bioihbjkbjnl/mcl2 huggingface dataset:
PED NEONAT 20-000599 Fetal Body Composition
Condition: IUGR; Gestational Diabetes; Pregnancy Related
MeSH terms: Diabetes, Gestational
Intervention: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging
Intervention description: Subject will have a one time MRI scan.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Pregnant mothers who's infants were diagnosed with intrauterine growth restriction and mothers with pregnancies complicated by gestational diabetes, and mothers with healthy uncomplicated pregnancies will be recruited to have a fetal MRI in the third trimester.
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Obesity is an ongoing public health problem that is difficult to treat. There is evidence
      that obesity has fetal origins. Body composition, including visceral, subcutaneous, brown,
      and hepatic fat have been found to be important predictors in obesity and metabolic syndrome.
      Magnetic resonance imaging (MRI) can quantify body composition that does not require
      radiation but is motion limited. The investigators have developed a motion-compensated MRI
      sequence, also known as "free breathing" MRI. In this study, the investigators plan to obtain
      free-breathing MRIs of pregnant women in the third trimester of pregnancy. MRIs will be
      obtained from healthy mothers, mothers with growth-restricted fetuses, and mothers with
      gestational diabetes. The different types of adipose tissue will be measured and compared
      between groups and correlated to birth growth parameters. The goal is this study is to assess
      if motion-compensated MRI can help predict early growth patterns in infancy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant women with singleton pregnancies (healthy cohort)

          -  Pregnant women with fetuses with weights < 10th percentile weight for gestational age
             (IUGR cohort)

          -  Pregnant women with gestational diabetes (diabetes cohort)

        Exclusion Criteria:

          -  Pregnant minors

          -  Major congenital anomalies or disease processes in the fetus

          -  Fetus with known chromosomal anomalies

          -  Mothers who do not plan to deliver at UCLA

          -  Multiple pregnancy (i.e. twins, triplets, etc)

          -  History of claustrophobia

          -  Contraindications to MRI such as metallic devices in the body that are not MRI
             compatible
A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body
Condition: Neoplasms; Neoplasm Metastasis; Melanoma; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms
MeSH terms: Neoplasms; Neoplasm Metastasis; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: LY3009120 capsule
Intervention description: Administered orally.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to see how safe the investigational drug known as LY3009120
      is and whether it will work to help people with advanced cancer or cancer that has spread to
      other parts of the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced or metastatic cancer

          -  Other available therapies have failed to cure the cancer

          -  The cancer that has no proven effective therapy

          -  The cancer can be biopsied (depending on the tumor type and/or the dose of drug
             received, tumor biopsies may be required)

          -  Able to swallow capsules

        Exclusion Criteria:

          -  Have active cancer in the brain or spinal cord

          -  Have an active infection of any kind (fungal, viral, or bacterial)

          -  Have a cancer of the blood

          -  Are pregnant or breastfeeding

          -  Have some types of eye problems or impairments
PP100-01 (Calmangafodipir) for Overdose of Paracetamol
Condition: Paracetamol Overdose
MeSH terms: Drug Overdose
Intervention: PP100-01 (calmangafodipir); Acetylcysteine
Intervention description: PP100-01; NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      Investigate the safety and tolerability of PP100-01 add-on treatment to the 12hr NAC
      treatment regime in patients treated for paracetamol/acetaminophen overdose (POD) when NAC
      treatment is initiated before 24hours post POD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Any patient with capacity admitted to hospital within 24 hrs either a single acute POD
             or more than one dose of paracetamol (staggered) and deemed to require treatment with
             NAC.

          2. Provision of written informed consent

          3. Males and females of at least 16 years of age

        Exclusion Criteria:

          1. Patients that do not have the capacity to consent to participate in the study

          2. Patients detained under the Mental Health Act or deemed unfit by the Investigator to
             participate due to mental health.

          3. Patients with known permanent cognitive impairment

          4. Patients who are pregnant or nursing

          5. Patients who have previously participated in the study

          6. Unreliable history of POD

          7. Patients presenting after 24hrs of POD

          8. Patients who take anticoagulants (e.g. warfarin) therapeutically or have taken an
             overdose of anticoagulants

          9. Patients who, in the opinion of the responsible clinician/nurse, are unlikely to
             complete the full course of NAC e.g. expressing wish to self-discharge

         10. Prisoners

         11. Non-English speaking patients. (Study information material will only be produced in
             English in view of the known and stable demographic of the Edinburgh self-harm
             population).
A Study of 2 Different Formulations of Blosozumab (LY2541546) in Post Menopausal Women
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Blosozumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the tolerability of two different formulations of
      blosozumab in women who have reached menopause.

