bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Denosumab on the Pharmacokinetics of Etanercept
Condition: Postmenopausal; Osteopenia; Rheumatoid Arthritis; Osteoporosis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Osteoporosis; Bone Diseases, Metabolic
Intervention: Etanercept; Denosumab
Intervention description: Administered by subcutaneous injection once a week; Administered by subcutaneous injection
Intervention MeSH terms: Denosumab; Etanercept
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Amgen; Phase 1; Postmenopausal; Osteopenia; Rheumatoid; Bone Mineral Density; Arthritis; Pharmacokinetics; Osteoporosis

Summary:

      The primary objective of the study was to characterize the effects of a single dose of
      denosumab on the pharmacokinetics (PK) of etanercept in postmenopausal women with low bone
      mineral density (BMD) and rheumatoid arthritis based on area under the serum
      concentration-time curve (AUC) and maximum observed serum concentration (Cmax).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women (postmenopausal is defined as no vaginal bleeding or spotting for
             at least 12 months)

          -  Low bone mineral density (BMD) as determined by screening BMD T-scores of the lumbar
             spine (L1 to L4), or total evaluable vertebrae (if fewer than L1 to L4), or total hip
             ≤ -1.0

          -  Receiving a 50 mg dose of etanercept once weekly ≥ 6 months prior to screening and
             expected to continue etanercept treatment at this dose and frequency through end of
             study (EOS)

          -  If currently taking methotrexate (MTX), receiving a stable dose (7.5 to 20 mg/week) of
             MTX ≥ 8 weeks prior to screening

          -  Willing and able to take ≥ 1,000 mg elemental calcium and ≥ 400 IU vitamin D daily
             upon enrollment

        Exclusion Criteria:

          -  Type 1 diabetes; OR poorly controlled Type 2 diabetes (hemoglobin A1c (HbA1c) > 8.0%
             at screening; HbA1c ≤ 8.0% within 6 months of screening is acceptable if supporting
             laboratory documentation is available)

          -  History of heart failure, coronary artery bypass graft, or cardiac arrhythmia; OR
             history of acute coronary syndrome

          -  Comorbid autoimmune disease, demyelinating disease, or hematologic abnormalities

          -  History of joint replacement in hand and/or wrist; OR history of fused joint in hand
             and/or wrist

          -  Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw; OR active
             dental or jaw condition that requires oral surgery, or non-healed dental/oral surgery;
             OR planned invasive dental procedure(s) during the course of the study

          -  Previous exposure to denosumab
A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal
Condition: Pharmacokinetics; Tolerability
Intervention: Androxal; Placebo
Intervention description: 125 mg Androxal, 250 mg Androxal separated by at least 7 days; Placebo, single dose
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To determine the tolerability and pharmacokinetics (PK) of a single dose of Androxal in
      healthy adult male subjects as the dose to be investigated in a thorough QT
      interval/corrected QT interval (QT/QTc) study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Speaks, reads, and understands English or Spanish and is willing and able to provide
             written informed consent on an institutional review board (IRB)-approved form prior to
             the initiation of any study procedures;

          -  Male, between the ages of 18-60 years;

          -  No significant abnormal findings at the screening physical examination as evaluated by
             the Investigator;

          -  Normal laboratory values (or abnormal but not clinically significant) at screening as
             determined by the Investigator;

          -  Subject is willing to remain in the clinic overnight for the Day 1 and Day 8 visits;

          -  Must be able to swallow gelatin capsules

        Exclusion Criteria:

          -  Known hypersensitivity to Clomid;

          -  Abnormal screening visit vital signs or clinical laboratory evaluation considered
             clinically significant by the Investigator;

          -  Subject with a significant organ abnormality or disease as determined by the
             Investigator;

          -  Any medical condition that would interfere with the study as determined by the
             Investigator;

          -  Slow cytochrome P450 2D6 (CYP2D6) metabolizer

          -  Participation in a clinical trial with investigational medication within 30 days prior
             to study medication administration;

