bioihbjkbjnl/mcl2 huggingface dataset:
Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators are selecting sixty (60) with breast cancer diagnoses where the surgical
      treatment is indicated.Furthermore the investigators divided in two groups : 1) surgical
      treatment using regular electric scalpel ; 2) surgical treatment using argon plasma
      coagulation scalpel. Our primary goal is to measure the bleeding during the surgery using the
      weight of the surgical tissues used. Secondary we'll evaluate the immediate post operative
      outcomes, like infection, hematomas and seromas. All these variables will be evaluated by a
      doctor using our standard clinical record and it will be measured using reliable parameters,
      for exemple: if the investigators clinically detect a hematoma then we'll perform an
      ultrasound to take the real extension; if the investigators clinically pick an infection
      we'll measure the extension of the hiperemia; and if the investigators clinically pick a
      seroma we'll drain and quantify it. Secondary the investigators going to evaluate and measure
      (centimeters) the terminal damage caused on the surgical specimens (samples) using the
      microscope.
    


Intervention name(s): argon plasma coagulation
Intervention type(s): Procedure
Intervention description(s): On the first group we use the regular electric scalpel to perform the surgery , and on the second group we use the argon plasma coagulation scalpel to perform the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of a Novel Technique for Intrauterine Contraceptive Devices Insertion
Condition: Contraception
Study type: Interventional

Summary: 
      The intrauterine devices are a safe, reliable, long-acting and reversible contraceptive
      method. It is also sound safe and cheap contraceptive methods available and is nearly
      maintenance free for up to 10 years.

      The fear and the pain associated with intrauterine devices insertion consider barriers to
      using this contraception method, this is because that the mucosal lining of female genital
      tract is highly sensitive to touch and pain. However; most of small procedures done in this
      sensitive area are performed without analgesia.

      The pain during intrauterine devices insertion is due to application of the tenaculum ,
      traction of the cervical canal, passing the uterine sound, insertion of the intrauterine
      devices through the cervix, and irritation of the endometrial lining by the intrauterine
      devices .

      Previous studies have reported different lines to decrease pain during intrauterine device
      insertion starting by simple methods such as pre-insertion ibuprofen use, intracervical or
      intrauterine lidocaine and misoprostol up to paracervical blocks.

      Previous studies, in literature, have found that the most painful steps during intrauterine
      devices insertion were uterine sounding then intrauterine device insertion itself, followed
      by tenaculum placement. One recent study addressed pain effect using an atraumatic vulsellum
      and a single-tooth tenaculum on pain perception during intrauterine devices and found no
      difference in reported pain.
    


Intervention name(s): Classic group; Uterine sounding sparing group; Transvaginal ultrasound; Cu-IUD
Intervention type(s): Procedure; Procedure; Radiation; Device
Intervention description(s): The speculum was placed into the vagina and the cervix was cleansed with povidone iodine. After placement of single toothed vulsellum on the anterior lip of the cervix, for traction and fixation of the uterus, the uterine sound was inserted for determination of uterine length and uterine position followed by Cu-IUD insertion. The duration of IUD insertion were reported.; after bimanual examination, the same sonographer (Level II experience) performed transvaginal /US using a SonoAce X6 machine (Medison, Korea) with transvaginal probe (4-8 MHz frequency, using an average 6.5 MHz). Firstly, he evaluated the uterine position. Then, he measured the endometrial and cervical stripe lengths in the sagittal view of the uterus and summed to have the actual length of the uterus; by which the IUD tube was adjusted before insertion.The same speculum and vulsellum were used and the IUD was inserted directly into the uterine cavity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety (serious adverse events [SAEs]), and severe
      adverse events [AEs] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5
      year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity
      (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in
      vaccine-naïve infants.
    

