bioihbjkbjnl/mcl2 huggingface dataset:
Haemodynamic Response to Aortic Surgery
Condition: Aortic Aneurysm, Abdominal; Aortic Diseases; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Aneurysm; Aortic Aneurysm; Aortic Diseases; Aortic Aneurysm, Abdominal
Study type: Observational

Summary: 
      Open elective abdominal aortic surgery is a high risk procedure involving clamping of the
      aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD)
      causing lower limb ischaemia.

      These patients are often regarded as one entity in postoperative study settings. However,
      previous studies indicate that risk profiles, inflammatory activity, and haemodynamic
      capacity may differ between these groups. The first aim of this study was to evaluate
      postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising
      that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute
      dialysis than did patients with AOD.

      The investigators see a relatively high incidence of postoperative acute kidney injury (AKI)
      following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in
      the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of
      inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory
      response to aortic cross clamping may per se induce a rise in NGAL despite intact renal
      function. Therefore NGAL may not be a reliable marker of AKI after AAS.

      The second aim of this study is to describe the changes in NGAL after AAS in patients with
      and without postoperative dialysis-dependent AKI.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        10 patients sceduled for elective open operation for aortic aneurysm disease and 10
        patients sceduled for elective open operation for aortic occlusive disease
      
Biospecimen description: 
      Urine samples taken from urinary catheter. Centrifuged, supernatant frozen at -80 degrees C.
      Immunoassay analyzed at Roche modular P quantifying NGAL.
Forceps Biopsy Versus Cryo-biopsy in the Diagnosis of Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      This study was comprised of 30 patients who were scheduled for a diagnostic bronchoscopy due
      to a suspicion of lung cancer in order to obtain tissue samples for a final diagnosis , four
      biopsies were taken by each of cryobiopsy and forceps biopsy , to evaluate and compare the
      diagnostic yield of endobronchial cryobiopsy and forceps biopsy in the diagnosis of lung
      cancer .
    

Detailed description: 
      Diagnostic bronchoscopic interventions are used to evaluate and tissue sample from
      endobronchial lesions utilising variety of devices that can be delivered through the
      operative channel of a fibrio-optic bronchoscope.

      All of the procedures were carried out with 2% lidocaine instillation and midazolam IV
      sedation All patients signed a written informed consent form for bronchoscopy and tissue
      sampling with forceps and a cryoprobe.between August 2020 and June 2021. All interventions
      were performed in the bronchoscopy unit of the Chest Medicine Department at Benha university
      Data were collected, revised, coded and entered to the Statistical Package for Social Science
      (IBM SPSS) version 23. The quantitative data with parametric distribution were presented as
      mean, standard deviations and ranges.
    

Intervention name(s): bronchoscpe
Intervention type(s): Procedure
Intervention description(s): bronchoscopic biopsy from lung mass using cryobiopsy and forceps
Other intervention name(s): bronchoscope
Intervention model: Single Group Assignment
Intervention model description: A total number of 30 participants were enrolled in our study. These individuals had a diagnostic bronchoscopy because they had a suspicion of lung cancer and needed tissue samples to confirm the diagnosis. All of the procedures were carried out with 2% lidocaine instillation and midazolam IV sedation
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: bronchoscope, cryo-biopsy
A Phase I Study of SB939 in Pediatric Patients With Refractory Solid Tumours and Leukemia
Condition: Leukemia; Solid Tumours
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This research is being done because SB939 has been shown to shrink tumours in animals and in
      some people and seems promising, but we are not sure if it can offer better results than
      standard treatment.
    

Detailed description: 
      In Part A of this study, SB939 was given to children with solid tumours. The purpose of Part
      A of this study is to ind the highest dose of a new drug SB939 that can be giben to children
      without causing very severe side effects that are tolerable.

      In Part B of this study, SB939 will be given to children with leukemia. The purpose of Part
      B, is to see whether the dose that was determined to be the best dose for patients with solid
      tumours is also the best dose for children with leukemia.

      In Part C of this study, SB939 will be given together with 13-cis-retinoic acid. The purpose
      of Part C, is to see whether the SB939 dose that was determined to be the best dose in Part A
      is also the best dose when given in combination with 13-cis-retinoic acid.
    

