bioihbjkbjnl/mcl2 huggingface dataset:
Navelbine And Radiotherapy in Locally Advanced Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Navelbine; 66 Gy/33F; 60 Gy/30F
Intervention description: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks; irradiation to 66 Gy (2 Gy x 30, 5 F á weeks); irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
Intervention MeSH terms: Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: No blinding after randomization
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Induction chemotherapy; Non-small cell lung cancer; Randomized phase II study; Navelbine Oral (R); 3D-conformal radiotherapy; Chemo-radiotherapy; Local-regionally advanced non-small cell lung cancer

Summary:

      This study is an open label randomized multi-centre phase II trial in patients with
      inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general
      criteria for curatively intended irradiation. The treatment plan consists of two courses of
      inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day
      1 of the last induction chemotherapy has been given. The patients will be included in the
      study after completing the induction chemotherapy. Randomization will take place only if an
      acceptable dose plan can be obtained.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Patients with histologically or cytologically documented diagnosis of locally advanced
             NSCLC stage IIB to IIIB without pleural effusion

          -  Performance status 0-1 on the ECOG scale

          -  Weight loss ≤10% during the last 6 months

          -  Adequate lung function measured as FEV1 ≥1.0

          -  Neutrophile count ≥1.5 x 109/L and platelet count ≥100 x 109/L

          -  Serum bilirubin ≤1.5 upper limit of normal (ULN)

          -  ALAT ≤2 x ULN

          -  Able to comply with study and follow-up procedures

          -  Patients with reproductive potential must use effective contraception

          -  Written (signed) informed consent to participate in the study

        Exclusion Criteria:

          -  Any unstable systemic disease (including active infection, unstable angina, congestive
             heart failure, severe hepatic, renal, or metabolic disease)

          -  Any other active malignancies within 5 years (except for adequately treated carcinoma
             in situ of the cervix or basal or squamous cell skin cancer)

          -  Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy

          -  Inability to take oral medication, or requirement of intravenous alimentation

          -  Active peptic ulcer disease

          -  Nursing mothers
Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease
Condition: Huntington Disease
MeSH terms: Huntington Disease
Intervention: Fenofibrate; Placebo
Intervention description: 145mg of fenofibrate; Placebo
Intervention MeSH terms: Fenofibrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to study the safety and efficacy of fenofibrate, an
      FDA-approved drug for high cholesterol and/or elevated triglycerides (fats), as a treatment
      for Huntington's disease (HD). Subjects who meet the entry criteria will be randomized (3:1)
      to either 145mg of fenofibrate or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An adult of either sex, ages 25-85 inclusive,

          -  Have proficiency with written and spoken English and corrected vision or hearing to
             complete the cognitive testing,

          -  Are able to give informed consent,

          -  Have good overall health status with no known problems anticipated over the course of
             the trial,

          -  Have a diagnosis of HD supported by positive gene test within the past 6 months.

        Exclusion Criteria:

          -  Other major neurological disease [e.g., multiple sclerosis, parkinson's disease,
             cortical stroke, etc]

          -  Clinically significant hepatic or renal disease,

          -  Current or recent (< 1 month) use of dopamine blocking agents such as tetrabenazine,
             anticonvulsants, neuroleptics, HAART, antiemetics, and antipsychotics for any reason,

          -  Current use of Warfarin (Coumadin). Enrollment in another investigational drug study
             within the prior three months.
Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Everolimus (RAD001)
Intervention description: Everolimus (RAD001) 10 mg (two 5mg tablets) given orally once daily and packed in blisters.
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hodgkin's Lymphoma; Hodgkin Lymphoma; Hodgkin's Disease; Hodgkin Disease; Lymphoma; Lymphoproliferative Disorders; Neoplasms by Histological type; Lymphatic Diseases; Hemic and Lymphatic Diseases; Recurrent Lymphoma; Refractory Lymphoma; Relapsed Lymphoma; Classical Hodgkin Lymphoma; Classical Hodgkin's Disease; Nodular sclerosing Hodgkin Lymphoma; Mixed-cellularity Hodgkin Lymphoma; Lymphocyte-rich Hodgkin Lymphoma; Lymphocyte depleted Hodgkin Lymphoma

Summary:

      This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that
      has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after
      gemcitabine- or vinorelbine- or vinblastine-based treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a history of classical Hodgkin's lymphoma that has progressed after
             high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine-
             or vinorelbine- or vinblastine-based treatment

          -  Patients with at least one site of measurable disease measuring ≥ 2.0cm confirmed by
             PET and CT Scan (or MRI)

          -  Patients with adequate bone marrow, liver and renal function (confirmed by laboratory
             values)

          -  Patients with fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting
             triglycerides ≤ 2.5 x ULN

