bioihbjkbjnl/mcl2 huggingface dataset:
Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      Operational conditions amplify soldier's constraints and stress factors, upsetting individual
      and collective adaptive landmarks. The soldier's resistance is strained by the high intensity
      of stressors, by the long duration of exposure and by their cumulative effect.

      This may lead to a state of "operational strain" that refers to chronic stress and the
      allostatic load imposed by operational constraint.

      The investigators believe that operational strain could manifest itself by a kind of
      accelerated aging of the organism due to the increased allostatic load without sufficient
      resource restoration (neurotransmitter precursors, partial and repeated sleep deprivation,
      etc.).

      This aging mechanism would be reversible after a sufficient period of resource restoration
      (sleep, physical activity, adapted diet, etc.).
    


Intervention name(s): Blood collection; L-Tyrosine 500 Mg; Psychological questionnaires; Photoplethysmography; Placebo
Intervention type(s): Biological; Drug; Behavioral; Device; Drug
Intervention description(s): A blood sample will be collected before during and after the treatment.; The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.; The participants will fill in several psychological questionnaires before, during and after treatment administration:
Life Event Checklist
Moral injury
Posttraumatic Checklist
Burnout Assessment Tool
State-Trait Anger Expression Inventory-2
Ruminative Response Scale - Reconsidered
Deployment Risk and Resilience Inventory-2
Questionnaire about tobacco use; Photoplethysmography recording will be performed before during and after the treatment.; The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is composed of 2 groups, each of which is composed of 2 arms:
External Operation group
L-Tyrosine arm
Placebo arm
Rear Base group
L-Tyrosine arm
Placebo arm
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: L-tyrosine
Bioavailability of Insulin Administered in Duodenum
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A study of the bioavailability of insulin after infusion in the duodenum in healthy
      volunteers.
    

Detailed description: 
      METHODOLOGY All subjects will be admitted fasting to the Clinical Trial Unit at Århus
      Community Hospital at 8 a.m. A Gastrointestinal tube will be placed in Duodenum distal to
      papilla Vaterii with a pH of approximately 7.0 as measured by the pH meter distal in the
      tube. An indwelling catheter for glucose infusion (20 %) in cases of hypoglycaemia will be
      placed in an antecubital vein. In the contralateral anticubital vein a catheter will be
      placed for blood sampling. All subjects will have 4 tests with duodenal infusion of the
      insulin Aspart solution. The first 4 volunteers will receive 4 doses of insulin Aspart
      solution in 1 ml (150, 300, 600 and 1000 IU) with 3-6 hours apart. Blood sampling for Insulin
      Aspart, total insulin, and glucose (Beckmann apparatus) will be done every 10 minutes the
      first two hours, and then every 20 minutes. When final the subjects will receive a meal
      before leaving the hospital.

      Based on data from the pilot a dose will be determined for the remaining 8 subjects. These
      will then based again on results from the pilot on two separate study days receive 4
      infusions with 3-6 hours split. Two infusions will be at pH 7 and two infusions will be more
      proximal at a pH of 5.5 (two different insulin concentrations but the same dose given at the
      two places in Duodenum). Frequency and interval of blood sampling in the second part will be
      determined by results from the pilot study. For comparison with the clinical situation and
      estimation of bioavailability all subjects will receive a subcutaneous and an intravenous
      (iv) bolus injection of 6 IU of insulin Aspart. The iv injection will be followed by blood
      sampling for three hours as above, but every 5 minutes the first two hours, and the sc
      injection will be followed by blood sampling for three hours as above, but again with 10
      minutes interval the first two hours.
    

Intervention name(s): Insulin Aspart
Intervention type(s): Drug
Intervention MeSH terms: Insulin Aspart
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: insulin; bioavailability; duodenum; infusion; healthy; diabetes; absorption
Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      An 8-week, Open-Label Study to Characterize the Response to Modafinil (85mg Film-Coated
      Tablet) Treatment at Dosages up to 425mg/Day in Children and Adolescents with
      Attention-Deficit/Hyperactivity Disorder (ADHD) (With an Open-Ended Extension Period)
    


Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study
Condition: Pulmonary Alveolar Proteinosis, Autoimmune
MeSH terms: Respiratory Aspiration; Pulmonary Alveolar Proteinosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose
      inhalation.

      Study Design: Pharmacokinetic open study
    


Intervention name(s): Sargramostim
Intervention type(s): Drug
Intervention MeSH terms: Sargramostim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia
Condition: Sickle Cell Anemia
MeSH terms: Anemia; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      Hydroxyurea (HU) is approved by the United States Food and Drug Administration (FDA) to treat
      adults with sickle cell anemia. Hydroxyurea has also been tested and used with children with
      sickle cell anemia. However, there are not many studies describing the disposition of drug in
      children less than 5 years old. The FDA has requested this study to better understand how
      children ages 2 to 17 years with sickle anemia absorb and eliminate the drug (this is called
      pharmacokinetics). The investigators will measure how much Hydroxyurea (HU) gets into the
      bloodstream at different time points after taking this medication.
    


