bioihbjkbjnl/mcl2 huggingface dataset:
Asthma and Indoor-air: Reducing Exposures
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Two hundred moderate to severely asthmatic children (6-12 years) will be enrolled in a study
      to look at the effectiveness of high efficiency filtration of indoor air in homes on reducing
      asthma symptoms. One intervention group will have high efficiency filters or filtration
      systems installed in their central heating and air conditioning (HVAC) system. The second
      intervention group will have high efficiency portable air cleaners placed in the child's
      bedroom and in the main living area. Each participant will receive true air filtration for a
      year and a placebo for a year. During the placebo period a sham filter will be used that
      removes very little of the particles. Measures of health effects will include days of
      symptoms, unplanned utilization of the healthcare system for asthma-related illness,
      short-term medication use, peak exhaled flow, spirometry, and exhaled nitric oxide (eNO).
    


Intervention name(s): Stand Alone Air Cleaner; HVAC Modification
Intervention type(s): Other; Other
Intervention description(s): This is an environmental intervention using a stand alone air cleaner designed to reduce the air pollution levels in the home.; This is an environmental intervention that modifies the home HVAC system to include high efficiency air filtration designed to reduce the air pollution levels in the home.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if inhaled urea can be used to detect the presence
      of Pseudomonas Aeruginosa in the lungs
    

Detailed description: 
      Dose Escalation study
    

Intervention name(s): 13C urea breath test Kit
Intervention type(s): Device
Intervention description(s): 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: CF
End Tidal Anesthetic Concentration in Different Anesthesia Techniques Where Depth of Anesthesia Adjusted With Entropy
Condition: General Anesthesia; Inhalation; Gas
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The aim of this study is to adjust the end tidal inhalation anesthetic concentration by
      observing the entropy value in patients who will be provided anesthesia maintenance with
      volatile anesthetics after applying the routine epidural anesthesia technique and to observe
      the end tidal volatile concentration that will provide to remain in the target entropy limits
      during the operation.
    

Detailed description: 
      The hypothesis of this study is that in general anesthesia cases which is combined with
      thoracic epidural anesthesia (TEA), lower alveolar concentration will be required to reach
      the same anesthesia depth. The main aim of the study is observing and comparing the alveolar
      concentrations of anesthetic agents with entropy monitoring which is an anesthesia depth
      monitor in major abdominal surgeries where general anesthesia is combined or not with TEA.

      In cases where TEA is combined with general anesthesia or not, anesthesia depth will be
      effectively monitored by entropy monitoring, in this way the adequate depth of anesthesia
      will be provided with the use of minimal volatile anesthetics and we will be able to prevent
      the use of large amounts of volatile anesthetics., It will be determined how much reduction
      in alveolar concentration is required in cases combined with TEA.

      Nowadays, with the development of reliable anesthesia machines, "low-flow anesthesia" (LFA)
      is becoming more widespread, and its benefits on patient health, economy and ecology have
      been demonstrated. In LFA, the depth of anesthesia should not be too superficial or too deep
      during the time the alveolar concentration of volatile agent reaches equilibrium. Therefore,
      alveolar concentrations of volatile anesthetics are monitored in modern anesthesia machines.
      Some machines may also adjust the depth of anesthesia according to the alveolar concentration
      of the agent.
    

Intervention name(s): Bupivacaine; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): %0.25 bupivacaine solution; End tidal sevoflurane concentration
Other intervention name(s): marcaine; Sevorane
Intervention MeSH terms: Bupivacaine; Sevoflurane
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Keywords: Minumum alveoler concentration; Entropy monitorining; General anesthesia; General anesthesia combined with TEA
This Study Tests BI 1467335 in Healthy Male Volunteers. The Study Tests How Different Doses of BI 1467335 Are Taken up and Handled by the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective mass balance, excretion pathways and metabolism following a single oral
      dose of [14C]BI 1467335 given to healthy male subjects (a selected number of subjects will be
      treated with [14C]BI 1467335 after a preceding 27 days treatment with non-radiolabelled
      compound of BI 1467335 QD).

      Secondary objectives is to investigate the basic pharmacokinetics after single and multiple
      doses of BI 1467335 and its metabolites.
    


