bioihbjkbjnl/mcl2 huggingface dataset:
Variable Effects of Anti-diabetics on Stress Hyperglycemia Ratio
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Observational

Summary: 
      A blood glucose level of equal to or greater than 180 mg/dL that occurred during stress in a
      patient without diabetes mellitus (DM) is termed stress hyperglycemia (SH). The stress
      hyperglycemia ratio (SHR) is defined as the fasting blood glucose divided by the blood
      glucose level that is calculated from the glycosylated hemoglobin (HBA1c) value on admission.
      A significantly higher SHR is associated with worse prognostic biomarkers in diabetic
      patients with complications
    

Detailed description: 
      Stress hyperglycemia (SH) is an increase in circulating glucose levels in biological fluids
      as a physiological response to stress in diabetic patients who are known or newly diagnosed,
      or a pathological condition associated with in-hospital-related hyperglycemia.

      Interventions. Through their pleiotropic effects, some oral hypoglycemic agents improved
      stress hyperglycemia. When compared to non-SGLT-I (sodium glucose transporter-inhibitor)
      users, diabetic patients who used (SGLT-I) and had an acute myocardial infarction had less
      prevalent stress hyperglycemia, a smaller infarct size, and evidence of a low inflammatory
      response. The rationale this study is to evaluate the SHR in T2D patients who do not have
      serious illnesses and are managed with oral hypoglycemic agents
    

Intervention name(s): Sitagliptin/metformin ( 50/500mg) Oral Tablet; Empagliflozin/metformin(10/500mg) Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): The drug was prescribed once daily per oral for 10 weeks; The drug was prescribed once daily per oral for 10 weeks
Other intervention name(s): Group I; Group II
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Empagliflozin
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Known cases of type 2 diabetes who were attending the diabetes centers and private clinics
        seeking for diabetes control and follow-up.

        The authors discussed with the participants about the study design and outcomes
      
Biospecimen description: 
      Blood samples
    
Keywords: Stress hyperglycemia ratio; Sitagliptin; Empagliflozin
Tolerance, Efficacy, revAlidation, Myostim
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in
      postoperative revalidation of patients after reconstructive surgery of anterior cruciate
      ligament.

      The food supplement (MYOSTIM®) has been developped and is supplied as food bars and composed
      of pomegranate, leucine, creatine, proteins and D vitamin. The aim of this exploratory study
      is to assess the efficacy and tolerance of MYOSTIM® on muscle performance after ACL
      reconstructive surgery and in postoperative revalidation phase.
    


Intervention name(s): MYOSTIM®; PLACEBO
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Food supplement n° NCT 2485/8 (Red fruits flavor bar) and NCT 2485/7 (Black chocolate flavor bar) delivered by the Federal Public Service, Health, Food chain safety and environment.; Bars with no active ingredient and the same flavor (chocolate and red fruits).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, exploratory study, monocentric, with a group of control patient with placebo.
Two parallel-groups receiving during 12 weeks either the MYOSTIM® or a PLACEBO in a double blinded manner.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: food supplement; revalidation after surgery
Effects of Transcranial Magnetic Stimulation to the Cerebellum on Cognition
Condition: Cognitive Performance
Study type: Interventional

Summary: 
      Functional neuroimaging studies have shown that the cerebellum is active during cognitive
      performance. The investigators hypothesize that stimulation of the cerebellum with
      transcranial magnetic stimulation will produce brief changes in performance of the task,
      suggesting that cerebellar activation is necessary for normal cognitive function.
    


Intervention name(s): Cerebellar transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): single pulse TMS or repetitive TMS at 1 Hz frequency
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: TMS; fMRI; verbal working memory; classical conditioning; eyeblink; classical eyeblink conditioning; Healthy subjects; Memory
Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.
Condition: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with
      a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2
      vs placebo and compare how well each dose affects how their cancer responds. It will also
      help us to understand the tolerability profile of the different dosing regimens in these
      patients
    

Detailed description: 
      A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and
      Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel,
      Compared with Placebo in Combination with Docetaxel, in Patients receiving second line
      treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)
    

Intervention name(s): Selumetinib 75 mg; Docetaxel 75 mg/m2; Docetaxel 60 mg/m2; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.; Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.; Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.; Three placebo capsules will be administered orally uninterrupted twice daily.
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mitogen-Activated Protein Kinase Kinase inhibitor; Non Small Cell Lung Cancer; Metastatic; Second line treatment for Non Small Cell Lung Cancer
Taste Physiology in Healthy, Normal-weight Volunteers
Condition: Exploratory Behavior
Study type: Interventional

Summary: 
      Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and
      bitter. The receptors found on the tongue are also found in the entire gut. The correlation
      of stimulation of these gut receptors and brain activity has not yet been examined. The
      objectives are to investigate the effect of different taste substances on i) regional brain
      activity and ii) satiation peptide release.
    


