bioihbjkbjnl/mcl2 huggingface dataset:
Establish and Apply the Evaluation System of Ultrasonic Integrated Technology for Prevention and Treatment of Acute Kidney Injury
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      Establish an integrated evaluation system of ultrasound technology for the prognosis of acute
      kidney injury, and in order to achieve non-invasive, reliable early diagnosis "gold
      standard". Set up collabration with the expert in National Cheng Kung University Medical
      Center of Taiwan who did a lot of excellent work in basic research of prevention the
      progression of acut kidney injury. Study the experience about prevention progression of
      kidney disease in clinical and basic field. Establish cooperation with the professional in
      Hong Kong University of Science and Technology. To set up the system of natural products
      research and assess the Astragalus medicinal value.
    


Intervention name(s): kidney ultrasound
Intervention type(s): Other
Intervention description(s): kidney ultrasound
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Confirmed acute kidney injury
      
Biospecimen description: 
      only plasma and urine
    
Keywords: acute kidney injury; ultrasound technology
Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an
      Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation). In
      addition, this study intends to evaluate the safety and tolerability of Test and Reference
      formulations.
    

Detailed description: 
      The study was conducted in 1 site and included 26 successfully screened and randomized
      healthy subjects(12 female and 14 male).

      The study consisted of:

        -  Screening Visit (performed within 3 weeks prior to 1st PK study session), for the
           evaluation of study eligibility.

        -  Two pharmacokinetic (PK) study sessions, separated by a minimum of a 7 day washout
           period, including the administration of one out of 2 study treatments at each study
           session (namely 25mg DKP.TRIS given as Enantyum® oral solution or Keral® tablet)
           according to the sequence as per randomisation list, and blood sampling for PK
           assessment on plasma at pre-defined time up to 24 hours post-dose.

        -  End of Study Visit (7-10 days after last treatment administration).
    

Intervention name(s): Enantyum® oral solution; Keral® tablet
Intervention type(s): Drug; Drug
Intervention description(s): One dose of 25 mg DKP oral solution; One dose of 25 mg DKP tablet
Intervention MeSH terms: Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Dexketoprofen; Bioavailability; Comparative; Pharmacokinetic
A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      PF 04620110 is an acylCoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitor that is being
      developed for the treatment of type 2 diabetes mellitus (T2DM). It is anticipated that PF
      04620110 will have anti diabetic effects through inhibition of intestinal triglyceride
      absorption and potentially weight loss. The primary purpose of this study is to evaluate the
      pharmacokinetics, safety and tolerability of multiple oral formulations of PF 04620110
      administered to healthy volunteers.
    


Intervention name(s): PF-04620110
Intervention type(s): Drug
Intervention description(s): The three treatments are A) a single dose of 5 mg PIC under fasted condition; B) a single dose of 5 mg tablet under fasted condition: and C) a single dose of 5 mg tablet under fed condition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection
Condition: Klinefelter Syndrome; Azoospermia
MeSH terms: Azoospermia; Klinefelter Syndrome; Syndrome
Study type: Interventional

Summary: 
      Klinefelter syndrome KS is caused by an additional X chromosome in males (47,XXY). Clinical
      findings are nonspecific during childhood; thus, the diagnosis commonly is made during
      adolescence or adulthood in males who have small testes with hypergonadotropic hypogonadism
      and gynecomastia. Virtually all men with Klinefelter syndrome are infertile.

      Approximately one in 1,000 boys is born with an additional X chromosome-47,XXY, the karyotype
      that causes Klinefelter syndrome. This karyotype is detected at or before birth in 10 percent
      of affected boys, and it is found during adulthood in 25 percent of affected men. Almost all
      men with a 47,XXY karyotype will be infertile; Klinefelter syndrome accounts for 3 percent of
      male infertility.

      Klinefelter syndrome is common in infertile men with oligospermia or azoospermia (5 to 10
      percent).

      Infertility in men with Klinefelter syndrome is caused by a precipitous drop in sperm count.
      If sperm are present, cryopreservation is useful for future family planning with
      intracytoplasmic sperm injection, and if not, testicular sperm extraction may be pursued.
      Although there have been multiple reports of successful fertilization by men with Klinefelter
      syndrome.