Intervention name(s): Hydroxyurea
Intervention type(s): Drug
Intervention description(s): 20mg/kg of Hydroxyurea or the patient's standard daily dose
Other intervention name(s): Droxia Capsules; Hydrea
Intervention MeSH terms: Hydroxyurea
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: HU; Hydroxyurea; Sickle cell; Pediatric
Knee Osteoarthritis and Balneotherapy
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The goal of this clinical trial is to assess the efficacy of a 18-day balneotherapy program
      in the rheumatology indication in patients presented with knee osteoarthritis. The main
      questions of the study aims to answer are how balneotherapy improves functional incapacity
      and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus
      improves patients' quality of life.

      Participants are randomly assigned in control or treatment (spa) groups. All receive standard
      of care for knee osteoarthritis throughout the study. Balneotherapy program consists of
      18-days of spa treatment with Mineral Water of Saint Jean d'Angely. Functional incapacity,
      disorders and quality of life induced were measured at baseline and then 6 months later.

      Variation from baseline were compared in control and treatment groups to assess the efficacy
      of the balneotherapy program.
    


Intervention name(s): Balneotherapy program
Intervention type(s): Other
Intervention description(s): Whirlpool bath, bath with immersion showers, poultice application and underwater massage.
The baths were performed in an individual tub in ten-minute sessions. The temperature was set specifically for each patient, on average from 34 to 38°C. These were baths with jets and air diffusion.
The mud was applied as a poultice to the 2 knees and if necessary (duration of application: 10 minutes).
The massages were carried out by qualified physiotherapists under an affusion ramp of thermal water at 38°C for 10 minutes.
The water used is a mixed sulphated Natural Mineral Water, collected by drilling the "capuchins" at a depth of 975 m. The temperature of the water at the outlet of the borehole is 41.8°C and is lowered to 35°C.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled Trial, monocentric
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Balneotherapy, Osteoarthritis
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age
Condition: Tetanus; Diphtheria; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in
      US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection,
      booster response and safety of this formulation as a 5th dose.

      Primary Objective:

      - To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular
      pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all
      antigens) when each is administered as a 5th dose and given concurrently, to children aged 4
      to 6 years.

      Secondary/Observational Objectives:

        -  To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine
           (for pertussis antigens) when each is administered as a 5th dose and given concurrently,
           to children aged 4 to 6 years.

        -  To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after
           each long-term follow-up.

        -  To describe the safety profile following vaccine administration.
    


Intervention name(s): Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis); DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): Adacel; DAPTACEL in the US; TRIPACEL in Canada
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL
Measurement Algorithm Control, Optimization, and Performance Evaluation of the Vital USA GlucoseDetect
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Measurement Algorithm Control and Optimization with Subsequent Performance Evaluation of the
      Vital USA GlucoseDetect™ During a Standardized Meal Test in Patients with Diabetes mellitus
      Type 1 and Type 2
    

Detailed description: 
      This study is a combined, open label, prospective, comparative single-center study.

      The study is separated in 3 consecutive study parts. The first 2 study parts include 16
      patients each. In the third study part 16 additional patients will be enrolled. Study part 1
      and 2 will be used for optimization and validation of the measurement algorithms of the Vital
      USA biosensor. During the third study part with enrolment of 16 additional patients, the
      precision and accuracy of the final Vital USA biosensor algorithm will be demonstrated. The
      visit schedule for all participants of all 3 study parts will be exactly the same. In all
      groups of participants, the Vital USA non-invasive monitoring biosensor will be individually
      introduced and assigned. During the experimental study visit, a standardized meal will be
      given to the participants. Before and after the standardized meal, glucose, heart rate, and
      pO2 will be measured using the Vital USA monitoring biosensor at time-points -30, 0, 15, 30,
      45, 60, 75, 90, 120, 150 and 180 min. The glucose measurements will be compared to capillary
      blood glucose measurements by YSI Stat 2300. Parallel measurements of the heart rate and the
      pO2 using a patient monitor will be compared to the device readings.
    

Intervention name(s): Vital GlucoseDetect
Intervention type(s): Device
Intervention description(s): 11 time points for blood glucose measurements over 210 min including the ingestion of a standardized meal 30 min after the first blood glucose measurement.
Intervention model: Single Group Assignment
Intervention model description: patients are divided in two groups and both groups are enrolled sequential and undergo the same procedures
Masking: None (Open Label)
Primary purpose: Diagnostic
Self-Assessment of Medical Abortion Outcome Using Serial Multi-level Pregnancy Tests
Condition: Medical Abortion
Study type: Interventional

Summary: 
      This study aims to investigate the effectiveness and acceptability of the multi-level
      pregnancy test for self-assessment of abortion outcomes, without a routine provider contact.
    


