bioihbjkbjnl/mcl2 huggingface dataset:
Can Hyperoxia be Prevented With Noninvasive Monitoring in On-pump Cardiac Surgery?
Condition: Hyperoxia; Oxygen Reserve Index; Cardiac Surgery
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      In our study, we aimed to observe the usability of non-invasive monitoring methods in
      oxygenation management, using non-invasive monitoring techniques, preventing hyperoxia and
      avoiding oxidative damage-related complications in patients undergoing on-pump cardiac
      surgery.
    

Detailed description: 
      In on-pump cardiac surgery; The risk of organ perfusion disorders is high due to the
      heart-lung pump process they involve. It is essential to avoid hypoxia in such patient groups
      in order to prevent perfusion disorders. While preventing hypoxia, hyperoxia processes can be
      observed frequently in patients. In order to avoid complications related to hyperoxia and
      oxidative damage, oxygenation management should be followed closely. Today, non-invasive
      monitoring methods are being used in this field. In our study, we aimed to observe the
      usability of this method in oxygenation management and avoidance of hyperoxia by performing
      oxygenation management over ORI (oxygene reserve index) value using the Masimo Root + Radical
      7 Rainbow SET device with SPHB finger probe.

      30 patients will bi included in our study; and they will be divided into two groups: In one
      group oxygenation management will be performed by conventional method, such as blood gas
      analysis. In other group ORI values will be used to manage oxygenation. Lung ultrasound will
      be performed in both groups to see if there will be any sign for atelectasis, preoperatively
      and postoperatively.

      Kidney and liver functions will also be investigated before and after surgery. For cognitive
      disfunction evaluation; CAM-ICU scores will be recorded in both groups at 24 hours after the
      operation.
    

Intervention name(s): ORI group; Conventional group
Intervention type(s): Device; Other
Intervention description(s): The patient group whose oxygenation will be managed by ORI values. Hyperoxia or hypoxia will be prevented by using also blood gas analysis in critically ill patients.; In this patient group oxygenation will be managed as usual, using blood gas analysis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Device Feasibility
Keywords: hyperoxia; ORI
Smoking and Ventricular Repolarization
Condition: Sudden Cardiac Death; Prolonged QTc Interval
MeSH terms: Death, Sudden, Cardiac; Death
Study type: Interventional

Summary: 
      Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on
      parameters of ventricular repolarization.
    

Detailed description: 
      Non-user or chronic electronic cigarette (EC) users will use an EC or control on three
      occasions:1) EC with nicotine, 2) EC without nicotine, 3) empty EC (control).

      Chronic tobacco cigarette (TC) smokers will use a TC or control on three occasions: 1) TC
      with nicotine (subject's own brand), 2) research TC with very low nicotine, 3) straw
      (control). The electrocardiogram will be recorded before and after acute exposures and
      analyzed for parameters representative of ventricular repolarization.
    

Intervention name(s): EC with nicotine; EC without nicotine; control; TC with nicotine (own brand); research TC with very low level nicotine
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Use an EC with nicotine for up to 30 minutes; Use an EC without nicotine for up to 30 minutes; sham control; smoke a TC; smoke a research TC with very low level nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover with 4 week washout
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: e-cigarettes; tobacco cigarettes; nicotine; ventricular repolarization
Evaluation for the Effect of Smartphone Based Training on Chronic Ankle Instability Subjects
Condition: Chronic Ankle Instability
Study type: Interventional

Summary: 
      This study aims to verify the training effect of smartphone-based training for chronic ankle
      instability(CAI) subjects. By randomizing subjects to App training group, clinical training
      group and control group, the training effect will be compared among groups.
    

Detailed description: 
      Postural control ability may be damaged after ankle sprains. Poor postural control ability is
      the risk factors of the ankle sprain, forming a vicious circle of recurrent sprains. Proper
      and early assessment is the key to breaking down the circle. Smartphones have been utilized
      in the medical field. With built-in sensors, utilizing smartphones as assessment tools can
      provide quantitative data of postural control performance. This study aims to verify the
      training effect of smartphone-based training for CAI subjects.