      Mesenchymal stem cell injection in testicular tubules and intra testicular artery using
      surgical microscope.

      The period for follow up last from three months to twelve months including semen analysis to
      detect sperm and hormonal profile .
    

Detailed description: 
      The problem started with this kind of patinets when underwent multiple TESE without sperm.

      The investigators try to inject KS patients with mesenchymal stem cells to stimulate
      testicular tissue for production of sperms.

      before injection the investigators measure:( FSH, LH, Testosterone, Prolactin, Inhibin B,
      Karyotyping, Azoospermic Factor, Testicular size by ultrasound).

      Three to twelf months after stem cell injection the investigators reevaluate patients by the
      same measure to demoenstarte any changes.
    

Intervention name(s): Mesenchymal stem cell injection
Intervention type(s): Drug
Intervention description(s): Aspirated bone marrow then separation for Mesenchymal stem cell
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Stem cell; Kleinfelter syndrome; Azoospermia; Sterility; Infertility
Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to explore the effects of multiple regimens of
      natalizumab on disease activity and safety in participants with relapsing-remitting Multiple
      Sclerosis (RRMS).
    

Detailed description: 
      This is a a dose and frequency (but not route of administration) blinded, prospective,
      randomized, dose-ranging study in patients with RRMS who have received natalizumab for at
      least 12 months according to the local prescribing guidelines. The study will explore dosing
      of natalizumab by subcutaneous and intravenous routes. Participants will be randomly assigned
      to 1 of 6 dosing regimens, blinded to natalizumab dose, but not route, for 60 weeks of
      treatment.
    

Intervention name(s): natalizumab IV; natalizumab SC; IV Placebo; SC Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): natalizumab for IV Infusion; natalizumab for Subcutaneous Injection; Intravenous placebo to natalizumab; Subcutaneous placebo to natalizumab
Other intervention name(s): Tysabri; BG00002; Tysabri; BG00002
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
Condition: Glioma; Medulloblastoma
MeSH terms: Glioma; Medulloblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the rate of objective confirmed tumor response of irinotecan in
      combination with temozolomide in children with recurrent or refractory medulloblastoma and in
      children with newly diagnosed high-grade glioma.
    


Intervention name(s): Irinotecan; Temozolomide
Intervention type(s): Drug; Drug
Intervention description(s): Irinotecan 10 mg/m^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles; Temozolomide 100-125 mg/m^2 daily on days 1-5 in repeated 3 week cycles
Intervention MeSH terms: Irinotecan; Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized, Controlled Trial With Hybrid Fractional Laser
Condition: Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia
MeSH terms: Dyspareunia; Atrophy
Study type: Interventional

Summary: 
      This randomized, controlled trial will evaluate hybrid fractional laser treatment for
      vulvovaginal atrophy in breast cancer survivors and menopausal females
    


Intervention name(s): Hybrid Fractional Laser
Intervention type(s): Device
Intervention description(s): Hybrid Fractional Laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Myopia Control With the Multi-segment Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the Multiple-Segment (MS) spectacle lens can
      slow myopia progression in Hong Kong schoolchildren.

      MS lens is also called Defocus Incorporated Multiple Segments (DIMS) spectacle lens
    

Detailed description: 
      MS lens is a novel lens designed in attempt to slow myopia progression. It is a multifocal
      spectacle lens which corrects distance refractive error and at the same time produces myopic
      defocus images on the retina for all distances. The myopic defocus aims at slowing down
      myopia progression. The purpose of this study is to investigate if the MS lens can slow
      myopia progression in Hong Kong Chinese schoolchildren. The subjects will be randomly
      assigned to either treatment group (wear MS lenses) or control group (wear ordinary single
      vision lenses). Their cycloplegic refraction and axial length will be monitored every six
      months over 2 years. The changes in refractive errors and axial length in two groups will be
      compared.
    

