bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal Delivery of Testosterone and Its Effect on Doping Markers
Condition: Abuse of Anabolic Steroids
Intervention: Testosterone
Intervention description: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.
Intervention MeSH terms: Testosterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Male
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers; Sports Medicine; Men's Health; Athletes; Anti-Doping

Summary:

      Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic
      profile during anti-doping testing, which is different than the profile seen when
      testosterone is administered into muscle, on skin or under the tongue.

      Objective: The investigators aim to characterize the unique steroid doping profile following
      administration of intranasal testosterone to healthy, active volunteer subjects.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Males between the ages of 18 and 35 years-old who participate in regular, moderate to
        high intensity physical activity will be recruited for the study.

        Exclusion Criteria:

          1. Individuals below the age of 18 or greater than the age of 35 on the day of enrollment

          2. Individuals who are in a Registered Testing Pool for anti-doping purposes, or
             individuals who for any reason could be subject to doping control testing.

          3. Unwilling to provide blood or urine samples

          4. Not actively exercising

          5. Individuals with any history of cancer, cardiovascular disease, endocrine
             abnormalities, renal disease, hepatic disease, neurologic disease or any psychiatric
             history

          6. Individuals with a history of nasal disorders, nasal surgeries, sinus surgeries, or
             sinus disease

          7. Individuals that have a baseline hematocrit value above the normal range

          8. Individuals that are diabetic or are currently taking a diabetic medication

          9. Individuals that are currently using any WADA prohibited substances

         10. Individuals that have recently used or currently using anabolic androgenic steroids
Effect of Weight and/or Obesity on Ethambutol Drug Concentrations
Condition: Obesity; Tuberculosis
MeSH terms: Tuberculosis; Obesity
Intervention: Ethambutol
Intervention description: All volunteers in each category will receive a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines.1 We will not use any doses higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):
40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)
Intervention MeSH terms: Ethambutol
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Pharmacokinetics; Pharmacodynamics; Dose individualization; Tuberculosis

Summary:

      This study is designed to measure drug concentrations in the blood of healthy volunteers
      administered a single dose of ethambutol. Our hypothesis is that volunteers with a body mass
      index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner
      volunteers, and those with a BMI > 40 kg/m2 will have even greater clearance than those who
      are leaner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female volunteers, age 18 years of age or older, of all racial and ethnic
             origins. English and/or Spanish speaking volunteers are eligible to participate.

          -  We are recruiting 6 normal weight (BMI <25 kg/m2), 6 obese (BMI 25-40 kg/m2), and 6
             extremely obese (BMI > 40 kg/m2) for this study. Half of each group will be male, the
             other half will be female.

        Exclusion Criteria:

          -  Creatinine clearance < 70 ml/min as estimated by the Cockcroft-Gault equation.

          -  Pregnant or nursing or unwilling to use a reliable contraception method during the
             study period. The effects of ethambutol on pregnancy are unknown. In addition, the
             metabolic changes that accompany pregnancy may alter the concentration-time profile of
             ethambutol, so that the pregnancy and post-partum state would be a confounding
             variable.

          -  Abnormal liver function tests: transaminases >10 time the upper limit of normal,
             alkaline phosphatase > 5 time the upper limit of normal, total bilirubin >5 time the
             upper limit of normal.

          -  History of allergy to ethambutol.

          -  Ethambutol is contraindicated for any reason.

          -  Suspected or documented mycobacterial infection.

          -  History of gout.
Dexmedetomidine Sedation With Third Molar Surgery
Condition: Anesthesia
Intervention: Dexmedetomidine; Midazolam; Ketamine
Intervention description: Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.; Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.; Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam.
Intervention MeSH terms: Midazolam; Dexmedetomidine; Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dexmedetomidine sedation; Oral surgery sedation; Dexmedetomidine amnesia

Summary:

      Intravenous sedation is used frequently for the relief of pain and anxiety associated with
      oral surgical procedures performed under local anesthesia. The purpose of this study is to
      learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in
      combination with midazolam alone or with midazolam plus low dose ketamine while having wisdom
      teeth removed.

      The sedation produced by dexmedetomidine is unique in that it mimics natural sleep, a unique
      quality not shared by other drugs. Dexmedetomidine is often used in anesthesia in hospital
      operating rooms and has been approved by the US Food and Drug Administration for the use
      planned in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiology (ASA) physical status I and II

          -  Four asymptomatic third molars indicated for removal

        Exclusion Criteria:

          -  Clinical history or ECG evidence of:

               -  cardiac dysrhythmia or heart block

               -  ischemic heart disease

               -  asthma

               -  sleep apnea

               -  impaired liver, renal, or mental function

          -  chronic sedative or analgesic use

          -  allergies to any of the study drugs

          -  history of pericoronal infection with third molars
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Risperidone; Olanzapine (enrollment closed in this treatment); Molindone
Intervention description: oral risperidone 0.5mg to 6mg daily for up to 52 weeks; oral olanzapine 5-20mg per day for up to 52 weeks; oral molindone from 10-140mg/daily for up to 52 weeks
Intervention MeSH terms: Olanzapine; Risperidone; Molindone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 116.0
Sex: All
Minimum age: 8 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Psychotic Disorders; Schizophreniform Disorder

Summary:

      This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine
      (Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with
      schizophrenia or schizoaffective disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Schizophrenia, schizophreniform disorder, or schizoaffective disorder with psychotic
             symptoms

          -  Free of depot antipsychotic medication for at least 6 months. Oral antipsychotic
             medication at entry into the study is allowed, provided the participant has not had an
             adequate trial during the present episode of psychosis.

