bioihbjkbjnl/mcl2 huggingface dataset:
Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)
Condition: Solid Tumor; Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Dalotuzumab
Intervention description: IV infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly,
      every other week. or a every three week infusion.

      The hypothesis of this study is that administration of dalotuzumab as a one- to two-hour
      weekly, every other week, or every three week infusion in participants with advanced cancer
      will be generally safe and tolerated at a dose which achieves a trough concentration ≥3
      μg/mL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has metastatic or locally advanced solid tumor or multiple myeloma

          -  Tumor specimen has IGF-1R expression

          -  Participant agrees to use birth control throughout study

        Exclusion Criteria:

          -  Participant must not be recovering from antineoplastic therapy in the last 4 weeks

          -  Participant has participated in a clinical trial in the last 4 weeks

          -  Participant has a history of heart problems such as congestive heart failure, angina,
             heart attack or stroke in the last 3 months

          -  Participant is taking growth hormone or growth hormone inhibitors

          -  If female, participant is pregnant or breastfeeding

          -  Participant is human immunodeficiency virus (HIV) positive

          -  Participant has a history of hepatitis B or C
A Food-Drug Interaction Study of Serum Urate After Oral Inosine
Condition: Healthy
Intervention: Inosine
Intervention description: Inosine, 1000 mg
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the effects of food on the amount of urate in the body
      after a single oral dose of inosine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male subjects between the ages of 18 and 65 years

          2. Body-mass index between 18.0 kg/m2 and 32.0 kg/m2

          3. If not surgically sterile, willing to refrain from donating sperm and willing to use
             appropriate birth control when engaging in sexual intercourse for a period of 90 days
             following the last dose of the study medication

          4. Serum urate < 6.1 mg/dL (approximately 360 μM) at screening

          5. Non-smokers for at least 6 months prior to screening

          6. Adequate venous access at multiple sites in both arms

        Exclusion Criteria:

          1. History of alcohol or drug dependence in the past 2 years

          2. Had 400 mL of whole blood collection within four months or 200 mL of whole blood
             collection or who had blood component collection within one month of the screening
             test

          3. Used prescription or over-the-counter (OTC) drugs within 14 days prior to screening

          4. Used vitamin preparations or supplements (including St. John's Wort and ginseng)
             within 28 days prior to the screening test

          5. Not willing to refrain from alcohol, grapefruit, grapefruit juice or related products,
             caffeine consumption (including chocolate), and strenuous exercise within 72 h prior
             to day 1 and through the end of the PK study

          6. Treated with an investigational drug within 30 days or 7 half-lives of the
             investigational drug, whichever is longer, prior to the first dose of study drug

          7. Previously received inosine supplement within three months from the screening or
             subjects who have had any inosine and suffered an adverse reaction due to it

          8. Known HIV disease

          9. Had a febrile illness within 5 days prior to the first dose of study medication

         10. Vaccinated within 30 days prior to the first dose of medication

         11. Has gout or a history or suspicion of kidney stones

         12. Determined by the investigator or sub-investigator to be unsuitable for participating
             in the study based on medical conditions
Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Tezepelumab
Intervention description: Single dose subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: No masking is used. All involved know the identity of the intervention assignment.
Enrollment: 18.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Mild asthma; Moderate asthma; Severe asthma

Summary:

      This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose
      of tezepelumab in children aged ≥ 5 to 11 years with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and written informed assent and any locally required
             authorisation obtained from the subject and legal representative prior to any study
             related procedure taking place.

          -  Age 5 to 11 years (inclusive) at Visit 1 and Visit 2 (Day 1). Type of Subject and
             Disease Characteristics

          -  Documented physician diagnosed asthma for at least 6 months prior to Visit 1.

          -  Documented treatment with total daily dose of either low, medium, or high dose ICS for
             at least 6 months, as described in Step 2 to Step 4 of GINA guidelines (GINA 2020)
             with stable dose for at least 3 months prior to Visit 1.

          -  Pre bronchodilator (BD) FEV1 of ≥ 50% of predicted normal value at Visit 1

          -  Body weight ≥ 16 kg at Visit 1 and Visit 2 (Day 1).

        Exclusion Criteria:

          -  History of any clinically significant disease or disorder other than asthma which, in
             the opinion of the Investigator, may either put the subject at risk because of
             participation in the study, or influence the results or the subject's ability to
             participate in the study.

          -  History of a deterioration in asthma or asthma exacerbation that required a burst of
             systemic corticosteroids within 6 weeks of Visit 1, up to and including Visit 2 (Day
             1).

          -  History of hospitalisation (overnight admission) for asthma within 3 months of Visit
             1, up to and including Visit 2 (Day 1).

          -  History of a life threatening asthma exacerbation requiring intubation or mechanical
             ventilation.

          -  History of systemic corticosteroid use for the maintenance treatment of asthma within
             6 weeks of Visit 1, up to and including Visit 2 (Day 1) and discouraged until EOS.

