bioihbjkbjnl/mcl2 huggingface dataset:
Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia
Condition: Hemophilia A; Hemophilia B; Hemophilia A With Inhibitor; Hemophilia B With Inhibitor; Hemophilia A Without Inhibitor; Hemophilia B Without Inhibitor
MeSH terms: Hemophilia A; Hemophilia B
Intervention: MarzAA (marzeptacog alfa [activated])
Intervention description: Single intravenous dose and ascending doses of subcutaneous injection of MarzAA (Coagulation Faction VIIa Variant)
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multi-center, open label Phase 1 study will evaluate the pharmacokinetics,
      pharmacodynamics, and safety of a single IV dose of MarzAA followed by ascending single SC
      doses of MarzAA in adult subjects with moderate or severe Hemophilia A or B, with or without
      an inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate or severe congenital Hemophilia A or B, with or without an inhibitor

          -  Male, age 18 or older

          -  Affirmation of informed consent with signature confirmation before any trial related
             activities

        Exclusion Criteria:

          -  Inability to discontinue and washout prophylaxis treatment 72 hours prior to dosing.

          -  Previous participation in a trial involving SC Administration of rFVIIa or any trial
             using a modified amino-acid sequence FVIIa

          -  Known positive antibody to FVII or FVIIa detected by central laboratory at screening

          -  Have a coagulation disorder other than hemophilia A or B, with or without an inhibitor

          -  Significant contraindication to participate
Safety of Lactobacillus Reuteri in Healthy Volunteers
Condition: Healthy
Intervention: Lactobacillus reuteri; Placebo
Intervention description: Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period; 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: probiotics; lactobacillus; reuteri; none (safety only)

Summary:

      This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in
      healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial
      to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of
      pediatric diarrhea in Peru.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults 18-65 with no exclusion criteria

          -  Subject is a male or, if the subject is female and of childbearing potential then she
             must have a negative serum or urine pregnancy test result within 48 hours of
             initiating study preparations and agree to use an acceptable method of contraception.
             Acceptable methods of contraception include depot forms of progesterone containing
             therapies or an intrauterine device (IUD).

        Exclusion Criteria:

          -  No enrollment of family members in households where any of the following are present:

               -  Another study participant in the household

               -  Pregnancy or current breastfeeding by any household member

               -  Presence of an infant under age 6 months living in the household

               -  Presence of immune suppressed individuals or use of immunosuppressive agents
                  (corticosteroids, methotrexate) by any household member

               -  Presence of a serious congenital anomaly or chronic medical condition that would
                  contraindicate participation in any household member, including history of
                  gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal
                  anatomy, or abnormal bowel functionality

          -  Allergy to penicillin or cephalosporins

          -  History of antibiotic use in the last 30 days

          -  Use of probiotic products within the past 90 days

          -  History of diarrheal illness within the past 30 days

          -  Presence of fever or a pre-existing adverse event monitored in the study

          -  Positive results on serum diagnostic tests for antibodies to HIV, Hepatitis B core
             antigen, and Hepatitis C.
A Study of MK-0869 (Aprepitant) and MK-0517 (Fosaprepitant) in Pediatric Participants Receiving Chemotherapy (MK-0869-134)
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Vomiting
Intervention: Experimental: aprepitant; Experimental: fosaprepitant; Comparator: ondansetron; Ondansetron; Dexamethasone
Intervention description: aprepitant powder for suspension, 125 mg/sachet, PO; fosaprepitant lyophilized powder for suspension, 115 mg/vial or 150 mg/vial, IV; ondansetron solution for infusion, IV, administered per local standard of care; ondansetron solution for infusion, IV, administered per local standard of care; dexamethasone solution for infusion, IV, administered per local standard of care
Intervention MeSH terms: Dexamethasone; Ondansetron; Aprepitant; Fosaprepitant
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for
      the prevention of chemotherapy-induced nausea and vomiting in pediatric participants from 0
      months to 17 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is 0 (at least 37 weeks gestation) to 17 years of age

          -  Is scheduled to receive moderately to highly nausea-inducing chemotherapy or
             participant did not tolerate a previous chemotherapy regimen that is planned to be
             repeated

          -  Is expected to receive ondansetron

          -  Female participants who have begun menstruating must have a negative pregnancy test

          -  Weighs ≥3.0 kg if <6 months of age, ≥6.0 kg if >6 months of age, and ≥7.5 kg if > 2
             years of age

          -  Has a pre-existing venous catheter

        Exclusion Criteria:

          -  Uses any illicit drugs or abuses alcohol

          -  Is pregnant or breast feeding

          -  Has a symptomatic central nervous system (CNS) tumor

          -  Has an infection or other uncontrolled disease other than cancer

          -  Has known history of heart QT wave prolongation
Ketogenic Diet for Recurrent Glioblastoma
Condition: Recurrent Glioblastoma
MeSH terms: Glioblastoma; Recurrence
Intervention: TAVARLIN
Intervention description: ketogenic diet, dietary supplementary products provided by TAVARLIN
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glioblastoma; ketogenic diet

