bioihbjkbjnl/mcl2 huggingface dataset:
Variability in Adrenergic Response
Condition: Vascular Reaction to Medications
Study type: Interventional

Summary: 
      The goal of this project is to determine the genetic factors contributing to interindividual
      differences in response to physiological and pharmacological vasoconstrictors and
      vasodilators.
    

Detailed description: 
      The dorsal hand vein model is a relatively non-invasive and robust experimental model to
      examine the local in vivo effect of vasoactive drugs without elucidating systemic
      counterregulatory reflexes. Infusion of incremental low doses of phenylephrine into a dorsal
      hand vein results in increasing local venoconstriction, without systemic effects. Similarly,
      infusion of incremental low doses of nitroglycerin into a preconstricted dorsal hand vein
      results in increasing local venodilation, without systemic effects. Systemic vascular
      responses can be measured by the cold pressor test (CPT),that leads to increase in blood
      pressure and heart rate , or mental stress that is also known to stimulate cardiovascular
      responses. Individuals vary in their local and systemic vascular responses but the genetic
      determinants of these are not clear.
    

Intervention name(s): Phenylephrine
Intervention type(s): Drug
Intervention description(s): Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)
Other intervention name(s): generic medications used,not applicable
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hand vein sensitivity; phenylephrine; nitroglycerin
3Sm Challenge Model Protocol
Condition: Healthy
Study type: Interventional

Summary: 
      The 3Sm challenge study is a small clinical study in eight healthy volunteers who will be
      injected with a protein which includes a short portion ('3Sm peptide') which is derived from
      a part (the '3S region') of the coat protein of HIV. The researchers believe that the 3Sm
      peptide might trigger an immune response which includes rare antibodies able to neutralise a
      wide range of different strains of HIV. The results will be useful in guiding the development
      of future vaccines against HIV, and other diseases.
    


Intervention name(s): 3SM2-G-CRM197 with squalene adjuvant
Intervention type(s): Other
Intervention description(s): Immune challenge agent
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Comparison of Kidney Function After Nephrectomy in Living Donors Under Sevoflurane and Desflurane Anesthesia
Condition: Nephrectomy,Kidney Donation
Study type: Observational

Summary: 
      Living-donor kidney transplantation has been considered as the best treatment for patients
      with end-stage renal disease (ESRD). Kidney donation from living donors has been performed
      widely under their noble humanity and a belief that donation would not harm the donor.
      Although the overall evidences proposed that living kidney donor have medical outcomes
      similar to those in general population, several reports have demonstrated the potential risks
      for development of hypertension, proteinuria, and ESRD. Thus, all efforts should be
      concentrated on ensuring their safety and preserving the function of their remained kidney
      during anesthesia maintenance.

      Inhaled anesthetics have been frequently used for the induction and maintenance of general
      anesthesia. The metabolism of certain inhaled anesthetics can produce inorganic fluoride,
      which may be directly nephrotoxic through impairments of renal concentrating ability. The
      typical inhaled anesthetics commonly used nowadays are sevoflurane and desflurane. The
      defluorination of sevoflurane can results in increased serum inorganic fluoride ion
      concentrations, but any neprhotoxic effect of sevoflurane has not been proven yet in human.
      On the other hand, desflurane is extremely resistant to defluorination, and desflurane does
      not appear to be nephrotoxic.

      The inhaled anesthetics which are currently used in general anesthesia have no clinical
      evidence of nephrotoxicity, but the possible risks cannot be excluded entirely, especially in
      the patients who one kidney is donated. The purpose of the current retrospective, single
      center study was to evaluate and compare postoperative renal function of living kidney donor
      after nephrectomy under sevoflurane or desflurane anesthesia, and make evidence-based
      recommendations of proper inhaled anesthetics for anesthesia of living kidney donor.
    


