bioihbjkbjnl/mcl2 huggingface dataset:
Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine)
Condition: Coronary Arteriosclerosis; Valve Heart Disease
MeSH terms: Heart Diseases; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Heart Valve Diseases
Study type: Interventional

Summary: 
      Hypotension with potentially serious consequences for organ perfusion is a common
      complication in extracorporeal procedures such as heart-lung-machine. The exact reasons for
      this are still insufficiently clarified. Probably periinterventional vasorelaxant released
      substances play a crucial role in these procedures. These substances could be due to contact
      of blood cells with the Membrane in the HLM arise. In this project the hypothesis will be
      checked, if EETs / DHETs are released by Erythrocytes during this extracorporeal procedure
      and thus act as potential candidate products for the result of hypotonic phases during usage
      of heart-lung-machine.

      We will determine differences in RBC fatty acids profiling in patients before and after
      heart-lung-machine intervention. RBC fatty acids profiling will be achieved by using targeted
      HPLC-MS mass spectrometry.

      It is believed that during HLM there is an increase in EETs / DHETs in the serum and in the
      erythrocytes. It is believed that shear forces play an important role in the release of
      erythrocyte EETs / DHETs.
    


Intervention name(s): Heart-Lung-Machine
Intervention type(s): Procedure
Intervention description(s): blood sample before and during a single Heart-Lung-Machine procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fatty Acid Metabolism; Erythrocytes; Lipidomics; Heart-Lung-Machine
Amnios™ RT Outcomes Study
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate clinical outcomes of patients with plantar fasciitis
      following treatment with Amnios™ RT. Patients will be randomized to either Amnios™ RT or a
      placebo control.
    


Intervention name(s): Amnios™ RT; Saline
Intervention type(s): Other; Other
Intervention description(s): Acellular human allograft; Sterile saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Physical Activity Guidelines for People With Spinal Cord Injury (SCI)
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The first evidence-based physical activity guidelines for people with spinal cord injury were
      released in March, 2011. This project will evaluate the implementation of the new physical
      activity guidelines in a community exercise setting in Hamilton, Ontario. The investigators
      hypothesize that persons who follow the guidelines will experience increased aerobic fitness
      and muscle strength. The investigators also hypothesize that participants will find the
      guidelines easy to follow and that their self-efficacy for participating in physical activity
      will be improved following the study period.
    


Intervention name(s): Physical Activity Guidelines
Intervention type(s): Behavioral
Intervention description(s): Participants in the Physical Activity Guidelines Arm will be asked to participate in at least 20 minutes of moderate to heavy intensity aerobic activity 2 times per week as well as strength training exercises (moderate intensity) 2 times per week. The Control Arm will not be supervised to follow the physical activity guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: spinal cord injury; physical activity; physical fitness
Systematic Follow up of Drug Treatment by Pharmacists in Secondary Prevention After Transient Ischemic Attack
Condition: Ischemic Attack, Transient; Stroke
MeSH terms: Ischemic Attack, Transient; Ischemia
Study type: Interventional

Summary: 
      Use of drugs is an important factor in secondary prophylaxis after transient ischemic attack
      (TIA), but studies show that adherence to the prescribed drugs is often poor. This randomised
      controlled trial aims to investigate whether a systematic follow up of drug treatment using
      medication reconciliation, medication reviews and patient counselling by clinical
      pharmacists, improves adherence and/or decreases cardiovascular events the first three months
      and the first year after TIA. Patient satisfaction will also be compared between the two
      groups.
    


Intervention name(s): Drug use counselling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Secondary Prevention; Pharmacists; Directive Counseling; Medication Adherence; Patient Compliance
CSD1805: Study to Assess Nicotine Uptake and Product Use Behavior in Moist Snuff Consumers Using Two Moist Snuff Products
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of this study is to compare nicotine uptake and product use behavior during and
      following use of two moist snuff products in generally healthy, adult moist snuff users.
    