Detailed description: 
      This will be a single center, open study in children (aged 1 to 5 years) and vaccine-naïve
      infants, as follows: 50 OPV-vaccinated children aged 1 to 5 years to receive 1 dose of tOPV
      (Group 1); 104 vaccine-naïve infants to receive 3 doses of tOPV administered 28 days apart
      (Group 2)
    

Intervention name(s): Oral Polio Vaccine
Intervention type(s): Biological
Intervention description(s): Opvero™ (oral) is a trivalent, live attenuated poliomyelitis virus vaccine containing at least 6.0 log 50% cell culture infective dose (CCID50) of LS c2ab strain of live attenuated polio virus type 1, 5.0 log CCID50 of P712, Ch, 2ab strain of live attenuated polio virus type 2, 5.8 log CCID50 Leon I2aIb strain of polio virus type 3. Excipients: human albumin, HEPES buffer solution, magnesium chloride solution (containing polysorbate 80 and phenol red), hydrochloric acid or sodium hydroxide for pH adjustment.
The vaccine is presented as a suspension for oral administration. One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the dropper supplied with the multidose container.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Effectiveness Study of Combo Bio-engineered Sirolimus Eluting Stent
Condition: Coronary Artery Lesions
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting
      Stent (Combo Stent) compared to the Taxus® Liberté® Stent in the treatment of coronary artery
      lesions.
    


Intervention name(s): coronary stenting
Intervention type(s): Device
Intervention description(s): Balloon dilatation of obstructive coronary artery disease with deployment of a metallic stent to scaffold the dilated lesion; stent incorporating sustained release of anti-proliferative agent to control neointimal proliferation and reocclusion; test device incorporates affinity surface for circulating EPCs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intracoronary stent; drug eluting stent; sirolimus; endothelial progenitor cells
Efficacy of LNG-IUS for Treatment of Non-atypical Endometrial Hyperplasia in Perimenopausal Women
Condition: Endometrial Hyperplasia
MeSH terms: Endometrial Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of the Levonorgestrel releasing
      Intrauterine System (Mirena) and Norethisterone Acetate for treatment of non-atypical
      endometrial hyperplasia in perimenopausal women.
    


Intervention name(s): LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland; Norethisterone Acetate tablets
Intervention type(s): Drug; Drug
Intervention description(s): Initial release rate of 20µg Levonorgestrel per day for one year follow up.; Norethisterone Acetate tablets at a dose of 5 mg three times daily (15mg/day) for 3 weeks over three months.With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months
Intervention MeSH terms: Norethindrone; Norethindrone Acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endometrial hyperplasia,; LNG-IUS,; Progestin
Neural Bases of the Check Process
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Effective exploration of the environment, check for information to improve one's own
      performance, are fundamental abilities of human cognition. These abilities are dependent on
      the process of cognitive control.

      However, they are clearly impaired and uncontrollable in certain behavioral disorders such as
      obsessive-compulsive disorder (OCD). Compulsive checks of these patients, spontaneously
      associated with a feeling of intense uncertainty, suggest disturbances of evaluative and
      metacognitive functions. However, no biological observations have yet been able to feed these
      hypotheses.

      The evaluation of decisions and actions involves the middle cingulate cortex (MCC) (which
      belongs to a cortico-subcortical network structurally and functionally altered in OCD
      patients). Cingulotomy has long been used as a therapy in severe OCD, with However, the
      precise part of the cingulate cortex that contributes to check (and its pathological forms)
      remains to be discovered.

      The purpose of this research campaign is to determine, through functional magnetic resonance
      imaging (fMRI) and electroencephalography (EEG) in healthy human subjects:

        1. the location and role of the MCC region involved in normal check decision processes,

        2. determine the identity of the entire network involved
    


Intervention name(s): fMRI and EEG study
Intervention type(s): Other
Intervention description(s): fMRI and EEG study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gyrus Cinguli; Cognitive Control Process; Check process; Decision Making; fMRI
Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire
Condition: Lupus
Study type: Observational

Summary: 
      The evaluation of lupus patients must include several approaches, in particular disease
      activity and quality of life.

      The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to
      evaluate disease activity. It has the advantage of being inexpensive, easy to use in large
      cohorts and has been used in several studies. It has never been validated in French. The
      Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is
      specific to systemic lupus erythematous; it was developed from interviews with patients.

      This tool, validated in a British population, has never been validated in French.
    


