bioihbjkbjnl/mcl2 huggingface dataset:
BE Study of the Combinations of Gemigliptin/Metformin HCl Extended Release 50/1000mg(25/500mg x 2 Tablets) in Comparison to Each Component Administered Alone
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the
      fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg
      x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended
      release 1000 mg (500mg x 2 tablets) under fasting and fed conditions in healthy male
      volunteers.
    

Detailed description: 
      This study will be conducted in separtes 2 Parts.

      Part I is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics
      of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg
      (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl
      extended release 1000 mg (500mg x 2 tablets) under fasting condition.

      Part II is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics
      of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg
      (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl
      extended release 1000 mg (500mg x 2 tablets) under fed conditions.

      In total, 70 subjects will be enrolled in this study;Part I: 40, Part II :30 subjects.

      the study design and arms are the same in both parts.
    

Intervention name(s): Combination of gemigliptin/metformin HCl sustained release 50/1000mg; Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg
Intervention type(s): Drug; Drug
Intervention description(s): Gemigliptin/Metformin HCl extended release 25/500mg 2tablets; Zemiglo 50mg 1 tablet Glucophage XR 2 tablets
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Different Anesthetic Gases on Hemodynamics, Arterial Oxygenation and Lung Mechanics
Condition: Oxygenation; Spinal Surgery
Study type: Observational

Summary: 
      The bronchodilator effects of volatile anesthetics have been the subject of many clinical
      studies. It is known that all volatile anesthetics, especially halothane, have similar
      effects. Sevoflurane has been shown to reduce airway resistance more than halothane and
      isoflurane. Desflurane is difficult to use as an induction agent due to its harsh and
      extremely pungent odor and airway irritating effect. However, it has been shown that the risk
      of cough, respiratory arrest and laryngospasm is no different from sevoflurane when
      administered after intravenous induction. Although it irritates the airway, it is thought to
      have a bronchodilation effect as it stimulates the sympathetic system.

      In spinal surgeries, prone position is required to access the operating field. When the
      patient is placed in the prone position, pulmonary physiology are affected. In the prone
      position, V/Q mismatch decreases and arterial oxygenation increases. However, lung compliance
      decreases and the peak inspiratory pressure required to reach the required tidal volume
      increases. The main purpose of this study is the effect of volatile agents on lung mechanics
      and oxygenisation in the prone position.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA 1-2 patients between the ages of 18 and 65 who are scheduled for spinal surgery will be
        included in the study.
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
Condition: X-Linked Hypophosphatemia
MeSH terms: Familial Hypophosphatemic Rickets; Hypophosphatemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of the study are to:

        -  Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and
           4 years old

        -  Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers
           that reflect the status of phosphate homeostasis in children between 1 and 4 years old
           with XLH
    


Intervention name(s): Burosumab
Intervention type(s): Biological
Intervention description(s): solution for subcutaneous injection
Other intervention name(s): KRN23; Crysvita®; UX023
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Neural Therapy in Patients With Fibromiyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia
Study type: Interventional

Summary: 
      Neural therapy is a regulation therapy that tries to correct this underlying autonomic
      dysfunction. In neural therapy; local painful areas, trigger points and symptomatic segments
      are included in the injection using local anesthetics and the underlying disruptive areas are
      investigated and treated. The aim of this study was to investigate the efficacy of neural
      therapy in fibromyalgia syndrome which is thought to have a neuroendocrine dysregulation
      disorder.
    

Detailed description: 
      Fibromyalgia is a chronic disease characterized by widespread body pain, fatigue, sleep
      disturbance, and tenderness on palpation at trigger points in the musculoskeletal system.

      Fibromyalgia prevalence is reported between 3% and 9%, and is three times more common in
      women than men. Although pharmacological and non-pharmacological approaches play a role in
      the treatment of the disease, the interest in non-pharmacological therapies has recently
      increased. In several studies, it has been shown that almost every fibromyalgia patient has
      applied at least one alternative and complementary medicine method such as Qigong, Tai Chi,
      yoga, mind body interventions, acupuncture, hydrotherapy, balneotherapy or phytotherapy.

