bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children
Condition: Complication of Urinary Catheter
MeSH terms: Critical Illness
Intervention: Ethanol Lock
Intervention description: Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.
Intervention MeSH terms: Ethanol
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Ethanol Lock; Alcohol lock; Urinary catheter; Safety

Summary:

      Hypothesis 1: Blood alcohol concentration will be <25 mg/100ml (equivalent to a blood alcohol
      concentration of <0.025%) after a 1 hour urinary catheter ethanol lock.

      Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or
      increased urinary white cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 6 months - 17 years

          -  Urinary catheter placed at Children's Healthcare of Atlanta

          -  Anticipated urinary catheter need for > 48 hours

          -  Parent or legal guardian (or patient when applicable) consent for enrollment.

        Exclusion Criteria:

          -  18 yo or older.

          -  Urosepsis at time of study enrollment

          -  Known bladder or genitourinary abnormalities

          -  Chronic bladder drainage regimen

          -  Urologic surgeries (as part of the current admission)

          -  Medical urgency preventing timely administration of the consenting process, or any
             condition that, in the opinion of the attending physician, would place the patient at
             undue risk by participating.

          -  Anuria or oliguria (<0.5 cc/kg/hr averaged over the previous 12 hours)

          -  Other technical considerations that would prevent the timely acquisition of sufficient
             samples such as (but not limited to) absence of a study team member.

          -  Parent or legal guardian (or patient when applicable) refuses to sign informed
             consent.
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: Bevacizumab
Intervention description: Varying dosages in 10µl
Intervention MeSH terms: Bevacizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 8 bevacizumab doses were evaluated in this dose de-escalation study in the following dosage amounts: 0.250mg, 0.125mg, 0.063mg, 0.031mg, 0.016mg, 0.008mg, 0.004mg, 0.002mg. Each dose was planned to be used in up to 14 infants to ensure at least 10 infants with 4-week outcomes
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Maximum age: 6 Months
Healthy volunteers: No
Keywords: Retinopathy of Prematurity; Bevacizumab; ROP

Summary:

      The purpose of this study is to find a dose of intravitreal bevacizumab that is lower than
      currently used for severe retinopathy of prematurity (ROP), is effective in this study, and
      can be tested in future larger studies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type 1 ROP; defined as:

               -  Zone I, any stage ROP with plus disease, or

               -  Zone I, stage 3 ROP without plus disease, or

               -  Zone II, stage 2 or 3 ROP with plus disease

          2. No previous treatment for ROP in the study eye; no previous bevacizumab treatment in
             the non-study eye

        Exclusion Criteria:

        The following exclusions apply to the study eye:

          1. Nasolacrimal duct obstruction

          2. Major ocular anomalies (e.g., cataract, coloboma)

          3. Any opacity that precludes an adequate view of the retina

        If purulent ocular discharge is present in either eye, then the infant is ineligible.
Phase 1 Study Of Aurora Kinase Inhibitor PF-03814735 In Patients With Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: PF-03814735
Intervention description: 1, 5, and 25 mg gelatin capsules administered orally once a day from day 1 to day 5, or from day 1 to day 10 every 3 weeks until disease progression or unacceptable toxicity.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the maximum tolerated dose and recommended phase 2
      dose of PF-03814735 administered orally as single agent in patients with advanced solid
      tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic solid tumor resistant to standard therapy or for which no standard therapy
             is available

          -  Adequate bone marrow, liver and kidney function

        Exclusion Criteria:

          -  Brain metastases that are symptomatic and/or require treatment with steroids and/or
             anticonvulsants, or brain metastases that have been treated within 3 months prior to
             study start

          -  Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure,
             cerebrovascular accident in the previous 6 months
Cardiac Home Education and Support Trial (CHEST): A Pilot Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Peer Support
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Enrollment: 101.0
Sex: All
Healthy volunteers: No
Keywords: Pain; Depressive Symptoms; Coronary Artery Bypass; Convalescence; Quality of Life; Human Activities

Summary:

      Coronary artery bypass graft (CABG) surgery is performed more frequently on individuals who
      are older and sicker than in previous years. Increased patient acuity and reduced hospital
      length of stays leave individuals ill prepared for their recovery following discharge.
      Individuals experience pain, functional impairment and depressive symptoms following
      discharge, which persist for 8 weeks in 50% of individuals. Unrelieved pain, functional
      decline and depressive symptoms predispose individuals to adverse events, impaired
      health-related quality of life (HRQOL), and increased morbidity and mortality.

