bioihbjkbjnl/mcl2 huggingface dataset:
A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: JNJ-26866138 0.7 mg/m2; JNJ-26866138 1.0 mg/m2; JNJ-26866138 1.3 mg/m2; Melphalan; Prednisolone
Intervention description: JNJ-26866138 0.7 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles.; JNJ-26866138 1.0 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles; Phase I: JNJ-26866138 1.3 mg/m2 will be administered intravenously on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5 to 9 cycles.; Melphalan 9 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles; Prednisolone 60 mg/m2 will be taken orally (by mouth) on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
Intervention MeSH terms: Prednisolone; Bortezomib; Melphalan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Multiple myeloma; Hematopoietic stem cell transplant; HSCT; Melphalan; Prednisolone; Bortezomib; JNJ-26866138

Summary:

      The purpose of the study in Phase I is to select the recommended dose of bortezomib in
      combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess
      the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I
      portion).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with symptomatic or nonsecretory multiple myeloma

          -  Participants who have not received chemotherapy and are not hematopoietic stem cell
             transplantation candidates

          -  Participants with a measurable lesion

          -  Life expectancy greater than or equal to 3 months

        Exclusion Criteria:

          -  Previously received treatment for Multiple Myeloma

          -  Greater than or equal to Grade 2 peripheral neuropathy or neuropathic pain

          -  Myocardial infarction within 6 months prior to enrollment or uncontrolled angina,
             severe uncontrolled ventricular arrhythmias, or clinically significant conduction
             system abnormalities

          -  Patient is known to be seropositive for the human immunodeficiency virus (HIV),
             Hepatitis B surface antigen-positive or active hepatitis C infection

          -  Active prior malignancy diagnosed within the last 5 years

          -  Female participant who is pregnant or breast-feeding

          -  Participant is enrolled in another clinical research study and/or is receiving an
             investigational agent
Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer
Condition: Neoplasms,; Metastatic Cancer,; Non-Small Cell Lung Cancer; Advanced Solid Malignancies
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms
Intervention: AZD6244
Intervention description: Tablet Oral bid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 20 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Cancer,; Tumour,; Metastatic,; Lung cancer,; Non-Small Cell Lung Cancer

Summary:

      The objective of this study will be to investigate the safety and tolerability of AZD6244
      given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients
      with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung
      Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following
      the combination regimen dose escalation phase (Part A) of the study additional patients may
      be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability,
      pharmacokinetics and biological activity of the combination in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with lung cancer who have not responded to prior therapy or have
             become worse.

          -  Patients who have overall good general conditions.

          -  Patients who have at least one lesion that can be accurately assessed by imaging.

          -  Patients who have appropriate renal conditions confirmed by test results for taking
             part in the study.

          -  Evidence of non-childbearing status for women of childbearing potential, or
             postmenopausal status.

        Exclusion Criteria:

          -  Patients with brain metastases or spinal cord compression.

          -  Patients with significant abnormal ECG findings.

          -  Patients with evidence of severe or uncontrolled systemic disease.

          -  The main organ functional test values for bone marrow, kidney, and liver, etc., do not
             meet the standards.

          -  Patients with known hypersensitivity to docetaxel or products containing polysorbate
             80.

        Only for monotherapy cohort eligibility criteria Patients with advanced solid malignancies
        refractory to standard treatment or for which no standard therapy exists irrespective of
        the stage and previous treatment.

        Patients with histologically or cytologically confirmed advanced solid malignancies.
A Brief Educational Intervention to Improve Traumatic Brain Injury (TBI) Screening Outcomes
Condition: TBI
Intervention: TBI handout
Intervention description: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover.
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTSD; patient education handout

Summary:

      This research study is designed to learn about Veterans' understanding of mild TBI (traumatic
      brain injury) and the VA TBI screening process. All OEF/OIF Veterans who come to one of the
      study-related clinics for TBI screening will be invited to participate. An educational
      handout on TBI will be given to half of the participants along with their TBI screening. The
      other half of the participants will have the usual TBI screening without the educational
      handout.

      Veterans enrolled in the study will be asked to answer a 5-10 minute research questionnaire.
      The questionnaire will ask:

        -  About the individual: such as gender and branch of service

        -  About what happened during the TBI screening: such as whether the Veteran had a chance
           to ask the provider any questions

        -  About the Veteran's understanding of mild TBI: such as whether symptoms of mild TBI are
           long lasting

      Veterans who receive the educational handout will be asked specific questions about the
      handout and its information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All OEF/OIF Veterans screened for TBI at the designated clinic at 1 of the 4 study
             sites (during the 6 months of recruitment) will be eligible.