      CAI subjects were recruited and randomly assigned to App training group, Home training group
      and control group, receiving 6 weeks of intervention. Pre-test was conducted before the
      intervention, and the post-test was conducted after the 6-week intervention. The follow up
      assessment was conducted 4 weeks after the post-test.
    

Intervention name(s): App Balance training; Home Balance training
Intervention type(s): Other; Other
Intervention description(s): Training specially designed for balance ability of chronic ankle instability groups.
Guidance through smartphone application as home program.; Training specially designed for balance ability of chronic ankle instability groups.
Follow the usual home program provided in clinics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic ankle instability; Smartphone
Dietary Flavanols and Dentate Gyrus Function
Condition: Memory Loss
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      to assess the effect of differing amounts of a cocoa-derived dietary flavanol (epicatechin )
      on dentate gyrus function and corresponding cognitive function
    

Detailed description: 
      In this double blinded trial, the participants, age 50-75 years, will be randomized to
      receive 0, 260, 510, or 770 mg daily* for 12 weeks and will be tested before and after the
      intervention. Cognitive testing will be conducted prior to randomization, and at weeks 4, 12,
      and 20 of the study.

      In an optional substudy, fMRI (functional magnetic resonance imaging) with gadolinium
      contrast will be conducted to measure dentate gyrus function before randomization and then
      after completion of the 12-week intervention portion of the trial.

      *see note in Record Log regarding the change in the method of assessment of cocoa flavanol
      content of the capsules
    

Intervention name(s): Cocoa Flavanol
Intervention type(s): Dietary Supplement
Intervention description(s): 12 weeks administration of cocoa flavanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Breath Analysis in Chronic Obstructive Lung Disease (COPD)
Condition: COPD
Study type: Observational

Summary: 
      To answer the question whether a disease specific profile of breath in patients with COPD can
      be detected by an untargeted metabolomic study using exhaled breath analysis by mass
      spectrometry.
    

Detailed description: 
      This is an observational study comparing the volatile organic compounds (VOCs) in exhaled
      breath between COPD patients and matched control subjects (age, gender, smoking-state). 40
      COPD patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be
      examined by SESI-MS on the composition of exhaled breath for identification of COPD specific
      markers.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients will be recruited in primary, secondary and tertiary care clinics. Healthy
        controls will be recruited from a community sample.
      
Keywords: exhaled breath; volatile organic compounds (VOCs); SESI-MS
Hesperidin and Diosmin Effect on Metabolic Syndrome
Condition: Metabolic Syndrome and Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The components of metabolic syndrome (MetS), particularly obesity and dyslipidemia, are
      linked to peripheral neuropathy (PN) among patients with diabetes or even without diabetes.
      Several studies revealed that complementary and herbal medicine could provide a potential for
      PN management and MetS components. Thus, designing clinical trials with interventions
      combinations to achieve a considerable improvement is highly recommended. Hesperidin and
      diosmin, citrus-derived flavonoids, have been reported to possess anti-hyperlipidemic,
      anti-inflammatory, analgesic, antioxidant, antidiabetic, and anti-hypertensive effect with
      high tolerability and safety profile
    


Intervention name(s): dietary supplement flavonoids
Intervention type(s): Dietary Supplement
Intervention description(s): patients were allocated to receive either hesperidin, diosmin, or combination of both and the fourth group was assigned as a control group without intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of TAK-881 in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main aims of this study are to check for side effects from TAK-881 in healthy adults and
      to learn how much TAK-881 they can receive without getting side effects from it.

      During the study, participants will receive one infusion of TAK-881 under the skin
      (subcutaneous infusion) on Day 1 at a lower dose level followed by participants receiving one
      infusion of higher dose levels with ongoing safety monitored by the doctor to ensure optimal
      tolerability and safety.

      Participants will stay in the clinic for 4 days and will come back after 4 weeks. A follow up
      visit will take place 12 weeks after the TAK-881 infusion.
    