      Neural therapy is a regulation therapy that tries to correct this underlying autonomic
      dysfunction. In neural therapy; local painful areas, trigger points and symptomatic segments
      are included in the injection using local anesthetics and the underlying disruptive areas are
      investigated and treated. The aim of this study was to investigate the efficacy of neural
      therapy in fibromyalgia syndrome which is thought to have a neuroendocrine dysregulation
      disorder.
    

Intervention name(s): neural therapy; Physical Therapy
Intervention type(s): Procedure; Device
Intervention description(s): Intracutaneous quaddle injections were performed using 1% lidocaine preparation as a local anesthetic for local application to painful points with palpation on the back and shoulders and for the segmental application, 2 cm lateral to the midline of the C1-T5 vertebrae and on spinous processes.; Physical therapy program was consist of transcutaneous electrical nerve stimulation- TENS (30-40 Hz, 20 minutes), hotpack (20 minutes) and continuous ultrasound (1mHz, 1.5w / cm2, 10 minutes) on painful points with palpation on the back and shoulders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neural therapy; physical theraphy; lidocain injection
Effect of Ticagrelor and Clopidogrel on Coronary Microcirculation in Patients With Acute Myocardial Infarction
Condition: Coronary Microvascular Disease; Ticagrelor; Thrombolysis; Microbubble Contrasted Echocardiography
MeSH terms: Myocardial Infarction; Microvascular Angina; Infarction
Study type: Interventional

Summary: 
      Of the patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who
      underwent reperfusion therapy and have thrombolysis in myocardial infarction (TIMI) 3 flow,
      about 40% have flow alterations in the coronary microcirculation, which leads to worse
      remodeling of the left ventricle with a consequent increase in the mortality of this
      population. Clopidogrel is the only known antiplatelet medication that brings benefits to the
      coronary microcirculation. Ticagrelor is significantly superior to clopidogrel in terms of
      decreasing mortality.

      The main objective of this study is to compare the effect of ticagrelor versus clopidogrel on
      the coronary microcirculation by the Myocardial Perfusion Score Index (MPSI) obtained using
      Microbubble Contrasted Echocardiography (MCE) in patients who have STEMI and treated with
      thrombolysis.
    

Detailed description: 
      The present project should prospectively include patients participating in the TREAT study,
      who are including individuals with Acute Myocardial Infarction (AMI) treated with
      fibrinolytic and openly randomized to ticagrelor or clopidogrel within 24 hours of the onset
      of symptoms. Patients will be submitted to coronary angiography within 4 (± 2) days of the
      onset of symptoms, and those who, at the end of coronary angiography, present residual
      obstruction in the culprit vessel of less than 50% and have TIMI 3 flow, regardless of have
      undergone percutaneous coronary intervention will be included.

      Following, on day 2 (± 1) days after coronary angiography (therefore 6 ± 3 days from the
      onset of symptoms), they will be submitted to microcirculation perfusion evaluation by means
      of MPSI (myocardial perfusion score index) obtained by MCE (Microbubble contrasted
      echocardiography) - blood collection for evaluation of Platelet aggregability will be
      performed immediately prior to the start of MCE. Finally, in order to evaluate left
      ventricular remodeling, patients will undergo a new Echocardiography within 90 (± 10) days
      after discharge.
    

Intervention name(s): Microbubble Contrasted Echocardiography; Platelet Aggregability; Laboratory
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Myocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography; Obtained using Multiplate Analyzer; it will be collected at patients arrival, Reative C-Protein, BNP, CK-mass, Troponine, interleukine-6, Creatinine.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
New Method Using Deuterium Labelled Creatine to Measure Total Body Skeletal Muscle Mass
Condition: Sports Nutritional Sciences
Study type: Interventional

Summary: 
      Creatine (methyl-d3) dilution (D3-creatine) is a novel technique for the estimation of muscle
      mass. The method uses a dose of deuterium-labelled creatine to determine total skeletal
      muscle mass via estimation of total body creatine pool size.The aim of this study is to
      compare estimates of total body skeletal muscle mass by D3-creatine dilution method and whole
      body Magnetic Resonance Imaging (MRI) in an athletic population.
    