Intervention name(s): Multiple-Segment spectacle lens
Intervention type(s): Device
Intervention description(s): A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.
Other intervention name(s): MS lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      TAP-block has been shown to be a safe and effective postoperative analgesia method in a
      variety of general. Dexmedetomidine is a selective α2 agonist with 8 times more affinity for
      α2 adrenergic receptors compared to clonidine and possesses all the properties of α2 agonist
      without respiratory depression. Dexmedetomidine has been focus of interest for its broad
      spectrum (sedative, analgesic and anesthetic sparing) properties, making it a useful and safe
      adjunct in many clinical applications.
    


Intervention name(s): Dexmedetomidine; bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 20 ml of 0.5 % bupivacaine plus dexmedetomidine 1 μg•kg-1; 20 ml of 0.5 % bupivacaine
Other intervention name(s): active group; control
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps. A Multicenter Study
Condition: Lung Diseases, Interstitial
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the diagnostic yield and safety of transbronchial
      lung biopsies (TBLB) with cryoprobe versus conventional forceps in patients with diffuse lung
      disease.
    


Intervention name(s): Transbronchial lung biopsy.
Intervention type(s): Procedure
Intervention description(s): Transbronchial lung biopsy with cryoprobe and with conventional forceps.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cryoprobes; Transbronchial lung biopsy; Cryobiopsy
Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
Condition: Bipolar I Disorder; Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether treatment with Quetiapine Fumarate
      (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps
      patients who have Bipolar I Disorder with Alcohol Dependence
    


Intervention name(s): Quetiapine fumarate; lithium; divalproex
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Valproic Acid; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bipolar I Disorder; Alcohol Dependency
Manual Therapy to Treat Acute Whiplash Injury
Condition: Whiplash Injuries
MeSH terms: Whiplash Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine the short-term effects of a manual therapy protocol
      on pain, disability and cervical range of motion in individuals with acute whiplash injury.
    

Detailed description: 
      Design: Randomized clinical trial. Objectives: to determine the short-term effects of a a
      manual therapy protocol on pain, disability and cervical range of motion in individuals with
      acute whiplash injury.

      Methods and measures: sixty patients will be randomly assigned to 1 of 2 groups: the
      experimental group received a manual therapy protocol and the placebo group received two
      manual therapy techniques. Neck pain, disability and cervical range of motion data will be
      collected at baseline and 24-hr after the last manual therapy application. Mixed-model
      analyses of variance will be used to examine the effects of the treatment on each outcome
      variable.
    

Intervention name(s): Manual Therapy Protocol; Two manual techniques
Intervention type(s): Other; Other
Intervention description(s): The manual therapy protocol consists in the application of the following techniques: stretching diaphragm, Inhibition for phrenic center, Neuromuscular technique, technique jones and balance technique functional.; The two manual techniques applied to control group are: inhibition for phrenic center and neuromuscular technique.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervical spine; Neck pain; Manual therapy; Controlled clinical trial
Pathogenesis of Adverse Drug Reactions
Condition: Seizures
MeSH terms: Seizures; Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      The purpose of the study is to examine the individual metabolic profiles of pediatric
      patients receiving carbamazepine or valproate therapy, in an attempt to determine identities
      of the reactive metabolites or, alternatively, the identities of those metabolites that serve
      as potential precursors to reactive species.
    

Detailed description: 
      Adverse drug reactions can be broadly defined as any undesirable response associated with
      therapeutic drug use. A simple and clinically useful classification is to divide adverse
      events into those that are dose-dependent and largely predictable from the known
      pharmacologic properties of the compound in question, and those that are dependent on
      characteristics unique to susceptible individuals, or idiosyncratic in nature.

      The long term objective of this research is to characterize the mechanisms responsible for
      the pathogenesis of idiosyncratic hypersensitivity reactions in children, particularly those
      involving carbamazepine and other aromatic anticonvulsants.