        Exclusion Criteria:

          -  None
Cognitive Behavioral Therapy for the Treatment of Seasonal Affective Disorder (SAD)
Condition: Seasonal Affective Disorder; Depression
MeSH terms: Depression; Mood Disorders; Seasonal Affective Disorder
Intervention: Light Therapy; Cognitive behavioral therapy (CBT)
Intervention description: Light therapy will involve exposure to bright light twice a day.; CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phototherapy

Summary:

      This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating
      seasonal affective disorder (SAD), commonly called the "winter blues."
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of seasonal affective disorder (SAD)

          -  Willing and able to participate in the study procedures

        Exclusion Criteria:

          -  Major psychological diagnoses other than SAD

          -  Current psychological or psychiatric treatment
Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Intervention: RO7017773; [11C] Ro15-4513
Intervention description: RO7017773 will be administered orally. The doses to be tested will be determined by review of PET scan, PK, and safety results from the previous dose level.; At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer [11C]Ro15-4513.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 23 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with
      the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773
      in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy (absence of evidence of any active or chronic disease following a detailed
             medical and surgical history, a complete physical examination including vital signs,
             12-lead ECG, hematology, blood chemisty, serology, and urinalysis), as judged by the
             Investigator.

          -  Males and women of non-childbearing potential (WONCBP)

        Exclusion Criteria:

          -  History of convulsions (other than benign febrile convulsions of childhood) including
             epilepsy, or personal history of significant cerebral trauma or CNS infections

          -  Clinically significant abnormal finding from the MRI performed after the initial
             screening examination

          -  Abnormal blood pressure, i.e, systolic blood pressure (SBP) greater than 140 or less
             than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm
             Hg

          -  Abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm

          -  History or presence of clinically significant ECG abnormalities before study drug
             administration or cardiovascular disease

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Positive result on hepatitis B (HBV) or hepatitis C (HCV), presence of hepatitis B
             surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or
             within 3 months prior to starting study treatment
A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Intervention: NST-4016 600mg; Placebo oral capsule; Moxifloxacin 400mg; NST-4016 2000mg
Intervention description: Likely maximum therapeutic dose of NST-4016; Placebo for comparison with moxifloxacin and potential NST-4016 effects; Active comparator with known effect on QT interval; Supratherapeutic dose of NST-4016
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo
      and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and
      supratherapeutic doses of icosabutate in healthy male and female subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Males or females, of any race, between 18 and 55 years of age, inclusive, at
             Screening.

          -  2. Body mass index (BMI) between 18.0 and 33.0 kg/m2, inclusive, at Screening

          -  3. In good health

        Exclusion Criteria:

          -  1. An uninterpretable or abnormal ECG at Screening and/or Check in

          -  2. History of risk factors for Torsades de Pointes

          -  3. sustained supine systolic blood pressure >140 mmHg or <90 mmHg

          -  4. Unstable cardiovascular disease, including recent myocardial infarction or cardiac
             arrhythmia.

          -  5. Female subjects who are pregnant (or planning to become pregnant within 90 days
             after the final dose administration) or are currently lactating

          -  6. Subjects who, in the opinion of the Investigator (or designee), should not
             participate in this study
Relative Bioavailability of BI 201335 Capsule Versus Three Different Oral Solutions
Condition: Healthy
Intervention: BI 201335 (Reference); BI 201335 (Test); BI 201335 (Test); BI 201335 (Test); BI 201335 (Reference); BI 201335 (Test); BI 201335 (Test); BI 201335 (Test)
Intervention description: soft gelatine capsule, oral administration; oral solution 3; oral solution 3; oral solution 2; soft gelatine capsule, oral administration; oral solution 1; oral solution 1; oral solution 2
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current study is to investigate the relative bioavailability of two
      different doses of BI 201335, administered as soft gelatine capsule in comparison to the
      equivalent doses of three different oral solution per dose of BI 201335.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        Any relevant deviation from healthy conditions
Treatment Development for Glucose Transporter Type I Deficiency Syndrome (G1D)
Condition: Glucose Transporter Type 1 Deficiency Syndrome; GLUT1 Deficiency Syndrome
MeSH terms: Syndrome
Intervention: Triheptanoin
Intervention description: Triheptanoin is a 7-carbon medium chain triglyceride
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 1 Month
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: G1D; Glut1 Disorder; Glucose Transporter Type 1 Disorder; Glucose Transporter Type I Disorder

Summary:

      The purpose of this trial is to determine if an alternative energy source will impact brain
      metabolism in a disorder characterized by glucose metabolism failure in the brain.