          -  An acute illness within 5 days of study medication administration;

          -  Positive urine drug screen at the screening visit;

          -  A mental condition rendering the subject unable to understand the nature, scope, and
             possible consequences of the study and/or evidence of an uncooperative attitude, as
             determined by the Investigator;

          -  History of venous thromboembolic disease (e.g. deep vein thrombosis or pulmonary
             embolism);

          -  History of myocardial infarction, unstable angina, symptomatic heart failure,
             ventricular dysrhythmia, or known history of QTc interval prolongation;

          -  An employee or family member of an employee of the study site or the Sponsor;
Glutathione and Function in HIV Patients
Condition: HIV Infection; Erythrocyte Glutathione Deficiency
MeSH terms: HIV Infections
Intervention: GlyNAC (combination of glycine and n-acetylcysteine)
Intervention description: HIV patients will be studied before and after receiving GlyNAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine; Glycine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      We have recently reported that older patients with HIV are deficient in glutathione (GSH) due
      to decreased availability of cysteine and glycine, and that oral supplementation with
      cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their own levels, and
      improves (but does not fully normalize) concentrations of red-cell GSH. We also found that
      when GSH deficient, subjects had impaired mitochondrial fuel oxidation and this improved with
      an increase in intracellular GSH concentrations. These older HIV patients also had
      significant increases in muscle strength with improvement of GSH levels.The current proposal
      in older HIV patients will investigate study if cysteine and glycine supplementation for a
      duration of 12 weeks will result in changes in : (a) GSH levels; (b) body
      composition/anthropometry; (c) strength and function; (d) quality of life; (e) mitochondrial
      energetics; (f) biochemistry (including dyslipidemia and oxidative stress); (g) protein and
      glucose metabolism; (h) cognition and memory. After completing supplementation for 3 months,
      GSH concentrations, strength, function, mitochondrial energetics and neurocognitive tests
      will be measured for a further 2 months to determine the effects of washout.
    

Eligibility criteria:

        Inclusion Criteria:

        HIV patients:

          -  age 45-65 years

        Non-HIV subjects:

          -  age 45-65 years

        Exclusion Criteria:

          1. Hospitalization in the past 3 months

          2. Untreated hypothyroidism or hyperthyroidism

          3. Known diabetes mellitus, hypercortisolemia, coronary artery disease.

          4. Known liver impairment (ALT and AST >2ULN)

          5. Renal impairment (Creatinine>1.4)

          6. Inability to walk

          7. Patients on anticoagulation or antiplatelet therapy.

          8. Patient with triglyceride concentrations >500 mg/dl.
A Study of LY2439821 in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2439821
Intervention description: Administered subcutaneously
Intervention MeSH terms: Ixekizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and tolerability of LY2439821
      subcutaneously administered for 48 weeks in Japanese participants with rheumatoid arthritis
      who have completed Study I1F-JE-RHAL (NCT01253265).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have received 7 injections of LY2439821 subcutaneously in the 30-,
             80-, or 180-mg dose cohorts, or 11 injections in the 240-mg loading dose/120-mg
             once-a-week maintenance dose group, and completed the follow-up period (14 weeks) in
             Study I1F-JE-RHAL ((NCT01253265).

          -  Ambulatory male or female participants.

               -  Male participants: Agree to use a reliable method of birth control during the
                  study including barrier contraceptives or a monogamous relationship with a
                  partner who is not child bearing.

               -  Female participants: Are women who test negative for pregnancy at the time of
                  entry based on a pregnancy test and are not breast feeding. Women of child
                  bearing potential must agree to use a reliable method of birth control during the
                  study.

          -  Participants who have been treated with methotrexate (MTX) throughout Study
             I1F-JE-RHAL (NCT01253265). Bucillamine, sulfasalazine and/or hydroxychloroquine are
             allowed to be administered in addition to MTX. In such a case, the participant needs
             to have been on a stable dose of the drug(s) throughout Study I1F-JE-RHAL
             (NCT01253265) and I1F-JE-RHAM.