      Existing supports; including printed education materials, community care resources, cardiac
      rehabilitation programs and nurse-initiated telephone follow-up, fail to address concerns of
      individuals in this early period following hospital discharge.

      Despite the positive health outcomes in other patient populations, valid studies examining
      the impact of telephone-based peer support to men and women after hospital discharge from
      CABG surgery were not found. It is anticipated that a home-based peer support program,
      delivered by telephone, will improve recovery and enhance HRQOL for individuals in the early
      weeks post hospital discharge from CABG surgery.
    

Eligibility criteria:

        Inclusion Criteria (patients): Men and women who

          -  are having first-time non-emergency CABG surgery

          -  are judged ready for discharge

          -  are being discharged to home [either their own or to family/friends]

          -  have access to and are able to communicate over a telephone

          -  are able to read, write and understand English

        Inclusion Criteria (peers): Men and women who

          -  have undergone CABG surgery within the last 5 years

          -  have access to and are able to communicate clearly over a telephone

          -  are able to read, write and understand English

          -  have attended a formal cardiac rehabilitation program

          -  are not associated with the current in-hospital peer volunteer program
Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: monoclonal antibody hu3S193
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

Summary:

      RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
      tumor-killing substances to them without harming normal cells.

      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating
      patients who have advanced colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven stage IV colorectal carcinoma.

          -  Failed or refused conventional chemotherapy.

          -  Lewis Y antigen present on more than 50% of tumor cells.

          -  Measurable or evaluable disease.

          -  No central nervous system (CNS) tumor involvement.

          -  Karnofsky 80-100%.

          -  Life expectancy: At least 6 weeks.

          -  Granulocyte count greater than 1,500/mm^3.

          -  Platelet count greater than 100,000/mm^3.

          -  Bilirubin no greater than 1.0 mg/dL.

          -  Prothrombin time less than 3 times upper limit of normal.

          -  Creatinine no greater than 1.4 mg/dL.

          -  Female patients of childbearing age and male patients must be asked to use effective
             contraception during the study.

          -  At least 4 weeks since other prior immunotherapy. Exclusion Criteria

          -  New York Heart Association class III or IV heart disease.

          -  Serious infection requiring antibiotics or other serious illness.

          -  Pregnancy or nursing.

          -  History of bleeding gastric ulcers or pancreatitis.

          -  Diabetes mellitus requiring insulin.

          -  Human antimouse antibodies (HAMA).

          -  No prior mouse monoclonal antibody or antibody fragments.

          -  Illness requiring the use of steroids or other anti-inflammatory agents.

          -  Positive anti-hu3S193 antibody (HAHA) titer.
Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)
Condition: Type 2 Diabetes
Intervention: MK-0941; Comparator: Placebo
Intervention description: A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period; a single oral placebo will be administered in the designated period (Periods 1-5)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and tolerability of single doses of MK-0941 based on
      assessment of clinical and laboratory adverse experiences
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants of reproductive potential must test negative for pregnancy and
             agree to use two acceptable methods of birth control

          -  Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone
             or with a single or combination oral anti-hyperglycemic agent

          -  No treatment with three of more anti-hyperglycemic agents or any treatment regimen
             that includes insulin

          -  In good health (except for Type 2 Diabetes)

          -  Willingness to follow a specific diet throughout the study (consisting of 50%
             carbohydrates, 20%protein and 30% fat)

          -  Nonsmoker

        Exclusion Criteria:

          -  History of stroke, chronic seizure or major neurological disorder

          -  History of cancer

          -  History of Type 1 Diabetes

          -  Recent history of eye infection

          -  Glaucoma or blindness

          -  Eye surgery (by incision or laser) within the past three months
A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: Oseltamivir
Intervention description: Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.
Intervention MeSH terms: Oseltamivir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its
      metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for
      end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed
      oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than or equal to (>/=) 18 years of age