Intervention name(s): D3 Creatine; Creatine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One dose of D3 Creatine (60mg capsule) given orally on Day 1; Participants will consume an individual dosed level of creatine, based on their estimated muscle mass in doses of 0.03, 0.035, 0.04, 0.045 g.kg.Lean mass/day, increasing on a weekly basis. Final dose of 0.05 g.kg.Lean mass/day is then maintained throughout the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)
Condition: Chronic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare urticaria lesions (size, kinetics) by thermography,
      volumetry and digital time lapse photography in CU patients treated with desloratadine 5 mg
      or desloratadine 20 mg. Hypothesis: Updosing of desloratadine (20mg) is more efficient in the
      treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).
    


Intervention name(s): desloratadine; desloratadine
Intervention type(s): Drug; Drug
Intervention description(s): singel dose, oral, 20 mg; single dose, oral, 5 mg
Intervention MeSH terms: Loratadine; Desloratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: urticaria
Reversing Diabetic Peripheral Neuropathy Through Exercise
Condition: Peripheral Neuropathy; Diabetes
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      This project proposes a longitudinal design that uses multinuclear-MRI to evaluate the
      mechanistic effects of exercise on skeletal muscle function and peripheral nerve integrity in
      patients with diabetic peripheral neuropathy (DPN), and to determine whether exercise can
      reverse DPN symptoms. The investigators will prescribe a 10-week exercise program to 40 DPN
      patients. The investigators will acquire multinuclear-MRI data before and after the
      intervention that can provide mechanistic insight into the adaptations in lower leg muscle
      function and peripheral nerve integrity of patients with DPN, and their role in improving DPN
      symptoms following physical exercise intervention.
    


Intervention name(s): Exercise Program
Intervention type(s): Procedure
Intervention description(s): The exercise program will combine moderate intensity aerobic exercise with lower-extremity specific resistance training. A moderate level of intensity will be calculated based on results from a maximal graded exercise test (VO2R) conducted prior to the intervention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise
Re-Examination of Tumor Material and Re-Evaluation of Patient Data From Patients Treated With Neo-adjuvant Therapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This is a prospective examination of ribonucleic acid (RNA) extracted from tumor material of
      breast cancer patients treated with a neo-adjuvant therapy. The RNA will be analysed for
      expression of estrogen receptor (ER 1), progesterone receptor (PgR), HER2 and Ki-67 with
      MammaTyper™.

      According to the determined values for the individual parameters at least 4 subtypes can be
      distinguished to date

        -  Luminal A-type

        -  Luminal B-type

        -  HER2-type

        -  Triple-negative-type As non-clinical endpoint, the agreement of new subtyping with
           Immunohistochemical methods will be evaluated.

      As clinical objective, the 5 year Distant metastasis free survival (DMFS) and Overall
      survival (OS) will be reevaluated according to the new subtyping.
    

Detailed description: 
      Tumor material collected from patients who received neoadjuvant therapy either with four
      cycles of doxorubicin 60 mg/m² plus pemetrexed 500 mg/m² on day 1 every 21 days followed by
      four cycles of docetaxel 100 mg/m² on day 1 every 21 days or four cycles of doxorubicin 60
      mg/m² plus cyclophosphamide 600 mg/m² on day 1 every 21 days followed by four cycles of
      docetaxel 100 mg/m² on day 1 every 21 days will be re-analyzed with the MammaTyper Kit. The
      Kit is an in-vitro molecular diagnostic test for molecular subtyping of breast cancers into
      Luminal A & B, HER2 and Triple negative. It allows quantitative detection of the RNA
      expression status of the genes for estrogen receptor (ESR1), PgR, HER2 and Ki-67 on the basis
      of their mRNA present in the samples. This prospective diagnostic study will investigate the
      subtyping-results of the MammaTyper™ analysis and will compare them to the subtyping of the
      former immunohistochemical analysis performed. Based on the MammaTyper™-subtypes the
      efficiency of the therapy regimen and the outcome will be re-evaluated from the patient data.
    