        Exclusion Criteria:

          -  Previous treatment with mTOR inhibitors

          -  Prior allogeneic stem cell transplant

          -  Chemotherapy, monoclonal antibody therapy, major surgery or treatment with other
             investigational drugs within 4 weeks of starting study treatment

          -  Another malignancy within 3 years of study entry (except adequately treated
             non-melanoma skin cancer and carcinoma in situ of the cervix)

          -  Severe and/or uncontrolled medical conditions that could affect participation in this
             study

          -  Female patients who are pregnant or breastfeeding; patients who are not willing to use
             adequate birth control during the study and for 8 weeks after the last study treatment
             Other protocol-defined inclusion/exclusion criteria may apply
Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV
Condition: HIV I Infection
Intervention: Vacc-4x; Sterile water
Intervention description: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.; Sterile water is used in place of Vacc-4x and in place of Leukine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure
      the infection, making it a life-long treatment that requires sustained patient compliance and
      imposes significant individual and societal financial burdens on healthcare services.
      Furthermore, ART side effects often require medication that increases the inconveniences and
      financial burdens of HIV management. Of further concern is the emergence of viruses resistant
      to ART that can result in treatment failure.

      ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV
      immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this
      study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-55

          -  HIV positive at least one year

          -  Clinically stable on ART for at least six months

          -  Documented viral load less than 50 copies/mL for the last six months

          -  Documented prestudy CD4 cell count equal or more than 400x10exp6/L

          -  Nadir CD4 cell count equal or more than 200x10exp6/L

          -  Signed informed consent

        Exclusion Criteria:

          -  Reported pre-study AIDS-defining illness within the previous year

          -  Malignant disease

          -  On chronic treatment with immuno-suppressive therapy

          -  Unacceptable values of hematology and clinical chemistry parameters

          -  Current chronic infection such as HCV and HBV or active tuberculosis

          -  Pregnant or breastfeeding women

          -  Not using safe contraceptive methods

          -  Participation in other clinical trial

          -  Incapability of compliance
Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma
Condition: NK/T-cell Lymphoma of Nasal Cavity
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: CCRT followed by VIDL chemotherapy
Intervention description: CCRT followed by VIDL chemotherapy concomitant chemo-radiotherapy followed by VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) chemotherapy with risk-based application of autologous stem cell transplantation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: VIDL (Etoposide, ifosfamide, dexamethasone and L-asparaginase)
Masking: None (Open Label)
Masking description: Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Extranodal Lymphoma; Natural killer cell; T cell; Radiotherapy; Chemotherapy

Summary:

      This study is to evaluate the efficacy of risk-adapted treatment strategy for stage I/II
      extranodal NK/T cell lymphoma. The risk stratification is based on the Korean NK prognostic
      index. Thus, the group I/II will receive concomitant chemoradiation followed by VIDL
      chemotherapy. The group III/IV will receive high dose-chemotherapy followed by autologous
      stem cell transplantation after the completion of VIDL chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients were required to have a biopsy-proven diagnosis of nasal ENKTL

          -  at least 18 years old

          -  Ann Arbor stage IE or IIE

          -  measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          -  life expectancy greater than 12 weeks

          -  adequate hematologic (hemoglobin > 9.0 g/dL, absolute neutrophil count > 1,500/uL and
             platelets > 100,000/uL)

          -  renal (serum creatinine < 1.5 mg/dL, creatinine clearance > 50 mL/min)

          -  hepatic (total bilirubin < 2 times of upper limit of normal and aspartate transferase
             < 3 times of upper limit of normal) function

          -  Diagnosis of ENKTL is based on the presence of histological features and
             immunophenotypes compatible with ENKTL (e.g., cytoplasmic CD3+, CD20-, CD56+, positive
             for cytotoxic molecules, positive for EBV by in situ hybridization).

          -  Informed consent

        Exclusion Criteria:

          -  prior or concomitant malignant tumors

          -  any coexisting medical problems of sufficient severity to prevent full compliance with
             the study protocol.

          -  ENKTL with non-nasal sites such as skin or gastrointestinal tract was excluded even if
             it is localized.