Intervention name(s): Single intragastric instillation of 200 mL tap water via nasogastric tube; Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube; Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube; Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube; Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube; Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Quinine; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
Condition: Neoplasms, Prostate
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male
      hormone that leads to benign prostate growth. By blocking the conversion of testosterone to
      DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus
      prolonging bicalutamide's efficacy.
    


Intervention name(s): dutasteride; placebo; bicalutamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5mg dutasteride (Investigation Product); making placebo; 50 mg Casodex or generic equivalent
Intervention MeSH terms: Bicalutamide; Dutasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: prostate cancer; androgen deprivation therapy
A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study
Condition: Adjunctive Treatment of Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major
      Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The
      objective of the study is to assess CLE-100 for the treatment of MDD in participants
      currently treated with standard antidepressant therapy.
    

Detailed description: 
      CLEO study is performed in two parts (part A and Part B). The sponsor is currently recruiting
      only for the Part B of the study.

      Part A will be an inpatient study to assess the safety, tolerability, and pharmacokinetics of
      CLE-100 (oral esketamine) in MDD participants currently treated with an antidepressant drug.
      It will include a screening phase (up to 35 days), a 1 week inpatient double-blind treatment
      phase and an outpatient post treatment safety follow-up phase of 1 week after last study drug
      administration.

      Part B will be a study to assess the safety and efficacy of CLE-100 (oral esketamine) in MDD
      participants currently treated with an antidepressant drug with inadequate response to
      standard antidepressant therapy.

      The participants will remain on their current antidepressant therapy with no dose change
      during the study.
    

Intervention name(s): CLE-100; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet of CLE-100 administered once daily; 1 tablet of placebo administered once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part A - 15 patients, 2 arms, parallel; Part B - 122 patients, 2 arms, parallel
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MDD; depression; depressive disorder; major depression; adjunct therapy; oral; esketamine
Effects of Zolmitriptan on Sensory Transmission After Spinal Cord Injury
Condition: Spinal Cord Injuries; Muscle Spasticity
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      After spinal cord injury, patients develop a spastic syndrome that is characterized by
      hyperactive reflexes, increased muscle tone, clonus and involuntary muscle spasms. The
      neuronal mechanisms behind the development of spasticity remain largely unknown, though
      animal experiments have shown that changes occur both at the level of the motoneuron and
      sensory neurons. This project aims to examine the changes that occur in the modulation of
      sensory afferent transmission after spinal cord injury, and how these changes can contribute
      to the triggering and initiation of muscle spasms after chronic spinal cord injury in humans.

      It is known that after spinal cord injury, the majority of descending sources of monoamines,
      such as serotonin (5HT), are abolished. Animal experiments have shown that 5HT receptors on
      sensory neurons in the spinal cord are responsible for inhibiting sensory transmission. As a
      result, after spinal cord injury these receptors are no longer activated below an injury,
      resulting in the production of large, long excitatory responses in the motoneuron when
      sensory are activated. This large sensory activation of the motoneuron can, in turn, activate
      a long response in the motoneuron to produce an involuntary muscle spasm. The aim of our
      study is to determine whether, similar to animal experiments, the 5HT1 receptors are
      responsible for sensory inhibition in spinal cord injured subjects, and whether activating
      these receptors (through the 5HT1 agonist Zolmitriptan) will restore the normal inhibition of
      sensory transmission that is lost after injury, thereby resulting in a decrease in the
      initiation of involuntary muscle spasms.
    


Sampling method: Non-Probability Sample
Study population: 
        Spinal cord injury subjects
      
Keywords: spasticity; spinal cord injury; zolmitriptan
Triathlon PKR Study in Japan
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The Purpose of this study is to evaluate compatibility of the Triathlon Partial Knee
      Replacement (PKR) with the Japanese population. It is expected that patients who receive the
      Triathlon PKR will achieve excellent clinical results without adverse effects and that the
      device fits well with Japanese morphology.
    


Intervention name(s): Triathlon PKR
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Plasma Pharmacokinetics and Safety of LNZ101 and LNZ100 Ophthalmic Solutions in Healthy Adult Subjects With Presbyopia
Condition: Eye Diseases; Presbyopia; Refractive Errors; Brimonidine Tartrate; Aceclidine; Ophthalmic Solutions
MeSH terms: Eye Diseases; Presbyopia; Refractive Errors
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, randomized study to assess the plasma pharmacokinetic
      profile of LNZ101 and LNZ100.
    