          -  If taking antidepressant or mood stabilizing medication, stable dosing for at least 30
             days prior to entry.

          -  Good physical health

        Exclusion Criteria:

          -  Risperidone (RIS), olanzapine (OLA)*, or molindone (MOL) for 8 weeks or more during
             THIS episode, with 2 weeks at the maximal dose (6 mg/day of RIS, 20 mg/day of OLA, or
             140 mg/day of MOL)

          -  If using antidepressant and/or mood stabilizing medications, treatment for fewer than
             30 days immediately before entry

          -  Intolerance or nonresponse to RIS, OLA*, or MOL during any previous treatment

          -  Bipolar affective disorder,post traumatic stress disorder, personality disorder, or
             psychosis not otherwise specified

          -  Currently meeting Diagnostic and Statistical Manual version IV (DSM IV) criteria for
             major depression episode

          -  DSM IV criteria for substance abuse or dependence with intention to continue illicit
             substance abuse

          -  Endocrinological or neurological conditions which confound the diagnosis or are a
             contraindication to treatment with antipsychotics

          -  Mental retardation

          -  Risk of suicide or homicide that is not adequately controlled in the current setting

          -  Pregnancy or refusal to practice contraception during the study

        "*" OLA exclusion not applicable after 11/2005
Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: carboxymethylcellulose 0.5% +glycerin 0.9%; sodium hyaluronate 0.18%
Intervention description: To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.; To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.
Intervention MeSH terms: Carboxymethylcellulose Sodium; Hyaluronic Acid; Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the efficacy and safety of two non-preserved artificial tears,
      (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the
      treatment of the signs and symptoms of dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current use of an artificial tear product at least 2 times per day (e.g. for relief of
             dry eye symptoms of dryness).

          -  Be likely to complete the entire course of study and to comply with appropriate
             instructions

        Exclusion Criteria:

          -  Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery
             involving a limbal or corneal incision) within the last 12 months.

          -  Have uncontrolled systemic disease

          -  Are currently using, or have used within 14 days of study enrollment, any ocular
             medications other than artificial tears

          -  Have anticipated contact lens wear during the study

          -  Have an active ocular infection
Dexmedetomidine Versus Morphine and Midazolam in Prevention and Treatment of Delirium After Adult Cardiac Surgery
Condition: Delirium
MeSH terms: Delirium
Intervention: Dexmedetomidine Hydrochloride; Morphine and Midazolam
Intervention description: 30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h; 30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed.
Intervention MeSH terms: Midazolam; Dexmedetomidine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Cardiac surgery; delirium; dexmedetomidine; morphine; midazolam

Summary:

      This randomized double-blind parallel clinical study was conducted on 60 patients undergoing
      elective cardiac surgery under general anesthesia, at least 60 yr old, ASA I and II, 70-100
      kg body weight and height 160-180 cm. Patients were randomized to: group A=30 patients
      receiving dexmedetomidine infusion (0.4- 0.7 µg /kg/h) or group B= 30 patients receiving
      morphine in a dose of 10-50μg/kg/hr as an analgesic with midazolam in a dose of 0.05mg/kg up
      to 0.2 mg/kg repeated as needed. Titration of the study medications infusions was conducted
      to maintain light sedation (RASS) (-2 to +1). Primary outcome was the prevalence of delirium
      measured daily via Confusion Assessment Method for intensive care. If Delirium and agitation
      occurred: haloperidol 2.5-5 mg IV was given in repeated boluses. Secondary outcomes included
      ventilation time, additional sedation/analgesia, hemodynamics and adverse effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  elective cardiac surgery under general anesthesia

          -  at least 60 yr old

          -  ASA physical status I and II

          -  70-100 kg body weight

          -  height 160-180 cm.

