bioihbjkbjnl/mcl2 huggingface dataset:
Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
    


Intervention name(s): esolution catheter
Intervention type(s): Device
Intervention description(s): esolution is a catheter-based therapy designed to displace the esophagus away from the source of ablation energy during ablation of AF and to eliminate the risk of esophageal injury
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, multicenter, randomized controlled, double blinded clinical study to assess a reduction of esophageal lesions attributable to radiofrequency (RF) ablation with use of esolution (esophageal retractor) in comparison to conventional therapy (no use of an esophageal retractor). The randomization is with a 1:1 randomization scheme assigning consecutive patients who meet inclusion and exclusion criteria to either: placement of a luminal esophageal temperature probe(LET) (control group); or, to placement of a LET and insertion of esolution esophageal retractor (intervention group). In the control group, there will not be deviation of the esophagus and in the intervention group, esolution will be utilized to deviate the esophagus during RF catheter ablation. All randomized subjects will be included in the intent-to-treat population, which will be used in the primary study analysis.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Drug Interaction Study of ALXN2050 With Fluconazole and Rifampin in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part, open label, fixed-sequence study to evaluate the potential drug interaction
      between ALXN2050 and fluconazole (Part 1), and between ALXN2050 and rifampin (Part 2) in
      healthy adult participants. Part 1 will be a 2-period, fixed-sequence study. Part 2 will be a
      single-period, fixed-sequence study.
    


Intervention name(s): ALXN2050; Fluconazole; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablet.; Oral tablet.; Oral capsule.
Other intervention name(s): ACH-0145228 (formerly)
Intervention MeSH terms: Rifampin; Fluconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a 2-part, open-label, fixed-sequence study.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ALXN2050; Fluconazole; Rifampin; Drug-Drug Interaction
Study to Evaluate Markers of Response in Locally Advanced Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the association between image and certain molecular
      markers with complete response in patients with locally advanced breast cancer, treated with
      neoadjuvant chemotherapy composed of Bevacizumab, Docetaxel and Doxorubicin.
    

Detailed description: 
      This is a pharmacogenomic phase II, multicenter, prospective clinical trial whose main
      objective is to evaluate the association of molecular and imaging markers with the response
      to bevacizumab administration in combination with docetaxel and doxorubicin as neoadjuvant
      chemotherapy in patients diagnose with locally advanced breast cancer.
    

Intervention name(s): Bevacizumab, docetaxel and doxorubicin followed by surgery
Intervention type(s): Other
Intervention description(s): The dosage form is Parenteral Injection (I/V) for all study drugs. Bevacizumab 15mg/kg in a single dose on day 1. Then 3 weeks later begin the cycles. On the day 1 of the cycle the patient receives Bevacizumab 15mg/kg, docetaxel 60mg/m2 and doxorubicin 50mg/m2.
The cycles have a frequency of one every three weeks, and the protocol defines 4 cycles in total.
The surgical procedure will be done 4-6 weeks after completion of chemotherapy.
Other intervention name(s): Avastin; Taxotere; Adriamycin
Intervention MeSH terms: Bevacizumab; Docetaxel; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: breast; cancer; Pharmacogenomics; bevacizumab
HCV Epidemiological Survey in China Rural Area
Condition: Hepatitis
MeSH terms: Hepatitis
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to determine whether the morbidity of hepatitis C with Chinese
      population.
    

Detailed description: 
      Hepatitis C virus (HCV) infection rate in China is about 3%, which means about 30 million
      patients. More importantly, many of those patients with chronic hepatitis C eventually
      develop cirrhosis and hepatocellular carcinoma(HCC).Our survey found the rate of hepatitis c
      infection in northeastern China without intervention is 34.3%, due to the abuse of caffeine
      sodium benzoate. This population has the similar mode of transmission, which is a fine study
      of the natural outcome hepatitis C. We plan to carry out epidemiological studies for this
      population, review of the influencing factors of the disease, and analyze the host factors
      that can effect the prognosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients are from the northeast of China. Most of the patients have been infected by the
        hepatitis c virus due to the drug abuse. Many of them share the same syringe for drug
        intravenous injection. However, HIV infection has been rarely detected.
      