Intervention name(s): Sevoflurane; desflurane
Intervention type(s): Drug; Drug
Intervention description(s): maintenance of general anesthesia with sevoflurane; maintenance of general anesthesia with desflurane
Intervention MeSH terms: Sevoflurane; Desflurane
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From January 2006 through December 2011, donors who went through nephrectomy for kidney
        donation
A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and
      timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are
      diagnosed with glaucoma.
    


Intervention name(s): Timolol; latanoprost
Intervention type(s): Drug; Drug
Intervention description(s): Timolol 0.5% dosed twice-daily; Latanoprost 0.005% ophthalmic solution dosed once-daily
Intervention MeSH terms: Timolol; Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neural Correlates of Self
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Despite the increasing popularity of mindfulness meditation and hypnosis in healthcare and in
      the general community the underlying neurobiological mechanisms are unclear. The change in
      the relationship between the self and the conscious experience that they bring about may be
      crucial. This study aims to identify the neural correlates of self-consciousness in
      meta-awareness and absorption - using functional Magnetic Resonance Imaging (fMRI) in healthy
      participants combined with detailed first-person experiential accounts and behavioural tasks.
      This study will provide important clues about the widely reported effects of mindfulness
      meditation and hypnosis and shed light on the neural correlates of the conscious experience
      of self.
    


Intervention name(s): "control", "meditation", "hypnosis".
Intervention type(s): Behavioral
Intervention description(s): three instructions will be given to each participant: "control", "meditation", "hypnosis". The order of "meditation" and "hypnosis" will be randomized amongst two groups to avoid order effects.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: mindfulness meditation; hypnosis; meta-awareness; absorption; consciousness; self
Brain Injury Biomarkers in the General Population
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      The purpose of this study is to use an investigational assay to assess levels of putative
      biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in
      a correlative analysis with data collected under a separate study of severe TBI.
    


Intervention name(s): Blood draw at Days 0, 7, 14, and 21
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers who meet eligibility criteria
      
Biospecimen description: 
      Whole blood, serum, plasma
Bariatric Surgery on NASH
Condition: Non-Alcoholic Fatty Liver Disease; Obesity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      The study investigates non-alcoholic fatty liver disease from serial liver biopsies collected
      from participants referred for assessment of bariatric surgery, RYGB or SG.
    

Detailed description: 
      Non-alcoholic fatty liver disease (NAFLD) is an increasing health care problem closely
      related to obesity and has become the most common cause of chronic liver disease in developed
      countries. Today, bariatric surgery is the most efficient treatment of morbid obesity in
      terms of a rapid and sustained loss of weight. In addition, bariatric surgery is accompanied
      by improvement of weight-related comorbidities including features of the metabolic syndrome
      and possibly regression of the entire NAFLD spectrum.

      The study is designed as an observational study including 40 patients referred to
      laparoscopic bariatric surgery (either RYGB or SG). The primary endpoint is change in NAFLD
      activity score (NAS) in serial liver biopsies collected from participants. Additional tests
      include blood samples, anthropometry measurements, Fibroscan and full body dual-energy X-ray
      absorptiometry (DEXA) scan performed together with each biopsy.

      This unique model of serial liver biopsies in morbidly obese patients referred to bariatric
      surgery (RYGB or SG), combined with state-of-the-art technologies and bioinformatics, will
      provide important information about the effects of weight loss on NASH. The results will
      improve our understanding of the underlying mechanisms with the potential of identifying new
      potential NASH targets or diagnostic biomarkers.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30-40 patients referred to laparoscopic bariatric surgery (either RYGB or SG)
      
Biospecimen description: 
      Liver biopsies for histological and transcriptomic assessment
Efficacy of Digital Otoscope and Otoendoscope for Diagnosis of Middle Ear Pathology
Condition: Middle Ear Disease; Diagnosis
MeSH terms: Ear Diseases; Disease
Study type: Observational

Summary: 
      For diagnosis of external and middle ear diseases, an otoscope is a key instrument to use. A
      microscope has been used as a reference standard to confirm pathology. An endoscope has been
      also widely used. Both microscope and endoscope provide an excellent image quality, can
      record and capture the images, and the images can be visualized with an export system.