Intervention name(s): TAK-881
Intervention type(s): Biological
Intervention description(s): Participants will receive subcutaneous infusion of TAK-881 on Day 1.
Other intervention name(s): Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase.
Intervention MeSH terms: Immunoglobulins; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Demonstration of Microneedle Insertion
Condition: Allergic Reaction to Nickel
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of
      humans and animals. Side effects of these needle injections are pain, bleeding, and anxiety
      in patients. An alternative drug and vaccine delivery method is the use of hollow
      microneedles, which are sub-millimeter needle-like structures. Microneedles are pain- and
      bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. As a
      result, they are better received by patients and do not induce needle anxiety. As the
      investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel,
      the purpose of this study is to observe their biocompatibility and inertness.
    


Intervention name(s): Gold- or silver-coated, or uncoated nickel microneedles
Intervention type(s): Device
Intervention description(s): The stratum corneum of the participants will be breached with the gold- and silver-coated, or uncoated nickel microneedles.
Intervention MeSH terms: Nickel
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        15 subjects will be enrolled in the trial. Subjects who meet all of the inclusion criteria
        and none of the exclusion criteria will be eligible to enroll in the trial.
      
Keywords: Microneedles; Biocompatibility; Allergy; Metal; Nickel; Contact dermatitis
Attention Deficit Disorder and Exposure to Lead
Condition: Attention Deficit Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      We are examining the past exposure to lead in 250 well characterized children with ADHD, and
      a suitable group of controls. Our measure of past exposure is bone lead levels obtained by
      XRay fluorescence spectroscopy, a relatively new way of estimating bone lead concentrations,
      and by inference, body lead burdens. By comparing the lead concentrations in these two
      groups, controlling for other factors which could confound, we will estimate odds ratios for
      ADHD given elevated bone lead, and estimate the contribution of lead to this disease of
      childhood.
    


Observational model: Case-Control
Time perspective: Retrospective
Keywords: Lead exposure; Bone lead; Attention deficit
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the single dose pharmacokinetics of total
      radioactivity in plasma and whole blood following PO administration of [14C] TR-701 in
      healthy adult male subjects.
    

Detailed description: 
      This study will be an open-label, single-dose study of the absorption, metabolism, and
      excretion of 200 mg [14C]-TR-701 (approximately 100 μCi) administered orally following at
      least an 8-hour fast. Subjects will receive a single dose of 200 mg [14C] TR 701
      (approximately 100 μCi) administered as an oral solution.

      The dose will be administered following at least an 8-hour fast and followed by a 4-hour fast
      from food, not including water.
    

Intervention name(s): Human ADME
Intervention type(s): Drug
Intervention description(s): Oral single dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metabolic profile of TR-700 in plasma urine
Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
Condition: Cardiovascular Diseases; Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study will allow the assessment of pharmacokinetics, pharmacodynamics,
      elimination rate and clearance of dabigatran etexilate during and following haemodialysis in
      ESRD patients.
    


Intervention name(s): Dabigatran etexilate; Dabigatran etexilate; Dabigatran etexilate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 mg capsule; 75 mg capsule; 110 mg capsule
Intervention MeSH terms: Dabigatran
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Children with burns often require repeated reconstructive surgeries. These children tend to
      develop high levels of anxiety before coming to the operating room. Preoperative sedation,
      while somewhat effective in relieving this anxiety, has a number of side effects. The
      researchers hypothesized that preoperative anxiety could be effectively reduced by the
      utilization of a device which induces a relaxing hypnotic state through emmersion in a
      virtual reality environment.
    

Detailed description: 
      The virtual reality environment is created by a Virtual Reality Hypnosis (VRH) device. The
      patient wears a headset which contains video and audio display. A twenty minute program is
      viewed, which guides the patient into a relaxed state via soothing audio and video input.
    

