bioihbjkbjnl/mcl2 huggingface dataset:
Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV
Condition: Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV
    


Intervention name(s): Recombinant birch pollen
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergy; Birch pollen; Recombinant
Effectiveness of Online Visit Compared With In-person Clinic Visit on Weight Loss
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Online visit and online counseling via telemedicine technology is a new service for obese
      people who wish to lose weight but because of their active lifestyle and time limitation
      cannot come to clinic. The purpose of this study was to examine the efficacy this
      technology-based intervention on weight loss in obese and overweight female adults.
    


Intervention name(s): online visit group; Clinic visit group; self-directed group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): subjects has online visit with dietitian every 2 weeks+diet; Clinic visit group ,subjects has every 2 weeks in person visit at clinic+diet; self-directed group receives nutritional information via web and their energy needs for weight loss
Other intervention name(s): OV; CV; SD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: weight loss; Diet; online visit; clinic visit
Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The presence of persistent inadequate or suboptimal virologic response is a strong risk
      factor for viral resistance and breakthrough and also for disease progression of chronic
      hepatitis B, and thus, a change in therapy is required. The combination of entecavir (ETV)
      and adefovir (ADV) is a promising treatment for patients with lamivudine (LAM)-resistance who
      show suboptimal response to the combination of LAM and ADV.

      In this randomized, open labeled trial,the investigators will compare the efficacy of
      continuation of ADV plus LAM versus switch to ADV plus ETV in adults with LAM-resistant
      chronic hepatitis B who shows suboptimal response to the combination treatment of ADV and
      LAM.
    

Detailed description: 
      In this randomized, open label, two-arm, single center phase IV trial, the investigators will
      assess and compare the efficacy and safety of continuation of ADV plus LAM versus switching
      to ADV plus ETV up to 52-weeks in Korean adults with chronic hepatitis B who have resistant
      mutants to LAM and show suboptimal response to combination of ADV plus LAM.

      All study subjects who complete the initial treatments of 52-weeks will be thereafter treated
      with the combination of ADV plus ETV for 52 more weeks.

      Study period: Nov 2009 - October 2012 Patient enrollment period: November 2009 - December
      2010

      Study protocol

        1. Group A (ADV+LAM group): Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks,
           and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks

        2. Group B (ADV+ETV group): Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks
    

Intervention name(s): Adefovir; Entecavir; Lamivudine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Adefovir dipivoxil (Hepsera) 10 mg/day orally for 104 weeks; Entecavir 1 mg/day orally; Lamivudine (Zeffix) 100 mg/day orally
Other intervention name(s): Adefovir dipivoxil (Hepsera); Entecavir (Baraclude); Lamivudine (Zeffix)
Intervention MeSH terms: Lamivudine; Adefovir; Adefovir dipivoxil; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis B; lamivudine; adefovir; entecavir
Pregabalin (Lyrica) for the Treatment of Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a multi-site, prospective, double-blind, randomized, placebo-controlled,
      crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to
      treat symptoms of ET.
    


Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Gradually titrated dose ranging from 75mg po bid to 225mg po bid.; Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Essential tremor; tremor; pregabalin; lyrica
Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting Surgery
Condition: Surgery; Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether the use of Sugammadex will reduce time from
      reversal to extubation and improve other post extubation outcomes in Coronary artery bypass
      grafting patients. This study is a prospective, clinical interventional, randomized single
      blinded single-center design. The nurses in the cardiac intensive care unit will be blinded
      to treatment allocation (Group 1 or 2).
    

Detailed description: 
      Enhanced recovery pathways and early extubation of subjects undergoing cardiac procedures has
      now become mainstay, especially with the advent of minimally invasive procedures .

      To facilitate optimal recovery after extubation; muscle strength is vital to prevent
      reintubation, improved deglutition and quicker transition to lower oxygen requirements, and
      better respiratory and cardiac hemodynamics. It also expedites de-escalation of acuity of
      care. Several studies have shown residual muscle weakness after full reversal with
      neostigmine and glycopyrrolate. Sugammadex is a direct reversal agent and can provide
      superior muscle strength, which optimizes respiratory function thereby preventing
      atelectasis, hypoxia and potentially avoiding reintubation.
    