          -  Other subtypes of non-Hodgkin lymphoma (NHL), including myeloid/NK cell precursor
             acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia,
             aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified, were
             excluded.
A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
Condition: Cholestasis
MeSH terms: Cholestasis
Intervention: Omegaven
Intervention description: 0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 2 Weeks
Maximum age: 18 Years
Healthy volunteers: No
Keywords: liver; parenteral nutrition; fish oil; omegaven; children

Summary:

      The purpose of the study is to investigate if intravenous fish oil, commercially available as
      Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in
      children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical evidence of parenteral nutrition associated cholestasis

          -  Direct bilirubin greater or equal to 2 mg/dL on 2 consecutive measurements

          -  Expected parenteral nutrition course greater than 30 days

          -  Acquired or congenital gastrointestinal disease

          -  > 2 weeks of age and < 18 years of age

          -  > 60% calories from parenteral nutrition

          -  Failed standard therapies to prevent progression of liver disease (Actigal, cyclic
             parenteral nutrition, avoidance of overfeeding, reduction/removal of copper from
             parenteral nutrition if elevated my laboratory analysis, advancement of enteral feeds)

        Exclusion Criteria:

          -  Inborn errors of metabolism

          -  Extracorporeal Membrane Oxygenation

          -  Seafood, egg, or Omegaven allergy

          -  Documented case of liver disease other than Parenteral Nutrition Associated
             Cholestasis

          -  Hemorrhagic disorder

          -  Anticoagulant therapy

          -  Hemodynamically unstable or in shock

          -  Comatose state

          -  Stroke, pulmonary embolism, recent myocardial infarction

          -  Diabetes

          -  Fatal chromosomal disorder

          -  Enrollment in any other clinical trial involving an investigational agent

          -  Patient, parent, or legal guardians unable or unwilling to give consent

          -  Patient expected to be weaned from parenteral nutrition in 30 days

          -  unable to tolerate necessary monitoring

          -  Patient requiring aspirin or toradel or motrin

          -  Patient requiring dialysis
Neuromuscular Blockade for Post-Cardiac Arrest Care
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Intervention: Rocuronium; Normal Saline
Intervention description: Neuromuscular Blockade; Normal Saline
Intervention MeSH terms: Rocuronium
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac Arrest, NMB, Neuromuscular Blockade, Rocuronium

Summary:

      The main purpose of this study is to evaluate if neuromuscular blockade improves lactate
      clearance (and preliminary secondary clinical outcome measures) as compared to usual care in
      post-cardiac arrest patients undergoing targeted temperature management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 years)

          -  Cardiac arrest with sustained return of spontaneous circulation (ROSC)

          -  Comatose (i.e., not following commands) following ROSC

          -  Undergoing targeted temperature management (TTM)

          -  Time of enrollment ≤ 6 hours from initiation of targeted temperature management

          -  Serum Lactate ≥2

        Exclusion Criteria:

          -  Pre-existing dementia, severe brain injury, or dependence on others for activities of
             daily living (i.e. a modified Rankin scale (mRS) score of 4 or higher)

          -  Traumatic etiology of the cardiac arrest

          -  Protected population (pregnant, prisoner)
Omalizumab in Severe and Refractory Solar Urticaria
Condition: Solar Urticaria
MeSH terms: Urticaria; Urticaria, Solar
Intervention: Omalizumab
Intervention MeSH terms: Omalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Omalizumab; Efficacy; Safety

Summary:

      Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and
      with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual
      treatment, leading to a large impact on quality of life. New treatment options are warranted.
      The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody
      recently approved in chronic spontaneous urticaria, in this setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > or equal to 18 years,

          -  Appearance of wheals within 15 min after sun exposure and lasting < 2 hr in the shade,

          -  Wheals reproducible with phototesting: appearance after exposure to UVB, UVA or
             visible light less than 30 min after exposure and lasting < 2 hr,

          -  Severity criteria:

               -  Very large effect on quality of life, with Dermatology Life Quality Index (DLQI)
                  > 10, and

               -  At least 1 of the following: involvement of the face, per annual eruption,
                  extension of wheals on the non-photoexposed skin, SU triggered by artificial
                  light, SU flares accompanied by bronchospasm or syncope.

          -  Refractory criteria:

               -  Resistance to photoprotection with sunscreen with sun protection factor ≥ 50, and

               -  Resistance to administration of an association of 2 different antihistamines
                  during 3 months or to photodesensitization.

        Exclusion Criteria:

          -  Contra indication to omalizumab

          -  Previous treatment with omalizumab
3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
MeSH terms: Influenza, Human
Intervention: Hib-MenCY-TT vaccine; Hib-MenC-TT vaccine; Menjugate ®; Infanrix penta ®; Infanrix hexa ®
Intervention description: Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.; Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 388.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Invasive bacterial disease caused by Hib; Neisseria meningitidis serogroups C & Y

Summary:

      This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine
      and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed
      meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age.
      Antibody persistence and immune responses to booster vaccinations were additionally assessed
      at 12 to 18 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infants without major congenital illness, immunosuppression, or chronic
             disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at
             enrollment, and vaccinated against hepatitis B at birth.

        Exclusion Criteria:

          -  Infants should not have received any investigational drug, vaccine, chronic
             immunosuppressants, or immunoglobulin or blood products.