      This study will last approximately 12 weeks for each participant, not including screening.
      Screening is required within 28 days prior to starting the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Part A: Overtly healthy postmenopausal (PMP) females

          -  Part B: PMP women who are currently taking oral bisphosphonates for prevention or
             treatment of osteoporosis

          -  Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter
             (kg/m^2)

        Exclusion Criteria:

          -  Have known allergies to blosozumab, its constituents, or related compounds

          -  Have an abnormality in the 12-lead electrocardiogram (ECG)

          -  History of breast carcinoma

          -  Fracture of a long bone within 1 year of screening

          -  Have used teriparatide within 3 years prior to screening
Safety Trial of NK Cell DLI 3-5/6 Family Member Following Nonmyeloablative ASCT
Condition: Lymphoma
Intervention: NK-CD56
Intervention description: NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II aGVHD at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stem cell transplant; mismatched donor; NK infusion

Summary:

      Evaluate the safety of natural killer (NK) cell infusion using CD56 monoclonal antibody
      selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation
      (SCT) from mismatched donors. This pilot study will evaluate toxicity including mortality,
      occurrence of acute graft versus host disease (aGVHD) and other severe toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with who have undergone a non-myeloablative allogeneic transplant, using a
             3-5/6 HLA matched sibling donor. Measureable disease is not needed at study entry.

          -  Performance status must be Karnofsky 50-100%.

          -  Donor cellular engraftment of at least 2.5% from the non-myeloablative procedure.

          -  ≤ Grade 2 acute GVHD at time of infusion of NK cell infusion. Patients with treated
             acute GVHD must be on a stable dose of therapy (no increase in immunosuppressive
             therapy for the 2 weeks before planned NKI). The dosage/level of immunosuppressive
             therapy at the time of NKI should be no greater than 1 mg/kg of prednisone daily or
             mycophenolate 1000 mg bid daily or cyclosporine with a target level of 200 or
             equivalent.

          -  Estimated survival at least 8 weeks.

          -  Age > or equal to 18 years of age.

        Exclusion Criteria:

          -  Pregnant or lactating women,

          -  Patients with other major medical or psychiatric illnesses, which the treating
             physician feels, could seriously compromise tolerance to this protocol.

          -  Patients who had biopsy proven overall Grade 4 GVHD lasting longer than 7 days, from
             the non-myeloablative therapy, are not eligible
Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies
Condition: Relapsed/Refractory B-cell Malignancies
MeSH terms: Neoplasms
Intervention: Tirabrutinib
Intervention description: Tablets or capsules administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the long-term safety and tolerability of
      tirabrutinib in adults with relapsed/refractory B-cell malignancy who have tolerated and
      achieved stable disease or improved with tirabrutinib treatment while enrolled in a prior
      (parent study) tirabrutinib study (NCT01659255). The dosing regimen will be based on the
      prior dosing regimen from the parent study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently enrolled in a prior tirabrutinib study

          -  Did not discontinue treatment with tirabrutinib for any reason other than to enroll in
             this study

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at
             enrollment in this study

          -  Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to
             previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the
             baseline of the prior study prior to Day 1 of this study

          -  Negative serum and urine pregnancy test is required for female individuals (unless
             surgically sterile or greater than 2 years post menopausal)

          -  Male and female individuals of childbearing potential who engage in heterosexual
             intercourse must agree to use protocol specified method(s) of contraception as
             described in the protocol

          -  Lactating females must agree to discontinue nursing before the study drug is
             administered

          -  Ability and agreement to attend protocol-specified visits at the study site

          -  Able to comprehend and willing to sign the informed consent form

        Key Exclusion Criteria:

          -  Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Bioavailability Study of 2 Oral Formulations of ALXN1840
Condition: Healthy
Intervention: ALXN1840
Intervention description: ALXN1840 will be administered orally.
Intervention MeSH terms: Choline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 2-period, 2-sequence, crossover study with a parallel group extension.
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioavailability; Healthy

Summary:

      The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in
      healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No clinically significant history or presence of electrocardiogram findings

          -  Body weight ≥50 to ≤100 kilograms (kg) and body mass index 18 to <32 kg/meter squared
             for all participants

          -  Willing and able to follow protocol-specified contraception requirements

        Exclusion Criteria:

          -  History or presence of clinical and/or laboratory disorders

          -  Abnormal blood pressure, defined as supine blood pressure ≤90/60 millimeters of
             mercury (mmHg) or >140/90 mmHg

          -  Lymphoma, leukemia, or any malignancy within the past 5 years

          -  Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > upper limit
             of normal

          -  Serum copper or serum ceruloplasmin below lower limit of normal

          -  Hemoglobin <130 grams (g)/liter (L) for males and hemoglobin <115 g/L for females

          -  Significant allergies

          -  Smoker
Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL
Condition: Non Hodgkins Lymphoma; Chronic Lymphocytic Leukaemia
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Tirabrutinib
Intervention description: Capsules administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib
      (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory
      non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Males or females with a confirmed diagnosis of and documented history of relapsed or
             refractory malignant disease (B-cell lymphoma and/or CLL) for which no therapy of
             curative or high priority exists and for whom treatment with a Btk inhibitor may be
             deemed appropriate.