Summary:

      To determine whether a mild ketogenic diet can influences quality of life and survival of
      patients with recurrent glioblastoma
    

Eligibility criteria:

        Inclusion Criteria:

          -  age >= 18 years

          -  histological diagnosis of glioblastoma or gliosarcoma

          -  on MRI measurable tumor

          -  interval of at least 6 months after primary resection

          -  completed radiotherapy, interval of at least 3 months after completion of radiotherapy

          -  relapse during or after temozolomide chemotherapy, other chemotherapy not possible,
             not reasonable or not wanted by the patient

          -  Karnofsky-Index >= 60%, ECOG <= 2

          -  life expectancy of at least 12 weeks

          -  creatinine <= 1.5 mg/dl, urea <= 50 mg/dl

          -  INR <= 1,5, GOT <= 7 x of normal value, GPT <= 7 x of normal value

        Exclusion Criteria:

          -  bowel obstruction or subileus

          -  diabetes mellitus, HbA1c > 6,1 %

          -  heart failure (NYHA > 2), myocardial infarction within the last 6 months, atrial
             fibrillation

          -  acute infection

          -  conditions that may strongly reduce compliance to the diet or increase risk of the
             diet

          -  dementia or clinically relevant alterations of the mental state which interfere with
             the applicability of the diet
Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
Condition: Primary Sclerosing Cholangitis; Biliary Atresia
MeSH terms: Cholangitis; Cholangitis, Sclerosing; Biliary Atresia
Intervention: Vancomycin
Intervention description: Oral 50mg/Kg per day up to maximum of 1500 mg a day for three months.
Intervention MeSH terms: Vancomycin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 1 Month
Maximum age: 20 Years
Healthy volunteers: No
Keywords: PSC; BA

Summary:

      The goals of the proposed work are two fold:

      Firstly, to see if the antibiotic vancomycin may be used for the early treatment of Biliary
      Atresia (BA) and Primary Sclerosing Cholangitis (PSC). The investigators hope to learn what
      effect Vancomycin has on the bacteria that are present in stool, body fluid or intestinal
      tissue on someone who has BA and PSC and if so by what mechanism. Secondly, the investigators
      hope to learn to characterize human intestinal microbial communities (microbiome: the
      collection or collectivity of microorganisms) using molecular methods, examine the mechanisms
      of interaction between host and microbiome using genomic approaches, and determine how the
      microbiome both preserves local health and promotes pathology. The investigators will focus
      on primary sclerosing cholangitis, biliary atresia, as well as states of health. The
      composition of the associated microbiome will be assessed based on ribosomal DNA and RNA
      sequences, and attention will be given to richness (diversity), evenness (relative
      abundance), and variation with respect to time, person, and anatomic niche. Host response at
      the adjacent mucosal surface will be assessed based on genome-wide gene expression patterns.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of biliary atresia or primary sclerosing cholangitis.

          -  Clinical controls who are undergoing upper endoscopy or colonoscopy and do not have
             biliary atresia or primary sclerosing cholangitis.

          -  Subjects who have been on oral vancomycin for 1 year for biliary atresia or -

        Exclusion Criteria:

          -  Patients that have taken antibiotics within the last 3 month will be excluded as this
             will alter the original bacterial flora.
A Study of TAS-205 for Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: TAS-205; Placebo
Intervention description: Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals; Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals
Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: Male
Minimum age: 5 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and pharmacokinetic of TAS-205 in
      patients with Duchenne Muscular Dystrophy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to give an informed consent. If applicable, able to give an informed assent.

          -  Male and >= 5 years and < 16 years of age.

          -  Bodyweight of >= 15.0 kg and < 75.0 kg.

          -  Phenotypic evidence of DMD.

          -  Able to take tablets.

          -  If taking oral glucocorticosteroids no significant change in total daily dosage or
             dosing regimen after enrollment.

          -  Confirmed the urinary PD marker over its criteria.

          -  Able to follow the study protocol.

        Exclusion Criteria:

          -  Current diagnosis or history of any drug allergy.

          -  A forced vital capacity (FVC) < 50% of predicted value.

          -  A left ventricular ejection fraction (EF) < 50% or fractional shortening (FS) < 25%
             based on echocardiogram (ECHO).

          -  Ongoing immunosuppressive therapy (other than corticosteroids).

          -  With severe disease such as hepatic disease, kidney disease and others.

          -  With any systemic allergic disease or any chronic inflammatory disease.

          -  Treated with any other investigational agents within 90 days.