Intervention name(s): SLA Questionnaire; Lupus Qol Questionnaire
Intervention type(s): Other; Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with lupus meeting the 1997 classification criteria of the American College of
        Rheumatology for systemic lupus erythematous
Exploratory Study of the Efficacy and Safety of Juvista 250ng When Administered Following Excision of Ear Lobe Keloids
Condition: Keloid
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial will explore the efficacy and safety of 250ng Juvista per Linear cm, administered
      by intradermal injection following the excision of ear lobe keloids. Keloids commonly occur
      after ear piercing and are usually bilateral.One ear lobe will be treated with Juvist and one
      with placebo.
    


Intervention name(s): Avotermin (Juvista); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 patients undergoing surgical revision of bilateral ear lobe keloids. Injecting intradermally 250ng/100µL/linear cm of the wound margin to one ear lobe and placebo into the other wound margin immediately after surgery and then 24hrs after wound closure.; 20 patients undergoing surgical revision of bilateral ear lobe keloids. Injecting intradermally 250ng/100µL/linear cm of the wound margin to one ear lobe and placebo into the other wound margin immediately after surgery and then 24hrs after wound closure.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Physiological Study to Assess Awake Prone Positioning and Respiratory Support in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      Awake prone positioning (APP) has been proven to reduce the intubation rate for patients with
      COVID-19-induced hypoxemic respiratory failure. Our recent meta-analysis found APP was only
      effective for patients who were treated by high-flow nasal cannula (HFNC), not for patients
      using conventional oxygen therapy (COT).In a recent multicenter RCT, Perkins and colleagues
      reported that continuous positive airway pressure (CPAP) was superior to HFNC and
      conventional oxygen therapy in reducing intubation rate. Thus, it is essential to evaluate
      the physiological mechanism of APP under different respiratory supports, such as COT, HFNC,
      or CPAP.

      We hypothesize that HFNC or CPAP is more effective when combined with APP than COT combined
      with APP. Electrical impedance tomography (EIT imaging) has been broadly utilized to assess
      patient ventilation homogeneity and respiratory volume monitor (RVM) has been used to
      evaluate patient's tidal volumes breath-by-breath. In this study, 20 healthy volunteers will
      use different respiratory support devices (HFNC, CPAP, and COT) in different settings and
      their combinations withAPP in a random sequence, assessed by EIT and RVM.
    

Detailed description: 
      Awake prone positioning (APP) has been proven to reduce the intubation rate for patients with
      COVID-19-induced hypoxemic respiratory failure. Our recent meta-analysis found APP was only
      effective for patients who were treated by high-flow nasal cannula (HFNC), not for patients
      using conventional oxygen therapy (COT).In a recent multicenter RCT, Perkins and colleagues
      reported that continuous positive airway pressure (CPAP) was superior to HFNC and
      conventional oxygen therapy in reducing intubation rate. Thus, it is essential to evaluate
      the physiological mechanism of APP under different respiratory supports, such as COT, HFNC,
      or CPAP.
    

Intervention name(s): awake prone positioning with advanced respiratory support (high-flow nasal cannula or continuous positive airway pressure)
Intervention type(s): Other
Intervention description(s): in this group, healthy subjects will stay in prone position for 20 mins with respiratory support of high-flow nasal cannula or CPAP
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Prone positioning; high-flow nasal cannula; continuous positive airway pressure
Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients
Condition: Deafness
MeSH terms: Deafness; Hearing Loss
Study type: Interventional

Summary: 
      This study aims at investigating new automatic fitting techniques for cochlear implant
      patients based on objective measures. For this reason, the evolution of these
      neurophysiological measures, expressing the encoding of pure tones and speech, will be
      characterized in cochlear implanted patients as a function of post-implantation time and will
      be compared to those of normal hearing subjects. Moreover, the effect of auditory training
      with new tools based on serious games will be assessed.
    


Intervention name(s): Auditory steady-state response ASSR; Speech-ABR; Acoustic Change Complex ACC; P1-N1-P2 complex and Mismatch Negativity MMN
Intervention type(s): Other; Other; Other; Other
Intervention description(s): comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities; comparison of ACC complex in response to changes within speech stimulation; comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation
Other intervention name(s): comparison of spectro-temporal analysis of speech-ABR generated in response to speech syllables
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cochlear implant; deafness; audiometry; speech perception; severe to profound deafness restored with cochlear implantation
Pharmacokinetics, Safety and Tolerability of Digoxin With or Without Co-administration of BI 1356 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics, safety and tolerability of
      digoxin with and without co-administration of BI 1356. Additionally the steady state
      pharmacokinetics of BI 1356 when co-administered with digoxin will be determined.
    


