bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate drug-drug interaction between fimasartan and hydrochlorothiazide.
    

Detailed description: 
      Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and
      potent antihypertensive effect in many hypertensive models.

      Phase I study, Fimasartan (BR-A-657-K) 20 mg ~ 480 mg single dosing with healthy subjects,
      demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase
      I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that
      Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed
      in high dose.

      A open-labeled, multiple-dosing, crossover, parallel Clinical Study to Evaluate drug-drug
      interaction between fimasartan and hydrochlorothiazide.

      34 male healthy volunteers were enrolled during 2 months.

      In part A, 240 mg of fimasartan per day was taken for 1 week. After 7 day washout period, 240
      mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week. Then blood
      and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours at 7 day
      and 21 day.

      In part B, 25 mg of hydrochlorothiazide per day was taken for 1 week. After 7 day washout
      period, 240 mg of fimasartan and 25mg of hydrochlorothiazide per day were taken for 1 week.
      Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24
      hours at 7 day and 21 day.
    

Intervention name(s): Fimasartan; Hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention description(s): Fimasartan (7day) Fimasartan + Hydrochlorothiazide (7day); Hydrochlorothiazide (7day) Fimasartan + Hydrochlorothiazide (7day)
Intervention MeSH terms: Hydrochlorothiazide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fimasartan; Drug interaction
Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is
      being developed for once daily administration for the maintenance treatment of asthma and
      COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and
      compared with GW642444M and GW685698X administered separately in order to determine whether
      co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics
      of either compound.
    


Intervention name(s): GW685698X & GW642444M
Intervention type(s): Drug
Intervention description(s): study drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers
Cross-Sectional Iloperidone IVGTT
Condition: Schizophrenia; Serious Mental Illness; Metabolic Syndrome; Insulin Resistance; Glucose Metabolism
MeSH terms: Metabolic Syndrome; Insulin Resistance; Schizophrenia; Mental Disorders
Study type: Observational

Summary: 
      This study aims to utilize state of the art procedures such as the frequently sampled
      intravenous glucose tolerance test (FSIVGTT), Bergman's Minimal Model Analysis, lipoprotein
      analysis, and DEXA scans to demonstrate that a newer agent, iloperidone, is devoid of the
      metabolic abnormalities associated with other atypical antipsychotic treatments, namely
      olanzapine and risperidone, and offers an advantage over these other agents.
    

Detailed description: 
      This one-month research study examines how Fanapt® (iloperidone), Zyprexa® (olanzapine), or
      Risperdal® (risperidone) affect glucose metabolism in patients with schizophrenia,
      schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS,
      delusional disorder or paranoid disorder. This study requires 3 research visits and includes
      a physical exam, medical history, vitals, an EKG, cognitive testing, psychological rating
      scales, a DEXA scan, a nutritional assessment, a 3-hour intravenous glucose tolerance test
      (IVGTT) and a fasting blood draw.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects will include 60 outpatients between the ages of 18-65 with schizophrenia,
        schizoaffective disorder, bipolar disorder, major depressive disorder, psychosis NOS,
        delusional disorder or paranoid disorder. 60 subjects will be screened and 45 will enter
        the cross-sectional study (15 olanzapine, 15 iloperidone, 15 risperidone-treated subjects
        matched for BMI).
      
Biospecimen description: 
      Samples will be retained to test IL-6 and other inflammatory markers.
    
Keywords: metabolic side effects; atypical antipsychotics; FSIVGTT
Is Anxiety Affect the Anesthesia Type Performed In Patients During Caeserean Section ?
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      In this study, investigators wanted to investigate the effect of preoperative anxiety level
      on anesthesia preference of patient. Before surgery, patients will fill the forms of Pain
      catastrophising scale (PCS), Beck depression and Beck anxiety scale. After surgery, these
      forms will be evaluated according to the choice of anesthesia.
    

Detailed description: 
      Anxiety is present due to many gait in the preoperative period. In studies that investigated
      anxiety levels in the preoperative period was found that 60-80% of the patients had
      significant anxiety. The present study is aimed to investigate the effect of preoperative
      anxiety level on anesthesia preference of cesarean patients. After approval, patients
      enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire,
      Beck depression and Beck anxiety scale. After surgery, The effect of anxiety on the choice of
      anesthesia will be evaluated (general or spinal anesthesia).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Ceserean patients
Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood
Condition: Preterm Birth; Child Development; Child Behavior
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether supplementation with certain polyunsaturated
      fatty acids can help development and behavior of children born preterm.
    


Intervention name(s): LCPUFA oil supplement; Canola Oil Placebo
Intervention type(s): Drug; Other
Intervention description(s): 2.5mL per day for 90 days
Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg); 2.5mL per day for 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CSCC_ASC Therapy in Patients With Severe Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The present aim is to perform at small clinical safety trial in heart failure patients with
      allogeneic adipose tissue derived mesenchymal stem cells.
    