          -  Positive reaction in hepatitis B surface antigen (HbsAg), hepatitis C antibody test
             (HCV), or human immunodeficiency virus (HIV) test.
Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival
Condition: Healthy
Intervention: Mirasol System for Whole Blood.
Intervention description: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: red blood cells; transfusion; recovery; feasibility; white blood cell inactivation

Summary:

      Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from
      Mirasol-treated whole blood
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy adults who meet AABB (formerly known as the American Association of Blood
             Banks) criteria for whole blood donation

          -  females incapable of becoming pregnant

          -  males agreeing to use contraception during trial

        Exclusion Criteria:

          -  pregnancy or nursing

          -  abnormal medical history (bleeding disorders, anemia, myocardial ischemia,
             uncontrolled hypertension, heart disease, epilepsy)

          -  major surgery

          -  use of drugs affecting coagulation or RBC function

          -  recent participation in other trials which may confound results
An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous
Intervention: vorinostat; Comparator: bexarotene
Intervention description: Dose escalation study starting with vorinostat 200 mg q.d. capsules (1 capsule daily) and rising up to vorinostat 400 mg q.d. capsules (1 capsule daily). Up to 6 months of treatment.; Dose escalation with bexarotene 150 mg/m2 capsules rising up to 300 mg/m2 capsules (1 capsule daily). Up to 6 months of treatment.
Intervention MeSH terms: Vorinostat; Bexarotene
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an investigational study that increases the dosage to determine the
      safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with
      Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one
      prior systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women or men greater than or equal to 18 years of age

          -  Advanced cutaneous T-cell lymphoma, stage IB or higher including Sezary Syndrome with
             progressive, persistent, or recurrent disease

          -  Failure of at least one systemic therapy, not including Bexarotene (Targretin)

          -  Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2 (measurement
             to determine your ability to perform daily activities)

        Exclusion Criteria:

          -  Patient has had investigational treatment in the preceding 30 days

          -  Active hepatitis B or C, history of HIV

          -  Prior treatment with any HDAC inhibitor

          -  Patients must be disease free from prior malignancies for greater than 5 years, except
             for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma
             in-situ of the cervix
Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Condition: Healthy
Intervention: hyoscine butylbromide
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated
      tablets.
    

Eligibility criteria:

        Inclusion criteria:

        healthy males and females, aged 18-50years, BMI 18,5-30

        Exclusion criteria:

        History of hypersensitivity or allergy to IMP
Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects
Condition: Viral Infection
MeSH terms: Infections; Virus Diseases
Intervention: UV-4B 3 mg; UV-4B 10 mg; UV-4B 30 mg; UV-4B 90 mg; UV-4B 180 mg; UV-4B 360 mg; UV-4B 720 mg; UV-4B 1000 mg; Placebo
Intervention description: Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose; Oral solution, single dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; Arbovirus Infections; Flaviviridae Infections; Flavivirus Infections; Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Pharmaceutical Solutions; Pharmacologic Actions; Therapeutic Uses

Summary:

      The objective is to evaluate the safety and tolerability of a single-ascending oral dose of
      UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption
      and elimination following a single dose of UV-4B in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects

          -  Women: non-pregnant, non-lactating; if of childbearing potential, on specified
             contraception measures during the study period

          -  Men: using barrier contraception measures during the study period

        Exclusion Criteria:

          -  Health conditions

          -  Taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins,
             hormonal birth control)
Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: TRK-250; Placebo
Intervention description: single and multiple doses (4 weeks); single and multiple doses (4 weeks)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: TRK-250; Idiopathic Pulmonary Fibrosis

Summary:

      TRK-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by
      selectively suppressing the expression of transforming growth factor-beta 1 (TGF-β1) protein,
      at the gene expression level. This study is a double-blind, randomized, placebo-controlled
      Phase I study. The primary objective of the study is to assess the safety and tolerability of
      single and multiple inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis
      (IPF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical, radiographic, and histologic features consistent with the diagnosis of IPF

          -  SpO2 ≥90% at rest by pulse oximetry while breathing ambient air.

          -  FVC ≥50% of predicted.

          -  FEV1 ≥50% of predicted.

          -  Ratio of FEV1 to FVC ≥0.7.

          -  DLCO corrected for hemoglobin 30% to 79% of predicted, inclusive.

        Exclusion Criteria:

          -  History of acute exacerbation of IPF or respiratory tract infection within 3 months
             prior to Screening.

          -  Planned surgery during the study.

          -  History of malignant tumor within 5 years prior to Screening.

          -  History of emphysema or clinically significant respiratory diseases (other than IPF).

          -  Other known causes of interstitial lung disease (eg, drug toxicities, environmental
             exposures, connective tissue diseases).

          -  End-stage fibrotic disease expected to require organ transplantation within 6 months.

          -  Taking a systemic corticosteroid, cytotoxic therapy, vasodilator therapy for pulmonary
             hypertension, or unapproved treatment for IPF within 4 weeks prior to Screening.
             (Treatment with pirfenidone or nintedanib, though not both concurrently, is permitted,
             provided that the subject has been on a stable dose for at least 4 weeks prior to
             Screening and it is anticipated the dose will remain unchanged throughout enrollment.)