Detailed description: 
      To characterize the plasma pharmacokinetics and safety profile of LNZ101 and LNZ100
      ophthalmic solutions in both eyes once a day for 8 days in healthy volunteers with presbyopia
    

Intervention name(s): Aceclidine + Brimonidine; Aceclidine
Intervention type(s): Drug; Drug
Intervention description(s): LNZ101 (Aceclidine/Brimonidine) non-preserved ophthalmic solution; LNZ100 (Aceclidine) non-preserved ophthalmic solution
Intervention MeSH terms: Brimonidine Tartrate; Aceclidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections
Condition: Pain; Anxiety
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare four different analgesic strategies in adults
      undergoing routine influenza immunization
    

Detailed description: 
      In this study, we will compare relative effectiveness of 4 analgesic strategies (i.e.,
      topical local anesthetics, vapocoolant spray, tactile stimulation and distraction) in adults
      undergoing routine immunization in order to provide further evidence of the effectiveness of
      each intervention and to determine if one method is superior to another. We are not including
      a 'no treatment' group because we do not wish to subject participants to unnecessary pain
      when there are available analgesic treatments. Moreover, in the presence of a 'no treatment'
      group, we cannot rule out a placebo effect for all treatment groups unless we provide a
      matched placebo for each intervention, which is not feasible. In future studies, we plan to
      address the added benefit of combining analgesic interventions (i.e., evaluating the effect
      of a multimodal approach).
    

Intervention name(s): Liposomal lidocaine; Vapocoolant spray; Rubbing adjacent to the injection site; Distraction
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): 4% cream; approximately one gram applied to injection site under an occlusive dressing for 20 minutes prior to injection; medium stream spray on arm for 4-10 seconds prior to injection; rubbing adjacent to the injection site before and during injection; By means of self-selected reading material or video
Other intervention name(s): Maxilene™; PainEase™
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Analgesics; Influenza; Vapocoolant; vaccination; pain
A Study to Compare PK, PD and Safety of the AD-214-02 and Rabeprazole
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214-02 to Rabeprazole
      in healthy volunteers.
    

Detailed description: 
      This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics
      characteristics of AD-214-02 compared with administration of Rabeprazole in healthy
      volunteers.
    

Intervention name(s): AD-214-02; Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet administered before the breakfast during 7 days; 1 tablet administered before the breakfast during 7 days
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex
Condition: Vascular Diseases
MeSH terms: Vascular Diseases
Study type: Interventional

Summary: 
      Randomized study comparing the results between drug-eluting stents and standard bare metal
      stents, when treating femoropopliteal lesions in patients with critical limb ischemia.
    


Intervention name(s): Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions; Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
Intervention type(s): Device; Device
Intervention description(s): Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries; Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
Masking: Single (Participant)
Primary purpose: Treatment
Focusing Implementation to Bring Effective Reminders (FIBER)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      FIBER is 4-year study that will evaluate the implementation of a large-scale population-based
      colorectal cancer screening patient reminder and coordinated follow-up program. The CRC
      screening program began in 2007 with Kaiser Permanente Northwest (KPNW),a not-for- profit,
      integrated health system in Oregon and Washington. FIBER consists of 1)a practical randomized
      controlled trial at the start of the program, followed by 2) a longer-term cohort study as
      all remaining eligible patients receive the program, and 3)a qualitative evaluation. FIBER
      will evaluate the factors that are associated with implementation success across multiple
      levels: patient, primary care provider (PCP) team, specialists (gastroenterologists, general
      surgeons, pathologists), and other health plan staff and systems.
    


Intervention name(s): Patients receives letter, phone call, office visit, educational materials
Intervention type(s): Behavioral
Intervention description(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: colon; rectal; cancer; screening
Effect of Laryngeal Mask Airway on Image Quality n Pediatric Patients Undergoing Magnetic Resonant Imaging
Condition: Airway Obstruction
MeSH terms: Airway Obstruction
Study type: Interventional

Summary: 
      This study compare the effects of Oral airway vs LMA in preventing anesthesia-induced partial
      airway obstruction, in an attempt to lessen MRI motion artifacts, which would result in
      improvements in image quality.
    

Detailed description: 
      Magnetic resonance image (MRI) is a frequently used imaging technique especially in
      oncological patients, where it is used for diagnosis, following up response to treatment and
      later for detection of possible recurrence. The main problem encountered with MRI is the long
      time required for completion of the imaging, during which the patient is required to lie
      still. Patients who are unable to lie still require sedation or general anesthesia (GA).
      Almost all pediatric patients are uncooperative, making GA, the standard of care for
      pediatric MRI.

      Several general anesthetic techniques including airway management by endotracheal tube &
      various supraglottic devices (LMA) have been described. Choice of technique by
      anesthesiologist is influenced by the patient's age, craniofacial and airway anatomy,
      procedure duration, & illness acuity.
    

Intervention name(s): guedel airway; supraglottic airway; propofol bolus and then anesthesia sevoflurane
Intervention type(s): Device; Device; Drug
Intervention description(s): Anesthesia will be conducted by induction with 1-2
• Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%. The goal is to maintain the patient spontaneous ventilation throughout the procedure. Monitoring of the patients is done by MRI compatible pulse oximetry for heart rate and oxygen saturation which is connected to MRI control room.; supraglottic airway; Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control group : a Guedel oral airway will be inserted for airway management versus supraglottic group patients in which supraglottic airway laryngeal mask airway (LMA) will be used
Masking: Double (Participant, Investigator)
Primary purpose: Prevention