Intervention name(s): SB939
Intervention type(s): Drug
Intervention description(s): Dose Levels for Part A
-1 - 20mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
(starting dose) 25mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
- 35mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
- 45mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
4+ - Previous level + 10mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of AP 12009, Administered I.V. in Patients With Advanced Tumors Known to Overproduce TGF-beta-2
Condition: Pancreatic Neoplasms; Melanoma; Colorectal Neoplasms
MeSH terms: Neoplasms; Melanoma; Colorectal Neoplasms; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      In this national Phase I dose-escalation study the safety and tolerability of AP 12009 is
      evaluated in adult patients with advanced tumors known to overproduce TGF-β2, who are not or
      no longer amenable to established therapies.
    

Detailed description: 
      The purpose of this dose-finding study is to evaluate the safety and tolerability of AP
      12009. Two fixed dose-escalation schemes with predefined steps and increasing increments have
      been selected to determine the maximum tolerated dose (MTD) as well as the dose-limiting
      toxicity (DLT). At least two cycles of AP 12009 are administered intravenously in adult
      patients with no further acknowledged treatment options.

      AP 12009 (trabedersen) is a phosphorothioate antisense oligodeoxynucleotide specific for the
      mRNA of human Transforming Growth Factor beta 2 (TGF-beta-2). The growth factor TGF-beta
      plays a key role in malignant progression of various tumors by inducing proliferation,
      invasion, metastasis, angiogenesis, and escape from immunosurveillance. In patients with
      pancreatic cancer, colorectal cancer, and metastatic melanoma the TGF-beta-2 overexpression
      is associated with disease stage, clinical prognosis, and the immunodeficient state of the
      patients.
    

Intervention name(s): AP 12009
Intervention type(s): Drug
Intervention description(s): Initial scheme: AP 12009 (trabedersen), dose escalation scheme, continuous intravenous infusion (7 days), every other week, up to 10 cycles.
Modified scheme: AP 12009 (trabedersen), dose escalation scheme, continuous intravenous infusion (4 days), every other week, up to 10 cycles
Intervention MeSH terms: Trabedersen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic cancer; Metastatic melanoma; Advanced tumor; Targeted therapy; Antisense; Transforming Growth Factor beta 2; Dose escalation
Emerging Adults Who Use Alcohol and Marijuana
Condition: Alcohol Use; Marijuana Use; Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases; Marijuana Abuse; Alcohol Drinking; Marijuana Use
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to if a brief motivational intervention, compared to health
      education sessions, reduces alcohol and marijuana use and is related to fewer sexually
      transmitted infections (STI)in emerging adults who are engaging in alcohol and marijuana use.
    


Intervention name(s): motivational intervention; health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 7-session individual motivationally-based intervention; 7 individual sessions focusing on health education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol use; marijuana use; STI
Serum Levels of Otolin-1 and Vitamin D in Pre- and Post-treatments of BPPV
Condition: Benign Paroxysmal Positional Vertigo
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
Study type: Observational

Summary: 
      BPPV is the most common cause of vertigo. The pathophysiology of BPPV has not been cleared,
      several studies show that symptoms are caused by the displacement of otoconia from the macula
      of the utricle into the semicircular canals. These calcium carbonate particles then stimulate
      non-physiological movement of the endolymph leading to a false sensation of angular
      acceleration.

      Biomarkers represent measurable products of biological processes, thus making an assessment
      of those processes more practical. Biomarkers in circulation are powerful indicators of
      normal and pathological biological processes, as well as, responses to pharmacological
      treatments. The inner ear-inclusive protein that has been published included Otolin-1,
      Otoconin-90/95, Prestin, Otoancorin, Otogelin, α-tectorin, β-tectorin and Cochlin.
    

Detailed description: 
      The posterior canal BPPV is the most common BPPV variant, diagnosed with the Dix-Hallpike
      test. The lateral canal BPPV is diagnosed with a supine roll test. After treatment of the
      posterior canal BPPV with a single cycle of the CRP, the rate of negative DHT was 68-80% in
      the 1st week. Rate of an absence of vertigo and nystagmus on the supine roll test
      after-treatment of the lateral canal BPPV with the barbecue maneuver plus forced prolonged
      positioning was 81%.