Intervention name(s): [14C]BI 1467335; BI 1467335
Intervention type(s): Drug; Drug
Intervention description(s): Once Daily; Twice Daily
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The BreaD Study - Bio-availability of D2 Vitamin Present in Bread
Condition: Serum 25-hydroxyvitamin D Concentrations (25OHD)
Study type: Interventional

Summary: 
      Vitamin D3 is synthesized in skin exposed to ultraviolet-B-irradiation of sunlight. However,
      in Northern Europe, including Finland, exposure to sunlight is limited or non-existent in
      winter. Between November and March, dietary or supplementary vitamin D intake is essential to
      maintain adequate serum 25-hydroxyvitamin D (S-25(OH)D) concentrations. There are only a few
      natural dietary sources of vitamin D. Fish and egg yolks contain significant amounts of
      vitamin D3 (cholecalciferol), and some wild mushrooms are a source of vitamin D2
      (ergocalciferol). Thus, vitamin D fortification of certain foods has been accepted as one
      strategy to improve vitamin D status of these populations. Vitamin D3 is currently mostly
      used in fortified products in Europe, although the production of plant-derived vitamin D2
      would be more cost-effective. Data on the impact of food-derived vitamin D2 on S-25(OH)D3 are
      limited. An important consideration is whether food-based sources of vitamin D2 are effective
      in raising S-25(OH)D or whether they have a negative impact on S-25(OH)D3. The investigators
      investigated the bioavailability of vitamin D2 from UVB-radiated baking yeast in bread in
      terms of efficacy of raising total S-25(OH)D) as well its possible effects on S-25(OH)D2,
      S-25(OH)D3, serum parathyroid hormone (S-PTH) and serum calcium concentrations compared with
      D2 and D3 supplementation in a randomized placebo-controlled trial in young healthy females
      during winter in Finland.
    


Intervention name(s): Vitamin D2; Vitamin D3; Vitamin D2 fortified bread
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Experimental group 2: daily vitamin D2 supplement 25ug/d for 8 weeks; Experimental group 3: daily vitamin D3 supplement 25ug/d for 8 weeks; Experimental group 4: vitamin D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: vitamin D; Serum 25-hydroxyvitamin D; vitamin D2; UV-irradiated yeast; serum 25-hydroxyvitamin D3; serum 25-hydroxyvitamin D2; randomized controlled trial; vitamin D3; bioavailability
tAN to Mitigate Withdrawal Behaviors in Neonates
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome
Study type: Interventional

Summary: 
      This first in-human-neonates, open-label pilot trial is designed to determine whether use of
      tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and
      decrease morphine use altogether. Reducing Neonatal Opioid Withdrawal Syndrome (NOWS)
      symptoms may also help lessen or eliminate the need for opioid medication and shorten the
      length of the hospital stay. The neurostimulation device, currently called the Roo is a safe
      form of neurostimulation that uses sticker-like patches worn in and around the ear during the
      withdrawal period. The patches deliver a small and painless current of electrical pulses to
      the skin and underlying cranial nerves.
    

Detailed description: 
      This first in-human-neonates, open-label pilot trial is designed to determine whether use of
      tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and
      decrease morphine use altogether. After obtaining parental consent, tAN is delivered to the
      left ear in NOWS newborns who are on a stable morphine dose for >12h (control dose), using a
      disposable, multi-channel (Channel1: auricular branch of the vagus nerve (ABVN); Channel2:
      ATN) earpiece electrode (Spark Biomedical, Inc). 30-minutes of tAN is delivered one hour
      prior to scheduled morphine dose, up to four times daily for up to 12 days. The device is
      programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 milliamps (mA);
      channel 2: 100 Hz, mean intensity 0.6±0.2 mA. Nurses score the Finnegan Neonatal Abstinence
      Scoring Tool (FNAST) every 3h after feeding and morphine is weaned every 12h if FNAST scores
      <8.
    

Intervention name(s): Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
Intervention type(s): Device
Intervention description(s): Spark Roo tAN System programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
Condition: Obesity; Glucose Homeostasis; Postmenopausal Symptoms
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this pilot clinical study is to perform a randomized placebo-controlled study to
      assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens
      (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women.
      The recruitment will be performed at Tulane Health Sciences Center.
    


