bioihbjkbjnl/mcl2 huggingface dataset:
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: RO5185426
Intervention description: Continuous oral dosing b.i.d. , on Day 15 a C isotope labeled dose will be administered
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, non-randomized study will assess the mass balance, metabolism, routes and
      rates of elimination as well as efficacy and safety of RO5185426 (RG7204; PLEXXIKON; PLX4032)
      in previously treated or untreated patients with metastatic melanoma. Patients will receive
      continuous twice daily oral treatment with RO5185426. On Day 15, a 14C-labeled dose will be
      administered. Anticipated time on study treatment is until disease progression occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Histologically confirmed metastatic melanoma, surgically incurable and unresectable
             Stage IIIc or IV (AJCC)

          -  Prior treatment for metastatic melanoma allowed; >/= 28 days must be elapsed since
             previous systemic treatment prior to first administration of study drug

          -  Positive BRAF V600E mutation result (by Roche CoDx test)

          -  ECOG performance status 0-1

          -  Adequate hematologic, renal and liver function

          -  Body Mass Index (BMI) 18 to 32 kg/m2 inclusive

        Exclusion Criteria:

          -  Active CNS lesions

          -  History of or known spinal cord compression, or carcinomatous meningitis

          -  Anticipated or ongoing administration of any anticancer therapies other than those
             administered in this study

          -  Refractory nausea or vomiting, or other medical conditions that are capable of
             altering the absorption, metabolism or elimination of the study drug

          -  Known clinically significant active infection

          -  Known HIV positivity or AIDS-related illness, active HBV, or active HCV

          -  Previous malignancy within the past 5 years, except for basal or squamous cell
             carcinoma of the skin, melanoma in situ, and carcinoma in situ of the cervix

          -  Clinically significant cardiovascular disease or incident within the 6 months prior to
             study drug administration

          -  Patients who have had at least one dose of study drug (RO5185426 or comparator) in a
             clinical trial that includes RO5185426
A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Balovaptan; Itraconazole
Intervention description: In Period 1, balovaptan was administered orally once daily (qd) on Days 1 to 10.
In Period 2, balovaptan was administered qd on Days 6 to 20.; In Period 2, 200 mg itraconzole was administered bid for 4 days and qd on Days 5-20, approximately 12 hours apart. On Days 6-20, 200 mg itraconazole was administered qd.
Intervention MeSH terms: Itraconazole; Balovaptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was a non-randomized, open-label, one-sequence, two-period within-subject study to
      investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female
      volunteers using itraconazole as a CYP3A inhibitor. The study was conducted at 1 site in the
      Netherlands.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects. Healthy status is defined by 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
             chemistry, urinalysis, and serology.

          -  Body Mass Index of 18 to 30 kg/m2, inclusive.

          -  For women of childbearing potential: agreement to use at least 2 acceptable
             contraceptive methods during the treatment period and for 90 days after the last dose
             of study drug.

          -  For men: agreement to use contraceptive measures, and agreement to refrain from
             donating sperm until 90 days after the last dose of study drug.

        Exclusion Criteria:

          -  Female subjects who are pregnant or lactating.

          -  Any condition or disease detected during the medical interview/physical examination
             that would render the subject unsuitable for the study, place the subject at undue
             risk or interfere with the ability of the subject to complete the study in the opinion
             of the Investigator.
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 Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.
Condition: Cancer; Neoplasm
Intervention: NY-ESO-1b peptide plus CpG 7909 and Montanide® ISA-51
Intervention MeSH terms: Monatide (IMS 3015)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer vaccine; NY-ESO-1b peptide; CpG 7909; Montanide® ISA-51; LAGE-1; immune response; safety

Summary:

      This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with
      2 other agents to help stimulate the immune system. Peptides are small fragments of protein.
      NY- ESO-1 peptides are normally found in the testis and the placenta. They have also been
      found on various types of cancer cells. The purpose is to stimulate the immune system to
      react against the peptides that are found on cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed metastatic, measurable cancer or resected high risk Stage
             III/IV; resected Stage II, III, or IV non-small cell lung cancer or esophageal cancer
             who have declined, failed, or completed standard therapy; tumor expression of NY-ESO-1
             or LAGE-1 antigen; HLA-A2 positive; Karnofsky performance status greater than or equal
             to 60%; hematology and biochemistry laboratory results within the limits normally
             expected for the patient population; age greater than or equal to 18.