      Biomarkers are often measured in body fluids, they eliminate the need for costly modalities
      to diagnose and monitor progression. Otolin-1 is a secreted glycoprotein whose messenger RNA
      (mRNA) expression is restricted to the inner ear, specifically the support cells of the
      vestibular maculae, semicircular canal cristae, organ of Corti, and marginal cells of the
      stria vascularis. Otolin-1 blood levels are significantly higher in patients older than 65
      years old and increased prevalence of BPPV with age. There were reports of a relationship
      between vitamin D and otolin-1. Significantly higher serum levels of the otolin-1 protein in
      patients with BPPV than in healthy controls has been reported. This also confirmed evidence
      of the otolin-1 as a potential biomarker for BPPV episodes and maybe clinically used to
      promote better management of BPPV. No data on inner ear biomarkers has been exited in
      Thailand.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        BPPV cases in outpatient Ear Nose and Throat (ENT) Clinic at CMU Hospital, Faculty of
        Medicine, Chiang Mai University during the study period.
      
Keywords: otolin-1; vitamin D; biomarker; inner ear
Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens
Condition: Cataract Extraction
MeSH terms: Cataract
Study type: Interventional

Summary: 
      To determine quality of vision post cataract extraction and intraocular lens (IOL)
      implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and
      Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes,
      wavefront, corneal topography, and patient satisfaction.
    


Intervention name(s): Acrysof single piece (SA60AT); Acrysof IQ (SN60WF)
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effectiveness of Six Sessions CBT for Adolescents With Emotional Problems in Community Clinics
Condition: Generalized Anxiety Disorder; Social Phobia; Agoraphobia; Depression; Panic Disorder
MeSH terms: Anxiety Disorders; Panic Disorder; Phobia, Social; Agoraphobia
Study type: Interventional

Summary: 
      Background: There is need for more effectiveness studies concerning treatment of emotional
      symptom problems indicating anxiety and depression in adolescents. SMART is the only
      treatment manual for combined emotional disorders developed in Norwegian.

      Purpose: To find the best individualized treatment for adolescents with emotional
      difficulties by: Finding criteria for the selection of appropriate patients for treatment
      with cognitive-behavior therapy program SMART in an outpatient population (14-18 years).
      Finding predictors of completion of treatment program SMART. Examining the effects of
      treatment with the SMART program at 6 months follow-up.

      Design: A randomized controlled study in six outpatient clinics in the north of Norway. N=
      160 referred adolescents (14-18 years) with score above 6 on the Emotional Problems scale of
      the Strength and Difficulties Questionnaire (SDQ). Two thirds are treated according to the
      SMART-manual immediately, while the waiting list control group is treated with SMART after
      six weeks.

      Hypothesis: The SMART treatment is an effective treatment for emotional symptom problems.

      Publication: The results sought published internationally and nationally and will be
      communicated to clinicians.
    


Intervention name(s): SMART manual cognitive behavioral therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Communication Intervention Physical Activity
Condition: Physical Activity
Study type: Interventional

Summary: 
      The project is a two-arm randomized clinical trial to pilot the feasibility of a
      communication training intervention for primary care clinicians, linked to a community
      program referral, on use of the 5As to promote physical activity in underserved patients.
    

Detailed description: 
      This study will focus on training clinicians to communicate effectively using the 5As and
      patient-centered communication skills (Aim 1). When implemented fully, the intervention will
      also include referral to a community fitness program. Clinicians will be randomly assigned to
      two groups (1 and 2). Group 1 will participate in the training intervention first; group 2
      will act as a wait-list control for Group 1. The primary outcome, the effectiveness of the
      intervention on clinician use of the 5As during routine office visits, will be measured by
      examining 371 audio-recorded patient visits prior to, immediately, after, and 6 months after
      the clinician is trained. Secondary outcomes include whether the communication training
      intervention improved patients' perceived competence to adopt physical activity (Aim 2)and
      whether clinicians believe that the communication intervention addressed pertinent barriers
      to promoting exercise (Aim 3). Exploratory outcomes (Aim 4) will [assess potential mediators
      of the intervention's effect, examine the effect of the intervention on actual physical
      activity levels in a subset of participants, and create a taxonomy of communication markers
      for each of the 5As.]
    