          -  Participants who have given written informed consent approved by the Sponsor and the
             Institutional Review Board (IRB) governing the investigational site.

        Exclusion Criteria:

          -  Participants who have had, during Study I1F-JE-RHAL (NCT01253265), any safety event
             including having a recent, ongoing, or serious infection, a serious drug reaction, or
             any adverse event (AE) that caused discontinuation from treatment , that in the
             opinion of the investigator poses an unacceptable risk to participation in this study.

          -  Participants who have any of the following abnormalities of clinical laboratory test
             results by Week 26 of Study I1F-JE-RHAL (NCT01253265):

               -  Absolute neutrophil count <1000 cells/microliters (μL);

               -  Lymphocyte count <500 cells/μL; or

               -  White Blood Cells (WBC) count <2000 cells/μL
A Pilot Study of Robot-assisted Therapy for Post-stroke Forearm and Wrist Rehabilitation Training
Condition: Stroke
MeSH terms: Stroke
Intervention: Robot-assisted therapy for wrist and forearm; Standard rehabilitation therapy
Intervention description: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.; Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Stroke; Robot-assisted therapy; Rehabilitation

Summary:

      A pilot study to assess the effectiveness of CR2-Haptic and determine the feasibility of
      including robotic therapy into the daily rehabilitation program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sub-acute and chronic stroke patients

          -  Able to rest comfortable in training set-up

          -  Mini-Mental Status Examination (MMSE) Score (>21)

          -  Motor Assessment Scale (Balance sitting >3)

          -  Modified Ashworth Scale (Wrist < 2)

        Exclusion Criteria:

          -  Contractures in affected upper extremity which inhibit movements being tested
Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir
Condition: Healthy Participant
Intervention: PF-07321332/ritonavir; Carbamazepine; PF 07321332/ritonavir
Intervention description: PF-07321332/ritonavir administered orally as a single dose on Day 1, Period 1; In Period 2, Days 1-3, participants will receive low-dose of carbamazepine twice daily (BID), then a titrated mid-dose of carbamazepine BID on Days 4-7, and finally maintaining carbamazepine at the high-dose on Days 8-15.; In Period 2, Day 14, participants will receive a single dose of PF-07321332/ritonavir orally.
Intervention MeSH terms: Ritonavir; Nirmatrelvir; Carbamazepine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1, fixed sequence, 2-period study to estimate the effect of a strong CYP3A4 inducer, carbamazepine, on the PK of PF-07321332 and ritonavir in healthy participants. A total of approximately 12 healthy male and/or female participants will be enrolled into the study.
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug-drug interaction; Carbamazepine; CYP3A4 inducer

Summary:

      This is a drug-drug interaction study to assess the effects of a single dose of
      PF-07321332/ritonavir after multiple dose administrations of carbamazepine. Pharmacokinetic
      (PK) will be evaluated for PF-07321332 and ritonavir. Carbamazepine is being utilized as a
      cytochrome P450 3A4 (CYP3A4) inducer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female participants of childbearing potential must have a negative (urine or serum)
             pregnancy test.

          2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

        Exclusion Criteria:

          1. Positive test reverse-transcriptase polymerase chain reaction (RT-PCR) result for
             SARS-CoV-2 infection at the time of Screening or Day -1.

          2. Subjects shown to carry or be positive for human leukocyte antigen (HLA)-B*1502 and
             HLA-A*3101

          3. Participants taking monoamine oxidase inhibitors (MAOIs) should discontinue MAOI for a
             minimum of 14 days prior to dosing in the current study.