          -  History of cancer.

          -  History of hypersensitivity or anaphylactic reaction to any biologic therapy.
Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Apixaban; Apixaban
Intervention description: Tablets, Oral, 5 mg, Once, 4 days; Tablets, Oral, 5 mg, Twice, 15 days
Intervention MeSH terms: Apixaban
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PHARMACOKINETIC; NOS

Summary:

      The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg
      Apixaban in subjects with normal renal function and subjects with end stage renal disease
      (ESRD) maintained with hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The signed informed consent form.

          -  Subjects with normal renal function classified based on calculated creatinine
             clearance (CLCr) determined by the cockcroft-gault calculation.

          -  Eligible subjects with ESRD that is maintained with chronic and stable hemodialysis.

        Exclusion Criteria:

          -  Any history of abnormal bleeding or coagulation disorders including those in a first
             degree relative under 50 years of age.

          -  History of significant head injury within the last two years.

          -  Any gastrointestinal surgery that could impact the absorption of study drug.

          -  Not expected to continue the hemodialysis treatment for the duration of the study.

          -  INR, PT, or aPTT above the upper limit of normal, unless agreed upon between the
             investigator and BMS medical monitor.

          -  History of allergy to Apixaban or Factor Xa inhibitors.
A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers
Condition: Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,; Primary Peritoneal Cancer or Endometrial Cancer; Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer
MeSH terms: Breast Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Fallopian Tube Neoplasms
Intervention: MM-121; Paclitaxel
Intervention description: increasing doses of MM-121 IV QW; Paclitaxel - 80 mg/m2 IV QW
Intervention MeSH terms: Paclitaxel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian cancer; HER-2 negative breast cancer; Breast cancer; Fallopian tube cancer

Summary:

      This study was a Phase 1 and pharmacologic open-labeled dose-escalation trial of MM-121 in
      combination with paclitaxel using a "3+3" design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytological or histological confirmation of locally advanced/metastatic or recurrent
             epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or
             endometrial cancer; OR, cytological or histological confirmation of locally advanced
             /metastatic Her2 non-overexpressing breast cancer

          -  Eighteen years of age or above

          -  Candidates for chemotherapy

          -  Able to understand and sign an informed consent (or have a legal representative who is
             able to do so)

          -  Measurable disease according to RECIST v1.1

          -  ECOG Performance Score (PS) of ≤ 2

          -  Willing to abstain from sexual intercourse or to use an effective form of
             contraception during the study and for 90 days following the last dose of MM-121

        Exclusion Criteria:

          -  Prior radiation therapy to >25% of bone marrow-bearing areas

          -  Evidence of any other active malignancy

          -  Active infection or fever> 38.5°C during screening visits or on the first scheduled
             day of dosing

          -  Symptomatic CNS disease

          -  Known hypersensitivity to any of the components of MM-121 or who have had
             hypersensitivity reactions to fully human monoclonal antibodies

          -  Received treatment, within 30 days prior to the first scheduled day of dosing, with
             any investigational agents that have not received regulatory approval for any
             indication or disease state

          -  Pregnant or breast feeding
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Condition: Cachexia; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Wasting Syndrome; Cachexia
Intervention: Placebo Testosterone; Testosterone Enanthate 100 MG/ML
Intervention description: Placebo (Saline) Testosterone given IM once per week.; Testosterone Enanthate 100mg/ml given once per week IM.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: stage IIB cervical cancer; stage III cervical cancer; recurrent cervical cancer; cachexia; advanced head/neck carcinoma; recurrent head/neck carcinoma

Summary:

      RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in
      patients with cachexia caused by cancer.

      PURPOSE: This randomized phase I trial is studying whether testosterone administered during
      standard of care chemotherapy and/or radiation works by helping patients with squamous cell
      carcinoma to maintain their body weight and muscle size and strength during treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent squamous cell carcinoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Mini Mental State Examination score > 23

        Exclusion Criteria:

          -  Pregnancy

          -  Evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver enzymes

          -  Significant liver, renal, or heart disease

          -  Diabetes mellitus or other untreated endocrine disease

          -  Polycystic ovary syndrome and/or hyperthecosis

          -  Androgen secreting tumors of the ovary and adrenal or any ovarian tumors (e.g.,
             Sertoli- Leydig cell tumor)

          -  Non-classical adrenal hyperplasia

          -  Cushing's syndrome

          -  Glucocorticoid resistance

          -  Hyperprolactinoma or hypothyroidism

          -  Lactose intolerance

          -  Alcohol or drug abuse

          -  Recent treatment (within 3 months) with anabolic steroids

          -  Ongoing anticoagulant therapy

          -  Any other circumstance that would preclude study participation, in the opinion of the
             principal investigator or study physician
A Multiple Dose Study Of PF-04620110 In Type 2 Diabetes Patients
Condition: Type 2 Diabetes Patients
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-04620110; PF-04620110; Placebo
Intervention description: 5 mg of PF-04620110 given once daily; 2.5 mg of PF-04620110 given twice daily; Matching placebo giving for 4 weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: multiple dose study in type 2 diabetes patients