Intervention name(s): 5 A communication intervention
Intervention type(s): Other
Intervention description(s): This study will examine the effect of primary care clinicians' communication intervention linked to a community-based exercise program. We will use the 5As in discussion of physical activity in 371 office visits in an ethnically diverse, primarily low income patient population. Secondary and exploratory aims are to provide pilot information on [feasibility and sustainability of the intervention from the patients' and clinicians' perspective and derive effect sizes on the intervention's effect on objective changes in physical activity in a subset of participants.
Other intervention name(s): ethnically diverse physical activity clinician communication
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical Activity; Exercise
Closing the Loop in Adults With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The main objective of this study is to evaluate the feasibility of closed loop insulin pump
      therapy to improve overnight glucose control in adults with type 1 diabetes.
    

Detailed description: 
      People with type 1 diabetes(T1D) need regular insulin injections or continuous delivery of
      insulin using an insulin pump in order to keep the blood glucose levels normal. We know that
      keeping blood sugars in the normal range will help prevent long term diabetes related
      complications involving the eyes, kidneys and heart. However, achieving treatment goals can
      be very difficult as the tighter we try to control blood glucose levels, the greater the risk
      of the person developing episodes of low glucose levels (hypoglycaemia). This is a particular
      problem at night and one solution is to develop a system whereby the amount of insulin
      injected is very closely matched to the blood sugar levels on a continuous basis. This can be
      achieved by what is called a "closed loop system" where a small glucose sensor placed under
      the skin communicates with a computer containing an algorithm that drives an insulin pump.
      This system is being developed in Cambridge and we have trialed this on 16 children and
      adolescents with T1D in a clinical setting over the past year. We have found that this system
      is very effective at preventing hypoglycaemia in this group of patients.

      We will recruit 12 adults with T1D on insulin pump therapy, and the studies will be done in a
      clinical research facility. The subjects will be studied on two nights. On one night they
      will have their normal insulin pump therapy and on the other night their insulin pump will be
      varied according to information about blood glucose values from the continuous glucose
      sensor. This information will be manually typed into the computer every 15 minutes from 8pm
      until 8am. The algorithm will advise of the insulin infusion rate and this will be manually
      changed by a trained nurse every 15 minutes throughout the night.
    

Intervention name(s): Conventional insulin pump delivery; Closed loop
Intervention type(s): Device; Device
Intervention description(s): Subcutaneous delivery of Novorapid insulin according to usual pump regime; Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability Study in Healthy Subjects
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 of this study will assess the relative bioavailability of GSK1322322 administered as
      one of three investigational tablets compared to powder in a bottle formulation.
      Pharmacokinetics of these three tablets will be evaluated and the investigation tablet with
      the optimal PK profile will be progressed to Part 2. In Part 2 the investigational tablet
      selected from Part 1 will be coadministered with food alone, an H2 blocker alone, or an H2
      blocker given in combination with ascorbic acid to evaluate the effect on GSK1322322
      pharmacokinetics. Plasma GSK1322322 PK profile, safety, and tolerability will be assessed
      from each dose group.
    


Intervention name(s): GSK1322322; GSK1322322
Intervention type(s): Drug; Drug
Intervention description(s): Four different formulations of 1000mg of GSK1322322; GSK1322322 1000mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK1322322, relative bioavailability, single dose, food effect, H2 blocker, healthy subjects, open label, PIB, tablet
A Pharmacokinetic Study of Udenafil in Adult Subjects With or Without Impaired Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the effect of hepatic impairment on the pharmacokinetics,
      safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy
      subjects.
    


Intervention name(s): Udenafil
Intervention type(s): Drug
Intervention description(s): 100mg Single Oral Dose of Udenafil
Other intervention name(s): DA-8159; Zydena
Intervention MeSH terms: Udenafil
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Udenafil,DA-8159,hepatic impairment,healthy volunteers
Healthy Lifestyle in Adults With Attention Deficit Hyperactivity Disorder
Condition: ADHD; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The purpose of this study is to understand the relationship between ADHD and the overall
      health of someone with ADHD. People who have ADHD have trouble paying attention,
      concentrating, organizing, and planning. They may have trouble in school, at work, and at
      home. The investigators are interested in finding out whether these difficulties have had any
      influence in the past, current, or future health problems of someone with ADHD. About 100
      people with ADHD and 100 people without ADHD will take part in this research study, all
      through Massachusetts General Hospital (MGH).
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults ages 18-55 who have ADHD (for ADHD group) Healthy adult volunteers ages 18-55 who do
        not have ADHD (control group)
      
Keywords: ADHD; health; healthy lifestyle