Intervention name(s): Self-assessment
Intervention type(s): Behavioral
Intervention description(s): Patients enrolled into the study will do a multi-level pregnancy test (MLPT) at enrollment, and will receive one MLPT to do at home one week after taking mifepristone and misoprostol. They will be instructed to call the study site if the at-home MLPT result do not decline, or if they experience any abortion complications.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Effects of Exogenous Ketones on Glucose Tolerance
Condition: Dietary Supplement: Ketone Supplement; Dietary Supplement: Placebo
Study type: Interventional
Phase: Phase 1

Summary: 
      The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous
      carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous
      beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering
      potential but this has not been adequately studied. The purpose of this study is to determine
      whether supplementing with an acute dose of ketone monoester can improve the glycemic
      response to a high carbohydrate mixed meal in young healthy individuals.
    


Intervention name(s): Ketone monoester; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour high carbohydrate mixed meal tolerance test.; Acute ingestion of a taste-matched placebo prior a 2-hour high carbohydrate mixed meal tolerance test.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will
      result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).
    

Detailed description: 
      Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal condition. IBS
      is associated with a high use of health-care costs and can substantially reduce quality of
      life and work productivity.

      Several studies have demonstrated that the composition of the gut microbiota in IBS patients
      is different from healthy controls.

      Fecal microbiota transplantation (FMT) could therefore be a treatment option for IBS patients
      by exchanging the microbiota of an IBS patient with the microbiota of a healthy donor.
    

Intervention name(s): FMT capsules; FMT placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 25 capsules per day for 12 days; 25 capsules per day for 12 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Fecal Microbiota Transplantation; Microbiota
Modification of Doses of Efavirenz According to Its Blood Concentration in HIV Patients
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study on the utility of the modification of doses of efavirenz guided by its plasma
      concentration (therapeutic drug monitoring) in HIV-infected patients initiating treatment
      with Sustiva.
    

Detailed description: 
      Currently, efavirenz is dosed systematically, without taking into account the individual
      characteristics of each individual patient. However, plasma concentration of efavirenz may
      widely vary between different subjects that receive the same dose of the drug
      (interindividual variability).

      Therapeutic drug monitoring (TDM) signifies individualised pharmacological dosing, based on
      the plasma levels that each patient presents. This strategy has been broadly used in the
      field of the treatment of other medical conditions and is acquiring growing interest in the
      field of antiretroviral treatment. Thus, the use of TDM for the treatment of naïve patients
      with nelfinavir or with indinavir has translated into an increase in the proportion of
      individuals with suppressed viral load and also into a reduction in HAART-induced adverse
      events . However, data on the utility of the therapeutic monitoring of the levels of
      efavirenz in HIV-infected patients are very scant.

      On the basis of the above, it might be thought that the modification of the doses of
      efavirenz, guided by its plasma concentration, in patients receiving this drug and whose
      plasma levels of efavirenz are outside the therapeutic range, might improve the tolerability
      of the treatment without compromising virological efficacy.
    

Intervention name(s): Efavirenz capsules 200 mg and 600 mg
Intervention type(s): Drug
Intervention description(s): Modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring)
Other intervention name(s): Sustiva
Intervention MeSH terms: Efavirenz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Therapeutic drug monitoring; Treatment Naive; Treatment Experienced; HIV
Emergency Contraception Actual Use Study
Condition: Emergency Contraception
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a non-comparative case series study to assess the ability of females 11-16 years of
      age, inclusive, who are requesting emergency contraception (EC) to use the study product,
      DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.
    

Detailed description: 
      To simulate an over-the-counter (OTC) setting, each potential subject was expected to read
      the label text on the outside of the study package and determine whether and how to use the
      study product without provider direction or assistance. The study product, Plan B® 1.5, was
      to be dispensed only to those subjects who appropriately self-selected and indicated that
      they wanted to participate in the study and receive study product. Subjects could also
      appropriately self-select not to use the study product.

      Follow-up contact was to be conducted at approximately one, four, and eight weeks following
      the date the subject was dispensed study product. At these contacts, subjects answered
      questions regarding product use, health problems since last contact, and pregnancy status.
      Subjects were not to be permitted to enroll more than once in this Actual Use Study, however
      to assess repeat use of emergency contraceptives (EC) (use in addition to the study product)
      subjects were also queried at the one-, four-, and eight-week follow-up contacts regarding
      use of additional EC.
    

Intervention name(s): DR-104
Intervention type(s): Drug
Intervention description(s): One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.
Other intervention name(s): Plan B® 1.5; Plan B One-Step®; levonorgestrel
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of Pediatric Skin Disorders: The "Big" Study
Condition: Chronic Pediatric Skin Conditions
MeSH terms: Skin Diseases
Study type: Observational

Summary: 
      This study leverages the availability of a validated series of instruments to measure the
      effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on
      patients 8 years of age and above in causing stigma and psychiatric issues, particularly
      anxiety and depression.
    

Detailed description: 
      This is a multi center study with Northwestern University/Lurie Children's Hospital serving
      as the Data Coordinating Center. Site selection has been completed through members of PeDRA.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        3,500 parent/child dyads across all sites (at least 50 parent/child dyads at each site).