          2. Age ≥ 18 years.

          3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

        Key Exclusion Criteria:

          1. Central nervous system (CNS) lymphoma.

          2. Women who are pregnant or lactating.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment
Condition: HCV Infection
MeSH terms: Hepatitis C; Renal Insufficiency
Intervention: Voxilaprevir
Intervention description: 100 mg tablet administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the pharmacokinetics, safety, and
      tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment
      and matched healthy control participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  All individuals:

               -  Screening laboratory values within defined thresholds for group

               -  Use of two effective contraception methods if female of childbearing potential or
                  sexually active male

          -  For individuals with severe renal impairment:

               -  Stable chronic kidney disease

               -  Creatinine clearance (CLcr) < 30 mL/min

        Key Exclusion Criteria:

          -  All individuals:

               -  Pregnant or nursing female or male with pregnant female partner

               -  Hepatitis B virus, hepatitis C virus (HCV) or HIV infection

               -  History of clinically significant illness or any other medical disorder that may
                  interfere with the individual's treatment, assessment or compliance with the
                  protocol

          -  For individuals with severe renal impairment:

               -  Anticipated to require dialysis within 90 days of study dosing

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI10773; BI10773; BI10773; BI10773
Intervention description: BI10773 medium dose tablet single dose; BI10773 medium dose tablet single dose; BI10773 medium dose tablet single dose; BI10773 medium dose tablet single dose
Intervention MeSH terms: Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the effect of the different degrees of renal
      impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral
      administration of high dose BI10773 as a single dose in Japanese patients with type 2
      diabetes mellitus.
    

Eligibility criteria:

        Inclusion criteria:

          -  Type 2 diabetes patients

          -  Glycosylated haemoglobin>= 6.1% (Japan Diabetes Society)

          -  Estimated glomerular filtration rate based on the modification of diet in renal
             disease-formula at screening , of >= 15 mL/min/1.73m2

        Exclusion criteria:

          -  Any evidence of significant disease (other than renal impairment)

          -  Moderate and severe concurrent liver function impairment

          -  Gastrointestinal tract surgery, that might affect absorption and elimination of drugs

          -  Diseases of the central nervous system (such as epilepsy), psychiatric disorders, or
             neurological disorders

          -  Chronic or relevant acute infections

          -  Participation in another trial with investigational drug administration within 30 days
             prior to study drug administration or during the trial
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: HBV vaccine (Engerix B)
Intervention description: Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 3 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Therapeutic vaccine; HBsAg clearance; Immune clearance; HBsAg clearance induced by vaccination; s seroconversion in carriers after vaccination

Summary:

      Background:

      The HBsAg clearance rate in interferon-treated responders is significantly higher than that
      in lamivudine-treated responders, implying immune control is the key to HBsAg clearance.
      There is a good chance to further increase the cure rate if the investigators can enhance the
      HBV-specific immune response when the HBsAg level already comes to a low level.

      Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients
      whose HBsAg already <=2000 IU/ml.

      Patients and methods:

      This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no
      hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine
      (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one
      year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose
      during the treatment period and every 3 months for another year following the last dose.
      Viral and cellular factors will be studied to discover determinants affecting HBsAg
      clearance.

      Aims

        1. To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate
           chronic HBV infection in patients with low titer HBsAg.

        2. To delineate the doses to response (HBsAg clearance or decline rate) correlation so as
           to design a feasible schedule for future clinical trials in a larger group of patients.

        3. To discover viral and host factors which can be used as biomarkers for personalized
           vaccine therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Naïve or treated chronic hepatitis B patients with positive HBsAg and negative HBeAg;

          2. Quantitative serum HBsAg (qHBsAg) <2000 IU/ml;

          3. No HIV co-infection;

          4. No obvious immunodeficiency (such as renal failure, chemotherapy, radiotherapy,
             immunosuppressant);

          5. Aged 3 to 80 years;

        Exclusion Criteria:

          1. Pregnancy

          2. Allergic to HBV vaccine or yeast.

          3. Hepatic decompensation