        Exclusion Criteria:

          -  Clinically significant heart disease; other serious illnesses; patients with serious
             intercurrent illness, requiring hospitalization; patients taking immunosuppressive
             drugs; autoimmune disease; known HIV positivity; other active malignancy within 1 year
             prior to entry into the study; participation in chemotherapy, radiation therapy, or
             any other clinical trial involving another investigational agent within 4 weeks prior
             to enrollment; pregnancy or breastfeeding; women of childbearing potential: refusal or
             inability to use effective means of contraception.
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Fimasartan; Rosuvastatin; Fimasartan + Rosuvastatin
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fimasartan

Summary:

      The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and
      rosuvastatin when coadministered or administered alone as a single dose or as multiple doses
      to healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Caucasian male 19-55 years of age.

          2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.

          3. Medically healthy with no clinically significant medical history.

          4. Understands the study procedures in the Informed consent form (ICF), and be willing
             and able to comply with the protocol.

        Exclusion Criteria:

          1. History or presence of clinically significant medical or psychiatric condition or
             disease.

          2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus (HCV).

          3. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at
             screening.

          4. Plasma donation within 7 days prior to the first dose of study drug.

          5. Participation in another clinical trial within 28 days prior to the first dose of
             study drug(s).
Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.
Condition: Asymptomatic Necrotic Teeth
MeSH terms: Pain, Postoperative; Necrosis
Intervention: triple antibiotic paste with an anti-inflammatory drug
Intervention description: Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
Intervention MeSH terms: Anti-Bacterial Agents; Anti-Inflammatory Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: post operative pain; triple antibiotic paste; intracanal medication

Summary:

      The purpose of this study is to determine whether the use of triple antibiotic paste as
      intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will
      reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic
      necrotic teeth.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject's age between 18-50 years.

          2. Both male and female subjects.

          3. Medically free and healthy subjects.

          4. Mandibular and maxillary single rooted teeth.

          5. Asymptomatic non vital teeth.

        Exclusion Criteria:

          1. Teeth with acute dentoalveolar abscess.

          2. Subjects having more than one tooth that require root canal treatment.

          3. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the
             10 days prior to the start of treatment.

          4. Pregnant females.

          5. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or
             Psychological disturbance.

          6. Teeth with periodontal disease or pulp calcification.

          7. Subjects taking chronic pain medications.
A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants
Condition: Healthy
Intervention: Tirzepatide; EE/NGM
Intervention description: Administered SC; Combination oral contraceptive administered orally
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at how the body processes the commonly prescribed birth
      control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and
      the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side
      effects that may occur will also be collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the study will last about 20 weeks, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy females as determined by medical history, physical examination, and
             other screening procedures

          -  Have a body mass index (BMI) equal to or above 18.5 kilograms per meter squared
             (kg/m²), at screening

          -  Are not intending to start a family within 2 months after the study

        Exclusion Criteria:

          -  Have known allergies to either tirzepatide or ethinylestradiol or norgestimate or
             related compounds

          -  Have a medical condition or medical history that precludes the taking of combined oral
             contraceptives

          -  Have a history or presence of pancreatitis (history of chronic pancreatitis or
             idiopathic acute pancreatitis), elevation in serum amylase or lipase or
             gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder
             disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery,
             pyloric stenosis, with the exception of appendectomy) or could be aggravated by
             glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

          -  Have used hormonal implants or received hormonal injections in the past 12 months

          -  Unwilling to comply with smoking restrictions during the study

          -  Is a known user of drugs of abuse
A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants
Condition: Healthy
Intervention: Treprostinil; Placebo; LY900014; Insulin Lispro
Intervention description: Administered SC.; Administered SC.; Administered SC.; Administered SC.
Intervention MeSH terms: Insulin Lispro; Treprostinil
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aims of this study are to evaluate:

        -  The safety and tolerability of a single dose of treprostinil given subcutaneously (as an
           injection just under the skin)

        -  The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a
           single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.