        Exclusion Criteria:

          -  Patients with impaired kidney or liver functions

          -  history of cardiac or central nervous system disease

          -  uncontrolled medical disease (diabetes mellitus and hypertension)

          -  coagulation defect

          -  history of drug or alcohol abuse

          -  history of chronic pain or daily intake of analgesics

          -  history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h
             before surgery

          -  allergy to the used medications

          -  or patient's refusal
Iron Bioavailability of Fortified Oat Drink
Condition: Iron Absorption
Intervention: Dietary Intervention (with Vit C then without Vit C); Dietary Intervention (without Vit C followed by with Vit C)
Intervention description: Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C; Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: All
Minimum age: 6 Years
Maximum age: 6 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Iron absorption; Oats; fortified oat beverages

Summary:

      This study will follow a double blinded randomized controlled study design to enroll 20
      apparently healthy 6 year old children. The children will be fed with two different nutrient
      fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA).
      Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for
      stable isotope measurements and iron absorption will be calculated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6 year old children (inclusive)

          -  Normal BMI for age (WHO standard: 15.3-15.5 kg)

          -  Apparently healthy, no metabolic or gastrointestinal disorder; non-anemic (Hemoglobin
             values not less than 11.5 mg/dL -WHO cut-off for respective age)

          -  No medication or vitamin/mineral supplement will be consumed during the study; intake
             of vitamin/mineral supplement will be discontinued 2 weeks before the start of the
             study

          -  Parents demonstrate an understanding of the given information and ability to comply
             with the study procedure

          -  Obtained parental or legal representative's informed consent

        Exclusion Criteria:

          -  Known gastrointestinal or metabolic disorder or experiencing blood losses over the
             past 6 months;

          -  Children taking medication

          -  Children who are anemic (Hemoglobin values less than 11.5 mg/dL - WHO cut-off value
             for this age)

          -  Currently participating or having participated in another clinical trial during the
             past 3 months prior to the beginning of the study
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
Condition: Kidney Transplantation, Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Intervention: valganciclovir [Valcyte]
Intervention description: Oral, daily for up to 200 days.
Intervention MeSH terms: Valganciclovir
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 4 Months
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      This open-label, single arm study will evaluate the tolerability and efficacy of Valcyte
      (valganciclovir) in the prevention of cytomegalovirus disease in pediatric renal transplant
      recipients. After transplantation, patients (aged 4 months to 16 years) will receive Valcyte
      orally daily for up to 200 days post-transplant and will be followed for 52 weeks
      post-transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children, 4 months to 16 years of age

          -  Patient has received a kidney transplant

          -  At risk of developing cytomegalovirus disease

          -  Adequate hematological and renal function

          -  Able to tolerate oral medication

          -  Negative pregnancy test for females of childbearing potential

        Exclusion Criteria:

          -  Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in
             the past

          -  Severe uncontrolled diarrhea (more than 5 watery stools per day)

          -  Liver enzyme elevation of more than five times the upper limit of normal for aspartate
             aminotransferase [AST (SGOT)] or alanine aminotransferase [ALT (SGPT)]

          -  Patient requires use of any protocol prohibited concomitant medication

          -  Previous participation in this clinical study
A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Androderm®
Intervention description: Androderm® transdermal dose.
Intervention MeSH terms: Testosterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of a once daily Androderm® dose on Blood Pressure (BP) in
      adult hypogonadal men as measured by 24-hour ABPM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Naïve to testosterone replacement, clomiphene, compounded or over-the-counter
             androgenic steroid derivatives, and dehydroepiandrosterone (DHEA), including
             investigational products that may affect the reproductive hormonal system or has not
             been treated with these compounds in the past 6 months

          -  Male participants willing to minimize the risk of inducing pregnancy for the duration
             of the clinical study and follow-up period

          -  Participant must be 18 to 80 years of age inclusive, at the time of signing the
             informed consent

          -  Body mass index (BMI) < 35 kilograms per metre square (kg/m^2)

          -  Male

        Exclusion Criteria:

          -  Uncontrolled systemic disease or clinically significant disease, in particular, liver,
             kidney or heart disease, including hypertension, congestive heart failure, coronary
             heart disease, chronic atrial fibrillation, sleep apnea or psychiatric illness, that
             in the investigator's opinion, would put the participant at an unacceptable risk with
             exposure to Androderm®

          -  History of prostate (current or in the past) or breast cancer

          -  Had a recent (within 2 years) history of stroke, transient ischemic attack, acute
             coronary event, venous thrombotic, or thromboembolic event

          -  History of alcohol or other substance abuse within the previous 2 years

          -  Known allergy or sensitivity to the study intervention or its components or other
             testosterone replacement medications

          -  Participant who works night shifts or who will need to perform strenuous manual labor
             while wearing the ABPM monitor
Topical Antimicrobial Effectiveness Testing
Condition: Antimicrobial Effectiveness
Intervention: ChloraPrep One-Step; 70% isopropyl alcohol
Intervention description: 1.5 ml applicator patient preoperative skin preparation; Curity Alcohol Prep Pads
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to measure the antimicrobial effectiveness of
      ChloraPrep One-Step Frepp Applicator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  in good general health

          -  have skin within 6 inches of the test sites that is free of tattoos, dermatoses,
             abrasions, cuts, lesions or other skin disorders.

        Exclusion Criteria:

        - topical or systemic antimicrobial exposure within 14 days prior to the Screen Visit