          4. Hormonal methods of contraception (including oral and transdermal contraceptives,
             injectable progesterone, vaginal ring, and postcoital contraceptive methods) and
             hormone replacement therapy must have been discontinued at least 28 days prior to the
             first dose of investigational product. Depo Provera must be discontinued at least 6
             months prior to the first dose of study treatment.
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
Condition: Healthy
Intervention: SXC-2023; Placebo oral capsule
Intervention description: Oral capsule; Placebo given as oral capsule.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food
      effect study conducted at one study center in the United States. Safety and tolerability will
      be assessed throughout the study and serial blood samples and urine samples will be collected
      for the safety and pharmacokinetic assessment of SXC-2023.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult male or females (women of non child bearing potential), 18-55 years of
             age (inclusive).

          2. Medically healthy with no clinically significant screening results.

          3. Non-vasectomized male subjects must agree to use birth control or abstain from sexual
             intercourse during and until 90 days beyond the last dose of study drug/placebo.

          4. Continuous non-smoker, at least 3 months prior to first dose and throughout the study.

          5. Understands the study procedures in the informed consent form, and be willing and able
             to comply with the protocol

        Exclusion Criteria:

          1. Subject is mentally or legally incapacitated.

          2. History of any illness that, in the opinion of the PI, might confound the results of
             the study or poses an additional risk to the subjects by their participation in the
             study.

          3. History or presence of alcoholism or drug abuse within the past 2 years

          4. Female subject of childbearing potential.

          5. Blood donation or significant blood loss within 56 days prior to first dose.

          6. Plasma donation within 7 days prior to first dose.

          7. Participation in another clinical trial within 30 days prior to first dose.
Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
Condition: Healthy
Intervention: Amlodipine; Amlodipine; Amlodipine; Amlodipine
Intervention description: 3rd OD 5 mg tablet single oral dose administered with water; 2nd OD 5 mg tablet single oral dose administered with water; 3rd OD 5 mg tablet single oral dose administered without water; 2nd OD 5 mg tablet single oral dose administered without water
Intervention MeSH terms: Amlodipine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD)
      tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are
      bioequivalent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy;

          -  Body Mass Index (BMI) of 18 to 28 kg/m2;

          -  total body weight within the range of 50 to 100 kg

        Exclusion Criteria:

          -  History of regular alcohol consumption exceeding 14 drinks/week

          -  Use of tobacco- or nicotine-containing products in excess of the equivalent of 10
             cigarettes per day
A Study Of PF-03732010 In Patients With Advanced Solid Tumors
Condition: Neoplasms
Intervention: PF-03732010
Intervention description: IV infusion. Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose. Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly. Number of Cycles: Until Progression or unacceptable toxicity develops.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits
      P-cadherin. This study will test how well the drug is tolerated, and what effects there might
      be. Blood will also be taken to measure the amount of drug in blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced solid tumors refractory to (or intolerant of) established therapy known to
             provide clinical benefit, or for which there is no standard therapy

          -  Age >= 18 years of age

          -  Adequate bone marrow function as defined by: absolute neutrophil count (ANC) ≥1500/uL,
             hemoglobin ≥ 9 g/dL, platelets > 100,000/uL

          -  Adequate liver function as defined by: bilirubin < 1.5 x ULN, AST, ALT and ALP < 2.5 x
             ULN, or < 5 x ULN with documented liver and/or bone metastases

          -  Serum creatinine < 1.5 x ULN

          -  ECOG status 0-1

          -  Availability of biopsy tumor tissue (or fine needle aspirate) for testing of
             P-cadherin expression

          -  Tumor tissue (or fine needle aspirate) showing over-expression of P-cadherin

          -  Must be able to give written informed consent

          -  Be able to comply with scheduled study visits, treatment plans, laboratory tests and
             other procedures

        Exclusion Criteria:

          -  Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of
             study entry

          -  Patients with carcinomatous meningitis or untreated brain metastases.

          -  History of significant low platelet count, and/or bleeding disorders, requiring
             medical or surgical intervention

          -  History of significant bleeding episodes within 6 months, unless the source of
             bleeding has been resected