

          -  History of significant dermatologic (skin) disease within last 6 months

          -  History of diabetes mellitus

          -  History of thymic pathology, thymectomy, myasthenia or any immunodeficiency

          -  History of recurring headaches or migraines

          -  Hypersensitivity to any vaccine

          -  For participants ≥12 years, positive urine screen for cocaine, amphetamines, opiates,
             or cannabinoids

          -  History of alcohol abuse

          -  Pregnant or lactating female
Efficacy and Tolerability of BAF312 in Patients With Polymyositis
Condition: Polymyositis
MeSH terms: Polymyositis
Intervention: Placebo; BAF312
Intervention description: Matching placebo tablet for oral administration; BAF312 in 4 dosage strengths in tablet form: 0.25 mg, 0.5 mg, 1 mg, 2 mg for oral administration
Intervention MeSH terms: Siponimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Polymyositis; Myositis; PM; chronic muscle inflammation; inflammatory myopathy; inclusion body myositis

Summary:

      This study assessed the efficacy, safety and tolerability of BAF312 administered orally in
      patients with clinically active polymyositis and also in patients with polymyositis who had
      shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic
      drugs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  "definite" or "probable" for polymyositis at least three months before Baseline

          -  active disease as defined by elevated CK levels, or other enzymes, or MRI/biopsy if
             enzymes are normal, and persisting muscle weakness

          -  stable dose of corticosteroid for at least 2 weeks prior to Baseline and should not
             have received a medium or high dose in the last 8 weeks prior to study entry.

          -  patients treated with methotrexate must have been on a stable dose for at least 6
             weeks prior to Baseline.

        Exclusion Criteria:

          -  Patients with overlap polymyositis, late-stage polymyositis, or other types of
             myositis.

          -  Preexisting severe cardiac or pulmonary involvement, malignancy of any organ system or
             significant eye diseases.

          -  Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.

          -  Pregnant or nursing (lactating) women
Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma
Condition: Loco-regional Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Bevacizumab; Paclitaxel; Cisplatin; 5-Fluorouracil; Radiation Therapy; Esophagectomy
Intervention description: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days # 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.; Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m2 will be administered as a 1-hour intravenous infusion on days #2, 9, 16, 23, and 30. It will be given before cisplatin administration.; Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m2 over 1 hour on days #2, 9, 16, 23, and 30. It will be given after paclitaxel.; Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.; Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays. CT scans, the barium swallow, the endoscopy and endoscopic ultrasound reports and PET scans should be used for tumor definition. Post-Operative Radiotherapy: In the event that gross residual disease is left behind at the time of surgery or the patient is found to have a microscopic positive deep or gastric margin following surgery, additional treatment with radiation therapy will be considered.; Transhiatal esophagectomy performed on approximately Day #57 (6 weeks after last dose of bevacizumab.)
Intervention MeSH terms: Paclitaxel; Bevacizumab; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether bevacizumab can improve the outcome of
      treatment for patients with esophageal cancer whose disease is confined to the esophagus or
      the closely surrounding lymph nodes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. No prior treatment for esophageal cancer

          2. No prior radiation to the chest or upper abdominal area

          3. No prior treatment with an EGFR inhibitor or an anti-angiogenic agent

          4. Disease should be limited to the esophagus and regional lymph nodes -

        Exclusion Criteria:

          1. History of stroke

          2. History of heart attack

          3. Inadequately controlled high blood pressure