Summary:

      PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The
      primary purpose of this trial is to evaluate the safety and tolerability, and
      pharmacodynamics, of multiple oral doses of PF-04620110 in T2DM patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and/or female subjects between the ages of 18 and 60 years;

          -  Body Mass Index (BMI) of >25.0 kg/m2 and <40 kg/m2;

          -  Subjects must have a historical diagnosis of T2DM in accordance with the ADA
             guidelines;

          -  Subjects who have been on well-tolerated and stable doses of metformin

        Exclusion Criteria:

          -  Recent evidence (6 months prior to screening) or history of unstable major organ
             disease;

          -  Diagnosis of Type 1 diabetes mellitus;

          -  Current medical history of myocardial infarction, unstable angina, or history of
             stroke (including TIA) within 6 months prior to Screening;

          -  Treatment with thiazolidinediones (TZDs), or subcutaneously administered antidiabetic
             agents;
Ketamine for Relapse Prevention in Recurrent Depressive Disorder
Condition: Depression; Relapse; Recurrent Depressive Disorder; Major Depressive Disorder
MeSH terms: Recurrence; Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Ketamine; Midazolam
Intervention description: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.; A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.
Intervention MeSH terms: Midazolam; Ketamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised, double-blind, placebo-controlled study designed to assess feasibility of recruitment, randomisation and retention.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Masking took place by sealed envelope random allocation and double blinding of participants and raters was assessed throughout. The anaesthesiologist administering infusions was aware of the allocation.
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ketamine; glutamate; relapse prevention

Summary:

      Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam for
      depression relapse prevention in persons at high risk. The main purpose of the pilot study is
      to assess trial processes to help inform a future definitive trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years old

          -  Hamilton Rating Scale for Depression, 24-item (HRSD-24) score of ≥21

          -  Voluntary admission for treatment of acute depressive episode

          -  Meet DSM-IV criteria for recurrent depressive disorder (RDD): ≥2 previous depressive
             episodes with at least 2-months(consecutive) subthreshold or no symptoms in between
             PLUS(to enrich the sample for those at high risk for relapse) must also have
             experienced ≥3 major depressive episodes(including index episode) within the previous
             2 years

        For the randomised pilot trial, RDD patients must have:

          -  received antidepressant treatment for the acute depressive episode(pharmacological,
             psychotherapeutic or multidisciplinary)

          -  ≥60% decrease from baseline HRSD-24 score and score ≤16

          -  Standardised Mini-Mental State Examination (sMMSE) score of ≥24

          -  able to provide informed consent

        Exclusion Criteria:

          -  Current involuntary admission

          -  Medical condition rendering unfit for ketamine/midazolam

          -  Active suicidal intention

          -  Dementia

          -  History of Axis 1 diagnosis other than RDD

          -  Electroconvulsive therapy (ECT) for treatment of current depressive episode

          -  Alcohol/substance abuse in previous six months

          -  Pregnancy or inability to confirm use of adequate contraception during the trial
A Study of LY2886721 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY2886721; Placebo
Intervention description: Administered orally.; Administered orally.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Mild Cognitive Impairment

Summary:

      The purpose of this phase I study in healthy participants will be to evaluate the safety and
      tolerability of LY2886721 single and multiple doses, to evaluate how the body handles the
      drug, and to evaluate the drug's effect on the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and non-childbearing potential women

          -  Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m^2)

          -  Are reliable and willing to make yourself available for the duration of the study and
             are willing to follow study procedures and research unit policies

        Exclusion Criteria:

          -  Taking over-the-counter or prescription medication with the exception of vitamins or
             minerals

          -  Smoke more than 10 cigarettes per day

          -  Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per
             day
Study Of Sunitinib With S-1 And Cisplatin For Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Intervention: Cisplatin; S-1; Sunitinib
Intervention description: Cisplatin 60 mg/m2 on day 1 of each 28 day cycle; S-1 80 mg/m2 on days 1-21 of each 28 day cycle; Sunitinib 25 mg, 37.5 mg and 50 mg daily S-1 80 mg/m2 on days 1-21 of each 28 day cycle Cisplatin 60 mg/m2 on day 1 of each 28 day cycle
Intervention MeSH terms: Sunitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: chemotherapy; combination

Summary:

      To assess the maximal tolerated dose (MTD) and overall safety of sunitinib when administered
      in combination with S-1 and Cisplatin in patients with advanced/metastatic gastric cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of gastric cancer

          -  Chemonaive patients

          -  Adequate organ function

        Exclusion Criteria:

          -  Patients who meet the contra-indications of S-1 and Cisplatin.

          -  Prior chemotherapy failure patients