Detailed description: 
      Patients with heart failure will be treated with culture expanded adipose tissue derived
      mesenchymal stem cells from healthy donors stored in nitrogen until use. The cells will be
      injected directly into the myocardium using the NOGA XP method.

      The patients will be followed for 6 months for safety and efficacy registration.
    

Intervention name(s): Allogeneic adipose derived stem cells (CSCC_ASC)
Intervention type(s): Biological
Intervention description(s): Culture expanded allogeneic adipose derive stem cells (CSCC_ASC)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts
      differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favorable
      effect on alveolar bone.

      AloeVera Gel had also been used in dentistry and showed good results.The present study aims
      to explore the efficacy of 1% MF gel and aloe vera gel as a local drug delivery system in
      adjunct to scaling and root planing (SRP) for the treatment of subjects with chronic
      periodontitis (CP) with intrabody defects.
    

Detailed description: 
      Aim: To compare the efficacy of locally delivered 1% MF gel and aloe vera gel in treatment of
      intrabony defects in chronic periodontitis subjects and compare it with placebo gel.

      Methods: Ninety subjects were categorized into three treatment groups: Placebo, aloevera
      gel(AV) and 1% Metformin (MF)after Scaling and root planning (SRP). Clinical parameters were
      recorded at baseline, 6 and 12 months; they included plaque index (PI), modified sulcus
      bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment level (CAL).
      Radiologic assessment of intra-bony defect (IBD) and percentage defect depth reduction (DDR%)
      was done at baseline, 6 months and 12 months interval using computer-aided software Results:
      Mean PPD reduction and mean CAL gain was found to greater in MF group than AV and placebo
      group at all visits. The DDR% was greater in MF group as compared to AV and placebo group.

      Conclusion: There was a greater decrease in mSBI and PPD and more CAL gain at the sites
      treated with AV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony
      defects as compared to placebo. The significant IBD depth reduction effect was seen in case
      of MFgroup.
    

Intervention name(s): placebo gel; Aloevera; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.; Oral prophylaxis followed by placement of aloevera gel; Oral prophylaxis followed by placement of metformin gel
Other intervention name(s): inactive drug; AV; MF
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Use of Insulin Glargine to Treat Diabetic Ketoacidosis
Condition: Diabetic Ketoacidosis
MeSH terms: Ketosis; Acidosis; Diabetic Ketoacidosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of the addition of insulin glargine
      during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.

      The investigators hypothesize that the addition of insulin glargine during the early phase of
      management of DKA will accelerate acidosis correction, decrease the length of insulin
      infusion, and decrease the total intensive care unit time in children admitted to the ICU.
    


Intervention name(s): glargine; saline
Intervention type(s): Drug; Drug
Intervention description(s): 0.3u/kg of glargine, subcutaneously, once; 0.3u/kg of saline, subcutaneously, once
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pediatrics; Diabetes; Emergency Care; Endocrinology; Critical Care
Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than
      4 years old to less than 18 years old.
    


Intervention name(s): QIVc; TIV1c; TIV2c
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Novartis Investigational Quadrivalent Vaccine; Licensed Influenza Vaccine; Novartis Investigational Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Influenza; Influenza vaccine; Novartis; children
Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional

Summary: 
      The submitted trial is the first prospective, randomized trial comparing nasal intermittent
      positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress
      syndrome.
    

Detailed description: 
      Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives
      some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is
      safe and effective, and already in use as an alternate "standard" therapy. Nevertheless,
      NIPPV has never been used in chinese babies.

      The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in
      newborn infants with respiratory distress syndrome.
    

Intervention name(s): NIPPV; NIPPV; NIPPV
Intervention type(s): Device; Device; Device
Intervention description(s): Ventilator is Bird VIP.; Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.; Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: RDS; Infant, newborn; NIPPV; CPAP
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of elezanumab in
      participants with progressive Multiple Sclerosis (PMS).
    


Intervention name(s): elezanumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): solution for infusion; solution for infusion
Other intervention name(s): ABT-555
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Progressive multiple sclerosis; Elezanumab; ABT-555
Measuring and Modulating Changes in EEG Resting State Functional Connectivity During Short-term and Long-term Pain
Condition: Prolonged Pain, EEG, Resting State Functional Connectivity
Study type: Interventional

Summary: 
      Background and aims: Experimental prolonged pain models can shed more light on the cortical
      mechanisms involved in the transition from acute to chronic pain including changes in resting
      state functional connectivity (rsFC). This experiment aimed at examining the effect of
      24-hour-capsaicin application on the rsFC of the default mode network (DMN), a prominent
      network in the dynamic pain connectome.