Intervention name(s): Virtual Reality Hypnosis; Placebo
Intervention type(s): Device; Device
Intervention description(s): Use of virtual reality headset to induce hypnotic state; no use of device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: preoperative anxiety; burn reconstruction
The Attenuating Effect of Soluble Fiber Consumption on Postprandial Glycemia in Humans
Condition: Postprandial Hyperglycemia; Type2 Diabetes; Blood Sugar; High
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The main objective of the current study is to investigate whether consumption of soluble
      fibers (isomaltodextrin [IMD], partially digestible maltodextrin) and RS4 starch will lower
      postprandial glycemia as well as postprandial insulin in human subjects with relatively high
      fasting blood glucose, when consumed with a specific amount of digestible carbohydrate (rice
      porridge). The primary outcome of the study is the effect of fibers on postprandial blood
      glucose, whereas the secondary outcome will be its effect on postprandial blood insulin.
    


Intervention name(s): Control; Isomaltodextrin Low Dose; Isomaltodextrin High Dose; GPC partially digestible maltodextrin; Resistant Starch Type 4
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 300 g rice porridge + 150 ml drinking water; 300 g rice porridge + (5 g IMD in 150 ml drinking water); 300 g rice porridge + (10 g IMD in 150 ml drinking water); 300 g rice porridge + (15 g GPC fiber in 150 ml drinking water); 300 g rice porridge + (15 g RS4 starch in 150 ml drinking water)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Evaluating Efficacy of Investigational Products on Spontaneous Bowel Movements in Healthy People With ≤ 3 Complete Weekly Spontaneous Bowel Movements
Condition: Functional Constipation; Healthy
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Low and High doses of Actazin and Livaux will be compared against a control formula and
      placebo to evaluate how each investigational study product effects complete spontaneous bowel
      movements in healthy adults that currently experience less than or equal to 3 complete
      spontaneous bowel movements per week. During the 28-day study period, it is hypothesized that
      participants consuming Acatzin, Livaux, or control formula will have an increased number of
      complete spontaneous bowel movements when compared to participants consuming the placebo. It
      is hypothesized that participants consuming Actazin or Livaux will respond more than
      participants consuming the control formula. It is hypothesized that participants consuming
      Actazin or Livaux will have a favorable microbiome change than placebo.
    


Intervention name(s): Actazin (green kiwi powder) High Dose; Actazin (green kiwi powder) Low Dose; Control Formula (Actazin green kiwi powder + PreticX prebiotic); Livaux (gold kiwi powder) High Dose; Livaux (gold kiwi powder) Low Dose; Placebo (microcrystalline cellulose)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume 4 capsules (600 mg green kiwi powder) daily for 28-days; Participants will consume 4 capsules (150 mg green kiwi powder) daily for 28-days; Participants will consume 4 capsules (150 mg green kiwi powder + 250 mg PreticX prebiotic) daily for 28-days; Participants will consume 4 capsules (600 mg gold kiwi powder) daily for 28-days; Participants will consume 4 capsules (150 mg gold kiwi powder) daily for 28-days; Participants will consume 4 capsules containing no active ingredients daily for 28-days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo controlled, parallel study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Kiwi; Constipation; Bowel Movements; Healthy; Functional Constipation
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid
      parameters in hypercholesterolemic patients on a stable dose of a statin.
    


Intervention name(s): Gemcabene; Gemcabene; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1-300 mg tablet, QD, 56 days; 3-300 mg tablets, QD, 56 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LDL-C; Lipid Regulator
A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain
Condition: Neuropathic Pain; Diabetes Mellitus, Type 2
MeSH terms: Neuralgia; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to compare the efficacy and safety of pregabalin sustained release tablet and
      pregabalin immediate release capsule in type II diabetic patients with peripheral neuropathic
      pain.
    


Intervention name(s): pregabalin sustained release tablet; pregabalin immediate release capsule
Intervention type(s): Drug; Drug
Intervention description(s): pregabalin sustained release tablet 150mg qd for 8weeks; pregabalin immediate release capsule 75mg bid for 8weeks
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pregabalin sustained release tablet