bioihbjkbjnl/mcl2 huggingface dataset:
Brain Lesions Following Endovascular and Surgical Treatment of Unruptured Intracranial Aneurysms
Condition: Unruptured Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      The purpose of this study is to determine the incidence and impact of brain lesions in MRI
      after coiling and clipping of unruptured intracranial aneurysms on clinical and neurological
      outcome of patients.
    

Detailed description: 
      Silent ischemic lesions after treatment of unruptured intracranial aneurysm (UIA) might alter
      patients' clinical and neurological outcome. Furthermore silent brain lesions are not well
      documented after endovascular and surgical treatment of unruptured intracranial aneurysms.
      Therefore, the investigators investigate the incidence and influence of treatment-related
      ischemic lesions in magnetic resonance / diffusion-weighted-imaging after endovascular and
      surgical treatment of UIA.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with unruptured intracranial aneurysm undergoing endovascular or surgical
        treatment
      
Keywords: Treatment of
Intermittent Vibrational Force and Orthodontic Tooth Movement
Condition: Dental Crowding; Vibrational Force; Fixed Orthodontic Appliances
Study type: Interventional

Summary: 
      The aim of this study is to compare the clinical efficiency of conventional fixed appliance
      orthodontic treatment with that supplemented by the daily application of cyclic forces to the
      dentition via a removable (AcceleDent) vibrational appliance. The primary outcome measure is
      rapidity of tooth alignment; whilst secondary outcome measures include pain and discomfort
      during treatment, rapidity of orthodontic space closure, changes in arch dimensions and root
      length.
    


Intervention name(s): AcceleDent vibrational device; Sham AcceleDent device; Fixed appliance only
Intervention type(s): Device; Device; Other
Intervention description(s): Supplementary vibrational force with fixed appliances; Supplementary sham-vibrational device with fixed appliances; Fixed appliance treatment only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Vinorelbine + Cisplatin or No Further Therapy in Non-small Cell Lung Cancer That Has Been Surgically Removed
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. It is not yet known if combination chemotherapy is more effective
      than no further treatment for non-small cell lung cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of vinorelbine plus
      cisplatin with that of no further therapy in treating patients who have stage I or stage II
      non-small cell lung cancer that has been completely removed during surgery.
    

Detailed description: 
      OBJECTIVES: I. Compare the duration of overall and disease-free survival in patients with
      completely resected non-small cell lung cancer (NSCLC) randomized to adjuvant chemotherapy
      with vinorelbine and cisplatin versus observation only. II. Confirm the prognostic
      significance of ras mutations when present in the primary tumor. III. Provide a comprehensive
      tumor bank linked to a clinical database for the further study of molecular markers in
      resected NSCLC. IV. Measure and compare the health-related quality of life of patients on
      both treatment arms. V. Evaluate any toxicity related to this treatment regimen.

      OUTLINE: This is a randomized study. Patients are stratified according to participating
      institution, nodal status (N0 vs N1), and ras mutation status of primary tumor (absent vs
      present vs unknown). Patients are randomized to one of two treatment arms. Arm I: Patients
      are evaluated at 3 and 6 months after randomization. Arm II: Patients receive vinorelbine IV
      over 6-10 minutes weekly for 16 weeks. Patients also receive cisplatin IV on days 1 and 8
      every 4 weeks for a total of 4 courses. Treatment continues in the absence of disease
      progression or unacceptable toxicity. Quality of life is assessed at Canadian centers.
      Quality of life assessments are optional for ECOG and SWOG centers. Patients are followed
      every 3 months for 2 years and then every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 6.75 years.
    

Intervention name(s): cisplatin; vinorelbine ditartrate
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg/m2 IV; 25 mg/m2 IV
Intervention MeSH terms: Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer
Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium
Condition: Emergence Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional

Summary: 
      Delirium is a common postoperative complication in the elderly, often caused by multiple
      factors. It is defined as an acute neuropsychiatric disorder characterized by fluctuating
      disturbances in attention, awareness, and cognition. Postoperative delirium occurs in 17-61%
      of the major surgical procedures. It may be associated with cognitive decline, decreased
      functional independence, increased risk of dementia, caregiver burden, health care costs,
      morbidity, and mortality. Therefore, delirium is a possibly disastrous condition and is both
      a huge burden on a patient's health and on the health care system in general.
    

Detailed description: 
      Over the last few decades, numerous risk factors for delirium have been identified,
      emphasizing the importance of delirium prevention in patients undergoing surgery. It has
      already been identified as a state that may be associated with serious complications such as
      prolonged ICU and hospital stays, decreased quality of life, and increased mortality ).
      Previous studies on delirium pointed out old age and other factors as important predisposing
      factors. on the health care system in general. Extensive research on reducing the incidence
      of delirium has been conducted using both pharmacological and non-pharmacological preventive
      measures in the acute setting. As evidence recommending or opposing specific drugs for the
      prevention of postoperative delirium remains insufficient and the international guidelines
      can only recommend perioperative pharmacologic adjustments ("American Geriatrics Society
      Abstracted Clinical Practice Guideline for Postoperative Delirium in Older Adults," 2015) .
      Consequently, the challenge of developing reliable hospital algorithms for delirium
      prevention and treatment remains unresolved. Furthermore, there is a link between
      postoperative delirium and two biomarkers, cortisol and C- Reactive Protein (CRP), which have
      previously been linked to delirium but whose significance is unknown.
    

Intervention name(s): Ketamine Hcl 50Mg/Ml Inj
Intervention type(s): Drug
Intervention description(s): Patients will be given the active comparator or placebo only once right before the induction of anesthesia.
Other intervention name(s): Dexmedetomidine 1000 mcg/ml inj
Intervention MeSH terms: Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An anesthesiologist who is not involved in the study will prepare the intervention (ketamine, dexmedetomidine, or placebo) in a standardized syringe with the same volume. Patients will be given the active comparator or placebo only once right before the induction of anesthesia.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Spatial Relationship of I-gelTM and Ambu® AuraOnceTM on Paediatric Airway: A Comparison on Three Dimensional MRI
Condition: Pediatric Laryngeal Mask Airway; Spatial Relations With Pediatric Airway; Assessed With Three Dimensional Magnetic Resonance Imaging
Study type: Interventional

Summary: 
      At King Khalid University hospital approximately 1200-1500 MRI are done yearly on pediatric
      and neonatal patients. The investigating hospital is one of the pioneers in providing this
      service in the Kingdom (which was established about 10 years ago) to the patients of this age
      group. Only a small percentage of pediatric patients with age above 8 years accept the
      procedure to be done without anesthesia; and majority of MRI procedures are done under
      general anesthesia. The airway management of these patients is commonly accomplished with
      laryngeal mask airways (LMA).

      LMA are in practice of anesthesia since early 1980s. Pediatric and neonatal patients
      (including ex-premature) have also been benefited by the use of LMA. There are many
      advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion,
      securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat,
      post-operative hoarseness and coughing at the time of extubation, greater hemodynamic and
      intra ocular pressure (IOP) stability.

      There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA
      classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other
      (silicone, polyvinyl chloride or soft gel). Out of all this variety of LMAs only few are MRI
      compatible (do not produce any artifact in the MRI image), for example Ambu LMA and I-gel LMA
      and in King Khalid University Hospital (the investigating hospital) these two types are being
      used.

      On search of literature the investigators found only one study in adults in which such
      comparison has been made and there was no study comparing different LMAs on the basis of
      their spatial effects on anatomical structures of the neck and airway in pediatric patients
      with age 12 years or below.

      In this prospective randomized study, the investigators will compare the spatial relationship
      of I-gel Trademark (TM) and Ambu® AuraOnce (AO)TM on pediatric airway in pediatric patients
      undergoing 3-D MRI under general anesthesia (GA).
    


Intervention name(s): I-gel TM; Ambu AuraOnce (AO)
Intervention type(s): Device; Device
Intervention description(s): Airway management with I-gel; Airway management with Ambu AuraOnce (AO)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: I-gelTM; Ambu® AuraOnceTM; supraglottic devices; laryngeal mask effects on airway; 3D magnetic resonance imaging
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The aim of this study is to assess whether the 1 minute Sit to Stand (STS) test can be used
      as a measure of submaximal endurance during a pulmonary exacerbation of Cystic Fibrosis (CF)
      for patients in the acute care setting. We hypothesize that if the STS test is a valid
      measure of submaximal cardiovascular endurance, it will moderately correlate with 6 minute
      walk distance (6MWD).
    


Intervention name(s): Sit to stand test
Intervention type(s): Diagnostic Test
Intervention description(s): Participants will complete a sit to stand test in addition to a 6 minute walk test
Other intervention name(s): 6 minute walk test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: cystic fibrosis; walk test
Effect of Lidocaine Plus Dexmedetomidine Infusion on PONV
Condition: Lidocaine; Dexmedetomidine; Nausea and Vomiting, Postoperative
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      BACKGROUND: Few researches have manifested that intravenous (IV) lidocaine or dexmedetomidine
      decreased the incidence of postoperative nausea and vomiting (PONV). The investigators
      investigated whether IV lidocaine plus dexmedetomidine infusion could better reduce the
      incidence of PONV after laparoscopic hysterectomy.

      METHODS: One hundred and twenty women with elective laparoscopic hysterectomy were randomly
      divided into two groups: patients in the lidocaine combined with dexmedetomidine group (LD
      group, n=60) received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine
      (0.5 μg/kg loading, 0.4 μg/kg/h infusion) respectively. Patients in the control group (CON
      group, n=60) received the equal volume of saline. Primary outcome was the incidence of the
      first 48 h nausea, vomiting and PONV after surgery. The secondary outcomes included
      perioperative propofol and remifentanil consumption, postoperative fentanyl requirement,
      Ramsay sedation score, and bradycardia during post-anaesthesia care unit (PACU) stay.
    


Intervention name(s): lidocaine and dexmedetomidine IV; saline IV
Intervention type(s): Drug; Drug
Intervention description(s): Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively.; Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery
Intervention MeSH terms: Lidocaine; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Lidocaine; Dexmedetomidine; Postoperative nausea and vomiting; laparoscopic hysterectomy
Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults
Condition: COVID-19; SARS-CoV-2
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the
      prevention of COVID-19.
    

Detailed description: 
      The COVID-19 pandemic has caused major disruption to healthcare systems with significant
      socioeconomic impacts. Currently, there are no specific treatments available against COVID-19
      and accelerated vaccine development is urgently needed. A safe and effective vaccine for
      COVID-19 prevention would have significant public health impact.
    

Intervention name(s): AZD1222; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): AZD1222 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2-5 surface glycoprotein.; Commercially available 0.9% (n/V) saline for injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to one of two or more groups in parallel for the duration of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID-19 Vaccine
A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination of Fimasartan/Rosuvastatin in Comparison to Each Component Administered Alone in Patients With Essential Hypertension and Dyslipidemia
Condition: Essential Hypertension, Dyslipidemia
MeSH terms: Hypertension; Essential Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of combination of
      Fimasartan/Rosuvastatin in comparison to each component administered alone in patients with
      essential hypertension and dyslipidemia.
    


Intervention name(s): Fimasartan and Rosuvastatin; Fimasartan; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study to Determine the Safety and Tolerability of Varenicline (Chantix®) in Treating Spinocerebellar Ataxia Type 3
Condition: Spinocerebellar Ataxia Type 3
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations; Machado-Joseph Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Spinocerebellar ataxia (SCA) is a group of inherited disorders characterized by cerebellar
      degeneration leading to imbalance, incoordination, speech difficulties and problems with
      walking. Recently, individual case reports have suggested that varenicline, a drug used in
      smoking cessation, produces substantial improvement in patients with several inherited
      ataxias. A modest response was noted in 5 patients with SCA, suggesting that it is
      potentially efficacious in this disorder as well. Although this agent is available for
      off-label use, the severe side effects noted with its use and the lack of long-term toxicity
      data demand that it be systematically assessed. The present study will test whether
      varenicline is safe and potentially efficacious in a heterogeneous cohort of adults with SCA.
    


Intervention name(s): varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): up to 1mg BID for 8 weeks; placebo matching varenicline, up to 1mg BID for 8 weeks
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given
      concomitantly with routine paediatric vaccinations in India.
    


Intervention name(s): 13-valent Pneumococcal Conjugate Vaccine; 7 valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose at 6, 10, 14 weeks and 12 months of age; 1 dose at 6, 10, 14 weeks and 12 months of age
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccines, Pneumococcal
Hazardous Surgical Smoke: Risk Assessment and Evaluation of a New Smoke Extractor System in the Surgical Unit
Condition: Lung Cancer; Lung Injury
MeSH terms: Lung Injury
Study type: Observational

Summary: 
      The investigators will define two separate groups of surgical procedures: 1.) an 'open group'
      in which mainly open anatomic lung resections will be included, and 2.) a 'minimally
      invasive' group in which mainly thoracoscopic anatomic lung resections will be included.

      Both groups will then be randomized to either the performance of the surgical procedure under
      'standard conditions' or to the performance of the procedure with the additional use of a
      smoke evacuation system.

      During every procedure the hazardous smoke that is generated by the electrocautery in the
      surgical field will be collected through a tube at the height of the surgeons face. The smoke
      is then directly transferred to a mass spectrometer that is situated in the operating room
      (OR) and performs a real-time analysis of the chemical substances in the air. The degree of
      air pollution will be measured as well as the smoke evacuation systems' ability to reduce
      these hazardous chemical substances in the air can be evaluated.
    

Detailed description: 
      Smoke samples will be continuously analyzed with a latest generation time of flight mass
      spectrometer in real time. Concerning the smoke evacuation device, the investigators will use
      the model IES 2 (Intelligent Evacuation System) from Erbe Swiss medical for this study.

      Since this is only an observational study in which the investigators are only recording the
      type of surgery (i.e. open oder minimally invasive) and not recording sensitive patient data,
      the local ethics committee waived the need for an ethics committee approval of the study. In
      the end the smoke evacuation system does not have an effect on the patient or the procedure
      itself, but may rather influence the concentration of hazardous surgical fumes in the
      operating theatre.
    

Intervention name(s): Smoke evacuation system
Intervention type(s): Device
Intervention description(s): The smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All surgical procedures that will be performed during the study period at the
        investigators' department will be randomly allocated to either the performance of surgery
        with or the performance of surgery without the use of a mobile smoke evacuation device.
        Whether the procedure will be performed open or minimally invasive will be decided by the
        operating surgeon and is not part of the randomization process. During the respective
        surgeries, a mass spectrometer will be used to measure the smoke concentrations and its
        composition in the operating room.
      
Keywords: Smoke; Plume; Electrocautery; Mass spectrometer