          -  ESRD defined as no residual renal function or a creatinine clearance (CrCl) less than
             (<) 10 milliliters per minute (mL/min)

          -  Well established HD or CAPD therapy over a period of 3 months with stable CrCl < 10
             mL/min

          -  Body mass index (BMI) 18 to 34 kilograms per meter-squared (kg/m^2)

          -  Use of contraception among women of childbearing potential

        Exclusion Criteria:

          -  Clinical significant comorbid disease or terminal illness

          -  Known human immunodeficiency virus (HIV) or hepatitis B or C

          -  History of drug or alcohol abuse within the prior year

          -  Donation or loss of >/= 400 milliliters (mL) of blood in the 3 months prior to
             Screening

          -  Participation in a clinical study with an investigational drug in the 3 months prior
             to study drug

          -  Pregnant or lactating women
A Phase 1 Trial of OPA-15406 Ointment in Healthy Adult Male Subjects
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Intervention: 0.3% OPA-15406 Ointment; 1% OPA-15406 Ointment; 3% OPA-15406 Ointment; Placebo Ointment
Intervention description: 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 0.3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.; 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose; 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.; 32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration periodriod, subjects were treated with assigned placebo ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: Male
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the safety (especially skin findings) and pharmacokinetics by applying 0.3%, 1%, or
      3% formulation of 5g OPA-15406 ointment to a 1000 cm2 area as a single-dose and as a
      multiple-dose twice daily for 2 weeks in Japanese healthy adult male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI = Body weight (kg) / [Height (m)]2: at least 18.5 and less than 25.0

          -  Judged by the investigator or subinvestigator to be healthy based on test results at
             screening and prior to administration on Day 1 of the treatment period

        Exclusion Criteria:

          -  Findings (sunburn, abrasions, tattoos, etc) on the back that affect the evaluation of
             the safety of the skin

          -  Judged by the investigator or subinvestigator as inappropriate to participate in this
             trial for any other reasons
Phase 1 Study To Test the Bioequivalence Between Two 25 mg Tablets vs. One 50 mg Tablet Under Fast/Fed Condition and Evaluate Food Effect of Desvenlafaxine Succinate Sustained Release (DVS SR)
Condition: Depression - Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release; desvenlafaxine succinate sustained release
Intervention description: Two tablets of 25 mg, single administration, under fed condition; One tablet of 50 mg, single administration, under fed condition; Two tablets of 25 mg, single administration, under fast condition; One tablet of 50 mg, single administration, under fast condition
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: DVS SR; healthy; Bioequivalence study

Summary:

      To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of
      DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions.

      To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after
      administration of 50 mg SR formulation of DVS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease
Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Valacyclovir; Placebo
Intervention description: Valacyclovir 1.5 mg po bid; Matching placebo twice daily
Intervention MeSH terms: Valacyclovir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hepatitis C; herpes simplex type 2; veterans

Summary:

      The purpose of this study is to study the effects of valacyclovir on patients who have
      hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which
      causes genital herpes. Some persons with genital herpes have sores in their private areas but
      most persons do not have any symptoms at all. Valacyclovir is a medication which is commonly
      used to treat or prevent outbreaks of genital herpes. This medication is already approved by
      the Food and Drug Administration to treat genital herpes. Valacyclovir has not been approved
      to treat chronic hepatitis C.

      The study will take 16 weeks. Participants will be assigned to take either the study drug,
      valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and the
      persons participating will not know which medication they are receiving. Study visits will
      occur every two weeks and will take approximately 3-45 minutes. All study visits will occur
      at the G.V. Sonny Montgomery VA Medical Center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documentation of chronic HCV infection with genotype testing and previous positive
             HerpeSelect HSV-2 IgG assay

        Exclusion Criteria:

          -  Antiherpes or immunomodulatory therapy during the past 30 days

          -  HIV or chronic hepatitis B infection

          -  Decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy,
             jaundice/icterus)

          -  Creatinine clearance < 50 ml/min.

          -  Female subject who is pregnant or nursing

          -  Gastrointestinal disorder which might result in malabsorption of valacyclovir

          -  History of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic
             uremic syndrome

          -  Therapy for hepatitis C in the previous 6 months