Intervention name(s): Bazedoxifene/Conjugated Estrogens (BZA/CE); Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.; Daily placebo tablet
Other intervention name(s): DUAVEE
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety, Tolerability and PK of Multiple-ascending Doses of Emodepside
Condition: Filariasis
MeSH terms: Filariasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study evaluates safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of
      emodepside, after administration as a Liquid Service Formulation (LSF), over 10 days, in
      healthy male caucasian subjects.
    

Detailed description: 
      There is an urgent need for a macrofilaricidal drug, killing or sterilizing permanently O.
      volvulus adult worms, which could be used in individual case management and, after
      appropriate testing, as an alternative drug to ivermectin in Mass Drug Administration (MDA)
      programs. Emodepside is a promising candidate to kill the adult and sexually mature O.
      volvulus as explained below. Emodepside was shown to be macrofilaricidal against a variety of
      filarial nematodes and is a registered drug for animal health, commercialized by Bayer AG
      under the name of Profender® (in combination with praziquantel) or Procox® (in combination
      with toltrazuril).

      A first-in-human (FIH) double-blind, placebo-controlled study of single ascending doses of
      emodepside in healthy Caucasian men has been conducted and the preliminary results are
      favourable, supporting continuation of the Phase I development program. In the present repeat
      dose study, PK as well as safety and tolerability of the liquid service formulation of
      emodepside, given over 10 days, will be tested.
    

Intervention name(s): LSF emodepside (BAY 44-4400) or matching placebo
Intervention type(s): Drug
Intervention description(s): Emodepside administered as an LSF oral solution (1mg/mL)
Intervention MeSH terms: Emodepside
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
MRI in Diagnosing and Monitoring CIDP
Condition: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
MeSH terms: Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Observational

Summary: 
      We want to study whether MRI can be useful in diagnosing and monitoring patients with CIDP in
      maintenance treatment with immunoglobulin
    

Detailed description: 
      Chronic inflammatory neuropathies such as chronic inflammatory demyelinating
      polyradiculoneuropathy (CIDP) can be successfully treated with immunoglobulin either
      intravenously (IVIG) or subcutaneously (SCIG).

      CIDP is diagnosed by electrophysiology which is time-consuming and unpleasant for the
      patient.

      New techniques suggest that Magnetic Resonance Imaging (MRI) and ultrasound imaging can be
      used to detect injuries in the peripheral nerves

      We want to study if MRI and ultrasound is able to detect damages in peripheral nerves, nerve
      roots and plexus in patients with CIDP.

      Moreover, we want to compare these findings to healthy matched controls and to see if
      treatment with immunoglobulin changes findings in MRI
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with subcutaneous immunoglobulin for CIDP are invited to participate. They
        will be recruited from the outpatient clinic at Department of Neurology in Aarhus, Odense
        and at Rigshospitalet (Copenhagen)

        Healthy controls will be recruited by public announcement
      
Keywords: Subcutaneous immunoglobulin; Magnetic resonance imaging
Multimodal Drug Infiltration in Total Knee Arthroplasty: Is Posterior Capsular Infiltration Worth the Risk?
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Multimodal local anesthetic infiltration (LAI) provides effective pain control in patients
      undergoing total knee arthroplasty (TKA). Some surgeons avoid posterior capsular infiltration
      (PCI) for fear of damaging posterior neurovascular structures. Data are limited on the added
      benefits of PCI using different combinations of local anesthetic agents. Therefore, the
      investigator wanted to know the effectiveness of pain control in LAI with and without PCI.

      Half of participants received LAI with PCI, while the other half received LAI without PCI
      during total knee arthroplasty.
    

Detailed description: 
      Analgesic agents were bupivacaine, morphine, ketorolac and epinephrine. All patients received
      spinal anesthesia and patient controlled analgesia (PCA) for 24 hours post surgery. The
      surgical technique and postoperative medication protocols were identical in both groups. The
      visual analogue scale (VAS) for pain during activity and at rest, and morphine consumption
      were recorded at 6, 12, 18 and 24 hours postoperatively. LAI-related side effects, blood
      loss, length of hospital stay, and VAS for satisfaction were monitored. The reviewer was
      blinded to treatment groups.
    