Intervention name(s): Rocuronium; Neostigmine; Glycopyrrolate; Sugammadex
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure.; Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage); Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage); Reversal with Sugammadex (2mg/kg)
Intervention MeSH terms: Glycopyrrolate; Rocuronium; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 (control) will receive reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage) and glycopyrrolate (0.07-0.015 mg/kg up to 1mg maximal dosage).
Group 2 (treatment) will receive reversal with sugammadex 2 mg/kg.
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Coronary Artery Bypass Grafting Surgery; Sugammadex
The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
Condition: Sleep Apnea, Obstructive; Tonsillectomy; Adenoidectomy; Postoperative Complications
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Postoperative Complications
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study using caffeine in children who have an obstructive sleep apnea
      (OSA). OSA means children who stop breathing during their sleep due to obstruction in their
      airway. The purpose of this study is to determine whether caffeine when given in the vein,
      will wake children up faster and decrease post-anesthesia airway obstruction, as well as the
      safety and if the drug agrees with the child compared to a placebo (an inactive or dummy
      agent).
    

Detailed description: 
      Patients with OSA are reported to have a higher rate of severe respiratory complications
      associated with upper airway obstruction during anesthesia and sedation or immediately after
      anesthesia. Children with OSA (especially those under three years of age, those with severe
      OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative
      complications, and require careful monitoring post-operatively.

      Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and
      neuromuscular abnormalities, we believe that a central element may contribute to OSA.

      The aim of this study is to evaluate whether administration of caffeine to children with OSA,
      scheduled for elective T & A under general anesthesia contributes to a faster recovery, less
      post-operative complications, and a shorter stay in the PACU, DSU and the hospital.
    

Intervention name(s): Caffeine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.; Children in group two will receive an amount of normal saline equal to Caffeine
Other intervention name(s): Saline
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obstructive Sleep Apnea (OSA); Tonsillectomy and Adenoidectomy (T&A); Postoperative Complications; Recovery
Ventricular Volume as Assessed by Cardiac Magnetic Resonance
Condition: Arrhythmogenic Right Ventricular Cardiomyophathy (ARVC)
Study type: Observational

Summary: 
      One of the many uses of cardiac magnetic resonance (CMR) is the assessment of right
      ventricular (RV) volumes. There are a number of congenital heart defects and acquired
      conditions in which management decisions are fundamentally based on ventricular volumes. The
      "gold standard" for assessment of RV volume is CMR. It has better near-field resolution than
      echo and excellent contrast between the blood pool and the myocardium. CMR is more suitable
      to the irregular geometry of the RV. The objectives of this study are (1) to assess
      ventricular volumes in the fasting state and after oral hydration in order to assess the
      effect of fluid status on ventricular volumes as measured by CMR; (2) to evaluate the effect
      of hydration on ventricular volumes compared the effect of with inter-observer and
      intra-observer variability, and; (3) to evaluate the effects of chamber volume on chamber
      deformation, including strain and peak strain rate. This study hypothesizes that (1)
      hydration status has an effect on right and left heart volumes, measured by CMR in healthy
      volunteers; (2) the effect of volume status will be a more significant contributor to
      variability in RV volumetry than that of inter-observer variability and intra-observer
      variability, and; (3) atrial and Ventricular deformation corrected for chamber size or volume
      is more accurate than when uncorrected for volume.
    

Detailed description: 
      1. To assess ventricular volumes in the fasting state and after oral hydration in order to
           assess the effect of fluid status on ventricular volumes as measured by CMR.

        2. To evaluate the effect of hydration on ventricular volumes compared the effect of with
           inter-observer and intra-observer variability.

        3. To evaluate the effects of chamber volume on chamber deformation, including strain and
           peak strain rate.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Staff from the Heart Centre at The Hospital for Sick Children will be sent an email
        notifying them of the study. They will be invited to obtain the particulars of the study by
        replying to Dr. Daryl Schantz or Dr. Lars Grosse-Wortmann. If they agree to participate Dr.
        Schantz will obtain written informed consent.
      
Keywords: Ventricular Volume; Cardiac Magnetic Resonance; Echocardiogram
Rivaroxaban Versus Low-molecular-weight Heparin for Preventing Thrombosis in Cancer Patients
Condition: Neoplasms
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is designed to compare the efficacy and safety of oral rivaroxaban and subcutaneous
      low-molecular-weight heparin in preventing femoral venepuncture associated thrombosis among
      cancer patients.
    


Intervention name(s): Rivaroxaban 10 MG; Rivaroxaban 20 MG; Low-molecular-weight heparin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture; Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture; 0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)
Intervention MeSH terms: Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Impact of Muscle Fat Accumulation on the Genomic Profile of Skeletal Muscle in Older Adults
Condition: Intermuscular Adipose Tissue Quantification
Study type: Observational

Summary: 
      Subjects were asked to come to the Purdue facilities after an overnight fast on 2 different
      testing days for 2.5 hours each day. On one day the subjects participated in blood pressure
      and body weight measurements as well as a muscle biopsy from the thigh. On the second day the
      subjects underwent an MRI and MRS scan of the thigh and calf.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        normal weight and obese older adults
      
Biospecimen description: 
      muscle tissue, RNA
Evaluation of the Effect of Saffron (Crocus Sativus) on Pain Control After Root Canal Therapy in Teeth With Vital Pulps
Condition: Post-treatment Pain Following Root Canal Therapy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether saffron is effective in the pain control
      after root canal therapy in vital teeth.
    

Detailed description: 
      Among patients refer to endodontics department of Zahedan Faculty of Dentistry whom with
      moderate to severe pain in a single canal tooth will be selected and randomly divided in 2
      groups of saffron and placebo. After root canal therapy each patient in each group will
      receive a box of 8 similar capsules. They will use 1 capsule exactly after treatment
      completion and then each 6 hours up to 48 hours. Patients will record their pain intensity in
      each time period according to Visual Analog Scale(VAS)and finally mean pain intensity will be
      compared between 2 groups.
    

Intervention name(s): starch; saffron
Intervention type(s): Other; Other
Intervention description(s): 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day); 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
Other intervention name(s): Crocus sativus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; root canal therapy
Analysis of GERD Symptoms Using Gastroesophageal Reflux Impact Score Questionnaire for Quality of Life
Condition: Reflux Esophagitis (RE); Non-erosive Reflux Disease (NERD); Functional Heartburn (FH)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Esophagitis; Heartburn
Study type: Observational

Summary: 
      Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final
      diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even
      functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal
      symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the
      measurement of GERD symptoms and response of proton pump inhibitor in short time. Several
      questionnaires have been made for the assessment of GERD symptoms in recent years However,
      their screening tools do not include the impact of symptoms on everyday life and take a long
      time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been
      developed to compensate for this. It is a simple, one-page, questionnaire to communicate to
      the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing
      that it might also prompt clinicians to make appropriate treatment for patients' symptoms.
      However, there was no report regarding comparison of the characteristics and response to PPI
      in RE, NERD and FH groups using GIS questionnaire so far.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final
        diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even
        functional heartburn (FH).
Isokinetic Performance and Function After Total Hip Arthroplasty
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      There are ongoing debates on the effects of the surgical approach on outcome after total hip
      arthroplasty. It was hypothesized that with the anterolateral approach, trauma to the
      abductor arm can be occured and related detrimental effects can diminish the post-operative
      outcomes. In this first randomized controlled trial in the literature on this subject,
      isokinetic performance and patient-reported functional outcomes were evaluated in patients
      undergoing total hip arthroplasty. with a posterior approach (PA) and a anterolateral
      approach (ALA), at 6 and 12 months postoperatively.
    

Detailed description: 
      Patients undergoing total hip arthroplasty are randomized to posterior approach (PA) and
      anterolateral approach (ALA) groups. The patients are evaluated preoperatively and at 6 and
      12 months postoperatively, with flexion, extension and abduction strength measurements and
      the Harris Hip Score (HHS). The physiatrist performing isokinetic tests and the patients are
      blinded to the study groups.All data are calculated as mean and standard deviation values.
      The Student's t-test is used for statistical analysis of the patient data. Statistical
      calculations are performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows,
      Version 22.0. Armonk, NY, USA).
    

Intervention name(s): hip arthroplasty
Intervention type(s): Procedure
Intervention description(s): two different approaches of total hip arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: anterolateral approach; posterior approach; isokinetic test
A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas
Condition: Newly Diagnosed High-Grade Gliomas; Diffuse Intrinsic Pontine Glioma
MeSH terms: Glioma; Diffuse Intrinsic Pontine Glioma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The outcome for children with high-grade gliomas and diffuse intrinsic brainstem gliomas
      remains poor despite the use of multi-modal therapy with surgery, radiation therapy and
      chemotherapy.
    

Detailed description: 
      Novel therapies are needed to improve the outcome of these children. Recent studies have
      demonstrated very promising results of treatment with bevacizumab/irinotecan in patients with
      recurrent high grade gliomas. Based on these promising results, and the tolerability of the
      irinotecan and bevacizumab in children with recurrent CNS malignancies both anecdotally and
      in a study conducted by the Pediatric Brain Tumor Consortium, we have designed a novel study
      incorporating concurrent radiation therapy with bevacizumab ± temozolomide followed by
      bevacizumab, irinotecan ±temozolomide in patients with newly diagnosed high-grade gliomas and
      diffuse intrinsic pontine gliomas.
    

Intervention name(s): Temozolomide; Bevacizumab; Irinotecan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): High Grade Glioma Temozolomide during radiotherapy: 90mg/m2/day PO daily (for patients ≤ 18 years of age); 75mg/m2/day PO daily (for patients ≥ 19 years of age); must begin by Day 5 of radiotherapy for a total of 42 days consecutively.
High Grade Glioma Temozolomide during maintenance chemotherapy: 150mg/m2/day PO on Days 1-5.; High Grade Glioma Bevacizumab during radiotherapy: 10 mg/kg as a 90 minute infusion on Day 22 (± 2 days)and Day 36 (± 2 days) of radiotherapy.
High Grade Glioma Bevacizumab during maintenance chemotherapy:10 mg/kg as a 90 minute infusion on Day 1 (+ 2 days)and Day 15 (± 2 days) of each course.
Diffuse Intrinsic Pontine Gliomas Bevacizumab during radiotherapy: 10 mg/kg as a 90 minute infusion on Days 1 (+ 2 days),15, 29, and 43(±2 days for all 3 doses) of radiotherapy.
Diffuse Intrinsic Pontine Gliomas Bevacizumab during maintenance chemotherapy: 10 mg/kg as a 90 minute infusion on Day 1 (+2 days)and 15 (±2 days).; High Grade Glioma Irinotecan during maintenance chemotherapy:125 mg/m2/day IV over 90 minutes on Days 1 (+ 2 days)and 15 (±2 days) of each course, given no sooner than one hour after temozolomide on Day 1.
Diffuse Intrinsic Pontine Gliomas Irinotecan maintenance chemotherapy: 125 mg/m2/day IV on Day 1 (+2 days)and Day 15 (±2 days).
Other intervention name(s): Temodar; Avastin; Camptosar
Intervention MeSH terms: Bevacizumab; Irinotecan; Temozolomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Short Term Refractive and Ocular Parameter Changes After Topical Atropine
Condition: Myopia, Left Eye
MeSH terms: Myopia
Study type: Interventional

Summary: 
      In order we had designed a prospective clinical trial. Spherical equivalent refractive error
      (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and
      intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125%
      atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated,
      and their correlations were analyzed with multiple linear regression models.
    


Intervention name(s): 0.125% Atropine
Intervention type(s): Drug
Intervention description(s): patients used 0.125% atropine eyedrop per night before sleep for 7 days.
Intervention MeSH terms: Atropine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atropine; cycloplegia; refraction; axial length; anterior chamber depth