Detailed description: 
      This will be an single-blind, multi-center, randomized, two-way crossover study, conducted in
      generally healthy, adult moist snuff users who will be randomly assigned to the order in
      which they will use two moist snuff study products (comparator product, test product). The
      study will evaluate pharmacokinetic (PK) measures for two moist snuff products in a 7-day
      confinement setting.
    

Intervention name(s): 1805AA; 1805AB
Intervention type(s): Other; Other
Intervention description(s): A moist snuff product; A moist snuff product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
Condition: Headache; Migraine
MeSH terms: Headache
Study type: Interventional

Summary: 
      In this study the investigators will research the hypothesis that the gas carbon monoxide
      induces headache and increases the blood flow velocity in the middle cerebral artery.
    

Detailed description: 
      To investigate headache score and accompanying symptoms during and after inhalation of carbon
      monoxide.

      With transcranial Doppler imaging, c-scan and laser speckle the investigators will
      investigate changes in blood flow velocity of the middle cerebral artery (MCA), diameter of
      the superficial temporal artery (STA), the radial artery and facial skin perfusion.
    

Intervention name(s): Carbon monoxide; Placebo
Intervention type(s): Other; Other
Intervention description(s): carbon monoxide, 4.7, Purity 99.997, inhalation of carbon monoxide in a volume corresponding to carboxyhemoglobin 10 and 20%, calculated from baseline Hg and body mass.
Intervention MeSH terms: Carbon Monoxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Carbon monoxide; Headache; Migraine
A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP)
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to evaluate the effectiveness and safety of the study drug
      known as duloxetine in participants with diabetic peripheral neuropathic pain.
    


Intervention name(s): Duloxetine; Pregabalin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Other intervention name(s): LY248686
Intervention MeSH terms: Pregabalin; Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Laser in Orthodontic Leveling and Alignment
Condition: Dental Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      to evaluate the outcome of LLLT regarding leveling and alignment of the mandibular anterior
      segment.
    

Detailed description: 
      Thirty patients, 18 females and 12 males, were included who had Class I malocclusion with
      moderate mandibular crowding and an average age was 19.23 ± 3.1years.They were randomly
      divided into two parallel groups; a control group without laser intervention and a laser
      group which received LLLT. All patients followed a non-extraction approach using one category
      of fixed appliance and matching conventional NiTi archwire sequence during 3 months
      observation period. In laser group, mandibular anterior teeth were irradiated by gallium
      aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10
      seconds at 10 points (0.2 J/point) on facial and lingual aspects. This protocol was started
      immediately after first wire insertion and then at days 3,7,14 of the first month and
      repeated for additional 2 months. In both groups, relief of mandibular crowding was assessed
      by Little's irregularity index (LII) after 4 weeks (T1), after 8 weeks (T2), and after 12
      weeks (T3) intervals. Changes in LII scores were evaluated through scanned 3D models via
      software. In addition, the monthly rate of OTM was calculated and compared. The level of
      significance was set at p ≤ 0.05.
    

Intervention name(s): low level laser therapy
Intervention type(s): Radiation
Intervention description(s): mandibular anterior teeth were irradiated by gallium aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10 seconds at 10 points (0.2 J/point) on facial and lingual aspects. This protocol was started immediately after first wire insertion and then at days 3,7,14 of the first month and repeated for additional 2 months
Other intervention name(s): photobiomodulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: control group laser group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low-level laser therapy; Orthodontic Tooth Movement; Leveling and Alignment; Little Irregularity Index.
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for
      three months among patients with pulmonary arterial hypertension.
    

Detailed description: 
      Idiopathic pulmonary arterial hypertension (PAH) is a life-threatening disorder of uncertain
      cause that leads to progressive right heart failure and death. Average survival has improved
      from about 2.8 years in the early 1990s to approximately 5-7 years with current treatments,
      but most patients will still die of their disease. Two classes of oral medications are
      approved for use in PAH: endothelin-1 antagonists, and phosphodiesterase-5 inhibitors. Both
      improve walk distance and symptoms in PAH, but most patients still have continued dyspnea,
      fatigue and significant elevations in pulmonary pressures. Those who remain severely impaired
      are generally started on a continuous intravenous prostacyclin. For those who are less ill
      but still symptomatic, few options are available.