      The study has two parts. Participants may only enroll in one part.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy Japanese

          -  Body mass index (BMI) 18.5 - 25 kilograms per square meter (kg/m²)

          -  Fasting plasma glucose ≥71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter
             [mmol/L]) and <108 mg/dL (6.0 mmol/L) (Part B only)

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

        Exclusion Criteria:

          -  Are currently enrolled in a clinical trial involving an investigational product or any
             other type of medical research judged not to be scientifically or medically compatible
             with this study

          -  Have participated in a clinical trial involving an investigational product within the
             30 days before study entry.

          -  Have previously completed or withdrawn from this study or any other study
             investigating treprostinil or LY900014, and have previously received the
             investigational product

          -  Have or used to have health problems or laboratory test results or ECG readings that,
             in the opinion of the doctor, could make it unsafe to participate, or could interfere
             with understanding the results of the study
Phase I Study of OPC-61815
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: OPC-61815 16mg; OPC-61815 32mg; Moxifloxacin; Placebos
Intervention description: OPC-61815 16mg will be intravenously administered once a week.; OPC-61815 32mg will be intravenously administered once a week.; 400mg tablet will be administrated once a week.; Placebo will be intravenously administered once a week.
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: 48.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on
      QT/QTc interval in healthy male subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) [body weight in kg / (height in m)2] of at least 18.5 kg/m2 and
             less than 25.0 kg/m2 as a result of at the screening examination

          -  Judged by the investigator or subinvestigator to be capable of providing written
             informed consent prior to start of any trial-related procedures and capable of
             complying with the procedures for this trial

        Exclusion Criteria:

          -  Subjects with a medical history of convulsive disorder, long QT syndrome (including
             family history), syncope during swimming, or any other type of syncope or cryptogenic
             loss of consciousness

          -  Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia,
             hypocalcemia, etc)

          -  Subjects with a family history of sudden death
Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate
Condition: Healthy
Intervention: Salmeterol; fluticasone propionate
Intervention description: A, D 2 puffs; B, E 6 puffs; C, F 12 puffs; A, D 2 puffs; B, E 6 puffs; C, F 12 puffs
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: long-acting beta agonist (LABA); corticosteroid; pMDI; inhaler

Summary:

      The purpose of this study is to test the body's response to several doses of two different
      inhalation products in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Volunteer

          -  Willing and able to give informed consent

          -  Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing
             foods and beverages for 24 hours prior to reporting to clinic

          -  Male and female subjects aged 18 to 55 years (inclusive)

          -  Subjects must agree to use an adequate method of contraception from admission through
             12 weeks after last administration

        Exclusion Criteria:

          -  Evidence or history of clinically significant abnormalities or disease or chronic
             respiratory disorders

          -  Any presence or history of a clinically significant allergy including any adverse
             reaction to study drug

          -  History of drug or alcohol abuse within the past 2 years

          -  Smoked tobacco within the past 6 months or have a history of more than 10- pack years
             (number of packs smoked per day x number of years smoked)

          -  Donation or loss of greater than 400 mL of blood within the previous 3 months

          -  Have received any prescription medication within 4 weeks or investigational medication
             within 12 weeks of study (exception: contraceptives are permitted)

          -  Have received any non-prescription medication within 14 days prior to dosing
             (exception: paracetamol use within 2 days)

          -  Upper respiratory tract infection (excluding otitis media) within 14 days of the first
             study day, or lower respiratory tract infection within the last 3 months

          -  If female, nursing, lactating or pregnant

          -  Regular alcohol consumption in males >21 units per week and females >14 units per week
             (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

          -  Surgery scheduled during the study or within 3 weeks after last dose

          -  History of familial long QT syndrome or history of sudden death in family members aged
             < 30 years