      A digital otoscope is widely available and more affordable. A comparative study of the
      efficacy of the endoscope and the digital endoscope will be performed.
    

Detailed description: 
      A comparative study for the diagnosis of middle ear disease usingTeslong digital otoscope,
      model MS450D39, and the otoendoscope will be performed. The participants will be recruited at
      the ENT clinic, University Hospital. A handheld otoscope will be used to identify the
      patients who have the pathology of the middle ear.

      The images will be captured with both endoscopes and will be reviewed by staff, residents
      training in ENT, and residents training in ENT and family medicine.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who visit at ENT clinic, Chiang Mai University Hospital
      
Keywords: Middle Ear Disease; otoscope; Diagnosis
To Assess the Effects of Valsartan on Albuminuria/Proteinuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Condition: Microalbuminuria; Proteinuria
MeSH terms: Proteinuria; Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to assess the efficacy of the different dosage forms of Valsartan[80,
      160, and 320 mg] in reducing microalbuminuria/proteinuria in hypertensive patients with type
      2 diabetes.
    


Intervention name(s): valsartan
Intervention type(s): Drug
Intervention MeSH terms: Valsartan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microalbuminuria/proteinuria; hypertensive patients with type 2 diabetes; Valsartan; microalbuminuria/proteinuria in hypertensive patients with type 2 diabetes
Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Galeterone
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, single dose, 1 period study of [14C] galeterone.
    

Detailed description: 
      This is an open label, 1 period study under fed conditions. Six (6), healthy, adult, non
      tobacco using, male subjects will be enrolled. Screening of subjects will occur within 28
      days prior to dosing. On Day 1, a single dose of radio-labeled galeterone will be
      administered orally. Blood, urine, and fecal samples will be collected until release criteria
      are met to measure total radioactivity, for analysis of galeterone concentrations, and for
      potential metabolic profiling.
    

Intervention name(s): galeterone
Intervention type(s): Drug
Intervention MeSH terms: 3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers
Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability after multiple ascending
      oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.

      Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and
      urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related
      parameters in the blood and stool samples (pharmacodynamics) will be characterized compared
      to placebo.

      Also, the effect of the compound on glucose tolerance will be explored as well as the
      potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.
    


Intervention name(s): GLPG0974; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)
Condition: Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Urticaria; Pruritus
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Pruritus; Urticaria
Study type: Observational

Summary: 
      The purpose of this study is to collect information on unexpected adverse reactions (ADRs),
      how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin
      (loratadine) when used in children. Patients will be observed while they are taking Claritin,
      and ADRs and symptom scores will be recorded. At the end of treatment, improvement in
      symptoms will be recorded.

      Post-marketing surveys are not considered applicable clinical trials and thus the results of
      this survey will not be posted at its conclusion. The results will be submitted to public
      health officials as required by applicable national and international laws.
    


Intervention name(s): loratadine
Intervention type(s): Drug
Intervention description(s): Claritin Tablet 10 mg, Claritin RediTabs 10 mg: For pediatric patients aged 7 years and older, 10 mg of loratadine is orally administered once daily after a meal in usual cases.
Claritin Dry Syrup 1%: For pediatric patients aged 3 to < 7 years, 5 mg loratadine (0.5 g dry syrup); and for pediatric patients aged 7 years and older, 10 mg of loratadine (1 g dry syrup) is dissolved immediately before use and orally administered once daily after a meal in usual cases.
The observation period will not be specified.
Other intervention name(s): Claritin, SCH 29851
Intervention MeSH terms: Loratadine
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients who are treated with Claritin at a department of pediatrics, department
        of otorhinology, department of dermatology, etc. at approximately 120 institutions
Accelerated Immunosenescence and Chronic Kidney Disease
Condition: Renal Failure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Interventional

Summary: 
      The aim of this study is to investigate the impact of renal function and dialysis techniques
      on the percentage of senescent T lymphocytes.
    