      The study is divided into two phases. Phase 1 of the study involves collecting urine from 50
      patients taking CBZ therapeutically. Participants will be asked to provide a spot urine
      sample during routine health visits. The urine will be analyzed for the presence of CBZ and
      its metabolites. In Phase 2 of the study, urine will be collected from patients taking either
      CBZ or VPA therapeutically. If blood samples are drawn from these patients for medical
      purposes not related to this study the residual blood sample will be recovered before it is
      discarded for use in genotyping analysis. Participants will be asked to provide a urine
      sample covering one complete dosing interval of CBZ or VPA (preferably overnight). Patients
      will also be followed longitudinally, with urine collections at each clinic visit over at
      least a two year period.
    

Intervention name(s): No intervention; Urine Collection
Intervention type(s): Other
Intervention description(s): Urine collected from children receiving carbamazepine or valproic acid as part of their clinical management
Other intervention name(s): carbamazepine: Tegretol; valproic acid: Depakote
Intervention MeSH terms: Carbamazepine; Valproic Acid
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients of both genders between 1 and 16 years of age receiving carbamazepine
        (CBZ) or valproic acid (VPA) as monotherapy or polytherapy
      
Biospecimen description: 
      Urine DNA (source: blood or saliva)
    
Keywords: seizures; Epilepsy
Treatment Of Partial Reversible Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      Relatively little information is available about the effects of salmeterol/fluticasone
      combination and fluticasone alone in COPD patients with a partial reversible pulmonary
      obstruction. The purpose of this study is to compare the effects of salmeterol/fluticasone
      combination with fluticasone alone delivered via Diskus/ACCUHALER inhaler in subjects with
      COPD on lung function over a 1 year period.
    

Detailed description: 
      Multi-centre, double-blind, randomised and stratified parallel group study to compare the
      efficacy and safety of fluticasone propionate 500 mcg bd versus salmeterol/fluticasone
      combination 50/250 mcg bd both via Diskus inhaler during 1 year in Chronic Obstructive
      Pulmonary Disease(COPD) patients with a partially reversible obstruction.
    

Intervention name(s): fluticasone propionate/salmeterol 250/50 DISKUS combination product; fluticasone propionate DISKUS 500mcg
Intervention type(s): Drug; Drug
Other intervention name(s): fluticasone propionate/salmeterol 250/50 DISKUS combination product
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: reversibility; COPD; lung function
Validation/Dissemination Of A Temporal Bone Dissection Simulator
Condition: Computer Simulation; Education
Study type: Interventional
Phase: Phase 2

Summary: 
      Designed to test the efficacy of a computer based virtual simulation for teaching ear
      surgery.
    

Detailed description: 
      This research is designed to test the efficacy of a computer based virtual simulation for
      teaching ear surgery. Subjects will be randomized to training in the usual fashion and
      training in the simulation environment. Subjects performance will be tested in a standard
      fashion by dissecting cadaveric temporal bones (human ears) before and after training. The
      subjects will also perform a dissection in the virtual environment before and after training.
      The results will be tabulated to compare the different training arms. There is minimal risk
      associated with the projects and is limited to exposure to cadaveric material. Current
      training techniques utilize cadaveric material so exposure to this type of material is
      already a part of the standard training process and this study should not constitute an
      increased risk beyond what is encountered during their regular training. Demographic
      information will be obtained for each of the study subject on age, sex, information regarding
      previous otologic training, year of training and prior experience using computers. The
      anticipated benefits to society will be that future otologic surgeons can obtain operative
      experience in a controlled and non threatening environment. They will have access to a
      greater number of variations in pathology. This will allow each novice surgeon to obtain
      significantly more experience outside the operating room prior to working with live patients.
      This will result in less risk to the patient and better trained ear surgeons.
    

Intervention name(s): Simulator training for temporal bone surgery
Intervention type(s): Other
Intervention description(s): Subjects in experimental arm are asked to spend 2 weeks practicing temporal bone surgical procedures using a computer simulation.
Other intervention name(s): Simulator training; Surgical training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Surgical Simulation; Surgical skills training; Temporal bone surgery; Computer simulation
Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction
Condition: Foetal Growth Problem; Small for Gestational Age
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Europe. The aim of this trial is to assess satisfaction with
      growth hormone treatment in children of both sexes born small for gestational age and who are
      receiving growth hormone treatment.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment