bioihbjkbjnl/mcl2 huggingface dataset:
Driving Pressure in Trauma
Condition: Sever Chest Trauma; Mechanical Ventilation
MeSH terms: Wounds and Injuries; Thoracic Injuries
Study type: Observational

Summary: 
      Traumatic chest injuries are responsible for significant morbidity and the cause of
      trauma-related death in 20%-25% of cases. Thoracic trauma can include multiple injuries,
      mainly osseous (ribs, sternal fractures, flail chest), pulmonary contusions or lacerations,
      pneumothoraces and pleural effusions, and sometimes involve wounds to the heart and vessels
      (aortic dissection, cardiac contusion) or diaphragm. Following trauma, patients with thoracic
      injuries are at risk of developing acute respiratory distress syndrome (ARDS). This worsening
      of respiratory function can lead to requirement for mechanical ventilation. In addition,
      changes to gas exchange may also be generated or aggravated by mechanical ventilation as a
      result of barotrauma, biotrauma, or ventilation-associated pneumonia. Many mechanical
      ventilation strategies have been tried in trauma patients in the last 30 years to determine
      the optimal method of maximizing gas exchange with minimal lung damage. The driving pressure
      of the respiratory system has been shown to strongly correlate with mortality in a recent
      large retrospective ARDSnet study. Respiratory system driving pressure [plateau
      pressure-positive end-expiratory pressure (PEEP)] does not account for variable chest wall
      compliance especially in cases of chest trauma. Esophageal manometry can be utilized to
      determine transpulmonary driving pressure. A recent study suggests that utilizing PEEP
      titration to target positive transpulmonary pressure via esophageal manometry causes both
      improved elastance and driving pressures. Treatment strategies leading to decreased
      respiratory system and transpulmonary driving pressure at 24 h may be associated with
      improved 28 day mortality. However, currently no specific study with chest trauma patients
      exists. We propose to investigate the effect of hight transpulmonary driving pressure on
      duration on mechanical ventilation, length of stay and mortality in patients with sever chest
      trauma.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with sever chest trauma under mechanical ventilation
      
Keywords: Thoracic trauma; mechanical ventilation; Acute respiratory distress syndrome; Esophageal pressure; Pleural pressure
The Impact of Actos Treatment of Diabetes on Glucose Transporters in Muscle
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects with type 2 diabetes will be treated with Actos or placebo for eight weeks and
      needle biopsies of muscle will quantify changes in any of seven different glucose transport
      proteins in muscle.
    

Detailed description: 
      Twelve subjects with type 2 diabetes, with fair control on oral medication, will be recruited
      to participate in a randomized, double-blind, placebo-controlled study of the impact on
      muscle glucose transporter expression of the addition of the insulin-sensitizing agent,
      pioglitizone (Takeda Pharmaceuticals). Therapy with the active drug will be at 30 mg daily.
      The other oral medications will be adjusted downward if hypoglycemia occurs. Glycemic control
      will be monitored by at least twice daily home blood glucose monitoring, weekly telephone
      contacts, and follow-up visits to the ETSU/VAMC Clinical Research Unit (CRU) every two weeks.
      During the eight weeks of therapy, subjects will be instructed to maintain their weight and
      keep their dietary and exercise regimens unchanged. Muscle biopsies will be obtained before
      and at the end of eight weeks of therapy. Specimens will be assayed for GLUT1, GLUT3, GLUT4,
      GLUT5, GLUT8, GLUT11, and GLUT12 mRNA and protein content and the subcellular distribution of
      these proteins as described below. Peroxisome proliferator-activated receptor gamma
      (PPARgamma), a member of the ligand-activated nuclear hormone receptor superfamily (14), will
      be quantified in these specimens by immunoblot as described below.

      This study design involving a randomized, double-blinded, placebo-controlled treatment
      regimen is needed to control for confounding variables causing changes in glucose transporter
      expression that may be erroneously attributed to the drug. These potential variables include
      close contact with the diabetes management team resulting in improved compliance with diet,
      exercise, medication, and monitoring and thus better glycemic control, weight loss, or
      improved fitness.
    

Intervention name(s): Pioglitazone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): pioglitazone 30 mg daily, pill, eight weeks, placebo randomly assigned; placebo assigned randomly, double blind
Other intervention name(s): Actos or placebo; sugar pill
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: muscle; glucose transporters; GLUT4; GLUT5; Actos
EEG Studies of Ketamine General Anesthesia
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We are doing this research study to find out how and where ketamine acts in the brain.
      Ketamine is an anesthetic (a drug or agent used to decrease or eliminate the feeling of pain
      by putting you in an unconscious state). We will look at the brain using a machine that
      records the brain's electrical activity, called an electroencephalogram (EEG). We will assess
      how it impacts patient's pain responses.
    

Detailed description: 
      In this trial, participants will be given ketamine at a high enough dosage to induce general
      anesthesia. EEG recording will be conducted during this time. Cognitive assessments and pain
      monitoring will be administered at various points before and after ketamine induction.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Clinical Trial
Condition: Early Detection of Cancer; Cancer; Socioeconomic Status
Study type: Interventional

Summary: 
      This randomized trial aims to understand how effective a reminder letter is compared to a
      reminder phone call in improving breast, cervical and colorectal cancer screening rates and
      reducing screening disparities.
    


Intervention name(s): Letter; Phone call
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: recall; income-related disparities; cancer screening
Efficacy of Telerehabilitation Based Exercises in Patients With Bell's Palsy
Condition: Bell Palsy
MeSH terms: Bell Palsy; Facial Paralysis
Study type: Interventional

Summary: 
      The study will be carried out with volunteer patients who are diagnosed with Bell's Palsy and
      comply with the study criteria.The aim of the study is to compare the home PNF exercise
      program with video-based telerehabilitation and the conventional training program in terms of
      outcome measures in patients with Bell's Palsy lesions.
    

Detailed description: 
      With the telerehabilitation program, it is aimed that patients can easily adapt to home
      exercise programs and be followed up remotely. In this way, the most effective treatment of
      the disease will provide the patient with both motor function gain and psychosocial gain.
      This study was planned to examine the effectiveness of telerehabilitation in patients with
      Bell's Palsy.
    

Intervention name(s): Telerehabilitation; Conventional Education Program
Intervention type(s): Other; Other
Intervention description(s): The telerehabilitation platform is used to deliver the home exercise program.; The patient is given education about the points to be considered for the disease and the exercises to be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bells Pasly; Telerehabilitation; Peripheral Facial Paralysis; Proprioceptive Neuromuscular Facilitation
Budesonide Treatment for Lymphocytic Colitis
Condition: Microscopic Colitis
MeSH terms: Colitis; Colitis, Microscopic; Colitis, Lymphocytic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether orale budesonide is effective in the
      treatment of lymphocytic colitis
    

Detailed description: 
      The purpose of this study is to determine whether orale budesonide is effective in the
      treatment of lymphocytic colitis
    

Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: lymphocytic colitis; microscopic colitis; budesonide
Clinical Outcomes and Urodynamic Effects After Vaginal Tailored Mesh Surgery for Pelvic Organ Prolapse
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the clinical outcome and urodynamic effect of two novel vaginal tailored mesh
      surgeries.
    

Detailed description: 
      We will review the medical records (including medical data, urodynamic data, pad weight data,
      etc) of women who underwent either anterior or posterior novel vaginal tailored mesh
      surgeries at National Taiwan University Hospital between November 2011 and November 2013.
    

Intervention name(s): Anterior vaginal tailored mesh surgery; Posterior vaginal tailored mesh surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence; Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pelvic organ prolapse, vaginal mesh, urodynamic studies
Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      A six-month study to determine the safety and efficacy with an additional open-label
      extension to determine the long-term safety of eszopiclone in the treatment of adult subjects
      with primary insomnia.
    

Detailed description: 
      A six month, randomized, double-blind and six month open-label extension, multi-center,
      outpatient study to determine the safety of eszopiclone in the treatment of adult subjects
      with primary insomnia. Approximately 800 subjects were to be randomized using a 3:1 ratio to
      receive one of the two treatments, eszopiclone 3 mg or placebo, for 6 months. All subjects
      completing 6 months of treatment were eligible to receive open-label 3 mg eszopiclone for an
      additional 6 months. Subjects were allowed to stay on study for up to 12 months.
    

Intervention name(s): eszopiclone 3 mg; placebo
Intervention type(s): Drug; Drug
Intervention description(s): eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).; placebo
Other intervention name(s): lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep
A Study to Determine the Relative Bioavailability of a Tablet Formulation of GDC-0941 and the Effect of Ketoconazole on the Pharmacokinetics of the GDC-0941 Tablet
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single-center, open-label, randomized, 2-part study to determine the relative
      bioavailability of GDC-0941 capsule and market-image tablet formulations and the effect of
      ketoconazole on the pharmacokinetics of the GDC-0941 market-image tablet formulation.
    


Intervention name(s): GDC-0941; GDC-0941; ketoconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral repeating dose; Oral repeating dose; Oral repeating dose
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TCMS for the Treatment of Foot Pain Caused By Diabetic Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate whether an experimental medical device that emits a series of brief,
      intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN). The United
      States Food and Drug Administration (FDA) has approved a similar device for treatment of
      migraine headaches, but this type of device has not been studied for the treatment of DN.
    

Detailed description: 
      The study will evaluate whether an experimental medical device that emits a series of brief,
      intense magnetic pulse will relieve foot pain from Diabetic Neuropathy (DN). The United
      States Food and Drug Administration (FDA) has approved a similar device for treatment of
      migraine headaches, but this type of device has not been studied for the treatment of DN. No
      significant adverse reactions or side effects have been reported from the use of magnetic
      stimulation for the headache treatment. Some patients who have migraine headaches have
      excellent pain relief with the magnetic treatment even if they did not get pain relief using
      medications.

      The investigators do not know whether this magnetic treatment will relieve the foot pain
      caused by diabetic neuropathy, so they will test this by applying 50 strong magnet pulses to
      the painful area of each foot. This procedure will be repeated onto three parts of each foot.
      First onto the bottom of the foot, then the top of the foot and then the back of the foot
      including a portion of the ankle. The effect on pain in each foot while walking for about 10
      steps will be recorded before the study begins and periodically for 28 days. This testing
      will provide data as to any improvement in pain relief. If the participants' reported pain is
      reduced as a result of the magnetic treatment, then the magnetic pulses will have shown that
      they have reduced the pain. Additional studies will be needed to further investigate this
      treatment and to determine how to obtain statistically significant data as to whether this
      therapy reduces the foot pain caused by diabetic neuropathy.

      One side effect of this treatment may be some muscular jerking of the foot or the leg during
      the application of the magnetic pulses. This jerking will last only during the treatment and
      will not be painful or harmful.
    

Intervention name(s): TransCutaneous Magnetic Stimulator (TCMS)
Intervention type(s): Device
Intervention description(s): TCMS coils which are connected to feet and pulse generator. The generator will then be turned on to deliver 50 pulses at a pulse period of 6 seconds and at a pulse intensity of 100% to the bottom of the foot with the TCMS coil.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Silent Brain Infarction After Endovascular Arch Procedures
Condition: Aortic Arch Aneurysm
MeSH terms: Brain Infarction; Aneurysm; Aneurysm, Aortic Arch; Infarction
Study type: Observational [Patient Registry]

Summary: 
      This is the largest study to evaluate incidence and distribution of silent cerebral
      infarction (SBI) following endovascular repair for disease of the aortic arch. Also, it is
      the first cohort to include total endovascular arch repair and devices flushed with carbon
      dioxide (CO2) to prevent gaseous cerebral embolization.
    

Detailed description: 
      Introduction. Poor data exist concerning the rate of silent cerebral ischemic events
      following endovascular treatment of the aortic arch. The objective of this work was to
      quantify these lesions using the STEP registry.

      Methods. This multicentre retrospective cohort study included consecutive patients treated
      with an aortic endoprosthesis deployed in Ishimaru zone 0 to 3 and brain diffusion-weighted
      magnetic resonance imaging (DW-MRI) within 7 days after the procedure. DW-MRI was performed
      to identify the location and number of new silent brain infarctions (SBI), microbleeds ans
      general outcome of the patients.
    

Intervention name(s): Endovascular Arch Procedures
Intervention type(s): Device
Intervention description(s): Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)
Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Consecutive patients, who received routine postoperative DW-MRI within 7 days after
        endovascular aortic arch repair between September 2018 and January 2020 at the University
        Hospital Hamburg-Eppendorf (Hamburg, Germany) and Marie Lannelongue Hospital (Paris,
        France) were identified.
      
Keywords: Thoracic endovascular aortic repair; Silent cerebral infarction; Stroke; Magnetic resonance imaging; DW-MRI; Aortic arch disease
Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients
Condition: Kidney Transplantation; Pediatric Patients; Maintenance With Tacrolimus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable
      pediatric kidney transplant recipients.

      Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and
      after that, the same dose of advagraf will be prescribed. The patients will have another
      pharmacokinetic study of tacrolimus after conversion to advagraf.
    


Intervention name(s): tacrolimus
Intervention type(s): Drug
Other intervention name(s): Prograf; Advagraf
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sleep Apnoea Management by a Communication Based Technology (ICT)
Condition: Obstructive Sleep Apnea; Telemedicine
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This project develops a new form of management of subjects with suspected SAHS and different
      sleep disorders by applying Information and communications technologies (ICT).
    

Detailed description: 
      Sleep apnea hypopnea syndrome (SAHS) is a prevalent disease with significant morbidity
      resulting in long waiting lists and high health care costs. Therefore, alternative
      cost-effective approaches are urgently needed. A possible procedure is telemedicine based on
      ICT.

      The design of the study is prospective, randomized, controlled, open and parallel.

      A ICT-based out of hospital management of SAHS is implemented to be compared with the
      classical in-hospital management.

      The main objectives were the evaluation of both groups and the analysis of efficacy and cost
      effectiveness of two SAHS management programs.

      This is a 3 month randomized, with parallel groups study. Participants will be patients with
      suspicion of SAHS derived to the Investigators' Sleep Unit.

      Patients are randomized in two groups; 1) classical in-hospital group: polysomnography or
      home respiratory polygraphy (HRP), CPAP titration and treatment and hospital follow-up; and
      2) ICT group: 3 consecutive HRPs, automatic CPAP treatment and control by phone/video
      conferences and data transmission by using a custom designed platform.
    

Intervention name(s): Remote control of patients
Intervention type(s): Other
Intervention description(s): Diagnosis outside the hospital (3 Home PR) CPAP (if needed) titration at home REmote control of patient's during 3 months by video or phonoconference
Other intervention name(s): Communication based technology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sleep Apnea; Communication Based Technology; ICT
Temporary Clipping of the Uterine Arteries During Laparoscopic Myomectomy
Condition: Leiomyoma; Laparoscopic Myomectomy
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The aim is to verify, whether intraoperative temporary clipping of the uterine vessels with
      vascular clips can reduce blood loss significantly.
    


Intervention name(s): clipping of uterine arteries during laparoscopic myomectomy
Intervention type(s): Procedure
Intervention description(s): For laparoscopy standard instruments were used.For vascular clamping we used titan made YASARGIL vessel clips. The patient is put in a 20° Trendelenburg. The surgeon coagulates a 3-4 cm long segment of peritoneum over the ileopsoas muscle. Along the coagulated segment the peritoneum is opened. The surgeon identifies the ureter at its crossing over the common iliac vessels. After medializing the ureter, the pararectal space is opened and the internal iliac artery is identified and dissected till the origin of the uterine artery. The uterine artery is isolated over a distance of about 2 cm. The vascular clip is placed over the uterine artery. Yasargil Clips are applied exclusively in patients of intervention group. Myomectomy is performed in identical fashion in both groups. At the end of myomectomy the vessel clips are removed. The metroplasty is controlled for hemostasis after reopening of the uterine vessels.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: laparoscopic myomectomy, leiomyoma, blood loss, uterine artery
Alternate-Day Buprenorphine Administration. Phase II - 4
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if two times a subject's daily maintenance dose
      will hold for 48 hours without changes in agonist and antagonist effects.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Intervention model: Crossover Assignment
Primary purpose: Treatment