Detailed description: 
      The immunosenescence is a complex and profound remodeling of the immune system during life.
      It is mainly due to thymic involution and repeated antigenic stimulation. Kidney disease is
      associated with a decrease in adaptive immunity as evidenced by the decrease in vaccine
      response and increased susceptibility to infections, similar to those observed in the elderly
      population.

      However, data on aging of the immune system in chronic kidney disease remains incomplete.
      Furthermore, the determinants of immunosenescence are not also not known. It is possible that
      "uremic" factors help explain the phenotypic and functional changes of lymphocytes, as
      antigenic stimuli associated with repeated bio-compatible materials used in dialysis contact.

      The purpose of this study is to describe the phenotypes of the immune system of renal and
      analyze the determinants of these changes.
    

Intervention name(s): Blood sample
Intervention type(s): Biological
Intervention description(s): 3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Renal Failure; Dialysis; Biological Aging
Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Patient on an intermittent androgen deprivation protocol for biochemical recurrence after
      radical local therapy for prostate cancer,the addition of continuous dutasteride treatment,
      significantly prolongs the duration of the off treatment interval and time to androgen
      independence.
    

Detailed description: 
      The study is to assess the effect of therapy with repeat oral daily dosing of dutasteride 05
      mg on the length of the off treatment interval in men receiving intermittent androgen therapy
      for localized prostate cancer.
    

Intervention name(s): Dutasteride
Intervention type(s): Drug
Intervention description(s): dutasteride 0.5mg capsule daily until serum PSA rises to 5ng/ml in the off treatment interval
Other intervention name(s): placebo
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
The Postoperative Analgesic Effect of Combination With Dexmedetomidine in Fentanyl-based Intravenous Patient Controlled Analgesia Compared With Conventional Thoracic Epidural and Intravenous Patient Controlled Analgesia After Radical Open Gastrectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study to test hypothesis that addition of dexmedetomidine to fentanyl based
      intravenous patient controlled analgesia (PCA) improves postoperative pain compared with
      conventional thoracic epidural and intravenous patient controlled analgesia after radical
      open gastrectomy.
    


Intervention name(s): Dexmedetomidine; Fentanyl 1; Fentanyl 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexmedetomidine mixed fentanyl based intravenous PCA; conventional fentanyl-based epidural PCA; conventional fentanyl based intravenous PCA
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate two potential treatments for children with
      Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication.
      Our goal is to develop new interventions for preschoolers with ADHD that will result in
      enduring reductions of ADHD symptoms and associated impairments in children, and thus prevent
      long-term difficulties characteristic of many children with ADHD.

      Both interventions involve weekly playgroups (of roughly five children) in which children
      engage in designated activities while parents engage in groups focusing on parent education,
      support, and their children's activities. It is hypothesized that both interventions will be
      helpful, but that only one will have lasting effects well beyond the end of active treatment.
    

Detailed description: 
      Children eligible for this study are:

        -  4 and 5 years-old (between the ages of 48 - 72 months)

        -  shows signs and symptoms of hyperactivity, impulsiveness and/or inattention. To enter
           the study, following our evaluation, they will need to meet diagnostic criteria for ADHD

        -  enrolled in a preschool or daycare setting

      Children are ineligible to participate in this study if they:

        -  are currently being treated with psychotropic medication

        -  have a diagnosed neurological disorder

        -  have an autism spectrum pr pervasive developmental disorder

        -  are intellectually impaired

        -  are highly physically aggressive
    

Intervention name(s): Training Executive, Attention and Motor Skills (TEAMS); Parent support and education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children will be taught games targeting these skills and parents will be encouraged to play these games with children at home; Parents will participate in groups designed to provide information about ADHD and support for working with their child.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Preschool Children; ADHD; Treatment; Non-pharmacological