      Methods: Electroencephalographic (EEG) rsFC measured by Granger causality was acquired at
      baseline, 1-hour, and 24-hour following the initial patch application (placebo or capsaicin).
      After 24 hours, the patch was cooled down then heated up to assess rsFC changes in response
      to pain relief and facilitation. Pain was induced using a topical capsaicin patch (or placebo
      as control) on the right forearm and assessed on a 0-10 numerical rating scale (NRS).
    


Intervention name(s): 8% Capsaicin patch; placebo patch
Intervention type(s): Other; Other
Intervention description(s): Cutaneous pain was induced using a (5x10 cm) 8% topical capsaicin patch (transdermal patch, 'Qutenza', Astellas) on the volar part of the dominant right forearm (5 cm from the wrist) of each participant.; A transparent patch with no formulation or effect but the same size of the capsaicin patch was applied to the same location.
Intervention MeSH terms: Capsaicin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants experienced both experimental (capsaicin) condition and placebo conditions. Due to the long-lasting effects of capsaicin after 24 hours of application, placebo condition always preceded the capsaicin condition.
Masking: Single (Participant)
Primary purpose: Basic Science
Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A
      vaccinations in patients with Parkinson's disease. Patients, who have already participated in
      the AFF008 program will be involved and will receive a second boost immunization with
      AFFITOPE® PD01A. One study site in Vienna (Austria) will be involved.

      In addition, up to 6 patients will be offered participation within an untreated control
      Group.
    


Intervention name(s): AFFITOPE® PD01A
Intervention type(s): Biological
Intervention description(s): s.c. injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Comparison of Beverages Consumed Within a Meal to Satiation on Meal-time Food Intake and Post-meal Appetite and Glycemic Response in Healthy Young Adults
Condition: Obesity; Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The objective of the current study is to determine the effects of an ad libitum intake of 1%
      milk, fruit juice, regular cola, diet cola and water, as part of a pizza meal, on meal food
      intake, appetite and postprandial blood glucose in healthy men and women. We hypothesize that
      1% milk will reduce food intake and result in better post-meal glycemic response compared to
      the other beverages.
    


Intervention name(s): Nutritional Intervention
Intervention type(s): Other
Intervention description(s): Ad libitum amounts of beverage at a meal
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Estrogen and Perimenopausal Depression
Condition: Depressive Disorder, Major; Menopause
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      During perimenopause (the time just prior to menopause), women often notice many biological,
      psychological, and social changes. In particular, some women experience depressive symptoms
      during perimenopause that are severe enough to warrant antidepressant medication. Whether or
      not women with perimenopausal depression respond to antidepressant medication may depend on
      the level of estrogen in their blood. This study will investigate whether estrogen will help
      women who only partially respond to antidepressant medications, as well as examine how
      different doses of estrogen may affect individuals differently.
    


Intervention name(s): Estrogen
Intervention type(s): Drug
Intervention description(s): 0.625 mg/day of conjugated Estrogen
Intervention MeSH terms: Estrogens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; menopause; perimenopause; mood; memory; perimenopausal; antidepressant; estrogen
Endothelial Dysfunction and Plaque Vulnerability
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Observational

Summary: 
      Thinning of fibrous cap in atherosclerotic plaques is associated with plaque vulnerability.
      The high resolution of optical coherence tomography (OCT) provides an accurate measurement of
      fibrous cap thickness. Endothelial dysfunction is a key component of vulnerable plaque and
      digital reactive hyperemia-peripheral arterial tonometry (RH-PAT) is a non-invasive automatic
      and quantitative method to evaluate endothelial function. The investigators will investigate
      the association between endothelial function assessed by RH-PAT and plaque vulnerability
      determined by OCT-derived thin-cap fibroatheroma (TCFA).
    

Detailed description: 
      Consecutive patients with acute coronary syndrome (ACS) who undergo both OCT examination and
      RH-PAT examination are enrolled. OCT examination is performed to observe the culprit lesion
      before percutaneous coronary intervention, and endothelial function is evaluated using RH-PAT
      before discharge.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Yokohama City University Medical Center
      
Keywords: Coronary artery disease; Endothelial function; Optical coherence tomography; Thin cap fibroatheroma
Comparison of NIV-NAVA vs. N-CPAP After Extubation in Preterm Infants Study
Condition: Endotracheal Extubation; Infant, Premature
Study type: Interventional

Summary: 
      This study is a randomized controlled study to compare if a a non-invasive neurally adjusted
      ventilatory assist (NIV-NAVA) is better than nasal continuous positive airway pressure
      (N-CPAP) after extubation in infants' < 30 weeks of gestation.
    


Intervention name(s): NIV-NAVA; N-CPAP
Intervention type(s): Device; Device
Intervention description(s): Non-invasive neurally adjusted ventilatory assist; Nasal-continuous positive airway pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-invasive ventilation; non-invasive neurally adjusted ventilatory assist; nasal continuous positive airway pressure