      Primary endpoint: the primary endpoint will be change in pulmonary vascular resistance (PVR)
      measured by right heart catheterization after three months of therapy.

      Secondary endpoints

        -  Six minute walk distance

        -  QIDS-SR depression scale

      Safety and tolerability endpoints will include a tabulation of adverse events to include but
      not limited to:

        -  Death

        -  Hospitalization

        -  Symptomatic hypotension

        -  Gastrointestinal side effects

        -  Depression
    

Intervention name(s): Fluoxetine
Intervention type(s): Drug
Intervention description(s): Total dose How to take:
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-6 40 mg BID Week 7-12 40mg BID
Other intervention name(s): Total dose How to take:; Week 1-2 20 mg daily; Week 3-4 40 mg daily; Week 5-6 40 mg BID; Week 7-12 40mg BID
Intervention MeSH terms: Fluoxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; Pulmonary Hypertension
A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
Condition: Probiotics; Hirschsprung's Disease Associated Enterocolitis
MeSH terms: Enterocolitis; Hirschsprung Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's
      disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when
      administered in adequate amounts, confer health benefit to the host.Based on this previous
      knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the
      gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the
      incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators
      conducted a prospective, multicenter, randomized and controlled trial to assess whether oral
      probiotics could decrease the incidence and severity of Hirschsprung's disease associated
      enterocolitis(HAEC).
    


Intervention name(s): Bifico
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Singapore Study to Assess How Neurovision Improve the Vision of Adults With Low to Moderate Myopia
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      To evaluate the efficacy of NeuroVision NVC vision correction technology to improve the
      vision of subjects with Low and Moderate Myopia in Asian eyes in Singapore
    

Detailed description: 
      NeuroVision has developed a novel vision correction technology, which is a scientifically
      based treatment to improve vision based on new principles of visual psychophysics.
      NeuroVision NVC Vision Correction Technology is a non-invasive, patient-specific treatment
      based on visual stimulation and facilitation of neural connections responsible for vision.
      The treatment involves a programmed series of interactive visual exercises in front of a
      computer, and does not involve any form of prescription medications, or surgical treatment.

      The technology has been proven in both Israel and Singapore's pilot study to work for myopia
      -1.50D and below.

      This study is a clinical trial for Singapore Ministry of Defence personnel to evaluate the
      efficacy of this treatment beyond the proven myopia range. There will be 2 phases in the
      study; Phase 1 will include low myopes from -0.50D to -1.50D while Phase 2 covers moderate
      myopes from -1.75D to -3.00D. Subjects will be randomised into treatment and placebo group in
      the ratio of 3:1.

      A randomized double masked controlled trial conducted in 2 Phases:

      Phase I will involve 140 study subjects with low myopia randomized in a 3:1 randomization to
      receive NVC treatment versus placebo treatment.

      It is assumed that the withdrawal rate will not exceed 20%, so that at least 112 study
      subjects will complete the treatment phase.

      Interim analysis with stopping rule will be conducted after 3/4 of the patients complete the
      treatment phase.

      Phase II will involve 180 study subjects with moderate myopia randomized in a 3:1
      randomization to receive NVC treatment versus placebo treatment.

      The 2 phases will be separate RCTs, with recruitment of Phase II subjects subsequent to
      completion of Phase I NVC treatments.
    

Intervention name(s): Neurovision
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Neurovision; Adult myopia; Therapy
Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects
Condition: PK in Patients With Various Degrees of Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, multi-center, open-label, PK and safety study of a single dose of AAI101
      in combination with cefepime in male and female subjects with mild renal impairment (Group 1,
      n = 6), moderate renal impairment (Group 2, n = 6), severe renal impairment (Group 3, n = 6),
      ESRD requiring dialysis (Group 4, n = 6), and normal renal function (Group 5, n = 6) as
      defined using the estimated value for creatinine clearance (CLcr) at Screening.