Intervention name(s): Digoxin; BI 1356
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin; Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial
Condition: Vasomotor Rhinitis
MeSH terms: Rhinitis; Common Cold; Rhinitis, Vasomotor
Study type: Interventional

Summary: 
      The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in
      treating non-allergic rhinitis
    


Intervention name(s): esomeprazole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40mg by mouth twice daily
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: non-allergic rhinitis, laryngopharyngeal reflux
Subjective and Objective Refraction in Pseudophakic Patients
Condition: Pseudophakia
MeSH terms: Pseudophakia
Study type: Interventional

Summary: 
      Targeting of post-cataract refraction depends mainly on the prediction of the post-operative
      lens position, but also on the post-operative refraction itself. Hence, aim of this study is
      to evaluate the agreement and variability of subjective refraction performed by two
      independent examiners, autorefraction, and wavefront aberrometry in pseudophakic patients
      after uneventful cataract surgery.
    

Detailed description: 
      One of the main goals of modern cataract surgery, beside removing the cataractous lens, is to
      achieve the patient's desired post-operative refraction. Targeting this post-operative
      refraction depends mainly on the prediction of the post-operative lens position and the
      post-operative refraction itself. Reason for the contributing effect of post-operative
      refraction in the error-propagation analyses is that refraction in phakic patients was shown
      to have only moderate reproducibility.

      In the past, different studies evaluated refraction methods. However, there is no study that
      included reproducibility of subjective refraction in pseudophakic patients and compares it
      with objective refraction methods (autorefraction, wavefront aberrometry).

      100 eyes of 100 patients, which underwent uneventful cataract surgery, will be included in
      the study. Refraction of one eye of each patient will be tested using subjective refraction
      by two different examiners, autorefraction, and wavefront aberrometry at two separate
      occasions.
    

Intervention name(s): Subjective refraction; Autorefraction; Wavefront aberrometry
Intervention type(s): Device; Device; Device
Intervention description(s): Subjective refraction measurements will be performed by two testers for all the patients included; Five autorefraction measurements will be performed for all the patients included; Five wavefront measurements will be performed for all the patients included
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Subjective Refraction; Autorefraction; Wavefront Aberrometry
The Light- and Environment Project in Psychiatric Inpatient Care
Condition: Mental Ill-health; Care Environment; Light Installations
Study type: Interventional

Summary: 
      The care environment influences both patients' experiences of care as well as staff's
      experiences of the work environment. A radical change in physical environment is planned at a
      psychiatric ward, aiming at creating a care environment that supports patients' opportunities
      for recovery from mental ill-health and to create a better and more attractive work
      environment for the staff. The rebuilding involves a new ward layout and new innovations such
      as light installations, a comfort room and an activity room.

      The study uses a single-system design to evaluate the effects of the intervention - the
      rebuilt ward. Both quantitative and qualitative data will be used in the evaluation. Data
      will be collected using questionnaires measuring dimensions of patients' well-being and
      experiences of the care environment, staff's experiences of work-related stress and work
      environment, quality of care, a device measuring physical activity, existing clinical
      registers and data from medical files, staff' sick leave, participant observations, and
      semi-structured interviews.

      This evaluation study, to our knowledge the first of it's kind in Sweden, is expected to
      generate important knowledge of the effect of the change process that can be used at other
      psychiatric wards to design the inpatient care environment. In the long run, the study could
      lead to a better reputation of psychiatric nursing and to more attractive workplaces.
    


Intervention name(s): The light and environment project in psychiatric inpatient care
Intervention type(s): Other
Intervention description(s): Complete rebuilding of a hospital ward.
The ward layout is remodeled and different devices and services are installed such as light, sound, and color settings, increased opportunities for physical activity, social harmony, privacy, peace, and quiet. A comfort room and a activity room will be built.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: single-system-design; mixed methods; psychiatric inpatient care; work environment; rebuilding