      The central hypothesis tested in this investigation is whether circumventing impaired glucose
      metabolism is feasible, safe and potentially promising by supplying anaplerotic precursors
      through metabolism of odd-carbon fatty acids that can enter the citric acid cycle (CAC)
      through alternative metabolic pathways.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female

          -  Ages 1 month to <21 years of age

          -  Diagnosed with glucose transporter type I deficiency.

          -  Age matched (within 1 year) controls not diagnosed with G1D.

        Exclusion Criteria:

          -  All subjects carrying body metal implants incompatible with the exposure to a magnetic
             field

          -  Subjects unable to tolerate the MRI and MRS procedures due to anxiety

          -  Subjects receiving oxygen supplementation or those confined to a bed or stretcher

          -  Subjects currently receiving a ketogenic diet, due to a high risk of seizure
             recurrence while transitioning off ketosis.

          -  Patients behaviorally unable to hold still for imaging procedures (rather than limited
             by seizure activity) will be excluded.
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Condition: Post-operative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Intervention: 14C-APD421
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass
      balance recovery, metabolite profile, metabolite identification and pharmacokinetics of
      14C-labelled APD421
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males

          -  Age 18 to 65 years of age at time of signing informed consent

          -  Body mass index (BMI) of 18 to 30 kg/m2 or, if outside the range, considered not
             clinically significant by the investigator

          -  Must be willing and able to communicate and participate in the whole study

          -  Must provide written informed consent

          -  Must agree to use an adequate method of contraception (as defined in Section 8.4)

          -  Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per
             day)

        Exclusion Criteria:

          -  Prior participation in another study with a radiation burden of > 0.1 mSv and ≤ 1 mSv
             in the period of 1 year prior to screening; a radiation burden of > 1 mSv and ≤ 2 mSv
             in the period of 2 years prior to screening; a radiation burden of > 2 mSv and ≤ 3 mSv
             in the period of 3 years prior to screening, etc (add 1 year per 1 mSv)
Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.
Condition: Hepatitis, Chronic; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Hepatitis, Chronic
Intervention: Small Molecule Agent (PF-868554); Small Molecule Agent (PF-868554)
Intervention description: Study drug will be administered 700mg BID in the fed state for three days.; Study drug will be given 450mg BID for a duration of 10 days.
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: 65 Years
Healthy volunteers: No

Summary:

      Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics,
      safety and efficacy in subjects with no or inadequate response to prior treatment.
    

Eligibility criteria:

        Inclusion Criteria:

        HCV Positive With HCV RNA>100,000 iu/ml Genotype 1; COHORT A- non responders or partial

        Exclusion Criteria:

        HIV HBV co-infection Decompensated liver disease Liver disease due to causes other than
        HCV, AFP>200ng/ml
Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: D6-25-hydroxyvitamin D3
Intervention description: Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3
Intervention MeSH terms: Hydroxycholecalciferols; Calcifediol
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic kidney disease; vitamin d catabolism

Summary:

      The goal of this study is to better understand vitamin D catabolism and how it is affected by
      CKD and race.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Self-reported race Caucasian, African American, or African

          -  Serum total 25(OH)D 10-50 ng/mL

          -  Estimated GFR:

               -  60 mL/min/1.73m2 (N=40) 15-45 mL/min/1.73m2 (N=40) <15 mL/min/1.73m2, treated
                  with hemodialysis (N=40)

        Exclusion Criteria:

          -  Primary hyperparathyroidism

          -  Gastric bypass

          -  Tuberculosis or sarcoidosis

          -  Current pregnancy

          -  Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic
             encephalopathy, bilirubin >=2 mg/dL, serum albumin <=3.5 g/dL, or PT >= 4 seconds)

          -  Use of vitamin D3, or vitamin D2 supplements exceeding a mean daily dose of 400 IU,
             within 3 months (wash-out allowed)

          -  Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce
             CYP24A1 within 4 weeks (wash-out allowed)

          -  Serum calcium > 10.1 mg/dL

          -  Hemoglobin < 10 g/dL