Intervention name(s): 0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL; Drug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL); Drug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mL
Intervention type(s): Drug; Procedure; Procedure
Intervention MeSH terms: Ketorolac; Epinephrine; Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Local anesthetic infiltration; Posterior capsular infiltration; Multimodal anesthesia; Knee arthroplasty; Pain control; Osteoarthritis, Knee
The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical study is to evaluate and compare the efficacy and safety of
      Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate
      hypertension.
    

Detailed description: 
      A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study
      to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to
      moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South
      Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks,
      treatment period 12 weeks). All of the subjects who agreed to participate in this study and
      gave the written informed consent voluntary are assessed the exclusion and inclusion criteria
      and receive the investigational product(placebo) at screening visit.

      During more than 14 days of placebo run-in period, subjects have to stop the previous
      anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and
      randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at
      baseline visit. Subjects take physical and laboratory tests and receive the investigational
      products per 4weeks during treatment period (12weeks).
    

Intervention name(s): Fimasartan 60mg; Fimasartan 120mg; Candesartan cilexetil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.; Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.; Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
Other intervention name(s): Atacand 8mg
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; ARB; Fimasartan
Evaluate Safety and Biological Activity of ATYR1940 in Participants With Limb Girdle Muscular Dystrophy 2B (LGMD2B) and Facioscapulohumeral Muscular Dystrophy (FSHD)
Condition: Limb-Girdle Muscular Dystrophies; Facioscapulohumeral Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophies, Limb-Girdle; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and biological activity of ATYR1940 in
      participants with LGMD2B and FSHD.
    


Intervention name(s): ATYR1940; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Concentrate for solution for infusion; Concentrate for solution for infusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LGMD2B; FSHD
Gauging Of Light Dependent Experiences Through Neuroimaging (GOLDEN)
Condition: Compulsive and Infrequent Tanners
Study type: Observational

Summary: 
      In the proposed study, the investigators will assess the brain's dopamine response to UVR
      light in individuals who use tanning beds both frequently and infrequently.
    

Detailed description: 
      UV radiation has recently been classified as a known human carcinogen by the US Department of
      Health and Human Services. Nevertheless, the voluntary exposure to sunlight continues
      unabated despite progressively increasing rates of ultraviolet radiation (UVR)-induced
      illness and death, particularly skin cancer. An increasingly common form of UVR
      administration is through the use of indoor tanning salons. Almost 30 million Americans,
      including 20% of 18-39 year olds, visit indoor tanning salons each year. Frequent and
      excessive tanning, despite a growing understanding by those who tan of the morbidity and
      mortality associated with tanning, suggests that UVR may impart rewarding effects beyond the
      assumed cosmetic benefits. Recent studies, in fact, have shown that up to 40% of both
      frequent beach and salon tanners exhibit signs and symptoms consistent with an addictive
      disorder, including an inability to decrease their tanning frequencies, compulsive tanning,
      and/or continued tanning despite adverse consequences. As the mesostriatal dopaminergic
      pathway plays a key role in reward and addiction, the investigators propose to extend this
      novel finding by directly assessing the mesostriatal dopaminergic reward pathway in
      compulsive and infrequent tanners. This pathway plays a key role in the experience and
      integration of reward and alterations in this system have been observed in addicted
      populations. Specifically, 1) striatal dopamine is released in response to rewarding
      substances and experiences, 2) striatal dopamine2/3 receptor densities are lower in cocaine,
      alcohol, opioid, and nicotine dependent, as well as obese, subjects, and 3) reward-induced
      striatal dopamine efflux has been shown to be decreased in addicted, relative to
      non-addicted, subjects.
    

Intervention name(s): Tanning
Intervention type(s): Device
Intervention description(s): Participants will be placed under a tanning canopy for 4-10 minutes.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects will be recruited though flyers and advertisements. Advertisements will be placed
        in college newspapers. Flyers will be placed on college campuses, and local Dallas stores
        and beauty salons.
      
Keywords: Tanning; neuroimaging; dopamine; MRI; SPECT