Intervention name(s): MammaTyper™
Intervention type(s): Device
Intervention description(s): MammaTyper™ is an in vitro molecular diagnostic test for the quantitative detection of the biomarkers estrogen receptor (ESR1), progesterone receptor ( PgR), Human epidermal growth factor receptor 2 (HER2) and proliferation antigen Ki-67 on the basis of the values of the messenger ribonucleic acid (mRNA).
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        See Eligibility Criteria
      
Keywords: diagnostic study; analysis of estrogen receptor; progesterone receptor; Human epidermal growth factor receptor 2; Ki-67
Early Intervention for Minors in Possession of Alcohol/Drugs: A Feasibility Study
Condition: Substance Use Disorder; Delinquency
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate two brief, sustainable interventions for a sample of
      280 adolescents charged with an initial drug-related offense: Motivational Enhancement
      Therapy (MET) intervention for youth and the Parenting Wisely (PW) intervention for parents.
      Families are assessed for adolescent substance use, HIV-risk, recidivist substance-related
      offenses, treatment entry, and other areas of individual and family functioning.

      It is expected that the combined MET+PW interventions will be more effective than a
      treatment-as-usual intervention (drug education group) for adolescents with parents not
      participating in PW.
    

Detailed description: 
      Illicit substance use and related problems among adolescents has been consistently high over
      the past decade and remains one of the most pressing public health concerns in the United
      States. The objective of this study is to conduct a pilot investigation of the feasibility
      and effectiveness of two brief empirically based treatments for adolescent substance abuse
      when implemented as early interventions for youth arrested and charged with first- or
      second-offense possession of alcohol or drugs. The two examined interventions are
      Motivational Enhancement therapy (MET) and Parenting Wisely (PW).

      Over a one-year period, 280 adolescents and their parents will be referred to the study by
      the Juvenile Justice Centers in two Oregon counties within the Portland metro area. Families
      will be randomized to one of four intervention conditions; youth will receive either MET or a
      drug education intervention (EDUC), and the PW intervention for parents is present or absent.
      Participants will be assessed for adolescent substance use, HIV-risk, recidivist
      substance-related offenses, treatment entry, and other areas of individual and family
      functioning at intake and at 3- and 6-month follow-ups.
    

Intervention name(s): Motivational Enhancement Therapy /Adol and PW for parents; Motivational Enhancement Therapy for adolescents; Drug Education for adolescents, Parenting Wisely for parents; Drug Education for adolescents
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Motivational Enhancement Therapy for adolescents, Parenting Wisely for parents; Motivational Enhancement Therapy for adolescents; Drug Education for adolescents, Parenting Wisely for parents; Drug Education for adolescents
Other intervention name(s): MET / PW; MET; EDUC / PW; EDUC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Teens; Parenting; Substance Abuse; Treatment Efficacy
Exercise Capacity in Pediatric Sickle Cell Anemia
Condition: Sickle Cell Anemia
MeSH terms: Anemia; Anemia, Sickle Cell
Study type: Observational

Summary: 
      The purpose of this study is to use comprehensive exercise testing to examine causes of
      exercise limitation in children and young adults with sickle cell anemia.
    

Detailed description: 
      Although the burden of sickle cell anemia (SCA) on affected individuals is significant, few
      studies have examined the influence of having SCA on such measures of physical function as
      exercise capacity. Moreover, the physiologic basis of poor physical functioning in children
      with SCA is unknown and has not been studied extensively. The purpose of this proposal is to
      use cardiopulmonary exercise testing (CPET) to gain a comprehensive understanding of exercise
      capacity, as a measure of physical function, in children and young adults with SCA. The
      specific aims of this project are to: 1) Measure peak oxygen consumption (VO2), the reference
      standard for exercise capacity, in children and young adults with SCA classified by primary
      pathophysiologic contributor to their decreased exercise capacity, and 2) Examine the acute
      inflammatory response, measured by an increase in soluble vascular cell adhesion molecule
      (sVCAM) activity, in subjects undergoing CPET. These aims will be performed in 60 subjects
      with SCA and 30 matched controls without SCA. In a secondary analysis, we will also study the
      impact of baseline exercise capacity and the inflammatory response to exercise on short and
      long-term disease related morbidity. This study is essential because it will address several
      areas of exercise capacity, including the physiologic contributors to exercise limitation
      that remain fundamental knowledge gaps in SCA.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Sickle cell anemia patients followed at Children's Memorial Hospital. Healthy controls
        without sickle cell anemia are recruited through flyers posted in Children's Memorial
        Hospital.
      
Biospecimen description: 
      Plasma is collected and stored to be analyzed
    
Keywords: Sickle cell anemia; Exercise testing; Cardiopulmonary disease