Biospecimen description: 
      Blood serum,Peripheral blood mononuclear cells (PBMC),Urine
    
Keywords: Predict; Hepatitis C Virus; Metabolomics
Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children
Condition: Inhalation of Nitrous Oxide; Opioid Analgesic Adverse Reaction; Pain
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 3

Summary: 
      This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined
      with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for
      analgosedation for short and painful procedures in children.
    

Detailed description: 
      Nitrous oxide 70% (N20 70%) combined with 30% oxygen meets many criteria of an ideal pain
      medication for procedural analgosedation in children. At the emergency department of the
      Children's Hospital of Zurich, Switzerland, N20 70% is regularly used for short and painful
      orthopaedic procedures, mostly for reduction of dislocated forearm or finger fractures. The
      analgesic efficacy of N20 70% still remains controversial. Therefore, all children who are
      eligible for N20 70% receive additionally either fentanyl or placebo intranasal and then
      their behavior, level of sedation and adverse events are measured during the painful
      procedure. The hypothesis is that a combination of N20 70% and fentanyl intranasal is not
      significant better than N20 70% combined with basic analgetics.
    

Intervention name(s): Fentanyl intranasal; NaCl 0.9% intranasal
Intervention type(s): Drug; Drug
Intervention description(s): fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation; Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation
Other intervention name(s): Fentanyl Sintetica; NaCl 0.9% Sintetica
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
Condition: Macular Telangiectasia
MeSH terms: Telangiectasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a prospective, phase 2 extension study of participants previously enrolled in
      NTMT-01 and NTMT-02. This study is designed to evaluate long term safety and efficacy of the
      NT-501 implant in participants previously enrolled in the NTMT-01 and NTMT-02 protocols.
    


Intervention name(s): Ciliary neurotrophic factor (CNTF); Surgery; Surgery
Intervention type(s): Biological; Procedure; Procedure
Intervention description(s): The investigational product is the NT-501 encapsulated cell system, which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that secrete recombinant human CNTF, which were derived from genetically modified NTC-200 cells.; Surgery to implant device for NT-501; Sham surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Nalbuphine Versus Ketamine for Prevention of Emergence Agitation After Sevoflurane in Children Undergoing Tonsillectomy
Condition: Pediatric ALL; Pediatric Anesthesia
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      The effect of low dose nalbuphine or ketamine in the prevention of emergence agitation after
      sevoflurane anesthesia in children undergoing tonsillectomy with or without adenoidectomy.

      This randomized double-blind study was carried out at, Ain shams University Hospitals, from
      March 2021 to June 2021 on 90 patients after approval of the ethical committee.
    

Detailed description: 
      Emergence agitation (EA) in children is increased after sevoflurane anesthesia. Nalbuphine
      and midazolam have been used for prophylactic treatment with controversial results.

      Patients and Methods:Totally, 90 children between 4 and 10 years of age and of American
      Society of Anesthesiologists I-II undergoing adenotonsillectomy under sevoflurane-based
      anesthesia were enrolled in the study. Children were randomly allocated to one of the three
      groups: Group N received nalbuphine 0.1 mg/kg, Group K received ketamine 0.25 mg /kg and
      Group S received the equivalent volume saline. The study medications was given after
      discontinuation of sevoflurane by the end of surgery. In the post anesthesia care unit
      emergence agitation was assessed with emergence agitation scale upon admission (T0), after 5
      min (T5), 10 min (T10), 15 min (T15), 20 min (T20), 25 min (T25) and 30 min (T30).
    

Intervention name(s): Nalbuphine Injection; Ketamine; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): At the end of the surgery and just before discontinuation of sevoflurane and extubation the study medications will be prepared by the local pharmacy as 10 ml syringes that were handed to the anesthesiologist in charge in OR room who was blinded to the nature of the medications.; At the end of the surgery and just before discontinuation of sevoflurane and extubation the study medications will be prepared by the local pharmacy as 10 ml syringes that were handed to the anesthesiologist in charge in OR room who was blinded to the nature of the medications.; At the end of the surgery and just before discontinuation of sevoflurane and extubation the study medications will be prepared by the local pharmacy as 10 ml syringes that were handed to the anesthesiologist in charge in OR room who was blinded to the nature of the medications.
Intervention MeSH terms: Ketamine; Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Emergence agitation; Ketamine; Nalbuphine; Sevoflurane.
Tobacco Approach Avoidance Training for Adolescent Smokers-2
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a two part study. In Study 2, smokers who want to quit smoking will participate in a
      4 week smoking cessation program combining weekly cognitive behavioral therapy (CBT) with
      weekly regular-AAT or placebo-AAT training. We hypothesize that adolescent smokers will
      exhibit stronger approach tendencies towards smoking-related stimuli in the tobacco Approach
      Avoidance Training (AAT) task when compared with nonsmokers and that adolescent smokers who
      are trained to avoid smoking related stimuli using the AAT will avoid tobacco approach
      tendencies in the AAT test trials and the Implicit Association Task, when compared to
      adolescent smokers who are not exposed to AAT training. We also hypothesize that adolescent
      smokers who are trained to avoid tobacco in a training AAT in combination with CBT will have
      better abstinence rates compared to those who receive placebo AAT training with CBT.
    


Intervention name(s): AAT-experiment; AAT-placebo
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This AAT condition trains kids to avoid cigarettes; This AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Nicotine; Smoking; Adolescent; Tobacco
Cervarix Long-term Safety Surveillance
Condition: Infections, Papillomavirus
Study type: Observational

Summary: 
      This study aims to assess whether the use of Cervarix® is associated with a modified risk of
      central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis,
      idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and dermatomyositis,
      Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx
      information system.
    

Detailed description: 
      PGRx is an information system that intends to bridge the resource gap to assess the effect of
      a drug on the risk of adverse events that are infrequent and/or with a long delay of onset.
      It uses some characteristics of the ad hoc case-control or case-referent design, transposed
      on a prospective, on-going, population-based recruitment plan. This particular design is
      called here systematic case-referent design in contrast to the ad hoc case-control or
      case-referent methodology. The PGRx information system is based on the routine and targeted
      recruitment of cases of a series of pathologies, compared to population-based referents for
      the study of exposure to a wide variety of drugs. Drug exposure ascertainment is obtained
      from two different sources in the PGRx.

      system: A) A structured patient interview (telephone-administered questionnaire) B) The
      medical data form with the computerized medical prescriptions (interview guide)
    

Intervention name(s): Cervarix; Data collection
Intervention type(s): Biological; Other
Intervention description(s): 3 doses over a period of 6 months (Month 0 and ideally Month 1 and Month 6, with 1 month minimum between any two doses).; PGRx information system
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects reporting an Autoimmune diseases (AID) in the previous 12 months before
        recruitment consultation and those whose AID is reported by physicians in general practice
      
Keywords: Autoimmune diseases (AIDs); Cervarix; PGRx information system
Impact of Blueberries on Uric Acid and Quality of Life
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of blueberries on uric acid in patients
      with hyperuricemia that are not receiving uric acid pharmacotherapy. The central hypothesis
      the investigators propose is that daily blueberries added to a pre-existing diet will promote
      uric acid lowering and improve quality of life without detriment to vital signs.
    


Intervention name(s): Blueberry Powder; Placebo Powder
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Patients will take 30 grams of blueberry powder daily for up to 30 days; Patients will take 30 grams of placebo powder daily for up to 30 days.
Other intervention name(s): Blueberry powder from the U.S. Highbush Blueberry Council.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Blueberry
Lokomat Treadmill Training Effects on MS Gait
Condition: Gait, Unsteady; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Gait Disorders, Neurologic; Sclerosis
Study type: Interventional

Summary: 
      This study is being done to test the possible benefits of gait-specific training using
      body-weight supported, Lokomat assisted, treadmill training in people with Multiple
      Sclerosis.
    


Intervention name(s): Body-weight supported treadmill training +/- Lokomat assistance; Usual Care - no active intervention
Intervention type(s): Other; Other
Intervention description(s): walking; No treatment used for comparison
Other intervention name(s): Lokomat; control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; gait; falls; lokomat; body-weight support treadmill training
Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly
Condition: Arm Injuries; Anesthesia
MeSH terms: Arm Injuries
Study type: Interventional

Summary: 
      The aim of this study is to determine the minimum effective volume of local anesthetic (50:50
      mixture of 0.5% levobupivacaine and 2% lidocaine) required to produce an effective US-SCB for
      surgical anesthesia in 50% of patients and to calculate the effective volume required to
      produce an effective US-SCB in 95% of the patients (MEAV95) in elderly group (>65 years) and
      in middle aged group (<45years) of patients.
    

Detailed description: 
      We believe that known data regarding the minimum anesthetic volume required for effective
      US-SCB from middle age population can not be applicable to the elderly population since our
      preliminary data, presented at Euroanesthesia meeting in Amsterdam, 2011, and published in
      abstract form in the European Journal of Anaesthesiology, showed that involutional changes of
      brachial plexus in elderly, assessed by measuring the cross-sectional area (CSA) of brachial
      plexus at the first rib, allowed a 35% reduction in local anesthetic volume for an effective
      US-SCB for surgical anesthesia in elderly patients in comparison with the younger patients.
    

Intervention name(s): Elderly population, Middle aged population
Intervention type(s): Device
Intervention description(s): The study method is a step-up/step-down sequence model where the dose of local anesthetic for the following patient is determined by the outcome of the preceding block. The starting dose of 50:50 mixture of 0.5% levobupivacaine and 2% lidocaine is 30 mL. In the case of block failure, the dose will be increased by 5 mL. Conversely, block success will result in a reduction in dose by 5 mL. A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous) at 5-min intervals up to 30 min after completion of US-SCB. Effective US-SCB will be defined as complete sensory blockade in the distribution of the radial, ulnar, median and musculocutaneous nerve.
Other intervention name(s): Levobupivacaine 0.5%; Lidocaine 2%
Intervention MeSH terms: Lidocaine; Levobupivacaine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultrasound; Brachial block; Levobupivacaine; Minimum; Volume; Minimum volume of Levobupivacaine 0,5%
Paracétamol PMB by Sublingual et Buccal Routes
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Paracetamol is the analgesic most used, indicated in the symptomatic treatment of fever and
      pain of mild to moderate. It comes in different dosage forms intended for oral, intravenous
      and rectal.

      The per-oral mucosal route is not used for the administration of paracetamol. It is a very
      interesting way for the rapid absorption of drugs such as nitrates used in angina pectoris,
      as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows
      very rapid action. In addition, the oral administration-oral mucosa, less restrictive than IV
      administration and faster than oral administration, seek a single medical procedure
      unattended after dosing, will entail no pain or risk for infections the patient (in contrast
      to the IV). The investigators tested a new oral dosage form permucosal (at 250mg/ml) of
      paracetamol and compared at pharmacological (pharmacokinetic and pharmacodynamic) with the
      only dosage form of reference used by the IV route in the protocol "Pilot study Pharmacology
      paracetamol administered oral permucosal PMB. It seems interesting now to reduce the dose by
      half permucosal to assess how changing the pharmacodynamics of the form permucosal to
      125mg/ml. This form will be administered in oral permucosal buccal as well as sublingual
      (under the pillar of the language) and compared with paracetamol in IV.
    

Detailed description: 
      Crossover study, double-blind, randomized, controlled versus placebo.
    

Intervention name(s): Von Frey electronic
Intervention type(s): Other
Intervention description(s): Change in pain threshold testing mechanical stimulation (von Frey electronic)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Paracetamol; per-oral mucosa PMB; No disease, healthy volunteers