      The study consists of a 28-day screening period, followed by a single dose administration of
      AAI101 in combination with cefepime antibiotic on Day 1, an in house period (assessment
      period) and follow-up visit. All subjects will be confined to the study site from Day -1 (the
      day before dosing) until the morning of Day 3. The follow-up visits will occur on Day 7 (±2
      days), on Day 14 (±2 days), and on Day 30 (±2 days), if the results of the safety hepatic
      assessments are abnormal on Day 14 (±2 days).

      Group 4 (ESRD requiring dialysis) will have 2 in-house periods (separated by at least 7
      days), and will receive the single doses of AAI101 in combination with cefepime antibiotic
      once after dialysis and once before dialysis. The follow-up visit for Group 4 will occur on
      Day 7 (±2 days), on Day 14 (±2 days), and on Day 30 (±2 days), if the results of the safety
      hepatic assessments are abnormal on Day 14 (±2 days), counting from Day 1 of the second
      period.
    


Intervention name(s): cefepime/AAI101
Intervention type(s): Drug
Intervention description(s): Fixed dose combination of cefepime and AAI101
Intervention MeSH terms: Cefepime; Enmetazobactam
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability, and to evaluate the
      pharmacokinetic characteristics and food effect of Methosulide after oral administration in
      healthy adult subjects.
    

Detailed description: 
      1. Dose-escalation study of single oral administration of Methosulide in healthy adults to
           assess the safety and tolerability.

        2. Multiple-dose study of Methosulide in healthy adults to assess the safety and
           tolerability.

        3. Dose-escalation study of single oral administration of Methosulide in healthy adults to
           evaluate the pharmacokinetic characteristics

        4. Multiple-dose study of Methosulide in healthy adults to evaluate the pharmacokinetics
           characteristics

        5. Single dose,and cross-over study of Methosulide in healthy adults to evaluate the
           pharmacokinetic characteristics and effect of food.
    

Intervention name(s): Methosulide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tolerability Study:
Period I:Single oral administration,dose-escalation of Methosulide(six dose groups:25mg-250mg) Period II:Repeated oral administration of Methosulide(group 1:MTD（maximum tolerated dose）/250mg ,group 2:depending on the adverse drug reaction,150mg/250mg)
Pharmacokinetic Study:
Period I:Single oral administration,dose-escalation of Methosulide(three dose groups:50mg,100mg,200mg/250mg) Period II:Repeated oral administration of Methosulide(group 1:MTD（maximum tolerated dose）/250mg
,group 2:depending on the adverse drug reaction,150mg/250mg)
Food Effect on the Pharmacokinetics:
single dose(100mg),two status(Feeding and fasting), washout period(7 days); Placebo to match with experimental groups
Other intervention name(s): CM2010-01
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anti-Inflammatory Agents, Non-Steroidal
A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age
Condition: Healthy or Stable Underlying Chronic Medical Condition
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study was to show that quadrivalent live attenuated influenza vaccine
      (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial
      vaccine, FluMist.
    

Detailed description: 
      This randomized, double-blind, active controlled, multicenter study enrolled 1,800 subjects
      who were 18 to 49 years of age. Subjects were randomized by site in a 4:1:1 fashion to
      receive a single dose of Q/LAIV, trivalent FluMist containing an influenza B strain from the
      Yamagata lineage (FluMist/B/Yamagata), or trivalent FluMist containing an influenza B strain
      from the Victoria lineage (FluMist/B/Victoria). The study was conducted at multiple sites in
      the USA in the influenza off-season.
    

Intervention name(s): Q/LAIV (MEDI3250); FluMist/B/Yamagata; FluMist/B/Victoria
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.2 mL dose at Day 0; 0.2 mL dose at Day 0; 0.2 mL dose at Day 0
Other intervention name(s): MEDI3250; FluMist; FluMist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza, FluMist, adults, vaccine
Plasma and Intrapulmonary Concentrations Study of WCK 5222
Condition: PHA1A
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and
      female subjects.
    


Intervention name(s): FEP-ZID
Intervention type(s): Drug
Intervention description(s): A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other